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APPROVED

DRUG

PRODUCTS

WITH

THERAPEUTIC

EQUIVALENCE

EVALUATIONS

30th EDITION

THE PRODUCTS IN THIS LIST HAVE BEEN APPROVED UNDER


SECTION 505 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF PHARMACEUTICAL SCIENCE


OFFICE OF GENERIC DRUGS

2010
APPROVED DRUG PRODUCTS

with

THERAPEUTIC EQUIVALENCE EVALUATIONS

The products in this list have been approved under section 505 of the
Federal Food, Drug, and Cosmetic Act. This volume is current through
December 31, 2009.

30th EDITION

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF PHARMACEUTICAL SCIENCE

OFFICE OF GENERIC DRUGS

2010

FOOD AND DRUG ADMINISTRATION


CENTER FOR DRUG EVALUATION AND RESEARCH
APPROVED DRUG PRODUCTS

with

Therapeutic Equivalence Evaluations

CONTENTS
PAGE

PREFACE TO THIRTIETH EDITION………………………………...…………..….......iv

1 INTRODUCTION...................................................................................................................vi

1.1 Content and Exclusion......................................................................................................vi


1.2 Therapeutic Equivalence-Related Terms .........................................................................vi


1.3 Statistical Criteria for Bioequivalence ............................................................................. viii


1.4 Reference Listed Drug.......................................................................................................x


1.5 General Policies and Legal Status ....................................................................................x


1.6 Practitioner/User Responsibilities.....................................................................................xi


1.7 Therapeutic Equivalence Evaluations Codes ................................................................. xiii


1.8 Description of Special Situations .....................................................................................xx


1.9 Therapeutic Equivalence Code Change for a Drug Entity............................................. xxii


1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product ..................... xxii

1.11 Discontinued Section.................................................................................................... xxiii


1.12 Changes to the Orange Book ....................................................................................... xxiii


1.13 Availability of the Edition............................................................................................... xxiii

2 HOW TO USE THE DRUG PRODUCTS LISTS ..............................................................2-1

2.1 Key Sections for Using the Drug Product Lists …………………….….………………......2-1

2.2 Drug Product Illustration ……………………………………………..….…………….……..2-3

2.3 Therapeutic Equivalence Evaluations Illustration ………………….….…………..………2-4

DRUG PRODUCT LISTS

Prescription Drug Product List ……………………………………….…………….………………...3-1

OTC Drug Product List ……………………………………………….…………….…………………4-1

Drug Products with Approval under Section 505 of the Act Administered

by the Center for Biologics Evaluation and Research List ...……….…….………………...5-1

Discontinued Drug Product List .…………………………………………….…….………………....6-1

Orphan Products Designations and Approvals List …………….………….…….………………..7-1

Drug Products Which Must Demonstrate in vivo Bioavailability

Only if Product Fails to Achieve Adequate Dissolution …………………..………………………..8-1

APPENDICES
A. Product Name Index ……….…...………………………….………..……………………A-1
B. Product Name Index Listed by Applicant ………………….……..……………………..B-1

C. Uniform Terms …………………………………………….………..…………...………...C-1

PATENT AND EXCLUSIVITY INFORMATION ADDENDUM ……….……..………………..........AD1

A. Patent and Exclusivity Lists …………………………….…..……..……………..……ADA1


B. Patent and Exclusivity Terms ...……………………….….………...…………………ADB1

iii
FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

APPROVED DRUG PRODUCTS

with

Therapeutic Equivalence Evaluations


PREFACE TO THIRTIETH EDITION


The publication, Approved Drug Products with Therapeutic Equivalence
Evaluations (the List, commonly known as the Orange Book), identifies drug
products approved on the basis of safety and effectiveness by the Food and
Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the
Act). Drugs on the market approved only on the basis of safety (covered by
the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal®
Tablets and Librax® Capsules] or pre-1938 drugs [e.g., Phenobarbital
Tablets]) are not included in this publication. The main criterion for the
inclusion of any product is that the product is the subject of an application
with an effective approval that has not been withdrawn for safety or efficacy
reasons. Inclusion of products on the List is independent of any current
regulatory action through administrative or judicial means against a drug
product. In addition, the List contains therapeutic equivalence evaluations
for approved multisource prescription drug products. These evaluations have
been prepared to serve as public information and advice to state health
agencies, prescribers, and pharmacists to promote public education in the area
of drug product selection and to foster containment of health care costs.
Therapeutic equivalence evaluations in this publication are not official FDA
actions affecting the legal status of products under the Act.

Background of the Publication. To contain drug costs, virtually every


state has adopted laws and/or regulations that encourage the substitution of
drug products. These state laws generally require either that substitution be
limited to drugs on a specific list (the positive formulary approach) or that
it be permitted for all drugs except those prohibited by a particular list
(the negative formulary approach). Because of the number of requests in the
late 1970s for FDA assistance in preparing both positive and negative
formularies, it became apparent that FDA could not serve the needs of each
state on an individual basis. The Agency also recognized that providing a
single list based on common criteria would be preferable to evaluating drug
products on the basis of differing definitions and criteria in various state
laws. As a result, on May 31, 1978, the Commissioner of the Food and Drug
Administration sent a letter to officials of each state stating FDA's intent
to provide a list of all prescription drug products that are approved by FDA
for safety and effectiveness, along with therapeutic equivalence
determinations for multisource prescription products.

The List was distributed as a proposal in January l979. It included only


currently marketed prescription drug products approved by FDA through new drug
applications (NDAs) and abbreviated new drug applications (ANDAs) under the
provisions of Section 505 of the Act.

The therapeutic equivalence evaluations in the List reflect FDA's


application of specific criteria to the multisource prescription drug products
on the List approved under Section 505 of the Act. These evaluations are
presented in the form of code letters that indicate the basis for the
evaluation made. An explanation of the code appears in the Introduction.

A complete discussion of the background and basis of FDA's therapeutic


equivalence evaluation policy was published in the Federal Register on
January 12, 1979 (44 FR 2932). The final rule, which includes FDA's responses
to the public comments on the proposal, was published in the Federal Register
on October 31, 1980 (45 FR 72582). The first publication, October 1980, of
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the final version of the List incorporated appropriate corrections and
additions. Each subsequent edition has included the new approvals and made
appropriate changes in data.

On September 24, 1984, the President signed into law the Drug Price
Competition and Patent Term Restoration Act (1984 Amendments). The 1984
Amendments require that FDA, among other things, make publicly available a
list of approved drug products with monthly supplements. The Approved Drug
Products with Therapeutic Equivalence Evaluations publication and its monthly
Cumulative Supplements satisfy this requirement. The Addendum to this
publication identifies drugs that qualify under the 1984 Amendments for
periods of exclusivity (during which ANDAs or applications described in
Section 505(b)(2) of the Act for those drugs may not be submitted for a
specified period of time and, if allowed to be submitted, would be tentatively
approved) and provides patent information concerning the listed drugs which
also may delay the approval of ANDAs or Section 505(b)(2) applications. The
Addendum also provides additional information that may be helpful to those
submitting a new drug application to the Agency.

The Agency intends to use this publication to further its objective of


obtaining input and comment on the publication itself and related Agency
procedures. Therefore, if you have comments on how the publication can be
improved, please send them to the Director, Division of Labeling and Program
Support, HFD-610, Office of Generic Drugs, Center for Drug and Evaluation and
Research, 7500 Standish Place, Rockville, MD 20855. Comments received are
publicly available to the extent allowable under the Freedom of Information
regulations.

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1. INTRODUCTION

1.1 Content and Exclusion

The List is composed of four parts: (1) approved prescription drug


products with therapeutic equivalence evaluations; (2) approved
over-the-counter (OTC) drug products for those drugs that may not be marketed
without NDAs or ANDAs because they are not covered under existing OTC
monographs; (3) drug products with approval under Section 505 of the Act
administered by the Center for Biologics Evaluation and Research; and (4) a
cumulative list of approved products that have never been marketed, are for
exportation, are for military use, have been discontinued from marketing, or
have had their approvals withdrawn for other than safety or efficacy reasons
subsequent to being discontinued from marketing.1 This publication also
includes indices of prescription and OTC drug products by trade or established
name (if no trade name exists) and by applicant name (holder of the approved
application). All established names for active ingredients generally conform
to official compendial names or United States Adopted Names (USAN) as
prescribed in (21 CFR 299.4(e)). The latter list includes applicants’ names
as abbreviated in this publication; in addition, a list of uniform terms is
provided.

An Addendum contains drug patent and exclusivity information for the


Prescription, OTC, Discontinued Drug Product Lists, and for the Drug Products
with Approval under Section 505 of the Act Administered by the Center for
Biologics Evaluation and Research. The publication may include additional
information that the Agency deems appropriate to disseminate.

Prior to the 6th Edition, the publication had excluded OTC drug products
and drug products with approval under Section 505 of the Act administered by
the Center for Biologics Evaluation and Research because the main purpose of
the publication was to provide information to states regarding FDA's
recommendation as to which generic prescription drug products were acceptable
candidates for drug product selection. The 1984 Amendments required the
Agency to begin publishing an up-to-date list of all marketed drug products,
OTC as well as prescription, that have been approved for safety and efficacy
and for which new drug applications are required.

Under the 1984 Amendments, some drug products were given tentative
approvals. Prior to the effective date, the Agency will not include drug
products with tentative approval in the List; however, they are available at
http://www.fda.gov/cder/ogd/approvals/default.htm. When the tentative
approval becomes a full approval through a subsequent action letter to the
application holder, the Agency will list the drug product and the final,
effective approval date in the appropriate approved drug product list.

Distributors or repackagers of products on the List are not identified.


Because distributors or repackagers are not required to notify FDA when they
shift their sources of supply from one approved manufacturer to another, it is
not possible to maintain complete information linking product approval with
the distributor or repackager handling the products.

1.2 Therapeutic Equivalence-Related Terms

Pharmaceutical Equivalents. Drug products are considered pharmaceutical


equivalents if they contain the same active ingredient(s), are of the same
dosage form, route of administration and are identical in strength or
concentration (e.g., chlordiazepoxide hydrochloride, 5mg capsules).

1
Newly approved products are added to parts 1, 2, or 3, of the List, depending on the dispensing
requirements (prescription or OTC) or approval authority, unless the Orange Book staff is
otherwise notified before publication.

iii
Pharmaceutically equivalent drug products are formulated to contain the same
amount of active ingredient in the same dosage form and to meet the same or
compendial or other applicable standards (i.e., strength, quality, purity, and
identity), but they may differ in characteristics such as shape, scoring
configuration, release mechanisms, packaging, excipients (including colors,
flavors, preservatives), expiration time, and, within certain limits,
labeling.

Pharmaceutical Alternatives. Drug products are considered pharmaceutical


alternatives if they contain the same therapeutic moiety, but are different
salts, esters, or complexes of that moiety, or are different dosage forms or
strengths (e.g., tetracycline hydrochloride, 250mg capsules vs. tetracycline
phosphate complex, 250mg capsules; quinidine sulfate, 200mg tablets vs.
quinidine sulfate, 200mg capsules). Data are generally not available for FDA
to make the determination of tablet to capsule bioequivalence. Different
dosage forms and strengths within a product line by a single manufacturer are
thus pharmaceutical alternatives, as are extended-release products when
compared with immediate-release or standard-release formulations of the same
active ingredient.

Therapeutic Equivalents. Drug products are considered to be therapeutic


equivalents only if they are pharmaceutical equivalents and if they can be
expected to have the same clinical effect and safety profile when administered
to patients under the conditions specified in the labeling.

FDA classifies as therapeutically equivalent those products that meet the


following general criteria: (1) they are approved as safe and effective; (2)
they are pharmaceutical equivalents in that they (a) contain identical amounts
of the same active drug ingredient in the same dosage form and route of
administration, and (b) meet compendial or other applicable standards of
strength, quality, purity, and identity; (3) they are bioequivalent in that
(a) they do not present a known or potential bioequivalence problem, and they
meet an acceptable in vitro standard, or (b) if they do present such a known
or potential problem, they are shown to meet an appropriate bioequivalence
standard; (4) they are adequately labeled; (5) they are manufactured in
compliance with Current Good Manufacturing Practice regulations. The concept
of therapeutic equivalence, as used to develop the List, applies only to drug
products containing the same active ingredient(s) and does not encompass a
comparison of different therapeutic agents used for the same condition (e.g.,
propoxyphene hydrochloride vs. pentazocine hydrochloride for the treatment of
pain). Any drug product in the List repackaged and/or distributed by other
than the application holder is considered to be therapeutically equivalent to
the application holder's drug product even if the application holder's drug
product is single source or coded as non-equivalent (e.g., BN). Also,
distributors or repackagers of an application holder's drug product are
considered to have the same code as the application holder. Therapeutic
equivalence determinations are not made for unapproved, off-label indications.

FDA considers drug products to be therapeutically equivalent if they meet


the criteria outlined above, even though they may differ in certain other
characteristics such as shape, scoring configuration, release mechanisms,
packaging, excipients (including colors, flavors, preservatives), expiration
date/time and minor aspects of labeling (e.g., the presence of specific
pharmacokinetic information) and storage conditions. When such differences
are important in the care of a particular patient, it may be appropriate for
the prescribing physician to require that a particular brand be dispensed as a
medical necessity. With this limitation, however, FDA believes that products
classified as therapeutically equivalent can be substituted with the full
expectation that the substituted product will produce the same clinical effect
and safety profile as the prescribed product.

Bioavailability. This term means the rate and extent to which the active
ingredient or active moiety is absorbed from a drug product and becomes
available at the site of action. For drug products that are not intended to
be absorbed into the bloodstream, bioavailability may be assessed by

iv
measurements intended to reflect the rate and extent to which the active
ingredient or active moiety becomes available at the site of action.

Bioequivalent Drug Products. This term describes pharmaceutical equivalent


or pharmaceutical alternative products that display comparable bioavailability
when studied under similar experimental conditions. Section 505 (j)(7)(B) of
the Act describes one set of conditions under which a test and reference
listed drug (see Section 1.4) shall be considered bioequivalent:

the rate and extent of absorption of the test drug do not show a
significant difference from the rate and extent of absorption of the
reference drug when administered at the same molar dose of the
therapeutic ingredient under similar experimental conditions in either
a single dose or multiple doses; or

the extent of absorption of the test drug does not show a significant
difference from the extent of absorption of the reference drug when
administered at the same molar dose of the therapeutic ingredient under
similar experimental conditions in either a single dose or multiple
doses and the difference from the reference drug in the rate of
absorption of the drug is intentional, is reflected in its proposed
labeling, is not essential to the attainment of effective body drug
concentrations on chronic use, and is considered medically
insignificant for the drug.

Where these above methods are not applicable (e.g., for drug products that
are not intended to be absorbed into the bloodstream), other in vivo or in
vitro test methods to demonstrate bioequivalence may be appropriate.

Bioequivalence may sometimes be demonstrated using an in vitro


bioequivalence standard, especially when such an in vitro test has been
correlated with human in vivo bioavailability data. In other situations,
bioequivalence may sometimes be demonstrated through comparative clinical
trials or pharmacodynamic studies.

1.3 Statistical Criteria for Bioequivalence

Under the Drug Price Competition and Patent Term Restoration Act of 1984,
manufacturers seeking approval to market a generic drug product must submit
data demonstrating that the drug product is bioequivalent to the pioneer
(innovator) drug product. A major premise underlying the 1984 law is that
bioequivalent drug products are therapeutically equivalent, and therefore,
interchangeable.

Bioavailability refers to the rate and extent to which the active


ingredient or therapeutic ingredient is absorbed from a drug product and
becomes available at the site of drug action (Federal Food, Drug and Cosmetic
Act, section 505(j)(8)). Bioequivalence refers to equivalent release of the
same drug substance from two or more drug products or formulations. This
leads to an equivalent rate and extent of absorption from these formulations.
Underlying the concept of bioequivalence is the thesis that, if a drug product
contains a drug substance that is chemically identical and is delivered to the
site of action at the same rate and extent as another drug product, then it is
equivalent and can be substituted for that drug product. Methods used to
define bioequivalence can be found in 21 CFR 320.24, and include (1)
pharmacokinetic (PK) studies, (2) pharmacodynamic (PD) studies, (3)
comparative clinical trials, and (4) in-vitro studies. The choice of study
used is based on the site of action of the drug and the ability of the study
design to compare drug delivered to that site by the two products.

The standard bioequivalence (PK) study is conducted using a two-treatment


crossover study design in a limited number of volunteers, usually 24 to 36
adults. Alternately, a four-period, replicate design crossover study may also
be used. Single doses of the test and reference drug products are
administered and blood or plasma levels of the drug are measured over time.

v
Pharmacokinetic parameters characterizing rate and extent of drug absorption
are evaluated statistically. The PK parameters of interest are the resulting
area under the plasma concentration-time curve (AUC), calculated to the last
measured concentration (AUC(0-t)) and extrapolated to infinity (AUC(0-inf)), for
extent of absorption; and the maximum or peak drug concentrations (Cmax), for
rate of absorption. Crossover studies may not be practical in drugs with a
long half-life in the body, and a parallel study design may be used instead.
Alternate study methods, such as in-vitro studies or equivalence studies with
clinical or pharmacodynamic endpoints, are used for drug products where plasma
concentrations are not useful to determine delivery of the drug substance to
the site of activity (such as inhalers, nasal sprays and topical products
applied to the skin).

The statistical methodology for analyzing these bioequivalence studies is


called the two one-sided test procedure. Two situations are tested with this
statistical methodology. The first of the two one-sided tests determines
whether a generic product (test), when substituted for a brand-name product
(reference) is significantly less bioavailable. The second of the two one-
sided tests determines whether a brand-name product when substituted for a
generic product is significantly less bioavailable. Based on the opinions of
FDA medical experts, a difference of greater than 20% for each of the above
tests was determined to be significant, and therefore, undesirable for all
drug products. Numerically, this is expressed as a limit of test-product
average/reference-product average of 80% for the first statistical test and a
limit of reference-product average/test-product average of 80% for the second
statistical test. By convention, all data is expressed as a ratio of the
average response (AUC and Cmax) for test/reference, so the limit expressed in
the second statistical test is 125% (reciprocal of 80%).

For statistical reasons, all data is log-transformed prior to conducting


statistical testing. In practice, these statistical tests are carried out
using an analysis of variance procedure (ANOVA) and calculating a 90%
confidence interval for each pharmacokinetic parameter (Cmax and AUC). The
confidence interval for both pharmacokinetic parameters, AUC and Cmax, must be
entirely within the 80% to 125% boundaries cited above. Because the mean of
the study data lies in the center of the 90% confidence interval, the mean of
the data is usually close to 100% (a test/reference ratio of 1). Different
statistical criteria are sometimes used when bioequivalence is demonstrated
through comparative clinical trials pharmacodynamic studies, or comparative
in-vitro methodology.

The bioequivalence methodology and criteria described above simultaneously


control for both, differences in the average response between test and
reference, as well as the precision with which the average response in the
population is estimated. This precision depends on the within-subject (normal
volunteer or patient) variability in the pharmacokinetic parameters (AUC and
Cmax) of the two products and on the number of subjects in the study. The
width of the 90% confidence interval is a reflection in part of the within-
subject variability of the test and reference products in the bioequivalence
study. A test product with no differences in the average response when
compared to the reference might still fail to pass the bioequivalence criteria
if the variability of one or both products is high and the bioequivalence
study has insufficient statistical power (i.e., insufficient number of
subjects). Likewise, a test product with low variability may pass the
bioequivalence criteria, when there are somewhat larger differences in the
average response.

This system of assessing bioequivalence of generic products assures that


these substitutable products do not deviate substantially in in-vivo
performance from the reference product. The Office of Generic Drugs has
conducted two surveys to quantify the differences between generic and brand
name products. The first survey included 224 bioequivalence studies submitted
in approved applications during 1985 and 1986. The observed average
differences between reference and generic products for AUC was 3.5% (JAMA,
Sept. 4, 1987, Vol. 258, No. 9). The second survey included 127
bioequivalence studies submitted to the agency in 273 ANDAs approved in 1997.

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The three measures reviewed include AUC(0-t), AUC(0-inf), and Cmax. The observed
average differences between the reference and generic products were + 3.47%
(SD 2.84) for AUC(0-t), + 3.25% (SD 2.97) for AUC(0-inf), and + 4.29% (SD 3.72)
for Cmax (JAMA, Dec. 1, 1999, Vol. 282, No. 21).

The primary concern from the regulatory point of view is the protection of
the patient against approval of products that are not bioequivalent. The
current practice of carrying out two one-sided tests at the 0.05 level of
significance ensures that there is no more than a 5% chance that a generic
product that is not truly equivalent to the reference will be approved.

1.4 Reference Listed Drug

A reference listed drug (21 CFR 314.94(a)(3)) means the listed drug
identified by FDA as the drug product upon which an applicant relies in
seeking approval of its ANDA.

FDA has identified in the Prescription Drug Product and OTC Drug Product
Lists those reference listed drugs to which the in vivo bioequivalence
(reference standard) and, in some instances, the in vitro bioequivalence of
the applicant's product is compared. By designating a single reference listed
drug as the standard to which all generic versions must be shown to be
bioequivalent, FDA hopes to avoid possible significant variations among
generic drugs and their brand name counterpart. Such variations could result
if generic drugs were compared to different reference listed drugs. However,
in some instances when listed drugs are approved for a single drug product, a
product not designated as the reference listed drug and not shown to be
bioequivalent to the reference listed drug may be shielded from generic
competition. A firm wishing to market a generic version of a listed drug that
is not designated as the reference listed drug may petition the Agency through
the Citizen Petition procedure (see 21 CFR 10.25(a) and CFR 10.30). When the
Citizen Petition is approved, the second listed drug will be designated as an
additional reference listed drug and the petitioner may submit an Abbreviated
New Drug Application citing the designated reference listed drug. Section
1.7, Therapeutic Equivalence Evaluations Codes products meeting necessary
bioequivalence requirements explains the (AB, AB1, AB2, AB3... coding system
for multisource drug products listed under the same heading with two reference
listed drugs.

In addition, there are two situations in which two listed drugs that have
been shown to be bioequivalent to each other may both be designated as
reference listed drugs. The first situation occurs when the in vivo
determination of bioequivalence is self-evident and a waiver of the in vivo
bioequivalence may be granted. The second situation occurs when the
bioequivalence of two listed products may be determined through in vitro
methodology. The reference listed drug is identified by the symbol "+" in the
Prescription and Over-the-Counter (OTC) Drug Product Lists. These identified
reference listed drugs represent the best judgment of the Division of
Bioequivalence at this time. The Prescription and OTC Drug Product Lists
identify reference drugs for oral dosage forms, Injectables, ophthalmics,
otics, and topical products. It is recommended that a firm planning to
conduct an in vivo bioequivalence study, or planning to manufacture a batch of
a drug product for which an in vivo waiver of bioequivalence will be
requested, contact the Division of Bioequivalence, Office of Generic Drugs, to
confirm the appropriate reference listed drug.

1.5 General Policies and Legal Status

The List contains public information and advice. It does not mandate the
drug products which may be purchased, prescribed, dispensed, or substituted
for one another, nor does it, conversely, mandate the products that should be
avoided. To the extent that the List sets forth FDA's evaluations of the
therapeutic equivalence of drug products that have been approved, it contains
FDA's advice to the public, to practitioners and to the states regarding drug
vii
product selection. These evaluations do not constitute determinations that
any product is in violation of the Act or that any product is preferable to
any other. Therapeutic equivalence evaluations are a scientific judgment
based upon evidence, while generic substitution may involve social and
economic policy administered by the states, intended to reduce the cost of
drugs to consumers. To the extent that the List identifies drug products
approved under Section 505 of the Act, it sets forth information that the
Agency is required to publish and that the public is entitled to under the
Freedom of Information Act. Exclusion of a drug product from the List does
not necessarily mean that the drug product is either in violation of Section
505 of the Act, or that such a product is not safe or effective, or that such
a product is not therapeutically equivalent to other drug products. Rather,
the exclusion is based on the fact that FDA has not evaluated the safety,
effectiveness, and quality of the drug product.

1.6 Practitioner/User Responsibilities

Professional care and judgment should be exercised in using the List.


Evaluations of therapeutic equivalence for prescription drugs are based on
scientific and medical evaluations by FDA. Products evaluated as
therapeutically equivalent can be expected, in the judgment of FDA, to have
equivalent clinical effect and no difference in their potential for adverse
effects when used under the conditions of their labeling. However, these
products may differ in other characteristics such as shape, scoring
configuration, release mechanisms, packaging, excipients (including colors,
flavors, preservatives), expiration date/time, and, in some instances,
labeling. If products with such differences are substituted for each other,
there is a potential for patient confusion due to differences in color or
shape of tablets, inability to provide a given dose using a partial tablet if
the proper scoring configuration is not available, or decreased patient
acceptance of certain products because of flavor. There may also be better
stability of one product over another under adverse storage conditions, or
allergic reactions in rare cases due to a coloring or a preservative
ingredient, as well as differences in cost to the patient.

FDA evaluation of therapeutic equivalence in no way relieves practitioners


of their professional responsibilities in prescribing and dispensing such
products with due care and with appropriate information to individual
patients. In those circumstances where the characteristics of a specific
product, other than its active ingredient, are important in the therapy of a
particular patient, the physician's specification of that product is
appropriate. Pharmacists must also be familiar with the expiration
dates/times and labeling directions for storage of the different products,
particularly for reconstituted products, to assure that patients are properly
advised when one product is substituted for another.

Multisource and single-source drug products. FDA has evaluated for


therapeutic equivalence only multisource prescription drug products approved
under Section 505 of the Act, which in most instances means those
pharmaceutical equivalents available from more than one manufacturer. For
such products, a therapeutic equivalence code is included and, in addition,
product information is highlighted in bold face and underlined. Those
products with approved applications that are single-source (i.e., there is
only one approved product available for that active ingredient, dosage form,
route of administration, and strength) are also included on the List, but no
therapeutic equivalence code is included with such products. Any drug product
in the List repackaged and/or distributed by other than the application holder
is considered to be therapeutically equivalent to the application holder's
drug product even if the application holder's drug product is single source or
coded as non-equivalent (e.g., BN). Also, although not identified in the
List, distributors or repackagers of an application holder's drug product are
considered to have the same code as the application holder. The details of
these codes and the policies underlying them are discussed in Section 1.7,
Therapeutic Equivalence Evaluations Codes.

viii
Products on the List are identified by the names of the holders of
approved applications (applicants) who may not necessarily be the manufacturer
of the product. The applicant may have had its product manufactured by a
contract manufacturer and may simply be distributing the product for which it
has obtained approval. In most instances, however, the manufacturer of the
product is also the applicant. The name of the manufacturer is permitted by
regulation to appear on the label, even when the manufacturer is not the
marketer.

Although the products on the List are identified by the names of the
applicants, circumstances, such as changing corporate ownership, have
sometimes made identification of the applicant difficult. The Agency
believes, based on continuing document review and communication with firms,
that the applicant designations on the List are, in most cases, correct.

To relate firm name information on a product label to that on the List,


the following should be noted: the applicant's name always appears on the
List. This applies whether the applicant (firm name on the Form FDA 356h in
the application) is the marketer (firm name in largest letters on the label)
or not. However, the applicant's name may not always appear on the label of
the product.

If the applicant is the marketer, its name appears on the List and on the
label; if the applicant is not the marketer, and the Agency is aware of a
corporate relationship (e.g., parent and subsidiary) between the applicant and
the marketer, the name of the applicant appears on the List and both firm
names may appear on the label. Firms with known corporate relationships are
displayed in Appendix B. If there is no known corporate relationship between
the applicant and the marketer, the applicant's name appears on the List;
however, unless the applicant is the manufacturer, packager, or distributor,
the applicant's name may not appear on the label. In this case, the
practitioner, from labeling alone, will not be able to relate the marketed
product to an applicant cited in the List, and hence to a specific approved
drug product. In such cases, to assure that the product in question is the
subject of an approved application, the firm named on the label should be
contacted.

To relate trade name (proprietary name) information on a product label to


that on the List, the following should be noted: if the applicant is the
marketer, its name appears on the List and on the label; if the Agency is
aware of a corporate relationship between the applicant and the marketer, the
trade name (proprietary name) of the drug product (established drug name if no
trade name exists) appears on the List. If a corporate relationship exists
between an application holder and a marketer and both firms are distributing
the drug product, the FDA reserves the right to select the trade name of
either the marketer or the application holder to appear on the List. If there
is no known corporate relationship between the applicant and the marketer, the
established drug name appears on the List.

Every product on the List is subject at all times to regulatory action.


From time to time, approved products may be found in violation of one or more
provisions of the Act. In such circumstances, the Agency will commence
appropriate enforcement action to correct the violation, if necessary, by
securing removal of the product from the market by voluntary recall, seizure,
or other enforcement actions. Such regulatory actions are, however,
independent of the inclusion of a product on the List. The main criterion for
inclusion of a product is that it has an application with an effective
approval that has not been withdrawn for safety or efficacy reasons. FDA
believes that retention of a violative product on the List will not have any
significant adverse health consequences, because other legal mechanisms are
available to the Agency to prevent the product's actual marketing. FDA may
however, change a product's therapeutic equivalence rating if the
circumstances giving rise to the violation change or otherwise call into
question the data upon which the Agency's assessment of whether a product
meets the criteria for therapeutic equivalence was made.

ix
1.7 Therapeutic Equivalence Evaluations Codes

The coding system for therapeutic equivalence evaluations is constructed


to allow users to determine quickly whether the Agency has evaluated a
particular approved product as therapeutically equivalent to other
pharmaceutically equivalent products (first letter) and to provide additional
information on the basis of FDA's evaluations (second letter). With few
exceptions, the therapeutic equivalence evaluation date is the same as the
approval date.

The two basic categories into which multisource drugs have been placed are
indicated by the first letter as follows:

A Drug products that FDA considers to be therapeutically equivalent to


other pharmaceutically equivalent products, i.e., drug products for which:

(1) there are no known or suspected bioequivalence problems. These are


designated AA, AN, AO, AP, or AT, depending on the dosage form; or

(2) actual or potential bioequivalence problems have been resolved with


adequate in vivo and/or in vitro evidence supporting
bioequivalence. These are designated AB.

B Drug products that FDA at this time, considers not to be


therapeutically equivalent to other pharmaceutically equivalent products,
i.e.,

drug products for which actual or potential bioequivalence problems


have not been resolved by adequate evidence of bioequivalence. Often
the problem is with specific dosage forms rather than with the active
ingredients. These are designated BC, BD, BE, BN, BP, BR, BS, BT, BX,
or B*.

Individual drug products have been evaluated as therapeutically equivalent


to the reference product in accordance with the definitions and policies
outlined below:

"A" CODES

Drug products that are considered to be therapeutically equivalent to other pharmaceutically


equivalent products.

"A" products are those for which actual or potential bioequivalence


problems have been resolved with adequate in vivo and/or in vitro evidence
supporting bio-equivalence. Drug products designated with an "A" code fall
under one of two main policies:

(1) for those active ingredients or dosage forms for which no in vivo
bioequivalence issue is known or suspected, the information necessary to
show bioequivalence between pharmaceutically equivalent products is
presumed and considered self-evident based on other data in the
application for some dosage forms (e.g., solutions) or satisfied for
solid oral dosage forms by a showing that an acceptable in vitro
dissolution standard is met. A therapeutically equivalent rating is
assigned such products so long as they are manufactured in accordance
with Current Good Manufacturing Practice regulations and meet the other
requirements of their approved applications (these are designated AA, AN,
AO, AP, or AT, depending on the dosage form, as described below); or

x
(2) for those DESI drug products containing active ingredients or dosage

forms that have been identified by FDA as having actual or potential

bioequivalence problems, and for post-1962 drug products in a dosage

form presenting a potential bioequivalence problem, an evaluation of

therapeutic equivalence is assigned to pharmaceutical equivalents only

if the approved application contains adequate scientific evidence

establishing through in vivo and/or in vitro studies the bioequivalence

of the product to a selected reference product (these products are

designated as AB).

There are some general principles that may affect the substitution of
pharmaceutically equivalent products in specific cases. Prescribers and
dispensers of drugs should be alert to these principles so as to deal
appropriately with situations that require professional judgment and
discretion.

There may be labeling differences among pharmaceutically equivalent


products that require attention on the part of the health professional. For
example, pharmaceutically equivalent powders to be reconstituted for
administration as oral or injectable liquids may vary with respect to their
expiration time or storage conditions after reconstitution. An FDA evaluation
that such products are therapeutically equivalent is applicable only when each
product is reconstituted, stored, and used under the conditions specified in
the labeling of that product.

The Agency will use notes in this publication to point out special
situations such as potential differences between two drug products that have
been evaluated as bioequivalent and otherwise therapeutically equivalent, when
they should be brought to the attention of health professionals. These notes
are contained in Section 1.8, Description of Special Situations.

For example, in rare instances, there may be variations among


therapeutically equivalent products in their use or in conditions of
administration. Such differences may be due to patent or exclusivity rights
associated with such use. When such variations may, in the Agency's opinion,
affect prescribing or substitution decisions by health professionals, a note
will be added to Section 1.8.

Also, occasionally a situation may arise in which changes in a listed drug


product after its approval (for example, a change in dosing interval) may have
an impact on the substitutability of already approved generic versions of that
product that were rated by the Agency as therapeutically equivalent to the
listed product. When such changes in the listed drug product are considered
by the Agency to have a significant impact on therapeutic equivalence, the
Agency will change the therapeutic equivalence ratings for other versions of
the drug product unless the manufacturers of those other versions of the
product provide additional information to assure equivalence under the changed
conditions. Pending receipt of the additional data, the Agency may add a note
to Section 1.8, or, in rare cases, may even change the therapeutic equivalence
rating.

In some cases (e.g., Isolyte® S w/ Dextrose 5% in Plastic Container and


Plasma-Lyte® 148 and Dextrose 5% in Plastic Container), closely related
products are listed as containing the same active ingredients, but in somewhat
different amounts. In determining which of these products are
pharmaceutically equivalent, the Agency has considered products to be
pharmaceutically equivalent with labeled strengths of an ingredient that do
not vary by more than 1%.

Different salts and esters of the same therapeutic moiety are regarded as
pharmaceutical alternatives. For the purpose of this publication, such
products are not considered to be therapeutically equivalent. There are no
instances in this List where pharmaceutical alternatives are evaluated or
coded with regard to therapeutic equivalence. Anhydrous and hydrated entities,
as well as different polymorphs, are considered pharmaceutical equivalents and
must meet the same standards and, where necessary, as in the case of

xi
ampicillin/ampicillin trihydrate, their equivalence is supported by
appropriate bioavailability/bioequivalence studies.

The codes in this book are not intended to preclude health care
professionals from converting pharmaceutically different concentrations into
pharmaceutical equivalents using accepted professional practice.

Where package size variations have therapeutic implications, products so


packaged have not been considered pharmaceutically equivalent. For example,
some oral contraceptives are supplied in 21-tablet and 28-tablet packets; the
28-tablet packets contain 7 placebo or iron tablets. These two packaging
configurations are not regarded as pharmaceutically equivalent; thus, they are
not designated as therapeutically equivalent.

Preservatives may differ among some therapeutically equivalent drug


products. Differences in preservatives and other inactive ingredients do not
affect FDA's evaluation of therapeutic equivalence except in cases where these
components may influence bioequivalence or routes of administration.

The specific sub-codes for those drugs evaluated as therapeutically


equivalent and the policies underlying these sub-codes follow:

AA Products in conventional dosage forms not presenting bioequivalence problems

Products coded as AA contain active ingredients and dosage forms that are
not regarded as presenting either actual or potential bioequivalence
problems or drug quality or standards issues. However, all oral dosage
forms must, nonetheless, meet an appropriate in vitro bioequivalence
standard that is acceptable to the Agency in order to be approved.

AB, AB1, AB2, AB3... Products meeting necessary bioequivalence requirements

Multisource drug products listed under the same heading (i.e., identical
active ingredients(s), dosage form, and route(s) of administration) and
having the same strength (see Section 1.2, Therapeutic Equivalence-Related
Terms, Pharmaceutical Equivalents) generally will be coded AB if a study
is submitted demonstrating bioequivalence.

In certain instances, a number is added to the end of the AB code to make


a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes
are assigned only in situations when more than one reference listed drug
of the same strength has been designated under the same heading. Two or
more reference listed drugs are generally selected only when there are at
least two potential reference drug products which are not bioequivalent to
each other. If a study is submitted that demonstrates bioequivalence to a
specific listed drug product, the generic product will be given the same
three-character code as the reference listed drug it was compared against.
For example, Adalat® CC (Miles) and Procardia XL® (Pfizer), extended-
release tablets, are listed under the active ingredient nifedipine. These
drug products, listed under the same heading, are not bioequivalent to
each other. Generic drug products deemed by FDA to be bioequivalent to
Adalat® CC and Procardia XL® have been approved, Adalat® CC and Procardia
XL® have been assigned ratings of AB1 and AB2, respectively. The generic
drug products bioequivalent to Adalat® CC would be assigned a rating of
AB1 and those bioequivalent to Procardia XL® would be assigned a rating of
AB2. (The assignment of an AB1 or AB2 rating to a specific product does
not imply product preference.) Even though drug products of distributors
and/or repackagers are not included in the List, they are considered
therapeutically equivalent to the application holder's drug product if the
application holder's drug product is rated either with an AB or three-
character code or is single source in the List. Drugs coded as AB under a
heading are considered therapeutically equivalent only to other drugs
coded as AB under that heading. Drugs coded with a three-character code

xii
under a heading are considered therapeutically equivalent only to other
drugs coded with the same three-character code under that heading.

AN Solutions and powders for aerosolization

Uncertainty regarding the therapeutic equivalence of aerosolized products


arises primarily because of differences in the drug delivery system.
Solutions and powders intended for aerosolization that are marketed for
use in any of several delivery systems are considered to be
pharmaceutically and therapeutically equivalent and are coded AN. Those
products that are compatible only with a specific delivery system or those
products that are packaged in and with a specific delivery system are
coded BN, unless they have met an appropriate bioequivalence standard.
Solutions or suspensions in a specific delivery system will be coded AN if
the bioequivalence standard is based upon in vitro methodology, if
bioequivalence needs to be demonstrated by in vivo methodology then the
drug products will be coded AB.

AO Injectable oil solutions

The absorption of drugs in injectable (parenteral) oil solutions may vary


substantially with the type of oil employed as a vehicle and the
concentration of the active ingredient. Injectable oil solutions are
therefore considered to be pharmaceutically and therapeutically equivalent
only when the active ingredient, its concentration, and the type of oil
used as a vehicle are all identical.

AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous


solutions

It should be noted that even though injectable (parenteral) products under


a specific listing may be evaluated as therapeutically equivalent, there
may be important differences among the products in the general category,
Injectable; Injection. For example, some injectable products that are
rated therapeutically equivalent are labeled for different routes of
administration. In addition, some products evaluated as therapeutically
equivalent may have different preservatives or no preservatives at all.
Injectable products available as dry powders for reconstitution,
concentrated sterile solutions for dilution, or sterile solutions ready
for injection are pharmaceutical alternative drug products. They are not
rated as therapeutically equivalent (AP) to each other even if these
pharmaceutical alternative drug products are designed to produce the same
concentration prior to injection and are similarly labeled. Consistent
with accepted professional practice, it is the responsibility of the
prescriber, dispenser, or individual administering the product to be
familiar with a product's labeling to assure that it is given only by the
route(s) of administration stated in the labeling.

Certain commonly used large volume intravenous products in glass


containers are not included on the List (e.g., dextrose injection 5%,
dextrose injection 10%, sodium chloride injection 0.9%) since these
products are on the market without FDA approval and the FDA has not
published conditions for marketing such parenteral products under approved
NDAs. When packaged in plastic containers, however, FDA regulations
require approved applications prior to marketing. Approval then depends
on, among other things, the extent of the available safety data involving
the specific plastic component of the product. All large volume
parenteral products are manufactured under similar standards, regardless
of whether they are packaged in glass or plastic. Thus, FDA has no reason
to believe that the packaging container of large volume parenteral drug
products that are pharmaceutically equivalent would have any effect on
their therapeutic equivalence.
xiii
The strength of parenteral drugs products is defined as the total drug
content of the container. Until recently the strength of liquid
parenteral drug products in the Orange Book have not been displayed. The
concentration of the liquid parenteral drug product in the Orange Book has
been shown as xmg/ml. The amount of dry powder or freeze dried powder in
a container has always been identified as the strength.

With the finalization of the Waxman-Hatch amendments that characterized


each strength of a drug product as a listed drug, it became evident that
the format of the Orange Book should be changed to reflect each strength
of a parenteral solution. To this end the OGD has started to display the
strength of all new approvals of parenteral solutions. Previously we
would have displayed only the concentration of an approved parenteral
solution, e.g. 50mg/ml. If this drug product had a 20 ml and 60 ml
container approved the two products would be shown as 1Gm / 20ml (50mg/ml)
and 3Gm / 60ml (50mg/ml).

AT Topical products

There are a variety of topical dosage forms available for dermatologic,


ophthalmic, otic, rectal, and vaginal administration, including creams,
gels, lotions, oils, ointments, pastes, solutions, sprays and
suppositories. Even though different topical dosage forms may contain the
same active ingredient and potency, these dosage forms are not considered
pharmaceutically equivalent. Therefore, they are not considered
therapeutically equivalent. All solutions and DESI drug products
containing the same active ingredient in the same topical dosage form for
which a waiver of in vivo bioequivalence has been granted and for which
chemistry and manufacturing processes are adequate to demonstrate
bioequivalence, are considered therapeutically equivalent and coded AT.
Pharmaceutically equivalent topical products that raise questions of
bioequivalence, including all post-1962 non-solution topical drug
products, are coded AB when supported by adequate bioequivalence data, and
BT in the absence of such data.

"B" CODES

Drug products that FDA, at this time, considers not to be therapeutically equivalent to other
pharmaceutically equivalent products.

"B" products, for which actual or potential bioequivalence problems have


not been resolved by adequate evidence of bioequivalence, often have a problem
with specific dosage forms rather than with the active ingredients. Drug
products designated with a "B" code fall under one of three main policies:

(1) the drug products contain active ingredients or are manufactured in


dosage forms that have been identified by the Agency as having
documented bio-equivalence problems or a significant potential for
such problems and for which no adequate studies demonstrating
bioequivalence have been submitted to FDA; or

(2) the quality standards are inadequate or FDA has an insufficient basis
to determine therapeutic equivalence; or

(3) the drug products are under regulatory review.

The specific coding definitions and policies for the "B" sub-codes are as
follows:

xiv
B* Drug products requiring further FDA investigation and review to determine therapeutic
equivalence

The code B* is assigned to products previously assigned an A or B code


when FDA receives new information that raises a significant question
regarding therapeutic equivalence that can be resolved only through
further Agency investigation and/or review of data and information
submitted by the applicant. The B* code signifies that the Agency will
take no position regarding the therapeutic equivalence of the product
until the Agency completes its investigation and review.

BC Extended-release dosage forms (capsules, injectables and tablets)

Extended-release tablets are formulated in such a manner as to make the


contained medicament available over an extended period of time following
ingestion.

Although bioavailability studies have been conducted on these dosage


forms, they may be subject to bioavailability differences, primarily
because firms developing extended-release products for the same active
ingredient rarely employ the same formulation approach. FDA, therefore,
does not consider different extended-release dosage forms containing the
same active ingredient in equal strength to be therapeutically equivalent
unless equivalence between individual products in both rate and extent has
been specifically demonstrated through appropriate bioequivalence studies.
Extended-release products for which such bioequivalence data have not been
submitted are coded BC, while those for which such data are available have
been coded AB.

BD Active ingredients and dosage forms with documented bioequivalence problems

The BD code denotes products containing active ingredients with known


bioequivalence problems and for which adequate studies have not been
submitted to FDA demonstrating bioequivalence. Where studies showing
bioequivalence have been submitted, the product has been coded AB.

BE Delayed-release oral dosage forms

Where the drug may be destroyed or inactivated by the gastric juice or


where it may irritate the gastric mucosa, the use of “enteric” coatings is
indicated. Such coatings are intended to delay the release of the
medication until the tablet has passed through the stomach. Drug products
in delayed-release dosage forms containing the same active ingredients are
subject to significant differences in absorption. Unless otherwise
specifically noted, the Agency considers different delayed-release
products containing the same active ingredients as presenting a potential
bioequivalence problem and codes these products BE in the absence of
in vivo studies showing bioequivalence. If adequate in vivo studies have
demonstrated the bioequivalence of specific delayed-release products, such
products are coded AB.

BN Products in aerosol-nebulizer drug delivery systems

This code applies to drug solutions or powders that are marketed only as a
component of, or as compatible with, a specific drug delivery system.
There may, for example, be significant differences in the dose of drug and
particle size delivered by different products of this type. Therefore,
the Agency does not consider different metered aerosol dosage forms
containing the same active ingredient(s) in equal strengths to be
therapeutically equivalent unless the drug products meet an appropriate
bioequivalence standard, such products are coded AB.

xv
BP Active ingredients and dosage forms with potential bioequivalence problems

FDA's bioequivalence regulations (21 CFR 320.33) contain criteria and


procedures for determining whether a specific active ingredient in a
specific dosage form has a potential for causing a bioequivalence problem.
It is FDA's policy to consider an ingredient meeting these criteria as
having a potential bioequivalence problem even in the absence of positive
data demonstrating inequivalence. Pharmaceutically equivalent products
containing these ingredients in oral dosage forms are coded BP until
adequate in vivo bioequivalence data are submitted, such products are
coded AB. Injectable suspensions containing an active ingredient
suspended in an aqueous or oleaginous vehicle have also been coded BP.
Injectable suspensions are subject to bioequivalence problems because
differences in particle size, polymorphic structure of the suspended
active ingredient, or the suspension formulation can significantly affect
the rate of release and absorption. FDA does not consider pharmaceutical
equivalents of these products bioequivalent without adequate evidence of
bioequivalence, such products would be coded AB.

BR Suppositories or enemas that deliver drugs for systemic absorption

The absorption of active ingredients from suppositories or enemas that are


intended to have a systemic effect (as distinct from suppositories
administered for local effect) can vary significantly from product to
product. Therefore, FDA considers pharmaceutically equivalent systemic
suppositories or enemas bio-equivalent only if in vivo evidence of
bioequivalence is available. In those cases where in vivo evidence is
available, the product is coded AB. If such evidence is not available,
the products are coded BR.

BS Products having drug standard deficiencies

If the drug standards for an active ingredient in a particular dosage form


are found by FDA to be deficient so as to prevent an FDA evaluation of
either pharmaceutical or therapeutic equivalence, all drug products
containing that active ingredient in that dosage form are coded BS. For
example, if the standards permit a wide variation in pharmacologically
active components of the active ingredient such that pharmaceutical
equivalence is in question, all products containing that active ingredient
in that dosage form are coded BS.

BT Topical products with bioequivalence issues

This code applies mainly to post-1962 dermatologic, ophthalmic, otic,


rectal, and vaginal products for topical administration, including creams,
ointments, gels, lotions, pastes, and sprays, as well as suppositories not
intended for systemic drug absorption. Topical products evaluated as
having acceptable clinical performance, but that are not bioequivalent to
other pharmaceutically equivalent products or that lack sufficient
evidence of bioequivalence, will be coded BT.

BX Drug products for which the data are insufficient to determine therapeutic equivalence

The code BX is assigned to specific drug products for which the data that
have been reviewed by the Agency are insufficient to determine therapeutic
equivalence under the policies stated in this document. In these
situations, the drug products are presumed to be therapeutically

xvi
inequivalent until the Agency has determined that there is adequate
information to make a full evaluation of therapeutic equivalence.

1.8 Description of Special Situations

Certain drugs listed in the Orange Book present special situations that
merit further discussion. Following is a description of those special
situations:

Amino Acid and Protein Hydrolysate Injections. These products differ in


the amount and kinds of amino acids they contain and, therefore, are not
considered pharmaceutical equivalents. For this reason, these products are
not considered therapeutically equivalent. At the same time, the Agency
believes that it is appropriate to point out that where nitrogen balance is
the sole therapeutic objective and individual amino acid content is not a
consideration, pharmaceutical alternatives with the same total amount of
nitrogen content may be considered therapeutically equivalent.

Follitropin Alfa and Beta. Based on available data derived from physico­
chemical tests and bioassay, follitropin alfa and follitropin beta are
indistinguishable.

Gaviscon®. Gaviscon® is an OTC product which has been marketed since


September 1970. The active ingredients in this product, aluminum hydroxide
and magnesium trisilicate, were reviewed by the Agency's OTC Antacid Panel and
were considered to be safe and effective ingredients (Category I) by that
Panel. However, the tablet failed to pass the antacid test which is required
of all antacid products. The Agency, therefore, placed the tablet in Category
III for lack of effectiveness. A full NDA with clinical studies was submitted
by Marion Laboratories, Inc., and approved by FDA on December 9, 1983.
Gaviscon®’s activity in treating reflux acidity is made possible by the
physical-chemical properties of the inactive ingredients, sodium bicarbonate
and alginic acid. Therefore, all ANDAs which cite Gaviscon® tablets as the
listed drug must contain the inactive ingredients sodium bicarbonate and
alginic acid. A full NDA will be required to support the effectiveness of the
drug product if different inactive ingredients are to be substituted for
sodium bicarbonate or alginic acid or if different proportions of these
ingredients are to be used.

Levothyroxine Sodium. Because there are multiple reference listed drugs


of levothyroxine sodium tablets and some reference listed drugs' sponsors have
conducted studies to establish their drugs' therapeutic equivalence to other
reference listed drugs, FDA has determined that its usual practice of
assigning two or three character TE codes may be potentially confusing and
inadequate for these drug products. Accordingly, FDA provides the following
explanation and chart of therapeutic equivalence evaluations for levothyroxine
sodium drug products.

Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be


therapeutically equivalent to corresponding strengths of Unithroid (Jerome
Stevens NDA 021210) tablets.

Levo-T (Alara NDA 021342), Levothyroxine Sodium (Mylan ANDA 76187), Unithroid
(Jerome Stevens NDA 021210), and Levothyroxine Sodium (Merck KGAA ANDA
76752)tablets have been determined to be therapeutically equivalent to
corresponding strengths of Synthroid (Abbott NDA 021402) tablets.

Levo-T (Alara NDA 021342), Unithroid (Jerome Stevens NDA 021210),


Levothyroxine Sodium (Mylan ANDA 076187), and Levothyroxine Sodium (Merck KGAA
ANDA 76752) tablets have been determined to be therapeutically equivalent to
corresponding strengths of Levoxyl (King Pharms NDA 021301) tablets.

Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be


therapeutically equivalent to corresponding strengths of Levothroid (Lloyd NDA
021116) tablets.
xvii
The chart outlines TE codes for all 0.025mg products with other products being
similar. Therapeutic equivalence has been established between products that
have the same AB+number TE code. More than one TE code may apply to some
products. One common TE code indicates therapeutic equivalence between
products.

TE Appl Product
Trade Name Applicant Potency
Code No No
UNITHROID STEVENS J 0.025MG AB1 21210 001
LEVOTHYROXINE SODIUM MYLAN 0.025MG AB1 76187 001
LEVOXYL KING PHARMS 0.025MG AB1 21301 001
SYNTHROID ABBOTT 0.025MG AB1 21402 001

SYNTHROID ABBOTT 0.025MG AB2 21402 001


LEVOTHYROXINE SODIUM MYLAN 0.025MG AB2 76187 001
LEVO-T ALARA PHARM 0.025MG AB2 21342 001
UNITHROID STEVENS J 0.025MG AB2 21210 001
LEVOTHYROXINE SODIUM MERCK KGAA 0.025MG AB2 76752 001

LEVOXYL KING PHARMS 0.025MG AB3 21301 001


LEVO-T ALARA PHARM 0.025MG AB3 21342 001
UNITHROID STEVENS J 0.025MG AB3 21210 001
LEVOTHYROXINE SODIUM MYLAN 0.025MG AB3 76187 001
LEVOTHYROXINE SODIUM MERCK KGAA 0.025MG AB3 76752 001

LEVOTHROID LLOYD 0.025MG AB4 21116 001


LEVOTHYROXINE SODIUM MYLAN 0.025MG AB4 76187 001

Patent Certification(s) Reference Listed Drug based upon a suitability


petition. An abbreviated new drug application that refers to a Reference
Listed Drug (RLD) approved pursuant to a suitability petition must demonstrate
that the proposed product is bioequivalent to the RLD, and it must include
appropriate patent certification(s) and an exclusivity statement with respect
to the listed drug which served as the basis for the approved suitability
petition. This concept also applies to an ANDA applicant that cites a RLD
that was based upon an NDA that is still covered by patent (s) and/or
exclusivity, e.g. a second RLD that was selected when the in vivo
determination of bioequivalence of the original RLD is self evident and the
waiver of the in vivo determination of bioequivalence may be granted.

Waived exclusivity. If a new drug application (NDA) submitted under


section 505(b) of the Federal Food, Drug, and Cosmetic Act (Act) qualifies for
exclusivity under sections 505(c)(3)(D) and 505(j)(5)(D), the exclusivity is
listed in the Patent and Exclusivity Section of the Orange Book. If a drug
product has received this exclusivity, the FDA will delay the approval of a
505(b)(2) application or an abbreviated new drug application (ANDA) under
section 505(j) of the Act until the expiration of the exclusivity. If the
listed drug is also protected by one or more patents, the approval date for
the 505(b)(2) application or ANDA will be determined by the latest expiring
patent or exclusivity listed in the Orange Book. However, the holder of the
NDA may waiver its exclusivity as to any or all 505(b)(2) and ANDA
applications referencing the protected drug product. If an NDA sponsor
waivers its right to the exclusivity protection, qualified 505(b)(2) or ANDA
applications may be approved without regard to the NDA holder's exclusivity.
An NDA for which the holder has waived its exclusivity as to all 505(b)(2) and
ANDA applications will be coded with a W in the Patent and Exclusivity Section
of the Orange Book and be referred to this section. The applicant referencing
xviii
this listed drug should indicate in the exclusivity statement that the holder
of the listed drug has waived its exclusivity.

1.9 Therapeutic Equivalence Code Change for a Drug Entity

The Agency will use the following procedures when, in response to a


petition or on its own initiative, it is considering a change in the
therapeutic equivalence code for approved multi-source drug products. Such
changes will generally occur when the Agency becomes aware of new scientific
information affecting the therapeutic equivalence of an entire category of
drug products in the List (e.g., information concerning the active ingredient
or the dosage form), rather than information concerning a single drug product
within the category. These procedures will be used when a change in
therapeutic equivalence code is under consideration for all drug products
found in the Prescription Drug Product List under a specific drug entity and
dosage form. The change may be from the code signifying that the drug does
not present a bioequivalence problem (e.g., AA) to a code signifying a
bioequivalence problem (e.g., BP), or vice versa. This procedure does not
apply to a change of a particular product code (e.g., a change from BP to AB
or from AB to BX).

Before making a change in a therapeutic equivalence code for an entire


category of drugs, the Agency will announce in the Introduction to the
Cumulative Supplement that it is considering the change and will invite
comment. Comments, along with scientific data, may be sent to the Director,
Division of Bioequivalence, Office of Generic Drugs, Center for Drug
Evaluation and Research, HFD-650, 7500 Standish Place, Rockville, MD 20855.

The comment period will generally be 60 days in length, and the closing
date for comments will be listed in the description of the proposed change for
each drug entity.

The most useful type of scientific data submission is an in vivo


bioavailability/bioequivalence study conducted on batches of the subject drug
products. These submissions should present a full description of the
analytical procedures and equipment used, a validation of the analytical
methodology, including the standard curve, a description of the method of
calculating results, and a description of the pharmacokinetic and statistical
models used in analyzing the data. Anecdotal or testimonial information is
the least useful to the Agency, and such submissions are discouraged. Copies
of supporting reports published in the scientific literature or unpublished
material, however, are welcome.

1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product

The aforementioned procedure does not apply to a change in a single drug


product code. For example, a change in a single drug product's code from BP
to AB as a result of the submission of an acceptable bioequivalence study
ordinarily will not be the subject of notice and comment. Likewise, a change
in a single drug product's code from AB to BX (e.g., as a result of new
information raising a significant question as to bioequivalence) does not
require notice and comment. The Agency's responsibility to provide the public
with the Agency's most current information related to therapeutic equivalence
may require a change in a drug product's code prior to any formal notice and
opportunity for the applicant to be heard. The publication in the Federal
Register of a proposal to withdraw approval of a drug product will ordinarily
result in a change in a product's code from AB to BX if this action has not
already been taken.

xix
1.11 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in


which a determination has already been made that the products were not
withdrawn for safety or efficacy reasons have “**Federal Register
determination that product was not discontinued or withdrawn for safety or
efficacy reasons**” following the product strength. Those drug products are
only reflective of citizen petitions determinations made since 1995. The
identification of these drug products in the Discontinued Section of the
Orange Book should avoid the submission of multiple citizen petitions for the
same drug product. FR notices no longer applicable are removed from the Annual
Edition (i.e., there is a currently marketed Reference Listed Drug and no
applicable patent or exclusivity). FR Safety or Effectiveness Determinations
List lists products that have current and removed notices. The list is
updated quarterly. Notices issued during the year are added to the Electronic
Orange Book Query in the month they become effective.

Generally, approved products are added to the Discontinued Section of the


Orange Book when the applicant holder notifies the Orange Book staff of the
products’ not marketed status. Products may also be added if annual reports
indicate the product is no longer marketed or other Agency administrative
action (e.g., Withdrawal of an Application). Changes to the Orange Book are
not affected by the drug registration and listing requirements of Section 510
of the Act.

1.12 Changes to the Orange Book

Every effort is made to ensure the Annual Edition is current and


accurate. Applicant holders are requested to inform the FDA Orange Book Staff
(OBS) of any changes or corrections. Please inform the OBS when products are
no longer marketed. Notification of the Orange Book staff to include the
newly approved product in the Discontinued Drug Product List rather than parts
1, 2 or 3 of the List (as discussed in Section 1.1) must occur by the end of
the month in which the product is approved to ensure that the product is not
included in the “active” portions of the next published Orange Book update

We can be contacted by email at drugproducts@fda.hhs.gov. Send Changes by


FAX: 240-276-8974; mail to:

FDA/CDER Orange Book Staff


Office of Generic Drugs, HFD-610
7500 Standish Place
Rockville, MD 20855

1.13 Availability of the Edition

Commencing with the 25th edition, the Annual Edition and current monthly
Cumulative Supplement are available in a Portable Document Format (PDF) at the
EOB home page, http://www.fda.gov/cder/ob/default.htm, by clicking on
Publications. The PDF annual format duplicates previous paper versions except
for the Orphan Products Designations and Approvals List. An annual
subscription of the PDF format may be obtained from the U.S. Government
Printing Office, 866-512-1800.

xx
2. HOW TO USE THE DRUG PRODUCT LISTS

2.1 Key Sections for Using the Drug Product Lists

This publication contains illustrations, along with Drug Product Lists,


indices, and lists of abbreviations and terms which facilitate their use.

Illustrations. The annotated Drug Product Illustration, see Section


2.2, and the Therapeutic Equivalence Evaluations Illustration, see
Section 2.3, are offered to provide further clarification. These depict the
format found in the Prescription Drug Product List (the only list in which
therapeutic equivalence evaluation codes are displayed).

Drug Product Lists. The Prescription and OTC Drug Product Lists,
arranged alphabetically by active ingredient(s), contain product
identification information (active ingredients, dosage forms, routes of
administration, product names, application holders, strengths) for single and
multiple ingredient drug products. Also shown are the application number and
drug product number (FDA internal computer data use only) and approval dates
for those drug products approved on or after January 1, 1982. The application
number preceded by “N” is a New Drug Application (NDA or commonly the
innovator). The application number preceded by an “A” is an Abbreviated New
Drug Application (ANDA or commonly the generic).

The Discontinued Product List, arranged alphabetically by active


ingredient(s), contains product identification information (dosage form,
product name, strength, and application number).

If a prescription drug product is available from more than one source


(multisource), a therapeutic equivalence code will appear in front of the
applicant's name. If a product is therapeutically equivalent to one or more
products or to an appropriate reference, it will be designated with a code
beginning with "A" and the entry will be underlined and printed in bold font
for emphasis.

Active ingredient headings for multiple ingredient (combination) drug


products are arranged alphabetically. For purposes of this publication, this
alphabetical sort takes precedence over United States Pharmacopeia official
monograph order (i.e., Reserpine, Hydralazine Hydrochloride,
Hydrochlorothiazide). For example, product information labeled as Reserpine,
Hydrochlorothiazide and Hydralazine Hydrochloride appears under the active
ingredient heading Hydralazine Hydrochloride; Hydrochlorothiazide; Reserpine.
A cross-reference to the product information (for prescription and OTC
products) appears for each additional active ingredient in the product. For
combination drug products, the ingredient strengths are separated by
semicolons and appear in the same relative sequence as the ingredients in the
heading. Available strengths of the dosage form from an applicant appear on
separate lines.

To use the Drug Product Lists, determine by alphabetical order the


ingredient under which the product information is listed, using the Product
Name Index, if necessary. Then, find the ingredient in the applicable Drug
Product List. Proceed to the dosage form and route of administration and
compare products within that ingredient heading only. Therapeutic equivalence
or inequivalence for prescription products is determined on the basis of the
therapeutic equivalence codes provided within that specific dosage form and
route heading. The OTC Drug Product List, Discontinued Drug Product List, and

2-1

Drug Products with Approval under Section 505 of the Act Administered by the
Center for Biologics Evaluation and Research List have their data arranged
similarly.
The Discontinued Drug Product List contains approved products that have
never been marketed, have been discontinued from marketing, are for military
use, or have had their approvals withdrawn for other than safety or efficacy
reasons subsequent to being discontinued from marketing. All products having
a "@" in the 12th Cumulative Supplement of the 29th Edition List have been
added to the Discontinued Drug Product List appearing in the 30th Edition. In
addition, approved drug products that are not in the commercial distribution
channel e.g., approved drug products in applications for export only are also
listed in the Discontinued Section of the Orange Book.

Product Name Index (Prescription and OTC Drug Product Lists). This is an
index of drug products by established or trade name. The second term of each
entry indicates the active ingredient name under which product information can
be found in the appropriate Drug Product List. For those drug products with
multiple active ingredients, only the first active ingredient (in alphabetical
order) will appear. OTC products are so designated.

Product Name Index Listed by Applicant (Prescription and OTC Drug


Product Lists). This is an index that cross-references applicants to drug
products. The bolded and underlined entry represents the applicant name
abbreviation used in this publication. Each complete applicant name that is
represented by the abbreviated name is marked with an asterisk (*). Listed
under each complete applicant name is the first alphabetically arranged
ingredient under which product information can be found in the appropriate
Drug Product List. OTC products are so designated. To use the Drug Product
Lists, determine by alphabetical order the ingredient under which the product
information is listed, using the Product Name Index, if appropriate.

Uniform Terms. To improve readability, uniform terms are used to


designate dosage forms, routes of administration, and abbreviations used to
express strengths. These terms are listed in Appendix C. In some cases, the
terms used may differ from those used in product labels and other labeling.

2-2

2.2 DRUG PRODUCT ILLUSTRATION

SINGLE INGREDIENT

ACTIVE INGREDIENT
MEPERIDINE HYDROCHLORIDE
DOSAGE FORM; ROUTE OF ADMINISTRATION
HEXANONINJECTION
INJECTABLE;
TRADE OR GENERIC NAMES
AP + 25MG/ML N13111 001
LEMLEY PHARMA
AP + 50MG/ML N13111 002

AP + 75MG/ML N13111 003


AUG 22, 1983
REFERENCE LISTED DRUG AP + 100MG/ML A13111 004
JAN 04, 1985
MEPERIDINE HCL
THERAPEUTIC EQUIVALENCE (TE) AP DONHARE PHARM 25MG/ML A42242 001
AP 50MG/ML A42296 001
CODE FOR MULTISOURCE PRODUCT AP 75MG/ML A42301 002
AUG 27, 1987
AP 100MG/ML A42301 003
FINAL APPROVAL DATE

SINGLE SOURCE PRODUCT (NO TE CODE) HOLOVAC LLC 10MG/ML A40000 001

AP JOHNSON MED 25MG/ML A47222 001


OBS PHARM 150MG/ML A47100 001

APPLICANT

AVAILABLE STRENGTH(S) OF A PRODUCT

APPLICATION NUMBER AND PRODUCT NUMBER


PRODUCT NUMBER IS FOR FDA INTERNAL COMPUTER DATA USE ONLY

MULTIPLE INGREDIENTS WITH PRODUCT INFORMATION

ALPHABETICALLY SORTED BY
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE
ACTIVE INGREDIENT
TABLET; ORAL
PRODUCT INFORMATION HYDROCHLOROTHIAZIDE, RESERPINE AND HYDRALAZINE HCL
AUG 27, MADISON
1987 25MG;15MG;0.1MG N41290 001
JAN 18, 1982

THIS EXAMPLE IS FOR PURPOSES OF ILLUSTRATION ONLY. IT DOES NOT REPRESENT ACTUAL PRODUCTS FROM THE PRESCRIPTION DRUG PRODUCT LIST.
2.3 THERAPEUTIC EQUIVALENCE EVALUATIONS ILLUSTRATION
DRUG PRODUCTS CODED AB (OR ANY CODE BEGINNING WITH AN "A") UNDER AN INGREDIENT AND DOSAGE FORM HEADING ARE CONSIDERED
THERAPEUTICALLY EQUIVALENT ONLY TO OTHER PRODUCTS CODED AB (OR ANY CODE BEGINNING WITH AN A") AND NOT TO THOSE CODED BP (OR ANY
CODE BEGINNING WITH "B") AND ANY PRODUCTS NOT LISTED. DRUG PRODUCTS CODED BP (OR ANY CODE BEGINNING WITH A "B") ARE NOT CONSIDERED
THERAPEUTICALLY EQUIVALENT TO ANY OTHER PRODUCT. FOR A COMPLETE EXPLANATION OF THE TE CODES REFER TO SECTION 1.7 OF THE
INTRODUCTION.

SULFASALAZINE

TABLET; ORAL

FAZINE

AB PARKLAND 500MG A42999 001

PRODUCTS CONSIDERED THERAPEUTICALLY SULAZINE

AB URSA 500MG A40222 001


EQUIVALENT TO EACH OTHER

SULFASALAZINE

PRODUCTS CONSIDERED NOT THERAPEUTICALLY BP BROWN 500MG A41297 001

EQUIVALENT TO ANY OTHER PRODUCTS LISTED

SULFASALAZINE

TABLET; ORAL

FAZINE

AB PARKLAND 500MG A42999 001

PRODUCTS CONSIDERED NOT THERAPEUTICALLY SULFASALAZINE

BP BROWN 500MG A41297 001


EQUIVALENT TO EACH OTHER
SOUTH 500MG A40627 001

NOTE: BOLD FONT AND UNDERLINING DENOTES MULTISOURCE PRODUCTS WHICH ARE CONSIDERED THERAPEUTICALLY EQUIVALENT.

THIS EXAMPLE IS FOR PURPOSES OF ILLUSTRATION ONLY. IT DOES NOT REPRESENT ACTUAL PRODUCTS FROM THE PRESCRIPTION DRUG PRODUCT LIST.
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 1 (of 393)

ABACAVIR SULFATE
SOLUTION; ORAL

ZIAGEN

XX + VIIV HLTHCARE EQ 20MG BASE/ML N020978 001 Dec 17, 1998


TABLET; ORAL

ZIAGEN

XX + VIIV HLTHCARE EQ 300MG BASE N020977 001 Dec 17, 1998

ABACAVIR SULFATE; LAMIVUDINE


TABLET; ORAL

EPZICOM

XX + VIIV HLTHCARE EQ 600MG BASE;300MG N021652 001 Aug 02, 2004

ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE


TABLET; ORAL

TRIZIVIR

XX + VIIV HLTHCARE EQ 300MG BASE;150MG;300MG N021205 001 Nov 14, 2000

ACAMPROSATE CALCIUM
TABLET, DELAYED RELEASE; ORAL

CAMPRAL

XX + FOREST LABS 333MG N021431 001 Jul 29, 2004

ACARBOSE
TABLET; ORAL
ACARBOSE
AB COBALT LABS INC 25MG A077532 001 May 07, 2008
AB 50MG A077532 002 May 07, 2008
AB 100MG A077532 003 May 07, 2008
AB IMPAX LABS 25MG A078441 001 May 14, 2009
AB 50MG A078441 002 May 14, 2009
AB 100MG A078441 003 May 14, 2009
AB ROXANE 25MG A078470 001 May 07, 2008
AB 50MG A078470 002 May 07, 2008
AB 100MG A078470 003 May 07, 2008
PRECOSE
AB + BAYER HLTHCARE 25MG N020482 004 May 29, 1997
AB 50MG N020482 001 Sep 06, 1995
AB 100MG N020482 002 Sep 06, 1995

ACEBUTOLOL HYDROCHLORIDE
CAPSULE; ORAL
ACEBUTOLOL HYDROCHLORIDE
AB AMNEAL PHARM EQ 200MG BASE A075047 001 Dec 30, 1999
AB EQ 400MG BASE A075047 002 Dec 30, 1999
AB MYLAN EQ 200MG BASE A074288 001 Apr 24, 1995
AB EQ 400MG BASE A074288 002 Apr 24, 1995
AB WATSON LABS EQ 200MG BASE A074007 001 Oct 18, 1995
AB EQ 400MG BASE A074007 002 Oct 18, 1995
SECTRAL
AB PROMIUS PHARMA EQ 200MG BASE N018917 001 Dec 28, 1984
AB + EQ 400MG BASE N018917 003 Dec 28, 1984

ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE


CAPSULE; ORAL

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE


XX + MIKART 150MG;180MG;30MG A081096 001 Oct 26, 1990


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 2 (of 393)

ACETAMINOPHEN; BUTALBITAL
CAPSULE; ORAL

PHRENILIN FORTE

XX + VALEANT 650MG;50MG
A088831 001 Jun 19, 1985
TABLET; ORAL
BUTAPAP
AB MIKART 325MG;50MG A089987 001 Oct 26, 1992
PHRENILIN
AB + VALEANT 325MG;50MG A087811 001 Jun 19, 1985
BUTAPAP
XX + MIKART 650MG;50MG A089988 001 Oct 26, 1992

ACETAMINOPHEN; BUTALBITAL; CAFFEINE


CAPSULE; ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
AB WEST WARD 500MG;50MG;40MG A040261 001 Oct 28, 1998
ESGIC-PLUS
AB + MIKART 500MG;50MG;40MG A040085 001 Mar 28, 1996
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
XX + MIKART 325MG;50MG;40MG A089007 001 Mar 17, 1986

XX NEXGEN PHARMA 300MG;50MG;40MG A040885 001 Nov 16, 2009

SOLUTION; ORAL

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

XX + MIKART 325MG/15ML;50MG/15ML;40MG/15ML A040387 001 Jan 31, 2003


TABLET; ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
AB CONCORD LABS NJ 325MG;50MG;40MG A040864 001 Dec 01, 2008
AB 500MG;50MG;40MG A040883 001 Dec 23, 2008
AB MALLINCKRODT 325MG;50MG;40MG A087804 001 Jan 24, 1985
AB MIKART 325MG;50MG;40MG A089175 001 Jan 21, 1987
AB VINTAGE PHARMS 325MG;50MG;40MG A040511 001 Aug 27, 2003
AB 500MG;50MG;40MG A040513 001 Aug 25, 2003
AB WATSON LABS 500MG;50MG;40MG A040267 001 Jul 30, 1998
AB WEST WARD 325MG;50MG;40MG A089718 001 Jun 12, 1995
AB 500MG;50MG;40MG A040336 001 Aug 18, 1999
ESGIC-PLUS
AB + MIKART 500MG;50MG;40MG A089451 001 May 23, 1988
FIORICET
AB + WATSON PHARMS 325MG;50MG;40MG A088616 001 Nov 09, 1984
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

XX + MIKART 750MG;50MG;40MG
A040496 001 Dec 23, 2003

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE


CAPSULE; ORAL
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
AB NEXGEN PHARMA INC 325MG;50MG;40MG;30MG A076560 001 Jun 10, 2004
AB VINTAGE PHARMS 325MG;50MG;40MG;30MG A075929 001 Apr 22, 2002
AB WEST WARD 325MG;50MG;40MG;30MG A075618 001 Mar 23, 2001
FIORICET W/ CODEINE
AB + WATSON PHARMS 325MG;50MG;40MG;30MG N020232 001 Jul 30, 1992
PHRENILIN WITH CAFFEINE AND CODEINE
AB VALEANT 325MG;50MG;40MG;30MG A074911 001 Aug 22, 2001

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE


CAPSULE; ORAL
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
AA E5 PHARMA INC 356.4MG;30MG;16MG A040688 001 Apr 03, 2007
AA + MIKART 356.4MG;30MG;16MG A040109 001 Aug 26, 1997
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PRESCRIPTION DRUG PRODUCT LIST 3 - 3 (of 393)

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE


TABLET; ORAL
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
AA BOCA PHARMA 712.8MG;60MG;32MG A040701 001 Apr 03, 2007
AA + MIKART 712.8MG;60MG;32MG A040316 001 Apr 28, 1999
AA WEST WARD 712.8MG;60MG;32MG A040637 001 Sep 22, 2006

ACETAMINOPHEN; CODEINE PHOSPHATE


SOLUTION; ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
AA + ACTAVIS MID ATLANTIC 120MG/5ML;12MG/5ML A085861 001
AA HI TECH PHARMA 120MG/5ML;12MG/5ML A040119 001 Apr 26, 1996
AA MIKART 120MG/5ML;12MG/5ML A089450 001 Oct 27, 1992
AA MORTON GROVE 120MG/5ML;12MG/5ML A087006 001
AA PHARM ASSOC 120MG/5ML;12MG/5ML A087508 001
SUSPENSION; ORAL
CAPITAL AND CODEINE
AA ACTAVIS MID ATLANTIC 120MG/5ML;12MG/5ML A085883 001
AA + VALEANT 120MG/5ML;12MG/5ML A086024 001
TABLET; ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
AA AMNEAL PHARMS NY 300MG;30MG A040779 001 May 29, 2008
AA + DURAMED PHARMS BARR 300MG;15MG A040223 001 Nov 18, 1997
AA 300MG;30MG A040223 002 Nov 18, 1997
AA 300MG;60MG A040223 003 Nov 18, 1997
AA MALLINCKRODT 300MG;15MG A040419 001 May 31, 2001
AA 300MG;30MG A040419 002 May 31, 2001
AA 300MG;60MG A040419 003 May 31, 2001
AA MIKART 300MG;30MG A089238 001 Feb 25, 1986
AA RANBAXY 300MG;30MG A085868 001
AA 300MG;60MG A087083 001
AA TEVA 300MG;15MG A088627 001 Mar 06, 1985
AA 300MG;30MG A088628 001 Mar 06, 1985
AA + 300MG;60MG A088629 001 Mar 06, 1985
AA VINTAGE 300MG;15MG A089990 001 Sep 30, 1988
AA 300MG;30MG A089805 001 Sep 30, 1988
AA VINTAGE PHARMS 300MG;60MG A089828 001 Sep 30, 1988
AA WATSON LABS 300MG;15MG A089997 001 Dec 28, 1994
AA 300MG;30MG A089998 001 Dec 28, 1994
AA 300MG;60MG A089999 001 Dec 28, 1994
AA WATSON LABS FLORIDA 300MG;15MG A040443 001 Jan 22, 2003
AA 300MG;30MG A040443 002 Jan 22, 2003
AA 300MG;60MG A040443 003 Jan 22, 2003
TYLENOL W/ CODEINE NO. 3
AA + ORTHO MCNEIL JANSSEN 300MG;30MG A085055 003
TYLENOL W/ CODEINE NO. 4
AA ORTHO MCNEIL JANSSEN 300MG;60MG A085055 004
ACETAMINOPHEN AND CODEINE PHOSPHATE
XX + MIKART 650MG;30MG A089231 001 Mar 03, 1986
XX + 650MG;60MG A089363 001 Sep 09, 1991

ACETAMINOPHEN; HYDROCODONE BITARTRATE


CAPSULE; ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
AA MIKART 500MG;5MG A081067 001 Nov 30, 1989
AA 500MG;5MG A089008 001 Feb 21, 1986
SOLUTION; ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
AA KV PHARM 500MG/15ML;7.5MG/15ML A040366 001 Jan 23, 2002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 4 (of 393)

ACETAMINOPHEN; HYDROCODONE BITARTRATE


SOLUTION; ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
AA MALLINCKRODT 500MG/15ML;7.5MG/15ML A040418 001 Jun 27, 2001
AA + MIKART 500MG/15ML;7.5MG/15ML A081051 001 Aug 28, 1992
AA PHARM ASSOC 500MG/15ML;7.5MG/15ML A040182 001 Mar 13, 1998
AA VINTAGE PHARMS 500MG/15ML;7.5MG/15ML A040520 001 Oct 30, 2003
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
XX + MALLINCKRODT 500MG/15ML;10MG/15ML A040508 001 Aug 29, 2003
XX + MIKART 325MG/15ML;7.5MG/15ML A040482 001 Sep 25, 2003
XX + PHARM ASSOC 325MG/15ML;10MG/15ML A040834 001 Apr 18, 2008
TABLET; ORAL
ANEXSIA
AA MALLINCKRODT 500MG;5MG A089160 001 Apr 23, 1987
AA 750MG;10MG A040468 001 Oct 31, 2002
ANEXSIA 5/325
AA MALLINCKRODT 325MG;5MG A040409 001 Oct 20, 2000
ANEXSIA 7.5/325
AA MALLINCKRODT 325MG;7.5MG A040405 001 Sep 08, 2000
ANEXSIA 7.5/650
AA MALLINCKRODT 650MG;7.5MG A089725 001 Sep 30, 1987
CO-GESIC
AA SCHWARZ PHARMA 500MG;5MG A087757 001 May 03, 1982
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
AA AMNEAL PHARMS NY 325MG;5MG A040736 001 Aug 25, 2006
AA 325MG;10MG A040746 001 Aug 25, 2006
AA 500MG;5MG A040729 001 Aug 25, 2006
AA 500MG;7.5MG A040748 001 Aug 25, 2006
AA 500MG;10MG A040813 001 Feb 23, 2007
AA 650MG;7.5MG A040754 001 Aug 25, 2006
AA 650MG;10MG A040757 001 Aug 25, 2006
AA 750MG;7.5MG A040769 001 Aug 28, 2006
AA MALLINCKRODT 325MG;10MG A040400 001 Jul 26, 2000
AA 500MG;5MG A040084 002 Jun 01, 1995
AA 500MG;7.5MG A040201 001 Feb 27, 1998
AA 500MG;10MG A040201 002 Feb 27, 1998
AA 650MG;10MG A040084 004 Oct 16, 1996
AA + 660MG;10MG A040084 003 Jul 29, 1996
AA 750MG;7.5MG A040084 001 Jun 01, 1995
AA MIKART 325MG;7.5MG A040432 001 Jan 22, 2003
AA + 500MG;2.5MG A089698 001 Aug 25, 1989
AA + 500MG;7.5MG A089699 001 Aug 25, 1989
AA + 650MG;7.5MG A089689 001 Jun 29, 1988
AA + 650MG;10MG A081223 001 May 29, 1992
AA RANBAXY 325MG;10MG A040826 001 Aug 16, 2007
AA 500MG;5MG A040825 001 Aug 16, 2007
AA 500MG;10MG A040824 001 Aug 16, 2007
AA 750MG;7.5MG A040822 001 Aug 16, 2007
AA SANDOZ 500MG;5MG A040149 001 Jan 27, 1997
AA 750MG;7.5MG A040149 002 Jan 27, 1997
AA SUN PHARM INDS INC 325MG;5MG A090118 001 Dec 23, 2008
AA 325MG;7.5MG A090118 002 Dec 23, 2008
AA 325MG;10MG A090118 003 Dec 23, 2008
AA 500MG;5MG A090265 001 Dec 23, 2008
AA 500MG;7.5MG A090265 002 Dec 23, 2008
AA 500MG;10MG A090265 003 Dec 23, 2008
AA 650MG;7.5MG A090380 001 Dec 23, 2008
AA 650MG;10MG A090380 002 Dec 23, 2008
AA 660MG;10MG A090380 003 Dec 23, 2008
AA 750MG;7.5MG A090380 004 Dec 23, 2008
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PRESCRIPTION DRUG PRODUCT LIST 3 - 5 (of 393)

ACETAMINOPHEN; HYDROCODONE BITARTRATE


TABLET; ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
AA VINTAGE PHARMS 325MG;5MG A040655 001 Jan 19, 2006
AA 325MG;7.5MG A040656 001 Jan 19, 2006
AA 325MG;10MG A040355 001 May 31, 2000
AA 500MG;2.5MG A040144 002 Apr 25, 1997
AA 500MG;5MG A089971 001 Dec 02, 1988
AA 500MG;7.5MG A040144 001 Feb 22, 1996
AA 500MG;10MG A040356 001 May 31, 2000
AA 650MG;7.5MG A040155 001 Apr 14, 1997
AA 650MG;10MG A040143 001 Feb 22, 1996
AA 660MG;10MG A040358 001 May 31, 2000
AA 750MG;7.5MG A040157 001 Apr 12, 1996
AA WATSON LABS 325MG;10MG A040248 002 Apr 28, 2000
AA 500MG;2.5MG A040123 003 Mar 04, 1996
AA 500MG;2.5MG A081079 001 Aug 30, 1991
AA 500MG;5MG A089883 001 Dec 01, 1988
AA 500MG;7.5MG A040123 004 Mar 04, 1996
AA 500MG;7.5MG A081080 001 Aug 30, 1991
AA 500MG;10MG A040148 002 Feb 14, 1997
AA 650MG;7.5MG A040094 001 Sep 29, 1995
AA 650MG;7.5MG A040123 001 Mar 04, 1996
AA 650MG;10MG A040094 002 Sep 29, 1995
AA 650MG;10MG A040123 002 Mar 04, 1996
AA 660MG;10MG A040094 003 Aug 08, 2000
AA 750MG;7.5MG A081083 001 Aug 30, 1991
AA + 750MG;10MG A040094 004 Mar 22, 1999
AA WATSON LABS FLORIDA 500MG;5MG A040493 001 May 28, 2003
AA 660MG;10MG A040495 001 May 28, 2003
AA 750MG;7.5MG A040494 001 May 28, 2003
LORTAB
AA MALLINCKRODT 500MG;5MG A087722 001 Jul 09, 1982
AA + UCB INC 500MG;10MG A040100 001 Jan 26, 1996
NORCO
AA + WATSON LABS 325MG;5MG A040099 001 Jun 25, 1997
AA + 325MG;7.5MG A040148 003 Sep 12, 2000
AA + 325MG;10MG A040148 001 Feb 14, 1997
VICODIN
AA + ABBOTT 500MG;5MG A088058 001 Jan 07, 1983
VICODIN ES
AA + ABBOTT 750MG;7.5MG A089736 001 Dec 09, 1988
VICODIN HP
AA ABBOTT 660MG;10MG A040117 001 Sep 23, 1996
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
XX MIKART 300MG;5MG A040658 001 Jan 19, 2006
XX + 300MG;7.5MG A040556 002 Mar 24, 2006
XX + 300MG;10MG A040556 001 Jun 23, 2004
ZYDONE
XX + ENDO PHARMS 400MG;5MG A040288 001 Nov 27, 1998
XX + 400MG;7.5MG A040288 002 Nov 27, 1998
XX + 400MG;10MG A040288 003 Nov 27, 1998

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE


CAPSULE; ORAL
OXYCODONE AND ACETAMINOPHEN
AA ACTAVIS TOTOWA 500MG;5MG A040199 001 Dec 30, 1998
AA DURAMED PHARMS BARR 500MG;5MG A040289 001 Mar 16, 1999
AA ENDO PHARMS 500MG;5MG A040303 001 Dec 30, 1999
AA MALLINCKRODT 500MG;5MG A040257 001 Aug 04, 1998
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 6 (of 393)

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE


CAPSULE; ORAL
OXYCODONE AND ACETAMINOPHEN
AA VINTAGE PHARMS 500MG;5MG A040106 001 Jul 30, 1996
AA WATSON LABS 500MG;5MG A040234 001 Oct 30, 1997
ROXILOX
AA ROXANE 500MG;5MG A040061 001 Jul 03, 1995
TYLOX
AA + ORTHO MCNEIL JANSSEN 500MG;5MG A088790 001 Dec 12, 1984
SOLUTION; ORAL
OXYCODONE AND ACETAMINOPHEN
AA MALLINCKRODT 325MG/5ML;5MG/5ML A040680 001 Sep 29, 2006
ROXICET
AA + ROXANE 325MG/5ML;5MG/5ML A089351 001 Dec 03, 1986
TABLET; ORAL
OXYCET
AA MALLINCKRODT 325MG;5MG A087463 001 Dec 07, 1983
OXYCODONE AND ACETAMINOPHEN
AA ACTAVIS TOTOWA 325MG;5MG A040203 001 Mar 15, 1999
AA AMNEAL PHARMS NY 325MG;5MG A040777 001 Nov 27, 2007
AA 325MG;10MG A040778 001 Nov 27, 2007
AA 500MG;7.5MG A040789 001 Nov 27, 2007
AA 650MG;10MG A040789 002 Nov 27, 2007
AA COASTAL PHARMS 325MG;2.5MG A090177 001 Oct 20, 2008
AA 325MG;5MG A090177 002 Oct 20, 2008
AA 325MG;7.5MG A090177 003 Oct 20, 2008
AA 325MG;10MG A090177 004 Oct 20, 2008
AA 500MG;7.5MG A090177 005 Oct 20, 2008
AA 650MG;10MG A090177 006 Oct 20, 2008
AA MALLINCKRODT 325MG;7.5MG A040545 001 Jun 30, 2004
AA 325MG;10MG A040545 002 Jun 30, 2004
AA 500MG;7.5MG A040550 001 Jun 30, 2004
AA 650MG;10MG A040550 002 Jun 30, 2004
AA VINTAGE PHARMS 325MG;5MG A040105 001 Jul 30, 1996
AA WATSON LABS 325MG;5MG A040171 001 Oct 30, 1997
AA 325MG;7.5MG A040535 001 Sep 05, 2003
AA 325MG;10MG A040535 002 Sep 05, 2003
AA 500MG;7.5MG A040371 001 Dec 29, 2000
AA 650MG;10MG A040371 002 Dec 29, 2000
PERCOCET
AA + ENDO PHARMS 325MG;2.5MG A040330 001 Jun 25, 1999
AA + 325MG;5MG A040330 002 Jun 25, 1999
AA + 325MG;7.5MG A040434 001 Nov 23, 2001
AA + 325MG;10MG A040434 002 Nov 23, 2001
AA + 500MG;7.5MG A040341 001 Jul 26, 1999
AA + 650MG;10MG A040341 002 Jul 26, 1999
ROXICET
AA ROXANE 325MG;5MG A087003 001
OXYCODONE AND ACETAMINOPHEN
XX + MIKART 300MG;2.5MG A040608 001 Dec 30, 2005
XX + 300MG;5MG A040608 002 Dec 30, 2005
XX + 300MG;7.5MG A040608 003 Dec 30, 2005
XX + 300MG;10MG A040608 004 Dec 30, 2005
XX + 400MG;2.5MG A040679 001 May 16, 2006
XX + 400MG;5MG A040687 001 Apr 27, 2006
XX + 400MG;7.5MG A040698 001 Apr 27, 2006
XX + 400MG;10MG A040692 001 Apr 27, 2006
XX 500MG;10MG A040676 001 Apr 19, 2006
ROXICET 5/500
XX + ROXANE 500MG;5MG A089775 001 Jan 12, 1989
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 7 (of 393)

ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE


TABLET; ORAL
ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE
AB ACTAVIS TOTOWA 650MG;EQ 25MG BASE A076202 001 Aug 02, 2002
AB WATSON LABS 650MG;EQ 25MG BASE A074699 001 Mar 24, 2000
TALACEN
AB + SANOFI AVENTIS US 650MG;EQ 25MG BASE N018458 001 Sep 23, 1982

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE


TABLET; ORAL
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
AA + MYLAN 650MG;65MG A083978 001
AA VINTAGE PHARMS 650MG;65MG A040507 001 Jul 30, 2003

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE


TABLET; ORAL
DARVOCET A500
AB XANODYNE PHARM 500MG;100MG A076429 001 Sep 10, 2003
DARVOCET-N 100
AB + XANODYNE PHARM 650MG;100MG N017122 002
DARVOCET-N 50
AB XANODYNE PHARM 325MG;50MG N017122 001
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
AB CONCORD LABS NJ 650MG;100MG A077821 001 Feb 11, 2008
AB CORNERSTONE 500MG;100MG A076750 001 Jun 28, 2004
AB MYLAN 650MG;100MG A070145 001 Jun 12, 1985
AB TEVA 650MG;100MG A074119 001 Dec 19, 1994
AB VINTAGE PHARMS 325MG;50MG A074843 002 Feb 15, 2001
AB 650MG;100MG A074843 001 Feb 12, 1997
AB WOCKHARDT 325MG;50MG A077677 001 Mar 16, 2007
AB 650MG;100MG A077677 002 Mar 16, 2007
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
XX CORNERSTONE 325MG;100MG A076743 001 May 07, 2004

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE


TABLET; ORAL
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
AB AMNEAL PHARMS 325MG;37.5MG A090485 001 Dec 09, 2009
AB CARACO 325MG;37.5MG A077184 001 Dec 16, 2005
AB KALI LABS 325MG;37.5MG A076475 001 Apr 21, 2005
AB MYLAN 325MG;37.5MG A077858 001 Sep 26, 2008
AB WATSON LABS 325MG;37.5MG A076914 001 Jul 26, 2006
ULTRACET
AB + ORTHO MCNEIL JANSSEN 325MG;37.5MG N021123 001 Aug 15, 2001

ACETAZOLAMIDE
CAPSULE, EXTENDED RELEASE; ORAL
ACETAZOLAMIDE
AB ZYDUS PHARMS USA INC 500MG A040904 001 Dec 10, 2008
DIAMOX
AB + DURAMED PHARMS BARR 500MG N012945 001
TABLET; ORAL
ACETAZOLAMIDE
AB LANNETT 250MG A084840 001
AB MUTUAL PHARM 125MG A089752 001 Jun 22, 1988
AB TARO 125MG A040195 001 May 28, 1997
AB + 250MG A040195 002 May 28, 1997
AB WATSON LABS 250MG A088882 001 Oct 22, 1985
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 8 (of 393)

ACETAZOLAMIDE SODIUM
INJECTABLE; INJECTION
ACETAZOLAMIDE SODIUM
AP BEDFORD EQ 500MG BASE/VIAL A040089 001 Feb 28, 1995
AP X GEN PHARMS EQ 500MG BASE/VIAL A040784 001 Dec 10, 2008
DIAMOX
AP + DURAMED PHARMS BARR EQ 500MG BASE/VIAL N009388 001 Dec 05, 1990

ACETIC ACID, GLACIAL


SOLUTION; IRRIGATION, URETHRAL
ACETIC ACID 0.25% IN PLASTIC CONTAINER
AT B BRAUN 250MG/100ML N018161 001
AT BAXTER HLTHCARE 250MG/100ML N018523 001 Feb 19, 1982
AT HOSPIRA 250MG/100ML N017656 001
SOLUTION/DROPS; OTIC
ACETASOL
AT ACTAVIS MID ATLANTIC 2% A087146 001
ACETIC ACID
AT + MORTON GROVE 2% A040166 001 Jul 26, 1996
AT TARO 2% A088638 001 Sep 06, 1984
AT VINTAGE 2% A040607 001 Feb 24, 2005
VOSOL
AT HI TECH PHARMA 2% N012179 001

ACETIC ACID, GLACIAL; ALUMINUM ACETATE


SOLUTION/DROPS; OTIC

ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE

XX + BAUSCH AND LOMB 2%;0.79% A040063 001 Feb 25, 1994

ACETIC ACID, GLACIAL; HYDROCORTISONE


SOLUTION/DROPS; OTIC
ACETASOL HC
AT ACTAVIS MID ATLANTIC 2%;1% A087143 001 Jan 13, 1982
HYDROCORTISONE AND ACETIC ACID
AT TARO 2%;1% A088759 001 Mar 04, 1985
AT VINTAGE 2%;1% A040609 001 Feb 06, 2006
VOSOL HC
AT + HI TECH PHARMA 2%;1% N012770 001

ACETOHEXAMIDE
TABLET; ORAL
ACETOHEXAMIDE
XX WATSON LABS 250MG A071893 001 Nov 25, 1987
XX + 500MG A071894 001 Nov 25, 1987

ACETOHYDROXAMIC ACID
TABLET; ORAL

LITHOSTAT

XX + MISSION PHARMA 250MG N018749 001 May 31, 1983

ACETYLCHOLINE CHLORIDE
FOR SOLUTION; OPHTHALMIC

MIOCHOL-E

XX + NOVARTIS 20MG/VIAL N020213 001 Sep 22, 1993

ACETYLCYSTEINE
INJECTABLE; INTRAVENOUS

ACETADOTE

XX + CUMBERLAND PHARMS 6GM/30ML (200MG/ML) N021539 001 Jan 23, 2004


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 9 (of 393)

ACETYLCYSTEINE
SOLUTION; INHALATION, ORAL
ACETYLCYSTEINE
AN BEDFORD 10% A072323 001 Apr 30, 1992
AN 20% A072324 001 Apr 30, 1992
AN HOSPIRA 10% A073664 001 Aug 30, 1994
AN 20% A074037 001 Aug 30, 1994
AN + LUITPOLD 10% A072489 001 Jul 28, 1995
AN + 20% A072547 001 Jul 28, 1995

ACITRETIN
CAPSULE; ORAL
SORIATANE
XX STIEFEL LABS INC 10MG N019821 001 Oct 28, 1996
XX + 25MG N019821 002 Oct 28, 1996

ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE


CAPSULE; ORAL

SEMPREX-D

XX + UCB INC 8MG;60MG N019806 001 Mar 25, 1994

ACYCLOVIR
CAPSULE; ORAL
ACYCLOVIR
AB ACTAVIS ELIZABETH 200MG A074906 001 Aug 26, 1997
AB APOTEX INC 200MG A075677 001 Sep 28, 2005
AB DAVA PHARMS INC 200MG A074833 001 Apr 22, 1997
AB GENPHARM 200MG A074977 001 Apr 13, 1998
AB IVAX SUB TEVA PHARMS 200MG A074674 001 Apr 22, 1997
AB RANBAXY 200MG A074975 001 Sep 30, 1998
AB STASON 200MG A075090 001 Jan 26, 1999
AB TEVA 200MG A074578 001 Apr 22, 1997
AB WATSON LABS 200MG A075101 001 Apr 15, 1998
ZOVIRAX
AB + GLAXOSMITHKLINE 200MG N018828 001 Jan 25, 1985
CREAM; TOPICAL

ZOVIRAX

XX + GLAXOSMITHKLINE 5% N021478 001 Dec 30, 2002


OINTMENT; TOPICAL

ZOVIRAX

XX + GLAXOSMITHKLINE 5% N018604 001 Mar 29, 1982


SUSPENSION; ORAL
ACYCLOVIR
AB ACTAVIS MID ATLANTIC 200MG/5ML A074738 001 Apr 28, 1997
AB HI TECH PHARMA 200MG/5ML A077026 001 Jun 07, 2005
ZOVIRAX
AB + GLAXOSMITHKLINE 200MG/5ML N019909 001 Dec 22, 1989
TABLET; ORAL
ACYCLOVIR
AB ACTAVIS ELIZABETH 400MG A074870 001 Jun 05, 1997
AB 800MG A074870 002 Jun 05, 1997
AB APOTEX INC 400MG A077309 001 Sep 29, 2005
AB 800MG A077309 002 Sep 29, 2005
AB CARLSBAD 400MG A075382 001 Apr 30, 1999
AB 800MG A075382 002 Apr 30, 1999
AB DAVA PHARMS INC 400MG A074946 001 Nov 19, 1997
AB 800MG A074946 002 Nov 19, 1997
AB GENPHARM 400MG A074976 001 Apr 13, 1998
AB 800MG A074976 002 Apr 13, 1998
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 10 (of 393)

ACYCLOVIR
TABLET; ORAL
ACYCLOVIR
AB IVAX SUB TEVA PHARMS 400MG A074836 001 Apr 22, 1997
AB 800MG A074836 002 Apr 22, 1997
AB RANBAXY 400MG A074980 001 Sep 30, 1998
AB 800MG A074980 002 Sep 30, 1998
AB TEVA 400MG A074556 002 Apr 22, 1997
AB 800MG A074556 003 Apr 22, 1997
ZOVIRAX
AB GLAXOSMITHKLINE 400MG N020089 001 Apr 30, 1991
AB + 800MG N020089 002 Apr 30, 1991

ACYCLOVIR SODIUM
INJECTABLE; INJECTION
ACYCLOVIR SODIUM
AP + APP PHARMS EQ 50MG BASE/ML A074930 001 May 13, 1998
AP EQ 500MG BASE/VIAL A075015 001 Apr 30, 1998
AP BAXTER HLTHCARE EQ 500MG BASE/VIAL A074913 001 Oct 15, 1997
AP EQ 1GM BASE/VIAL A074913 002 Oct 15, 1997
AP BEDFORD EQ 500MG BASE/VIAL A074596 002 Apr 22, 1997
AP EQ 1GM BASE/VIAL A074596 001 Apr 22, 1997
AP HOSPIRA EQ 50MG BASE/ML A075065 001 Feb 25, 1999
AP TEVA PARENTERAL EQ 50MG BASE/ML A075627 001 Mar 28, 2001
AP EQ 500MG BASE/VIAL A074969 001 Aug 26, 1997
AP EQ 1GM BASE/VIAL A074969 002 Aug 26, 1997
ZOVIRAX
AP + GLAXOSMITHKLINE EQ 500MG BASE/VIAL N018603 001 Oct 22, 1982
AP + EQ 1GM BASE/VIAL N018603 002 Jun 29, 1989
ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE
XX + BAXTER HLTHCARE EQ 500MG BASE/VIAL A074885 001 Dec 19, 1997
XX EQ 1GM BASE/VIAL A074885 002 Dec 19, 1997
ACYCLOVIR SODIUM
XX + HOSPIRA EQ 25MG BASE/ML A074720 001 Apr 22, 1997

ACYCLOVIR; HYDROCORTISONE
CREAM; TOPICAL

ACYCLOVIR AND HYDROCORTISONE


XX + MEDIVIR 5%;1% N022436 001 Jul 31, 2009

ADAPALENE
CREAM; TOPICAL

DIFFERIN

XX + GALDERMA LABS LP 0.1% N020748 001 May 26, 2000


GEL; TOPICAL

DIFFERIN

XX + GALDERMA LABS LP 0.1% N020380 001 May 31, 1996


XX + 0.3% N021753 001 Jun 19, 2007

ADAPALENE; BENZOYL PEROXIDE


GEL; TOPICAL

EPIDUO

XX + GALDERMA LABS 0.1%;2.5% N022320 001 Dec 08, 2008

ADEFOVIR DIPIVOXIL
TABLET; ORAL

HEPSERA

XX + GILEAD 10MG N021449 001 Sep 20, 2002


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 11 (of 393)

ADENOSINE
INJECTABLE; INJECTION
ADENOCARD
AP + ASTELLAS 3MG/ML N019937 002 Oct 30, 1989
ADENOSINE
AP AKORN 3MG/ML A078076 001 Oct 31, 2008
AP APP PHARMS 3MG/ML A077133 001 Apr 27, 2005
AP BAXTER HLTHCARE 3MG/ML A076500 001 Jun 16, 2004
AP 3MG/ML A076501 001 Jun 16, 2004
AP BEDFORD 3MG/ML A076404 001 Jun 16, 2004
AP GLAND PHARMA LTD 3MG/ML A077283 001 Jun 14, 2007
AP LUITPOLD 3MG/ML A090010 001 Apr 28, 2009
AP STRIDES ARCOLAB LTD 3MG/ML A078686 001 May 13, 2009
AP TEVA PARENTERAL 3MG/ML A076564 001 Jun 16, 2004
AP 3MG/ML A078676 001 Jul 31, 2008
AP WOCKHARDT 3MG/ML A090220 001 Jul 20, 2009
ADENOSCAN
XX + ASTELLAS 3MG/ML N020059 001 May 18, 1995

ALBENDAZOLE
TABLET; ORAL

ALBENZA

XX + GLAXOSMITHKLINE 200MG N020666 001 Jun 11, 1996

ALBUMIN HUMAN
INJECTABLE; INJECTION

OPTISON

XX + GE HEALTHCARE 10MG/ML N020899 001 Dec 31, 1997

ALBUMIN IODINATED I-125 SERUM


INJECTABLE; INJECTION
JEANATOPE
XX ISO TEX 100UCI/10ML (10UCI/ML) N017836 003 Jun 08, 2004
XX 500uCi/0.5ML N017836 001
XX + 1,000uCi/ML N017836 002

ALBUMIN IODINATED I-131 SERUM


INJECTABLE; INJECTION

MEGATOPE

XX + ISO TEX 0.5mCi/VIAL N017837 001


XX + 1mCi/VIAL N017837 002

ALBUTEROL SULFATE
AEROSOL, METERED; INHALATION
PROAIR HFA
BX + TEVA GLOBAL EQ 0.09MG BASE/INH N021457 001 Oct 29, 2004
PROVENTIL-HFA
BX + 3M EQ 0.09MG BASE/INH N020503 001 Aug 15, 1996
VENTOLIN HFA
BX + GLAXOSMITHKLINE EQ 0.09MG BASE/INH N020983 001 Apr 19, 2001
SOLUTION; INHALATION
ACCUNEB
AN + DEY EQ 0.021% BASE N020949 002 Apr 30, 2001
AN + EQ 0.042% BASE N020949 001 Apr 30, 2001
ALBUTEROL SULFATE
AN ACTAVIS MID ATLANTIC EQ 0.083% BASE A073533 001 Sep 26, 1995
AN APOTEX INC EQ 0.083% BASE A075717 001 Feb 02, 2007
AN + BAUSCH AND LOMB EQ 0.5% BASE A075050 001 Jun 18, 1998
AN COBALT LABS INC EQ 0.083% BASE A076370 001 Nov 24, 2003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 12 (of 393)

ALBUTEROL SULFATE
SOLUTION; INHALATION
ALBUTEROL SULFATE
AN + DEY EQ 0.083% BASE A072652 001 Feb 21, 1992
AN HI TECH PHARMA EQ 0.083% BASE A075063 001 Feb 09, 1999
AN EQ 0.5% BASE A074543 001 Jan 15, 1998
AN HOLOPACK INTL EQ 0.083% BASE A077839 001 Dec 16, 2008
AN LANDELA PHARM EQ 0.083% BASE A077569 001 Apr 04, 2006
AN MORTON GROVE EQ 0.083% BASE A075394 001 Nov 22, 1999
AN NEPHRON EQ 0.042% BASE A076355 001 Jun 28, 2004
AN EQ 0.083% BASE A074880 001 Sep 17, 1997
AN EQ 0.5% BASE A075664 001 Jun 26, 2001
AN NOVEX EQ 0.5% BASE A076391 001 Apr 01, 2003
AN TEVA PARENTERAL EQ 0.083% BASE A075343 001 Nov 09, 1999
AN WATSON LABS EQ 0.021% BASE A077772 001 Sep 25, 2007
AN EQ 0.042% BASE A077772 002 Sep 25, 2007
SYRUP; ORAL
ALBUTEROL SULFATE
AA ACTAVIS MID ATLANTIC EQ 2MG BASE/5ML A074454 001 Sep 25, 1995
AA HI TECH PHARMA EQ 2MG BASE/5ML A074749 001 Jan 30, 1998
AA + TEVA EQ 2MG BASE/5ML A073419 001 Mar 30, 1992
AA VINTAGE EQ 2MG BASE/5ML A078105 001 Dec 27, 2006
AA VISTAPHARM EQ 2MG BASE/5ML A077788 001 Jun 26, 2007
TABLET; ORAL
ALBUTEROL SULFATE
AB MUTUAL PHARM EQ 2MG BASE A072637 002 Dec 05, 1989
AB EQ 4MG BASE A072637 001 Dec 05, 1989
AB MYLAN EQ 2MG BASE A072894 002 Jan 17, 1991
AB + EQ 4MG BASE A072894 001 Jan 17, 1991
AB WATSON LABS EQ 2MG BASE A072764 001 Aug 28, 1991
TABLET, EXTENDED RELEASE; ORAL
ALBUTEROL SULFATE
AB MYLAN EQ 4MG BASE A078092 002 Jan 29, 2007
AB EQ 8MG BASE A078092 001 Jan 29, 2007
VOSPIRE ER
AB DAVA PHARMS INC EQ 4MG BASE A076130 002 Sep 26, 2002
AB + EQ 8MG BASE A076130 003 Sep 26, 2002

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE


AEROSOL, METERED; INHALATION

COMBIVENT

XX + BOEHRINGER INGELHEIM EQ 0.09MG BASE/INH;0.018MG/INH N020291 001 Oct 24, 1996


SOLUTION; INHALATION
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
AN APOTEX CORP EQ 0.083% BASE;0.017% A077117 001 Dec 31, 2007
AN COBALT LABS INC EQ 0.083% BASE;0.017% A077063 001 Dec 31, 2007
AN NEPHRON EQ 0.083% BASE;0.017% A076749 001 Dec 31, 2007
AN SANDOZ EQ 0.083% BASE;0.017% A076867 001 Dec 21, 2006
AN TEVA PARENTERAL EQ 0.083% BASE;0.017% A076724 001 Dec 31, 2007
AN WATSON LABS EQ 0.083% BASE;0.017% A077559 001 Dec 31, 2007
DUONEB
AN + DEY EQ 0.083% BASE;0.017% N020950 001 Mar 21, 2001

ALCLOMETASONE DIPROPIONATE
CREAM; TOPICAL
ACLOVATE
AB + GLAXOSMITHKLINE 0.05% N018707 001 Dec 14, 1982
ALCLOMETASONE DIPROPIONATE
AB ALTANA 0.05% A076973 001 Jul 12, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 13 (of 393)

ALCLOMETASONE DIPROPIONATE
CREAM; TOPICAL
ALCLOMETASONE DIPROPIONATE
AB GLENMARK GENERICS 0.05% A079061 001 Jun 23, 2009
AB TARO 0.05% A076587 001 Sep 15, 2005
OINTMENT; TOPICAL
ACLOVATE
AB + GLAXOSMITHKLINE 0.05% N018702 001 Dec 14, 1982
ALCLOMETASONE DIPROPIONATE
AB ALTANA 0.05% A076884 001 Jul 18, 2005
AB GLENMARK GENERICS 0.05% A079227 001 Jul 30, 2009
AB TARO 0.05% A076730 001 Jul 29, 2004

ALCOHOL; DEXTROSE
INJECTABLE; INJECTION
ALCOHOL 5% AND DEXTROSE 5%
AP + B BRAUN 5ML/100ML;5GM/100ML N004589 004
ALCOHOL 5% IN D5-W
AP HOSPIRA 5ML/100ML;5GM/100ML A083263 001
ALCOHOL 10% AND DEXTROSE 5%
XX + B BRAUN 10ML/100ML;5GM/100ML N004589 006

ALENDRONATE SODIUM
SOLUTION; ORAL

FOSAMAX

XX + MERCK EQ 70MG BASE/75ML N021575 001 Sep 17, 2003


TABLET; ORAL
ALENDRONATE SODIUM
AB APOTEX EQ 5MG BASE A077982 001 Aug 04, 2008
AB EQ 10MG BASE A077982 002 Aug 04, 2008
AB EQ 35MG BASE A077982 003 Aug 04, 2008
AB EQ 70MG BASE A077982 004 Aug 04, 2008
AB AUROBINDO PHARMA EQ 10MG BASE A090124 001 Aug 04, 2008
AB EQ 35MG BASE A090124 002 Aug 04, 2008
AB EQ 70MG BASE A090124 003 Aug 04, 2008
AB AUSTARPHARMA LLC EQ 5MG BASE A090258 001 Sep 24, 2009
AB EQ 10MG BASE A090258 002 Sep 24, 2009
AB EQ 35MG BASE A090258 003 Sep 24, 2009
AB EQ 70MG BASE A090258 004 Sep 24, 2009
AB BARR EQ 35MG BASE A076184 002 Aug 04, 2008
AB EQ 70MG BASE A076184 001 Feb 06, 2008
AB COBALT LABS INC EQ 35MG BASE A076984 001 Aug 04, 2008
AB EQ 40MG BASE A076984 002 Aug 04, 2008
AB EQ 70MG BASE A076984 003 Aug 04, 2008
AB DR REDDYS LABS LTD EQ 5MG BASE A079109 001 Aug 04, 2008
AB EQ 10MG BASE A079109 002 Aug 04, 2008
AB EQ 35MG BASE A079049 001 Aug 04, 2008
AB EQ 70MG BASE A079049 002 Aug 04, 2008
AB GENPHARM ULC EQ 35MG BASE A078638 001 Aug 04, 2008
AB EQ 70MG BASE A078638 002 Aug 04, 2008
AB MYLAN EQ 5MG BASE A076584 001 Aug 04, 2008
AB EQ 10MG BASE A076584 002 Aug 04, 2008
AB EQ 35MG BASE A076584 003 Aug 04, 2008
AB EQ 70MG BASE A076584 004 Aug 04, 2008
AB SANDOZ EQ 5MG BASE A075871 001 Apr 22, 2009
AB EQ 10MG BASE A075871 002 Apr 22, 2009
AB EQ 35MG BASE A075871 004 Apr 22, 2009
AB EQ 40MG BASE A075871 003 Apr 22, 2009
AB EQ 70MG BASE A075871 005 Apr 22, 2009
AB SUN PHARM INDS EQ 5MG BASE A090022 001 Sep 10, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 14 (of 393)

ALENDRONATE SODIUM
TABLET; ORAL
ALENDRONATE SODIUM
AB SUN PHARM INDS EQ 10MG BASE A090022 002 Sep 10, 2008
AB EQ 35MG BASE A090022 003 Sep 10, 2008
AB EQ 70MG BASE A090022 004 Sep 10, 2008
AB TEVA PHARMS EQ 5MG BASE A075710 001 Feb 06, 2008
AB EQ 10MG BASE A075710 002 Feb 06, 2008
AB EQ 35MG BASE A075710 003 Feb 06, 2008
AB EQ 40MG BASE A075710 004 Feb 06, 2008
AB EQ 70MG BASE A075710 005 Feb 06, 2008
AB WATSON LABS EQ 5MG BASE A076768 001 Aug 04, 2008
AB EQ 10MG BASE A076768 002 Aug 04, 2008
AB EQ 35MG BASE A076768 003 Aug 04, 2008
AB EQ 40MG BASE A076768 004 Aug 04, 2008
AB EQ 70MG BASE A076768 005 Aug 04, 2008
FOSAMAX
AB MERCK AND CO INC EQ 5MG BASE N020560 003 Apr 25, 1997
AB EQ 10MG BASE N020560 001 Sep 29, 1995
AB EQ 35MG BASE N020560 004 Oct 20, 2000
AB EQ 40MG BASE N020560 002 Sep 29, 1995
AB + EQ 70MG BASE N020560 005 Oct 20, 2000

ALENDRONATE SODIUM; CHOLECALCIFEROL


TABLET; ORAL
FOSAMAX PLUS D
XX MERCK EQ 70MG BASE;2,800 IU N021762 001 Apr 07, 2005
XX + EQ 70MG BASE;5,600 IU N021762 002 Apr 26, 2007

ALFENTANIL HYDROCHLORIDE
INJECTABLE; INJECTION
ALFENTA
AP + AKORN EQ 0.5MG BASE/ML N019353 001 Dec 29, 1986
ALFENTANIL
AP HOSPIRA EQ 0.5MG BASE/ML A075221 001 Oct 28, 1999

ALFUZOSIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL

UROXATRAL

XX + SANOFI AVENTIS US 10MG N021287 001 Jun 12, 2003

ALGLUCERASE
INJECTABLE; INJECTION

CEREDASE

XX + GENZYME 80 UNITS/ML N020057 003 Apr 05, 1991

ALISKIREN HEMIFUMARATE
TABLET; ORAL
TEKTURNA
XX NOVARTIS EQ 150MG BASE N021985 001 Mar 05, 2007
XX + EQ 300MG BASE N021985 002 Mar 05, 2007

ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE


TABLET; ORAL
TEKTURNA HCT
XX NOVARTIS EQ 150MG BASE;12.5MG N022107 001 Jan 18, 2008
XX EQ 150MG BASE;25MG N022107 002 Jan 18, 2008
XX + EQ 300MG BASE;12.5MG N022107 003 Jan 18, 2008
XX + EQ 300MG BASE;25MG N022107 004 Jan 18, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 15 (of 393)

ALISKIREN HEMIFUMARATE; VALSARTAN


TABLET; ORAL
VALTURNA
XX NOVARTIS EQ 150MG BASE;160MG N022217 001 Sep 16, 2009
XX + EQ 300MG BASE;320MG N022217 002 Sep 16, 2009

ALITRETINOIN
GEL; TOPICAL

PANRETIN

XX + EISAI INC EQ 0.1% BASE N020886 001 Feb 02, 1999

ALLOPURINOL
TABLET; ORAL
ALLOPURINOL
AB APOTEX INC 100MG A077353 001 Sep 08, 2005
AB 300MG A077353 002 Sep 08, 2005
AB CARACO 100MG A078390 001 Aug 30, 2007
AB 300MG A078390 002 Aug 30, 2007
AB MUTUAL PHARM 100MG A071449 001 Jan 09, 1987
AB 300MG A071450 001 Jan 09, 1987
AB MYLAN 100MG N018659 001 Oct 24, 1986
AB 300MG N018659 002 Oct 24, 1986
AB NORTHSTAR HLTHCARE 100MG A078253 001 Sep 11, 2007
AB 300MG A078253 002 Sep 11, 2007
AB VINTAGE PHARMS 100MG A075798 001 Jun 27, 2003
AB 300MG A075798 002 Jun 27, 2003
AB WATSON LABS 100MG N018832 002 Sep 28, 1984
AB 300MG N018877 001 Sep 28, 1984
LOPURIN
AB DR REDDYS LA 100MG A071586 001 Apr 02, 1987
AB 300MG A071587 001 Apr 02, 1987
ZYLOPRIM
AB PROMETHEUS LABS 100MG N016084 001
AB + 300MG N016084 002

ALLOPURINOL SODIUM
INJECTABLE; INJECTION
ALLOPURINOL SODIUM
AP BEDFORD LABS EQ 500MG BASE/VIAL A076870 001 Aug 26, 2004
ALOPRIM
AP + BIONICHE PHARMA EQ 500MG BASE/VIAL N020298 001 May 17, 1996

ALMOTRIPTAN MALATE
TABLET; ORAL
AXERT
XX ORTHO MCNEIL JANSSEN EQ 6.25MG BASE N021001 001 May 07, 2001
XX + EQ 12.5MG BASE N021001 002 May 07, 2001

ALOSETRON HYDROCHLORIDE
TABLET; ORAL
LOTRONEX
XX PROMETHEUS LABS EQ 0.5MG BASE N021107 002 Dec 23, 2003
XX + EQ 1MG BASE N021107 001 Feb 09, 2000
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 16 (of 393)

ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN;


DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-
PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K
INJECTABLE; INJECTION

INFUVITE ADULT

XX + SANDOZ 2 IU/ML;40MG/ML;12MCG/ML;40 N021163 001 May 18, 2000


IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1
.2MG/ML;0.72MG/ML;1.2MG/ML;660
IU/ML;0.03MG/ML

INJECTABLE; IV (INFUSION)

INFUVITE ADULT

XX + SANDOZ 2 IU/ML;40MG/ML;12MCG/ML;40 N021559 001 Jun 16, 2003


IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1
.2MG/ML;0.72MG/ML;1.2MG/ML;660
IU/ML;30MCG/ML

ALPRAZOLAM
CONCENTRATE; ORAL

ALPRAZOLAM

XX + ROXANE 1MG/ML A074312 001 Oct 31, 1993


TABLET; ORAL
ALPRAZOLAM
AB ACTAVIS ELIZABETH 0.25MG A074342 001 Oct 31, 1993
AB 0.5MG A074342 002 Oct 31, 1993
AB 1MG A074342 003 Oct 31, 1993
AB 2MG A074342 004 Oct 31, 1993
AB ALPHAPHARM 0.25MG A074046 001 Oct 19, 1993
AB 0.5MG A074046 002 Oct 19, 1993
AB 1MG A074046 003 Oct 19, 1993
AB 2MG A074046 004 May 07, 1997
AB APOTEX INC 0.25MG A077741 001 Jan 19, 2007
AB 0.5MG A077741 002 Jan 19, 2007
AB 1MG A077741 003 Jan 19, 2007
AB 2MG A077741 004 Jan 19, 2007
AB DAVA INTL INC 0.25MG A074174 001 Oct 19, 1993
AB 0.5MG A074174 002 Oct 19, 1993
AB 1MG A074174 003 Oct 19, 1993
AB 2MG A074174 004 Oct 19, 1993
AB MYLAN 0.25MG A074215 001 Jan 27, 1994
AB 0.5MG A074215 002 Jan 27, 1994
AB 1MG A074215 003 Jan 27, 1994
AB 2MG A074215 004 Jan 27, 1994
AB SANDOZ 0.25MG A074112 001 Dec 29, 1995
AB 0.5MG A074112 002 Dec 29, 1995
AB 1MG A074112 003 Dec 29, 1995
AB 2MG A074909 001 Mar 25, 1998
AB VINTAGE 0.25MG A078491 001 Sep 25, 2008
AB 0.5MG A078491 002 Sep 25, 2008
AB 1MG A078491 003 Sep 25, 2008
AB 2MG A078491 004 Dec 12, 2008
XANAX
AB PHARMACIA AND UPJOHN 0.25MG N018276 001
AB 0.5MG N018276 002
AB + 1MG N018276 003
AB 2MG N018276 004 Nov 27, 1985
TABLET, EXTENDED RELEASE; ORAL
ALPRAZOLAM
AB ACTAVIS ELIZABETH 0.5MG A078056 001 Feb 13, 2007
AB 1MG A078056 002 Feb 13, 2007
AB 2MG A078056 003 Feb 13, 2007
AB 3MG A078056 004 Feb 13, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 17 (of 393)

ALPRAZOLAM
TABLET, EXTENDED RELEASE; ORAL
ALPRAZOLAM
AB AMNEAL PHARMS NY 0.5MG A078387 001 May 30, 2008
AB 1MG A078387 002 May 30, 2008
AB 2MG A078387 003 May 30, 2008
AB 3MG A078387 004 May 30, 2008
AB APOTEX INC 0.5MG A078449 001 Nov 12, 2008
AB 2MG A078449 002 Nov 12, 2008
AB 3MG A078449 003 Nov 12, 2008
AB BARR 0.5MG A077725 001 Jul 31, 2006
AB 1MG A077725 002 Jul 31, 2006
AB 2MG A077725 004 Jul 31, 2006
AB 3MG A077725 003 Jul 31, 2006
AB COREPHARMA 0.5MG A077996 001 Jan 31, 2007
AB 1MG A077996 002 Jan 31, 2007
AB 2MG A077996 003 Jan 31, 2007
AB 3MG A077996 004 Jan 31, 2007
AB IMPAX LABS 0.5MG A077968 004 May 24, 2007
AB 1MG A077968 003 May 24, 2007
AB 2MG A077968 002 May 24, 2007
AB 3MG A077968 001 May 24, 2007
AB MYLAN 0.5MG A077391 002 Jan 26, 2006
AB 1MG A077391 003 Jan 26, 2006
AB 2MG A077391 004 Jan 26, 2006
AB 3MG A077391 001 Jan 26, 2006
AB SANDOZ 0.5MG A077777 001 Jun 30, 2006
AB 1MG A077777 002 Jun 30, 2006
AB 2MG A077777 003 Jun 30, 2006
AB 3MG A077777 004 Jun 30, 2006
AB TEVA PHARMS 0.5MG A077979 001 Feb 28, 2007
AB 1MG A077979 002 Feb 28, 2007
AB 2MG A077979 003 Feb 28, 2007
AB 3MG A077979 004 Feb 28, 2007
AB VINTAGE 0.5MG A078442 001 Oct 15, 2007
AB 1MG A078442 002 Oct 15, 2007
AB 2MG A078442 003 Oct 15, 2007
AB 3MG A078442 004 Oct 15, 2007
AB ZYDUS PHARMS USA INC 0.5MG A078489 001 Oct 17, 2008
AB 1MG A078489 002 Oct 17, 2008
AB 2MG A078489 003 Oct 17, 2008
AB 3MG A078489 004 Oct 17, 2008
XANAX XR
AB PHARMACIA AND UPJOHN 0.5MG N021434 001 Jan 17, 2003
AB 1MG N021434 002 Jan 17, 2003
AB 2MG N021434 003 Jan 17, 2003
AB + 3MG N021434 004 Jan 17, 2003
TABLET, ORALLY DISINTEGRATING; ORAL
ALPRAZOLAM
AB KALI LABS 0.25MG A078088 001 Jan 09, 2009
AB 0.5MG A078088 002 Jan 09, 2009
AB 1MG A078088 003 Jan 09, 2009
AB 2MG A078088 004 Jan 09, 2009
NIRAVAM
AB SCHWARZ PHARMA 0.25MG N021726 001 Jan 19, 2005
AB 0.5MG N021726 002 Jan 19, 2005
AB + 1MG N021726 003 Jan 19, 2005
AB 2MG N021726 004 Jan 19, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 18 (of 393)

ALPROSTADIL
INJECTABLE; INJECTION
ALPROSTADIL
AP BEDFORD 0.5MG/ML A074815 001 Jan 20, 1998
AP TEVA PARENTERAL 0.5MG/ML A075196 001 Apr 30, 1999
CAVERJECT
AP PHARMACIA AND UPJOHN 0.01MG/VIAL N020379 001 Jul 06, 1995
AP + 0.02MG/VIAL N020379 002 Jul 06, 1995
AP + 0.04MG/VIAL N020379 004 May 19, 1997
EDEX
AP SCHWARZ PHARMA 0.01MG/VIAL N020649 002 Jun 12, 1997
AP 0.02MG/VIAL N020649 003 Jun 12, 1997
AP + 0.04MG/VIAL N020649 004 Jun 12, 1997
PROSTIN VR PEDIATRIC
AP + PHARMACIA AND UPJOHN 0.5MG/ML N018484 001
CAVERJECT
XX PHARMACIA AND UPJOHN 0.005MG/VIAL N020379 003 Jun 27, 1996
CAVERJECT IMPULSE
XX PHARMACIA AND UPJOHN 0.01MG/VIAL N021212 001 Jun 11, 2002
XX 0.02MG/VIAL N021212 002 Jun 11, 2002
EDEX
XX + SCHWARZ PHARMA 0.01MG/VIAL N020649 005 Jul 30, 1998
XX + 0.02MG/VIAL N020649 006 Jul 30, 1998
XX + 0.04MG/VIAL N020649 007 Jul 30, 1998
SUPPOSITORY; URETHRAL
MUSE
XX VIVUS 0.125MG N020700 001 Nov 19, 1996
XX 0.25MG N020700 002 Nov 19, 1996
XX 0.5MG N020700 003 Nov 19, 1996
XX + 1MG N020700 004 Nov 19, 1996

ALTRETAMINE
CAPSULE; ORAL

HEXALEN

XX + EISAI INC 50MG N019926 001 Dec 26, 1990

ALVIMOPAN
CAPSULE; ORAL

ENTEREG

XX + ADOLOR 12MG N021775 001 May 20, 2008

AMANTADINE HYDROCHLORIDE
CAPSULE; ORAL
AMANTADINE HYDROCHLORIDE
AB ACTAVIS TOTOWA 100MG A077659 001 Feb 23, 2006
AB BANNER PHARMACAPS 100MG A078720 001 May 29, 2008
AB SANDOZ 100MG A071293 001 Feb 18, 1987
AB + USL PHARMA 100MG A070589 001 Aug 05, 1986
SYRUP; ORAL
AMANTADINE HYDROCHLORIDE
AA + CAROLINA MEDCL 50MG/5ML A075819 001 Sep 11, 2002
AA + HI TECH PHARMA 50MG/5ML A074170 001 Oct 28, 1994
AA + MIKART 50MG/5ML A074028 001 Jun 28, 1993
AA + MORTON GROVE 50MG/5ML A075060 001 Dec 24, 1998
AA + PHARM ASSOC 50MG/5ML A074509 001 Jul 17, 1995
AA + SILARX 50MG/5ML A076352 001 Sep 10, 2004
AA + VINTAGE 50MG/5ML A077992 001 Dec 12, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 19 (of 393)

AMANTADINE HYDROCHLORIDE
TABLET; ORAL
AMANTADINE HYDROCHLORIDE
AB USL PHARMA 100MG A076186 001 Dec 16, 2002
SYMMETREL
AB + ENDO PHARMS 100MG N018101 001

AMBENONIUM CHLORIDE
TABLET; ORAL

MYTELASE

XX + SANOFI AVENTIS US 10MG N010155 002

AMBRISENTAN
TABLET; ORAL
LETAIRIS
XX GILEAD 5MG N022081 001 Jun 15, 2007
XX + 10MG N022081 002 Jun 15, 2007

AMCINONIDE
CREAM; TOPICAL
AMCINONIDE
AB + ALTANA 0.1% A076065 001 May 15, 2003
AB TARO PHARM INDS 0.1% A076229 001 May 31, 2002
LOTION; TOPICAL

AMCINONIDE

XX + ALTANA 0.1% A076329 001 Nov 06, 2002


OINTMENT; TOPICAL
AMCINONIDE
AB + ALTANA 0.1% A076096 001 Nov 19, 2002
AB TARO PHARM INDS 0.1% A076367 001 Mar 19, 2003

AMIFOSTINE
INJECTABLE; INJECTION
AMIFOSTINE
AP SUN PHARM INDS 500MG/VIAL A077126 001 Mar 14, 2008
ETHYOL
AP + MEDIMMUNE 500MG/VIAL N020221 001 Dec 08, 1995

AMIKACIN SULFATE
INJECTABLE; INJECTION
AMIKACIN SULFATE
AP + BEDFORD EQ 50MG BASE/ML A063313 001 Apr 11, 1994
AP + EQ 250MG BASE/ML A063315 001 Apr 11, 1994
AP HOSPIRA EQ 50MG BASE/ML A063263 001 Nov 30, 1994
AP EQ 250MG BASE/ML A063264 001 Nov 30, 1994
AP TEVA PARENTERAL EQ 250MG BASE/ML A064045 002 Sep 28, 1993
AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
XX HOSPIRA EQ 500MG BASE/100ML A064146 001 Apr 02, 1997

AMILORIDE HYDROCHLORIDE
TABLET; ORAL
AMILORIDE HYDROCHLORIDE
AB + PAR PHARM 5MG A070346 001 Jan 22, 1986
AB SIGMAPHARM LABS LLC 5MG A079133 001 Jan 30, 2009
MIDAMOR
AB PADDOCK LABS 5MG N018200 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 20 (of 393)

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE


TABLET; ORAL
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
AB BARR EQ 5MG ANHYDROUS;50MG A071111 001 May 10, 1988
AB + MYLAN EQ 5MG ANHYDROUS;50MG A073209 001 Oct 31, 1991

AMINO ACIDS
INJECTABLE; INJECTION
AMINOSYN 10%
XX HOSPIRA 10% (10GM/100ML) N017673 003
AMINOSYN 10% (PH6)
XX HOSPIRA 10% (10GM/100ML) N017673 008 Nov 18, 1985
AMINOSYN 3.5%
XX HOSPIRA 3.5% (3.5GM/100ML) N017789 004
AMINOSYN 5%
XX HOSPIRA 5% (5GM/100ML) N017673 001
AMINOSYN 7%
XX HOSPIRA 7% (7GM/100ML) N017673 002
AMINOSYN 7% (PH6)
XX HOSPIRA 7% (7GM/100ML) N017673 006 Nov 18, 1985
AMINOSYN 8.5%
XX HOSPIRA 8.5% (8.5GM/100ML) N017673 004
AMINOSYN 8.5% (PH6)
XX HOSPIRA 8.5% (8.5GM/100ML) N017673 007 Nov 18, 1985
AMINOSYN II 10%
XX HOSPIRA 10% (10GM/100ML) N019438 005 Apr 03, 1986
AMINOSYN II 10% IN PLASTIC CONTAINER
XX HOSPIRA 10% (10GM/100ML) N020015 001 Dec 19, 1991
AMINOSYN II 15% IN PLASTIC CONTAINER
XX HOSPIRA 15% (15GM/100ML) N020041 001 Dec 19, 1991
AMINOSYN II 7%
XX HOSPIRA 7% (7GM/100ML) N019438 003 Apr 03, 1986
AMINOSYN II 8.5%
XX HOSPIRA 8.5% (8.5GM/100ML) N019438 004 Apr 03, 1986
AMINOSYN-HBC 7%
XX HOSPIRA 7% (7GM/100ML) N019374 001 Jul 12, 1985
AMINOSYN-HF 8%
XX HOSPIRA 8% (8GM/100ML) N020345 001 Apr 04, 1996
AMINOSYN-PF 10%
XX HOSPIRA 10% (10GM/100ML) N019492 002 Oct 17, 1986
AMINOSYN-PF 7%
XX HOSPIRA 7% (7GM/100ML) N019398 001 Sep 06, 1985
AMINOSYN-RF 5.2%
XX HOSPIRA 5.2% (5.2GM/100ML) N018429 001
BRANCHAMIN 4% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 4% (4GM/100ML) N018684 001 Sep 28, 1984
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER
XX CLINTEC NUTR 15% (15GM/100ML) A020512 001 Aug 30, 1996
FREAMINE HBC 6.9%
XX B BRAUN 6.9% (6.9GM/100ML) N016822 006 May 17, 1983
FREAMINE III 10%
XX B BRAUN 10% (10GM/100ML) N016822 005
FREAMINE III 8.5%
XX B BRAUN 8.5% (8.5GM/100ML) N016822 004
HEPATAMINE 8%
XX B BRAUN 8% (8GM/100ML) N018676 001 Aug 03, 1982
HEPATASOL 8%
XX BAXTER HLTHCARE 8% (8GM/100ML) N020360 001 Apr 04, 1996
NEPHRAMINE 5.4%
XX B BRAUN 5.4% (5.4GM/100ML) N017766 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 21 (of 393)

AMINO ACIDS
INJECTABLE; INJECTION

NOVAMINE 11.4%

XX + HOSPIRA 11.4% (11.4GM/100ML) N017957 003 Aug 09, 1982


NOVAMINE 15%
XX + HOSPIRA 15% (15GM/100ML) N017957 004 Nov 28, 1986
PREMASOL 10% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 10% (10GM/100ML) A075880 002 Jun 19, 2003
PREMASOL 6% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 6% (6GM/100ML) A075880 001 Jun 19, 2003
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE 20% (20GM/100ML) N020849 001 Aug 26, 1998
RENAMIN W/O ELECTROLYTES
XX BAXTER HLTHCARE 6.5% (6.5GM/100ML) N017493 007 Oct 15, 1982
TRAVASOL 10% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 10% (10MG/100ML) N018931 003 Aug 23, 1984
TRAVASOL 10% W/O ELECTROLYTES
XX BAXTER HLTHCARE 10% (10GM/100ML) N017493 006
TRAVASOL 5.5% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 5.5% (5.5GM/100ML) N018931 001 Aug 23, 1984
TRAVASOL 5.5% W/O ELECTROLYTES
XX BAXTER HLTHCARE 5.5% (5.5GM/100ML) N017493 004
TRAVASOL 8.5% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 8.5% (8.5GM/100ML) N018931 002 Aug 23, 1984
TRAVASOL 8.5% W/O ELECTROLYTES
XX BAXTER HLTHCARE 8.5% (8.5GM/100ML) N017493 005

TROPHAMINE

XX + B BRAUN 6% (6GM/100ML) N019018 001 Jul 20, 1984


TROPHAMINE 10%
XX + B BRAUN 10% (10GM/100ML) N019018 003 Sep 07, 1988

AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID;


POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE; INJECTION

PROCALAMINE

XX B BRAUN 3%;26MG/100ML;3GM/100ML;54MG/100ML;41MG N018582 001 May 08, 1982


/100ML;150MG/100ML;200MG/100ML;120MG/10
0ML

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE;


POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE; INJECTION
AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
XX HOSPIRA 3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML N019683 001 Nov 07, 1988
;22.4MG/100ML;261MG/100ML;205MG/100ML
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
XX HOSPIRA 4.25%;36.8MG/100ML;20GM/100ML;51MG/100M N019683 002 Nov 07, 1988
L;22.4MG/100ML;261MG/100ML;205MG/100ML
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
XX HOSPIRA 4.25%;36.8MG/100ML;25GM/100ML;51MG/100M N019683 003 Nov 07, 1988
L;22.4MG/100ML;261MG/100ML;205MG/100ML

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE,


DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE; INJECTION
CLINIMIX E 2.75/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE 2.75%;33MG/100ML;10GM/100ML;51MG/100ML; N020678 002 Mar 26, 1997
261MG/100ML;217MG/100ML;112MG/100ML
CLINIMIX E 2.75/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE 2.75%;33MG/100ML;25GM/100ML;51MG/100ML; N020678 005 Mar 26, 1997
261MG/100ML;217MG/100ML;112MG/100ML
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 22 (of 393)

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE,


DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE; INJECTION

CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER

XX + BAXTER HLTHCARE 2.75%;33MG/100ML;5GM/100ML;51MG/100ML;2 N020678 001 Mar 26, 1997


61MG/100ML;217MG/100ML;112MG/100ML
CLINIMIX E 4.25/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE 4.25%;33MG/100ML;10GM/100ML;51MG/100ML; N020678 009 Mar 26, 1997
261MG/100ML;297MG/100ML;77MG/100ML
CLINIMIX E 4.25/20 SULFITE-FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE 4.25%;33MG/100ML;20GM/100ML;51MG/100ML; N020678 011 Mar 26, 1997
261MG/100ML;297MG/100ML;77MG/100ML
CLINIMIX E 4.25/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE 4.25%;33MG/100ML;25GM/100ML;51MG/100ML; N020678 012 Mar 26, 1997
261MG/100ML;297MG/100ML;77MG/100ML
CLINIMIX E 4.25/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE 4.25%;33MG/100ML;5GM/100ML;51MG/100ML;2 N020678 008 Mar 26, 1997
61MG/100ML;297MG/100ML;77MG/100ML
CLINIMIX E 5/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE 5%;33MG/100ML;10GM/100ML;51MG/100ML;261 N020678 016 Mar 26, 1997
MG/100ML;340MG/100ML;59MG/100ML
CLINIMIX E 5/15 SULFITE-FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE 5%;33MG/100ML;15GM/100ML;51MG/100ML;261 N020678 017 Mar 26, 1997
MG/100ML;340MG/100ML;59MG/100ML
CLINIMIX E 5/20 SULFITE-FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE 5%;33MG/100ML;20GM/100ML;51MG/100ML;261 N020678 018 Mar 26, 1997
MG/100ML;340MG/100ML;59MG/100ML
CLINIMIX E 5/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE 5%;33MG/100ML;25GM/100ML;51MG/100ML;261 N020678 019 Mar 26, 1997
MG/100ML;340MG/100ML;59MG/100ML
CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE 5%;33MG/100ML;35GM/100ML;51MG/100ML;261 N020678 021 Mar 26, 1997
MG/100ML;340MG/100ML;59MG/100ML

AMINO ACIDS; DEXTROSE


INJECTABLE; INJECTION
AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER
XX HOSPIRA 3.5%;25GM/100ML N019681 001 Nov 01, 1988
AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER
XX HOSPIRA 3.5%;5GM/100ML N019681 002 Nov 01, 1988
AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER
XX HOSPIRA 4.25%;10GM/100ML N019681 004 Nov 01, 1988
AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
XX HOSPIRA 4.25%;20GM/100ML N019681 005 Nov 01, 1988
AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER
XX HOSPIRA 4.25%;25GM/100ML N019681 003 Nov 01, 1988
AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER
XX HOSPIRA 5%;25GM/100ML N019681 006 Nov 01, 1988
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 2.75%;10GM/100ML N020734 002 Sep 29, 1997
CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 2.75%;25GM/100ML N020734 005 Sep 29, 1997
CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 2.75%;5GM/100ML N020734 001 Sep 29, 1997
CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 4.25%;10GM/100ML N020734 008 Sep 29, 1997
CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 4.25%;20GM/100ML N020734 010 Sep 29, 1997
CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 4.25%;25GM/100ML N020734 011 Sep 29, 1997
CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 4.25%;5GM/100ML N020734 007 Sep 29, 1997
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 23 (of 393)

AMINO ACIDS; DEXTROSE


INJECTABLE; INJECTION
CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 5%;10GM/100ML N020734 014 Sep 29, 1997
CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 5%;15GM/100ML N020734 015 Sep 29, 1997
CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 5%;20GM/100ML N020734 016 Sep 29, 1997
CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 5%;25GM/100ML N020734 017 Sep 29, 1997
CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 5%;35GM/100ML N020734 018 Sep 29, 1997

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE;


SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE; INJECTION
AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER
XX HOSPIRA 3.5%;5GM/100ML;30MG/100ML;97MG/100ML;12 N019682 001 Nov 01, 1988
0MG/100ML;49.3MG/100ML
AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER
XX HOSPIRA 4.25%;5GM/100ML;30MG/100ML;97MG/100ML;1 N019682 002 Nov 01, 1988
20MG/100ML;49.3MG/100ML

AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM


CHLORIDE; SODIUM ACETATE
INJECTABLE; INJECTION
FREAMINE III 8.5% W/ ELECTROLYTES
XX B BRAUN 8.5%;110MG/100ML;230MG/100ML;10MG/100ML N016822 007 Jul 01, 1988
;440MG/100ML;690MG/100ML

AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE
INJECTABLE; INJECTION

AMINOSYN 3.5% M

XX HOSPIRA 3.5%;21MG/100ML;40MG/100ML;128MG/100ML; N017789 003


234MG/100ML

AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE;
SODIUM CHLORIDE
INJECTABLE; INJECTION

FREAMINE III 3% W/ ELECTROLYTES

XX B BRAUN 3%;54MG/100ML;40MG/100ML;150MG/100ML;20 N016822 003


0MG/100ML;120MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC;


SODIUM CHLORIDE
INJECTABLE; INJECTION
AMINOSYN II 10% W/ ELECTROLYTES
XX HOSPIRA 10%;102MG/100ML;45MG/100ML;522MG/100ML; N019437 004 Apr 03, 1986
410MG/100ML
AMINOSYN II 8.5% W/ ELECTROLYTES
XX HOSPIRA 8.5%;102MG/100ML;45MG/100ML;522MG/100ML N019437 005 Apr 03, 1986
;410MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE;


SODIUM CHLORIDE
INJECTABLE; INJECTION
TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 3.5%;51MG/100ML;131MG/100ML;218MG/100ML N020177 001 Oct 23, 1995
;35MG/100ML
TRAVASOL 3.5% W/ ELECTROLYTES
XX BAXTER HLTHCARE 3.5%;51MG/100ML;131MG/100ML;218MG/100ML N017493 003
;35MG/100ML
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 24 (of 393)

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE;


SODIUM CHLORIDE
INJECTABLE; INJECTION
TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 5.5%;102MG/100ML;522MG/100ML;431MG/100M N020173 001 Oct 27, 1995
L;224MG/100ML
TRAVASOL 5.5% W/ ELECTROLYTES
XX BAXTER HLTHCARE 5.5%;102MG/100ML;522MG/100ML;431MG/100M N017493 001
L;224MG/100ML
TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 8.5%;102MG/100ML;522MG/100ML;594MG/100M N020173 002 Oct 27, 1995
L;154MG/100ML
TRAVASOL 8.5% W/ ELECTROLYTES
XX BAXTER HLTHCARE 8.5%;102MG/100ML;522MG/100ML;594MG/100M N017493 002
L;154MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE


INJECTABLE; INJECTION

AMINOSYN 7% W/ ELECTROLYTES

XX HOSPIRA 7%;102MG/100ML;522MG/100ML;410MG/100ML N017789 002


AMINOSYN 8.5% W/ ELECTROLYTES

XX HOSPIRA 8.5%;102MG/100ML;522MG/100ML;410MG/100M N017673 005


AMINOCAPROIC ACID
INJECTABLE; INJECTION
AMINOCAPROIC ACID
AP LUITPOLD 250MG/ML A071192 001 Dec 01, 1987
AMINOCAPROIC ACID IN PLASTIC CONTAINER
AP + HOSPIRA 250MG/ML A070010 001 Mar 09, 1987
SYRUP; ORAL
AMICAR
AA + XANODYNE PHARM 1.25GM/5ML N015230 002
AMINOCAPROIC ACID
AA MIKART 1.25GM/5ML A074759 001 Sep 02, 1998
TABLET; ORAL
AMICAR
AB XANODYNE PHARM 500MG N015197 001
AMINOCAPROIC
AB MIKART 500MG A075602 001 May 24, 2001
AMICAR
XX + XANODYNE PHARM 1GM N015197 002 Jun 24, 2004

AMINOHIPPURATE SODIUM
INJECTABLE; INJECTION

AMINOHIPPURATE SODIUM

XX + MERCK 20% N005619 001

AMINOLEVULINIC ACID HYDROCHLORIDE


SOLUTION; TOPICAL

LEVULAN

XX + DUSA 20% N020965 001 Dec 03, 1999

AMINOPHYLLINE
INJECTABLE; INJECTION
AMINOPHYLLINE
AP + HOSPIRA 25MG/ML A087242 001 Oct 26, 1983
AP INTL MEDICATION 25MG/ML A087209 001 Feb 01, 1982
AP LUITPOLD 25MG/ML A087240 001
AP 25MG/ML A087600 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 25 (of 393)

AMINOPHYLLINE
INJECTABLE; INJECTION
AMINOPHYLLINE
AP PHARMA SERVE NY 25MG/ML A087392 001 Dec 15, 1983
AP TEVA PARENTERAL 25MG/ML A081142 001 Sep 25, 1991
TABLET; ORAL

AMINOPHYLLINE

XX + WEST WARD 100MG A084540 001


XX + 200MG A085003 001

AMINOSALICYLIC ACID
GRANULE, DELAYED RELEASE; ORAL

PASER

XX + JACOBUS 4GM/PACKET A074346 001 Jun 30, 1994

AMIODARONE HYDROCHLORIDE
INJECTABLE; INJECTION
AMIODARONE HYDROCHLORIDE
AP + AKORN 50MG/ML A076232 001 Jul 05, 2006
AP + APOTEX INC 50MG/ML A076394 001 Apr 25, 2003
AP + APP PHARMS 50MG/ML A075761 001 Oct 15, 2002
AP + BEDFORD 50MG/ML A076018 001 Oct 15, 2002
AP + BEDFORD LABS 50MG/ML A076299 001 Oct 24, 2002
AP + BIONICHE PHARMA 50MG/ML A076217 001 Oct 15, 2002
AP + GLAND PHARMA LTD 50MG/ML A077161 001 Apr 20, 2005
AP HIKMA FARMACEUTICA 50MG/ML A077234 001 Feb 25, 2008
AP + HOSPIRA 50MG/ML A075955 001 Oct 18, 2002
AP + TEVA PARENTERAL 50MG/ML A076163 001 Sep 05, 2003
AP WOCKHARDT 50MG/ML A077610 001 Oct 30, 2008
AP 50MG/ML A077834 001 Oct 30, 2008
NEXTERONE
AP PRISM PHARMS 50MG/ML N022325 001 Dec 24, 2008
TABLET; ORAL
AMIODARONE HYDROCHLORIDE
AB APOTEX CORP 200MG A078578 001 Nov 06, 2008
AB AUROSAL PHARMS 200MG A077069 001 Apr 08, 2005
AB 400MG A077069 002 Apr 08, 2005
AB BARR 200MG A075389 001 Jan 25, 2001
AB MYLAN 200MG A075188 001 Feb 24, 1999
AB SANDOZ 200MG A075315 001 Dec 23, 1998
AB 400MG A075315 002 Jun 30, 2000
AB TARO 100MG A075424 002 Dec 18, 2002
AB 200MG A075424 001 Mar 30, 2001
AB 400MG A076362 001 Nov 29, 2002
AB TEVA PHARMS 200MG A074739 001 Nov 30, 1998
AB ZYDUS PHARMS USA INC 200MG A079029 001 Sep 16, 2008
CORDARONE
AB + WYETH PHARMS INC 200MG N018972 001 Dec 24, 1985
PACERONE
AB UPSHER SMITH 100MG A075135 002 Apr 12, 2005
AB 200MG A075135 001 Apr 30, 1998
AMIODARONE HYDROCHLORIDE
XX TARO 300MG A076362 002 Dec 02, 2003

AMITRIPTYLINE HYDROCHLORIDE
TABLET; ORAL
AMITRIPTYLINE HYDROCHLORIDE
AB CARACO 10MG A040815 001 Jun 27, 2008
AB 25MG A040816 001 Jun 27, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 26 (of 393)

AMITRIPTYLINE HYDROCHLORIDE
TABLET; ORAL
AMITRIPTYLINE HYDROCHLORIDE
AB CARACO 50MG A040817 001 Jun 27, 2008
AB 75MG A040818 001 Jun 27, 2008
AB 100MG A040819 001 Jun 27, 2008
AB 150MG A040820 001 Jun 27, 2008
AB MUTUAL PHARM 10MG A089398 001 Jul 14, 1987
AB 25MG A089399 001 Jul 14, 1987
AB 50MG A089400 001 Jul 14, 1987
AB 75MG A089401 001 Jul 14, 1987
AB 100MG A089402 001 Jul 14, 1987
AB 150MG A089403 001 Jul 14, 1987
AB MYLAN 10MG A086009 002
AB 25MG A086009 003
AB 50MG A086009 001
AB 75MG A086009 004
AB 100MG A086009 005
AB 150MG A086009 006
AB SANDOZ 10MG A085969 001
AB + 25MG A085966 001
AB 50MG A085968 001
AB 75MG A085971 001
AB 100MG A085967 001
AB 150MG A085970 001
AB VINTAGE PHARMS 10MG A040218 001 Sep 11, 1997
AB 25MG A040218 002 Sep 11, 1997
AB 50MG A040218 003 Sep 11, 1997
AB 75MG A040218 004 Sep 11, 1997
AB 100MG A040218 005 Sep 11, 1997
AB 150MG A040218 006 Sep 11, 1997

AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE


TABLET; ORAL
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
AB MYLAN EQ 12.5MG BASE;5MG A071297 002 Dec 10, 1986
AB EQ 25MG BASE;10MG A071297 001 Dec 10, 1986
LIMBITROL
AB VALEANT PHARM INTL EQ 12.5MG BASE;5MG N016949 001
LIMBITROL DS
AB + VALEANT PHARM INTL EQ 25MG BASE;10MG N016949 002

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE


TABLET; ORAL
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
XX MYLAN 10MG;2MG A071443 002 Nov 10, 1988
XX 10MG;4MG A071443 003 Nov 10, 1988
XX + 25MG;2MG A071443 004 Nov 10, 1988
XX + 25MG;4MG A071443 005 Nov 10, 1988
XX + 50MG;4MG A071443 001 Nov 10, 1988

AMLEXANOX
PASTE; DENTAL

APHTHASOL

XX + ULURU 5% N020511 001 Dec 17, 1996

AMLODIPINE BESYLATE
TABLET; ORAL
AMLODIPINE BESYLATE
AB ACTAVIS TOTOWA EQ 2.5MG BASE A078131 001 Sep 04, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 27 (of 393)

AMLODIPINE BESYLATE
TABLET; ORAL
AMLODIPINE BESYLATE
AB ACTAVIS TOTOWA EQ 5MG BASE A078131 002 Sep 04, 2007
AB EQ 10MG BASE A078131 003 Sep 04, 2007
AB ALKEM EQ 2.5MG BASE A078925 001 May 04, 2009
AB EQ 5MG BASE A078925 002 May 04, 2009
AB EQ 10MG BASE A078925 003 May 04, 2009
AB AMNEAL PHARMS NY EQ 2.5MG BASE A078477 001 Jan 16, 2008
AB EQ 5MG BASE A078477 002 Jan 16, 2008
AB EQ 10MG BASE A078477 003 Jan 16, 2008
AB APOTEX EQ 2.5MG BASE A076719 001 May 23, 2007
AB EQ 5MG BASE A076719 002 May 23, 2007
AB EQ 10MG BASE A076719 003 May 23, 2007
AB AUROBINDO PHARMA EQ 2.5MG BASE A078021 001 Jul 17, 2007
AB EQ 5MG BASE A078021 002 Jul 17, 2007
AB EQ 10MG BASE A078021 003 Jul 17, 2007
AB CARACO EQ 2.5MG BASE A078231 001 Nov 30, 2007
AB EQ 5MG BASE A078231 002 Nov 30, 2007
AB EQ 10MG BASE A078231 003 Nov 30, 2007
AB COBALT EQ 2.5MG BASE A077671 001 Jul 19, 2007
AB EQ 5MG BASE A077671 002 Jul 19, 2007
AB EQ 10MG BASE A077671 003 Jul 19, 2007
AB DR REDDYS LABS LTD EQ 2.5MG BASE A076692 001 Jul 20, 2007
AB EQ 5MG BASE A076692 002 Jul 20, 2007
AB EQ 10MG BASE A076692 003 Jul 20, 2007
AB GEDEON RICHTER USA EQ 2.5MG BASE A077333 001 Jul 17, 2007
AB EQ 5MG BASE A077333 002 Jul 17, 2007
AB EQ 10MG BASE A077333 003 Jul 17, 2007
AB GLENMARK GENERICS EQ 2.5MG BASE A078552 001 Apr 08, 2009
AB EQ 5MG BASE A078552 002 Apr 08, 2009
AB EQ 10MG BASE A078552 003 Apr 08, 2009
AB INVAGEN PHARMS EQ 2.5MG BASE A077955 001 Aug 28, 2007
AB EQ 5MG BASE A077955 002 Aug 28, 2007
AB EQ 10MG BASE A077955 003 Aug 28, 2007
AB KALI LABS INC EQ 2.5MG BASE A077516 001 Jul 11, 2007
AB EQ 5MG BASE A077516 002 Jul 11, 2007
AB EQ 10MG BASE A077516 003 Jul 11, 2007
AB LEK PHARMS DD EQ 2.5MG BASE A076859 001 Sep 10, 2007
AB EQ 5MG BASE A076859 002 Sep 10, 2007
AB EQ 10MG BASE A076859 003 Sep 10, 2007
AB LUPIN EQ 2.5MG BASE A078043 001 Jul 12, 2007
AB EQ 5MG BASE A078043 002 Jul 12, 2007
AB EQ 10MG BASE A078043 003 Jul 12, 2007
AB MATRIX LABS LTD EQ 2.5MG BASE A078224 001 Feb 27, 2008
AB EQ 5MG BASE A078224 002 Feb 27, 2008
AB EQ 10MG BASE A078224 003 Feb 27, 2008
AB MYLAN EQ 2.5MG BASE A076418 001 Oct 03, 2005
AB EQ 5MG BASE A076418 002 Oct 03, 2005
AB EQ 10MG BASE A076418 003 Oct 03, 2005
AB ORCHID HLTHCARE EQ 2.5MG BASE A078453 001 Jul 02, 2009
AB EQ 5MG BASE A078453 002 Jul 02, 2009
AB EQ 10MG BASE A078453 003 Jul 02, 2009
AB RANBAXY EQ 2.5MG BASE A077974 001 Jul 09, 2007
AB EQ 5MG BASE A077974 002 Jul 09, 2007
AB EQ 10MG BASE A077974 003 Jul 09, 2007
AB ROXANE EQ 2.5MG BASE A077262 001 Jul 09, 2007
AB EQ 5MG BASE A077262 002 Jul 09, 2007
AB EQ 10MG BASE A077262 003 Jul 09, 2007
AB SYNTHON PHARMS EQ 2.5MG BASE A077080 001 Jun 27, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 28 (of 393)

AMLODIPINE BESYLATE
TABLET; ORAL
AMLODIPINE BESYLATE
AB SYNTHON PHARMS EQ 5MG BASE A077080 002 Jun 27, 2007
AB EQ 10MG BASE A077080 003 Jun 27, 2007
AB TEVA EQ 2.5MG BASE A076846 001 Jun 28, 2007
AB EQ 5MG BASE A076846 002 Jun 28, 2007
AB EQ 10MG BASE A076846 003 Jun 28, 2007
AB TORRENT PHARMS EQ 2.5MG BASE A078573 001 Sep 22, 2008
AB EQ 5MG BASE A078573 002 Sep 22, 2008
AB EQ 10MG BASE A078573 003 Sep 22, 2008
AB UPSHER SMITH EQ 2.5MG BASE A077759 001 Jul 09, 2007
AB EQ 5MG BASE A077759 002 Jul 09, 2007
AB EQ 10MG BASE A077759 003 Jul 09, 2007
AB WATSON LABS EQ 2.5MG BASE A077073 001 Sep 26, 2007
AB EQ 5MG BASE A077073 002 Sep 26, 2007
AB EQ 10MG BASE A077073 003 Sep 26, 2007
AB WOCKHARDT EQ 2.5MG BASE A078500 001 Sep 06, 2007
AB EQ 5MG BASE A078500 002 Sep 06, 2007
AB EQ 10MG BASE A078500 003 Sep 06, 2007
AB ZYDUS PHARMS USA EQ 2.5MG BASE A078226 001 Jul 09, 2007
AB EQ 5MG BASE A078226 002 Jul 09, 2007
AB EQ 10MG BASE A078226 003 Jul 09, 2007
NORVASC
AB PFIZER EQ 2.5MG BASE N019787 001 Jul 31, 1992
AB EQ 5MG BASE N019787 002 Jul 31, 1992
AB + EQ 10MG BASE N019787 003 Jul 31, 1992

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM


TABLET; ORAL
CADUET
XX PFIZER EQ 2.5MG BASE;EQ 10MG BASE N021540 009 Jul 29, 2004
XX EQ 2.5MG BASE;EQ 20MG BASE N021540 010 Jul 29, 2004
XX EQ 2.5MG BASE;EQ 40MG BASE N021540 011 Jul 29, 2004
XX EQ 5MG BASE;EQ 10MG BASE N021540 001 Jan 30, 2004
XX EQ 5MG BASE;EQ 20MG BASE N021540 002 Jan 30, 2004
XX EQ 5MG BASE;EQ 40MG BASE N021540 003 Jan 30, 2004
XX EQ 5MG BASE;EQ 80MG BASE N021540 004 Jan 30, 2004
XX EQ 10MG BASE;EQ 10MG BASE N021540 005 Jan 30, 2004
XX EQ 10MG BASE;EQ 20MG BASE N021540 006 Jan 30, 2004
XX EQ 10MG BASE;EQ 40MG BASE N021540 007 Jan 30, 2004
XX + EQ 10MG BASE;EQ 80MG BASE N021540 008 Jan 30, 2004

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE


CAPSULE; ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
AB TEVA PHARMS EQ 2.5MG BASE;10MG A077179 001 May 18, 2007
AB EQ 5MG BASE;10MG A077179 002 May 18, 2007
AB EQ 5MG BASE;20MG A077179 003 May 18, 2007
AB EQ 10MG BASE;20MG A077179 004 May 18, 2007
LOTREL
AB NOVARTIS EQ 2.5MG BASE;10MG N020364 002 Mar 03, 1995
AB EQ 5MG BASE;10MG N020364 003 Mar 03, 1995
AB EQ 5MG BASE;20MG N020364 004 Mar 03, 1995
AB EQ 10MG BASE;20MG N020364 005 Jun 20, 2002
LOTREL
XX NOVARTIS EQ 5MG BASE;40MG N020364 007 Apr 11, 2006
XX + EQ 10MG BASE;40MG N020364 006 Apr 11, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 29 (of 393)

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL


TABLET; ORAL
AZOR
XX DAIICHI SANKYO EQ 5MG BASE;20MG N022100 001 Sep 26, 2007
XX EQ 5MG BASE;40MG N022100 002 Sep 26, 2007
XX EQ 10MG BASE;20MG N022100 003 Sep 26, 2007
XX + EQ 10MG BASE;40MG N022100 004 Sep 26, 2007

AMLODIPINE BESYLATE; TELMISARTAN


TABLET; ORAL
TWYNSTA
XX BOEHRINGER INGELHEIM EQ 5MG BASE;40MG N022401 001 Oct 16, 2009
XX EQ 5MG BASE;80MG N022401 003 Oct 16, 2009
XX EQ 10MG BASE;40MG N022401 002 Oct 16, 2009
XX + EQ 10MG BASE;80MG N022401 004 Oct 16, 2009

AMLODIPINE BESYLATE; VALSARTAN


TABLET; ORAL
EXFORGE
XX NOVARTIS EQ 5MG BASE;160MG N021990 002 Jun 20, 2007
XX EQ 5MG BASE;320MG N021990 004 Jun 20, 2007
XX + EQ 10MG BASE;160MG N021990 003 Jun 20, 2007
XX + EQ 10MG BASE;320MG N021990 005 Jun 20, 2007

AMLODIPINE; HYDROCHLOROTHIAZIDE; VALSARTAN


TABLET; ORAL
EXFORGE HCT
XX NOVARTIS 5MG;12.5MG;160MG N022314 001 Apr 30, 2009
XX 5MG;25MG;160MG N022314 002 Apr 30, 2009
XX 10MG;12.5MG;160MG N022314 003 Apr 30, 2009
XX 10MG;25MG;160MG N022314 004 Apr 30, 2009
XX + 10MG;25MG;320MG N022314 005 Apr 30, 2009

AMMONIA, N-13
INJECTABLE; INTRAVENOUS

AMMONIA N 13

XX + FEINSTEIN 30MCI-300MCI/8ML (3.75-37.5MCI/ML) N022119 001 Aug 23, 2007

AMMONIUM CHLORIDE
INJECTABLE; INJECTION

AMMONIUM CHLORIDE IN PLASTIC CONTAINER


XX + HOSPIRA 5MEQ/ML A088366 001 Jun 13, 1984

AMMONIUM LACTATE
CREAM; TOPICAL
AMMONIUM LACTATE
AB PADDOCK EQ 12% BASE A076829 001 Feb 07, 2006
AB PERRIGO NEW YORK EQ 12% BASE A075774 001 May 01, 2002
AB TARO EQ 12% BASE A075883 001 Apr 10, 2003
LAC-HYDRIN
AB + RANBAXY EQ 12% BASE N020508 001 Aug 29, 1996
LOTION; TOPICAL
AMMONIUM LACTATE
AB PADDOCK EQ 12% BASE A075575 001 Jun 11, 2002
AB PERRIGO NEW YORK EQ 12% BASE A075570 001 Jun 23, 2004
AB TARO EQ 12% BASE A076216 001 May 28, 2004
LAC-HYDRIN
AB + RANBAXY EQ 12% BASE N019155 001 Apr 24, 1985
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 30 (of 393)

AMOXAPINE
TABLET; ORAL
AMOXAPINE
XX WATSON LABS 25MG A072688 001 Aug 28, 1992
XX 50MG A072689 001 Aug 28, 1992
XX 100MG A072690 001 Aug 28, 1992
XX + 150MG A072691 001 Aug 28, 1992

AMOXICILLIN
CAPSULE; ORAL
AMOXICILLIN
AB AUROBINDO 250MG A065271 001 Nov 09, 2005
AB 500MG A065271 002 Nov 09, 2005
AB DAVA PHARMS INC 250MG A062884 001 Feb 25, 1988
AB 500MG A062881 001 Feb 25, 1988
AB HIKMA PHARMS 250MG A065291 001 Feb 05, 2007
AB 500MG A065291 002 Feb 05, 2007
AB RANBAXY 250MG A065016 001 Apr 08, 1999
AB 500MG A065016 002 Apr 08, 1999
AB SANDOZ 250MG A064076 001 Sep 30, 1994
AB 500MG A064076 002 Sep 30, 1994
AB TEVA 250MG A061926 001
AB + 500MG A061926 003
FOR SUSPENSION; ORAL
AMOXICILLIN
AB AUROBINDO 200MG/5ML A065334 001 Dec 28, 2006
AB 400MG/5ML A065334 002 Dec 28, 2006
AB DAVA PHARMS INC 125MG/5ML A062927 001 Nov 25, 1988
AB 250MG/5ML A062927 002 Nov 25, 1988
AB HIKMA 125MG/5ML A065322 002 Jun 19, 2006
AB 200MG/5ML A065325 002 Jun 19, 2006
AB 250MG/5ML A065322 001 Jun 19, 2006
AB 400MG/5ML A065325 001 Jun 19, 2006
AB MORTON GROVE 400MG/5ML A065319 002 Jun 18, 2007
AB RANBAXY 200MG/5ML A065113 001 Nov 29, 2002
AB 400MG/5ML A065113 002 Nov 29, 2002
AB SANDOZ 125MG/5ML A065387 001 Mar 26, 2007
AB 200MG/5ML A065378 001 Mar 26, 2007
AB 250MG/5ML A065387 002 Mar 26, 2007
AB 400MG/5ML A065378 002 Mar 26, 2007
AB TEVA 125MG/5ML A061931 001
AB 200MG/5ML A065119 001 Dec 04, 2002
AB + 250MG/5ML A061931 002
AB + 400MG/5ML A065119 002 Dec 04, 2002
AMOXICILLIN PEDIATRIC
AB TEVA 50MG/ML A061931 003 Dec 01, 1982
LAROTID
AB GLAXOSMITHKLINE 125MG/5ML A062226 003
AB 250MG/5ML A062226 004
TRIMOX
AB APOTHECON 50MG/ML A061886 001
AB 125MG/5ML A061886 002
AB 125MG/5ML A062885 001 Mar 08, 1988
AB 250MG/5ML A061886 003
AB 250MG/5ML A062885 002 Mar 08, 1988
TABLET; ORAL
AMOXICILLIN
AB AUROBINDO 500MG A065256 001 Nov 09, 2005
AB 875MG A065256 002 Nov 09, 2005
AB DAVA PHARMS INC 875MG A065344 001 Jan 15, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 31 (of 393)

AMOXICILLIN
TABLET; ORAL
AMOXICILLIN
AB HIKMA 875MG A065255 001 Mar 29, 2006
AB RANBAXY 500MG A065059 001 Nov 24, 2000
AB 875MG A065059 002 Nov 24, 2000
AB SANDOZ 500MG A065228 001 Jul 13, 2005
AB 875MG A065228 002 Jul 13, 2005
AB TEVA 500MG A065056 001 Sep 18, 2000
AB + 875MG A065056 002 Sep 18, 2000
TABLET, CHEWABLE; ORAL
AMOXICILLIN
AB DAVA PHARMS INC 125MG A064139 001 Jan 29, 1996
AB 250MG A064139 002 Jan 29, 1996
AB RANBAXY 125MG A065021 001 Dec 23, 1999
AB 250MG A065021 002 Dec 23, 1999
AB TEVA 125MG A064013 002 Sep 11, 1995
AB 250MG A064013 001 Dec 22, 1992
AMOXICILLIN
XX RANBAXY 200MG A065060 001 Nov 29, 2000
XX 400MG A065060 002 Nov 29, 2000
TABLET, EXTENDED RELEASE; ORAL

MOXATAG

XX + MIDDLEBROOK PHARMS 775MG N050813 001 Jan 23, 2008


TABLET, FOR SUSPENSION; ORAL
AMOXICILLIN
AB AUROBINDO PHARMA 200MG A065324 001 Jan 17, 2007
AB 400MG A065324 002 Jan 17, 2007
DISPERMOX
AB RANBAXY 200MG A065080 002 Aug 11, 2003
AB + 400MG A065080 001 Aug 11, 2003
DISPERMOX
XX + RANBAXY 600MG A065159 001 Dec 04, 2003

AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE


CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS; ORAL

PREVPAC

XX + TAKEDA PHARMS NA 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30M N050757 001 Dec 02, 1997


G

AMOXICILLIN; CLAVULANATE POTASSIUM


FOR SUSPENSION; ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
AB HIKMA PHARMS 200MG/5ML;EQ 28.5MG BASE/5ML A065191 002 Jan 25, 2005
AB 400MG/5ML;EQ 57MG BASE/5ML A065191 001 Jan 25, 2005
AB 600MG/5ML;EQ 42.9MG BASE/5ML A065373 001 Nov 09, 2007
AB LEK PHARMS 200MG/5ML;EQ 28.5MG BASE/5ML A065098 001 Dec 16, 2002
AB 400MG/5ML;EQ 57MG BASE/5ML A065098 002 Dec 16, 2002
AB LEK PHARMS DD 600MG/5ML;EQ 42.9MG BASE/5ML A065358 001 Aug 13, 2007
AB RANBAXY 200MG/5ML;EQ 28.5MG BASE/5ML A065132 001 Mar 19, 2003
AB 400MG/5ML;EQ 57MG BASE/5ML A065132 002 Mar 19, 2003
AB 600MG/5ML;EQ 42.9MG BASE/5ML A065207 002 Jan 30, 2007
AB SANDOZ 200MG/5ML;EQ 28.5MG BASE/5ML A065066 001 Jun 05, 2002
AB 400MG/5ML;EQ 57MG BASE/5ML A065066 002 Jun 05, 2002
AB TEVA 200MG/5ML;EQ 28.5MG BASE/5ML A065089 001 May 25, 2004
AB + 400MG/5ML;EQ 57MG BASE/5ML A065089 002 May 25, 2004
AB + 600MG/5ML;EQ 42.9MG BASE/5ML A065162 001 Mar 12, 2004
AMOXICILLIN AND CLAVULANATE POTASSIUM
XX MORTON GROVE PHARMS 250MG/5ML;EQ 62.5MG BASE/5ML A065431 001 Nov 25, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 32 (of 393)

AMOXICILLIN; CLAVULANATE POTASSIUM


TABLET; ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
AB APOTEX 250MG;EQ 125MG BASE A065333 001 Feb 24, 2009
AB 500MG;EQ 125MG BASE A065333 002 Feb 24, 2009
AB APOTEX INC 875MG;EQ 125MG BASE A065317 003 Oct 20, 2008
AB LEK PHARMS 500MG;EQ 125MG BASE A065117 001 Nov 27, 2002
AB 875MG;EQ 125MG BASE A065093 001 Nov 21, 2002
AB RANBAXY 500MG;EQ 125MG BASE A065109 001 Nov 04, 2002
AB 875MG;EQ 125MG BASE A065102 001 Sep 17, 2002
AB SANDOZ 250MG;EQ 125MG BASE A065189 001 Aug 23, 2005
AB 500MG;EQ 125MG BASE A065064 001 Mar 15, 2002
AB 875MG;EQ 125MG BASE A065063 001 Mar 14, 2002
AB TEVA 500MG;EQ 125MG BASE A065101 001 Oct 30, 2002
AB + 875MG;EQ 125MG BASE A065096 001 Oct 29, 2002
TABLET, CHEWABLE; ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
AB RANBAXY 200MG;EQ 28.5MG BASE A065161 001 Dec 03, 2003
AB 400MG;EQ 57MG BASE A065161 002 Dec 03, 2003
AB SANDOZ 200MG;EQ 28.5MG BASE A065065 001 Apr 18, 2002
AB 400MG;EQ 57MG BASE A065065 002 Apr 18, 2002
AB TEVA 200MG;EQ 28.5MG BASE A065205 001 Feb 09, 2005
AB + 400MG;EQ 57MG BASE A065205 002 Feb 09, 2005

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE;


DEXTROAMPHETAMINE SULFATE
CAPSULE, EXTENDED RELEASE; ORAL

ADDERALL XR 10

XX SHIRE 2.5MG;2.5MG;2.5MG;2.5MG N021303 001 Oct 11, 2001


ADDERALL XR 15

XX SHIRE 3.75MG;3.75MG;3.75MG;3.75MG N021303 006 May 22, 2002

ADDERALL XR 20

XX SHIRE 5MG;5MG;5MG;5MG N021303 002 Oct 11, 2001


ADDERALL XR 25

XX SHIRE 6.25MG;6.25MG;6.25MG;6.25MG N021303 004 May 22, 2002

ADDERALL XR 30

XX + SHIRE 7.5MG;7.5MG;7.5MG;7.5MG N021303 003 Oct 11, 2001


ADDERALL XR 5

XX SHIRE 1.25MG;1.25MG;1.25MG;1.25MG N021303 005 May 22, 2002


TABLET; ORAL
ADDERALL 10
AB DURAMED RES 2.5MG;2.5MG;2.5MG;2.5MG N011522 007 Feb 13, 1996
ADDERALL 12.5
AB DURAMED RES 3.125MG;3.125MG;3.125MG;3.125MG N011522 012 Aug 31, 2000
ADDERALL 15
AB DURAMED RES 3.75MG;3.75MG;3.75MG;3.75MG N011522 013 Aug 31, 2000
ADDERALL 20
AB DURAMED RES 5MG;5MG;5MG;5MG N011522 008 Feb 13, 1996
ADDERALL 30
AB + DURAMED RES 7.5MG;7.5MG;7.5MG;7.5MG N011522 010 May 12, 1997
ADDERALL 5
AB DURAMED RES 1.25MG;1.25MG;1.25MG;1.25MG N011522 009 May 12, 1997
ADDERALL 7.5
AB DURAMED RES 1.875MG;1.875MG;1.875MG;1.875MG N011522 011 Aug 31, 2000
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
AB BARR 1.25MG;1.25MG;1.25MG;1.25MG A040422 001 Feb 11, 2002
AB 1.875MG;1.875MG;1.875MG;1.875MG A040422 005 Mar 19, 2003
AB 2.5MG;2.5MG;2.5MG;2.5MG A040422 002 Feb 11, 2002
AB 3.125MG;3.125MG;3.125MG;3.125MG A040422 006 Mar 19, 2003
AB 3.75MG;3.75MG;3.75MG;3.75MG A040422 007 Mar 19, 2003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 33 (of 393)

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE;


DEXTROAMPHETAMINE SULFATE
TABLET; ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
AB BARR 5MG;5MG;5MG;5MG A040422 003 Feb 11, 2002
AB 7.5MG;7.5MG;7.5MG;7.5MG A040422 004 Feb 11, 2002
AB COREPHARMA 1.25MG;1.25MG;1.25MG;1.25MG A040444 001 Jun 19, 2002
AB 2.5MG;2.5MG;2.5MG;2.5MG A040444 002 Jun 19, 2002
AB 5MG;5MG;5MG;5MG A040444 003 Jun 19, 2002
AB 7.5MG;7.5MG;7.5MG;7.5MG A040444 004 Jun 19, 2002
AB MALLINCKRODT 1.25MG;1.25MG;1.25MG;1.25MG A040440 001 Oct 07, 2003
AB 1.875MG;1.875MG;1.875MG;1.875MG A040440 002 Oct 07, 2003
AB 2.5MG;2.5MG;2.5MG;2.5MG A040440 003 Oct 07, 2003
AB 3.125MG;3.125MG;3.125MG;3.125MG A040440 004 Oct 07, 2003
AB 3.75MG;3.75MG;3.75MG;3.75MG A040440 005 Oct 07, 2003
AB 5MG;5MG;5MG;5MG A040440 006 Oct 07, 2003
AB 7.5MG;7.5MG;7.5MG;7.5MG A040440 007 Oct 07, 2003
AB SANDOZ 1.25MG;1.25MG;1.25MG;1.25MG A040439 004 Sep 27, 2002
AB 2.5MG;2.5MG;2.5MG;2.5MG A040439 001 Jun 14, 2002
AB 5MG;5MG;5MG;5MG A040439 002 Jun 14, 2002
AB 7.5MG;7.5MG;7.5MG;7.5MG A040439 003 Jun 14, 2002
AB TEVA PHARMS 1.25MG;1.25MG;1.25MG;1.25MG A040472 001 Sep 30, 2003
AB 2.5MG;2.5MG;2.5MG;2.5MG A040472 002 Sep 30, 2003
AB 5MG;5MG;5MG;5MG A040472 003 Sep 30, 2003
AB 7.5MG;7.5MG;7.5MG;7.5MG A040472 004 Sep 30, 2003

AMPHOTERICIN B
INJECTABLE; INJECTION
AMPHOTERICIN B
AP TEVA PARENTERAL 50MG/VIAL A064062 001 Mar 31, 1995
AP X GEN PHARMS 50MG/VIAL A063206 001 Apr 29, 1992
FUNGIZONE
AP + APOTHECON 50MG/VIAL A060517 001
INJECTABLE, LIPID COMPLEX; INJECTION

ABELCET

XX + ENZON 5MG/ML N050724 001 Nov 20, 1995


AMPHOTEC
XX + THREE RIVERS PHARMS 50MG/VIAL N050729 001 Nov 22, 1996
XX + 100MG/VIAL N050729 002 Nov 22, 1996
INJECTABLE, LIPOSOMAL; INJECTION

AMBISOME

XX + ASTELLAS 50MG/VIAL N050740 001 Aug 11, 1997

AMPICILLIN SODIUM
INJECTABLE; INJECTION
AMPICILLIN SODIUM
AP ACIC FINE CHEMS EQ 250MG BASE/VIAL A090354 001 Dec 28, 2009
AP EQ 500MG BASE/VIAL A090354 002 Dec 28, 2009
AP EQ 1GM BASE/VIAL A090354 003 Dec 28, 2009
AP EQ 2GM BASE/VIAL A090354 004 Dec 28, 2009
AP HANFORD GC EQ 500MG BASE/VIAL A063146 001 Apr 15, 1993
AP EQ 1GM BASE/VIAL A062772 001 Apr 15, 1993
AP EQ 2GM BASE/VIAL A063140 001 Apr 15, 1993
AP EQ 10GM BASE/VIAL A063142 001 Apr 15, 1993
AP IBI EQ 250MG BASE/VIAL A062719 001 May 12, 1987
AP EQ 500MG BASE/VIAL A062719 003 May 12, 1987
AP EQ 1GM BASE/VIAL A062719 002 May 12, 1987
AP INSTITUTO BIOCHEMICO EQ 125MG BASE/VIAL A062797 001 Jul 12, 1993
AP EQ 2GM BASE/VIAL A062797 002 Jul 12, 1993
AP + SANDOZ EQ 125MG BASE/VIAL A061395 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 34 (of 393)

AMPICILLIN SODIUM
INJECTABLE; INJECTION
AMPICILLIN SODIUM
AP + SANDOZ EQ 250MG BASE/VIAL A061395 002
AP + EQ 500MG BASE/VIAL A061395 003
AP + EQ 1GM BASE/VIAL A061395 004
AP EQ 1GM BASE/VIAL A062738 001 Feb 19, 1987
AP + EQ 2GM BASE/VIAL A061395 005
AP EQ 2GM BASE/VIAL A062738 002 Feb 19, 1987
AP + EQ 10GM BASE/VIAL A061395 006

AMPICILLIN SODIUM; SULBACTAM SODIUM


INJECTABLE; INJECTION
AMPICILLIN AND SULBACTAM
AP ACS DOBFAR EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065406 001 Dec 22, 2009
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065406 002 Dec 22, 2009
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A065403 001 Dec 23, 2009
AP BAXTER HLTHCARE EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065074 001 Mar 19, 2002
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065074 002 Mar 19, 2002
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A065076 001 Mar 19, 2002
AP GENERAMEDIX EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065316 001 Jun 29, 2007
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065316 002 Jun 29, 2007
AP HANFORD GC EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065176 001 Nov 30, 2005
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065176 002 Nov 30, 2005
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A065188 001 Nov 25, 2005
AP INSTITUTO BIOCHIMICO EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065222 001 Nov 29, 2005
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065222 002 Nov 29, 2005
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A065314 001 Nov 27, 2006
AP SANDOZ EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065241 001 Jul 25, 2006
AP EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065310 001 Jul 25, 2006
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065241 002 Jul 25, 2006
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065310 002 Jul 25, 2006
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A065240 001 Jul 25, 2006
UNASYN
AP PFIZER EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A062901 001 Nov 23, 1988
AP + EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL N050608 002 Dec 31, 1986
AP + EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL N050608 001 Dec 31, 1986
AP + EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL N050608 005 Dec 10, 1993

AMPICILLIN/AMPICILLIN TRIHYDRATE
CAPSULE; ORAL
AMPICILLIN TRIHYDRATE
AB DAVA PHARMS INC EQ 250MG BASE A062883 001 Feb 25, 1988
AB + EQ 500MG BASE A062882 001 Feb 25, 1988
AB SANDOZ EQ 250MG BASE A064082 001 Aug 29, 1995
AB EQ 500MG BASE A064082 002 Aug 29, 1995
FOR SUSPENSION; ORAL
AMPICILLIN TRIHYDRATE
AB DAVA PHARMS INC EQ 125MG BASE/5ML A062982 001 Feb 10, 1989
PRINCIPEN
AB APOTHECON EQ 125MG BASE/5ML A061394 002
AMPICILLIN TRIHYDRATE
XX + DAVA PHARMS INC EQ 250MG BASE/5ML A062982 002 Feb 10, 1989

AMPRENAVIR
CAPSULE; ORAL

AGENERASE

XX + GLAXOSMITHKLINE 50MG N021007 001 Apr 15, 1999


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 35 (of 393)

AMPRENAVIR
SOLUTION; ORAL

AGENERASE

XX + GLAXOSMITHKLINE 15MG/ML N021039 001 Apr 15, 1999

ANAGRELIDE HYDROCHLORIDE
CAPSULE; ORAL
AGRYLIN
AB SHIRE EQ 0.5MG BASE N020333 001 Mar 14, 1997
ANAGRELIDE HYDROCHLORIDE
AB ALPHAPHARM EQ 0.5MG BASE A077613 001 Jun 27, 2006
AB EQ 1MG BASE A077613 002 Jun 27, 2006
AB BARR EQ 0.5MG BASE A076530 001 Apr 18, 2005
AB EQ 1MG BASE A076530 002 Apr 18, 2005
AB IMPAX LABS EQ 0.5MG BASE A076910 001 Apr 18, 2005
AB EQ 1MG BASE A076910 002 Apr 18, 2005
AB IVAX SUB TEVA PHARMS EQ 0.5MG BASE A076468 001 Apr 18, 2005
AB + EQ 1MG BASE A076468 002 Apr 18, 2005
AB MYLAN EQ 0.5MG BASE A076811 001 Apr 18, 2005
AB EQ 1MG BASE A076811 002 Apr 18, 2005
AB SANDOZ EQ 0.5MG BASE A076683 001 Apr 18, 2005
AB EQ 1MG BASE A076683 002 Apr 18, 2005
AB WATSON LABS EQ 0.5MG BASE A076417 001 Apr 18, 2005
AB EQ 1MG BASE A076417 002 Apr 18, 2005

ANASTROZOLE
TABLET; ORAL

ARIMIDEX

XX + ASTRAZENECA 1MG N020541 001 Dec 27, 1995

ANIDULAFUNGIN
INJECTABLE; IV (INFUSION)

ERAXIS

XX + VICURON 50MG/VIAL N021632 001 Feb 17, 2006


XX + 100MG/VIAL N021632 002 Nov 14, 2006

APOMORPHINE HYDROCHLORIDE
INJECTABLE; SUBCUTANEOUS

APOKYN

XX + IPSEN LTD 30MG/3ML (10MG/ML) N021264 002 Apr 20, 2004

APRACLONIDINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
APRACLONIDINE HYDROCHLORIDE
AT AKORN INC EQ 0.5% BASE A077764 001 Mar 12, 2009
IOPIDINE
AT + ALCON EQ 0.5% BASE N020258 001 Jul 30, 1993
IOPIDINE
XX + ALCON EQ 1% BASE N019779 001 Dec 31, 1987

APREPITANT
CAPSULE; ORAL
EMEND
XX MERCK 40MG N021549 003 Jun 30, 2006
XX 80MG N021549 001 Mar 26, 2003
XX + 125MG N021549 002 Mar 26, 2003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 36 (of 393)

APROTININ
INJECTABLE; INJECTION

TRASYLOL

XX + BAYER HLTHCARE 10,000KIU/ML N020304 001 Dec 29, 1993

ARFORMOTEROL TARTRATE
SOLUTION; INHALATION

BROVANA

XX + SEPRACOR EQ 0.015MG BASE/2ML N021912 001 Oct 06, 2006

ARGATROBAN
INJECTABLE; INJECTION

ARGATROBAN

XX + PFIZER 100MG/ML N020883 001 Jun 30, 2000

ARGININE HYDROCHLORIDE
INJECTABLE; INJECTION

R-GENE 10

XX + PHARMACIA AND UPJOHN 10GM/100ML N016931 001

ARIPIPRAZOLE
INJECTABLE; INTRAMUSCULAR

ABILIFY

XX + OTSUKA 9.75MG/1.3ML (7.5MG/ML) N021866 001 Sep 20, 2006


SOLUTION; ORAL

ABILIFY

XX + OTSUKA 1MG/ML N021713 001 Dec 10, 2004


TABLET; ORAL
ABILIFY
XX OTSUKA 2MG N021436 006 Nov 15, 2002
XX + 5MG N021436 005 Nov 15, 2002
XX + 10MG N021436 001 Nov 15, 2002
XX 15MG N021436 002 Nov 15, 2002
XX 20MG N021436 003 Nov 15, 2002
XX 30MG N021436 004 Nov 15, 2002
TABLET, ORALLY DISINTEGRATING; ORAL

ABILIFY

XX + OTSUKA 10MG N021729 002 Jun 07, 2006


XX 15MG N021729 003 Jun 07, 2006

ARMODAFINIL
TABLET; ORAL
NUVIGIL
XX CEPHALON 50MG N021875 001 Jun 15, 2007
XX 100MG N021875 002 Mar 26, 2009
XX 150MG N021875 003 Jun 15, 2007
XX 200MG N021875 005 Mar 26, 2009
XX + 250MG N021875 004 Jun 15, 2007

ARSENIC TRIOXIDE
INJECTABLE; INJECTION

TRISENOX

XX + CEPHALON 1MG/ML N021248 001 Sep 25, 2000

ARTEMETHER; LUMEFANTRINE
TABLET; ORAL
COARTEM
XX NOVARTIS 20MG;120MG N022268 001 Apr 07, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 37 (of 393)

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE


INJECTABLE; INJECTION

SEPTOCAINE

XX + DEPROCO 4%;EQ 0.0085MG BASE/1.7ML (4%;EQ N022010 001 Mar 30, 2006
0.005MG BASE/ML)
XX + 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG N020971 001 Apr 03, 2000
BASE/ML)

ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID;


NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A;
VITAMIN K
INJECTABLE; IV (INFUSION)

INFUVITE PEDIATRIC

XX + SANDOZ 80MG/VIAL;0.02MG/VIAL;400 N021265 001 Feb 21, 2001


IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VI
AL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/
VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)
XX + SANDOZ 80MG/VIAL;0.02MG/VIAL;400 N021646 001 Jan 29, 2004
IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VI
AL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/
VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID;


NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM;
THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E
FOR SOLUTION; IV (INFUSION)
M.V.I. PEDIATRIC
XX + HOSPIRA 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/ N018920 001 Sep 21, 2000
VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;
0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ
1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID;


NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE
HYDROCHLORIDE; VITAMIN A; VITAMIN E
INJECTABLE; INJECTION

M.V.I.-12 (WITHOUT VITAMIN K)

XX + HOSPIRA 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML; N008809 006 Sep 09, 2004


0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0
.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID;


NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE
HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K
INJECTABLE; IV (INFUSION)
M.V.I. ADULT
XX + HOSPIRA 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15M N021625 001 Jan 30, 2004
G/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIA
L;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL
;10MG/VIAL;0.15MG/VIAL
M.V.I. ADULT (PHARMACY BULK PACKAGE)
XX + HOSPIRA 200MG/5ML;0.06MG/5ML;0.005MG/5ML;15MG/5 N021643 001 Feb 18, 2004
ML;0.005MG/5ML;0.6MG/5ML;40MG/5ML;6MG/5
ML;3.6MG/5ML;6MG/5ML;1MG/5ML;10MG/5ML;0
.15MG/5ML

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE;


SODIUM CHLORIDE; SODIUM SULFATE
FOR SOLUTION; ORAL

MOVIPREP

XX + SALIX PHARMS 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM N021881 001 Aug 02, 2006


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 38 (of 393)

ASENAPINE MALEATE
TABLET; SUBLINGUAL

SAPHRIS

XX ORGANON USA INC EQ 5MG BASE


N022117 001 Aug 13, 2009

XX + EQ 10MG BASE N022117 002 Aug 13, 2009

ASPIRIN; BUTALBITAL; CAFFEINE


CAPSULE; ORAL
FIORINAL
AB + WATSON PHARMS 325MG;50MG;40MG N017534 005 Apr 16, 1986
LANORINAL
AB LANNETT 325MG;50MG;40MG A086996 002 Oct 11, 1985

TABLET; ORAL
BUTALBITAL, ASPIRIN AND CAFFEINE
AB ACTAVIS ELIZABETH 325MG;50MG;40MG A086710 002 Aug 23, 1983

AB + WEST WARD 325MG;50MG;40MG A086162 002 Feb 16, 1984

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE


CAPSULE; ORAL
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
AB NEXGEN PHARMA INC 325MG;50MG;40MG;30MG A075231 001 Nov 30, 2001
AB STEVENS J 325MG;50MG;40MG;30MG A074951 001 Aug 31, 1998
AB WATSON LABS 325MG;50MG;40MG;30MG A074359 001 Aug 31, 1995
FIORINAL W/CODEINE
AB + WATSON PHARMS 325MG;50MG;40MG;30MG N019429 003 Oct 26, 1990

ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE


CAPSULE; ORAL

SYNALGOS-DC

XX + CARACO 356.4MG;30MG;16MG N011483 004 Sep 06, 1983

ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE


TABLET; ORAL
INVAGESIC
AB SANDOZ 385MG;30MG;25MG A074817 001 Nov 27, 1996
INVAGESIC FORTE
AB SANDOZ 770MG;60MG;50MG A074817 002 Nov 27, 1996
NORGESIC
AB GRACEWAY 385MG;30MG;25MG N013416 003 Oct 27, 1982
NORGESIC FORTE
AB + GRACEWAY 770MG;60MG;50MG N013416 004 Oct 27, 1982
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
AB SANDOZ 385MG;30MG;25MG A074654 001 Dec 31, 1996
AB 770MG;60MG;50MG A074654 002 Dec 31, 1996
AB STEVENS J 385MG;30MG;25MG A074988 001 Apr 30, 1999
AB 770MG;60MG;50MG A074988 002 Apr 30, 1999

ASPIRIN; CARISOPRODOL
TABLET; ORAL
CARISOPRODOL AND ASPIRIN
AB ACTAVIS TOTOWA 325MG;200MG A040252 001 Dec 10, 1997
AB CONCORD LABS NJ 325MG;200MG A040832 001 Jan 07, 2010
AB PAR PHARM 325MG;200MG A089594 001 Mar 31, 1989
AB SANDOZ 325MG;200MG A040116 001 Apr 25, 1996
SOMA COMPOUND
AB + MEDA PHARMS 325MG;200MG N012365 005 Jul 11, 1983
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 39 (of 393)

ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE


TABLET; ORAL
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
AB ACTAVIS TOTOWA 325MG;200MG;16MG A040283 001 Dec 29, 1998
AB CONCORD LABS NJ 325MG;200MG;16MG A040860 001 Jan 07, 2010
AB SANDOZ 325MG;200MG;16MG A040118 001 Apr 16, 1996
SOMA COMPOUND W/ CODEINE
AB + MEDA PHARMS 325MG;200MG;16MG N012366 002 Jul 11, 1983

ASPIRIN; DIPYRIDAMOLE
CAPSULE, EXTENDED RELEASE; ORAL
AGGRENOX
AB + BOEHRINGER INGELHEIM 25MG;200MG N020884 001 Nov 22, 1999
ASPIRIN AND DIPYRIDAMOLE
AB BARR 25MG;200MG A078804 001 Aug 14, 2009

ASPIRIN; METHOCARBAMOL
TABLET; ORAL
METHOCARBAMOL AND ASPIRIN
AB + IVAX PHARMS 325MG;400MG A087211 001 Dec 22, 1982
AB STEVENS J 325MG;400MG A081145 001 Jan 31, 1995

ASPIRIN; OXYCODONE HYDROCHLORIDE


TABLET; ORAL

PERCODAN

XX + ENDO PHARMS 325MG;4.8355MG N007337 007 Aug 05, 2005

ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE


TABLET; ORAL
OXYCODONE AND ASPIRIN
AA WATSON LABS 325MG;4.5MG;0.38MG A040255 001 Feb 27, 1998
PERCODAN
AA + ENDO PHARMS 325MG;4.5MG;0.38MG N007337 006

ATAZANAVIR SULFATE
CAPSULE; ORAL
REYATAZ
XX BRISTOL MYERS SQUIBB EQ 100MG BASE N021567 001 Jun 20, 2003
XX EQ 150MG BASE N021567 002 Jun 20, 2003
XX EQ 200MG BASE N021567 003 Jun 20, 2003
XX + EQ 300MG BASE N021567 004 Oct 16, 2006

ATENOLOL
TABLET; ORAL
ATENOLOL
AB AUROBINDO PHARMA 25MG A078512 001 Oct 31, 2007
AB 50MG A078512 002 Oct 31, 2007
AB 100MG A078512 003 Oct 31, 2007
AB CARACO 25MG A078210 001 Jul 10, 2007
AB 50MG A078210 002 Jul 10, 2007
AB 100MG A078210 003 Jul 10, 2007
AB DAVA PHARMS INC 25MG A074099 001 Apr 28, 1992
AB 50MG A073542 001 Dec 19, 1991
AB 100MG A073543 001 Dec 19, 1991
AB GENPHARM 25MG A074126 003 Aug 26, 1998
AB 50MG A074126 001 Mar 23, 1994
AB 100MG A074126 002 Mar 23, 1994
AB IPCA LABS LTD 25MG A077877 001 Dec 27, 2006
AB 50MG A077877 002 Dec 27, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 40 (of 393)

ATENOLOL
TABLET; ORAL
ATENOLOL
AB IPCA LABS LTD 100MG A077877 003 Dec 27, 2006
AB IPR 25MG A073646 001 Jul 31, 1992
AB 50MG A072303 001 Jul 15, 1988
AB 100MG A072304 001 Jul 15, 1988
AB MUTUAL PHARM 25MG A074499 001 Jul 30, 1997
AB 50MG A073475 001 Mar 30, 1993
AB 100MG A073476 001 Mar 30, 1993
AB MYLAN 25MG A073457 002 Apr 26, 1999
AB 50MG A073456 001 Jan 24, 1992
AB 100MG A073457 001 Jan 24, 1992
AB NORTHSTAR HLTHCARE 25MG A078254 001 Sep 25, 2009
AB 50MG A078254 002 Sep 25, 2009
AB 100MG A078254 003 Sep 25, 2009
AB SANDOZ 25MG A074052 001 May 01, 1992
AB 50MG A073025 001 Sep 17, 1991
AB 100MG A073026 001 Sep 17, 1991
AB TEVA 25MG A074056 003 Jul 19, 2004
AB 50MG A074056 001 Jan 18, 1995
AB 100MG A074056 002 Jan 18, 1995
AB UNIQUE PHARM LABS 25MG A077443 001 Sep 13, 2006
AB 50MG A077443 002 Sep 13, 2006
AB 100MG A077443 003 Sep 13, 2006
AB WATSON LABS 50MG A073352 001 Dec 27, 1991
AB 100MG A073353 001 Dec 27, 1991
AB ZYDUS PHARMS USA 25MG A076900 001 Jan 28, 2005
AB 50MG A076900 002 Jan 28, 2005
AB 100MG A076900 003 Jan 28, 2005
TENORMIN
AB ASTRAZENECA 25MG N018240 004 Apr 09, 1990
AB 50MG N018240 001
AB + 100MG N018240 002

ATENOLOL; CHLORTHALIDONE
TABLET; ORAL
ATENOLOL AND CHLORTHALIDONE
AB IPR 50MG;25MG A072301 001 May 31, 1990
AB 100MG;25MG A072302 001 May 31, 1990
AB MUTUAL PHARM 50MG;25MG A073581 001 Apr 29, 1993
AB 100MG;25MG A073582 001 Apr 29, 1993
AB MYLAN 50MG;25MG A074203 001 Oct 31, 1993
AB 100MG;25MG A074203 002 Oct 31, 1993
AB WATSON LABS 50MG;25MG A073665 001 Jul 02, 1992
AB 100MG;25MG A073665 002 Jul 02, 1992
TENORETIC 100
AB + ASTRAZENECA 100MG;25MG N018760 001 Jun 08, 1984
TENORETIC 50
AB ASTRAZENECA 50MG;25MG N018760 002 Jun 08, 1984

ATOMOXETINE HYDROCHLORIDE
CAPSULE; ORAL

STRATTERA

XX LILLY
10MG N021411 002 Nov 26, 2002
XX 18MG N021411 003 Nov 26, 2002
XX 25MG N021411 004 Nov 26, 2002
XX 40MG N021411 005 Nov 26, 2002
XX + 60MG N021411 006 Nov 26, 2002
XX 80MG N021411 007 Feb 14, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 41 (of 393)

ATOMOXETINE HYDROCHLORIDE
CAPSULE; ORAL
STRATTERA
XX LILLY 100MG N021411 008 Feb 14, 2005

ATORVASTATIN CALCIUM
TABLET; ORAL
LIPITOR
XX PFIZER EQ 10MG BASE N020702 001 Dec 17, 1996
XX EQ 20MG BASE N020702 002 Dec 17, 1996
XX EQ 40MG BASE N020702 003 Dec 17, 1996
XX + EQ 80MG BASE N020702 004 Apr 07, 2000

ATOVAQUONE
SUSPENSION; ORAL

MEPRON

XX + GLAXOSMITHKLINE 750MG/5ML N020500 001 Feb 08, 1995

ATOVAQUONE; PROGUANIL HYDROCHLORIDE


TABLET; ORAL

MALARONE

XX + GLAXOSMITHKLINE 250MG;100MG N021078 001 Jul 14, 2000


MALARONE PEDIATRIC
XX + GLAXOSMITHKLINE 62.5MG;25MG N021078 002 Jul 14, 2000

ATRACURIUM BESYLATE
INJECTABLE; INJECTION

ATRACURIUM BESYLATE

XX + BEDFORD 10MG/ML A074901 001 Jul 18, 1997


ATRACURIUM BESYLATE PRESERVATIVE FREE
XX + BEDFORD 10MG/ML A074900 001 Jul 18, 1997

ATROPINE
INJECTABLE; INJECTION

ATROPEN

XX + MERIDIAN MEDCL TECHN EQ 0.25MG SULFATE/0.3ML N017106 004 Sep 17, 2004
XX + EQ 0.5MG SULFATE/0.7ML N017106 003 Jun 19, 2003
XX + EQ 1MG SULFATE/0.7ML N017106 002 Jun 19, 2003
XX + EQ 2MG SULFATE/0.7ML N017106 001

ATROPINE SULFATE
INJECTABLE; IM-IV-SC
ATROPINE SULFATE ANSYR PLASTIC SYRINGE
XX HOSPIRA 0.05MG/ML N021146 002 Jul 09, 2001
XX + 0.1MG/ML N021146 001 Jul 09, 2001

ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE


TABLET; ORAL

MOTOFEN

XX + VALEANT 0.025MG;1MG N017744 002

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE


SOLUTION; ORAL
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
AA ROXANE 0.025MG/5ML;2.5MG/5ML A087708 001 May 03, 1982
LOMOTIL
AA + GD SEARLE LLC 0.025MG/5ML;2.5MG/5ML N012699 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 42 (of 393)

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE


TABLET; ORAL
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
AA LANNETT 0.025MG;2.5MG A085372 001
AA MYLAN 0.025MG;2.5MG A085762 001
AA PAR PHARM 0.025MG;2.5MG A040357 001 May 02, 2000
LOMOTIL
AA + GD SEARLE LLC 0.025MG;2.5MG N012462 001
LONOX
AA SANDOZ 0.025MG;2.5MG A085311 002

ATROPINE SULFATE; EDROPHONIUM CHLORIDE


INJECTABLE; INJECTION

ENLON-PLUS

XX + BIONICHE PHARMA 0.14MG/ML;10MG/ML N019677 001 Nov 06, 1991


XX + 0.14MG/ML;10MG/ML N019678 001 Nov 06, 1991

ATROPINE; PRALIDOXIME CHLORIDE


INJECTABLE; INTRAMUSCULAR

DUODOTE

XX + MERIDIAN MEDCL 2.1MG/0.7ML;600MG/2ML N021983 001 Sep 28, 2006

AURANOFIN
CAPSULE; ORAL

RIDAURA

XX + PROMETHEUS LABS 3MG N018689 001 May 24, 1985

AZACITIDINE
INJECTABLE; IV-SC

VIDAZA

XX + CELGENE 100MG/VIAL N050794 001 May 19, 2004

AZATHIOPRINE
TABLET; ORAL
AZASAN
AB AAIPHARMA LLC 25MG A075252 002 Feb 03, 2003
AB 50MG A075252 001 Jun 07, 1999
AB 75MG A075252 003 Feb 03, 2003
AB 100MG A075252 004 Feb 03, 2003
AZATHIOPRINE
AB MYLAN 50MG A075568 001 Dec 13, 1999
AB ROXANE 50MG A074069 001 Feb 16, 1996
AB ZYDUS PHARMS USA 25MG A077621 002 Sep 05, 2008
AB 50MG A077621 001 Mar 15, 2007
AB 75MG A077621 003 Sep 05, 2008
AB 100MG A077621 004 Sep 05, 2008
IMURAN
AB + PROMETHEUS LABS 50MG N016324 001

AZATHIOPRINE SODIUM
INJECTABLE; INJECTION

AZATHIOPRINE SODIUM

XX + BEDFORD EQ 100MG BASE/VIAL A074419 001 Mar 31, 1995

AZELAIC ACID
CREAM; TOPICAL

AZELEX

XX + ALLERGAN 20% N020428 001 Sep 13, 1995


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 43 (of 393)

AZELAIC ACID
GEL; TOPICAL

FINACEA

XX + INTENDIS 15% N021470 001 Dec 24, 2002

AZELASTINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
AZELASTINE HYDROCHLORIDE
AT APOTEX INC 0.05% A078621 001 Aug 03, 2009
OPTIVAR
AT + MEDA PHARMS 0.05% N021127 001 May 22, 2000
SPRAY, METERED; NASAL

ASTELIN

XX + MEDA PHARMS EQ 0.125MG BASE/SPRAY N020114 001 Nov 01, 1996


ASTEPRO
XX + MEDA PHARMS EQ 0.125MG BASE/SPRAY N022203 001 Oct 15, 2008
XX + EQ 0.1876MG BASE/SPRAY N022371 001 Aug 31, 2009

AZITHROMYCIN
FOR SUSPENSION; ORAL
AZITHROMYCIN
AB PLIVA EQ 100MG BASE/5ML A065246 002 Jul 05, 2006
AB EQ 200MG BASE/5ML A065246 001 Jul 05, 2006
AB SANDOZ EQ 100MG BASE/5ML A065297 001 Sep 18, 2006
AB EQ 200MG BASE/5ML A065297 002 Sep 18, 2006
AB TEVA PHARMS EQ 100MG BASE/5ML A065419 001 Jun 24, 2008
AB EQ 200MG BASE/5ML A065419 002 Jun 24, 2008
ZITHROMAX
AB PFIZER EQ 100MG BASE/5ML N050710 001 Oct 19, 1995
AB + EQ 200MG BASE/5ML N050710 002 Oct 19, 1995
ZITHROMAX
XX + PFIZER EQ 1GM BASE/PACKET N050693 001 Sep 28, 1994
FOR SUSPENSION, EXTENDED RELEASE; ORAL

ZMAX

XX + PFIZER GLOBAL EQ 2GM BASE/BOT N050797 001 Jun 10, 2005


INJECTABLE; INJECTION
AZITHROMYCIN
AP APP PHARMS EQ 500MG BASE/VIAL A065179 001 Dec 13, 2005
AP GENERAMEDIX EQ 500MG BASE/VIAL A065501 001 Nov 09, 2009
AP HOSPIRA EQ 500MG BASE/VIAL A065500 001 Jun 26, 2009
AP EQ 500MG BASE/VIAL A065511 001 Jun 26, 2009
AP PLIVA HRVATSKA DOO EQ 500MG BASE/VIAL A065265 001 Jan 18, 2007
AP SAGENT STRIDES EQ 500MG BASE/VIAL A065506 001 Mar 24, 2009
AP + TEVA PARENTERAL EQ 500MG BASE/VIAL N050809 001 Dec 19, 2006
ZITHROMAX
AP + PFIZER EQ 500MG BASE/VIAL N050733 001 Jan 30, 1997
AZITHROMYCIN
XX + TEVA PARENTERAL EQ 2.5GM BASE/VIAL N050809 002 Dec 19, 2006
SOLUTION/DROPS; OPHTHALMIC

AZASITE

XX + INSPIRE 1% N050810 001 Apr 27, 2007


TABLET; ORAL
AZITHROMYCIN
AB MYLAN EQ 250MG BASE A065365 001 May 30, 2007
AB EQ 500MG BASE A065366 001 May 30, 2007
AB EQ 600MG BASE A065360 001 Jan 08, 2007
AB PLIVA EQ 250MG BASE A065225 001 Nov 14, 2005
AB EQ 500MG BASE A065223 001 Nov 14, 2005
AB EQ 600MG BASE A065218 001 Nov 14, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 44 (of 393)

AZITHROMYCIN
TABLET; ORAL
AZITHROMYCIN
AB SANDOZ EQ 250MG BASE A065211 001 Nov 14, 2005
AB EQ 500MG BASE A065212 001 Nov 14, 2005
AB EQ 600MG BASE A065209 001 Nov 14, 2005
AB TEVA EQ 250MG BASE A065153 001 Nov 14, 2005
AB EQ 500MG BASE A065193 001 Nov 14, 2005
AB EQ 600MG BASE A065150 001 Nov 14, 2005
AB WOCKHARDT EQ 250MG BASE A065404 001 Feb 11, 2008
AB EQ 500MG BASE A065405 001 Feb 11, 2008
AB EQ 600MG BASE A065302 003 Feb 11, 2008
ZITHROMAX
AB PFIZER EQ 250MG BASE N050711 001 Jul 18, 1996
AB EQ 500MG BASE N050784 001 May 24, 2002
AB + EQ 600MG BASE N050730 001 Jun 12, 1996

AZTREONAM
INJECTABLE; INJECTION

AZACTAM

XX + BRISTOL MYERS SQUIBB 1GM/VIAL N050580 002 Dec 31, 1986


XX + 2GM/VIAL N050580 003 Dec 31, 1986
AZACTAM IN PLASTIC CONTAINER
XX + BRISTOL MYERS SQUIBB 20MG/ML N050632 002 May 24, 1989
XX + 40MG/ML N050632 001 May 24, 1989

BACITRACIN
INJECTABLE; INJECTION
BACIIM
AP X GEN PHARMS 50,000 UNITS/VIAL A064153 001 May 09, 1997
BACITRACIN
AP APP PHARMS 50,000 UNITS/VIAL A065116 001 Dec 03, 2002
AP + PHARMACIA AND UPJOHN 50,000 UNITS/VIAL A060733 002
BACITRACIN

XX PHARMACIA AND UPJOHN 10,000 UNITS/VIAL A060733 001


OINTMENT; OPHTHALMIC

BACITRACIN

XX + ALTANA 500 UNITS/GM A061212 001


POWDER; FOR RX COMPOUNDING

BACI-RX

XX X GEN PHARMS 5,000,000 UNITS/BOT A061580 001


BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


OINTMENT; OPHTHALMIC

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE

XX + BAUSCH AND LOMB 400 UNITS/GM;1%;EQ 3.5MG A064068 001 Oct 30, 1995
BASE/GM;10,000 UNITS/GM

OINTMENT; TOPICAL

CORTISPORIN

XX + MONARCH PHARMS 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 N050168 002 May 04, 1984
UNITS/GM

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


OINTMENT; OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC
AT AKORN 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 A065088 001 Feb 06, 2004
UNITS/GM
AT ALTANA 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 A060764 002
UNITS/GM
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 45 (of 393)

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


OINTMENT; OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC
AT + BAUSCH AND LOMB 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 A064064 001 Oct 30, 1995
UNITS/GM

BACITRACIN ZINC; POLYMYXIN B SULFATE


OINTMENT; OPHTHALMIC
BACITRACIN ZINC AND POLYMYXIN B SULFATE
AT AKORN 500 UNITS/GM;10,000 UNITS/GM A064028 001 Jan 30, 1995
AT ALTANA 500 UNITS/GM;10,000 UNITS/GM A065022 001 Feb 27, 2002
AT + BAUSCH AND LOMB 500 UNITS/GM;10,000 UNITS/GM A064046 001 Jan 26, 1995

BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


OINTMENT; OPHTHALMIC

BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE

XX + PHARMADERM 400 UNITS/GM;1%;EQ 3.5MG A062166 002


BASE/GM;10,000 UNITS/GM

BACLOFEN
INJECTABLE; INTRATHECAL

LIORESAL

XX + MEDTRONIC 0.05MG/ML N020075 003 Nov 07, 1996


XX + 0.5MG/ML N020075 001 Jun 17, 1992
XX + 2MG/ML N020075 002 Jun 17, 1992
TABLET; ORAL
BACLOFEN
AB ACTAVIS TOTOWA 10MG A077089 001 Oct 31, 2007
AB 20MG A077088 001 Oct 31, 2007
AB CARACO 10MG A077984 001 Aug 14, 2006
AB 20MG A077862 002 Aug 14, 2006
AB IMPAX LABS 10MG A078146 001 Oct 26, 2007
AB 20MG A077971 002 Oct 26, 2007
AB IVAX SUB TEVA PHARMS 10MG A072234 001 Jul 21, 1988
AB + 20MG A072235 001 Jul 21, 1988
AB LANNETT 10MG A078220 001 Jul 06, 2007
AB 20MG A077241 001 Dec 20, 2005
AB MYLAN 10MG A077181 001 Jul 29, 2005
AB 20MG A077121 002 Jul 29, 2005
AB NORTHSTAR HLTHCARE 10MG A078504 001 Sep 18, 2009
AB 20MG A078401 001 Sep 18, 2009
AB USL PHARMA 10MG A074584 001 Aug 19, 1996
AB 20MG A074584 002 Aug 19, 1996
AB VINTAGE PHARMS 10MG A077156 001 Aug 30, 2005
AB 20MG A077068 001 Aug 30, 2005
AB WATSON LABS 10MG A072824 001 Sep 18, 1991
AB 20MG A072825 001 Sep 18, 1991
TABLET, ORALLY DISINTEGRATING; ORAL
KEMSTRO
XX SCHWARZ PHARMA 10MG N021589 001 Oct 30, 2003
XX + 20MG N021589 002 Oct 30, 2003

BALSALAZIDE DISODIUM
CAPSULE; ORAL
BALSALAZIDE DISODIUM
AB APOTEX INC 750MG A077883 001 Dec 28, 2007
AB MYLAN 750MG A077807 001 Dec 28, 2007
AB ROXANE 750MG A077806 001 Dec 28, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 46 (of 393)

BALSALAZIDE DISODIUM
CAPSULE; ORAL
COLAZAL
AB + SALIX PHARMS 750MG N020610 001 Jul 18, 2000

BECLOMETHASONE DIPROPIONATE
AEROSOL, METERED; INHALATION

QVAR 40

XX + TEVA GLOBAL 0.04MG/INH N020911 002 Sep 15, 2000

QVAR 80

XX + TEVA GLOBAL 0.08MG/INH N020911 001 Sep 15, 2000

BECLOMETHASONE DIPROPIONATE MONOHYDRATE


SPRAY, METERED; NASAL

BECONASE AQ

XX + GLAXOSMITHKLINE EQ 0.042MG DIPROP/SPRAY N019389 001 Jul 27, 1987

BENAZEPRIL HYDROCHLORIDE
TABLET; ORAL
BENAZEPRIL HYDROCHLORIDE
AB APOTEX INC 5MG A077128 001 Mar 08, 2006
AB 10MG A077128 002 Mar 08, 2006
AB 20MG A077128 003 Mar 08, 2006
AB 40MG A077128 004 Mar 08, 2006
AB AUROBINDO PHARMA 10MG A078212 001 May 22, 2008
AB 20MG A078212 002 May 22, 2008
AB 40MG A078212 003 May 22, 2008
AB BIOKEY 5MG A076820 001 Feb 03, 2006
AB 10MG A076820 002 Feb 03, 2006
AB 20MG A076820 003 Feb 03, 2006
AB 40MG A076820 004 Feb 03, 2006
AB IVAX SUB TEVA PHARMS 5MG A076333 001 Feb 11, 2004
AB 10MG A076333 002 Feb 11, 2004
AB 20MG A076333 003 Feb 11, 2004
AB 40MG A076333 004 Feb 11, 2004
AB KV PHARM 5MG A076118 001 Feb 11, 2004
AB 10MG A076118 002 Feb 11, 2004
AB 20MG A076118 003 Feb 11, 2004
AB 40MG A076118 004 Feb 11, 2004
AB MYLAN 5MG A076430 001 Feb 11, 2004
AB 10MG A076430 002 Feb 11, 2004
AB 20MG A076430 003 Feb 11, 2004
AB 40MG A076430 004 Feb 11, 2004
AB RANBAXY 5MG A076344 001 Feb 11, 2004
AB 10MG A076344 002 Feb 11, 2004
AB 20MG A076344 003 Feb 11, 2004
AB 40MG A076344 004 Feb 11, 2004
AB SANDOZ 5MG A076402 001 Feb 11, 2004
AB 10MG A076402 002 Feb 11, 2004
AB 20MG A076402 003 Feb 11, 2004
AB 40MG A076402 004 Feb 11, 2004
AB TEVA 5MG A076211 001 Feb 11, 2004
AB 10MG A076211 002 Feb 11, 2004
AB 20MG A076211 003 Feb 11, 2004
AB 40MG A076211 004 Feb 11, 2004
AB WATSON LABS FLORIDA 5MG A076267 001 Feb 11, 2004
AB 10MG A076267 002 Feb 11, 2004
AB 20MG A076267 003 Feb 11, 2004
AB 40MG A076267 004 Feb 11, 2004
AB ZYDUS PHARMS USA 5MG A078848 001 May 23, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 47 (of 393)

BENAZEPRIL HYDROCHLORIDE
TABLET; ORAL
BENAZEPRIL HYDROCHLORIDE
AB ZYDUS PHARMS USA 10MG A078848 002 May 23, 2008
AB 20MG A078848 003 May 23, 2008
AB 40MG A078848 004 May 23, 2008
LOTENSIN
AB NOVARTIS 5MG N019851 001 Jun 25, 1991
AB 10MG N019851 002 Jun 25, 1991
AB 20MG N019851 003 Jun 25, 1991
AB + 40MG N019851 004 Jun 25, 1991

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE


TABLET; ORAL
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
AB GENPHARM 5MG;6.25MG A076612 001 Feb 11, 2004
AB 10MG;12.5MG A076612 002 Feb 11, 2004
AB 20MG;12.5MG A076612 003 Feb 11, 2004
AB 20MG;25MG A076612 004 Feb 11, 2004
AB IVAX SUB TEVA PHARMS 5MG;6.25MG A076348 001 Feb 11, 2004
AB 10MG;12.5MG A076348 002 Feb 11, 2004
AB 20MG;12.5MG A076348 003 Feb 11, 2004
AB 20MG;25MG A076348 004 Feb 11, 2004
AB MYLAN 5MG;6.25MG A076688 001 Feb 11, 2004
AB 10MG;12.5MG A076688 002 Feb 11, 2004
AB 20MG;12.5MG A076688 003 Feb 11, 2004
AB 20MG;25MG A076688 004 Feb 11, 2004
AB RANBAXY 5MG;6.25MG A077483 001 Sep 08, 2005
AB 10MG;12.5MG A077483 002 Sep 08, 2005
AB 20MG;12.5MG A077483 003 Sep 08, 2005
AB 20MG;25MG A077483 004 Sep 08, 2005
AB SANDOZ 5MG;6.25MG A076631 001 Feb 11, 2004
AB 10MG;12.5MG A076631 002 Feb 11, 2004
AB 20MG;12.5MG A076631 003 Feb 11, 2004
AB 20MG;25MG A076631 004 Feb 11, 2004
AB WATSON LABS FLORIDA 5MG;6.25MG A076342 001 Feb 11, 2004
AB 10MG;12.5MG A076342 002 Feb 11, 2004
AB 20MG;12.5MG A076342 003 Feb 11, 2004
AB 20MG;25MG A076342 004 Feb 11, 2004
LOTENSIN HCT
AB NOVARTIS 5MG;6.25MG N020033 001 May 19, 1992
AB 10MG;12.5MG N020033 002 May 19, 1992
AB 20MG;12.5MG N020033 004 May 19, 1992
AB + 20MG;25MG N020033 003 May 19, 1992

BENDAMUSTINE HYDROCHLORIDE
POWDER; IV (INFUSION)

TREANDA

XX + CEPHALON 25MG/VIAL N022249 002 May 01, 2009


XX + 100MG/VIAL N022249 001 Mar 20, 2008

BENDROFLUMETHIAZIDE; NADOLOL
TABLET; ORAL
CORZIDE
AB KING PHARMS 5MG;40MG N018647 001 May 25, 1983
AB + 5MG;80MG N018647 002 May 25, 1983
NADOLOL AND BENDROFLUMETHAZIDE
AB MYLAN 5MG;40MG A078688 001 Feb 15, 2008
AB 5MG;80MG A078688 002 Feb 15, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 48 (of 393)

BENDROFLUMETHIAZIDE; NADOLOL
TABLET; ORAL
NADOLOL AND BENDROFLUMETHIAZIDE
AB IMPAX LABS 5MG;40MG A077833 001 Mar 30, 2007
AB 5MG;80MG A077833 002 Mar 30, 2007

BENZONATATE
CAPSULE; ORAL
BENZONATATE
AA BANNER PHARMACAPS 100MG A081297 001 Jan 29, 1993
AA 200MG A081297 002 Oct 30, 2007
AA KV PHARM 100MG A040795 001 Oct 31, 2007
AA 200MG A040795 002 Oct 31, 2007
AA MIKART 100MG A040851 001 Nov 09, 2009
AA 200MG A040851 003 Nov 09, 2009
AA ORIT LABS LLC 100MG A040682 001 Jul 30, 2007
AA 200MG A040682 002 Jul 30, 2007
AA SUN PHARM INDS INC 100MG A040587 001 Mar 19, 2008
AA 200MG A040587 002 Mar 19, 2008
AA THE PHARMA NETWORK 100MG A040627 001 Mar 30, 2007
AA 200MG A040749 001 Jul 25, 2007
AA ZYDUS PHARMS USA 100MG A040597 001 Jun 08, 2007
AA 200MG A040597 002 Jun 08, 2007
TESSALON
AA + FOREST LABS 100MG N011210 001
AA + 200MG N011210 003 Jun 25, 1999
BENZONATATE
XX MIKART 150MG A040851 002 Nov 09, 2009

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE


GEL; TOPICAL
BENZACLIN
AB + SANOFI AVENTIS US 5%;EQ 1% BASE N050756 001 Dec 21, 2000
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
AB DOW PHARM SCIENCES 5%;EQ 1% BASE A065443 001 Aug 11, 2009
BENZACLIN
BT + SANOFI AVENTIS US 5%;EQ 1% BASE N050756 002 Apr 20, 2007
DUAC
BT + STIEFEL 5%;EQ 1% BASE N050741 001 Aug 26, 2002
ACANYA
XX + DOW PHARM SCI 2.5%;1.2% N050819 001 Oct 23, 2008

BENZOYL PEROXIDE; ERYTHROMYCIN


GEL; TOPICAL
BENZAMYCIN
AB + SANOFI AVENTIS US 5%;3% N050557 001 Oct 26, 1984
ERYTHROMYCIN AND BENZOYL PEROXIDE
AB TOLMAR 5%;3% A065112 001 Mar 29, 2004
BENZAMYCIN PAK
XX + SANOFI AVENTIS US 5%;3% N050769 001 Nov 27, 2000

BENZPHETAMINE HYDROCHLORIDE
TABLET; ORAL
BENZPHETAMINE HYDROCHLORIDE
AA COREPHARMA 50MG A040714 001 Oct 29, 2007
AA IMPAX LABS 50MG A040845 001 Nov 18, 2008
AA PADDOCK 50MG A040578 001 Apr 17, 2006
AA TEDOR PHARM 50MG A040747 001 Mar 30, 2007
AA TYCO HLTHCARE 50MG A040773 001 Apr 25, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 49 (of 393)

BENZPHETAMINE HYDROCHLORIDE
TABLET; ORAL
DIDREX
AA + PHARMACIA AND UPJOHN 50MG N012427 002

BENZTROPINE MESYLATE
INJECTABLE; INJECTION
BENZTROPINE MESYLATE
AP HIKMA FARMACEUTICA 1MG/ML A090287 001 Aug 31, 2009
AP NEXUS PHARMS 1MG/ML A090233 001 Jul 28, 2009
COGENTIN
AP + LUNDBECK INC 1MG/ML N012015 001
TABLET; ORAL
BENZTROPINE MESYLATE
AA ACTAVIS TOTOWA 0.5MG A040699 001 Feb 14, 2008
AA 1MG A040705 001 Feb 14, 2008
AA 2MG A040706 001 Feb 14, 2008
AA COREPHARMA 0.5MG A072264 001 Feb 27, 1989
AA 1MG A072265 001 Feb 27, 1989
AA 2MG A072266 001 Feb 27, 1989
AA + PAR PHARM 0.5MG A088877 001 Apr 11, 1985
AA + 1MG A088894 001 Apr 11, 1985
AA + 2MG A088895 001 Apr 11, 1985
AA PLIVA 0.5MG A089058 001 Aug 10, 1988
AA 1MG A089059 001 Aug 10, 1988
AA 2MG A089060 001 Aug 10, 1988
AA USL PHARMA 0.5MG A040103 001 Dec 12, 1996
AA 1MG A040103 002 Dec 12, 1996
AA 2MG A040103 003 Dec 12, 1996
AA VINTAGE 0.5MG A040738 001 Aug 27, 2007
AA 1MG A040742 001 Aug 27, 2007
AA 2MG A040715 003 Aug 27, 2007

BENZYL ALCOHOL
LOTION; TOPICAL

ULESFIA

XX + SCIELE PHARMA INC 5% N022129 001 Apr 09, 2009

BEPOTASTINE BESILATE
SOLUTION/DROPS; OPHTHALMIC

BEPREVE

XX + ISTA PHARMS 1.5% N022288 001 Sep 08, 2009

BERACTANT
SUSPENSION; INTRATRACHEAL

SURVANTA

XX + ROSS LABS 25MG/ML N020032 001 Jul 01, 1991

BESIFLOXACIN HYDROCHLORIDE
SUSPENSION/DROPS; OPHTHALMIC

BESIVANCE

XX + BAUSCH AND LOMB EQ 0.6% BASE N022308 001 May 28, 2009

BETAINE HYDROCHLORIDE
FOR SOLUTION; ORAL

CYSTADANE

XX + RARE DIS THERAP 1GM/SCOOPFUL N020576 001 Oct 25, 1996


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 50 (of 393)

BETAMETHASONE
SYRUP; ORAL

CELESTONE

XX + SCHERING 0.6MG/5ML N014215 002

BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE


INJECTABLE; INJECTION
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
AB PHARMAFORCE 3MG/ML;EQ 3MG BASE/ML A090747 001 Jul 31, 2009
CELESTONE SOLUSPAN
AB + SCHERING 3MG/ML;EQ 3MG BASE/ML N014602 001

BETAMETHASONE DIPROPIONATE
CREAM; TOPICAL
BETAMETHASONE DIPROPIONATE
AB ACTAVIS MID ATLANTIC EQ 0.05% BASE A070885 001 Feb 03, 1987
AB + FOUGERA EQ 0.05% BASE N019137 001 Jun 26, 1984
AB TARO EQ 0.05% BASE A073552 001 Apr 30, 1992
CREAM, AUGMENTED; TOPICAL
BETAMETHASONE DIPROPIONATE
AB ALTANA EQ 0.05% BASE A076215 001 Dec 09, 2003
AB GLENMARK GENERICS EQ 0.05% BASE A078930 001 Sep 23, 2008
AB PERRIGO NEW YORK EQ 0.05% BASE A076592 001 Dec 09, 2003
AB TARO EQ 0.05% BASE A076543 001 Dec 09, 2003
AB TOLMAR EQ 0.05% BASE A076603 001 Jan 23, 2004
DIPROLENE AF
AB + SCHERING EQ 0.05% BASE N019555 001 Apr 27, 1987
GEL, AUGMENTED; TOPICAL
BETAMETHASONE DIPROPIONATE
AB + ALTANA EQ 0.05% BASE A075276 001 May 13, 2003
AB TARO EQ 0.05% BASE A076508 001 Dec 02, 2003
LOTION; TOPICAL
BETAMETHASONE DIPROPIONATE
AB ACTAVIS MID ATLANTIC EQ 0.05% BASE A070281 001 Jul 31, 1985
AB + FOUGERA EQ 0.05% BASE A070275 001 Aug 12, 1985
AB PERRIGO NEW YORK EQ 0.05% BASE A072538 001 Jan 31, 1990
AB TEVA EQ 0.05% BASE A071467 001 Aug 10, 1987
LOTION, AUGMENTED; TOPICAL
BETAMETHASONE DIPROPIONATE
AB ALTANA EQ 0.05% BASE A077111 001 May 21, 2007
AB TARO EQ 0.05% BASE A077477 001 May 21, 2007
DIPROLENE
AB + SCHERING EQ 0.05% BASE N019716 001 Aug 01, 1988
OINTMENT; TOPICAL
BETAMETHASONE DIPROPIONATE
AB ACTAVIS MID ATLANTIC EQ 0.05% BASE A071012 001 Feb 03, 1987
AB + FOUGERA EQ 0.05% BASE N019141 001 Sep 04, 1984
AB TARO EQ 0.05% BASE A074271 001 Sep 15, 1994
OINTMENT, AUGMENTED; TOPICAL
BETAMETHASONE DIPROPIONATE
AB ACTAVIS MID ATLANTIC EQ 0.05% BASE A074304 001 Aug 31, 1995
AB ALTANA EQ 0.05% BASE A075373 001 Jun 22, 1999
AB TARO EQ 0.05% BASE A076753 001 Oct 12, 2004
DIPROLENE
AB + SCHERING EQ 0.05% BASE N018741 001 Jul 27, 1983
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 51 (of 393)

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE


OINTMENT; TOPICAL

TACLONEX

XX + LEO PHARM 0.064%;0.005% N021852 001 Jan 09, 2006


SUSPENSION; TOPICAL

TACLONEX SCALP

XX + LEO PHARM PRODS 0.064%;0.005% N022185 001 May 09, 2008

BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE


CREAM; TOPICAL
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
AB ACTAVIS MID ATLANTIC EQ 0.05% BASE;1% A076002 001 Aug 02, 2002
AB ALTANA EQ 0.05% BASE;1% A075502 001 Jun 05, 2001
AB TARO EQ 0.05% BASE;1% A075673 001 May 29, 2001
LOTRISONE
AB + SCHERING EQ 0.05% BASE;1% N018827 001 Jul 10, 1984
LOTION; TOPICAL
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
AB ALTANA PHARMA EQ 0.05% BASE;1% A076516 001 Jun 16, 2005
AB TARO EQ 0.05% BASE;1% A076493 001 Jul 28, 2004
LOTRISONE
AB + SCHERING PLOUGH RES EQ 0.05% BASE;1% N020010 001 Dec 08, 2000

BETAMETHASONE VALERATE
AEROSOL, FOAM; TOPICAL

LUXIQ

XX + CONNECTICS EQ 0.12% BASE N020934 001 Feb 28, 1999


CREAM; TOPICAL
BETAMETHASONE VALERATE
AB + FOUGERA EQ 0.1% BASE N018861 001 Aug 31, 1983
BETA-VAL
AB TEVA EQ 0.1% BASE N018642 001 Mar 24, 1983
DERMABET
AB TARO EQ 0.1% BASE A072041 001 Jan 06, 1988
VALNAC
AB ACTAVIS MID ATLANTIC EQ 0.1% BASE A070050 001 Oct 10, 1984
LOTION; TOPICAL
BETAMETHASONE VALERATE
AB + FOUGERA EQ 0.1% BASE N018866 001 Aug 31, 1983
AB STAT TRADE EQ 0.1% BASE A070052 001 Jul 31, 1985
BETA-VAL
AB TEVA EQ 0.1% BASE A070072 001 Jun 27, 1985
OINTMENT; TOPICAL
BETAMETHASONE VALERATE
AB ACTAVIS MID ATLANTIC EQ 0.1% BASE A070051 001 Oct 10, 1984
AB + FOUGERA EQ 0.1% BASE N018865 001 Aug 31, 1983

BETAXOLOL
SOLUTION/DROPS; OPHTHALMIC
BETAXOLOL
AT WOCKHARDT EQ 0.5% BASE A078694 001 Nov 16, 2009

BETAXOLOL HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
BETAXOLOL
AT AKORN EQ 0.5% BASE A075386 001 Jun 30, 2000
AT NOVEX EQ 0.5% BASE A075446 001 Sep 28, 2000
BETAXOLOL HYDROCHLORIDE
AT BAUSCH AND LOMB EQ 0.5% BASE A075630 001 Apr 12, 2001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 52 (of 393)

BETAXOLOL HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
BETOPTIC
AT + ALCON EQ 0.5% BASE N019270 001 Aug 30, 1985
SUSPENSION/DROPS; OPHTHALMIC

BETOPTIC S

XX + ALCON EQ 0.25% BASE N019845 001 Dec 29, 1989


TABLET; ORAL
BETAXOLOL HYDROCHLORIDE
AB ACTAVIS TOTOWA 10MG A075541 001 Oct 22, 1999
AB + 20MG A075541 002 Oct 22, 1999
AB KVK TECH 10MG A078962 001 Jun 27, 2008
AB 20MG A078962 002 Jun 27, 2008

BETHANECHOL CHLORIDE
TABLET; ORAL
BETHANECHOL CHLORIDE
AA ACTAVIS TOTOWA 5MG A040552 001 Oct 28, 2004
AA 10MG A040553 001 Oct 28, 2004
AA 25MG A040554 001 Oct 28, 2004
AA AMNEAL PHARM 5MG A040855 001 Nov 21, 2007
AA 10MG A040855 002 Nov 21, 2007
AA 25MG A040855 003 Nov 21, 2007
AA 50MG A040855 004 Nov 21, 2007
AA IMPAX LABS 5MG A040739 001 Nov 01, 2006
AA 10MG A040741 001 Nov 01, 2006
AA 25MG A040740 001 Nov 01, 2006
AA 50MG A040721 004 Nov 01, 2006
AA LANNETT 5MG A040703 001 Mar 27, 2008
AA 10MG A040704 001 Mar 27, 2008
AA 25MG A040678 003 Mar 27, 2008
AA 50MG A040677 001 Mar 27, 2008
AA PHARMAX 5MG A040725 001 Oct 26, 2007
AA 10MG A040726 001 Oct 26, 2007
AA 25MG A040727 001 Oct 26, 2007
AA 50MG A040728 001 Oct 26, 2007
AA SUN PHARM INDS INC 5MG A040897 001 Apr 22, 2009
AA 10MG A040897 002 Apr 22, 2009
AA 25MG A040897 003 Apr 22, 2009
AA 50MG A040897 004 Apr 22, 2009
AA UPSHER SMITH 5MG A040633 001 Jun 01, 2005
AA 10MG A040634 001 Jun 01, 2005
AA 25MG A040635 001 Jun 01, 2005
AA 50MG A040636 001 Jun 01, 2005
AA WOCKHARDT 5MG A040532 001 Sep 29, 2003
AA 10MG A040533 001 Sep 29, 2003
AA 25MG A040534 001 Sep 29, 2003
AA 50MG A040518 001 Sep 29, 2003
DUVOID
AA WELLSPRING PHARM 10MG A086262 001
AA 25MG A086263 001
AA 50MG A085882 003
URECHOLINE
AA + ODYSSEY PHARMS 5MG A089095 001 Dec 19, 1985
AA + 10MG A088440 001 May 29, 1984
AA + 25MG A088441 001 May 29, 1984
AA + 50MG A089096 001 Dec 19, 1985
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 53 (of 393)

BEXAROTENE
CAPSULE; ORAL

TARGRETIN

XX + EISAI INC 75MG N021055 001 Dec 29, 1999


GEL; TOPICAL

TARGRETIN

XX + EISAI INC 1% N021056 001 Jun 28, 2000

BICALUTAMIDE
TABLET; ORAL
BICALUTAMIDE
AB ACCORD HLTHCARE INC 50MG A078917 001 Jul 06, 2009
AB ACTAVIS TOTOWA 50MG A078634 001 Aug 28, 2009
AB KUDCO IRELAND 50MG A077995 001 Jul 06, 2009
AB MYLAN 50MG A079185 001 Jul 06, 2009
AB SANDOZ 50MG A078575 001 Jul 06, 2009
AB SUN PHARMA GLOBAL 50MG A079110 001 Jul 06, 2009
AB SYNTHON PHARMS 50MG A077973 001 Jul 06, 2009
AB TEVA 50MG A076932 001 Jul 06, 2009
AB ZYDUS PHARMS USA INC 50MG A079089 001 Jul 06, 2009
CASODEX
AB + ASTRAZENECA 50MG N020498 001 Oct 04, 1995

BIMATOPROST
SOLUTION/DROPS; OPHTHALMIC

LUMIGAN

XX + ALLERGAN 0.03% N021275 001 Mar 16, 2001


SOLUTION/DROPS; TOPICAL

LATISSE

XX + ALLERGAN 0.03% N022369 001 Dec 24, 2008

BIPERIDEN HYDROCHLORIDE
TABLET; ORAL

AKINETON

XX + ABBOTT 2MG N012003 001

BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM


CHLORIDE
TABLET, DELAYED RELEASE, FOR SOLUTION; ORAL

HALFLYTELY

XX + BRAINTREE 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM N021551 002 Sep 24, 2007


;N/A,5.6GM

BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE


CAPSULE; ORAL

PYLERA

XX + AXCAN SCANDIPHARM 140MG;125MG;125MG N050786 001 Sep 28, 2006

BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE


TABLET, CHEWABLE, TABLET, CAPSULE; ORAL

HELIDAC

XX + PROMETHEUS LABS 262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,5 N050719 001 Aug 15, 1996


00MG

BISOPROLOL FUMARATE
TABLET; ORAL
BISOPRODOL FUMARATE
AB UNICHEM PHARMS (USA) 5MG A078635 001 Aug 18, 2009

AB 10MG A078635 002 Aug 18, 2009

30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 54 (of 393)

BISOPROLOL FUMARATE
TABLET; ORAL
BISOPROLOL FUMARATE
AB AUROBINDO PHARMA 5MG A077910 001 Dec 27, 2006
AB 10MG A077910 002 Dec 27, 2006
AB MYLAN 5MG A075831 001 Dec 14, 2005
AB 10MG A075831 002 Dec 14, 2005
AB SANDOZ 5MG A075643 001 Nov 16, 2000
AB 10MG A075643 002 Nov 16, 2000
AB TEVA PHARMS 5MG A075644 001 Jun 26, 2001
AB 10MG A075644 002 Jun 26, 2001
ZEBETA
AB DURAMED PHARMS BARR 5MG N019982 002 Jul 31, 1992
AB + 10MG N019982 001 Jul 31, 1992

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE


TABLET; ORAL
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
AB ACTAVIS ELIZABETH 2.5MG;6.25MG A075672 001 Sep 25, 2000
AB 5MG;6.25MG A075672 002 Sep 25, 2000
AB 10MG;6.25MG A075672 003 Sep 25, 2000
AB MYLAN 2.5MG;6.25MG A075768 001 Sep 25, 2000
AB 5MG;6.25MG A075768 002 Sep 25, 2000
AB 10MG;6.25MG A075768 003 Sep 25, 2000
AB SANDOZ 2.5MG;6.25MG A075579 001 Sep 25, 2000
AB 5MG;6.25MG A075579 002 Sep 25, 2000
AB 10MG;6.25MG A075579 003 Sep 25, 2000
AB WATSON LABS 2.5MG;6.25MG A075469 001 Sep 25, 2000
AB 5MG;6.25MG A075469 002 Sep 25, 2000
AB 10MG;6.25MG A075469 003 Sep 25, 2000
ZIAC
AB DURAMED PHARMS BARR 2.5MG;6.25MG N020186 003 Mar 26, 1993
AB 5MG;6.25MG N020186 001 Mar 26, 1993
AB + 10MG;6.25MG N020186 002 Mar 26, 1993

BIVALIRUDIN
INJECTABLE; INTRAVENOUS

ANGIOMAX

XX + MEDICINES CO 250MG/VIAL N020873 001 Dec 15, 2000

BLEOMYCIN SULFATE
INJECTABLE; INJECTION
BLENOXANE
AP + BRISTOL MYERS SQUIBB EQ 15 UNITS BASE/VIAL N050443 001
AP + EQ 30 UNITS BASE/VIAL N050443 002 Sep 07, 1995
BLEOMYCIN SULFATE
AP APP PHARMS EQ 15 UNITS BASE/VIAL A065185 001 Jan 28, 2008
AP EQ 30 UNITS BASE/VIAL A065185 002 Jan 28, 2008
AP BEDFORD EQ 15 UNITS BASE/VIAL A065042 002 Oct 17, 2001
AP EQ 30 UNITS BASE/VIAL A065042 001 Oct 17, 2001
AP HOSPIRA EQ 15 UNITS BASE/VIAL A065031 001 Mar 10, 2000
AP EQ 30 UNITS BASE/VIAL A065031 002 Mar 10, 2000
AP PHARMACHEMIE BV EQ 15 UNITS BASE/VIAL A065201 001 Dec 13, 2007
AP TEVA PARENTERAL EQ 15 UNITS BASE/VIAL A065033 001 Jun 27, 2000
AP EQ 30 UNITS BASE/VIAL A065033 002 Jun 27, 2000

BORTEZOMIB
INJECTABLE; INTRAVENOUS

VELCADE

XX + MILLENNIUM PHARMS 3.5MG/VIAL N021602 001 May 13, 2003


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 55 (of 393)

BOSENTAN
TABLET; ORAL
TRACLEER
XX ACTELION 62.5MG N021290 001 Nov 20, 2001
XX + 125MG N021290 002 Nov 20, 2001

BRETYLIUM TOSYLATE
INJECTABLE; INJECTION
BRETYLIUM TOSYLATE
AP + HOSPIRA 50MG/ML N019030 001 Apr 29, 1986
AP LUITPOLD 50MG/ML A070891 001 Jul 26, 1988
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 200MG/100ML N019121 002 Apr 29, 1986
AP + 400MG/100ML N019121 003 Apr 29, 1986
AP + HOSPIRA 200MG/100ML N019008 002 Apr 29, 1986
AP + 400MG/100ML N019008 003 Apr 29, 1986
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
XX + B BRAUN 100MG/100ML N019121 001 Apr 29, 1986

BRIMONIDINE TARTRATE
SOLUTION/DROPS; OPHTHALMIC
ALPHAGAN P
AT + ALLERGAN 0.15% N021262 001 Mar 16, 2001
BRIMONIDINE TARTRATE
AT AKORN 0.2% A076439 001 Mar 14, 2006
AT ALCON 0.2% A076254 001 Sep 16, 2003
AT ALCON RES 0.15% N021764 001 May 22, 2006
AT + BAUSCH AND LOMB 0.2% A076260 001 May 28, 2003
AT SANDOZ 0.2% A078075 001 Jan 30, 2008
AT TEVA PARENTERAL 0.2% A076372 001 Sep 10, 2004
ALPHAGAN P
XX + ALLERGAN 0.1% N021770 001 Aug 19, 2005

BRIMONIDINE TARTRATE; TIMOLOL MALEATE


SOLUTION/DROPS; OPHTHALMIC

COMBIGAN

XX + ALLERGAN 0.2%;0.5% N021398 001 Oct 30, 2007

BRINZOLAMIDE
SUSPENSION/DROPS; OPHTHALMIC

AZOPT

XX + ALCON 1% N020816 001 Apr 01, 1998

BROMFENAC SODIUM
SOLUTION/DROPS; OPHTHALMIC

XIBROM

XX + ISTA PHARMS 0.09% N021664 001 Mar 24, 2005

BROMOCRIPTINE MESYLATE
CAPSULE; ORAL
BROMOCRIPTINE MESYLATE
AB MYLAN EQ 5MG BASE A077226 001 Apr 04, 2005
AB ZYDUS PHARMS USA INC EQ 5MG BASE A078899 001 Jul 30, 2008
PARLODEL
AB + NOVARTIS EQ 5MG BASE N017962 002 Mar 01, 1982
TABLET; ORAL
BROMOCRIPTINE MESYLATE
AB LEK PHARMS EQ 2.5MG BASE A074631 001 Jan 13, 1998
AB MYLAN EQ 2.5MG BASE A076962 001 Sep 24, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 56 (of 393)

BROMOCRIPTINE MESYLATE
TABLET; ORAL
BROMOCRIPTINE MESYLATE
AB PADDOCK EQ 2.5MG BASE A077646 001 Oct 01, 2008
PARLODEL
AB + NOVARTIS EQ 2.5MG BASE N017962 001
CYCLOSET
XX + VEROSCIENCE EQ 0.8MG BASE N020866 001 May 05, 2009

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE


SYRUP; ORAL

BROMFED-DM

XX + MORTON GROVE 2MG/5ML;10MG/5ML;30MG/5ML A088811 001 Jun 07, 1985

BUDESONIDE
CAPSULE; ORAL

ENTOCORT EC

XX + ASTRAZENECA 3MG N021324 001 Oct 02, 2001


POWDER, METERED; INHALATION

PULMICORT

XX + ASTRAZENECA 0.16MG/INH N020441 002 Jun 24, 1997


PULMICORT FLEXHALER
XX ASTRAZENECA 0.08MG/INH N021949 001 Jul 12, 2006
XX + 0.16MG/INH N021949 002 Jul 12, 2006
SPRAY, METERED; NASAL

RHINOCORT

XX + ASTRAZENECA 0.032MG/INH N020746 001 Oct 01, 1999


SUSPENSION; INHALATION
BUDESONIDE
AN APOTEX 0.25MG/2ML A078202 001 Mar 30, 2009
AN 0.5MG/2ML A078202 002 Mar 30, 2009
AN TEVA PARENTERAL 0.25MG/2ML A077519 001 Nov 18, 2008
AN 0.5MG/2ML A077519 002 Nov 18, 2008
PULMICORT RESPULES
AN ASTRAZENECA 0.25MG/2ML N020929 001 Aug 08, 2000
AN 0.5MG/2ML N020929 002 Aug 08, 2000
PULMICORT RESPULES
XX + ASTRAZENECA 1MG/2ML N020929 003 Aug 08, 2000

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE


SPRAY, METERED; INHALATION

SYMBICORT

XX + ASTRAZENECA 0.08MG/INH;0.0045MG/INH N021929 001 Jul 21, 2006


XX + 0.16MG/INH;0.0045MG/INH N021929 002 Jul 21, 2006

BUMETANIDE
INJECTABLE; INJECTION
BUMETANIDE
AP BAXTER HLTHCARE 0.25MG/ML A079196 001 Apr 30, 2008
AP + BEDFORD 0.25MG/ML A074441 001 Jan 27, 1995
AP HOSPIRA 0.25MG/ML A074332 001 Oct 31, 1994
AP TEVA PARENTERAL 0.25MG/ML A074613 001 Nov 18, 1997
TABLET; ORAL
BUMETANIDE
AB IVAX SUB TEVA PHARMS 0.5MG A074225 001 Apr 24, 1995
AB 1MG A074225 002 Apr 24, 1995
AB 2MG A074225 003 Apr 24, 1995
AB SANDOZ 0.5MG A074700 001 Nov 21, 1996
AB 1MG A074700 002 Nov 21, 1996
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 57 (of 393)

BUMETANIDE
TABLET; ORAL
BUMETANIDE
AB + SANDOZ 2MG A074700 003 Nov 21, 1996

BUPIVACAINE HYDROCHLORIDE
INJECTABLE; INJECTION
BUPIVACAINE HYDROCHLORIDE
AP HOSPIRA 0.25% A070583 001 Feb 17, 1987
AP 0.25% A070586 001 Mar 03, 1987
AP 0.25% A070590 001 Feb 17, 1987
AP 0.25% N018053 002
AP 0.5% A070584 001 Feb 17, 1986
AP 0.5% A070597 001 Mar 03, 1987
AP 0.5% A070609 001 Mar 03, 1987
AP 0.5% N018053 001
AP 0.75% A070585 001 Mar 03, 1987
AP 0.75% A070587 001 Mar 03, 1987
AP 0.75% N018053 003
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
AP INTL MEDICATED 0.25% A076012 001 Jan 09, 2002
AP 0.5% A076012 002 Jan 09, 2002
AP 0.75% A076012 003 Jan 09, 2002
MARCAINE HYDROCHLORIDE
AP + HOSPIRA 0.25% N016964 001
AP + 0.5% N016964 006
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
AP + HOSPIRA 0.25% N016964 012
AP + 0.5% N016964 005
AP + 0.75% N016964 009
SENSORCAINE
AP APP PHARMS 0.25% A070552 001 May 21, 1986
AP 0.25% N018304 001
AP 0.5% A070553 001 May 21, 1986
AP 0.5% N018304 002
AP 0.75% A070554 001 May 21, 1986
AP 0.75% N018304 003
INJECTABLE; SPINAL
BUPIVACAINE HYDROCHLORIDE
AP HOSPIRA 0.75% A071810 001 Dec 11, 1987
MARCAINE
AP + HOSPIRA 0.75% N018692 001 May 04, 1984
SENSORCAINE
AP APP PHARMS 0.75% A071202 001 Apr 15, 1987

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE


INJECTABLE; INJECTION

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

XX + HOSPIRA 0.25%;0.005MG/ML A071165 001 Jun 16, 1988


XX 0.25%;0.005MG/ML A071167 001 Jun 16, 1988
XX + 0.5%;0.005MG/ML A071168 001 Jun 16, 1988

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE


INJECTABLE; INJECTION
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
AP SEPTODONT 0.5%;0.0091MG/ML A077250 001 Sep 27, 2006
BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE
AP + HOSPIRA 0.5%;0.0091MG/ML N022046 001 Jul 13, 1983
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
AP + HOSPIRA 0.25%;0.0091MG/ML N016964 004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 58 (of 393)

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE


INJECTABLE; INJECTION
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
AP + HOSPIRA 0.5%;0.0091MG/ML N016964 008
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE
AP + HOSPIRA 0.25%;0.0091MG/ML N016964 013
AP + 0.5%;0.0091MG/ML N016964 007
AP + 0.75%;0.0091MG/ML N016964 010
SENSORCAINE
AP APP PHARMS 0.25%;0.0091MG/ML A070966 001 Oct 13, 1987
AP 0.25%;0.0091MG/ML A070967 001 Oct 13, 1987
AP 0.5%;0.0091MG/ML A070968 001 Oct 13, 1987
AP 0.5%;0.0091MG/ML N018304 004 Sep 02, 1983
AP 0.75%;0.0091MG/ML N018304 005 Sep 02, 1983

BUPRENORPHINE HYDROCHLORIDE
INJECTABLE; INJECTION
BUPRENEX
AP + RECKITT BENCKISER EQ 0.3MG BASE/ML N018401 001
BUPRENORPHINE HYDROCHLORIDE
AP BEDFORD EQ 0.3MG BASE/ML A076931 001 Mar 02, 2005
AP HOSPIRA EQ 0.3MG BASE/ML A074137 001 Jun 03, 1996
AP PHARMAFORCE EQ 0.3MG BASE/ML A078331 001 Mar 27, 2007
TABLET; SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE
AB ROXANE EQ 2MG BASE A078633 001 Oct 08, 2009
AB EQ 8MG BASE A078633 002 Oct 08, 2009
SUBUTEX
AB RECKITT BENCKISER EQ 2MG BASE N020732 002 Oct 08, 2002
AB + EQ 8MG BASE N020732 003 Oct 08, 2002

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE


TABLET; SUBLINGUAL

SUBOXONE

XX RECKITT BENCKISER 2MG;0.5MG


N020733 001 Oct 08, 2002
XX + 8MG;2MG
N020733 002 Oct 08, 2002

BUPROPION HYDROBROMIDE
TABLET, EXTENDED RELEASE; ORAL

APLENZIN

XX + BIOVAIL LABS INTL 174MG


N022108 001 Apr 23, 2008
XX 348MG
N022108 002 Apr 23, 2008
XX 522MG
N022108 003 Apr 23, 2008

BUPROPION HYDROCHLORIDE
TABLET; ORAL
BUPROPION HYDROCHLORIDE
AB APOTEX INC 75MG A076143 001 Jan 17, 2006
AB 100MG A076143 002 Jan 17, 2006
AB MYLAN 75MG A075491 001 Apr 17, 2000
AB 100MG A075491 002 Apr 17, 2000
AB SANDOZ 75MG A075584 001 Feb 07, 2000
AB 100MG A075584 002 Feb 07, 2000
AB TEVA 75MG A075310 001 Nov 29, 1999
AB 100MG A075310 002 Nov 29, 1999
WELLBUTRIN
AB GLAXOSMITHKLINE 75MG N018644 002 Dec 30, 1985
AB + 100MG N018644 003 Dec 30, 1985
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 59 (of 393)

BUPROPION HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL
BUPROPION HYDROCHLORIDE
AB1 ACTAVIS 150MG A077455 002 Mar 12, 2008
AB1 IMPAX LABS 100MG A075913 001 Jan 28, 2004
AB1 150MG A075913 002 Mar 22, 2004
AB1 200MG A076711 001 Dec 03, 2004
AB1 SANDOZ 100MG A075932 001 Nov 25, 2003
AB1 150MG A075932 002 Mar 22, 2004
AB1 200MG A075932 003 Jun 22, 2005
AB1 WATSON LABS 100MG A079095 001 Mar 24, 2009
AB1 150MG A079095 002 Mar 24, 2009
AB1 200MG A079095 003 Mar 24, 2009
WELLBUTRIN SR
AB1 GLAXOSMITHKLINE 100MG N020358 002 Oct 04, 1996
AB1 + 150MG N020358 003 Oct 04, 1996
AB1 200MG N020358 004 Jun 14, 2002
BUPROPION HYDROCHLORIDE
AB2 ACTAVIS 150MG A077475 001 Mar 12, 2008
AB2 IMPAX LABS 150MG A075914 001 May 27, 2004
AB2 WATSON LABS 150MG A079094 001 Mar 24, 2009
ZYBAN
AB2 + GLAXOSMITHKLINE 150MG N020711 003 May 14, 1997
BUPROPION HYDROCHLORIDE
AB3 ACTAVIS 150MG A077285 001 Nov 26, 2008
AB3 300MG A077285 002 Aug 15, 2008
AB3 ANCHEN PHARMS 150MG A077284 001 Dec 14, 2006
AB3 300MG A077284 002 Dec 14, 2006
AB3 IMPAX LABS 150MG A077415 001 Nov 26, 2008
AB3 300MG A077415 002 Dec 15, 2006
AB3 WATSON LABS 150MG A077715 001 Nov 26, 2008
AB3 300MG A077715 002 Jun 13, 2007
WELLBUTRIN XL
AB3 + BIOVAIL LABS INTL 150MG N021515 001 Aug 28, 2003
AB3 300MG N021515 002 Aug 28, 2003
WELLBUTRIN SR
XX GLAXOSMITHKLINE 50MG N020358 001 Oct 04, 1996

BUSPIRONE HYDROCHLORIDE
TABLET; ORAL
BUSPAR
AB BRISTOL MYERS SQUIBB 5MG N018731 001 Sep 29, 1986
AB 10MG N018731 002 Sep 29, 1986
AB + 15MG N018731 003 Apr 22, 1996
BUSPIRONE HYDROCHLORIDE
AB ACTAVIS TOTOWA 5MG A075388 001 May 09, 2002
AB 10MG A075388 002 May 09, 2002
AB 15MG A075388 003 May 09, 2002
AB 30MG A078302 001 Dec 17, 2007
AB APOTEX 5MG A075521 001 Apr 05, 2002
AB 10MG A075521 002 Apr 05, 2002
AB 15MG A075521 003 Apr 05, 2002
AB DR REDDYS LABS LTD 5MG A078246 001 Feb 27, 2009
AB 10MG A078246 002 Feb 27, 2009
AB 15MG A078246 003 Feb 27, 2009
AB 30MG A078246 004 Feb 27, 2009
AB EGIS 5MG A075119 001 Mar 14, 2002
AB 10MG A075119 002 Mar 14, 2002
AB 15MG A075119 003 Jan 23, 2003
AB KV PHARM 5MG A075572 001 Feb 27, 2002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 60 (of 393)

BUSPIRONE HYDROCHLORIDE
TABLET; ORAL
BUSPIRONE HYDROCHLORIDE
AB KV PHARM 10MG A075572 002 Feb 27, 2002
AB 15MG A075572 003 Feb 27, 2002
AB MYLAN 5MG A075272 001 Mar 01, 2002
AB 5MG A075467 001 Feb 28, 2002
AB 7.5MG A075467 002 Mar 28, 2001
AB 10MG A075272 002 Mar 01, 2002
AB 10MG A075467 003 Feb 28, 2002
AB 15MG A075272 003 Mar 28, 2001
AB 15MG A075467 004 Feb 28, 2002
AB 30MG A076008 001 Jun 28, 2001
AB TEVA 5MG A075022 001 Feb 28, 2002
AB 10MG A075022 002 Feb 28, 2002
AB 15MG A075022 003 Feb 28, 2002
AB 30MG A075022 004 Mar 25, 2004
AB WATSON LABS 5MG A074253 001 Mar 28, 2001
AB 10MG A074253 002 Mar 28, 2001
AB 15MG A074253 003 Mar 13, 2002
AB ZENITH GOLDLINE 5MG A075385 001 Mar 01, 2002
AB 10MG A075385 002 Mar 01, 2002
AB 15MG A075385 003 Mar 01, 2002

BUSULFAN
INJECTABLE; INJECTION

BUSULFEX

XX + OTSUKA PHARM 6MG/ML N020954 001 Feb 04, 1999


TABLET; ORAL

MYLERAN

XX + GLAXOSMITHKLINE 2MG N009386 001

BUTABARBITAL SODIUM
ELIXIR; ORAL

BUTISOL SODIUM

XX + MEDA PHARMS 30MG/5ML A085380 001


TABLET; ORAL

BUTISOL SODIUM

XX + MEDA PHARMS 30MG N000793 004


XX + 50MG N000793 003

BUTENAFINE HYDROCHLORIDE
CREAM; TOPICAL

MENTAX

XX + MYLAN BERTEK 1% N020524 001 Oct 18, 1996


MENTAX-TC
XX + MYLAN BERTEK 1% N021408 001 Oct 17, 2002

BUTOCONAZOLE NITRATE
CREAM; VAGINAL

GYNAZOLE-1

XX + KV PHARM 2% N019881 001 Feb 07, 1997

BUTORPHANOL TARTRATE
INJECTABLE; INJECTION
BUTORPHANOL TARTRATE
AP APOTEX INC 2MG/ML A075697 001 Oct 23, 2001
AP BEDFORD 2MG/ML A075046 001 Aug 12, 1998
AP HIKMA FARMACEUTICA 1MG/ML A078400 001 May 01, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 61 (of 393)

BUTORPHANOL TARTRATE
INJECTABLE; INJECTION
BUTORPHANOL TARTRATE
AP HIKMA FARMACEUTICA 2MG/ML A078247 001 Apr 29, 2009
AP 2MG/ML A078400 002 May 01, 2009
BUTORPHANOL TARTRATE PRESERVATIVE FREE
AP APOTEX INC 1MG/ML A075695 001 Oct 23, 2001
AP 2MG/ML A075695 002 Oct 23, 2001
AP BEDFORD 1MG/ML A075045 001 Aug 12, 1998
AP 2MG/ML A075045 002 Aug 12, 1998
AP HOSPIRA 1MG/ML A074626 001 Jan 23, 1997
AP 2MG/ML A074626 002 Jan 23, 1997
STADOL
AP + APOTHECON 2MG/ML N017857 004
STADOL PRESERVATIVE FREE
AP + APOTHECON 1MG/ML N017857 001
AP + 2MG/ML N017857 002
SPRAY, METERED; NASAL
BUTORPHANOL TARTRATE
AB + MYLAN 1MG/SPRAY A075759 001 Aug 08, 2001
AB NOVEX 1MG/SPRAY A075499 001 Dec 04, 2002
AB ROXANE 1MG/SPRAY A075824 001 Mar 12, 2002

CABERGOLINE
TABLET; ORAL
CABERGOLINE
AB COBALT LABS INC 0.5MG A078035 001 Apr 21, 2008
AB IVAX PHARMS INC 0.5MG A077750 001 Mar 07, 2007
AB + PAR PHARM 0.5MG A076310 001 Dec 29, 2005
AB WATSON LABS 0.5MG A077843 001 Jul 03, 2007

CAFFEINE CITRATE
SOLUTION; INTRAVENOUS
CAFCIT
AP + MEAD JOHNSON EQ 30MG BASE/3ML (EQ 10MG BASE/ML) N020793 001 Sep 21, 1999
CAFFEINE CITRATE
AP APP PHARMS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A077997 001 Jul 20, 2007
AP LUITPOLD EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A077906 001 May 15, 2007
AP PADDOCK LABS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A077233 001 Sep 21, 2006
AP SUN PHARM INDS LTD EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A090077 001 Sep 30, 2009
SOLUTION; ORAL
CAFCIT
AA + MEAD JOHNSON EQ 30MG BASE/3ML (EQ 10MG BASE/ML) N020793 002 Apr 12, 2000
CAFFEINE CITRATE
AA APP PHARMS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A078002 001 Jan 31, 2008
AA LUITPOLD EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A090064 001 Nov 20, 2009
AA PHARMAFORCE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A077304 001 Sep 21, 2006
AA SUN PHARM INDS LTD EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A090357 001 Sep 30, 2009

CAFFEINE; ERGOTAMINE TARTRATE


SUPPOSITORY; RECTAL

MIGERGOT

XX + G AND W LABS 100MG;2MG A086557 001 Oct 04, 1983


TABLET; ORAL
CAFERGOT
AA + SANDOZ 100MG;1MG A084294 001
ERGOTAMINE TARTRATE AND CAFFEINE
AA MIKART 100MG;1MG A040590 001 Sep 16, 2005
AA WEST WARD 100MG;1MG A040510 001 Sep 17, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 62 (of 393)

CALCIPOTRIENE
CREAM; TOPICAL

DOVONEX

XX + LEO PHARM 0.005% N020554 001 Jul 22, 1996


SOLUTION; TOPICAL
CALCIPOTRIENE
AT HI TECH PHARMA 0.005% A077579 001 Nov 19, 2009
AT NYCOMED US 0.005% A078305 001 May 06, 2008
AT TOLMAR 0.005% A077029 001 Nov 20, 2009
DOVONEX
AT + LEO PHARM 0.005% N020611 001 Mar 03, 1997

CALCITONIN SALMON RECOMBINANT


SPRAY, METERED; NASAL

FORTICAL

XX + UPSHER SMITH 200 IU/SPRAY N021406 001 Aug 12, 2005

CALCITONIN, SALMON
INJECTABLE; INJECTION

MIACALCIN

XX + NOVARTIS 200 IU/ML N017808 002 Mar 29, 1991


SPRAY, METERED; NASAL
CALCITONIN-SALMON
AB APOTEX INC 200 IU/SPRAY A076396 001 Nov 17, 2008
AB PAR PHARM 200 IU/SPRAY A076979 001 Jun 08, 2009
MIACALCIN
AB + NOVARTIS 200 IU/SPRAY N020313 002 Aug 17, 1995

CALCITRIOL
CAPSULE; ORAL
CALCITRIOL
AB ROXANE 0.25MCG A076917 001 Mar 27, 2006
AB TEVA 0.25MCG A075765 001 Oct 12, 2001
AB 0.5MCG A075765 002 Oct 12, 2001
ROCALTROL
AB VALIDUS PHARMS 0.25MCG N018044 001
AB + 0.5MCG N018044 002
INJECTABLE; INJECTION
CALCIJEX
AP + ABBOTT 0.001MG/ML N018874 001 Sep 25, 1986
AP + 0.002MG/ML N018874 002 Sep 25, 1986
CALCITRIOL
AP AKORN 0.001MG/ML A078066 001 Jan 29, 2008
AP 0.002MG/ML A078066 002 Jan 29, 2008
AP APP PHARMS 0.001MG/ML A075836 001 Dec 31, 2002
AP 0.002MG/ML A075836 002 Dec 31, 2002
AP FRESENIUS MEDCL 0.001MG/ML A075766 001 Feb 20, 2003
AP 0.002MG/ML A075766 002 Feb 20, 2003
AP GENIX THERAP 0.001MG/ML A077102 001 Feb 08, 2006
AP LUITPOLD 0.001MG/ML A075746 001 Sep 26, 2003
AP 0.002MG/ML A075746 002 Sep 26, 2003
AP LYNE 0.001MG/ML A076206 001 Sep 17, 2003
AP TEVA PARENTERAL 0.001MG/ML A075823 001 Mar 31, 2003
AP 0.002MG/ML A075823 002 Mar 31, 2003
OINTMENT; TOPICAL

VECTICAL

XX + GALDERMA LABS LP 3MCG/GM N022087 001 Jan 23, 2009


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 63 (of 393)

CALCITRIOL
SOLUTION; ORAL
CALCITRIOL
AA ROXANE 1MCG/ML A076242 001 Jul 18, 2003
ROCALTROL
AA + VALIDUS PHARMS 1MCG/ML N021068 001 Nov 20, 1998

CALCIUM ACETATE
CAPSULE; ORAL
CALCIUM ACETATE
AB ROXANE EQ 169MG CALCIUM A077728 001 Feb 26, 2008
PHOSLO GELCAPS
AB + FRESENIUS MEDCL EQ 169MG CALCIUM N021160 003 Apr 02, 2001
TABLET; ORAL

ELIPHOS

XX + CYPRESS PHARM EQ 169MG CALCIUM A078502 001 Nov 25, 2008

CALCIUM CHLORIDE
INJECTABLE; INJECTION

CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER


XX + HOSPIRA 100MG/ML N021117 001 Jan 28, 2000

CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM


CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE
SOLUTION; IRRIGATION
BSS PLUS
AT + ALCON 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/M N018469 001
L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M
L
ENDOSOL EXTRA
AT + AKORN 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/M N020079 001 Nov 27, 1991
L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M
L
NAVSTEL
XX + ALCON 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/M N022193 001 Jul 24, 2008
L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M
L

CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE;


SODIUM BICARBONATE; SODIUM CHLORIDE
INJECTABLE; INJECTION

PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER

XX + GAMBRO RENAL PRODS N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0 N021703 010 Oct 10, 2008


5GM/1000ML;0.157GM/1000ML;2.21GM/1000ML
;7.07GM/1000ML
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER
XX + GAMBRO RENAL PRODS N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0 N021703 011 Oct 10, 2008
5GM/1000ML;0.314GM/1000ML;2.21GM/1000ML
;7.07GM/1000ML
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER
XX + GAMBRO RENAL PRODS 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML; N021703 013 Oct 10, 2008
3.05GM/1000ML;0.314GM/1000ML;2.21GM/100
0ML;7.07GM/1000ML
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER
XX + GAMBRO RENAL PRODS 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML; N021703 006 Oct 25, 2006
3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;
6.46GM/1000ML
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER
XX + GAMBRO RENAL PRODS N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.0 N021703 002 Oct 25, 2006
3GM/1000ML;0.157GM/1000ML;3.09GM/1000ML
;6.46GM/1000ML
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 64 (of 393)

CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE;


SODIUM BICARBONATE; SODIUM CHLORIDE
INJECTABLE; INJECTION

PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER


XX + GAMBRO RENAL PRODS 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML; N021703 003 Oct 25, 2006


2.03GM/1000ML;0.157GM/1000ML;3.09GM/100
0ML;6.46GM/1000ML
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER
XX + GAMBRO RENAL PRODS N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.4 N021703 015 Oct 10, 2008
4GM/1000ML;0.314GM/1000ML;3.09GM/1000ML
;6.46GM/1000ML
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER
XX + GAMBRO RENAL PRODS 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML; N021703 004 Oct 25, 2006
3.05GM/1000ML;0.314GM/1000ML;3.09GM/100
0ML;6.46GM/1000ML
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER
XX + GAMBRO RENAL PRODS N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44 N021703 014 Oct 10, 2008
GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46
GM/1000ML
PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER
XX + GAMBRO RENAL PRODS 5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2 N021703 001 Oct 25, 2006
.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6
.46GM/1000ML

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE;


SODIUM CHLORIDE
INJECTABLE; INJECTION

ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER

XX + B BRAUN 37MG/100ML;5GM/100ML;31MG/100ML;120MG/1 N019864 001 Jun 10, 1993


00ML;330MG/100ML;88MG/100ML

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE;


SODIUM CHLORIDE; SODIUM CITRATE
INJECTABLE; INJECTION

ISOLYTE E IN DEXTROSE 5% IN PLASTIC CONTAINER

XX + B BRAUN 35MG/100ML;5GM/100ML;30MG/100ML;74MG/10 N019867 001 Dec 20, 1993


0ML;640MG/100ML;500MG/100ML;74MG/100ML

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE;


SODIUM CHLORIDE; SODIUM LACTATE
INJECTABLE; INJECTION

PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER


XX + BAXTER HLTHCARE 37MG/100ML;5GM/100ML;30MG/100ML;119MG/1 N017390 001


00ML;161MG/100ML;94MG/100ML;138MG/100ML

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE


SOLUTION; INTRAPERITONEAL

DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER

XX + B BRAUN 510MG/100ML;30GM/100ML;200MG/100ML;9.4G N018807 003 Aug 26, 1983


M/100ML;11GM/100ML
XX + 510MG/100ML;30GM/100ML;200MG/100ML;9.2G N018807 001 Aug 26, 1983
M/100ML;9.6GM/100ML
DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER
XX + B BRAUN 510MG/100ML;50GM/100ML;200MG/100ML;9.4G N018807 004 Aug 26, 1983
M/100ML;11GM/100ML
XX + 510MG/100ML;50GM/100ML;200MG/100ML;9.2G N018807 002 Aug 26, 1983
M/100ML;9.6GM/100ML

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE


SOLUTION; INTRAPERITONEAL
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5 N018379 002
67MG/100ML;392MG/100ML
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 65 (of 393)

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE


SOLUTION; INTRAPERITONEAL
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5 N018883 001 Nov 30, 1984
67MG/100ML;392MG/100ML
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N018883 004 Nov 30, 1984
38MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N020171 001 Aug 19, 1992
38MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5 N018379 003
67MG/100ML;392MG/100ML
AT 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5 N018883 002 Nov 30, 1984
67MG/100ML;392MG/100ML
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N018883 005 Nov 30, 1984
38MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N020171 002 Aug 19, 1992
38MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;5 N018379 007 Jun 24, 1988
67MG/100ML;392MG/100ML
DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML; N018379 001
567MG/100ML;392MG/100ML
AT 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML; N018883 003 Nov 30, 1984
567MG/100ML;392MG/100ML
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML; N018883 006 Nov 30, 1984
538MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML; N020171 003 Aug 19, 1992
538MG/100ML;448MG/100ML
DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N018379 004 Jul 07, 1982
38MG/100ML;448MG/100ML
DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N018379 005 Jul 07, 1982
38MG/100ML;448MG/100ML
DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;5 N018379 008 Jun 24, 1988
38MG/100ML;448MG/100ML
DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML; N018379 006 Jul 07, 1982
538MG/100ML;448MG/100ML
DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5 N017512 001
67MG/100ML;392MG/100ML
DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5 N017512 003
67MG/100ML;392MG/100ML
DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML; N017512 002
567MG/100ML;392MG/100ML
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N020183 001 Dec 04, 1992
38MG/100ML;448MG/100ML
DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5 N017512 007 Jul 09, 1984
67MG/100ML;392MG/100ML
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 66 (of 393)

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE


SOLUTION; INTRAPERITONEAL
DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5 N017512 008 Jul 09, 1984
67MG/100ML;392MG/100ML
DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;5 N017512 010 Nov 18, 1985
67MG/100ML;392MG/100ML
DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML; N017512 009 Jul 09, 1984
567MG/100ML;392MG/100ML
DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N017512 004
38MG/100ML;448MG/100ML
AT 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N020163 001 Dec 04, 1992
38MG/100ML;448MG/100ML
DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N017512 005
38MG/100ML;448MG/100ML
AT 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N020163 002 Dec 04, 1992
38MG/100ML;448MG/100ML
DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;5 N017512 011 Nov 18, 1985
38MG/100ML;448MG/100ML
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML; N017512 006
538MG/100ML;448MG/100ML
AT 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML; N020163 003 Dec 04, 1992
538MG/100ML;448MG/100ML
INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT FRESENIUS 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N020374 001 Jun 13, 1994
38MG/100ML;448MG/100ML
INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
AT FRESENIUS 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N020374 002 Jun 13, 1994
38MG/100ML;448MG/100ML
INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
AT FRESENIUS 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML; N020374 004 Jun 13, 1994
538MG/100ML;448MG/100ML
DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER
XX B BRAUN 26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/ N018460 007 Jan 29, 1986
100ML;450MG/100ML
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER
XX B BRAUN 26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/ N018460 005 Nov 02, 1983
100ML;450MG/100ML
DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER
XX B BRAUN 26MG/100ML;4.25GM/100ML;5MG/100ML;530MG N018460 009 Jan 29, 1986
/100ML;450MG/100ML
DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N020183 002 Dec 04, 1992
38MG/100ML;448MG/100ML
DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;5 N020183 003 Dec 04, 1992
38MG/100ML;448MG/100ML
DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML; N020183 004 Dec 04, 1992
538MG/100ML;448MG/100ML
INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
XX FRESENIUS 18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;5 N020374 003 Jun 13, 1994
38MG/100ML;448MG/100ML
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 67 (of 393)

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM


BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE; INTRATHECAL

ELLIOTTS B SOLUTION

XX + QOL MEDCL 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9 N020577 001 Sep 27, 1996


MG/ML;7.3MG/ML;0.2MG/ML

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE


INJECTABLE; INJECTION

DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER


XX + B BRAUN 20MG/100ML;5GM/100ML;30MG/100ML;380MG/1 N018258 001


00ML;600MG/100ML

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE


INJECTABLE; INJECTION
DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER
AP HOSPIRA 33MG/100ML;5GM/100ML;30MG/100ML;860MG/1 N018254 001
00ML
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER
AP B BRAUN 33MG/100ML;5GM/100ML;30MG/100ML;860MG/1 N020000 001 Apr 17, 1992
00ML
AP BAXTER HLTHCARE 33MG/100ML;5GM/100ML;30MG/100ML;860MG/1 N016695 001
00ML

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE


INJECTABLE; INJECTION
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
AP HOSPIRA 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N017608 001
00ML;310MG/100ML
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER
AP B BRAUN 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N019634 003 Feb 24, 1988
00ML;310MG/100ML
LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N016679 001
00ML;310MG/100ML
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019367 006 Apr 05, 1985
100ML;310MG/100ML
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019367 004 Apr 05, 1985
100ML;310MG/100ML
AP 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019367 005 Apr 05, 1985
100ML;310MG/100ML
AP HOSPIRA 20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019685 002 Oct 17, 1988
100ML;310MG/100ML
AP 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019685 008 Oct 17, 1988
100ML;310MG/100ML
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019367 007 Apr 05, 1985
100ML;310MG/100ML
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019367 008 Apr 05, 1985
100ML;310MG/100ML
AP HOSPIRA 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019685 004 Oct 17, 1988
100ML;310MG/100ML
DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER
XX B BRAUN 10MG/100ML;2.5GM/100ML;15MG/100ML;300MG N019634 001 Feb 24, 1988
/100ML;160MG/100ML
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 20MG/100ML;5GM/100ML;105MG/100ML;600MG/ N019367 002 Apr 05, 1985
100ML;310MG/100ML
XX 20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019367 003 Apr 05, 1985
100ML;310MG/100ML
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 68 (of 393)

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE


INJECTABLE; INJECTION
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 20MG/100ML;5GM/100ML;105MG/100ML;600MG/ N019367 001 Apr 05, 1985
100ML;310MG/100ML

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM


CHLORIDE
INJECTABLE; INJECTION

TPN ELECTROLYTES IN PLASTIC CONTAINER

XX + HOSPIRA 16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML; N018895 001 Jul 20, 1984


16.1MG/ML

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM


CHLORIDE; SODIUM CITRATE
INJECTABLE; INJECTION

ISOLYTE E IN PLASTIC CONTAINER

XX + B BRAUN 35MG/100ML;30MG/100ML;74MG/100ML;640MG/ N019718 001 Sep 29, 1989


100ML;500MG/100ML;74MG/100ML

SOLUTION; IRRIGATION
BALANCED SALT
AT AKORN 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6 A075503 001 Sep 27, 2006
.4MG/ML;1.7MG/ML
BSS
AT + ALCON 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6 N020742 001 Dec 10, 1997
.4MG/ML;1.7MG/ML

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM


CHLORIDE; SODIUM LACTATE
INJECTABLE; INJECTION

PLASMA-LYTE R IN PLASTIC CONTAINER


XX + BAXTER HLTHCARE 36.8MG/100ML;30.5MG/100ML;74.6MG/100ML; N017438 001


640MG/100ML;496MG/100ML;89.6MG/100ML

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE


SOLUTION; PERFUSION, CARDIAC
CARDIOPLEGIC IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 17.6MG/100ML;325.3MG/100ML;119.3MG/100M A075323 001 Apr 21, 2000
L;643MG/100ML
PLEGISOL IN PLASTIC CONTAINER
AT + HOSPIRA 17.6MG/100ML;325.3MG/100ML;119.3MG/100M N018608 001 Feb 26, 1982
L;643MG/100ML

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE


INJECTABLE; INJECTION
RINGER'S IN PLASTIC CONTAINER
AP B BRAUN 33MG/100ML;30MG/100ML;860MG/100ML N020002 001 Apr 17, 1992
AP BAXTER HLTHCARE 33MG/100ML;30MG/100ML;860MG/100ML N016693 001
AP HOSPIRA 33MG/100ML;30MG/100ML;860MG/100ML N018251 001
SOLUTION; IRRIGATION
RINGER'S IN PLASTIC CONTAINER
AT B BRAUN 33MG/100ML;30MG/100ML;860MG/100ML N018156 001
AT BAXTER HLTHCARE 33MG/100ML;30MG/100ML;860MG/100ML N018495 001 Feb 19, 1982
AT HOSPIRA 33MG/100ML;30MG/100ML;860MG/100ML N017635 001

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE


INJECTABLE; INJECTION
LACTATED RINGER'S IN PLASTIC CONTAINER
AP B BRAUN 20MG/100ML;30MG/100ML;600MG/100ML;310MG N019632 001 Feb 29, 1988
/100ML
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 69 (of 393)

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE


INJECTABLE; INJECTION
LACTATED RINGER'S IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20MG/100ML;30MG/100ML;600MG/100ML;310MG N016682 001
/100ML
AP HOSPIRA 20MG/100ML;30MG/100ML;600MG/100ML;310MG N017641 001
/100ML
SOLUTION; IRRIGATION
LACTATED RINGER'S IN PLASTIC CONTAINER
AT B BRAUN 20MG/100ML;30MG/100ML;600MG/100ML;310MG N018681 001 Dec 27, 1982
/100ML
AT BAXTER HLTHCARE 20MG/100ML;30MG/100ML;600MG/100ML;310MG N018494 001 Feb 19, 1982
/100ML
AT 20MG/100ML;30MG/100ML;600MG/100ML;310MG N018921 001 Apr 03, 1984
/100ML
AT 20MG/100ML;30MG/100ML;600MG/100ML;310MG N019933 001 Aug 29, 1989
/100ML
AT HOSPIRA 20MG/100ML;30MG/100ML;600MG/100ML;310MG N019416 001 Jan 17, 1986
/100ML

CALFACTANT
SUSPENSION; INTRATRACHEAL

INFASURF PRESERVATIVE FREE


XX + ONY 35MG/ML N020521 001 Jul 01, 1998

CANDESARTAN CILEXETIL
TABLET; ORAL
ATACAND
XX ASTRAZENECA 4MG N020838 001 Jun 04, 1998
XX 8MG N020838 002 Jun 04, 1998
XX 16MG N020838 003 Jun 04, 1998
XX + 32MG N020838 004 Jun 04, 1998

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE


TABLET; ORAL
ATACAND HCT
XX ASTRAZENECA 16MG;12.5MG N021093 001 Sep 05, 2000
XX 32MG;12.5MG N021093 002 Sep 05, 2000
XX + 32MG;25MG N021093 003 May 16, 2008

CAPECITABINE
TABLET; ORAL
XELODA
XX HOFFMANN LA ROCHE 150MG N020896 001 Apr 30, 1998
XX + 500MG N020896 002 Apr 30, 1998

CAPREOMYCIN SULFATE
INJECTABLE; INJECTION

CAPASTAT SULFATE

XX + AKORN EQ 1GM BASE/VIAL N050095 001

CAPSAICIN
PATCH; TOPICAL

QUTENZA

XX + NEUROGESX 8% N022395 001 Nov 16, 2009

CAPTOPRIL
TABLET; ORAL
CAPOTEN
AB PAR PHARM 12.5MG N018343 005 Jan 17, 1985
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 70 (of 393)

CAPTOPRIL
TABLET; ORAL
CAPOTEN
AB PAR PHARM 25MG N018343 002
AB 50MG N018343 001
AB + 100MG N018343 003
CAPTOPRIL
AB APOTEX 12.5MG A074737 001 Oct 28, 1998
AB 25MG A074737 002 Oct 28, 1998
AB 50MG A074737 003 Oct 28, 1998
AB 100MG A074737 004 Oct 28, 1998
AB KALI LABS 12.5MG A074477 001 Feb 13, 1996
AB 25MG A074477 002 Feb 13, 1996
AB 50MG A074477 003 Feb 13, 1996
AB 100MG A074477 004 Feb 13, 1996
AB MYLAN 12.5MG A074434 001 Feb 13, 1996
AB 25MG A074434 002 Feb 13, 1996
AB 50MG A074434 003 Feb 13, 1996
AB 100MG A074434 004 Feb 13, 1996
AB SANDOZ 12.5MG A074363 001 Nov 09, 1995
AB 25MG A074363 002 Nov 09, 1995
AB 50MG A074363 003 Nov 09, 1995
AB 100MG A074363 004 Nov 09, 1995
AB STASON 12.5MG A074677 004 May 30, 1997
AB 25MG A074677 002 May 30, 1997
AB 50MG A074677 001 May 30, 1997
AB 100MG A074677 003 May 30, 1997
AB TEVA 12.5MG A074322 001 Feb 13, 1996
AB 12.5MG A074483 001 Feb 13, 1996
AB 25MG A074322 002 Feb 13, 1996
AB 25MG A074483 002 Feb 13, 1996
AB 50MG A074322 003 Feb 13, 1996
AB 50MG A074483 003 Feb 13, 1996
AB 100MG A074322 004 Feb 13, 1996
AB 100MG A074483 004 Feb 13, 1996
AB WATSON LABS 12.5MG A074386 001 May 23, 1996
AB 12.5MG A074451 001 Feb 13, 1996
AB 25MG A074386 002 May 23, 1996
AB 25MG A074451 002 Feb 13, 1996
AB 50MG A074386 003 May 23, 1996
AB 50MG A074451 003 Feb 13, 1996
AB 100MG A074386 004 May 23, 1996
AB 100MG A074451 004 Feb 13, 1996
AB WEST WARD 12.5MG A074505 001 Feb 13, 1996
AB 25MG A074505 002 Feb 13, 1996
AB 50MG A074505 003 Feb 13, 1996
AB 100MG A074505 004 Feb 13, 1996
AB WOCKHARDT 12.5MG A074532 001 Mar 28, 1997
AB 25MG A074532 002 Mar 28, 1997
AB 50MG A074532 003 Mar 28, 1997
AB 100MG A074532 004 Mar 28, 1997

CAPTOPRIL; HYDROCHLOROTHIAZIDE
TABLET; ORAL
CAPOZIDE 25/15
AB APOTHECON 25MG;15MG N018709 001 Oct 12, 1984
CAPOZIDE 25/25
AB + APOTHECON 25MG;25MG N018709 002 Oct 12, 1984
CAPOZIDE 50/15
AB + APOTHECON 50MG;15MG N018709 004 Oct 12, 1984
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 71 (of 393)

CAPTOPRIL; HYDROCHLOROTHIAZIDE
TABLET; ORAL
CAPOZIDE 50/25
AB APOTHECON 50MG;25MG N018709 003 Oct 12, 1984
CAPTOPRIL AND HYDROCHLOROTHIAZIDE
AB IVAX SUB TEVA PHARMS 25MG;15MG A075055 001 Jun 18, 1998
AB 25MG;25MG A075055 002 Jun 18, 1998
AB 50MG;15MG A075055 004 Jun 18, 1998
AB 50MG;25MG A075055 003 Jun 18, 1998
AB MYLAN 25MG;15MG A074896 001 Dec 29, 1997
AB 25MG;25MG A074896 002 Dec 29, 1997
AB 50MG;15MG A074896 004 Dec 29, 1997
AB 50MG;25MG A074896 003 Dec 29, 1997
AB TEVA 25MG;15MG A074827 001 Dec 29, 1997
AB 25MG;25MG A074827 002 Dec 29, 1997
AB 50MG;15MG A074827 004 Dec 29, 1997
AB 50MG;25MG A074827 003 Dec 29, 1997

CARBACHOL
SOLUTION; INTRAOCULAR

MIOSTAT

XX + ALCON 0.01% N016968 001

CARBAMAZEPINE
CAPSULE, EXTENDED RELEASE; ORAL
CARBATROL
XX SHIRE 100MG N020712 003 Sep 30, 1997
XX 200MG N020712 001 Sep 30, 1997
XX + 300MG N020712 002 Sep 30, 1997
EQUETRO
XX VALIDUS PHARMS INC 100MG N021710 001 Dec 10, 2004
XX 200MG N021710 002 Dec 10, 2004
XX + 300MG N021710 003 Dec 10, 2004
SUSPENSION; ORAL
CARBAMAZEPINE
AB MORTON GROVE 100MG/5ML A075714 001 Jun 05, 2002
TEGRETOL
AB + NOVARTIS 100MG/5ML N018927 001 Dec 18, 1987
TERIL
AB TARO 100MG/5ML A076729 001 Sep 20, 2004
TABLET; ORAL
CARBAMAZEPINE
AB APOTEX INC 200MG A075948 001 Feb 27, 2002
AB INWOOD LABS 200MG A070231 001 Aug 14, 1986
AB TARO 200MG A074649 001 Oct 03, 1996
AB TORRENT PHARMS 200MG A077272 002 Dec 07, 2005
EPITOL
AB TEVA 200MG A070541 001 Sep 17, 1986
TEGRETOL
AB + NOVARTIS 200MG N016608 001
CARBAMAZEPINE
XX TORRENT PHARMS 100MG A077272 001 Dec 07, 2005
XX 300MG A077272 003 Dec 07, 2005
XX 400MG A077272 004 Dec 07, 2005
TABLET, CHEWABLE; ORAL
CARBAMAZEPINE
AB TARO PHARM INDS 100MG A075687 001 Oct 24, 2000
AB TORRENT PHARMS 100MG A075712 001 Jul 05, 2001
EPITOL
AB TEVA 100MG A073524 001 Jul 29, 1992
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 72 (of 393)

CARBAMAZEPINE
TABLET, CHEWABLE; ORAL
TEGRETOL
AB + NOVARTIS 100MG N018281 001
CARBAMAZEPINE
XX + TARO PHARM INDS 200MG A075687 002 Jul 29, 2002
TABLET, EXTENDED RELEASE; ORAL
CARBAMAZEPINE
AB TARO 100MG A078115 001 Mar 31, 2009
AB 200MG A078115 002 Mar 31, 2009
AB 400MG A078115 003 Mar 31, 2009
TEGRETOL-XR
AB NOVARTIS 100MG N020234 001 Mar 25, 1996
AB 200MG N020234 002 Mar 25, 1996
AB + 400MG N020234 003 Mar 25, 1996

CARBIDOPA
TABLET; ORAL

LODOSYN

XX + BRISTOL MYERS SQUIBB 25MG N017830 001

CARBIDOPA; ENTACAPONE; LEVODOPA


TABLET; ORAL

STALEVO 100

XX ORION 25MG;200MG;100MG N021485 002 Jun 11, 2003


STALEVO 125

XX ORION 31.25MG;200MG;125MG N021485 006 Aug 29, 2008

STALEVO 150

XX ORION 37.5MG;200MG;150MG N021485 003 Jun 11, 2003


STALEVO 200

XX + ORION 50MG;200MG;200MG N021485 004 Aug 02, 2007

STALEVO 50

XX + ORION 12.5MG;200MG;50MG N021485 001 Jun 11, 2003


STALEVO 75

XX ORION 18.75MG;200MG;75MG N021485 005 Aug 29, 2008


CARBIDOPA; LEVODOPA
TABLET; ORAL
CARBIDOPA AND LEVODOPA
AB ACTAVIS ELIZABETH 10MG;100MG A074260 001 Sep 03, 1993
AB 25MG;100MG A074260 002 Sep 03, 1993
AB 25MG;250MG A074260 003 Sep 03, 1993
AB APOTEX INC 10MG;100MG A077120 001 Jun 02, 2008
AB 25MG;100MG A077120 002 Jun 02, 2008
AB 25MG;250MG A077120 003 Jun 02, 2008
AB MYLAN 10MG;100MG A090324 001 Sep 28, 2009
AB 25MG;100MG A090324 002 Sep 28, 2009
AB 25MG;250MG A090324 003 Sep 28, 2009
AB SUN PHARM INDS 10MG;100MG A078536 001 Oct 28, 2008
AB 25MG;100MG A078536 002 Oct 28, 2008
AB 25MG;250MG A078536 003 Oct 28, 2008
AB TEVA 10MG;100MG A073618 001 Aug 28, 1992
AB 25MG;100MG A073589 001 Aug 28, 1992
AB 25MG;250MG A073607 001 Aug 28, 1992
SINEMET
AB BRISTOL MYERS SQUIBB 10MG;100MG N017555 001
AB 25MG;100MG N017555 003
AB + 25MG;250MG N017555 002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 73 (of 393)

CARBIDOPA; LEVODOPA
TABLET, EXTENDED RELEASE; ORAL
CARBIDOPA AND LEVODOPA
AB APOTEX 25MG;100MG A076212 001 Jun 16, 2004
AB 50MG;200MG A076212 002 Jun 16, 2004
AB IMPAX LABS 25MG;100MG A076521 001 May 14, 2004
AB 50MG;200MG A076521 002 May 14, 2004
AB MYLAN 25MG;100MG A075091 002 Apr 21, 2000
AB 50MG;200MG A075091 001 Sep 30, 1999
AB SUN PHARM INDS 25MG;100MG A077828 001 Aug 23, 2007
AB 50MG;200MG A077828 002 Aug 23, 2007
SINEMET CR
AB BRISTOL MYERS SQUIBB 25MG;100MG N019856 002 Dec 24, 1992
AB + 50MG;200MG N019856 001 May 30, 1991
TABLET, ORALLY DISINTEGRATING; ORAL
CARBIDOPA AND LEVODOPA
AB MYLAN 10MG;100MG A078893 001 Sep 18, 2008
AB 25MG;100MG A078893 002 Sep 18, 2008
AB 25MG;250MG A078893 003 Sep 18, 2008
AB SUN PHARM INDS 10MG;100MG A078690 001 Jul 31, 2009
AB 25MG;100MG A078690 002 Jul 31, 2009
AB 25MG;250MG A078690 003 Jul 31, 2009
PARCOPA
AB SCHWARZ PHARMA 10MG;100MG A076699 001 Aug 27, 2004
AB 25MG;100MG A076699 002 Aug 27, 2004
AB + 25MG;250MG A076699 003 Aug 27, 2004

CARBINOXAMINE MALEATE
SOLUTION; ORAL
CARBINOXAMINE MALEATE
AA BOCA PHARMA 4MG/5ML A040814 001 Feb 26, 2008
AA + MIKART 4MG/5ML A040458 001 Apr 25, 2003
TABLET; ORAL
CARBINOXAMINE MALEATE
AA BOCA PHARMA 4MG A040639 002 May 30, 2008
AA + MIKART 4MG A040442 001 Mar 19, 2003

CARBOPLATIN
INJECTABLE; INJECTION
CARBOPLATIN
AP APP PHARMS 50MG/VIAL A076235 001 Oct 14, 2004
AP 150MG/VIAL A076235 002 Oct 14, 2004
AP 450MG/VIAL A076235 003 Oct 14, 2004
AP BEDFORD 50MG/VIAL A076099 001 Oct 14, 2004
AP 150MG/VIAL A076099 002 Oct 14, 2004
AP 450MG/VIAL A076099 003 Oct 14, 2004
AP PLIVA 50MG/VIAL A076602 001 Nov 16, 2004
AP 150MG/VIAL A076602 002 Nov 16, 2004
AP 450MG/VIAL A076602 003 Nov 16, 2004
AP SANDOZ 50MG/VIAL A076959 001 Mar 18, 2005
AP 150MG/VIAL A076959 002 Mar 18, 2005
AP 450MG/VIAL A076959 003 Mar 18, 2005
AP + WATSON LABS 50MG/VIAL A076162 001 Oct 14, 2004
AP 50MG/VIAL A077383 001 Jan 27, 2006
AP + 150MG/VIAL A076162 002 Oct 14, 2004
AP 150MG/VIAL A077383 002 Jan 27, 2006
AP + 450MG/VIAL A076162 003 Oct 14, 2004
AP 450MG/VIAL A077383 003 Jan 27, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 74 (of 393)

CARBOPLATIN
INJECTABLE; IV (INFUSION)
CARBOPLATIN
AP AKORN 50MG/5ML (10MG/ML) A090475 001 Jul 29, 2009
AP 150MG/15ML (10MG/ML) A090475 002 Jul 29, 2009
AP 450MG/45ML (10MG/ML) A090475 003 Jul 29, 2009
AP APP PHARMS 50MG/5ML (10MG/ML) A077266 001 Feb 15, 2006
AP 150MG/15ML (10MG/ML) A077266 002 Feb 15, 2006
AP 450MG/45ML (10MG/ML) A077247 003 Oct 21, 2004
AP 450MG/45ML (10MG/ML) A077266 003 Feb 15, 2006
AP 600MG/60ML (10MG/ML) A077266 004 Feb 15, 2006
AP BEDFORD LABS 50MG/5ML (10MG/ML) A077244 001 Oct 15, 2004
AP 150MG/15ML (10MG/ML) A077244 002 Oct 15, 2004
AP 450MG/45ML (10MG/ML) A077244 003 Oct 15, 2004
AP 600MG/60ML (10MG/ML) A077244 004 Jan 20, 2006
AP EBEWE PHARMA 50MG/5ML (10MG/ML) A078280 001 May 08, 2008
AP 150MG/15ML (10MG/ML) A078280 002 May 08, 2008
AP 450MG/45ML (10MG/ML) A078280 003 May 08, 2008
AP FRESENIUS KABI ONCOL 50MG/5ML (10MG/ML) A077432 001 Sep 29, 2006
AP 150MG/15ML (10MG/ML) A077432 002 Sep 29, 2006
AP 450MG/45ML (10MG/ML) A077432 003 Sep 29, 2006
AP GENERAMEDIX 50MG/5ML (10MG/ML) A077998 001 Apr 24, 2007
AP 150MG/15ML (10MG/ML) A077998 002 Apr 24, 2007
AP 450MG/45ML (10MG/ML) A077998 003 Apr 24, 2007
AP HOSPIRA 50MG/5ML (10MG/ML) A076517 001 Oct 14, 2004
AP 150MG/15ML (10MG/ML) A076517 002 Oct 14, 2004
AP 450MG/45ML (10MG/ML) A076517 003 Oct 14, 2004
AP 600MG/60ML (10MG/ML) A077059 001 Nov 23, 2004
AP + PHARMACHEMIE 50MG/5ML (10MG/ML) A077269 001 Oct 14, 2004
AP + 150MG/15ML (10MG/ML) A077269 002 Oct 14, 2004
AP + 450MG/45ML (10MG/ML) A077269 003 Oct 14, 2004
AP + 600MG/60ML (10MG/ML) A077269 004 Dec 28, 2007
AP PHARMACHEMIE BV 50MG/5ML (10MG/ML) A077679 001 Feb 25, 2009
AP 150MG/15ML (10MG/ML) A077679 002 Feb 25, 2009
AP 450MG/45ML (10MG/ML) A077679 003 Feb 25, 2009
AP PLIVA LACHEMA 50MG/5ML (10MG/ML) A078631 001 Dec 02, 2008
AP 150MG/15ML (10MG/ML) A078631 002 Dec 02, 2008
AP 450MG/45ML (10MG/ML) A078631 003 Dec 02, 2008
AP 600MG/60ML (10MG/ML) A078631 004 Dec 02, 2008
AP SUN PHARM INDS 50MG/5ML (10MG/ML) A077926 001 Sep 19, 2008
AP 150MG/15ML (10MG/ML) A077926 002 Sep 19, 2008
AP 450MG/45ML (10MG/ML) A077926 003 Sep 19, 2008
AP + TEVA PARENTERAL 50MG/5ML (10MG/ML) A077139 001 Sep 21, 2005
AP 50MG/5ML (10MG/ML) A077389 001 Mar 30, 2007
AP + 150MG/15ML (10MG/ML) A077139 002 Sep 21, 2005
AP 150MG/15ML (10MG/ML) A077389 002 Mar 30, 2007
AP + 450MG/45ML (10MG/ML) A077139 003 Sep 21, 2005
AP 450MG/45ML (10MG/ML) A077389 003 Mar 30, 2007
AP + 600MG/60ML (10MG/ML) A077139 004 Sep 21, 2005
AP WATSON LABS 50MG/5ML (10MG/ML) A077861 001 Jan 18, 2007
AP 150MG/15ML (10MG/ML) A077861 002 Jan 18, 2007
AP 450MG/45ML (10MG/ML) A077861 003 Jan 18, 2007
AP 600MG/60ML (10MG/ML) A077861 004 Jan 18, 2007
PARAPLATIN
AP + BRISTOL MYERS SQUIBB 50MG/5ML (10MG/ML) N020452 001 Jul 14, 2003
AP + 150MG/15ML (10MG/ML) N020452 002 Jul 14, 2003
AP + 450MG/45ML (10MG/ML) N020452 003 Jul 14, 2003
AP + 600MG/60ML (10MG/ML) N020452 004 Jan 15, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 75 (of 393)

CARBOPROST TROMETHAMINE
INJECTABLE; INJECTION

HEMABATE

XX + PHARMACIA AND UPJOHN EQ 0.25MG BASE/ML N017989 001

CARISOPRODOL
TABLET; ORAL
CARISOPRODOL
AA ACTAVIS TOTOWA 350MG A040188 001 Mar 07, 1997
AA ADVENT PHARMS 350MG A040576 001 Jun 07, 2005
AA AUROBINDO PHARMA 350MG A040792 001 Aug 06, 2009
AA CONCORD LABS NJ 350MG A040823 001 Oct 22, 2008
AA COREPHARMA 350MG A040397 001 Sep 21, 2000
AA MUTUAL PHARM 350MG A089346 001 Oct 17, 1991
AA SUN PHARM INDS LTD 350MG A040755 001 Feb 27, 2007
AA VINTAGE PHARMS 350MG A040245 001 Sep 08, 1997
AA WATSON LABS 350MG A087499 001 Apr 20, 1982
AA WEST WARD 350MG A040124 001 Jan 24, 1996
SOMA
AA MEDA PHARMS 350MG N011792 001
SOMA
XX + MEDA PHARMS 250MG N011792 004 Sep 13, 2007

CARMUSTINE
IMPLANT; INTRACRANIAL

GLIADEL

XX + EISAI INC 7.7MG N020637 001 Sep 23, 1996


INJECTABLE; INJECTION

BICNU

XX + BRISTOL 100MG/VIAL N017422 001

CARTEOLOL HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
CARTEOLOL HYDROCHLORIDE
AT ALCON 1% A075476 001 Jan 03, 2000
AT BAUSCH AND LOMB 1% A075546 001 Jan 20, 2000
AT NOVEX 1% A076097 001 Feb 06, 2002
OCUPRESS
AT + NOVARTIS 1% N019972 001 May 23, 1990

CARVEDILOL
TABLET; ORAL
CARVEDILOL
AB ACTAVIS ELIZABETH 3.125MG A078384 001 Sep 05, 2007
AB 6.25MG A078384 002 Sep 05, 2007
AB 12.5MG A078384 003 Sep 05, 2007
AB 25MG A078384 004 Sep 05, 2007
AB APOTEX INC 3.125MG A078165 001 Sep 05, 2007
AB 6.25MG A078165 002 Sep 05, 2007
AB 12.5MG A078165 003 Sep 05, 2007
AB 25MG A078165 004 Sep 05, 2007
AB AUROBINDO PHARMA 3.125MG A078332 001 Sep 05, 2007
AB 6.25MG A078332 002 Sep 05, 2007
AB 12.5MG A078332 003 Sep 05, 2007
AB 25MG A078332 004 Sep 05, 2007
AB CARACO 3.125MG A077346 004 Sep 05, 2007
AB 6.25MG A077346 001 Sep 05, 2007
AB 12.5MG A077346 002 Sep 05, 2007
AB 25MG A077346 003 Sep 05, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 76 (of 393)

CARVEDILOL
TABLET; ORAL
CARVEDILOL
AB DR REDDYS LABS LTD 3.125MG A076649 001 Sep 05, 2007
AB 6.25MG A076649 002 Sep 05, 2007
AB 12.5MG A076649 003 Sep 05, 2007
AB 25MG A076649 004 Sep 05, 2007
AB GLENMARK GENERICS 3.125MG A078251 001 Sep 05, 2007
AB 6.25MG A078251 002 Sep 05, 2007
AB 12.5MG A078251 003 Sep 05, 2007
AB 25MG A078251 004 Sep 05, 2007
AB HIKMA 3.125MG A077887 001 Sep 07, 2007
AB 6.25MG A077887 002 Sep 07, 2007
AB 12.5MG A077887 003 Sep 07, 2007
AB 25MG A077887 004 Sep 07, 2007
AB LUPIN 3.125MG A078217 001 Sep 05, 2007
AB 6.25MG A078217 002 Sep 05, 2007
AB 12.5MG A078217 003 Sep 05, 2007
AB 25MG A078217 004 Sep 05, 2007
AB MYLAN 3.125MG A077316 001 Sep 05, 2007
AB 6.25MG A077316 002 Sep 05, 2007
AB 12.5MG A077316 003 Sep 05, 2007
AB 25MG A077316 004 Sep 05, 2007
AB PLIVA HRVATSKA DOO 3.125MG A078240 001 Oct 30, 2007
AB 6.25MG A078240 002 Oct 30, 2007
AB 12.5MG A078240 003 Oct 30, 2007
AB 25MG A078240 004 Oct 30, 2007
AB RANBAXY 3.125MG A076989 001 Sep 05, 2007
AB 6.25MG A076989 002 Sep 05, 2007
AB 12.5MG A076989 003 Sep 05, 2007
AB 25MG A076989 004 Sep 05, 2007
AB SANDOZ 3.125MG A078227 001 Sep 05, 2007
AB 6.25MG A078227 002 Sep 05, 2007
AB 12.5MG A078227 003 Sep 05, 2007
AB 25MG A078227 004 Sep 05, 2007
AB TARO 3.125MG A077780 001 Sep 05, 2007
AB 6.25MG A077780 002 Sep 05, 2007
AB 12.5MG A077780 003 Sep 05, 2007
AB 25MG A077780 004 Sep 05, 2007
AB TEVA 3.125MG A076373 001 Sep 05, 2007
AB 6.25MG A076373 002 Sep 05, 2007
AB 12.5MG A076373 003 Sep 05, 2007
AB 25MG A076373 004 Sep 05, 2007
AB WATSON LABS 3.125MG A077474 001 Sep 05, 2007
AB 6.25MG A077474 002 Sep 05, 2007
AB 12.5MG A077474 003 Sep 05, 2007
AB 25MG A077474 004 Sep 05, 2007
AB WOCKHARDT 3.125MG A078786 001 Dec 22, 2009
AB 6.25MG A078786 002 Dec 22, 2009
AB 12.5MG A078786 003 Dec 22, 2009
AB 25MG A078786 004 Dec 22, 2009
AB ZYDUS PHARMS USA INC 3.125MG A077614 004 Sep 05, 2007
AB 6.25MG A077614 001 Sep 05, 2007
AB 12.5MG A077614 002 Sep 05, 2007
AB 25MG A077614 003 Sep 05, 2007
COREG
AB SMITHKLINE BEECHAM 3.125MG N020297 004 May 29, 1997
AB 6.25MG N020297 003 Sep 14, 1995
AB + 12.5MG N020297 002 Sep 14, 1995
AB 25MG N020297 001 Sep 14, 1995
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 77 (of 393)

CARVEDILOL PHOSPHATE
CAPSULE, EXTENDED RELEASE; ORAL
COREG CR
XX SB PHARMCO 10MG N022012 001 Oct 20, 2006
XX 20MG N022012 002 Oct 20, 2006
XX 40MG N022012 003 Oct 20, 2006
XX + 80MG N022012 004 Oct 20, 2006

CASPOFUNGIN ACETATE
INJECTABLE; IV (INFUSION)

CANCIDAS

XX + MERCK 50MG/VIAL N021227 001 Jan 26, 2001


XX + 70MG/VIAL N021227 002 Jan 26, 2001

CEFACLOR
CAPSULE; ORAL
CEFACLOR
AB HIKMA EQ 250MG BASE A065350 001 Apr 03, 2007
AB EQ 500MG BASE A065350 002 Apr 03, 2007
AB RANBAXY EQ 250MG BASE A064156 001 Aug 28, 1997
AB + EQ 500MG BASE A064156 002 Aug 28, 1997
AB YUNG SHIN PHARM EQ 250MG BASE A065146 001 Jan 22, 2004
AB EQ 500MG BASE A065146 002 Jan 22, 2004
FOR SUSPENSION; ORAL

CEFACLOR

XX + RANBAXY EQ 125MG BASE/5ML A064166 001 Oct 02, 1997


XX + EQ 187MG BASE/5ML A064165 001 Oct 02, 1997
XX + EQ 250MG BASE/5ML A064164 001 Oct 02, 1997
XX + EQ 375MG BASE/5ML A064155 001 Oct 02, 1997
TABLET, CHEWABLE; ORAL
RANICLOR
XX RANBAXY EQ 125MG BASE A065092 001 Dec 22, 2003
XX EQ 187MG BASE A065092 002 Dec 22, 2003
XX EQ 250MG BASE A065092 003 Dec 22, 2003
XX + EQ 375MG BASE A065092 004 Dec 22, 2003
TABLET, EXTENDED RELEASE; ORAL
CEFACLOR
AB + PAR PHARM EQ 500MG BASE A065057 001 Jan 05, 2001
AB TEVA EQ 500MG BASE A065058 002 Sep 04, 2002
CEFACLOR
XX TEVA EQ 375MG BASE A065058 001 Sep 04, 2002

CEFADROXIL ANHYDROUS
FOR SUSPENSION; ORAL
CEFADROXIL
XX RANBAXY EQ 125MG BASE/5ML A065115 001 Mar 26, 2003
TABLET; ORAL

CEFADROXIL

XX + IVAX SUB TEVA PHARMS EQ 1GM BASE A062774 001 Apr 08, 1987

CEFADROXIL/CEFADROXIL HEMIHYDRATE
CAPSULE; ORAL
CEFADROXIL
AB AUROBINDO PHARMA EQ 500MG BASE A065352 001 Jan 25, 2007
AB HIKMA EQ 500MG BASE A065311 001 Feb 07, 2006
AB LUPIN EQ 500MG BASE A065392 001 May 29, 2007
AB ORCHID HLTHCARE EQ 500MG BASE A065309 001 Sep 18, 2006
AB RANBAXY EQ 500MG BASE A065015 001 Jun 22, 1999
AB SANDOZ EQ 500MG BASE A062291 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 78 (of 393)

CEFADROXIL/CEFADROXIL HEMIHYDRATE
CAPSULE; ORAL
CEFADROXIL
AB TEVA PHARMS EQ 500MG BASE A065282 001 Jan 20, 2006
FOR SUSPENSION; ORAL
CEFADROXIL
AB LUPIN EQ 250MG BASE/5ML A065396 001 Feb 21, 2008
AB EQ 500MG BASE/5ML A065396 002 Feb 21, 2008
AB ORCHID HLTHCARE EQ 250MG BASE/5ML A065307 002 Oct 16, 2006
AB EQ 500MG BASE/5ML A065307 003 Oct 16, 2006
AB RANBAXY EQ 250MG BASE/5ML A065115 002 Mar 26, 2003
AB EQ 500MG BASE/5ML A065115 003 Mar 26, 2003
AB TEVA PHARMS EQ 250MG BASE/5ML A065278 001 Jan 20, 2006
AB EQ 500MG BASE/5ML A065278 002 Jan 20, 2006
DURICEF
AB WARNER CHILCOTT EQ 250MG BASE/5ML N050527 003
AB + EQ 500MG BASE/5ML N050527 001
TABLET; ORAL
CEFADROXIL
AB HIKMA EQ 1GM BASE A065260 001 Mar 30, 2006
AB ORCHID HLTHCARE EQ 1GM BASE A065301 001 Sep 18, 2006
AB RANBAXY EQ 1GM BASE A065018 001 Apr 23, 1999

CEFAZOLIN SODIUM
INJECTABLE; INJECTION
CEFAZOLIN SODIUM
AP ACS DOBFAR EQ 500MG BASE/VIAL A065303 001 Oct 22, 2008
AP EQ 1GM BASE/VIAL A065303 002 Oct 22, 2008
AP EQ 10GM BASE/VIAL A065306 001 Oct 22, 2008
AP + APP PHARMS EQ 500MG BASE/VIAL A064169 001 Aug 14, 1998
AP + EQ 1GM BASE/VIAL A064169 002 Aug 14, 1998
AP + EQ 10GM BASE/VIAL A064170 001 Mar 18, 1998
AP + EQ 20GM BASE/VIAL A064170 002 Mar 18, 1998
AP AUROBINDO PHARMA EQ 500MG BASE/VIAL A065395 001 Aug 08, 2008
AP EQ 1GM BASE/VIAL A065395 002 Aug 08, 2008
AP CEPHAZONE PHARMA EQ 500MG BASE/VIAL A065280 001 Mar 18, 2009
AP EQ 1GM BASE/VIAL A065280 002 Mar 18, 2009
AP EQ 10GM BASE/VIAL A065295 001 Mar 18, 2009
AP EQ 20GM BASE/VIAL A065296 001 Mar 18, 2009
AP HANFORD GC EQ 1GM BASE/VIAL A063207 001 Dec 27, 1991
AP EQ 1GM BASE/VIAL A063208 001 Dec 27, 1991
AP EQ 10GM BASE/VIAL A063209 001 Dec 27, 1991
AP HIKMA FARMACEUTICA EQ 500MG BASE/VIAL A065047 001 Sep 18, 2001
AP EQ 1GM BASE/VIAL A065047 002 Sep 18, 2001
AP EQ 10GM BASE/VIAL A065143 001 Oct 18, 2004
AP ORCHID HLTHCARE EQ 500MG BASE/VIAL A065226 001 Apr 21, 2005
AP EQ 1GM BASE/VIAL A065226 002 Apr 21, 2005
AP EQ 1GM BASE/VIAL A065244 001 Aug 12, 2005
AP EQ 10GM BASE/VIAL A065247 001 Aug 12, 2005
AP SANDOZ EQ 500MG BASE/VIAL A062831 001 Dec 09, 1988
AP EQ 1GM BASE/VIAL A062831 002 Dec 09, 1988
AP EQ 1GM BASE/VIAL A065345 001 May 09, 2007
AP EQ 10GM BASE/VIAL A062831 003 Sep 25, 1992
KEFZOL
AP ACS DOBFAR EQ 500MG BASE/VIAL A061773 002
AP EQ 1GM BASE/VIAL A061773 003
AP EQ 10GM BASE/VIAL A061773 004
ANCEF IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE EQ 10MG BASE/ML A063002 001 Mar 28, 1991
XX + EQ 20MG BASE/ML A063002 002 Mar 28, 1991
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 79 (of 393)

CEFAZOLIN SODIUM
INJECTABLE; INJECTION

CEFAZOLIN AND DEXTROSE

XX + B BRAUN EQ 1GM BASE/VIAL N050779 002 Jul 27, 2000


CEFAZOLIN SODIUM
XX + SAMSON MEDCL EQ 100GM BASE/VIAL A065141 001 Nov 29, 2006
XX + EQ 300GM BASE/VIAL A065141 002 Nov 29, 2006

CEFDINIR
CAPSULE; ORAL
CEFDINIR
AB AUROBINDO PHARMA 300MG A065434 001 Jan 07, 2008
AB LUPIN 300MG A065264 001 May 19, 2006
AB ORCHID HLTHCARE 300MG A065418 001 Jul 18, 2007
AB SANDOZ 300MG A065330 001 Apr 06, 2007
AB TEVA PHARMS 300MG A065368 001 May 09, 2007
OMNICEF
AB + ABBOTT 300MG N050739 001 Dec 04, 1997
FOR SUSPENSION; ORAL
CEFDINIR
AB AUROBINDO PHARMA 125MG/5ML A065473 001 Dec 14, 2007
AB 250MG/5ML A065473 002 Dec 14, 2007
AB LUPIN 125MG/5ML A065259 001 May 31, 2006
AB 250MG/5ML A065259 002 May 07, 2007
AB ORCHID HLTHCARE 125MG/5ML A065429 001 Jul 18, 2007
AB 250MG/5ML A065429 002 Jul 18, 2007
AB SANDOZ 125MG/5ML A065337 001 Apr 06, 2007
AB 250MG/5ML A065337 002 Apr 06, 2007
AB TEVA PHARMS 125MG/5ML A065332 001 May 04, 2007
AB 250MG/5ML A065332 002 May 04, 2007
OMNICEF
AB ABBOTT 125MG/5ML N050749 001 Dec 04, 1997
AB + 250MG/5ML N050749 002 Jul 29, 2004

CEFDITOREN PIVOXIL
TABLET; ORAL
SPECTRACEF
XX CORNERSTONE 200MG N021222 001 Aug 29, 2001
XX + 400MG N021222 002 Jul 21, 2008

CEFEPIME HYDROCHLORIDE
INJECTABLE; INJECTION
CEFEPIME HYDROCHLORIDE
AP ACS DOBFAR EQ 1GM BASE/VIAL A065441 001 Mar 20, 2008
AP EQ 2GM BASE/VIAL A065441 002 Mar 20, 2008
AP ORCHID HLTHCARE EQ 500MG BASE/VIAL A065369 001 Jun 18, 2007
AP EQ 1GM BASE/VIAL A065369 002 Jun 18, 2007
AP EQ 2GM BASE/VIAL A065369 003 Jun 18, 2007
MAXIPIME
AP + BRISTOL MYERS SQUIBB EQ 500MG BASE/VIAL N050679 001 Jan 18, 1996
AP + EQ 1GM BASE/VIAL N050679 002 Jan 18, 1996
AP + EQ 2GM BASE/VIAL N050679 003 Jan 18, 1996
CEFEPIME IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE EQ 1GM BASE/50ML (EQ 20MG BASE/ML) N050817 001 Aug 05, 2008
XX + EQ 2GM BASE/100ML (EQ 20MG BASE/ML) N050817 002 Aug 05, 2008

CEFIXIME
SUSPENSION; ORAL
SUPRAX
XX LUPIN PHARMS 100MG/5ML A065129 001 Feb 23, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 80 (of 393)

CEFIXIME
SUSPENSION; ORAL

SUPRAX

XX + LUPIN PHARMS 200MG/5ML A065355 001 Apr 10, 2007


TABLET; ORAL

SUPRAX

XX + LUPIN 400MG A065130 001 Feb 12, 2004

CEFOTAXIME SODIUM
INJECTABLE; INJECTION
CEFOTAXIME
AP APP PHARMS EQ 500MG BASE/VIAL A064200 001 Mar 24, 2000
AP EQ 1GM BASE/VIAL A064200 002 Mar 24, 2000
AP EQ 2GM BASE/VIAL A064200 003 Mar 24, 2000
AP EQ 10GM BASE/VIAL A064201 001 Mar 24, 2000
AP HIKMA EQ 500MG BASE/VIAL A065072 001 Nov 20, 2002
AP EQ 1GM BASE/VIAL A065072 002 Nov 20, 2002
AP EQ 2GM BASE/VIAL A065072 003 Nov 20, 2002
AP EQ 10GM BASE/VIAL A065071 001 Nov 20, 2002
AP WOCKHARDT EQ 1GM BASE/VIAL A065197 001 Aug 29, 2006
CEFOTAXIME SODIUM
AP AUROBINDO PHARMA EQ 500MG BASE/VIAL A065517 001 Nov 06, 2009
AP EQ 1GM BASE/VIAL A065517 002 Nov 06, 2009
AP EQ 2GM BASE/VIAL A065517 003 Nov 06, 2009
AP EQ 10GM BASE/VIAL A065516 001 Nov 06, 2009
AP LUPIN EQ 500MG BASE/VIAL A065124 001 Sep 24, 2003
AP EQ 1GM BASE/VIAL A065124 002 Sep 24, 2003
AP EQ 2GM BASE/VIAL A065124 003 Sep 24, 2003
AP ORCHID HLTHCARE EQ 500MG BASE/VIAL A065290 001 Aug 11, 2006
AP EQ 1GM BASE/VIAL A065290 002 Aug 11, 2006
AP EQ 1GM BASE/VIAL A065293 001 Aug 10, 2006
AP EQ 2GM BASE/VIAL A065290 003 Aug 11, 2006
AP EQ 2GM BASE/VIAL A065293 002 Aug 10, 2006
AP EQ 10GM BASE/VIAL A065292 001 Aug 10, 2006
AP WOCKHARDT EQ 500MG BASE/VIAL A065197 002 Jun 20, 2008
AP EQ 2GM BASE/VIAL A065197 003 Jun 20, 2008
CLAFORAN
AP + SANOFI AVENTIS US EQ 500MG BASE/VIAL N050547 001
AP EQ 1GM BASE/VIAL A062659 001 Jan 13, 1987
AP + EQ 1GM BASE/VIAL N050547 002
AP EQ 2GM BASE/VIAL A062659 002 Jan 13, 1987
AP + EQ 2GM BASE/VIAL N050547 003
AP + EQ 10GM BASE/VIAL N050547 004 Dec 29, 1983
CEFOTAXIME
XX + APP PHARMS EQ 20GM BASE/VIAL A064201 002 Mar 24, 2000
CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
XX + SANOFI AVENTIS US EQ 20MG BASE/ML N050596 002 May 20, 1985
XX + EQ 40MG BASE/ML N050596 004 May 20, 1985

CEFOTETAN DISODIUM
INJECTABLE; INJECTION

CEFOTETAN

XX + APP PHARMS EQ 1GM BASE/VIAL A065374 001 Aug 09, 2007


XX + EQ 2GM BASE/VIAL A065374 002 Aug 09, 2007
XX + EQ 10GM BASE/VIAL A065375 001 Aug 09, 2007
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER
XX + B BRAUN EQ 1GM BASE/VIAL A065430 001 Aug 09, 2007
XX + EQ 2GM BASE/VIAL A065430 002 Aug 09, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 81 (of 393)

CEFOXITIN SODIUM
INJECTABLE; INJECTION
CEFOXITIN
AP ACS DOBFAR EQ 1GM BASE/VIAL A065414 001 Jun 12, 2009
AP EQ 2GM BASE/VIAL A065414 002 Jun 12, 2009
AP + APP PHARMS EQ 1GM BASE/VIAL A065012 001 Jul 03, 2000
AP + EQ 2GM BASE/VIAL A065012 002 Jul 03, 2000
AP + EQ 10GM BASE/VIAL A065011 001 Jul 03, 2000
AP BAXTER HLTHCARE EQ 1GM BASE/VIAL A065051 001 Sep 11, 2000
AP EQ 2GM BASE/VIAL A065051 002 Sep 11, 2000
AP EQ 10GM BASE/VIAL A065050 001 Sep 11, 2000
AP ORCHID HLTHCARE EQ 1GM BASE/VIAL A065313 001 Jan 23, 2006
AP EQ 2GM BASE/VIAL A065313 002 Jan 23, 2006
AP EQ 10GM BASE/VIAL A065312 001 Feb 13, 2006
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER
AP B BRAUN EQ 1GM BASE/VIAL A065214 001 Mar 10, 2006
AP EQ 2GM BASE/VIAL A065214 002 Mar 10, 2006
MEFOXIN IN PLASTIC CONTAINER
XX + BIONICHE PHARMA EQ 20MG BASE/ML A063182 001 Jan 25, 1993
XX + EQ 40MG BASE/ML A063182 002 Jan 25, 1993

CEFPODOXIME PROXETIL
FOR SUSPENSION; ORAL
CEFPODOXIME PROXETIL
AB AUROBINDO PHARMA EQ 50MG BASE/5ML A065409 001 Jun 08, 2007
AB + EQ 100MG BASE/5ML A065409 002 Jun 08, 2007
AB RANBAXY EQ 50MG BASE/5ML A065082 001 May 31, 2002
AB EQ 100MG BASE/5ML A065082 002 May 31, 2002
AB SANDOZ EQ 50MG BASE/5ML A090031 001 Jan 14, 2009
AB EQ 100MG BASE/5ML A090031 002 Jan 14, 2009
TABLET; ORAL
CEFPODOXIME PROXETIL
AB AUROBINDO PHARMA EQ 100MG BASE A065370 001 Jun 11, 2007
AB EQ 200MG BASE A065370 002 Jun 11, 2007
AB ORCHID HLTHCARE EQ 100MG BASE A065388 001 Nov 14, 2007
AB EQ 200MG BASE A065388 002 Nov 14, 2007
AB RANBAXY EQ 100MG BASE A065083 001 Aug 20, 2003
AB EQ 200MG BASE A065083 002 Aug 20, 2003
AB SANDOZ EQ 100MG BASE A065462 001 May 28, 2008
AB EQ 200MG BASE A065462 002 May 28, 2008
VANTIN
AB PHARMACIA AND UPJOHN EQ 100MG BASE N050674 001 Aug 07, 1992
AB + EQ 200MG BASE N050674 002 Aug 07, 1992

CEFPROZIL
FOR SUSPENSION; ORAL
CEFPROZIL
AB AUROBINDO PHARMA 125MG/5ML A065381 001 Jan 30, 2007
AB 250MG/5ML A065381 002 Jan 30, 2007
AB LUPIN 125MG/5ML A065261 001 Dec 19, 2005
AB 250MG/5ML A065261 002 Dec 19, 2005
AB ORCHID HLTHCARE 125MG/5ML A065284 002 Dec 30, 2005
AB 250MG/5ML A065284 001 Dec 30, 2005
AB RANBAXY 125MG/5ML A065202 001 Jun 30, 2006
AB 250MG/5ML A065202 002 Jun 30, 2006
AB SANDOZ 125MG/5ML A065257 001 Dec 08, 2005
AB 250MG/5ML A065257 002 Dec 08, 2005
AB TEVA PHARMS 125MG/5ML A065236 001 Dec 08, 2005
AB 250MG/5ML A065236 002 Dec 08, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 82 (of 393)

CEFPROZIL
FOR SUSPENSION; ORAL
CEFZIL
AB BRISTOL MYERS SQUIBB 125MG/5ML N050665 001 Dec 23, 1991
AB + 250MG/5ML N050665 002 Dec 23, 1991
TABLET; ORAL
CEFPROZIL
AB APOTEX INC 250MG A065327 001 Mar 26, 2008
AB 500MG A065327 002 Mar 26, 2008
AB AUROBINDO PHARMA LTD 250MG A065340 001 May 24, 2007
AB 500MG A065340 002 May 24, 2007
AB LUPIN 250MG A065276 001 Dec 08, 2005
AB 500MG A065276 002 Dec 08, 2005
AB ORCHID HLTHCARE 250MG A065267 001 Dec 19, 2005
AB 500MG A065267 002 Dec 19, 2005
AB RANBAXY 250MG A065198 001 Dec 13, 2006
AB 500MG A065198 002 Dec 13, 2006
AB SANDOZ 250MG A065235 001 Nov 14, 2005
AB 500MG A065235 002 Nov 14, 2005
AB TEVA 250MG A065208 001 Dec 06, 2005
AB 500MG A065208 002 Dec 06, 2005
AB WOCKHARDT 250MG A065428 001 Jun 14, 2007
AB 500MG A065428 002 Jun 14, 2007
CEFZIL
AB BRISTOL MYERS SQUIBB 250MG N050664 001 Dec 23, 1991
AB + 500MG N050664 002 Dec 23, 1991

CEFTAZIDIME
INJECTABLE; INJECTION
CEFTAZIDIME
AP ACS DOBFAR 500MG/VIAL A062640 001 Nov 20, 1985
AP 1GM/VIAL A062640 002 Nov 20, 1985
AP 2GM/VIAL A062640 003 Nov 20, 1985
AP 6GM/VIAL A062640 004 Feb 03, 1992
AP WOCKHARDT 1GM/VIAL A065196 001 Oct 15, 2008
FORTAZ
AP + GLAXOSMITHKLINE 500MG/VIAL N050578 001 Jul 19, 1985
AP + 1GM/VIAL N050578 002 Jul 19, 1985
AP + 2GM/VIAL N050578 003 Jul 19, 1985
AP + 6GM/VIAL N050578 004 Jul 19, 1985
TAZICEF
AP HOSPIRA 500MG/VIAL A062662 001 Mar 06, 1986
AP 1GM/VIAL A062662 002 Mar 06, 1986
AP 1GM/VIAL A064032 001 Oct 31, 1993
AP 2GM/VIAL A062662 003 Mar 06, 1986
AP 2GM/VIAL A064032 002 Oct 31, 1993
AP 6GM/VIAL A062662 004 Mar 06, 1986

CEFTAZIDIME SODIUM
INJECTABLE; INJECTION

FORTAZ IN PLASTIC CONTAINER


XX + GLAXOSMITHKLINE EQ 20MG BASE/ML N050634 002 Apr 28, 1989


XX + EQ 40MG BASE/ML N050634 003 Apr 28, 1989

CEFTIBUTEN DIHYDRATE
CAPSULE; ORAL

CEDAX

XX + SCIELE PHARMA INC EQ 400MG BASE N050685 002 Dec 20, 1995
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 83 (of 393)

CEFTIBUTEN DIHYDRATE
FOR SUSPENSION; ORAL

CEDAX

XX + SCIELE PHARMA INC EQ 90MG BASE/5ML N050686 001 Dec 20, 1995

CEFTRIAXONE SODIUM
INJECTABLE; IM-IV
CEFTRIAXONE
AP APP PHARMS EQ 250MG BASE/VIAL A065245 001 Feb 15, 2006
AP EQ 500MG BASE/VIAL A065245 002 Feb 15, 2006
AP EQ 1GM BASE/VIAL A065245 003 Feb 15, 2006
AP EQ 2GM BASE/VIAL A065245 004 Feb 15, 2006
AP AUROBINDO PHARMA EQ 250MG BASE/VIAL A065505 001 Jul 31, 2008
AP EQ 500MG BASE/VIAL A065505 002 Jul 31, 2008
AP EQ 1GM BASE/VIAL A065505 003 Jul 31, 2008
AP EQ 2GM BASE/VIAL A065505 004 Jul 31, 2008
AP BEDFORD EQ 250MG BASE/VIAL A065465 001 Aug 18, 2008
AP EQ 500MG BASE/VIAL A065465 002 Aug 18, 2008
AP EQ 1GM BASE/VIAL A065465 003 Aug 18, 2008
AP EQ 2GM BASE/VIAL A065465 004 Aug 18, 2008
AP CEPHAZONE PHARMA EQ 250MG BASE/VIAL A065294 001 Mar 26, 2007
AP EQ 500MG BASE/VIAL A065294 002 Mar 26, 2007
AP EQ 1GM BASE/VIAL A065294 003 Mar 26, 2007
AP EQ 2GM BASE/VIAL A065294 004 Mar 26, 2007
AP HANFORD GC EQ 1GM BASE/VIAL A065268 001 Feb 28, 2007
AP EQ 2GM BASE/VIAL A065268 002 Feb 28, 2007
AP HIKMA FARMACEUTICA EQ 250MG BASE/VIAL A065342 001 Jan 10, 2008
AP EQ 500MG BASE/VIAL A065342 002 Jan 10, 2008
AP EQ 1GM BASE/VIAL A065342 003 Jan 10, 2008
AP EQ 2GM BASE/VIAL A065342 004 Jan 10, 2008
AP LUITPOLD EQ 250MG BASE/VIAL A065305 001 Jan 11, 2008
AP EQ 500MG BASE/VIAL A065305 002 Jan 11, 2008
AP EQ 1GM BASE/VIAL A065305 003 Jan 11, 2008
AP EQ 2GM BASE/VIAL A065305 004 Jan 11, 2008
AP LUPIN EQ 250MG BASE/VIAL A065125 001 Sep 30, 2003
AP EQ 500MG BASE/VIAL A065125 002 Sep 30, 2003
AP EQ 1GM BASE/VIAL A065125 003 Sep 30, 2003
AP EQ 2GM BASE/VIAL A065125 004 Sep 30, 2003
AP ORCHID HLTHCARE EQ 250MG BASE/VIAL A065230 001 Aug 02, 2005
AP EQ 500MG BASE/VIAL A065230 002 Aug 02, 2005
AP EQ 1GM BASE/VIAL A065230 003 Aug 02, 2005
AP EQ 2GM BASE/VIAL A065230 004 Aug 02, 2005
AP + SANDOZ EQ 250MG BASE/VIAL A065169 001 May 09, 2005
AP + EQ 500MG BASE/VIAL A065169 002 May 09, 2005
AP + EQ 1GM BASE/VIAL A065169 003 May 09, 2005
AP + EQ 2GM BASE/VIAL A065169 004 May 09, 2005
AP TEVA EQ 1GM BASE/VIAL A065262 001 Jun 29, 2006
AP EQ 2GM BASE/VIAL A065262 002 Jun 29, 2006
AP TEVA PARENTERAL EQ 250MG BASE/VIAL A065227 001 Mar 15, 2007
AP EQ 500MG BASE/VIAL A065227 002 Mar 15, 2007
AP EQ 1GM BASE/VIAL A065227 003 Mar 15, 2007
AP EQ 2GM BASE/VIAL A065227 004 Mar 15, 2007
AP WOCKHARDT EQ 250MG BASE/VIAL A065391 001 Apr 12, 2007
AP EQ 500MG BASE/VIAL A065391 002 Apr 12, 2007
AP EQ 2GM BASE/VIAL A065391 003 Apr 12, 2007
INJECTABLE; INJECTION
CEFTRIAXONE
AP ACS DOBFAR EQ 500MG BASE/VIAL A065329 001 Jul 24, 2008
AP EQ 1GM BASE/VIAL A065329 002 Jul 24, 2008
AP EQ 2GM BASE/VIAL A065329 003 Jul 24, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 84 (of 393)

CEFTRIAXONE SODIUM
INJECTABLE; INJECTION
CEFTRIAXONE
AP ACS DOBFAR EQ 10GM BASE/VIAL A065328 001 Jul 24, 2008
AP APP PHARMS EQ 10GM BASE/VIAL A065252 001 Feb 15, 2006
AP AUROBINDO PHARMA EQ 10GM BASE/VIAL A065504 001 Jul 31, 2008
AP BEDFORD EQ 10GM BASE/VIAL A065475 001 Aug 18, 2008
AP HANFORD GC EQ 10GM BASE/VIAL A065269 001 Feb 28, 2007
AP LUPIN EQ 10GM BASE/VIAL A065263 001 Sep 12, 2006
AP ORCHID HLTHCARE EQ 1GM BASE/VIAL A065231 001 Aug 02, 2005
AP EQ 2GM BASE/VIAL A065231 002 Aug 02, 2005
AP EQ 10GM BASE/VIAL A065232 001 Aug 02, 2005
AP SANDOZ EQ 1GM BASE/VIAL A065204 001 May 03, 2005
AP EQ 2GM BASE/VIAL A065204 002 May 03, 2005
AP EQ 10GM BASE/VIAL A065168 001 May 17, 2005
AP TEVA EQ 10GM BASE/VIAL A065274 001 May 01, 2006
AP WOCKHARDT EQ 1GM BASE/VIAL A065180 001 May 12, 2006
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER
AP + B BRAUN EQ 1GM BASE/VIAL N050796 001 Apr 20, 2005
AP + EQ 2GM BASE/VIAL N050796 002 Apr 20, 2005
ROCEPHIN
AP + HLR EQ 500MG BASE/VIAL A063239 002 Aug 13, 1993
AP + EQ 1GM BASE/VIAL A063239 003 Aug 13, 1993
CEFTRIAXONE IN PLASTIC CONTAINER
XX BAXTER HLTHCARE EQ 20MG BASE/ML A065224 001 Aug 23, 2005
XX EQ 40MG BASE/ML A065224 002 Aug 23, 2005

CEFUROXIME AXETIL
FOR SUSPENSION; ORAL
CEFTIN
AB GLAXOSMITHKLINE EQ 125MG BASE/5ML N050672 001 Jun 30, 1994
AB + EQ 250MG BASE/5ML N050672 002 Apr 29, 1997
CEFUROXIME AXETIL
AB RANBAXY EQ 125MG BASE/5ML A065323 001 Feb 05, 2008
AB EQ 250MG BASE/5ML A065323 002 Feb 05, 2008
TABLET; ORAL
CEFTIN
AB GLAXOSMITHKLINE EQ 125MG BASE N050605 001 Dec 28, 1987
AB EQ 250MG BASE N050605 002 Dec 28, 1987
AB + EQ 500MG BASE N050605 003 Dec 28, 1987
CEFUROXIME AXETIL
AB APOTEX INC EQ 250MG BASE A065069 001 Oct 02, 2002
AB EQ 500MG BASE A065069 002 Oct 02, 2002
AB AUROBINDO PHARMA LTD EQ 125MG BASE A065308 001 Mar 29, 2006
AB EQ 250MG BASE A065308 002 Mar 29, 2006
AB EQ 500MG BASE A065308 003 Mar 29, 2006
AB LUPIN EQ 250MG BASE A065135 001 Jul 25, 2003
AB EQ 500MG BASE A065135 002 Jul 25, 2003
AB ORCHID HLTHCARE EQ 125MG BASE A065359 001 Feb 15, 2008
AB EQ 250MG BASE A065359 002 Feb 15, 2008
AB EQ 500MG BASE A065359 003 Feb 15, 2008
AB RANBAXY EQ 125MG BASE A065043 003 Feb 15, 2002
AB EQ 125MG BASE A065118 001 Apr 25, 2003
AB EQ 250MG BASE A065043 002 Feb 15, 2002
AB EQ 250MG BASE A065118 002 Apr 25, 2003
AB EQ 500MG BASE A065043 001 Feb 15, 2002
AB EQ 500MG BASE A065118 003 Apr 25, 2003
AB SANDOZ EQ 250MG BASE A065126 001 Oct 28, 2003
AB EQ 500MG BASE A065126 002 Oct 28, 2003
AB TEVA EQ 250MG BASE A065190 001 Oct 18, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 85 (of 393)

CEFUROXIME AXETIL
TABLET; ORAL
CEFUROXIME AXETIL
AB TEVA EQ 500MG BASE A065190 002 Oct 18, 2004
AB WOCKHARDT EQ 125MG BASE A065166 001 Jul 29, 2005
AB EQ 250MG BASE A065166 002 Jul 29, 2005
AB EQ 500MG BASE A065166 003 Jul 29, 2005

CEFUROXIME SODIUM
INJECTABLE; IM-IV
CEFUROXIME SODIUM
AB APP PHARMS EQ 750MG BASE/VIAL A065001 001 May 30, 2001
AB HANFORD GC EQ 750MG BASE/VIAL A064125 001 May 30, 1997
AB TEVA EQ 750MG BASE/VIAL A064192 002 Apr 16, 1998
ZINACEF
AB + GLAXOSMITHKLINE EQ 750MG BASE/VIAL N050558 002 Oct 19, 1983
CEFUROXIME SODIUM
AP HIKMA FARMACEUTICA EQ 750MG BASE/VIAL A065048 001 Jan 09, 2004
AP ORCHID HLTHCARE EQ 750MG BASE/VIAL A065483 001 Oct 15, 2008
INJECTABLE; INJECTION
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER
AP + B BRAUN EQ 750MG BASE/VIAL N050780 001 Feb 21, 2001
AP + EQ 1.5GM BASE/VIAL N050780 002 Feb 21, 2001
CEFUROXIME SODIUM
AP APP PHARMS EQ 1.5GM BASE/VIAL A065001 002 May 30, 2001
AP EQ 7.5GM BASE/VIAL A065002 001 Sep 28, 1998
AP HANFORD GC EQ 1.5GM BASE/VIAL A064125 002 May 30, 1997
AP EQ 7.5GM BASE/VIAL A064124 001 May 30, 1997
AP HIKMA FARMACEUTICA EQ 1.5GM BASE/VIAL A065048 002 Jan 09, 2004
AP EQ 7.5GM BASE/VIAL A065046 001 Jan 09, 2004
AP ORCHID HLTHCARE EQ 1.5GM BASE/VIAL A065483 002 Oct 15, 2008
AP EQ 1.5GM BASE/VIAL A065503 001 Oct 15, 2008
AP EQ 7.5GM BASE/VIAL A065484 001 Oct 15, 2008
AP TEVA EQ 1.5GM BASE/VIAL A064192 001 Apr 16, 1998
AP EQ 7.5GM BASE/VIAL A064191 001 Apr 16, 1998
ZINACEF
AP + GLAXOSMITHKLINE EQ 1.5GM BASE/VIAL N050558 003 Oct 19, 1983
AP + EQ 7.5GM BASE/VIAL N050558 004 Oct 23, 1986
CEFUROXIME SODIUM IN PLASTIC CONTAINER
XX + SAMSON MEDCL EQ 75GM BASE/VIAL A065251 001 Dec 30, 2009
XX + EQ 225GM BASE/VIAL A065251 002 Dec 30, 2009
ZINACEF IN PLASTIC CONTAINER
XX + GLAXOSMITHKLINE EQ 15MG BASE/ML N050643 001 Apr 28, 1989
XX + EQ 30MG BASE/ML N050643 002 Apr 28, 1989

CELECOXIB
CAPSULE; ORAL
CELEBREX
XX GD SEARLE 50MG N020998 004 Dec 15, 2006
XX 100MG N020998 001 Dec 31, 1998
XX 200MG N020998 002 Dec 31, 1998
XX + 400MG N020998 003 Aug 29, 2002

CEPHALEXIN
CAPSULE; ORAL
CEPHALEXIN
AB AUROBINDO PHARMA LTD EQ 250MG BASE A065253 001 Nov 16, 2005
AB EQ 500MG BASE A065253 002 Nov 16, 2005
AB BELCHER EQ 250MG BASE A062713 001 Jul 15, 1988
AB EQ 500MG BASE A062713 002 Jul 15, 1988
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 86 (of 393)

CEPHALEXIN
CAPSULE; ORAL
CEPHALEXIN
AB CEPH INTL EQ 250MG BASE A062118 001
AB EQ 500MG BASE A062118 002
AB HIKMA EQ 250MG BASE A065215 001 Jan 24, 2006
AB EQ 500MG BASE A065215 002 Jan 24, 2006
AB IVAX SUB TEVA PHARMS EQ 250MG BASE A061969 001
AB EQ 500MG BASE A061969 002
AB LUPIN EQ 250MG BASE A065229 001 Nov 25, 2005
AB EQ 500MG BASE A065229 002 Nov 25, 2005
AB ORCHID HLTHCARE EQ 250MG BASE A065248 001 Jun 28, 2005
AB EQ 500MG BASE A065248 002 Jun 28, 2005
AB RANBAXY EQ 250MG BASE A065007 001 Sep 16, 1999
AB EQ 500MG BASE A065007 002 Sep 16, 1999
AB STEVENS J EQ 250MG BASE A062870 001 Mar 17, 1988
AB SUN PHARM INDS (IN) EQ 250MG BASE A062791 001 Jun 11, 1987
AB EQ 500MG BASE A062791 002 Jun 11, 1987
AB TEVA EQ 250MG BASE A062702 001 Feb 13, 1987
AB EQ 500MG BASE A062702 002 Feb 13, 1987
AB YUNG SHIN PHARM EQ 250MG BASE A065152 001 Feb 24, 2005
AB EQ 500MG BASE A065152 002 Feb 24, 2005
KEFLEX
AB MIDDLEBROOK PHARMS EQ 250MG BASE N050405 002
AB EQ 500MG BASE N050405 003
KEFLEX
XX + MIDDLEBROOK PHARMS EQ 750MG BASE N050405 005 May 12, 2006
FOR SUSPENSION; ORAL
CEPHALEXIN
AB CEPH INTL EQ 125MG BASE/5ML A062117 002
AB + EQ 250MG BASE/5ML A062117 003
AB HIKMA PHARMS EQ 125MG BASE/5ML A065444 001 Aug 28, 2009
AB EQ 250MG BASE/5ML A065444 002 Aug 28, 2009
AB LUPIN EQ 125MG BASE/5ML A065234 001 Aug 17, 2005
AB EQ 250MG BASE/5ML A065234 002 Aug 17, 2005
AB ORCHID HLTHCARE EQ 125MG BASE/5ML A065326 001 Jul 10, 2006
AB EQ 250MG BASE/5ML A065326 002 Jul 10, 2006
AB RANBAXY EQ 125MG BASE/5ML A065081 001 Jul 27, 2001
AB EQ 250MG BASE/5ML A065081 002 Jul 27, 2001
AB TEVA EQ 125MG BASE/5ML A062703 001 Feb 13, 1987
AB EQ 250MG BASE/5ML A062703 002 Feb 13, 1987
AB YUNG SHIN PHARM EQ 125MG BASE/5ML A065336 001 Jul 25, 2007
AB EQ 250MG BASE/5ML A065336 002 Jul 25, 2007
TABLET; ORAL
CEPHALEXIN
XX TEVA EQ 250MG BASE A063023 001 Jan 12, 1989
XX + EQ 500MG BASE A063024 001 Jan 12, 1989
TABLET, FOR SUSPENSION; ORAL
PANIXINE DISPERDOSE
XX RANBAXY EQ 125MG BASE A065100 002 Sep 11, 2003
XX + EQ 250MG BASE A065100 001 Sep 11, 2003

CETIRIZINE HYDROCHLORIDE
SYRUP; ORAL
CETIRIZINE HYDROCHLORIDE
AA AMNEAL PHARMS 5MG/5ML A090766 001 Oct 07, 2009
AA APOTEX INC 5MG/5ML A078412 001 Jun 18, 2008
AA AUROBINDO PHARMA 5MG/5ML A090751 001 Dec 16, 2009
AA CYPRESS PHARM 5MG/5ML A078488 001 Oct 06, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 87 (of 393)

CETIRIZINE HYDROCHLORIDE
SYRUP; ORAL
CETIRIZINE HYDROCHLORIDE
AA DR REDDYS LABS LTD 5MG/5ML A078870 001 Apr 27, 2009
AA PERRIGO ISRAEL 5MG/5ML A078398 001 Jun 17, 2008
AA RANBAXY 5MG/5ML A077472 001 Jun 18, 2008
AA SUN PHARM INDS INC 5MG/5ML A090191 001 Nov 12, 2009
AA TARO 5MG/5ML A076601 001 Jun 20, 2008
AA TEVA PHARMS 5MG/5ML A077279 001 May 27, 2008
AA VINTAGE 5MG/5ML A078496 001 Sep 25, 2009
AA WOCKHARDT 5MG/5ML A078757 001 Aug 28, 2009
ZYRTEC
AA + MCNEIL CONSUMER 5MG/5ML N020346 001 Sep 27, 1996

CETRORELIX
INJECTABLE; INJECTION

CETROTIDE

XX + EMD SERONO EQ 0.25MG BASE/ML N021197 001 Aug 11, 2000


XX + EQ 3MG BASE/ML N021197 002 Aug 11, 2000

CEVIMELINE HYDROCHLORIDE
CAPSULE; ORAL

EVOXAC

XX + DAIICHI SANKYO CO EQ 30MG BASE N020989 002 Jan 11, 2000

CHENODIOL
TABLET; ORAL

CHENODIOL

XX + NEXGEN PHARMA 250MG A091019 001 Oct 22, 2009

CHLORAMBUCIL
TABLET; ORAL

LEUKERAN

XX + SMITHKLINE BEECHAM 2MG N010669 002

CHLORAMPHENICOL SODIUM SUCCINATE


INJECTABLE; INJECTION

CHLORAMPHENICOL SODIUM SUCCINATE


XX + APP PHARMS EQ 1GM BASE/VIAL A062365 001 Aug 25, 1982

CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE; ORAL
CHLORDIAZEPOXIDE HYDROCHLORIDE
AB BARR 5MG A084768 001
AB 10MG A083116 001
AB 25MG A084769 001
AB USL PHARMA 10MG A084623 001
AB WATSON LABS 5MG A086383 001
AB 10MG A086294 001
AB 25MG A086382 001
LIBRIUM
AB VALEANT PHARM INTL 5MG A085461 001
AB 10MG A085472 001
AB + 25MG A085475 001

CHLORHEXIDINE GLUCONATE
SOLUTION; DENTAL
CHLORHEXIDINE GLUCONATE
AT ACTAVIS MID ATLANTIC 0.12% A074291 001 Dec 28, 1995
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 88 (of 393)

CHLORHEXIDINE GLUCONATE
SOLUTION; DENTAL
CHLORHEXIDINE GLUCONATE
AT HI TECH PHARMA 0.12% A074356 001 May 07, 1996
AT JOHN O BUTLER CO 0.12% A076434 001 Nov 29, 2005
AT MORTON GROVE 0.12% A075006 001 Mar 03, 2004
AT NOVEX 0.12% A075561 001 Nov 14, 2000
AT TEVA 0.12% A074522 001 Dec 15, 1995
AT XTTRIUM 0.12% A077789 001 Jun 18, 2009
PERIDEX
AT + 3M 0.12% N019028 001 Aug 13, 1986
PERIOGARD
AT COLGATE 0.12% A073695 001 Jan 14, 1994
TABLET; DENTAL

PERIOCHIP

XX + DEXCEL PHARMA 2.5MG N020774 001 May 15, 1998

CHLOROPROCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
CHLOROPROCAINE HYDROCHLORIDE
AP BEDFORD 2% A040273 001 Sep 09, 1998
AP 3% A040273 002 Sep 09, 1998
AP HOSPIRA 2% A087447 001 Apr 16, 1982
AP 3% A087446 001 Apr 16, 1982
NESACAINE
AP APP PHARMS 2% N009435 002
NESACAINE-MPF
AP + APP PHARMS 2% N009435 006 May 02, 1996
AP + 3% N009435 007 May 02, 1996
NESACAINE
XX + APP PHARMS 1% N009435 001

CHLOROQUINE PHOSPHATE
TABLET; ORAL
ARALEN
AA + SANOFI AVENTIS US EQ 300MG BASE N006002 001
CHLOROQUINE PHOSPHATE
AA IMPAX LABS EQ 150MG BASE A080880 001
AA EQ 300MG BASE A040516 001 Aug 29, 2003
AA OHM LABS EQ 150MG BASE A090610 001 Dec 03, 2009
AA EQ 300MG BASE A090249 001 Dec 03, 2009
AA + WEST WARD EQ 150MG BASE A083082 001
AA EQ 300MG BASE A083082 002 Sep 17, 1999

CHLOROTHIAZIDE
SUSPENSION; ORAL

DIURIL

XX + SALIX PHARMS 250MG/5ML N011870 001


TABLET; ORAL
CHLOROTHIAZIDE
AB + MYLAN 250MG A084388 001
AB 500MG A084217 001
AB WEST WARD 250MG A086028 001 Jul 14, 1982
AB 500MG A087736 001 Jul 14, 1982

CHLOROTHIAZIDE SODIUM
INJECTABLE; INJECTION
CHLOROTHIAZIDE SODIUM
AP APP PHARMS EQ 500MG BASE/VIAL A090896 001 Oct 16, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 89 (of 393)

CHLOROTHIAZIDE SODIUM
INJECTABLE; INJECTION
DIURIL
AP + LUNDBECK INC EQ 500MG BASE/VIAL N011145 005

CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX


CAPSULE, EXTENDED RELEASE; ORAL
TUSSICAPS
XX TYCO HLTHCARE EQ 4MG MALEATE;EQ 5MG BITARTRATE A077273 002 Sep 24, 2007
XX + EQ 8MG MALEATE;EQ 10MG BITARTRATE A077273 001 Sep 24, 2007
SUSPENSION, EXTENDED RELEASE; ORAL

TUSSIONEX PENNKINETIC

XX + UCB INC EQ 8MG MALEATE/5ML;EQ 10MG N019111 001 Dec 31, 1987
BITARTRATE/5ML

CHLORPROMAZINE HYDROCHLORIDE
INJECTABLE; INJECTION

CHLORPROMAZINE HYDROCHLORIDE

XX + BAXTER HLTHCARE 25MG/ML A083329 001


TABLET; ORAL
CHLORPROMAZINE HYDROCHLORIDE
BP SANDOZ 10MG A080439 001
BP 25MG A080439 002
BP 50MG A080439 003
BP + 100MG A080439 004
BP 200MG A080439 005
BP USL PHARMA 10MG A083386 001
BP 25MG A084112 001
BP 50MG A084113 001
BP 100MG A084114 001
BP 200MG A084115 001

CHLORPROPAMIDE
TABLET; ORAL
CHLORPROPAMIDE
AB MYLAN 100MG A088549 002 Jun 01, 1984
AB 250MG A088549 001 Jun 01, 1984
AB PLIVA 100MG A088921 001 Apr 12, 1985
AB 250MG A088922 001 Apr 12, 1985
AB WATSON LABS 100MG A088852 001 Sep 26, 1984
AB 250MG A088826 001 Sep 26, 1984
DIABINESE
AB PFIZER 100MG N011641 003
AB + 250MG N011641 006

CHLORTHALIDONE
TABLET; ORAL
CHLORTHALIDONE
AB MYLAN 25MG A086831 002
AB + 50MG A086831 001
AB PLIVA 25MG A088902 001 Sep 19, 1985
AB 50MG A088903 001 Sep 19, 1985
THALITONE
XX + MONARCH PHARMS 15MG N019574 001 Dec 20, 1988

CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE


TABLET; ORAL
CLORPRES
XX MYLAN 15MG;0.1MG A071325 003 Feb 09, 1987
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 90 (of 393)

CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE


TABLET; ORAL
CLORPRES
XX MYLAN 15MG;0.2MG A071325 002 Feb 09, 1987
XX + 15MG;0.3MG A071325 001 Feb 09, 1987

CHLORZOXAZONE
TABLET; ORAL
CHLORZOXAZONE
AA ACTAVIS TOTOWA 250MG A088928 001 May 08, 1987
AA 500MG A040113 001 Sep 29, 1995
AA BARR 500MG A089895 001 May 04, 1988
AA OHM LABS 250MG A081298 001 Dec 29, 1993
AA 500MG A081299 001 Dec 29, 1993
AA WATSON LABS 500MG A040137 001 Aug 09, 1996
AA 500MG A081040 001 Aug 22, 1989
AA 500MG A089859 001 May 04, 1988
PARAFON FORTE DSC
AA + ORTHO MCNEIL JANSSEN 500MG N011529 002 Jun 15, 1987

CHOLESTYRAMINE
POWDER; ORAL
CHOLESTYRAMINE
AB PAR PHARM EQ 4GM RESIN/PACKET A077204 001 Aug 26, 2005
AB EQ 4GM RESIN/SCOOPFUL A077204 002 Aug 26, 2005
AB SANDOZ EQ 4GM RESIN/PACKET A074557 001 Aug 15, 1996
AB EQ 4GM RESIN/SCOOPFUL A074557 002 Aug 15, 1996
CHOLESTYRAMINE LIGHT
AB PAR PHARM EQ 4GM RESIN/SCOOPFUL A077203 002 Aug 26, 2005
AB EQ 4GM RESIN/PACKET A077203 001 Aug 26, 2005
AB SANDOZ EQ 4GM RESIN/SCOOPFUL A074558 002 Aug 15, 1996
AB EQ 4GM RESIN/PACKET A074558 001 Aug 15, 1996
LOCHOLEST
AB SANDOZ EQ 4GM RESIN/SCOOPFUL A074561 002 Aug 15, 1996
AB EQ 4GM RESIN/PACKET A074561 001 Aug 15, 1996
LOCHOLEST LIGHT
AB SANDOZ EQ 4GM RESIN/SCOOPFUL A074562 002 Aug 15, 1996
AB EQ 4GM RESIN/PACKET A074562 001 Aug 15, 1996
PREVALITE
AB UPSHER SMITH EQ 4GM RESIN/PACKET A073263 001 Feb 22, 1996
AB EQ 4GM RESIN/SCOOPFUL A073263 002 Oct 30, 1997
QUESTRAN
AB BRISTOL MYERS EQ 4GM RESIN/SCOOPFUL N016640 003
AB + EQ 4GM RESIN/PACKET N016640 001
QUESTRAN LIGHT
AB BRISTOL MYERS EQ 4GM RESIN/SCOOPFUL N019669 003 Dec 05, 1988
AB EQ 4GM RESIN/PACKET N019669 001 Dec 05, 1988

CHOLINE FENOFIBRATE
CAPSULE, DELAYED RELEASE; ORAL
TRILIPIX
XX ABBOTT LABS EQ 45MG FENOFIBRIC ACID N022224 001 Dec 15, 2008
XX + EQ 135MG FENOFIBRIC ACID N022224 002 Dec 15, 2008

CHORIOGONADOTROPIN ALFA
INJECTABLE; SUBCUTANEOUS

OVIDREL

XX + EMD SERONO EQ 0.25MG /0.5ML N021149 002 Oct 06, 2003


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 91 (of 393)

CHROMIC CHLORIDE
INJECTABLE; INJECTION

CHROMIC CHLORIDE IN PLASTIC CONTAINER


XX + HOSPIRA EQ 0.004MG CHROMIUM/ML N018961 001 Jun 26, 1986

CICLESONIDE
AEROSOL, METERED; INHALATION
ALVESCO
XX NYCOMED US 0.08MG/INH N021658 002 Jan 10, 2008
XX + 0.16MG/INH N021658 003 Jan 10, 2008
SPRAY, METERED; NASAL

OMNARIS

XX + NYCOMED US 0.05MG/INH N022004 001 Oct 20, 2006

CICLOPIROX
CREAM; TOPICAL
CICLOPIROX
AB ALTANA 0.77% A076435 001 Dec 29, 2004
AB GLENMARK PHARMS 0.77% A090273 001 Nov 10, 2009
AB PERRIGO 0.77% A077364 001 Mar 03, 2006
AB TARO 0.77% A076790 001 Apr 12, 2005
LOPROX
AB + MEDICIS 0.77% N018748 001 Dec 30, 1982
GEL; TOPICAL
CICLOPIROX
AB NYCOMED US 0.77% A077896 001 Jun 10, 2008
AB PADDOCK 0.77% A078266 001 Jan 07, 2009
LOPROX
AB + MEDICIS 0.77% N020519 001 Jul 21, 1997
SHAMPOO; TOPICAL
CICLOPIROX
AT PADDOCK LABS 1% A090490 001 Nov 24, 2009
LOPROX
AT + MEDICIS 1% N021159 001 Feb 28, 2003
SOLUTION; TOPICAL
CICLOPIROX
AT ACTAVIS MID ATLANTIC 8% A078046 001 Sep 18, 2007
AT APOTEX CORP 8% A078172 001 Sep 18, 2007
AT G AND W LABS 8% A078233 001 Sep 18, 2007
AT HI TECH PHARMA 8% A078270 001 Sep 18, 2007
AT PERRIGO NEW YORK 8% A077623 001 Sep 18, 2007
AT SYNERX PHARMA 8% A078567 001 Sep 18, 2007
AT TARO PHARM INDS 8% A078144 001 Sep 18, 2007
AT TEVA PHARMS 8% A078079 001 Sep 18, 2007
AT TOLMAR 8% A077687 001 Sep 18, 2007
AT WATSON LABS 8% A078124 001 Sep 18, 2007
PENLAC
AT + SANOFI AVENTIS US 8% N021022 001 Dec 17, 1999
SUSPENSION; TOPICAL
CICLOPIROX
AB ALTANA 0.77% A076422 001 Aug 06, 2004
AB PERRIGO NEW YORK 0.77% A077676 001 Dec 15, 2006
AB TARO 0.77% A077092 001 Aug 10, 2005
LOPROX
AB + MEDICIS 0.77% N019824 001 Dec 30, 1988
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 92 (of 393)

CIDOFOVIR
INJECTABLE; INJECTION

VISTIDE

XX + GILEAD EQ 75MG BASE/ML N020638 001 Jun 26, 1996

CILASTATIN SODIUM; IMIPENEM


INJECTABLE; INJECTION
PRIMAXIN
XX MERCK EQ 250MG BASE/VIAL;250MG/VIAL A062756 001 Jan 08, 1987
XX + EQ 250MG BASE/VIAL;250MG/VIAL N050587 001 Nov 26, 1985
XX EQ 500MG BASE/VIAL;500MG/VIAL A062756 002 Jan 08, 1987
XX + EQ 500MG BASE/VIAL;500MG/VIAL N050587 002 Nov 26, 1985
XX EQ 500MG BASE/VIAL;500MG/VIAL N050630 001 Dec 14, 1990

CILOSTAZOL
TABLET; ORAL
CILOSTAZOL
AB ACTAVIS TOTOWA 100MG A077028 002 Nov 26, 2004
AB ALPHAPHARM 50MG A077019 001 Nov 23, 2004
AB 100MG A077019 002 Nov 23, 2004
AB APOTEX INC 50MG A077030 001 Dec 10, 2004
AB 100MG A077030 002 Dec 10, 2004
AB BRECKENRIDGE PHARM 50MG A077708 001 Sep 28, 2009
AB 100MG A077708 002 Sep 28, 2009
AB COREPHARMA 50MG A077150 001 Mar 11, 2005
AB 100MG A077022 001 Nov 23, 2004
AB IVAX SUB TEVA PHARMS 100MG A077020 002 Mar 01, 2005
AB MYLAN 50MG A077323 002 Apr 20, 2006
AB 100MG A077323 001 Apr 20, 2006
AB PLIVA HRVATSKA DOO 50MG A077898 001 Oct 29, 2007
AB 100MG A077898 002 Oct 29, 2007
AB ROXANE 50MG A077024 001 May 17, 2005
AB 100MG A077024 002 May 17, 2005
AB SANDOZ 50MG A077310 001 Nov 08, 2005
AB 100MG A077021 001 Nov 23, 2004
AB TEVA 50MG A077027 001 Nov 24, 2004
AB 100MG A077027 002 Nov 24, 2004
PLETAL
AB + OTSUKA 50MG N020863 001 Jan 15, 1999
AB + 100MG N020863 002 Jan 15, 1999

CIMETIDINE
TABLET; ORAL
CIMETIDINE
AB APOTEX 200MG A074890 001 Dec 18, 1998
AB 300MG A074890 002 Dec 18, 1998
AB 400MG A074890 003 Dec 18, 1998
AB 800MG A074890 004 Dec 18, 1998
AB DAVA PHARMS INC 300MG A074340 001 Jun 23, 1995
AB 400MG A074340 002 Jun 23, 1995
AB 800MG A074339 001 Jun 23, 1995
AB IVAX SUB TEVA PHARMS 200MG A074424 001 Jul 28, 1995
AB 300MG A074424 002 Jul 28, 1995
AB 400MG A074424 003 Jul 28, 1995
AB 800MG A074424 004 Jul 28, 1995
AB MYLAN 200MG A074246 001 May 17, 1994
AB 300MG A074246 002 May 17, 1994
AB 400MG A074246 003 May 17, 1994
AB 800MG A074246 004 May 17, 1994
AB PLIVA 200MG A074568 001 Feb 27, 1997
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 93 (of 393)

CIMETIDINE
TABLET; ORAL
CIMETIDINE
AB PLIVA 300MG A074568 002 Feb 27, 1997
AB 400MG A074568 003 Feb 27, 1997
AB 800MG A074566 001 Feb 27, 1997
AB SANDOZ 200MG A074506 001 Jan 24, 1996
AB 300MG A074506 002 Jan 24, 1996
AB 400MG A074506 003 Jan 24, 1996
AB 800MG A074506 004 Jan 24, 1996
AB TEVA 200MG A074151 001 May 17, 1994
AB 300MG A074151 002 May 17, 1994
AB 400MG A074151 003 May 17, 1994
AB 800MG A074463 001 May 17, 1994
AB WATSON LABS 200MG A074349 001 Aug 30, 1996
AB 300MG A074349 002 Aug 30, 1996
AB 400MG A074349 003 Aug 30, 1996
AB 800MG A074316 001 Feb 28, 1996
TAGAMET
AB GLAXOSMITHKLINE 200MG N017920 002
AB 300MG N017920 003
AB 400MG N017920 004 Dec 14, 1983
AB + 800MG N017920 005 Apr 30, 1986

CIMETIDINE HYDROCHLORIDE
INJECTABLE; INJECTION
CIMETIDINE HYDROCHLORIDE
AP DAVA PHARMS INC EQ 300MG BASE/2ML A074428 001 Apr 25, 1996
AP HOSPIRA EQ 300MG BASE/2ML A074344 001 Jan 31, 1995
AP EQ 300MG BASE/2ML A074345 001 Jan 31, 1995
AP TEVA PARENTERAL EQ 300MG BASE/2ML A074252 001 Nov 26, 1997
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
XX + HOSPIRA EQ 6MG BASE/ML A074269 001 Dec 27, 1994
SOLUTION; ORAL
CIMETIDINE HYDROCHLORIDE
AA + HI TECH PHARMA EQ 300MG BASE/5ML A074664 001 Oct 28, 1997
AA MORTON GROVE EQ 300MG BASE/5ML A074757 001 Oct 17, 1997
AA NOVEX EQ 300MG BASE/5ML A075560 001 Mar 15, 2000
AA PHARM ASSOC EQ 300MG BASE/5ML A074553 001 Jan 27, 1997
AA TEVA EQ 300MG BASE/5ML A074610 001 Sep 26, 1996

CINACALCET HYDROCHLORIDE
TABLET; ORAL
SENSIPAR
XX AMGEN EQ 30MG BASE N021688 001 Mar 08, 2004
XX EQ 60MG BASE N021688 002 Mar 08, 2004
XX + EQ 90MG BASE N021688 003 Mar 08, 2004

CIPROFLOXACIN
FOR SUSPENSION; ORAL
CIPRO
XX BAYER HLTHCARE 250MG/5ML N020780 001 Sep 26, 1997
XX + 500MG/5ML N020780 002 Sep 26, 1997
INJECTABLE; INJECTION
CIPRO
AP + BAYER HLTHCARE 400MG/40ML (10MG/ML) N019847 001 Dec 26, 1990
AP + 200MG/20ML (10MG/ML) N019847 002 Dec 26, 1990
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + BAYER HLTHCARE 200MG/100ML N019857 001 Dec 26, 1990
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 94 (of 393)

CIPROFLOXACIN
INJECTABLE; INJECTION
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + BAYER HLTHCARE 400MG/200ML N019857 002 Dec 26, 1990
CIPROFLOXACIN
AP CLARIS LIFESCIENCES 200MG/20ML (10MG/ML) A078062 001 Apr 29, 2008
AP 400MG/40ML (10MG/ML) A078062 002 Apr 29, 2008
AP HOSPIRA 200MG/20ML (10MG/ML) A077245 001 Aug 28, 2006
AP 400MG/40ML (10MG/ML) A077245 002 Aug 28, 2006
AP TEVA PARENTERAL 200MG/20ML (10MG/ML) A077782 001 Aug 28, 2006
AP 400MG/40ML (10MG/ML) A077782 002 Aug 28, 2006
AP WEST WARD 200MG/20ML (10MG/ML) A076717 001 Dec 22, 2009
AP 400MG/40ML (10MG/ML) A076717 002 Dec 22, 2009
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
AP ACS DOBFAR INFO SA 200MG/100ML A078252 001 Mar 18, 2008
AP 400MG/200ML A078252 002 Mar 18, 2008
AP BAXTER HLTHCARE 200MG/100ML A077888 001 Mar 18, 2008
AP 400MG/200ML A077888 002 Mar 18, 2008
AP CLARIS LIFESCIENCES 200MG/100ML A078024 001 Mar 18, 2008
AP 400MG/200ML A078024 002 Mar 18, 2008
AP HIKMA FARMACEUTICA 400MG/200ML A078431 001 Nov 18, 2009
AP HOSPIRA 200MG/100ML A077753 001 Mar 18, 2008
AP 400MG/200ML A077753 002 Mar 18, 2008
AP TEVA PARENTERAL 200MG/100ML A077138 001 Mar 18, 2008
AP 400MG/200ML A077138 002 Mar 18, 2008

CIPROFLOXACIN HYDROCHLORIDE
OINTMENT; OPHTHALMIC

CILOXAN

XX + ALCON EQ 0.3% BASE N020369 001 Mar 30, 1998


SOLUTION/DROPS; OPHTHALMIC
CILOXAN
AT + ALCON EQ 0.3% BASE N019992 001 Dec 31, 1990
CIPROFLOXACIN HYDROCHLORIDE
AT AKORN INC EQ 0.3% BASE A076555 001 Dec 11, 2008
AT BAUSCH AND LOMB EQ 0.3% BASE A076754 001 Jun 09, 2004
AT FDC LTD EQ 0.3% BASE A077568 001 Jun 30, 2008
AT HITECH PHARMA EQ 0.3% BASE A076673 001 Jan 21, 2005
AT NEXUS PHARMS EQ 0.3% BASE A077689 001 Dec 13, 2006
AT NOVEX EQ 0.3% BASE A075928 001 Jun 09, 2004
AT PHARMAFORCE EQ 0.3% BASE A078598 001 Jan 16, 2008
SOLUTION/DROPS; OTIC

CETRAXAL

XX + WRASER PHARMS EQ 0.2% BASE N021918 001 May 01, 2009


TABLET; ORAL
CIPRO
AB BAYER HLTHCARE EQ 100MG BASE N019537 001 Apr 08, 1996
AB EQ 250MG BASE N019537 002 Oct 22, 1987
AB EQ 500MG BASE N019537 003 Oct 22, 1987
AB + EQ 750MG BASE N019537 004 Oct 22, 1987
CIPROFLOXACIN HYDROCHLORIDE
AB APOTEX EQ 250MG BASE A076896 001 Nov 04, 2004
AB EQ 500MG BASE A076896 002 Nov 04, 2004
AB EQ 750MG BASE A076896 003 Nov 04, 2004
AB AUROBINDO PHARMA EQ 250MG BASE A077859 001 Apr 26, 2007
AB EQ 500MG BASE A077859 002 Apr 26, 2007
AB EQ 750MG BASE A077859 003 Apr 26, 2007
AB CARLSBAD EQ 250MG BASE A076126 002 Jun 09, 2004
AB EQ 500MG BASE A076126 003 Jun 09, 2004
AB EQ 750MG BASE A076126 004 Jun 09, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 95 (of 393)

CIPROFLOXACIN HYDROCHLORIDE
TABLET; ORAL
CIPROFLOXACIN HYDROCHLORIDE
AB COBALT EQ 100MG BASE A076794 001 Feb 10, 2005
AB EQ 250MG BASE A076794 002 Jun 09, 2004
AB EQ 500MG BASE A076794 003 Jun 09, 2004
AB EQ 750MG BASE A076794 004 Jun 09, 2004
AB DR REDDYS LABS LTD EQ 100MG BASE A075593 002 Jun 09, 2004
AB EQ 250MG BASE A075593 003 Jun 09, 2004
AB EQ 500MG BASE A075593 004 Jun 09, 2004
AB EQ 750MG BASE A075593 001 Jun 09, 2004
AB HIKMA EQ 250MG BASE A076558 002 Jun 09, 2004
AB EQ 500MG BASE A076558 003 Jun 09, 2004
AB EQ 750MG BASE A076558 004 Jun 09, 2004
AB IVAX SUB TEVA PHARMS EQ 250MG BASE A076089 002 Jun 09, 2004
AB EQ 500MG BASE A076089 003 Jun 09, 2004
AB EQ 750MG BASE A076089 004 Jun 09, 2004
AB MYLAN EQ 100MG BASE A075817 001 Jun 25, 2007
AB EQ 250MG BASE A075685 002 Jun 09, 2004
AB EQ 250MG BASE A075817 002 Jun 09, 2004
AB EQ 500MG BASE A075685 003 Jun 09, 2004
AB EQ 500MG BASE A075817 003 Jun 09, 2004
AB EQ 750MG BASE A075685 001 Jun 09, 2004
AB EQ 750MG BASE A075817 004 Jun 09, 2004
AB RANBAXY EQ 250MG BASE A075747 001 Jun 09, 2004
AB EQ 500MG BASE A075747 002 Jun 09, 2004
AB EQ 750MG BASE A075747 003 Jun 09, 2004
AB TARO EQ 100MG BASE A076912 001 Feb 18, 2005
AB EQ 250MG BASE A076912 002 Oct 06, 2004
AB EQ 500MG BASE A076912 003 Oct 06, 2004
AB EQ 750MG BASE A076912 004 Oct 06, 2004
AB UNIQUE PHARM LABS EQ 250MG BASE A076639 001 Sep 10, 2004
AB EQ 500MG BASE A076639 002 Sep 10, 2004
AB EQ 750MG BASE A076639 003 Sep 10, 2004
CIPROFLOXACIN HYDROCHLORIDE
BX PLIVA EQ 100MG BASE A076426 001 Jun 15, 2005
BX EQ 250MG BASE A076426 002 Jun 15, 2005
BX EQ 500MG BASE A076426 003 Jun 15, 2005
BX EQ 750MG BASE A076426 004 Jun 15, 2005
TABLET, EXTENDED RELEASE; ORAL

PROQUIN XR

XX + DEPOMED INC EQ 500MG BASE N021744 001 May 19, 2005

CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE


SUSPENSION/DROPS; OTIC

CIPRO HC

XX + ALCON EQ 0.2% BASE;1% N020805 001 Feb 10, 1998

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE


TABLET, EXTENDED RELEASE; ORAL
CIPRO XR
AB + BAYER HLTHCARE 212.6MG;EQ 287.5MG BASE N021473 001 Dec 13, 2002
AB + 425.2MG;EQ 574.9MG BASE N021473 002 Aug 28, 2003
CIPROFLOXACIN EXTENDED RELEASE
AB DR REDDYS LABS LTD 212.6MG;EQ 287.5MG BASE A077902 001 Oct 31, 2007
AB 425.2MG;EQ 574.9MG BASE A077701 001 Mar 26, 2007
AB MYLAN 212.6MG;EQ 287.5MG BASE A078183 001 Mar 22, 2007
AB 425.2MG;EQ 574.9MG BASE A078183 002 Mar 22, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 96 (of 393)

CIPROFLOXACIN; DEXAMETHASONE
SUSPENSION/DROPS; OTIC

CIPRODEX

XX + ALCON 0.3%;0.1% N021537 001 Jul 18, 2003

CISATRACURIUM BESYLATE
INJECTABLE; INJECTION

NIMBEX

XX + ABBOTT EQ 2MG BASE/ML N020551 001 Dec 15, 1995


NIMBEX PRESERVATIVE FREE
XX + ABBOTT EQ 2MG BASE/ML N020551 003 Dec 15, 1995
XX + EQ 10MG BASE/ML N020551 002 Dec 15, 1995

CISPLATIN
INJECTABLE; INJECTION
CISPLATIN
AP APP PHARMS 1MG/ML A074735 001 Jul 16, 1999
AP BEDFORD 1MG/ML A075036 001 Nov 07, 2000
AP PHARMACHEMIE 1MG/ML A074656 001 May 16, 2000
AP TEVA PARENTERAL 1MG/ML A074814 001 May 16, 2000
PLATINOL-AQ
AP + BRISTOL MYERS 1MG/ML N018057 004 Nov 08, 1988
PLATINOL
XX + BRISTOL MYERS 10MG/VIAL N018057 001
XX + 50MG/VIAL N018057 002

CITALOPRAM HYDROBROMIDE
CAPSULE; ORAL
CITALOPRAM HYDROBROMIDE
XX ALPHAPHARM EQ 10MG BASE A077668 001 Feb 28, 2007
XX EQ 20MG BASE A077668 002 Feb 28, 2007
XX + EQ 40MG BASE A077668 003 Feb 28, 2007
SOLUTION; ORAL
CELEXA
AA + FOREST LABS EQ 10MG BASE/5ML N021046 001 Dec 22, 1999
CITALOPRAM HYDROBROMIDE
AA AUROBINDO PHARMA LTD EQ 10MG BASE/5ML A077812 001 Aug 28, 2006
AA ROXANE EQ 10MG BASE/5ML A077043 001 Dec 13, 2004
AA SILARX EQ 10MG BASE/5ML A077629 001 Jun 15, 2006
TABLET; ORAL
CELEXA
AB FOREST LABS EQ 10MG BASE N020822 001 Apr 27, 2000
AB EQ 20MG BASE N020822 002 Jul 17, 1998
AB + EQ 40MG BASE N020822 003 Jul 17, 1998
CITALOPRAM HYDROBROMIDE
AB ALPHAPHARM EQ 10MG BASE A077037 001 Nov 05, 2004
AB EQ 20MG BASE A077037 002 Nov 05, 2004
AB EQ 40MG BASE A077037 003 Nov 05, 2004
AB AMNEAL PHARMS NY EQ 10MG BASE A077289 001 Nov 30, 2006
AB EQ 20MG BASE A077289 002 Nov 30, 2006
AB EQ 40MG BASE A077289 003 Nov 30, 2006
AB APOTEX INC EQ 10MG BASE A077046 001 Nov 24, 2004
AB EQ 20MG BASE A077046 002 Nov 24, 2004
AB EQ 40MG BASE A077046 003 Nov 24, 2004
AB AUROBINDO EQ 10MG BASE A077031 001 Oct 28, 2004
AB EQ 20MG BASE A077031 002 Oct 28, 2004
AB EQ 40MG BASE A077031 003 Oct 28, 2004
AB CARACO EQ 10MG BASE A077032 001 Nov 12, 2004
AB EQ 20MG BASE A077032 002 Nov 12, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 97 (of 393)

CITALOPRAM HYDROBROMIDE
TABLET; ORAL
CITALOPRAM HYDROBROMIDE
AB CARACO EQ 40MG BASE A077032 003 Nov 12, 2004
AB COBALT EQ 10MG BASE A077034 001 Jun 30, 2005
AB EQ 20MG BASE A077034 002 Jun 30, 2005
AB EQ 40MG BASE A077034 003 Jun 30, 2005
AB COREPHARMA EQ 10MG BASE A077036 001 Oct 28, 2004
AB EQ 20MG BASE A077036 002 Oct 28, 2004
AB EQ 40MG BASE A077036 003 Oct 28, 2004
AB DR REDDYS LABS LTD EQ 10MG BASE A077038 001 Oct 28, 2004
AB EQ 20MG BASE A077038 002 Oct 28, 2004
AB EQ 40MG BASE A077038 003 Oct 28, 2004
AB GLENMARK GENERICS EQ 10MG BASE A077654 001 Feb 27, 2009
AB EQ 20MG BASE A077654 002 Feb 27, 2009
AB EQ 40MG BASE A077654 003 Feb 27, 2009
AB INVAGEN PHARMS EQ 10MG BASE A077534 001 Oct 03, 2006
AB EQ 20MG BASE A077534 002 Oct 03, 2006
AB EQ 40MG BASE A077534 003 Oct 03, 2006
AB IVAX SUB TEVA PHARMS EQ 10MG BASE A077048 001 Nov 16, 2004
AB EQ 20MG BASE A077048 002 Nov 16, 2004
AB EQ 40MG BASE A077048 003 Nov 16, 2004
AB MATRIX LABS INC EQ 10MG BASE A077042 001 Nov 05, 2004
AB EQ 20MG BASE A077042 002 Nov 05, 2004
AB EQ 40MG BASE A077042 003 Nov 05, 2004
AB MYLAN EQ 10MG BASE A077039 001 Feb 03, 2005
AB EQ 20MG BASE A077039 002 Feb 03, 2005
AB EQ 40MG BASE A077039 003 Feb 03, 2005
AB NATCO PHARMA LTD EQ 20MG BASE A077141 002 Apr 10, 2008
AB EQ 40MG BASE A077141 001 Apr 10, 2008
AB PLIVA EQ 10MG BASE A077232 001 Oct 31, 2005
AB EQ 20MG BASE A077232 002 Oct 31, 2005
AB EQ 40MG BASE A077232 003 Oct 31, 2005
AB SANDOZ EQ 10MG BASE A077035 001 Oct 28, 2004
AB EQ 20MG BASE A077035 002 Oct 28, 2004
AB EQ 40MG BASE A077035 003 Oct 28, 2004
AB TORRENT PHARMS EQ 10MG BASE A078216 001 Mar 27, 2007
AB EQ 20MG BASE A078216 002 Mar 27, 2007
AB EQ 40MG BASE A078216 003 Mar 27, 2007
AB WATSON LABS EQ 10MG BASE A077044 001 Nov 05, 2004
AB EQ 20MG BASE A077044 002 Nov 05, 2004
AB EQ 40MG BASE A077044 003 Nov 05, 2004

CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE


SOLUTION; IRRIGATION

RENACIDIN

XX + UNITED GUARDIAN 6.602GM/100ML;198MG/100ML;3.177GM/100ML N019481 001 Oct 02, 1990

CITRIC ACID; UREA C-13


FOR SOLUTION; TABLET, FOR SOLUTION; ORAL

IDKIT:HP

XX + EXALENZ BIOSCIENCE N/A,4GM;75MG,N/A N021314 001 Dec 17, 2002

CLADRIBINE
INJECTABLE; INJECTION
CLADRIBINE
AP APP PHARMS 1MG/ML A076571 001 Apr 22, 2004
AP BEDFORD 1MG/ML A075405 001 Feb 28, 2000
LEUSTATIN
AP + ORTHO BIOTECH 1MG/ML N020229 001 Feb 26, 1993
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 98 (of 393)

CLARITHROMYCIN
FOR SUSPENSION; ORAL
BIAXIN
AB ABBOTT 125MG/5ML N050698 001 Dec 23, 1993
AB + 250MG/5ML N050698 002 Dec 23, 1993
CLARITHROMYCIN
AB RANBAXY 125MG/5ML A065382 001 Aug 30, 2007
AB 250MG/5ML A065382 002 Aug 30, 2007
AB SANDOZ 125MG/5ML A065283 002 Sep 04, 2007
AB 250MG/5ML A065283 003 Sep 04, 2007
TABLET; ORAL
BIAXIN
AB + ABBOTT 250MG N050662 001 Oct 31, 1991
AB + 500MG N050662 002 Oct 31, 1991
CLARITHROMYCIN
AB APOTEX CORP 250MG A065384 001 Aug 20, 2007
AB 500MG A065384 002 Aug 20, 2007
AB IVAX SUB TEVA PHARMS 250MG A065137 001 May 31, 2005
AB 500MG A065137 002 May 31, 2005
AB MYLAN 250MG A065195 001 Mar 11, 2005
AB 500MG A065195 002 Mar 11, 2005
AB RANBAXY 250MG A065174 001 Sep 24, 2004
AB 500MG A065174 002 Sep 24, 2004
AB ROXANE 250MG A065178 002 May 25, 2004
AB 500MG A065178 001 May 25, 2004
AB SANDOZ 250MG A065144 001 Oct 18, 2005
AB 500MG A065136 001 Aug 25, 2005
AB TEVA 250MG A065155 001 May 31, 2005
AB 500MG A065155 002 May 31, 2005
AB WOCKHARDT 250MG A065266 001 May 31, 2006
AB 500MG A065266 002 May 31, 2006
TABLET, EXTENDED RELEASE; ORAL
BIAXIN XL
AB + ABBOTT 500MG N050775 001 Mar 03, 2000
CLARITHROMYCIN
AB SANDOZ 500MG A065250 001 Aug 25, 2005
AB TEVA 500MG A065154 001 May 18, 2005
AB WATSON LABS FLORIDA 500MG A065145 001 Jun 24, 2004

CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM


INJECTABLE; INJECTION

TIMENTIN

XX + GLAXOSMITHKLINE EQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL N050590 003 Aug 18, 1987
XX EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL A062691 001 Dec 19, 1986
XX + EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL N050590 001 Apr 01, 1985
XX + EQ 200MG BASE/VIAL;EQ 3GM BASE/VIAL N050590 002 Apr 01, 1985
TIMENTIN IN PLASTIC CONTAINER
XX + GLAXOSMITHKLINE EQ 100MG BASE/100ML;EQ 3GM BASE/100ML N050658 001 Dec 15, 1989

CLEMASTINE FUMARATE
SYRUP; ORAL
CLEMASTINE FUMARATE
AA ACTAVIS MID ATLANTIC EQ 0.5MG BASE/5ML A074075 001 Oct 31, 1993
AA MORTON GROVE EQ 0.5MG BASE/5ML A074863 001 Mar 13, 1998
AA NOVEX EQ 0.5MG BASE/5ML A075703 001 Nov 27, 2000
AA SILARX EQ 0.5MG BASE/5ML A074884 001 Dec 17, 1997
AA + TEVA EQ 0.5MG BASE/5ML A073399 001 Jun 30, 1994
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 99 (of 393)

CLEMASTINE FUMARATE
TABLET; ORAL
CLEMASTINE FUMARATE
AB SANDOZ 2.68MG A073459 001 Oct 31, 1993
AB + TEVA 2.68MG A073283 001 Jan 31, 1992

CLEVIDIPINE BUTYRATE
EMULSION; INTRAVENOUS

CLEVIPREX

XX + MEDICINES CO 25MG/50ML (0.5MG/ML) N022156 001 Aug 01, 2008


XX + 50MG/100ML (0.5MG/ML) N022156 002 Aug 01, 2008

CLINDAMYCIN HYDROCHLORIDE
CAPSULE; ORAL
CLEOCIN HYDROCHLORIDE
AB PHARMACIA AND UPJOHN EQ 75MG BASE N050162 001
AB EQ 150MG BASE N050162 002
AB + EQ 300MG BASE N050162 003 Apr 14, 1988
CLINDAMYCIN HYDROCHLORIDE
AB AUROBINDO PHARMA EQ 150MG BASE A065442 001 Aug 26, 2009
AB EQ 300MG BASE A065442 002 Aug 26, 2009
AB COREPHARMA EQ 150MG BASE A065194 001 Mar 22, 2004
AB EQ 300MG BASE A065194 002 Mar 22, 2004
AB LANNETT EQ 75MG BASE A065242 001 Aug 12, 2005
AB EQ 150MG BASE A065242 002 Aug 12, 2005
AB EQ 300MG BASE A065243 001 Aug 12, 2005
AB RANBAXY EQ 150MG BASE A065061 001 Feb 02, 2001
AB EQ 300MG BASE A065061 002 Feb 02, 2001
AB TEVA EQ 150MG BASE A063029 001 Sep 20, 1989
AB EQ 300MG BASE A063029 002 Aug 05, 2005
AB WATSON LABS EQ 150MG BASE A063083 001 Jul 31, 1991
AB EQ 300MG BASE A063083 002 Mar 18, 2003
AB ZYDUS PHARMS USA EQ 75MG BASE A065217 001 Jan 31, 2005
AB EQ 150MG BASE A065217 002 Jan 31, 2005
AB EQ 300MG BASE A065217 003 Jan 31, 2005

CLINDAMYCIN PALMITATE HYDROCHLORIDE


FOR SOLUTION; ORAL

CLEOCIN

XX + PHARMACIA AND UPJOHN EQ 75MG BASE/5ML A062644 001 Apr 07, 1986

CLINDAMYCIN PHOSPHATE
AEROSOL, FOAM; TOPICAL

EVOCLIN

XX + STIEFEL LABS INC 1% N050801 001 Oct 22, 2004


CREAM; VAGINAL
CLEOCIN
AB + PHARMACIA AND UPJOHN EQ 2% BASE N050680 002 Mar 02, 1998
CLINDAMYCIN PHOSPHATE
AB ALTANA PHARMA EQ 2% BASE A065139 001 Dec 27, 2004
CLINDESSE
XX + KV PHARM EQ 2% BASE N050793 001 Nov 30, 2004
GEL; TOPICAL
CLEOCIN T
AB + PHARMACIA AND UPJOHN EQ 1% BASE N050615 001 Jan 07, 1987
CLINDAMYCIN PHOSPHATE
AB ALTANA EQ 1% BASE A064160 001 Jan 28, 2000
CLINDAGEL
BT GALDERMA LABS LP EQ 1% BASE N050782 001 Nov 27, 2000
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 100 (of 393)

CLINDAMYCIN PHOSPHATE
INJECTABLE; INJECTION
CLEOCIN PHOSPHATE
AP PHARMACIA AND UPJOHN EQ 150MG BASE/ML
A062803 001 Oct 16, 1987
AP + EQ 150MG BASE/ML
N050441 001
CLINDAMYCIN PHOSPHATE
AP APP PHARMS EQ 150MG BASE/ML A065346 001 Mar 29, 2007
AP EQ 150MG BASE/ML A065347 001 May 09, 2007
AP BAXTER HLTHCARE EQ 150MG BASE/ML A062889 001 Apr 25, 1988
AP BEDFORD EQ 150MG BASE/ML A065206 001 Sep 24, 2004
AP HOSPIRA EQ 150MG BASE/ML A062800 001 Jul 24, 1987
AP EQ 150MG BASE/ML A062801 001 Jul 24, 1987
AP EQ 150MG BASE/ML A062943 001 Sep 29, 1988
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
XX + PHARMACIA AND UPJOHN EQ 6MG BASE/ML N050639 001 Aug 30, 1989
XX + EQ 12MG BASE/ML N050639 002 Aug 30, 1989
XX + EQ 18MG BASE/ML N050639 003 Apr 10, 1991
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
XX + ABRAXIS PHARM EQ 900MG BASE/100ML N050635 001 Dec 22, 1989
LOTION; TOPICAL
CLEOCIN T
AB + PHARMACIA AND UPJOHN EQ 1% BASE N050600 001 May 31, 1989
CLINDAMYCIN PHOSPHATE
AB ALTANA EQ 1% BASE A065067 001 Jan 31, 2002
SOLUTION; TOPICAL
CLEOCIN T
AT + PHARMACIA AND UPJOHN EQ 1% BASE N050537 001
CLINDA-DERM
AT PADDOCK EQ 1% BASE A063329 001 Sep 30, 1992
CLINDAMYCIN PHOSPHATE
AT ACTAVIS MID ATLANTIC EQ 1% BASE A062811 001 Sep 01, 1988
AT ALTANA EQ 1% BASE A065254 001 Feb 14, 2006
AT FOUGERA EQ 1% BASE A064159 001 Jun 05, 1997
AT MORTON GROVE EQ 1% BASE A063304 001 Jul 15, 1997
AT PERRIGO NEW YORK EQ 1% BASE A064050 001 Nov 30, 1995
AT TARO PHARM INDS EQ 1% BASE A065184 001 Mar 31, 2004
SUPPOSITORY; VAGINAL

CLEOCIN

XX + PHARMACIA AND UPJOHN 100MG N050767 001 Aug 13, 1999


SWAB; TOPICAL
CLEOCIN
AT PHARMACIA AND UPJOHN EQ 1% BASE N050537 002 Feb 22, 1994
CLINDAMYCIN PHOSPHATE
AT PERRIGO NEW YORK EQ 1% BASE A065049 001 May 25, 2000
CLINDETS
AT PERRIGO EQ 1% BASE A064136 001 Sep 30, 1996

CLINDAMYCIN PHOSPHATE; TRETINOIN


GEL; TOPICAL

ZIANA

XX + MEDICIS 1.2%;0.025% N050802 001 Nov 07, 2006

CLOBETASOL PROPIONATE
AEROSOL, FOAM; TOPICAL
CLOBETASOL PROPIONATE
AB PERRIGO ISRAEL 0.05% A077763 001 Mar 10, 2008
OLUX
AB + CONNETICS 0.05% N021142 001 May 26, 2000
OLUX E
XX + STIEFEL LABS INC 0.05% N022013 001 Jan 12, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 101 (of 393)

CLOBETASOL PROPIONATE
CREAM; TOPICAL
CLOBETASOL PROPIONATE
AB1 ACTAVIS MID ATLANTIC 0.05% A074139 001 Aug 03, 1994
AB1 FOUGERA 0.05% A074392 001 Sep 30, 1996
AB1 TARO 0.05% A074249 001 Jul 08, 1996
AB1 TEVA PHARMS 0.05% A074087 001 Feb 16, 1994
CORMAX
AB1 HI TECH PHARMA 0.05% A074220 001 May 16, 1997
TEMOVATE
AB1 + ALTANA 0.05% N019322 001 Dec 27, 1985
CLOBETASOL PROPIONATE (EMOLLIENT)
AB2 ALTANA 0.05% A075430 001 May 26, 1999
AB2 TARO 0.05% A075633 001 May 17, 2000
EMBELINE E
AB2 HI TECH PHARMA 0.05% A075325 001 Dec 24, 1998
TEMOVATE E
AB2 + ALTANA 0.05% N020340 001 Jun 17, 1994
GEL; TOPICAL
CLOBETASOL PROPIONATE
AB ALTANA 0.05% A075368 001 Feb 15, 2000
AB PERRIGO 0.05% A075027 001 Oct 31, 1997
AB TARO 0.05% A075279 001 May 28, 1999
EMBELINE
AB HI TECH PHARMA 0.05% A076141 001 Apr 12, 2002
TEMOVATE
AB + ALTANA 0.05% N020337 001 Apr 29, 1994
LOTION; TOPICAL
CLOBETASOL PROPIONATE
AB ACTAVIS MID ATLANTIC 0.05% A078223 001 Dec 04, 2008
CLOBEX
AB + GALDERMA LABS LP 0.05% N021535 001 Jul 24, 2003
OINTMENT; TOPICAL
CLOBETASOL PROPIONATE
AB ACTAVIS MID ATLANTIC 0.05% A074128 001 Aug 03, 1994
AB FOUGERA 0.05% A074407 001 Feb 23, 1996
AB TARO 0.05% A074248 001 Jul 12, 1996
AB TEVA PHARMS 0.05% A074089 001 Feb 16, 1994
EMBELINE
AB HI TECH PHARMA 0.05% A074221 001 Mar 31, 1995
TEMOVATE
AB + ALTANA 0.05% N019323 001 Dec 27, 1985
SHAMPOO; TOPICAL

CLOBEX

XX + GALDERMA LABS 0.05% N021644 001 Feb 05, 2004


SOLUTION; TOPICAL
CLOBETASOL PROPIONATE
AT ACTAVIS MID ATLANTIC 0.05% A074331 001 Dec 15, 1995
AT ALTANA 0.05% A075391 001 Feb 08, 1999
AT MORTON GROVE 0.05% A075205 001 Nov 13, 1998
AT TARO 0.05% A075224 001 Nov 16, 1998
AT 0.05% A075363 001 Dec 29, 2000
AT TOLMAR 0.05% A076977 001 Aug 05, 2005
EMBELINE
AT HI TECH PHARMA 0.05% A074222 001 Dec 06, 1995
TEMOVATE
AT + ALTANA 0.05% N019966 001 Feb 22, 1990
SPRAY; TOPICAL

CLOBEX

XX + GALDERMA LABS LP 0.05% N021835 001 Oct 27, 2005


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 102 (of 393)

CLOCORTOLONE PIVALATE
CREAM; TOPICAL

CLODERM

XX + DOW PHARM SCIENCES 0.1% N017765 001

CLOFARABINE
INJECTABLE; IV (INFUSION)

CLOLAR

XX + GENZYME 20MG/20ML (1MG/ML) N021673 001 Dec 28, 2004

CLOFAZIMINE
CAPSULE; ORAL

LAMPRENE

XX + NOVARTIS 50MG N019500 002 Dec 15, 1986

CLOMIPHENE CITRATE
TABLET; ORAL
CLOMID
AB + SANOFI AVENTIS US 50MG N016131 002
CLOMIPHENE CITRATE
AB PAR PHARM 50MG A075528 001 Aug 30, 1999
SEROPHENE
AB EMD SERONO 50MG N018361 001 Mar 22, 1982

CLOMIPRAMINE HYDROCHLORIDE
CAPSULE; ORAL
ANAFRANIL
AB TYCO HLTHCARE 25MG N019906 001 Dec 29, 1989
AB + 50MG N019906 002 Dec 29, 1989
AB 75MG N019906 003 Dec 29, 1989
CLOMIPRAMINE HYDROCHLORIDE
AB MYLAN 25MG A074947 001 Apr 30, 1998
AB 50MG A074947 002 Apr 30, 1998
AB 75MG A074947 003 Apr 30, 1998
AB SANDOZ 25MG A074364 001 Mar 29, 1996
AB 50MG A074364 002 Mar 29, 1996
AB 75MG A074364 003 Mar 29, 1996
AB TARO 25MG A074694 001 Dec 31, 1996
AB 50MG A074694 002 Dec 31, 1996
AB 75MG A074694 003 Dec 31, 1996
AB TEVA 25MG A074958 001 Aug 26, 1997
AB 50MG A074958 002 Aug 26, 1997
AB 75MG A074958 003 Aug 26, 1997

CLONAZEPAM
TABLET; ORAL
CLONAZEPAM
AB ACTAVIS ELIZABETH 0.5MG A074869 001 Oct 31, 1996
AB 1MG A074869 002 Oct 31, 1996
AB 2MG A074869 003 Oct 31, 1996
AB ALPHAPHARM 0.5MG A074940 001 Oct 30, 1997
AB 1MG A074940 002 Oct 30, 1997
AB 2MG A074940 003 Oct 30, 1997
AB APOTEX 0.5MG A075468 001 Oct 06, 2000
AB 1MG A075468 002 Oct 06, 2000
AB 2MG A075468 003 Oct 06, 2000
AB CARACO 0.5MG A075423 001 Apr 27, 2001
AB 1MG A075423 002 Apr 27, 2001
AB 2MG A075423 003 Apr 27, 2001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 103 (of 393)

CLONAZEPAM
TABLET; ORAL
CLONAZEPAM
AB MYLAN 0.5MG A075150 001 Oct 05, 1998
AB 1MG A075150 002 Oct 05, 1998
AB 2MG A075150 003 Oct 05, 1998
AB SANDOZ 0.5MG A074979 001 Aug 29, 1997
AB 1MG A074979 002 Aug 29, 1997
AB 2MG A074979 003 Aug 29, 1997
AB TEVA 0.5MG A074569 001 Sep 10, 1996
AB 1MG A074569 002 Sep 10, 1996
AB 2MG A074569 003 Sep 10, 1996
AB VINTAGE PHARMS 0.5MG A077856 001 Jun 28, 2006
AB 1MG A077856 002 Jun 28, 2006
AB 2MG A077856 003 Jun 28, 2006
AB WATSON LABS 0.5MG A074964 001 Dec 30, 1997
AB 1MG A074964 002 Dec 30, 1997
AB 2MG A074964 003 Dec 30, 1997
KLONOPIN
AB ROCHE 0.5MG N017533 001
AB + 1MG N017533 002
AB 2MG N017533 003
TABLET, ORALLY DISINTEGRATING; ORAL
CLONAZEPAM
AB BARR 0.125MG A077194 001 Aug 10, 2005
AB 0.25MG A077194 002 Aug 10, 2005
AB 0.5MG A077194 003 Aug 10, 2005
AB 1MG A077194 004 Aug 10, 2005
AB 2MG A077194 005 Aug 10, 2005
AB KALI LABS 0.125MG A077171 001 Aug 03, 2005
AB 0.25MG A077171 002 Aug 03, 2005
AB 0.5MG A077171 003 Aug 03, 2005
AB + 1MG A077171 004 Aug 03, 2005
AB 2MG A077171 005 Aug 03, 2005

CLONIDINE
FILM, EXTENDED RELEASE; TRANSDERMAL
CATAPRES-TTS-1
AB BOEHRINGER INGELHEIM 0.1MG/24HR N018891 001 Oct 10, 1984
CATAPRES-TTS-2
AB BOEHRINGER INGELHEIM 0.2MG/24HR N018891 002 Oct 10, 1984
CATAPRES-TTS-3
AB + BOEHRINGER INGELHEIM 0.3MG/24HR N018891 003 Oct 10, 1984
CLONIDINE
AB AVEVA 0.1MG/24HR A076157 001 Aug 18, 2009
AB 0.2MG/24HR A076157 002 Aug 18, 2009
AB 0.3MG/24HR A076157 003 Aug 18, 2009
SUSPENSION, EXTENDED RELEASE; ORAL

CLONIDINE

XX + TRIS PHARMA EQ 0.09MG BASE/ML N022499 001 Dec 03, 2009


TABLET, EXTENDED RELEASE; ORAL
CLONIDINE
XX TRIS PHARMA EQ 0.17MG BASE N022500 001 Dec 03, 2009
XX + EQ 0.26MG BASE N022500 002 Dec 03, 2009

CLONIDINE HYDROCHLORIDE
INJECTABLE; INJECTION
CLONIDINE HYDROCHLORIDE
AP PHARMAFORCE 1 MG/10 ML (0.1 MG/ML) A091104 001 Oct 08, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 104 (of 393)

CLONIDINE HYDROCHLORIDE
INJECTABLE; INJECTION
CLONIDINE HYDROCHLORIDE
AP PHARMAFORCE 5 MG/10 ML (0.5 MG/ML) A091104 002 Oct 08, 2009
DURACLON
AP XANODYNE PHARM 1 MG/10 ML (0.1 MG/ML) N020615 001 Oct 02, 1996
AP + 5 MG/10 ML (0.5 MG/ML) N020615 002 Apr 27, 1999
TABLET; ORAL
CATAPRES
AB BOEHRINGER INGELHEIM 0.1MG N017407 001
AB 0.2MG N017407 002
AB + 0.3MG N017407 003
CLONIDINE HYDROCHLORIDE
AB ACTAVIS ELIZABETH 0.1MG A070974 001 Dec 16, 1986
AB 0.2MG A070975 001 Dec 16, 1986
AB 0.3MG A070976 001 Dec 16, 1986
AB DAVA PHARMS INC 0.1MG A071783 001 Apr 05, 1988
AB 0.2MG A071784 001 Apr 05, 1988
AB 0.3MG A071785 001 Apr 05, 1988
AB IMPAX LABS 0.1MG A078099 001 Aug 27, 2009
AB 0.2MG A078099 002 Aug 27, 2009
AB 0.3MG A078099 003 Aug 27, 2009
AB MUTUAL PHARM 0.1MG A070925 001 Sep 04, 1987
AB 0.2MG A070924 001 Sep 04, 1987
AB 0.3MG A070923 001 Sep 04, 1987
AB MYLAN 0.1MG A070317 002 Jul 09, 1987
AB 0.2MG A070317 003 Jun 09, 1987
AB 0.3MG A070317 001 Jun 09, 1987
AB UNICHEM 0.1MG A078895 001 Aug 26, 2009
AB 0.2MG A078895 002 Aug 26, 2009
AB 0.3MG A078895 003 Aug 26, 2009
AB VINTAGE 0.1MG A077901 001 Mar 09, 2007
AB 0.2MG A077901 002 Mar 09, 2007
AB 0.3MG A077901 003 Mar 09, 2007
AB WATSON LABS 0.3MG A070963 001 Jul 08, 1986
JENLOGA
BX SCIELE PHARMA INC 0.1MG N022331 001 Sep 30, 2009

CLOPIDOGREL BISULFATE
TABLET; ORAL
PLAVIX
XX SANOFI AVENTIS US EQ 75MG BASE N020839 001 Nov 17, 1997
XX + EQ 300MG BASE N020839 002 Sep 20, 2007

CLORAZEPATE DIPOTASSIUM
TABLET; ORAL
CLORAZEPATE DIPOTASSIUM
AB MYLAN 3.75MG A071858 002 Jul 17, 1987
AB 7.5MG A071858 003 Jul 17, 1987
AB 15MG A071858 001 Jul 17, 1987
AB RANBAXY 3.75MG A076911 001 Sep 29, 2004
AB 7.5MG A076911 002 Sep 29, 2004
AB 15MG A076911 003 Sep 29, 2004
AB TARO 3.75MG A075731 003 Apr 27, 2000
AB 7.5MG A075731 002 Apr 27, 2000
AB 15MG A075731 001 Apr 27, 2000
AB WATSON LABS 3.75MG A071852 001 Feb 09, 1988
AB 7.5MG A071853 001 Feb 09, 1988
AB 15MG A071854 001 Feb 09, 1988
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 105 (of 393)

CLORAZEPATE DIPOTASSIUM
TABLET; ORAL
GEN-XENE
AB ALRA 3.75MG A071787 001 Apr 26, 1988
AB 7.5MG A071788 001 Apr 26, 1988
AB 15MG A071789 001 Apr 26, 1988
TRANXENE
AB LUNDBECK INC 3.75MG N017105 006
AB 7.5MG N017105 007
AB + 15MG N017105 008

CLOTRIMAZOLE
CREAM; TOPICAL
CLOTRIMAZOLE
AB NYCOMED US 1% A078338 001 Sep 02, 2008
AB + TARO 1% A072640 001 Aug 31, 1993
SOLUTION; TOPICAL
CLOTRIMAZOLE
AT TARO 1% A074580 001 Jul 29, 1996
AT TEVA 1% A073306 001 Feb 28, 1995
MYCELEX
AT + BAYER HLTHCARE 1% N018181 001
TROCHE/LOZENGE; ORAL
CLOTRIMAZOLE
AB PADDOCK 10MG A076763 001 Oct 28, 2005
AB ROXANE 10MG A076387 001 Jul 29, 2004
MYCELEX
AB + BAYER HLTHCARE 10MG N018713 001 Jun 17, 1983

CLOZAPINE
TABLET; ORAL
CLOZAPINE
AB CARACO 25MG A075713 001 Nov 15, 2002
AB 50MG A075713 003 Aug 19, 2005
AB 100MG A075713 002 Nov 15, 2002
AB GOLDLINE 50MG A076809 003 Dec 16, 2005
AB 100MG A076809 002 Dec 16, 2005
AB IVAX SUB TEVA PHARMS 25MG A074949 001 Nov 26, 1997
AB 50MG A074949 004 Apr 25, 2005
AB 100MG A074949 002 Nov 26, 1997
AB MYLAN 25MG A075417 001 May 27, 1999
AB 100MG A075417 002 May 27, 1999
CLOZARIL
AB NOVARTIS 25MG N019758 001 Sep 26, 1989
AB + 100MG N019758 002 Sep 26, 1989
CLOZAPINE
XX GOLDLINE 200MG A076809 001 Dec 16, 2005
XX IVAX SUB TEVA PHARMS 12.5MG A074949 003 Jul 31, 2003
TABLET, ORALLY DISINTEGRATING; ORAL
FAZACLO ODT
XX AZUR PHARMA INTL 12.5MG N021590 004 May 30, 2007
XX 25MG N021590 001 Feb 10, 2004
XX + 100MG N021590 002 Feb 10, 2004

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE


SYRUP; ORAL
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
AA VINTAGE 10MG/5ML;5MG/5ML;6.25MG/5ML A040660 001 Dec 07, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 106 (of 393)

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE


SYRUP; ORAL
PROMETH VC W/ CODEINE
AA + ACTAVIS MID ATLANTIC 10MG/5ML;5MG/5ML;6.25MG/5ML A088764 001 Oct 31, 1984

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE


SYRUP; ORAL
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
AA + ACTAVIS MID ATLANTIC 10MG/5ML;6.25MG/5ML A088763 001 Oct 31, 1984
AA HI TECH PHARMA 10MG/5ML;6.25MG/5ML A040151 001 Aug 26, 1997
AA MORTON GROVE 10MG/5ML;6.25MG/5ML A088875 001 Dec 17, 1984
AA PHARM ASSOC 10MG/5ML;6.25MG/5ML A089647 001 Dec 22, 1988
PROMETHAZINE WITH CODEINE
AA VINTAGE 10MG/5ML;6.25MG/5ML A040650 001 Jan 31, 2006

CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE


SYRUP; ORAL

TRIACIN-C

XX + STI PHARMA LLC 10MG/5ML;30MG/5ML;1.25MG/5ML A088704 001 Mar 22, 1985

CODEINE SULFATE
TABLET; ORAL
CODEINE SULFATE
XX ROXANE 15MG N022402 001 Jul 16, 2009
XX 30MG N022402 002 Jul 16, 2009
XX + 60MG N022402 003 Jul 16, 2009

COLCHICINE
TABLET; ORAL

COLCRYS

XX + AR HOLDING CO INC 0.6MG N022352 001 Jul 29, 2009

COLCHICINE; PROBENECID
TABLET; ORAL
COL-PROBENECID
AB + WATSON LABS 0.5MG;500MG A084279 001
PROBENECID AND COLCHICINE
AB CONCORD LABS NJ 0.5MG;500MG A040618 001 May 13, 2008
PROBENECID AND COLCHICINE
BP IVAX SUB TEVA PHARMS 0.5MG;500MG A083734 001

COLESEVELAM HYDROCHLORIDE
FOR SUSPENSION; ORAL
WELCHOL
XX DAIICHI SANKYO 1.875GM/PACKET N022362 001 Oct 02, 2009
XX + 3.75GM/PACKET N022362 002 Oct 02, 2009
TABLET; ORAL

WELCHOL

XX + DAIICHI SANKYO 625MG N021176 001 May 26, 2000

COLESTIPOL HYDROCHLORIDE
GRANULE; ORAL
COLESTID
AB PHARMACIA AND UPJOHN 5GM/SCOOPFUL N017563 003 Sep 22, 1995
AB + 5GM/PACKET N017563 004 Sep 22, 1995
COLESTIPOL HYDROCHLORIDE
AB IMPAX LABS 5GM/SCOOPFUL A077277 001 May 02, 2006
AB 5GM/PACKET A077277 002 May 02, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 107 (of 393)

COLESTIPOL HYDROCHLORIDE
GRANULE; ORAL

FLAVORED COLESTID

XX PHARMACIA AND UPJOHN 5GM/SCOOPFUL N017563 002


XX 5GM/PACKET N017563 001


TABLET; ORAL
COLESTID
AB + PHARMACIA AND UPJOHN 1GM N020222 001 Jul 19, 1994
COLESTIPOL HYDROCHLORIDE
AB IMPAX LABS 1GM A077510 001 Oct 24, 2006

COLISTIMETHATE SODIUM
INJECTABLE; INJECTION
COLISTIMETHATE SODIUM
AP APP PHARMS EQ 150MG BASE/VIAL A065364 001 Apr 17, 2008
AP PADDOCK EQ 150MG BASE/VIAL A065177 001 Mar 19, 2004
AP X GEN PHARMS EQ 150MG BASE/VIAL A064216 001 Feb 26, 1999
COLY-MYCIN M
AP + JHP PHARMS EQ 150MG BASE/VIAL N050108 002

COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE


SUSPENSION/DROPS; OTIC

COLY-MYCIN S

XX + JHP PHARMS EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG N050356 001


BASE/ML;0.5MG/ML

CONIVAPTAN HYDROCHLORIDE
INJECTABLE; IV (INFUSION)

VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER

XX + ASTELLAS 20MG/100ML (0.2MG/ML) N021697 002 Oct 08, 2008

COPPER
INTRAUTERINE DEVICE; INTRAUTERINE

PARAGARD T 380A

XX + DURAMED RES 309MG/COPPER N018680 001 Nov 15, 1984

CORTICORELIN OVINE TRIFLUTATE


INJECTABLE; INJECTION

ACTHREL

XX + FERRING EQ 0.1MG BASE/VIAL N020162 001 May 23, 1996

CORTICOTROPIN
INJECTABLE; INJECTION
H.P. ACTHAR GEL
XX + QUESTCOR PHARMS 80 UNITS/ML N008372 008

CORTISONE ACETATE
TABLET; ORAL

CORTISONE ACETATE

XX + WEST WARD 25MG A080776 002

COSYNTROPIN
INJECTABLE; INJECTION
CORTROSYN
AP + AMPHASTAR 0.25MG/VIAL N016750 001
COSYNTROPIN
AP GENERAMEDIX 0.25MG/VIAL A090574 001 Dec 17, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 108 (of 393)

COSYNTROPIN
SOLUTION; INTRAVENOUS
COSYNTROPIN
XX SANDOZ 0.25MG/ML (0.25MG/ML) N022028 001 Feb 21, 2008

CROMOLYN SODIUM
AEROSOL, METERED; INHALATION

INTAL

XX + KING PHARMS 0.8MG/INH N018887 001 Dec 05, 1985


CONCENTRATE; ORAL
CROMOLYN SODIUM
AA GENERA PHARMS 100MG/5ML A090954 001 Dec 18, 2009
GASTROCROM
AA + AZUR PHARMA 100MG/5ML N020479 001 Feb 29, 1996
SOLUTION; INHALATION
CROMOLYN SODIUM
AN ACTAVIS MID ATLANTIC 10MG/ML A075067 001 Jul 19, 1999
AN BAUSCH AND LOMB 10MG/ML A075585 001 Dec 21, 2000
AN DEY 10MG/ML A074209 001 Apr 26, 1994
AN MORTON GROVE 10MG/ML A075346 001 Oct 25, 1999
AN NOVEX 10MG/ML A075333 001 Apr 30, 2002
AN RESPIRARE 10MG/ML A076469 001 Jun 17, 2005
AN + TEVA PARENTERAL 10MG/ML A075271 001 Jan 18, 2000
SOLUTION/DROPS; OPHTHALMIC
CROLOM
AT BAUSCH AND LOMB 4% A074443 001 Jan 30, 1995
CROMOLYN SODIUM
AT AKORN 4% A074706 001 Apr 29, 1998
AT ALCON 4% A075282 001 Jun 16, 1999
AT NOVEX 4% A075615 001 Jan 26, 2001
OPTICROM
AT + ALLERGAN 4% N018155 001 Oct 03, 1984

CROTAMITON
CREAM; TOPICAL

EURAX

XX + RANBAXY 10% N006927 001


LOTION; TOPICAL
CROTAN
AT SUMMERS 10% A087204 001
EURAX
AT + RANBAXY 10% N009112 003

CUPRIC CHLORIDE
INJECTABLE; INJECTION

CUPRIC CHLORIDE IN PLASTIC CONTAINER


XX + HOSPIRA EQ 0.4MG COPPER/ML N018960 001 Jun 26, 1986

CYANOCOBALAMIN
INJECTABLE; INJECTION
CYANOCOBALAMIN
AP + LUITPOLD 1MG/ML A080737 001
VIBISONE
AP + APP PHARMS 1MG/ML A080557 003
SPRAY, METERED; NASAL

CALOMIST

XX + FLEMING 25MCG/SPRAY N022102 001 Jul 27, 2007


NASCOBAL
XX + PAR PHARM 0.5MG/SPRAY N021642 001 Jan 31, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 109 (of 393)

CYCLOBENZAPRINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
AMRIX
XX ANESTA AG 15MG N021777 001 Feb 01, 2007
XX + 30MG N021777 002 Feb 01, 2007
TABLET; ORAL
CYCLOBENZAPRINE HYDROCHLORIDE
AB ACTAVIS TOTOWA 5MG A077291 001 Feb 03, 2006
AB 10MG A077209 001 Oct 04, 2005
AB AUROBINDO PHARMA 5MG A078643 001 Sep 26, 2008
AB 10MG A078643 002 Sep 26, 2008
AB CADISTA PHARMS 5MG A077563 001 Apr 19, 2006
AB 10MG A077563 002 Apr 19, 2006
AB MUTUAL PHARM 5MG A073541 002 Apr 06, 2006
AB 10MG A073541 001 May 23, 1995
AB MYLAN 5MG A073144 002 Feb 03, 2006
AB 10MG A073144 001 May 30, 1991
AB ORIT LABS LLC 10MG A078218 001 Apr 18, 2008
AB PLIVA 10MG A074421 001 Sep 29, 1995
AB RANBAXY 5MG A078722 001 May 12, 2008
AB 7.5MG A078722 002 May 12, 2008
AB 10MG A078722 003 May 12, 2008
AB SANDOZ 5MG A072854 002 Feb 03, 2006
AB 10MG A072854 001 Nov 19, 1991
AB VINTAGE PHARMS 5MG A077797 001 Feb 28, 2007
AB 10MG A077797 002 Feb 28, 2007
AB WATSON LABS 5MG A071611 002 Feb 03, 2006
AB 7.5MG A071611 003 Feb 03, 2006
AB 10MG A071611 001 May 03, 1989
FLEXERIL
AB MCNEIL PED 5MG N017821 001
AB + 10MG N017821 002

CYCLOPENTOLATE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
AKPENTOLATE
AT AKORN 1% A040164 001 Jan 13, 1997
AT 2% A040165 001 Jan 13, 1997
CYCLOGYL
AT + ALCON 1% A084110 001
AT + 2% A084108 001
PENTOLAIR
AT BAUSCH AND LOMB 1% A040075 001 Apr 29, 1994
CYCLOGYL
XX + ALCON 0.5% A084109 001

CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE


SOLUTION/DROPS; OPHTHALMIC

CYCLOMYDRIL

XX + ALCON 0.2%;1% A084300 001

CYCLOPHOSPHAMIDE
INJECTABLE; INJECTION
CYCLOPHOSPHAMIDE
AP BAXTER HLTHCARE 500MG/VIAL A040745 001 May 21, 2008
AP 1GM/VIAL A040745 002 May 21, 2008
AP 2GM/VIAL A040745 003 May 21, 2008
LYOPHILIZED CYTOXAN
AP + BAXTER HLTHCARE 500MG/VIAL N012142 008 Jan 04, 1984
AP + 1GM/VIAL N012142 010 Sep 24, 1985
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 110 (of 393)

CYCLOPHOSPHAMIDE
INJECTABLE; INJECTION
LYOPHILIZED CYTOXAN
AP + BAXTER HLTHCARE 2GM/VIAL N012142 009 Dec 10, 1984
LYOPHILIZED CYTOXAN
XX + BAXTER HLTHCARE 100MG/VIAL N012142 006 Dec 05, 1985
XX + 200MG/VIAL N012142 007 Dec 10, 1985
TABLET; ORAL
CYCLOPHOSPHAMIDE
XX ROXANE 25MG A040032 001 Aug 17, 1999
XX + 50MG A040032 002 Aug 17, 1999

CYCLOSERINE
CAPSULE; ORAL

SEROMYCIN

XX + PURDUE GMP 250MG A060593 001

CYCLOSPORINE
CAPSULE; ORAL
CYCLOSPORINE
AB1 IVAX SUB TEVA PHARMS 25MG A065110 003 Mar 29, 2005
AB1 50MG A065110 001 Mar 29, 2005
AB1 100MG A065110 002 Mar 29, 2005
AB1 PLIVA 25MG A065044 002 Dec 20, 2000
AB1 100MG A065044 001 Dec 20, 2000
AB1 SANDOZ 25MG A065017 002 Jan 13, 2000
AB1 100MG A065017 001 Jan 13, 2000
GENGRAF
AB1 ABBOTT 25MG A065003 001 May 12, 2000
AB1 50MG A065003 002 May 12, 2000
AB1 100MG A065003 003 May 12, 2000
NEORAL
AB1 NOVARTIS 25MG N050715 001 Jul 14, 1995
AB1 + 100MG N050715 002 Jul 14, 1995
CYCLOSPORINE
AB2 APOTEX 25MG A065040 001 May 09, 2002
AB2 100MG A065040 002 May 09, 2002
SANDIMMUNE
AB2 NOVARTIS 25MG N050625 001 Mar 02, 1990
AB2 + 100MG N050625 002 Mar 02, 1990
SANDIMMUNE
BX NOVARTIS 50MG N050625 003 Nov 23, 1992
EMULSION; OPHTHALMIC

RESTASIS

XX + ALLERGAN 0.05% N050790 001 Dec 23, 2002


INJECTABLE; INJECTION
CYCLOSPORINE
AP BEDFORD 50MG/ML A065004 001 Oct 29, 1999
AP PHARMAFORCE 50MG/ML A065151 001 Oct 07, 2003
SANDIMMUNE
AP + NOVARTIS 50MG/ML N050573 001 Nov 14, 1983
SOLUTION; ORAL
CYCLOSPORINE
AB1 ABBOTT 100MG/ML A065025 001 Mar 03, 2000
AB1 IVAX SUB TEVA PHARMS 100MG/ML A065078 001 Mar 25, 2005
AB1 NOVEX 100MG/ML A065167 001 Jan 05, 2005
AB1 WATSON LABS 100MG/ML A065054 001 Dec 18, 2001
NEORAL
AB1 + NOVARTIS 100MG/ML N050716 001 Jul 14, 1995
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 111 (of 393)

CYCLOSPORINE
SOLUTION; ORAL
CYCLOSPORINE
AB2 MORTON GROVE 100MG/ML A065133 001 Sep 17, 2004
SANDIMMUNE
AB2 + NOVARTIS 100MG/ML N050574 001 Nov 14, 1983

CYPROHEPTADINE HYDROCHLORIDE
SYRUP; ORAL
CYPROHEPTADINE HYDROCHLORIDE
AA + ACTAVIS MID ATLANTIC 2MG/5ML A086833 001
AA LYNE 2MG/5ML A040668 001 Jun 28, 2006
TABLET; ORAL
CYPROHEPTADINE HYDROCHLORIDE
AA COREPHARMA 4MG A040537 001 Sep 30, 2003
AA + IVAX PHARMS 4MG A087056 001
AA PAR PHARM 4MG A087129 001
AA PLIVA 4MG A088205 001 Jul 26, 1983
AA STASON PHARMS 4MG A040644 001 May 30, 2006

CYSTEAMINE BITARTRATE
CAPSULE; ORAL
CYSTAGON
XX MYLAN EQ 50MG BASE N020392 001 Aug 15, 1994
XX + EQ 150MG BASE N020392 002 Aug 15, 1994

CYTARABINE
INJECTABLE; INJECTION
CYTARABINE
AP + APP PHARMS 100MG/ML A076512 001 Jan 15, 2004
AP BEDFORD 100MG/VIAL A071471 001 Aug 02, 1989
AP 500MG/VIAL A071472 001 Aug 02, 1989
AP 1GM/VIAL A074245 001 Aug 31, 1994
AP 2GM/VIAL A074245 002 Aug 31, 1994
AP HOSPIRA 20MG/ML A071868 001 Jun 04, 1990
AP + 20MG/ML A072945 001 Feb 28, 1994
AP 100MG/ML A075383 001 Nov 22, 1999
CYTOSAR-U
AP TEVA PARENTERAL 100MG/VIAL A075206 001 Dec 30, 1998
AP + 500MG/VIAL A075206 002 Dec 30, 1998
AP + 1GM/VIAL A075206 004 Dec 30, 1998
AP + 2GM/VIAL A075206 003 Dec 30, 1998
CYTARABINE
XX HOSPIRA 20MG/ML A072168 001 Aug 31, 1990
INJECTABLE, LIPOSOMAL; INJECTION

DEPOCYT

XX + PACIRA PHARMS INC 10MG/ML N021041 001 Apr 01, 1999

DACARBAZINE
INJECTABLE; INJECTION
DACARBAZINE
AP APP PHARMS 100MG/VIAL A075371 001 Aug 27, 1999
AP 200MG/VIAL A075371 002 Aug 27, 1999
AP BEDFORD 200MG/VIAL A075812 001 Jun 15, 2001
AP 500MG/VIAL A075812 002 Oct 31, 2002
AP HOSPIRA 200MG/VIAL A075940 001 Oct 18, 2001
AP TEVA PARENTERAL 200MG/VIAL A075259 002 Aug 27, 1998
AP + 500MG/VIAL A075259 001 Sep 22, 2000
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 112 (of 393)

DACARBAZINE
INJECTABLE; INJECTION
DTIC-DOME
AP + BAYER HLTHCARE 100MG/VIAL N017575 001
AP + 200MG/VIAL N017575 002

DACTINOMYCIN
INJECTABLE; INJECTION

COSMEGEN

XX + LUNDBECK INC 0.5MG/VIAL N050682 001

DALFOPRISTIN; QUINUPRISTIN
INJECTABLE; IV (INFUSION)

SYNERCID

XX + KING PHARMS 350MG/VIAL;150MG/VIAL N050748 001 Sep 21, 1999

DALTEPARIN SODIUM
INJECTABLE; SUBCUTANEOUS
FRAGMIN
XX EISAI INC 2,500IU/0.2ML (12,500IU/ML) N020287 001 Dec 22, 1994
XX 5,000IU/0.2ML (25,000IU/ML) N020287 003 Mar 18, 1996
XX 7,500IU/0.3ML (25,000IU/ML) N020287 005 Apr 04, 2002
XX 10,000IU/ML (10,000IU/ML) N020287 004 Jan 30, 1998
XX 10,000IU/0.4ML (25,000IU/ML) N020287 002 May 01, 2007
XX 12,500IU/0.5ML (25,000IU/ML) N020287 009 May 01, 2007
XX 15,000IU/0.6ML (25,000IU/ML) N020287 010 May 01, 2007
XX 18,000IU/0.72ML (25,000IU/ML) N020287 011 May 01, 2007
XX 95,000IU/9.5ML (10,000IU/ML) N020287 007 Apr 04, 2002
XX + 95,000IU/3.8ML (25,000IU/ML) N020287 006 Apr 04, 2002

DANAZOL
CAPSULE; ORAL
DANAZOL
AB BARR 50MG A074582 003 May 29, 1998
AB 100MG A074582 002 May 29, 1998
AB + 200MG A074582 001 Aug 09, 1996
AB LANNETT 50MG A078214 001 Apr 19, 2007
AB 100MG A078214 002 Apr 19, 2007
AB 200MG A077246 001 Sep 28, 2005

DANTROLENE SODIUM
CAPSULE; ORAL
DANTRIUM
AB JHP PHARMS 25MG N017443 001
AB 50MG N017443 003
AB + 100MG N017443 002
DANTROLENE SODIUM
AB ACTAVIS TOTOWA 25MG A076686 001 Oct 24, 2005
AB 50MG A076686 002 Oct 24, 2005
AB 100MG A076686 003 Oct 24, 2005
AB IMPAX LABS 25MG A076856 001 Mar 01, 2005
AB 50MG A076856 002 Mar 01, 2005
AB 100MG A076856 003 Mar 01, 2005
INJECTABLE; INJECTION
DANTRIUM
AP + JHP PHARMS 20MG/VIAL N018264 001
DANTROLENE SODIUM
AP US WORLDMEDS 20MG/VIAL A078378 001 Jul 24, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 113 (of 393)

DAPSONE
GEL; TOPICAL

ACZONE

XX + ALLERGAN 5% N021794 001 Jul 07, 2005


TABLET; ORAL

DAPSONE

XX JACOBUS 25MG A086841 001


XX + 100MG A086842 001

DAPTOMYCIN
INJECTABLE; IV (INFUSION)

CUBICIN

XX + CUBIST 500MG/VIAL N021572 002 Sep 12, 2003

DARIFENACIN HYDROBROMIDE
TABLET, EXTENDED RELEASE; ORAL
ENABLEX

XX NOVARTIS
EQ 7.5MG BASE
N021513 001 Dec 22, 2004

XX +
EQ 15MG BASE
N021513 002 Dec 22, 2004

DARUNAVIR ETHANOLATE
TABLET; ORAL

PREZISTA

XX CENTOCOR ORTHO
EQ 75MG BASE
N021976 004 Dec 18, 2008
XX EQ 150MG BASE
N021976 005 Dec 18, 2008
XX EQ 300MG BASE
N021976 001 Jun 23, 2006
XX EQ 400MG BASE
N021976 003 Oct 21, 2008
XX + EQ 600MG BASE
N021976 002 Feb 25, 2008

DASATINIB
TABLET; ORAL
SPRYCEL
XX BRISTOL MYERS SQUIBB 20MG N021986 001 Jun 28, 2006
XX 50MG N021986 002 Jun 28, 2006
XX 70MG N021986 003 Jun 28, 2006
XX + 100MG N021986 004 May 30, 2008

DAUNORUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION
CERUBIDINE
AP + BEDFORD EQ 20MG BASE/VIAL A064103 001 Feb 03, 1995
DAUNORUBICIN HYDROCHLORIDE
AP APP PHARMS EQ 20MG BASE/VIAL A065000 001 May 25, 1999
AP + BEDFORD EQ 5MG BASE/ML N050731 001 Jan 30, 1998
AP TEVA PARENTERAL EQ 5MG BASE/ML A065035 001 Jan 24, 2000
DAUNORUBICIN HYDROCHLORIDE
XX APP PHARMS EQ 5MG BASE/VIAL A065034 001 Nov 20, 2001

DECITABINE
INJECTABLE; INTRAVENOUS

DACOGEN

XX + EISAI INC 50MG/VIAL N021790 001 May 02, 2006

DEFERASIROX
TABLET, FOR SUSPENSION; ORAL

EXJADE

XX NOVARTIS 125MG
N021882 001 Nov 02, 2005
XX 250MG
N021882 002 Nov 02, 2005
XX + 500MG N021882 003 Nov 02, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 114 (of 393)

DEFEROXAMINE MESYLATE
INJECTABLE; INJECTION
DEFEROXAMINE MESYLATE
AP APP PHARMS 500MG/VIAL A078718 001 Sep 15, 2009
AP 2GM/VIAL A078718 002 Sep 15, 2009
AP BEDFORD 500MG/VIAL A078086 001 May 30, 2007
AP 2GM/VIAL A078086 002 May 30, 2007
AP HOSPIRA 500MG/VIAL A076019 001 Mar 17, 2004
AP 2GM/VIAL A076019 002 Mar 17, 2004
AP WATSON LABS 500MG/VIAL A076806 001 Mar 31, 2006
AP 2GM/VIAL A076806 002 Mar 31, 2006
DESFERAL
AP + NOVARTIS 500MG/VIAL N016267 001
AP + 2GM/VIAL N016267 002 May 25, 2000

DEGARELIX ACETATE
POWDER; SUBCUTANEOUS
FIRMAGON
XX FERRING EQ 80MG BASE/VIAL N022201 001 Dec 24, 2008
XX + EQ 120MG BASE/VIAL N022201 002 Dec 24, 2008

DELAVIRDINE MESYLATE
TABLET; ORAL
RESCRIPTOR
XX VIIV HLTHCARE 100MG N020705 001 Apr 04, 1997
XX + 200MG N020705 002 Jul 14, 1999

DEMECLOCYCLINE HYDROCHLORIDE
TABLET; ORAL
DECLOMYCIN
AB STIEFEL 150MG N050261 002
AB + 300MG N050261 003
DEMECLOCYCLINE HYDROCHLORIDE
AB AMNEAL PHARM 150MG A065425 001 Feb 27, 2008
AB 300MG A065425 002 Feb 27, 2008
AB BARR 150MG A065171 001 Dec 13, 2004
AB 300MG A065171 002 Dec 13, 2004
AB COVENANT PHARMA INC 150MG A065389 001 Dec 01, 2008
AB 300MG A065389 002 Dec 01, 2008
AB IMPAX LABS 150MG A065094 001 Mar 22, 2004
AB 300MG A065094 002 Mar 22, 2004

DESFLURANE
LIQUID; INHALATION

SUPRANE

XX + BAXTER HLTHCARE CORP 99.9% N020118 001 Sep 18, 1992

DESIPRAMINE HYDROCHLORIDE
TABLET; ORAL
DESIPRAMINE HYDROCHLORIDE
AB ACTAVIS TOTOWA 10MG A074430 001 Feb 09, 1996
AB 25MG A071601 001 Jun 05, 1987
AB 75MG A071602 001 Oct 05, 1987
AB 100MG A071766 001 Oct 05, 1987
AB 150MG A074430 002 Feb 09, 1996
AB AMIDE PHARM 50MG A071588 001 Jun 05, 1987
AB SANDOZ 10MG A072099 001 May 24, 1988
AB 25MG A072100 001 May 24, 1988
AB 50MG A072101 001 May 24, 1988
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 115 (of 393)

DESIPRAMINE HYDROCHLORIDE
TABLET; ORAL
DESIPRAMINE HYDROCHLORIDE
AB SANDOZ 75MG A072102 001 Jun 20, 1988
AB 100MG A072103 001 Jun 20, 1988
AB 150MG A072104 001 Jun 20, 1988
NORPRAMIN
AB SANOFI AVENTIS US 10MG N014399 007 Feb 11, 1982
AB 25MG N014399 001
AB + 50MG N014399 003
AB 75MG N014399 004
AB + 100MG N014399 005
AB 150MG N014399 006

DESIRUDIN RECOMBINANT
INJECTABLE; SUBCUTANEOUS

IPRIVASK

XX + CANYON 15MG/VIAL N021271 001 Apr 04, 2003

DESLORATADINE
SYRUP; ORAL

CLARINEX

XX + SCHERING 0.5MG/ML N021300 001 Sep 01, 2004


TABLET; ORAL

CLARINEX

XX + SCHERING PLOUGH 5MG N021165 001 Dec 21, 2001


TABLET, ORALLY DISINTEGRATING; ORAL
CLARINEX
XX SCHERING 2.5MG N021312 002 Jul 14, 2005
XX + 5MG N021312 001 Jun 26, 2002

DESLORATADINE; PSEUDOEPHEDRINE SULFATE


TABLET, EXTENDED RELEASE; ORAL

CLARINEX D 24 HOUR

XX + SCHERING 5MG;240MG N021605 001 Mar 03, 2005


CLARINEX-D 12 HOUR
XX + SCHERING 2.5MG;120MG N021313 001 Feb 01, 2006

DESMOPRESSIN ACETATE
INJECTABLE; INJECTION

DDAVP

AP + SANOFI AVENTIS US 0.004MG/ML N018938 001 Mar 30, 1984


DESMOPRESSIN ACETATE
AP HOSPIRA 0.004MG/ML A075220 001 Aug 28, 2000
AP TEVA PARENTERAL 0.004MG/ML A074888 001 Oct 15, 1997
SOLUTION; NASAL

DDAVP

XX + SANOFI AVENTIS US 0.01% N017922 001


SPRAY, METERED; NASAL
DDAVP (NEEDS NO REFRIGERATION)
AB + SANOFI AVENTIS US 0.01MG/SPRAY N017922 003 Aug 07, 1996
DESMOPRESSIN ACETATE
AB + BAUSCH AND LOMB 0.01MG/SPRAY A074830 001 Jan 25, 1999
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
AB APOTEX INC 0.01MG/SPRAY A076703 001 Jan 27, 2005
MINIRIN
AB + FERRING 0.01MG/SPRAY N021333 001 Sep 16, 2002
STIMATE
XX + CSL BEHRING 0.15MG/SPRAY N020355 001 Mar 07, 1994
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 116 (of 393)

DESMOPRESSIN ACETATE
TABLET; ORAL
DDAVP
AB SANOFI AVENTIS US 0.1MG N019955 001 Sep 06, 1995
AB + 0.2MG N019955 002 Sep 06, 1995
DESMOPRESSIN ACETATE
AB APOTEX INC 0.1MG A077414 001 Mar 07, 2006
AB 0.2MG A077414 002 Mar 07, 2006
AB TEVA PHARMS 0.1MG A077122 001 Jan 25, 2006
AB 0.2MG A077122 002 Jan 25, 2006
AB WATSON LABS 0.1MG A076470 001 Jul 01, 2005
AB 0.2MG A076470 002 Jul 01, 2005
DESMOPRESSIN ACETATE
XX FERRING 0.1MG N021795 001 May 08, 2008
XX + 0.2MG N021795 002 May 08, 2008

DESOGESTREL; ETHINYL ESTRADIOL


TABLET; ORAL-28
CYCLESSA
AB + ORGANON USA INC 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0. N021090 001 Dec 20, 2000
025MG
DESOGEN
AB ORGANON USA INC 0.15MG;0.03MG N020071 002 Dec 10, 1992
DESOGESTREL AND ETHINYL ESTRADIOL
AB DURAMED PHARMS BARR 0.15MG;0.03MG A075256 002 Aug 12, 1999
AB WATSON LABS 0.15MG,N/A;0.02MG,0.01MG A076916 001 Dec 29, 2008
AB 0.15MG;0.03MG A076915 001 Jul 29, 2005
KARIVA
AB BARR 0.15MG,N/A;0.02MG,0.01MG A075863 001 Apr 05, 2002
MIRCETTE
AB + DURAMED 0.15MG,N/A;0.02MG,0.01MG N020713 001 Apr 22, 1998
ORTHO-CEPT
AB + ORTHO MCNEIL JANSSEN 0.15MG;0.03MG N020301 002 Dec 14, 1992
VELIVET
AB DURAMED PHARMS BARR 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0. A076455 001 Feb 24, 2004
025MG

DESONIDE
AEROSOL, FOAM; TOPICAL

VERDESO

XX + STIEFEL LABS INC 0.05% N021978 001 Sep 19, 2006


CREAM; TOPICAL
DESONIDE
AB + PERRIGO NEW YORK 0.05% N017010 001
AB TARO 0.05% A073548 001 Jun 30, 1992
DESOWEN
AB GALDERMA LABS LP 0.05% N019048 001 Dec 14, 1984
GEL; TOPICAL

DESONATE

XX + INTENDIS 0.05% N021844 001 Oct 20, 2006


LOTION; TOPICAL
DESONIDE
AB ALTANA 0.05% A075860 001 Mar 19, 2002
DESOWEN
AB + GALDERMA LABS LP 0.05% A072354 001 Jan 24, 1992
OINTMENT; TOPICAL
DESONIDE
AB ALTANA 0.05% A075751 001 Mar 12, 2001
AB + PERRIGO NEW YORK 0.05% N017426 001
AB TARO 0.05% A074254 001 Aug 03, 1994
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 117 (of 393)

DESONIDE
OINTMENT; TOPICAL

DESOWEN

AB GALDERMA LABS LP 0.05% A071425 001 Jun 15, 1988

DESOXIMETASONE
CREAM; TOPICAL
DESOXIMETASONE
AB PERRIGO NEW YORK 0.25% A076510 001 Jul 01, 2003
AB TARO 0.05% A073210 001 Nov 30, 1990
AB 0.25% A073193 001 Nov 30, 1990
TOPICORT
AB + TARO PHARMS NORTH 0.25% N017856 001
TOPICORT LP
AB + TARO PHARMS NORTH 0.05% N018309 001
GEL; TOPICAL
DESOXIMETASONE
AB PERRIGO NEW YORK 0.05% A077552 001 Jan 09, 2006
AB TARO 0.05% A074904 001 Jul 14, 1998
TOPICORT
AB + TARO PHARMS NORTH 0.05% N018586 001 Mar 29, 1982
OINTMENT; TOPICAL
DESOXIMETASONE
AB TARO 0.25% A074286 001 Jun 07, 1996
TOPICORT
AB + TARO PHARMS NORTH 0.25% N018763 001 Sep 30, 1983

DESVENLAFAXINE SUCCINATE
TABLET, EXTENDED RELEASE; ORAL

PRISTIQ

XX + WYETH PHARMS INC EQ 50MG BASE N021992 001 Feb 29, 2008
XX + EQ 100MG BASE N021992 002 Feb 29, 2008

DEXAMETHASONE
CONCENTRATE; ORAL

DEXAMETHASONE INTENSOL

XX + ROXANE 1MG/ML A088252 001 Sep 01, 1983


ELIXIR; ORAL
DEXAMETHASONE
AA + MORTON GROVE 0.5MG/5ML A088254 001 Jul 27, 1983
AA + STI PHARMA LLC 0.5MG/5ML A084754 001
IMPLANT; INTRAVITREAL

OZURDEX

XX + ALLERGAN 0.7MG N022315 001 Jun 17, 2009


SOLUTION; ORAL

DEXAMETHASONE

XX + ROXANE 0.5MG/5ML A088248 001 Sep 01, 1983


SUSPENSION/DROPS; OPHTHALMIC

MAXIDEX

XX + ALCON 0.1% N013422 001


TABLET; ORAL
DEXAMETHASONE
AB ECR 1.5MG A040700 001 Aug 15, 2008
AB ROXANE 1.5MG A084610 001
DEXAMETHASONE
XX ROXANE 0.5MG A084611 001
XX 0.75MG A084613 001
XX 1MG A088306 001 Sep 15, 1983
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 118 (of 393)

DEXAMETHASONE
TABLET; ORAL
DEXAMETHASONE
XX ROXANE 2MG A087916 001 Aug 26, 1982
XX 4MG A084612 001
XX + 6MG A088316 001 Sep 15, 1983

DEXAMETHASONE SODIUM PHOSPHATE


INJECTABLE; INJECTION
DEXAMETHASONE SODIUM PHOSPHATE
AP AKORN STRIDES EQ 4MG PHOSPHATE/ML A040803 001 Aug 29, 2008
AP EQ 10MG PHOSPHATE/ML A040802 001 Aug 29, 2008
AP APP PHARMS EQ 4MG PHOSPHATE/ML A084916 001
AP EQ 10MG PHOSPHATE/ML A040491 001 Apr 11, 2003
AP EQ 10MG PHOSPHATE/ML A040572 001 Apr 22, 2005
AP + BAXTER HLTHCARE EQ 10MG PHOSPHATE/ML A087702 001 Sep 07, 1982
AP + LUITPOLD EQ 4MG PHOSPHATE/ML A087440 001 Jul 21, 1982
AP + TEVA PARENTERAL EQ 10MG PHOSPHATE/ML A081126 001 Aug 31, 1990
SOLUTION/DROPS; OPHTHALMIC, OTIC
DEXAMETHASONE SODIUM PHOSPHATE
AT + ALCON UNIVERSAL EQ 0.1% PHOSPHATE A088771 001 Jan 16, 1985
AT BAUSCH AND LOMB EQ 0.1% PHOSPHATE A040069 001 Jul 26, 1996

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


OINTMENT; OPHTHALMIC
MAXITROL
AT + FALCON PHARMS 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM N050065 002
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
AT BAUSCH AND LOMB 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM A064063 001 Jul 25, 1994
AT FOUGERA 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM A062938 001 Jul 31, 1989
SUSPENSION/DROPS; OPHTHALMIC
DEXASPORIN
AT BAUSCH AND LOMB 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A064135 001 Sep 13, 1995
MAXITROL
AT ALCON 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062341 001 May 22, 1984
AT + FALCON PHARMS 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N050023 002
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
AT ALCON UNIVERSAL 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062721 001 Nov 17, 1986

DEXAMETHASONE; TOBRAMYCIN
OINTMENT; OPHTHALMIC

TOBRADEX

XX + ALCON 0.1%;0.3% N050616 001 Sep 28, 1988


SUSPENSION/DROPS; OPHTHALMIC
TOBRADEX
AB + ALCON 0.1%;0.3% N050592 001 Aug 18, 1988
TOBRAMYCIN AND DEXAMETHASONE
AB BAUSCH AND LOMB 0.1%;0.3% A064134 001 Oct 27, 1999
TOBRADEX ST
XX + ALCON 0.05%;0.3% N050818 001 Feb 13, 2009

DEXCHLORPHENIRAMINE MALEATE
SYRUP; ORAL

DEXCHLORPHENIRAMINE MALEATE

XX + MORTON GROVE 2MG/5ML A088251 001 Mar 23, 1984


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 119 (of 393)

DEXLANSOPRAZOLE
CAPSULE, DELAYED RELEASE; ORAL
KAPIDEX
XX TAKEDA PHARMS 30MG N022287 001 Jan 30, 2009
XX + 60MG N022287 002 Jan 30, 2009

DEXMEDETOMIDINE
INJECTABLE; INJECTION

PRECEDEX

XX + HOSPIRA EQ 100MCG BASE/ML N021038 001 Dec 17, 1999

DEXMETHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
FOCALIN XR
XX NOVARTIS 5MG N021802 001 May 26, 2005
XX 10MG N021802 002 May 26, 2005
XX 15MG N021802 004 Aug 01, 2006
XX 20MG N021802 003 May 26, 2005
XX + 30MG N021802 005 Oct 23, 2009
TABLET; ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDE
AB TEVA PHARMS 2.5MG A077107 003 Jan 29, 2007
AB 5MG A077107 001 Jan 29, 2007
AB 10MG A077107 002 Jan 29, 2007
FOCALIN
AB NOVARTIS 2.5MG N021278 001 Nov 13, 2001
AB 5MG N021278 002 Nov 13, 2001
AB + 10MG N021278 003 Nov 13, 2001

DEXRAZOXANE HYDROCHLORIDE
INJECTABLE; INJECTION
DEXRAZOXANE HYDROCHLORIDE
AP BEDFORD EQ 250MG BASE/VIAL A076068 001 Sep 28, 2004
AP EQ 500MG BASE/VIAL A076068 002 Sep 28, 2004
ZINECARD
AP + PHARMACIA AND UPJOHN EQ 250MG BASE/VIAL N020212 001 May 26, 1995
AP + EQ 500MG BASE/VIAL N020212 002 May 26, 1995
TOTECT
XX + TOPOTARGET EQ 500MG BASE/VIAL N022025 001 Sep 06, 2007

DEXTROAMPHETAMINE SULFATE
CAPSULE, EXTENDED RELEASE; ORAL
DEXEDRINE
AB SMITHKLINE BEECHAM 5MG N017078 001
AB 10MG N017078 002
AB + 15MG N017078 003
DEXTROAMPHETAMINE SULFATE
AB BARR 5MG A076137 001 Jan 18, 2002
AB 10MG A076137 002 Jan 18, 2002
AB 15MG A076137 003 Jan 18, 2002
AB MALLINCKRODT 5MG A076353 001 May 06, 2003
AB 10MG A076353 002 May 06, 2003
AB 15MG A076353 003 May 06, 2003
SOLUTION; ORAL

DEXTROAMPHETAMINE SULFATE

XX + OUTLOOK PHARMS 5MG/5ML A040776 001 Jan 29, 2008


TABLET; ORAL
DEXTROAMPHETAMINE SULFATE
AA BARR 5MG A040361 001 Jan 31, 2001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 120 (of 393)

DEXTROAMPHETAMINE SULFATE
TABLET; ORAL
DEXTROAMPHETAMINE SULFATE
AA + BARR 10MG A040361 002 Jan 31, 2001
AA KV PHARM 5MG A040365 001 Oct 31, 2002
AA 10MG A040367 001 Oct 31, 2002
AA MALLINCKRODT 5MG A040436 001 Jan 29, 2002
AA 10MG A040436 002 Jan 29, 2002

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE


SYRUP; ORAL
PROMETH W/ DEXTROMETHORPHAN
AA + ACTAVIS MID ATLANTIC 15MG/5ML;6.25MG/5ML A088762 001 Oct 31, 1984
PROMETHAZINE DM
AA VINTAGE 15MG/5ML;6.25MG/5ML A040649 001 Feb 14, 2006
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
AA HI TECH PHARMA 15MG/5ML;6.25MG/5ML A040027 001 Jul 31, 1996
PROMETHAZINE W/ DEXTROMETHORPHAN
AA MORTON GROVE 15MG/5ML;6.25MG/5ML A088864 001 Jan 04, 1985

DEXTROSE
INJECTABLE; INJECTION
DEXTROSE 10% IN PLASTIC CONTAINER
AP + B BRAUN 10GM/100ML N019626 004 Feb 02, 1988
AP + BAXTER HLTHCARE 10GM/100ML N016694 001
AP + HOSPIRA 10GM/100ML N018080 001
DEXTROSE 20% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 20GM/100ML N017521 004
AP + HOSPIRA 20GM/100ML N018564 001 Mar 23, 1982
DEXTROSE 30% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 30GM/100ML N017521 003
AP + HOSPIRA 30GM/100ML N019345 001 Jan 26, 1985
DEXTROSE 40% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 40GM/100ML N017521 002
AP + HOSPIRA 40GM/100ML N018562 001 Mar 23, 1982
DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 50MG/ML N016730 002
AP + 5GM/100ML N016730 001
AP + 5GM/100ML N019626 002 Feb 02, 1988
AP + BAXTER HLTHCARE 50MG/ML N016673 003 Oct 30, 1985
AP + 50MG/ML N020179 002 Dec 07, 1992
AP + 5GM/100ML N016673 001
AP + 5GM/100ML N020179 001 Dec 07, 1992
AP + HOSPIRA 50MG/ML N016367 002
AP + 50MG/ML N019222 001 Jul 13, 1984
AP + 5GM/100ML N019466 001 Jul 15, 1985
AP + 5GM/100ML N019479 001 Sep 17, 1985
DEXTROSE 50% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 50GM/100ML N017521 001
AP + 50GM/100ML N020047 001 Jul 02, 1991
AP HOSPIRA 500MG/ML N019445 001 Jun 03, 1986
AP + 50GM/100ML N018563 001 Mar 23, 1982
AP + 50GM/100ML N019894 001 Dec 26, 1989
DEXTROSE 60% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 60GM/100ML N017521 005 Mar 26, 1982
DEXTROSE 70% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 70GM/100ML N017521 006 Mar 26, 1982
AP + 70GM/100ML N020047 003 Jul 02, 1991
AP + HOSPIRA 70GM/100ML N018561 001 Mar 23, 1982
AP + 70GM/100ML N019893 001 Dec 26, 1989
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 121 (of 393)

DEXTROSE
INJECTABLE; INJECTION

DEXTROSE 25%

XX + HOSPIRA 250MG/ML N019445 002 Nov 23, 1998

DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE


INJECTABLE; INJECTION

PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER


XX BAXTER HLTHCARE 5GM/100ML;32MG/100ML;128MG/100ML;234MG/ N017385 001


100ML

DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE


INJECTABLE; INJECTION

NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER


XX HOSPIRA 5GM/100ML;21MG/100ML;128MG/100ML;234MG/ N017610 001


100ML

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC;


SODIUM ACETATE
INJECTABLE; INJECTION
ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;31MG/100ML;130MG/100ML;26MG/1 N019873 001 Jun 10, 1993
00ML;320MG/100ML

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC;


SODIUM CHLORIDE; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS
INJECTABLE; INJECTION

IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER


XX HOSPIRA 5GM/100ML;53MG/100ML;100MG/100ML;100MG/ N019515 001 May 08, 1986


100ML;180MG/100ML;280MG/100ML;16MG/100M
L

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC;


SODIUM CHLORIDE; SODIUM LACTATE
INJECTABLE; INJECTION

DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER


XX BAXTER HLTHCARE 5GM/100ML;31MG/100ML;141MG/100ML;20MG/1 N017484 001


00ML;12MG/100ML;260MG/100ML

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC;


SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS
INJECTABLE; INJECTION
IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;30MG/100ML;141MG/100ML;15MG/1 N019513 001 May 08, 1986
00ML;260MG/100ML;25MG/100ML

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE


INJECTABLE; INJECTION
ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;30MG/100ML;97MG/100ML;220MG/1 N019844 001 Jun 10, 1993
00ML;140MG/100ML

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE;


SODIUM GLUCONATE
INJECTABLE; INJECTION
ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;30MG/100ML;37MG/100ML;370MG/1 N019843 001 Aug 09, 1993
00ML;530MG/100ML;500MG/100ML
NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;30MG/100ML;37MG/100ML;222MG/1 N017609 001
00ML;526MG/100ML;502MG/100ML
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 122 (of 393)

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE;


SODIUM GLUCONATE
INJECTABLE; INJECTION
PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 5GM/100ML;30MG/100ML;37MG/100ML;368MG/1 N017451 001
00ML;526MG/100ML;502MG/100ML

DEXTROSE; POTASSIUM CHLORIDE


INJECTABLE; INJECTION
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
AP BRISTOL MYERS SQUIBB 5GM/100ML;75MG/100ML N017634 004
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
AP BRISTOL MYERS SQUIBB 5GM/100ML;150MG/100ML N017634 001
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER
AP BRISTOL MYERS SQUIBB 5GM/100ML;224MG/100ML N017634 003
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
AP BRISTOL MYERS SQUIBB 5GM/100ML;300MG/100ML N017634 002
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;75MG/100ML N018744 001 Nov 09, 1982
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML N018744 002 Nov 09, 1982
AP 5GM/100ML;150MG/100ML N019699 004 Sep 29, 1989
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML N018744 004 Nov 09, 1982
AP 5GM/100ML;300MG/100ML N019699 006 Sep 29, 1989
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
AP HOSPIRA 5GM/100ML;224MG/100ML N018371 003
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;220MG/100ML N018744 003 Nov 09, 1982
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;149MG/100ML N018371 001
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;298MG/100ML N018371 002

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM LACTATE; SODIUM CHLORIDE; SODIUM PHOSPHATE,


MONOBASIC ANHYDROUS
INJECTABLE; INJECTION
IONOSOL T AND DEXTROSE 5% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;111MG/100ML;256MG/100ML;146MG N019514 001 May 08, 1986
/100ML;207MG/100ML

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM


CHLORIDE
INJECTABLE; INJECTION
ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;150MG/100ML;130MG/100ML;280MG N019870 001 Jun 10, 1993
/100ML;91MG/100ML

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE;


SODIUM LACTATE
INJECTABLE; INJECTION
DEXTROSE 5% AND ELECTROLYTE NO 75 IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 5GM/100ML;205MG/100ML;100MG/100ML;120MG N018840 001 Jun 29, 1983
/100ML;220MG/100ML

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE


INJECTABLE; INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;200MG/100ML N018037 006 Apr 13, 1982
AP 5GM/100ML;150MG/100ML;200MG/100ML N018037 007 Apr 13, 1982
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 123 (of 393)

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE


INJECTABLE; INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;200MG/100ML N018037 004
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;200MG/100ML N018037 008 Apr 13, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;200MG/100ML N018037 001
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;200MG/100ML N018037 005 Apr 13, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;200MG/100ML N018037 009 Apr 13, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;200MG/100ML N018037 002
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;200MG/100ML N018037 003
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;330MG/100ML N018629 005 Mar 23, 1982
AP 5GM/100ML;150MG/100ML;330MG/100ML N018629 002 Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;330MG/100ML N018629 003 Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;330MG/100ML N018629 004 Mar 23, 1982
AP 5GM/100ML;300MG/100ML;330MG/100ML N018629 006 Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;330MG/100ML N018629 007 Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;330MG/100ML N018629 008 Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;330MG/100ML N018629 001 Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;450MG/100ML N018008 010
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;75MG/100ML;200MG/100ML N019630 008 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;75MG/100ML;330MG/100ML N019630 014 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;75MG/100ML;450MG/100ML N019630 020 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;75MG/100ML;900MG/100ML N019630 026 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML;200MG/100ML N019630 010 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML;330MG/100ML N019630 016 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML;450MG/100ML N019630 022 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML;900MG/100ML N019630 028 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML;200MG/100ML N019630 012 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML;330MG/100ML N019630 018 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML;450MG/100ML N019630 024 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML;900MG/100ML N019630 030 Feb 17, 1988
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;450MG/100ML N018008 005 Apr 28, 1982
AP 5GM/100ML;150MG/100ML;450MG/100ML N018008 006 Apr 28, 1982
AP HOSPIRA 5GM/100ML;74.5MG/100ML;450MG/100ML N018362 005 Mar 28, 1988
AP 5GM/100ML;74.5MG/100ML;450MG/100ML N018362 009 Jul 05, 1983
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 124 (of 393)

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE


INJECTABLE; INJECTION
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;900MG/100ML N019308 004 Apr 05, 1985
AP 5GM/100ML;150MG/100ML;900MG/100ML N019308 002 Apr 05, 1985
AP HOSPIRA 5GM/100ML;74.5MG/100ML;900MG/100ML N019691 002 Mar 24, 1988
AP 5GM/100ML;149MG/100ML;900MG/100ML N019691 004 Mar 24, 1988
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP HOSPIRA 5GM/100ML;224MG/100ML;450MG/100ML N018362 006 Mar 28, 1988
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP HOSPIRA 5GM/100ML;224MG/100ML;900MG/100ML N019691 006 Mar 24, 1988
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;450MG/100ML N018008 007 Apr 28, 1982
AP HOSPIRA 5GM/100ML;149MG/100ML;450MG/100ML N018362 010 Jul 05, 1983
AP 5GM/100ML;298MG/100ML;450MG/100ML N018362 007 Mar 28, 1988
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;900MG/100ML N019308 005 Apr 05, 1985
AP 5GM/100ML;300MG/100ML;900MG/100ML N019308 003 Apr 05, 1985
AP HOSPIRA 5GM/100ML;149MG/100ML;900MG/100ML N019691 005 Mar 24, 1988
AP 5GM/100ML;298MG/100ML;900MG/100ML N019691 008 Mar 24, 1988
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;450MG/100ML N018008 008 Apr 28, 1982
AP HOSPIRA 5GM/100ML;224MG/100ML;450MG/100ML N018362 002
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;900MG/100ML N019308 006 Apr 05, 1985
AP HOSPIRA 5GM/100ML;224MG/100ML;900MG/100ML N019691 007 Mar 24, 1988
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;450MG/100ML N018008 009 Apr 28, 1982
AP HOSPIRA 5GM/100ML;298MG/100ML;450MG/100ML N018362 003
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;900MG/100ML N019308 007 Apr 05, 1985
AP HOSPIRA 5GM/100ML;298MG/100ML;900MG/100ML N019691 009 Mar 24, 1988
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;450MG/100ML N018008 004
AP HOSPIRA 5GM/100ML;74.5MG/100ML;450MG/100ML N018362 008 Mar 28, 1988
AP 5GM/100ML;149MG/100ML;450MG/100ML N018362 004 Mar 28, 1988
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;900MG/100ML N019308 001 Apr 05, 1985
AP HOSPIRA 5GM/100ML;74.5MG/100ML;900MG/100ML N019691 001 Mar 24, 1988
AP 5GM/100ML;149MG/100ML;900MG/100ML N019691 003 Mar 24, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;37MG/100ML;200MG/100ML N019630 031 Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;37MG/100ML;450MG/100ML N019630 037 Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;37MG/100ML;900MG/100ML N019630 043 Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;37MG/100ML;110MG/100ML N019630 001 Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;37MG/100ML;200MG/100ML N019630 007 Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;37MG/100ML;330MG/100ML N019630 013 Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;37MG/100ML;450MG/100ML N019630 019 Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;37MG/100ML;900MG/100ML N019630 025 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;75MG/100ML;200MG/100ML N019630 032 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;75MG/100ML;450MG/100ML N019630 038 Feb 17, 1988
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 125 (of 393)

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE


INJECTABLE; INJECTION
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;75MG/100ML;900MG/100ML N019630 044 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
XX B BRAUN 3.3GM/100ML;75MG/100ML;300MG/100ML N019630 049 May 07, 1992
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;75MG/100ML;110MG/100ML N019630 002 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;110MG/100ML;200MG/100ML N019630 033 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;110MG/100ML;450MG/100ML N019630 039 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;110MG/100ML;900MG/100ML N019630 045 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
XX B BRAUN 3.3GM/100ML;110MG/100ML;300MG/100ML N019630 050 May 07, 1992
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;110MG/100ML;110MG/100ML N019630 003 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;110MG/100ML;200MG/100ML N019630 009 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;110MG/100ML;330MG/100ML N019630 015 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;110MG/100ML;450MG/100ML N019630 021 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;110MG/100ML;900MG/100ML N019630 027 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;150MG/100ML;200MG/100ML N019630 034 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;150MG/100ML;450MG/100ML N019630 040 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;150MG/100ML;900MG/100ML N019630 046 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
XX B BRAUN 3.3GM/100ML;150MG/100ML;300MG/100ML N019630 051 May 07, 1992
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;150MG/100ML;110MG/100ML N019630 004 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;220MG/100ML;200MG/100ML N019630 035 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;220MG/100ML;450MG/100ML N019630 041 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;220MG/100ML;900MG/100ML N019630 047 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
XX B BRAUN 3.3GM/100ML;220MG/100ML;300MG/100ML N019630 052 May 07, 1992
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;220MG/100ML;110MG/100ML N019630 005 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;220MG/100ML;200MG/100ML N019630 011 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;220MG/100ML;330MG/100ML N019630 017 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;220MG/100ML;450MG/100ML N019630 023 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;220MG/100ML;900MG/100ML N019630 029 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;300MG/100ML;200MG/100ML N019630 036 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;300MG/100ML;450MG/100ML N019630 042 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;300MG/100ML;900MG/100ML N019630 048 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
XX B BRAUN 3.3GM/100ML;300MG/100ML;300MG/100ML N019630 053 May 07, 1992
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 126 (of 393)

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE


INJECTABLE; INJECTION
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;300MG/100ML;110MG/100ML N019630 006 Feb 17, 1988
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;74.5MG/100ML;225MG/100ML N018365 002 Jul 05, 1983
XX 5GM/100ML;149MG/100ML;225MG/100ML N018365 006 Mar 28, 1988
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;74.5MG/100ML;300MG/100ML N018876 001 Jan 17, 1986
XX 5GM/100ML;149MG/100ML;300MG/100ML N018876 006 Mar 28, 1988
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;224MG/100ML;225MG/100ML N018365 008 Mar 28, 1988
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;224MG/100ML;300MG/100ML N018876 007 Mar 28, 1988
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;149MG/100ML;225MG/100ML N018365 001
XX 5GM/100ML;298MG/100ML;225MG/100ML N018365 009 Mar 28, 1988
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;298MG/100ML;300MG/100ML N018876 008 Mar 28, 1988
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;149MG/100ML;300MG/100ML N018876 002 Jan 17, 1986
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;224MG/100ML;225MG/100ML N018365 003 Jul 05, 1983
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;224MG/100ML;300MG/100ML N018876 003 Jan 17, 1986
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;298MG/100ML;225MG/100ML N018365 004 Jul 05, 1983
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;298MG/100ML;300MG/100ML N018876 004 Mar 28, 1988
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;74.5MG/100ML;225MG/100ML N018365 005 Mar 28, 1988
XX 5GM/100ML;149MG/100ML;225MG/100ML N018365 007 Mar 28, 1988
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;74.5MG/100ML;300MG/100ML N018876 005 Mar 28, 1988
XX 5GM/100ML;149MG/100ML;300MG/100ML N018876 009 Mar 28, 1988

DEXTROSE; SODIUM CHLORIDE


INJECTABLE; INJECTION
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 10GM/100ML;900MG/100ML N019631 015 Feb 24, 1988
AP BAXTER HLTHCARE 10GM/100ML;900MG/100ML N016696 001
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 2.5GM/100ML;450MG/100ML N019631 004 Feb 24, 1988
AP BAXTER HLTHCARE 2.5GM/100ML;450MG/100ML N016697 001
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;200MG/100ML N019631 007 Feb 24, 1988
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;330MG/100ML N019631 008 Feb 24, 1988
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;450MG/100ML N019631 009 Feb 24, 1988
AP HOSPIRA 5GM/100ML;450MG/100ML N017607 001
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;900MG/100ML N019631 010 Feb 24, 1988
AP HOSPIRA 5GM/100ML;900MG/100ML N017585 001
DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;200MG/100ML N016689 001
DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;330MG/100ML N016687 001
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;450MG/100ML N016683 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 127 (of 393)

DEXTROSE; SODIUM CHLORIDE


INJECTABLE; INJECTION
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;900MG/100ML N016678 001
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;110MG/100ML N019631 011 Feb 24, 1988
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;200MG/100ML N019631 012 Feb 24, 1988
DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;330MG/100ML N019631 013 Feb 24, 1988
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
XX B BRAUN 10GM/100ML;450MG/100ML N019631 014 Feb 24, 1988
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
XX B BRAUN 2.5GM/100ML;110MG/100ML N019631 001 Feb 24, 1988
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
XX B BRAUN 2.5GM/100ML;200MG/100ML N019631 002 Feb 24, 1988
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
XX B BRAUN 2.5GM/100ML;330MG/100ML N019631 003 Feb 24, 1988
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
XX B BRAUN 2.5GM/100ML;900MG/100ML N019631 005 Feb 24, 1988
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
XX B BRAUN 3.3GM/100ML;300MG/100ML N019631 016 Jan 19, 1990
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
XX B BRAUN 5GM/100ML;110MG/100ML N019631 006 Feb 24, 1988
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;225MG/100ML N017606 001
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
XX HOSPIRA 5GM/100ML;300MG/100ML N017799 001

DIATRIZOATE MEGLUMINE
SOLUTION; URETHRAL
CYSTOGRAFIN
XX BRACCO 30% N010040 018
CYSTOGRAFIN DILUTE
XX BRACCO 18% N010040 022 Nov 09, 1982

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM


INJECTABLE; INJECTION
MD-76R
AP + MALLINCKRODT 66%;10% N019292 001 Sep 29, 1989
RENOGRAFIN-76
AP + BRACCO 66%;10% N010040 001
SOLUTION; ORAL, RECTAL
GASTROGRAFIN
AA + BRACCO 66%;10% N011245 003
MD-GASTROVIEW
AA MALLINCKRODT 66%;10% A087388 001

DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE


SOLUTION; INTRAUTERINE

SINOGRAFIN

XX + BRACCO 52.7%;26.8% N011324 002

DIATRIZOATE SODIUM
FOR SOLUTION; ORAL, RECTAL

HYPAQUE

XX GE HEALTHCARE 100% N011386 001


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 128 (of 393)

DIAZEPAM
CONCENTRATE; ORAL

DIAZEPAM INTENSOL

XX + ROXANE 5MG/ML A071415 001 Apr 03, 1987


GEL; RECTAL
DIASTAT
XX VALEANT 2.5MG/0.5ML (5MG/ML) N020648 001 Jul 29, 1997
DIASTAT ACUDIAL
XX VALEANT 10MG/2ML (5MG/ML) N020648 007 Sep 15, 2005
XX + 20MG/4ML (5MG/ML) N020648 006 Sep 15, 2005
INJECTABLE; INJECTION
DIAZEPAM
AP + HOSPIRA 5MG/ML A071583 001 Oct 13, 1987
AP 5MG/ML A071584 001 Oct 13, 1987
AP 5MG/ML A072079 001 Dec 20, 1988
AP WATSON LABS 5MG/ML A070296 001 Feb 12, 1986
SOLUTION; ORAL

DIAZEPAM

XX + ROXANE 5MG/5ML A070928 001 Apr 03, 1987


TABLET; ORAL
DIAZEPAM
AB ACTAVIS ELIZABETH 2MG A070781 001 Mar 19, 1986
AB 5MG A070706 001 Mar 19, 1986
AB 10MG A070707 001 Mar 19, 1986
AB BARR 2MG A070152 001 Nov 01, 1985
AB 5MG A070153 001 Nov 01, 1985
AB 10MG A070154 001 Nov 01, 1985
AB DAVA PHARMS INC 2MG A070226 001 Sep 26, 1985
AB IVAX SUB TEVA PHARMS 2MG A071307 001 Dec 10, 1986
AB 5MG A071321 001 Dec 10, 1986
AB 10MG A071322 001 Dec 10, 1986
AB MYLAN 2MG A070325 002 Sep 04, 1985
AB 5MG A070325 003 Sep 04, 1985
AB 10MG A070325 001 Sep 04, 1985
AB VINTAGE PHARMS 2MG A077749 001 Mar 31, 2006
AB 5MG A077749 002 Mar 31, 2006
AB 10MG A077749 003 Mar 31, 2006
AB WATSON LABS 2MG A071134 001 Feb 03, 1987
AB 5MG A071135 001 Feb 03, 1987
AB 10MG A071136 001 Feb 03, 1987
VALIUM
AB ROCHE 2MG N013263 002
AB 5MG N013263 004
AB + 10MG N013263 006

DIAZOXIDE
SUSPENSION; ORAL

PROGLYCEM

XX + TEVA GLOBAL 50MG/ML N017453 001

DICLOFENAC EPOLAMINE
PATCH; TOPICAL

FLECTOR

XX + INST BIOCHEM 1.3% N021234 001 Jan 31, 2007

DICLOFENAC POTASSIUM
CAPSULE; ORAL

ZIPSOR

XX + XANODYNE PHARM 25MG N022202 001 Jun 18, 2009


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 129 (of 393)

DICLOFENAC POTASSIUM
FOR SOLUTION; ORAL

CAMBIA

XX + KOWA PHARMS 50MG N022165 001 Jun 17, 2009


TABLET; ORAL
CATAFLAM
AB + NOVARTIS 50MG N020142 002 Nov 24, 1993
DICLOFENAC POTASSIUM
AB APOTEX 50MG A076561 001 Mar 18, 2004
AB MYLAN 50MG A075463 001 Jul 26, 1999
AB SANDOZ 50MG A075229 001 Nov 20, 1998
AB 50MG A075582 001 Feb 23, 2001
AB TEVA 50MG A075219 001 Aug 06, 1998
AB WATSON LABS 50MG A075152 001 Nov 27, 1998

DICLOFENAC SODIUM
GEL; TOPICAL

SOLARAZE

XX + NYCOMED US 3% N021005 001 Oct 16, 2000


VOLTAREN
XX + NOVARTIS 1% N022122 001 Oct 17, 2007
SOLUTION; TOPICAL

PENNSAID

XX + NUVO RES 1.5% N020947 001 Nov 04, 2009


SOLUTION/DROPS; OPHTHALMIC
DICLOFENAC SODIUM
AT AKORN 0.1% A077845 001 Apr 17, 2008
AT ALCON 0.1% A078031 001 Feb 06, 2008
AT APOTEX INC 0.1% A077600 001 Nov 13, 2008
AT BAUSCH AND LOMB 0.1% A078792 001 Dec 28, 2007
AT NEXUS PHARMS 0.1% A078553 001 Dec 28, 2007
VOLTAREN
AT + NOVARTIS 0.1% N020037 001 Mar 28, 1991
TABLET, DELAYED RELEASE; ORAL
DICLOFENAC SODIUM
AB ACTAVIS ELIZABETH 50MG A074514 001 Mar 26, 1996
AB 75MG A074514 002 Mar 26, 1996
AB ALPHAPHARM 50MG A075281 002 Feb 12, 2002
AB 75MG A075281 003 Feb 12, 2002
AB CARLSBAD 25MG A075185 002 Nov 13, 1998
AB 50MG A075185 003 Nov 13, 1998
AB 75MG A075185 001 Nov 13, 1998
AB NOSTRUM LABS 50MG A074986 001 Feb 26, 1999
AB 75MG A074986 002 Feb 26, 1999
AB + SANDOZ 25MG A074376 001 Sep 28, 1995
AB + 50MG A074376 002 Sep 28, 1995
AB 75MG A074394 001 Nov 30, 1995
AB UNIQUE PHARM LABS 75MG A077863 003 Jun 08, 2007
VOLTAREN
AB + NOVARTIS 75MG N019201 003 Jul 28, 1988
TABLET, EXTENDED RELEASE; ORAL
DICLOFENAC SODIUM
AB ACTAVIS ELIZABETH 100MG A075910 001 Jan 07, 2002
AB BIOVAIL 100MG A075492 001 Feb 11, 2000
AB DEXCEL LTD 100MG A076201 001 Nov 06, 2002
AB MYLAN 100MG A076152 001 Dec 13, 2001
VOLTAREN-XR
AB + NOVARTIS 100MG N020254 001 Mar 08, 1996
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 130 (of 393)

DICLOFENAC SODIUM; MISOPROSTOL


TABLET, DELAYED RELEASE; ORAL
ARTHROTEC
XX GD SEARLE LLC 50MG;0.2MG N020607 001 Dec 24, 1997
XX + 75MG;0.2MG N020607 002 Dec 24, 1997

DICLOXACILLIN SODIUM
CAPSULE; ORAL
DICLOXACILLIN SODIUM
AB SANDOZ EQ 250MG BASE A061454 001
AB + EQ 500MG BASE A061454 003
AB TEVA EQ 250MG BASE A062286 001 Jun 03, 1982
AB EQ 500MG BASE A062286 002 Jun 03, 1982
DICLOXACILLIN SODIUM

XX SANDOZ EQ 125MG BASE A061454 002


DICYCLOMINE HYDROCHLORIDE
CAPSULE; ORAL
BENTYL
AB + AXCAN 10MG N007409 003 Oct 15, 1984
DICYCLOMINE HYDROCHLORIDE
AB LANNETT 10MG A084285 001
AB MYLAN 10MG A040319 001 Sep 07, 1999
AB WATSON LABS 10MG A085082 001 Jun 19, 1986
AB WEST WARD 10MG A040204 001 Feb 28, 1997
INJECTABLE; INJECTION
BENTYL
AP + AXCAN 10MG/ML N008370 001 Oct 15, 1984
BENTYL PRESERVATIVE FREE
AP + AXCAN 10MG/ML N008370 002 Oct 15, 1984
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE)
AP BEDFORD 10MG/ML A040465 001 Jun 30, 2003
SYRUP; ORAL
BENTYL
AA + AXCAN 10MG/5ML N007961 002 Oct 15, 1984
DICYCLOMINE HYDROCHLORIDE
AA MIKART 10MG/5ML A040169 001 Mar 24, 2005
TABLET; ORAL
BENTYL
AB + AXCAN 20MG N007409 001 Oct 15, 1984
DICYCLOMINE HYDROCHLORIDE
AB LANNETT 20MG A040230 001 Feb 26, 1999
AB MYLAN 20MG A040317 001 Sep 07, 1999
AB WATSON LABS 20MG A085223 001 Jul 30, 1986
AB WEST WARD 20MG A040161 001 Oct 01, 1996

DIDANOSINE
CAPSULE, DELAYED REL PELLETS; ORAL
DIDANOSINE
AB AUROBINDO PHARMA 125MG A090094 001 Sep 24, 2008
AB 200MG A090094 002 Sep 24, 2008
AB 250MG A090094 003 Sep 24, 2008
AB 400MG A090094 004 Sep 24, 2008
AB BARR 200MG A077167 001 Dec 03, 2004
AB 250MG A077167 002 Dec 03, 2004
AB 400MG A077167 003 Dec 03, 2004
VIDEX EC
AB BRISTOL MYERS SQUIBB 125MG N021183 001 Oct 31, 2000
AB 200MG N021183 002 Oct 31, 2000
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 131 (of 393)

DIDANOSINE
CAPSULE, DELAYED REL PELLETS; ORAL
VIDEX EC
AB BRISTOL MYERS SQUIBB 250MG N021183 003 Oct 31, 2000

AB + 400MG N021183 004 Oct 31, 2000

FOR SOLUTION; ORAL


DIDANOSINE
AA AUROBINDO PHARMA 10MG/ML A078112 001 Mar 08, 2007

VIDEX
AA + BRISTOL MYERS SQUIBB 10MG/ML N020156 001 Oct 09, 1991

DIETHYLPROPION HYDROCHLORIDE
TABLET; ORAL
DIETHYLPROPION HYDROCHLORIDE
AA COREPHARMA 25MG A040828 001 Nov 05, 2008
TENUATE
AA + WATSON PHARMS 25MG N011722 002
TABLET, EXTENDED RELEASE; ORAL

TENUATE DOSPAN

XX + WATSON PHARMS 75MG N012546 001

DIFLORASONE DIACETATE
CREAM; TOPICAL
DIFLORASONE DIACETATE
AB1 ALTANA 0.05% A075187 001 Mar 30, 1998
AB1 TARO 0.05% A075508 001 Apr 24, 2000
PSORCON
AB1 + SANOFI AVENTIS US 0.05% N020205 001 Nov 20, 1992
DIFLORASONE DIACETATE
BX + ALTANA 0.05% A076263 001 Dec 20, 2002
OINTMENT; TOPICAL
DIFLORASONE DIACETATE
AB ALTANA 0.05% A075374 001 Apr 27, 1999
AB + TARO 0.05% A075331 001 May 14, 1999

DIFLUNISAL
TABLET; ORAL

DIFLUNISAL

XX + TEVA 500MG A073673 001 Jul 31, 1992

DIFLUPREDNATE
EMULSION; OPHTHALMIC

DUREZOL

XX + SIRION THERAP 0.05% N022212 001 Jun 23, 2008

DIGOXIN
CAPSULE; ORAL
LANOXICAPS
XX SMITHKLINE BEECHAM 0.05MG N018118 002 Jul 26, 1982
XX 0.1MG N018118 003 Jul 26, 1982
XX + 0.2MG N018118 001 Jul 26, 1982
ELIXIR; ORAL

DIGOXIN

XX + ROXANE 0.05MG/ML N021648 001 Aug 26, 2004


INJECTABLE; INJECTION
DIGOXIN
AP BAXTER HLTHCARE 0.25MG/ML A083391 001
AP HOSPIRA 0.25MG/ML A040093 001 May 16, 1996
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 132 (of 393)

DIGOXIN
INJECTABLE; INJECTION
DIGOXIN
AP SANDOZ 0.25MG/ML A040481 001 Aug 21, 2003
LANOXIN
AP + GLAXOSMITHKLINE 0.25MG/ML N009330 002
LANOXIN PEDIATRIC
XX + GLAXOSMITHKLINE 0.1MG/ML N009330 004
TABLET; ORAL
DIGOXIN
AB ACTAVIS TOTOWA 0.125MG A040282 001 Dec 23, 1999
AB 0.25MG A040282 002 Dec 23, 1999
AB CARACO 0.125MG A076363 001 Jan 31, 2003
AB 0.25MG A076363 002 Jan 31, 2003
AB IMPAX LABS 0.125MG A078556 001 Jul 20, 2009
AB 0.25MG A078556 002 Jul 20, 2009
AB STEVENS J 0.125MG A076268 001 Jul 26, 2002
AB 0.25MG A076268 002 Jul 26, 2002
AB WEST WARD 0.125MG A077002 002 Oct 30, 2007
AB 0.25MG A077002 001 Oct 30, 2007
LANOXIN
AB SMITHKLINE BEECHAM 0.125MG N020405 002 Sep 30, 1997
AB + 0.25MG N020405 004 Sep 30, 1997

DIHYDROERGOTAMINE MESYLATE
INJECTABLE; INJECTION
D.H.E. 45
AP + VALEANT 1MG/ML N005929 001
DIHYDROERGOTAMINE MESYLATE
AP BEDFORD LABS 1MG/ML A040453 001 Jun 09, 2003
AP PADDOCK 1MG/ML A040475 001 Apr 28, 2003
SPRAY, METERED; NASAL

MIGRANAL

XX + VALEANT 0.5MG/INH N020148 001 Dec 08, 1997

DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
DILACOR XR
AB2 WATSON LABS 120MG N020092 001 May 29, 1992
AB2 180MG N020092 002 May 29, 1992
AB2 + 240MG N020092 003 May 29, 1992
DILTIAZEM HYDROCHLORIDE
AB2 APOTEX 120MG A074943 003 Dec 19, 2000
AB2 180MG A074943 002 Dec 19, 2000
AB2 240MG A074943 001 Aug 06, 1998
AB2 MYLAN 120MG A075124 002 Mar 18, 1998
AB2 180MG A075124 003 Mar 18, 1998
AB2 240MG A075124 001 Mar 18, 1998
AB2 WATSON LABS FLORIDA 120MG A074852 001 Oct 10, 1997
AB2 180MG A074852 002 Oct 10, 1997
AB2 240MG A074852 003 Oct 10, 1997
CARDIZEM CD
AB3 BIOVAIL 120MG N020062 001 Aug 10, 1992
AB3 180MG N020062 002 Dec 27, 1991
AB3 240MG N020062 003 Dec 27, 1991
AB3 300MG N020062 004 Dec 27, 1991
CARTIA XT
AB3 WATSON LABS FLORIDA 120MG A074752 002 Jul 09, 1998
AB3 180MG A074752 001 Jul 09, 1998
AB3 240MG A074752 003 Jul 09, 1998
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 133 (of 393)

DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
CARTIA XT
AB3 WATSON LABS FLORIDA 300MG A074752 004 Jul 09, 1998
DILT-CD
AB3 APOTEX 120MG A076151 001 May 20, 2004
AB3 180MG A076151 002 May 20, 2004
AB3 240MG A076151 003 May 20, 2004
AB3 300MG A076151 004 May 20, 2004
DILTIAZEM HYDROCHLORIDE
AB3 ACTAVIS ELIZABETH 120MG A074984 001 Dec 20, 1999
AB3 180MG A074984 002 Dec 20, 1999
AB3 240MG A074984 003 Dec 20, 1999
AB3 300MG A074984 004 Dec 20, 1999
AB3 BIOVAIL 120MG A075116 001 Dec 23, 1999
AB3 180MG A075116 002 Dec 23, 1999
AB3 240MG A075116 003 Dec 23, 1999
AB3 300MG A075116 004 Dec 23, 1999
DILTIAZEM HYDROCHLORIDE
AB4 KV PHARM 120MG A076563 002 Sep 12, 2006
AB4 180MG A076563 003 Sep 12, 2006
AB4 240MG A076563 004 Sep 12, 2006
AB4 300MG A076563 005 Sep 12, 2006
AB4 360MG A076563 006 Sep 12, 2006
AB4 420MG A076563 001 Sep 12, 2006
DILTZAC
AB4 APOTEX INC 120MG A076395 001 Feb 01, 2006
AB4 180MG A076395 002 Feb 01, 2006
AB4 240MG A076395 003 Feb 01, 2006
AB4 300MG A076395 004 Feb 01, 2006
AB4 360MG A076395 005 Feb 01, 2006
TAZTIA XT
AB4 WATSON LABS FLORIDA 120MG A075401 001 Apr 10, 2003
AB4 180MG A075401 002 Apr 10, 2003
AB4 240MG A075401 003 Apr 10, 2003
AB4 300MG A075401 004 Apr 10, 2003
AB4 360MG A075401 005 Apr 10, 2003
TIAZAC
AB4 BIOVAIL 120MG N020401 001 Sep 11, 1995
AB4 180MG N020401 002 Sep 11, 1995
AB4 240MG N020401 003 Sep 11, 1995
AB4 300MG N020401 004 Sep 11, 1995
AB4 360MG N020401 005 Sep 11, 1995
AB4 + 420MG N020401 006 Oct 16, 1998
CARDIZEM CD
BC + BIOVAIL 360MG N020062 005 Aug 24, 1999
DILTIAZEM HYDROCHLORIDE
BC + MYLAN 120MG A074910 003 May 02, 1997
DILTIAZEM HYDROCHLORIDE
XX MYLAN 60MG A074910 001 May 02, 1997
XX 90MG A074910 002 May 02, 1997
INJECTABLE; INJECTION
DILTIAZEM HYDROCHLORIDE
AP APOTEX INC 5MG/ML A075375 001 Sep 30, 1999
AP BAXTER HLTHCARE 5MG/ML A078538 001 Dec 17, 2008
AP + BEDFORD 5MG/ML A074617 001 Feb 28, 1996
AP HOSPIRA 5MG/ML A074941 001 Apr 15, 1998
AP INTL MEDICATION 5MG/ML A075749 001 Nov 21, 2001
AP TAYLOR PHARMA 5MG/ML A075086 001 Apr 09, 1998
AP TEVA PARENTERAL 5MG/ML A074894 001 Aug 26, 1997
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 134 (of 393)

DILTIAZEM HYDROCHLORIDE
INJECTABLE; INJECTION

DILTIAZEM HYDROCHLORIDE

XX + HOSPIRA 100MG/VIAL A075853 001 Dec 17, 2002


XX + TEVA PARENTERAL 10MG/ML A074894 002 Apr 19, 2002
TABLET; ORAL
CARDIZEM
AB BIOVAIL LABS INTL 30MG N018602 001 Nov 05, 1982
AB 60MG N018602 002 Nov 05, 1982
AB 90MG N018602 003 Dec 08, 1986
AB + 120MG N018602 004 Dec 08, 1986
DILTIAZEM HYDROCHLORIDE
AB DAVA PHARMS INC 30MG A074093 001 Nov 05, 1992
AB 60MG A074093 002 Nov 05, 1992
AB 90MG A074093 003 Nov 05, 1992
AB 120MG A074093 004 Nov 05, 1992
AB MYLAN 30MG A073185 001 Nov 05, 1992
AB 60MG A073186 001 Nov 05, 1992
AB 90MG A072837 001 Nov 05, 1992
AB 120MG A072838 001 Nov 05, 1992
AB TEVA 30MG A074185 001 May 31, 1995
AB 60MG A074185 002 May 31, 1995
AB 90MG A074185 003 May 31, 1995
AB 120MG A074185 004 May 31, 1995
TABLET, EXTENDED RELEASE; ORAL
CARDIZEM LA
XX BIOVAIL LABS INTL 120MG N021392 001 Feb 06, 2003
XX 180MG N021392 002 Feb 06, 2003
XX 240MG N021392 003 Feb 06, 2003
XX 300MG N021392 004 Feb 06, 2003
XX 360MG N021392 005 Feb 06, 2003
XX + 420MG N021392 006 Feb 06, 2003

DIMENHYDRINATE
INJECTABLE; INJECTION
DIMENHYDRINATE
AP APP PHARMS 50MG/ML A040519 001 Jun 23, 2004
AP + WATSON LABS 50MG/ML A080615 001

DIMERCAPROL
INJECTABLE; INJECTION

BAL

XX + AKORN 10% N005939 001

DIMETHYL SULFOXIDE
SOLUTION; INTRAVESICAL
DIMETHYL SULFOXIDE
AT BIONICHE PHARMA 50% A076185 001 Nov 29, 2002
RIMSO-50
AT + BIONICHE PHARMA 50% N017788 001

DINOPROSTONE
GEL; ENDOCERVICAL

PREPIDIL

XX + PHARMACIA AND UPJOHN 0.5MG/3GM N019617 001 Dec 09, 1992


INSERT, EXTENDED RELEASE; VAGINAL
CERVIDIL
XX + CONTROLLED THERAP 10MG N020411 001 Mar 30, 1995
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 135 (of 393)

DINOPROSTONE
SUPPOSITORY; VAGINAL

PROSTIN E2

XX + PHARMACIA AND UPJOHN 20MG N017810 001

DIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE; ORAL

DIPHENHYDRAMINE HYDROCHLORIDE

XX + BARR 50MG A080738 001


ELIXIR; ORAL

DIPHENHYDRAMINE HYDROCHLORIDE

XX + PHARM ASSOC 12.5MG/5ML A087513 001 Feb 10, 1982


INJECTABLE; INJECTION
BENADRYL
AP + MCNEIL CONS 50MG/ML N006146 002
BENADRYL PRESERVATIVE FREE
AP + MCNEIL CONS 50MG/ML N009486 001
DIPHENHYDRAMINE HYDROCHLORIDE
AP APP PHARMS 50MG/ML A040466 001 May 28, 2002
AP BAXTER HLTHCARE 50MG/ML A080817 002
AP BIONICHE PHARMA 50MG/ML A040498 001 Jul 12, 2005
AP HOSPIRA 50MG/ML A040140 001 Nov 20, 1998
AP WATSON LABS 50MG/ML A080873 002
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
AP INTL MEDICATION 50MG/ML A084094 001
AP WATSON LABS 50MG/ML A080873 003
DIPHENHYDRAMINE HYDROCHLORIDE
XX + WATSON LABS 10MG/ML A080873 001

DIPIVEFRIN HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
AKPRO
AT AKORN 0.1% A074382 001 Sep 29, 1995
DIPIVEFRIN HYDROCHLORIDE
AT BAUSCH AND LOMB 0.1% A074188 001 May 19, 1995
AT FALCON PHARMS 0.1% A073636 001 Jun 30, 1994
PROPINE
AT + ALLERGAN 0.1% N018239 001

DIPYRIDAMOLE
INJECTABLE; INJECTION
DIPYRIDAMOLE
AP APOTEX INC 5MG/ML A075769 001 Nov 27, 2002
AP APP PHARMS 5MG/ML A074956 001 Sep 30, 1998
AP BAXTER HLTHCARE 5MG/ML A074521 001 Oct 18, 1996
AP + BEDFORD 5MG/ML A074939 001 Apr 13, 1998
AP HOSPIRA 5MG/ML A074601 001 Dec 19, 1997
AP TEVA PARENTERAL 5MG/ML A074952 001 Nov 26, 1997
TABLET; ORAL
DIPYRIDAMOLE
AB ACTAVIS TOTOWA 25MG A040542 001 Apr 21, 2006
AB 50MG A040542 002 Apr 21, 2006
AB 75MG A040542 003 Apr 21, 2006
AB BARR 25MG A087184 001 Oct 03, 1990
AB 50MG A087716 001 Oct 03, 1990
AB 75MG A087717 001 Oct 03, 1990
AB GLENMARK GENERICS 25MG A088999 001 Feb 05, 1991
AB 50MG A089000 001 Feb 05, 1991
AB 75MG A089001 001 Feb 05, 1991
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 136 (of 393)

DIPYRIDAMOLE
TABLET; ORAL
DIPYRIDAMOLE
AB IMPAX LABS 25MG A040782 001 Jul 18, 2007
AB 50MG A040782 002 Jul 18, 2007
AB 75MG A040782 003 Jul 18, 2007
AB LANNETT 25MG A040898 001 Apr 23, 2008
AB 50MG A040898 002 Apr 23, 2008
AB 75MG A040898 003 Apr 23, 2008
AB MURTY PHARMS 25MG A040733 001 Feb 13, 2007
AB 50MG A040733 002 Feb 13, 2007
AB 75MG A040733 003 Feb 13, 2007
AB PUREPAC PHARM 25MG A089425 001 Jul 12, 1990
AB WATSON LABS 50MG A087160 001 Jun 07, 1996
AB ZYDUS PHARMS USA INC 25MG A040874 001 Jan 28, 2008
AB 50MG A040874 002 Jan 28, 2008
AB 75MG A040874 003 Jan 28, 2008
PERSANTINE
AB BOEHRINGER INGELHEIM 25MG N012836 003 Dec 22, 1986
AB 50MG N012836 004 Feb 06, 1987
AB + 75MG N012836 005 Feb 06, 1987

DISOPYRAMIDE PHOSPHATE
CAPSULE; ORAL
DISOPYRAMIDE PHOSPHATE
AB TEVA EQ 100MG BASE A070101 001 Feb 22, 1985
AB EQ 150MG BASE A070102 001 Feb 22, 1985
AB WATSON LABS EQ 100MG BASE A070173 001 May 31, 1985
AB EQ 150MG BASE A070174 001 May 31, 1985
NORPACE
AB GD SEARLE LLC EQ 100MG BASE N017447 001
AB + EQ 150MG BASE N017447 002
CAPSULE, EXTENDED RELEASE; ORAL
DISOPYRAMIDE PHOSPHATE
AB KV PHARM EQ 150MG BASE A071200 001 Dec 15, 1987
NORPACE CR
AB + GD SEARLE LLC EQ 150MG BASE N018655 002 Jul 20, 1982
NORPACE CR
XX GD SEARLE LLC EQ 100MG BASE N018655 001 Jul 20, 1982

DISULFIRAM
TABLET; ORAL
ANTABUSE
XX ODYSSEY PHARMS 250MG A088482 001 Dec 08, 1983
XX + 500MG A088483 001 Dec 08, 1983

DIVALPROEX SODIUM
CAPSULE, DELAYED REL PELLETS; ORAL
DEPAKOTE
AB + ABBOTT EQ 125MG VALPROIC ACID N019680 001 Sep 12, 1989
DIVALPROEX SODIUM
AB DR REDDYS LABS LTD EQ 125MG VALPROIC ACID A078979 001 Jan 23, 2009
AB ZYDUS PHARMS USA INC EQ 125MG VALPROIC ACID A078919 001 Jan 27, 2009
TABLET, DELAYED RELEASE; ORAL
DEPAKOTE
AB ABBOTT EQ 125MG VALPROIC ACID N018723 003 Oct 26, 1984
AB EQ 250MG VALPROIC ACID N018723 001 Mar 10, 1983
AB + EQ 500MG VALPROIC ACID N018723 002 Mar 10, 1983
DIVALPROEX SODIUM
AB ANCHEN PHARMS EQ 500MG VALPROIC ACID A078411 001 Nov 03, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 137 (of 393)

DIVALPROEX SODIUM
TABLET, DELAYED RELEASE; ORAL
DIVALPROEX SODIUM
AB DR REDDYS LABS LTD EQ 125MG VALPROIC ACID A078755 001 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A078755 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A078755 003 Jul 29, 2008
AB LUPIN EQ 125MG VALPROIC ACID A078790 001 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A078790 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A078790 003 Jul 29, 2008
AB MYLAN EQ 125MG VALPROIC ACID A077254 001 Jul 29, 2008
AB EQ 125MG VALPROIC ACID A090062 001 Mar 17, 2009
AB EQ 250MG VALPROIC ACID A077254 002 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A090062 002 Mar 17, 2009
AB EQ 500MG VALPROIC ACID A077254 003 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A090062 003 Mar 17, 2009
AB NU PHARM EQ 125MG VALPROIC ACID A077615 003 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A077615 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A077615 001 Jul 29, 2008
AB ORCHID HLTHCARE EQ 125MG VALPROIC ACID A078853 001 Nov 25, 2008
AB EQ 250MG VALPROIC ACID A078853 002 Nov 25, 2008
AB EQ 500MG VALPROIC ACID A078853 003 Nov 25, 2008
AB SANDOZ EQ 125MG VALPROIC ACID A078290 003 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A078290 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A078290 001 Jul 29, 2008
AB SUN PHARM INDS EQ 125MG VALPROIC ACID A078597 001 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A078597 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A078597 003 Jul 29, 2008
AB TEVA EQ 125MG VALPROIC ACID A076941 001 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A076941 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A076941 003 Jul 29, 2008
AB UPSHER SMITH EQ 125MG VALPROIC ACID A078182 001 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A078182 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A078182 003 Jul 29, 2008
AB VINTAGE EQ 125MG VALPROIC ACID A090210 001 Nov 30, 2009
AB EQ 250MG VALPROIC ACID A090210 002 Nov 30, 2009
AB EQ 500MG VALPROIC ACID A090210 003 Nov 30, 2009
AB WOCKHARDT EQ 125MG VALPROIC ACID A077296 001 Jul 31, 2008
AB EQ 250MG VALPROIC ACID A077296 002 Jul 31, 2008
AB EQ 500MG VALPROIC ACID A077296 003 Jul 31, 2008
AB ZYDUS PHARMS USA INC EQ 125MG VALPROIC ACID A077100 001 Mar 05, 2009
AB EQ 250MG VALPROIC ACID A077100 002 Mar 05, 2009
AB EQ 500MG VALPROIC ACID A077100 003 Mar 05, 2009
TABLET, EXTENDED RELEASE; ORAL
DEPAKOTE ER
AB ABBOTT EQ 250MG VALPROIC ACID N021168 002 May 31, 2002
AB + EQ 500MG VALPROIC ACID N021168 001 Aug 04, 2000
DIVALPROEX SODIUM
AB ANCHEN PHARMS EQ 250MG VALPROIC ACID A078445 001 Feb 26, 2009
AB EQ 500MG VALPROIC ACID A078445 002 Aug 04, 2009
AB IMPAX LABS EQ 250MG VALPROIC ACID A078791 001 May 06, 2009
AB EQ 500MG VALPROIC ACID A078791 002 Aug 04, 2009
AB MYLAN EQ 250MG VALPROIC ACID A077567 001 Jan 29, 2009
AB EQ 500MG VALPROIC ACID A077567 002 Jan 29, 2009
AB TEVA PHARMS EQ 500MG VALPROIC ACID A078700 001 Aug 03, 2009
AB WOCKHARDT EQ 250MG VALPROIC ACID A078705 002 Feb 10, 2009
AB EQ 500MG VALPROIC ACID A078705 001 Aug 04, 2009
AB ZYDUS PHARMS USA INC EQ 250MG VALPROIC ACID A078239 001 Feb 27, 2009
AB EQ 500MG VALPROIC ACID A078239 002 Aug 04, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 138 (of 393)

DOBUTAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
DOBUTAMINE HYDROCHLORIDE
AP BEDFORD EQ 12.5MG BASE/ML A074277 001 Oct 31, 1994
AP HOSPIRA EQ 12.5MG BASE/ML A074086 001 Nov 29, 1993
AP EQ 12.5MG BASE/ML A074292 001 Feb 16, 1995
AP TEVA PARENTERAL EQ 12.5MG BASE/ML A074206 001 Oct 19, 1993
AP WATSON LABS EQ 12.5MG BASE/ML A074114 001 Nov 30, 1993
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
AP + HOSPIRA EQ 50MG BASE/100ML N020269 001 Oct 19, 1993
AP + EQ 100MG BASE/100ML N020269 002 Oct 19, 1993
AP + EQ 200MG BASE/100ML N020269 003 Oct 19, 1993
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE EQ 50MG BASE/100ML N020255 001 Oct 19, 1993
AP + EQ 100MG BASE/100ML N020255 003 Oct 19, 1993
AP + EQ 200MG BASE/100ML N020255 004 Oct 19, 1993
AP + EQ 400MG BASE/100ML N020255 005 Oct 19, 1993
AP + HOSPIRA EQ 50MG BASE/100ML N020201 003 Oct 19, 1993
AP + EQ 100MG BASE/100ML N020201 002 Oct 19, 1993
AP + EQ 200MG BASE/100ML N020201 001 Oct 19, 1993
AP + EQ 400MG BASE/100ML N020201 006 Jul 07, 1994

DOCETAXEL
INJECTABLE; INJECTION

TAXOTERE

XX + SANOFI AVENTIS US EQ 40MG BASE/ML N020449 001 May 14, 1996

DOFETILIDE
CAPSULE; ORAL
TIKOSYN
XX PFIZER 0.125MG N020931 001 Oct 01, 1999
XX 0.25MG N020931 002 Oct 01, 1999
XX + 0.5MG N020931 003 Oct 01, 1999

DOLASETRON MESYLATE
INJECTABLE; INJECTION

ANZEMET

XX + SANOFI AVENTIS US 12.5MG/0.625ML (20MG/ML) N020624 002 Sep 11, 1997


XX + 100MG/5ML (20MG/ML) N020624 001 Sep 11, 1997
XX + 500MG/25ML (20MG/ML) N020624 003 Dec 11, 2001
TABLET; ORAL
ANZEMET
XX SANOFI AVENTIS US 50MG N020623 001 Sep 11, 1997
XX + 100MG N020623 002 Sep 11, 1997

DONEPEZIL HYDROCHLORIDE
TABLET; ORAL
ARICEPT
AB EISAI INC 5MG N020690 002 Nov 25, 1996
AB + 10MG N020690 001 Nov 25, 1996
DONEPEZIL HYDROCHLORIDE
AB TEVA 5MG A077344 001 Apr 28, 2008
AB 10MG A077344 002 Apr 28, 2008
TABLET, ORALLY DISINTEGRATING; ORAL
ARICEPT ODT
AB EISAI INC 5MG N021720 001 Oct 18, 2004
AB + 10MG N021720 002 Oct 18, 2004
DONEPEZIL HYDROCHLORIDE
AB MUTUAL PHARM 5MG A077975 002 Dec 11, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 139 (of 393)

DONEPEZIL HYDROCHLORIDE
TABLET, ORALLY DISINTEGRATING; ORAL
DONEPEZIL HYDROCHLORIDE
AB MUTUAL PHARM 10MG A077975 001 Dec 11, 2009

DOPAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
DOPAMINE HYDROCHLORIDE
AP + HOSPIRA 40MG/ML N018132 001
AP + 80MG/100ML N018132 002 Feb 04, 1982
AP + 80MG/ML N018132 004 Jul 09, 1982
AP + 160MG/100ML N018132 003 Feb 04, 1982
AP + LUITPOLD 40MG/ML A070799 001 Feb 11, 1987
AP + 80MG/ML A070820 001 Feb 11, 1987
AP + 160MG/ML A070826 001 Feb 11, 1987
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%
AP + B BRAUN 80MG/100ML N019099 002 Oct 15, 1986
AP + 320MG/100ML N019099 004 Oct 15, 1986
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 160MG/100ML N019099 003 Oct 15, 1986
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 80MG/100ML N019615 001 Mar 27, 1987
AP + 160MG/100ML N019615 002 Mar 27, 1987
AP + 320MG/100ML N019615 003 Mar 27, 1987
AP + HOSPIRA 80MG/100ML N018826 001 Sep 30, 1983
AP + 160MG/100ML N018826 002 Sep 30, 1983
AP + 320MG/100ML N018826 003 Sep 30, 1983
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER
XX + B BRAUN 40MG/100ML N019099 001 Oct 15, 1986
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE 640MG/100ML N019615 004 Mar 27, 1987

DORIPENEM
INJECTABLE; IV (INFUSION)

DORIBAX

XX + ORTHO MCNEIL JANSSEN 500MG/VIAL N022106 001 Oct 12, 2007

DORZOLAMIDE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
DORZOLAMIDE HYDROCHLORIDE
AT ALCON EQ 2% BASE A078981 001 Apr 13, 2009
AT APOTEX INC EQ 2% BASE A078395 001 Oct 28, 2008
AT BAUSCH AND LOMB EQ 2% BASE A090143 001 Jun 25, 2009
AT HI TECH PHARMA EQ 2% BASE A077846 001 Oct 28, 2008
AT PHARMAFORCE EQ 2% BASE A079186 001 Nov 18, 2009
AT SANDOZ EQ 2% BASE A078748 001 Nov 06, 2008
AT TEVA PHARMS EQ 2% BASE A078756 001 Dec 04, 2008
TRUSOPT
AT + MERCK EQ 2% BASE N020408 001 Dec 09, 1994

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE


SOLUTION/DROPS; OPHTHALMIC
COSOPT
AT + MERCK EQ 2% BASE;EQ 0.5% BASE N020869 001 Apr 07, 1998
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
AT ALCON RES EQ 2% BASE;EQ 0.5% BASE A090604 001 Nov 18, 2009
AT APOTEX INC EQ 2% BASE;EQ 0.5% BASE A078201 001 Oct 28, 2008
AT BAUSCH AND LOMB EQ 2% BASE;EQ 0.5% BASE A090037 001 Jul 14, 2009
AT HI TECH PHARMA EQ 2% BASE;EQ 0.5% BASE A077847 001 Oct 28, 2008
AT SANDOZ EQ 2% BASE;EQ 0.5% BASE A078749 001 Nov 06, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 140 (of 393)

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE


SOLUTION/DROPS; OPHTHALMIC
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
AT TEVA PARNTL EQ 2% BASE;EQ 0.5% BASE A078704 001 Sep 28, 2009

DOXAPRAM HYDROCHLORIDE
INJECTABLE; INJECTION
DOPRAM
AP + BAXTER HLTHCARE 20MG/ML N014879 001
DOXAPRAM HYDROCHLORIDE
AP BEDFORD 20MG/ML A076266 001 Jan 10, 2003
AP WATSON LABS 20MG/ML A073529 001 Jan 30, 1992

DOXAZOSIN MESYLATE
TABLET; ORAL
CARDURA
AB + PFIZER EQ 1MG BASE N019668 001 Nov 02, 1990
AB EQ 2MG BASE N019668 002 Nov 02, 1990
AB EQ 4MG BASE N019668 003 Nov 02, 1990
AB EQ 8MG BASE N019668 004 Nov 02, 1990
DOXAZOSIN MESYLATE
AB ACTAVIS ELIZABETH EQ 1MG BASE A075574 001 Oct 18, 2000
AB EQ 2MG BASE A075574 002 Oct 18, 2000
AB EQ 4MG BASE A075574 003 Oct 18, 2000
AB EQ 8MG BASE A075574 004 Oct 18, 2000
AB APOTEX EQ 1MG BASE A075580 001 Oct 18, 2000
AB EQ 2MG BASE A075580 002 Oct 18, 2000
AB EQ 4MG BASE A075580 003 Oct 18, 2000
AB EQ 8MG BASE A075580 004 Oct 18, 2000
AB DAVA PHARMS INC EQ 1MG BASE A076161 001 Jun 10, 2004
AB EQ 2MG BASE A076161 002 Jun 10, 2004
AB EQ 4MG BASE A076161 003 Jun 10, 2004
AB EQ 8MG BASE A076161 004 Jun 10, 2004
AB IVAX SUB TEVA PHARMS EQ 1MG BASE A075453 001 Oct 18, 2000
AB EQ 2MG BASE A075453 002 Oct 18, 2000
AB EQ 4MG BASE A075453 003 Oct 18, 2000
AB EQ 8MG BASE A075453 004 Oct 18, 2000
AB KV PHARM EQ 1MG BASE A075609 001 Oct 18, 2000
AB EQ 2MG BASE A075609 002 Oct 18, 2000
AB EQ 4MG BASE A075609 003 Oct 18, 2000
AB EQ 8MG BASE A075609 004 Oct 18, 2000
AB MYLAN EQ 1MG BASE A075509 001 Oct 19, 2000
AB EQ 2MG BASE A075509 002 Oct 19, 2000
AB EQ 4MG BASE A075509 003 Oct 19, 2000
AB EQ 8MG BASE A075509 004 Oct 19, 2000
AB PLIVA EQ 1MG BASE A075750 001 Jun 08, 2001
AB EQ 2MG BASE A075750 002 Jun 08, 2001
AB EQ 4MG BASE A075750 003 Jun 08, 2001
AB EQ 8MG BASE A075750 004 Jun 08, 2001
AB SANDOZ EQ 1MG BASE A075432 001 Oct 18, 2000
AB EQ 2MG BASE A075432 002 Oct 18, 2000
AB EQ 4MG BASE A075432 003 Oct 18, 2000
AB EQ 8MG BASE A075432 004 Oct 18, 2000
AB TEVA EQ 1MG BASE A075536 001 Oct 18, 2000
AB EQ 2MG BASE A075536 002 Oct 18, 2000
AB EQ 4MG BASE A075536 003 Oct 18, 2000
AB EQ 8MG BASE A075536 004 Oct 18, 2000
AB WATSON LABS EQ 1MG BASE A075426 001 Oct 18, 2000
AB EQ 2MG BASE A075426 002 Oct 18, 2000
AB EQ 4MG BASE A075426 003 Oct 18, 2000
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 141 (of 393)

DOXAZOSIN MESYLATE
TABLET; ORAL
DOXAZOSIN MESYLATE
AB WATSON LABS EQ 8MG BASE A075426 004 Oct 18, 2000
TABLET, EXTENDED RELEASE; ORAL
CARDURA XL
XX PFIZER EQ 4MG BASE N021269 001 Feb 22, 2005
XX + EQ 8MG BASE N021269 002 Feb 22, 2005

DOXEPIN HYDROCHLORIDE
CAPSULE; ORAL
DOXEPIN HYDROCHLORIDE
AB MYLAN EQ 10MG BASE A070791 002 May 13, 1986
AB EQ 25MG BASE A070791 003 May 13, 1986
AB EQ 50MG BASE A070791 001 May 13, 1986
AB EQ 75MG BASE A070791 004 May 13, 1986
AB EQ 100MG BASE A070791 005 May 13, 1986
AB PAR PHARM EQ 10MG BASE A071697 001 Nov 09, 1987
AB + EQ 25MG BASE A071437 001 Nov 09, 1987
AB EQ 50MG BASE A071595 001 Nov 09, 1987
AB EQ 75MG BASE A071608 001 Nov 09, 1987
AB + EQ 100MG BASE A071422 001 Nov 09, 1987
AB WATSON LABS EQ 10MG BASE A071485 001 Apr 30, 1987
AB EQ 25MG BASE A071486 001 Apr 30, 1987
AB EQ 50MG BASE A071238 001 Apr 30, 1987
AB EQ 75MG BASE A071326 001 Apr 30, 1987
AB EQ 100MG BASE A071239 001 Apr 30, 1987
DOXEPIN HYDROCHLORIDE
XX PAR PHARM EQ 150MG BASE A071669 001 Nov 09, 1987
CONCENTRATE; ORAL
DOXEPIN HYDROCHLORIDE
AA MORTON GROVE EQ 10MG BASE/ML A071918 001 Jul 20, 1988
AA PHARM ASSOC EQ 10MG BASE/ML A075924 001 Jan 15, 2004
AA SILARX EQ 10MG BASE/ML A074721 001 Dec 29, 1998
AA + TEVA PHARMS EQ 10MG BASE/ML A071609 001 Nov 09, 1987
CREAM; TOPICAL

ZONALON

XX + NYCOMED US 5% N020126 001 Apr 01, 1994

DOXERCALCIFEROL
CAPSULE; ORAL
HECTOROL
XX GENZYME 0.5MCG N020862 002 Apr 23, 2004
XX 1MCG N020862 003 Jul 13, 2009
XX + 2.5MCG N020862 001 Jun 09, 1999
INJECTABLE; INJECTION

HECTOROL

XX + GENZYME 2MCG/ML N021027 001 Apr 06, 2000

DOXORUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION
DOXORUBICIN HYDROCHLORIDE
AP APP PHARMS 2MG/ML A063277 001 Oct 26, 1995
AP + BEDFORD 2MG/ML A062975 001 Mar 17, 1989
AP + 10MG/VIAL A062921 001 Mar 17, 1989
AP + 20MG/VIAL A062921 002 Mar 17, 1989
AP + 50MG/VIAL A062921 003 Mar 17, 1989
AP + 200MG/100ML A064097 001 Sep 13, 1994
AP PHARMACHEMIE 2MG/ML A063336 001 Feb 28, 1995
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 142 (of 393)

DOXORUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION
DOXORUBICIN HYDROCHLORIDE
AP PHARMACHEMIE 10MG/VIAL A063097 001 May 21, 1990
AP 20MG/VIAL A063097 002 May 21, 1990
AP 50MG/VIAL A063097 003 May 21, 1990
AP 200MG/100ML A063336 004 Feb 28, 1995
AP TEVA PARENTERAL 2MG/ML A064140 001 Jul 28, 1995
AP 200MG/100ML A064140 002 Jul 28, 1995
INJECTABLE, LIPOSOMAL; INJECTION

DOXIL

XX + ORTHO BIOTECH 20MG/10ML (2MG/ML) N050718 001 Nov 17, 1995


XX + 50MG/25ML (2MG/ML) N050718 002 Jun 13, 2000

DOXYCYCLINE
CAPSULE; ORAL
DOXYCYCLINE
AB PAR PHARM EQ 50MG BASE A065055 001 Dec 01, 2000
AB EQ 100MG BASE A065055 002 Dec 01, 2000
AB RANBAXY EQ 50MG BASE A065053 001 Nov 22, 2000
AB EQ 75MG BASE A065053 003 Sep 10, 2003
AB EQ 100MG BASE A065053 002 Nov 22, 2000
AB SANDOZ EQ 50MG BASE A065032 001 Jun 30, 2000
AB EQ 100MG BASE A065032 002 Jun 30, 2000
AB WATSON LABS EQ 50MG BASE A065041 001 Apr 28, 2000
AB EQ 100MG BASE A065041 002 Apr 28, 2000
MONODOX
AB WATSON PHARMS EQ 50MG BASE N050641 002 Feb 10, 1992
AB EQ 75MG BASE N050641 003 Oct 18, 2006
AB + EQ 100MG BASE N050641 001 Dec 29, 1989
DOXYCYCLINE
XX + PAR PHARM EQ 150MG BASE A065055 003 Jul 15, 2005
ORACEA
XX + GALDERMA LABS LP 40MG N050805 001 May 26, 2006
FOR SUSPENSION; ORAL
DOXYCYCLINE
AB IVAX SUB TEVA PHARMS EQ 25MG BASE/5ML A065454 001 Jul 16, 2008
VIBRAMYCIN
AB + PFIZER EQ 25MG BASE/5ML N050006 001
TABLET; ORAL
DOXYCYCLINE
AB LANNETT EQ 50MG BASE A065285 001 Dec 08, 2005
AB EQ 75MG BASE A065285 003 Jul 30, 2008
AB EQ 100MG BASE A065285 002 Dec 08, 2005
AB EQ 150MG BASE A065285 004 Jul 30, 2008
AB MUTUAL PHARM EQ 50MG BASE A065471 001 Apr 17, 2009
AB EQ 75MG BASE A065471 002 Apr 17, 2009
AB EQ 100MG BASE A065471 003 Apr 17, 2009
AB MYLAN EQ 50MG BASE A065377 001 Nov 07, 2006
AB EQ 75MG BASE A065377 002 Nov 07, 2006
AB EQ 100MG BASE A065377 003 Nov 07, 2006
AB EQ 150MG BASE A065427 001 Jun 07, 2007
AB PAR PHARM EQ 50MG BASE A065070 001 Dec 15, 2000
AB EQ 75MG BASE A065070 003 Dec 30, 2002
AB EQ 100MG BASE A065070 002 Dec 15, 2000
AB + EQ 150MG BASE A065070 004 Jul 14, 2005
AB RANBAXY EQ 50MG BASE A065356 001 May 31, 2006
AB EQ 75MG BASE A065356 002 May 31, 2006
AB EQ 100MG BASE A065356 003 May 31, 2006
AB SANDOZ EQ 50MG BASE A065353 001 Nov 27, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 143 (of 393)

DOXYCYCLINE
TABLET; ORAL
DOXYCYCLINE
AB SANDOZ EQ 75MG BASE A065353 002 Nov 27, 2006
AB EQ 100MG BASE A065353 003 Nov 27, 2006

DOXYCYCLINE CALCIUM
SUSPENSION; ORAL

VIBRAMYCIN

XX + PFIZER EQ 50MG BASE/5ML N050480 001

DOXYCYCLINE HYCLATE
CAPSULE; ORAL
DOXYCYCLINE HYCLATE
AB IVAX SUB TEVA PHARMS EQ 50MG BASE A062500 001 Sep 11, 1984
AB EQ 100MG BASE A062500 002 Sep 11, 1984
AB MUTUAL PHARM EQ 50MG BASE A062675 001 Jul 10, 1986
AB EQ 100MG BASE A062676 001 Jul 10, 1986
AB WATSON LABS EQ 50MG BASE A062031 002 Oct 13, 1982
AB EQ 100MG BASE A062031 001
AB WEST WARD EQ 50MG BASE A062396 002 Nov 07, 1984
AB EQ 100MG BASE A062396 001 May 07, 1984
VIBRAMYCIN
AB PFIZER EQ 50MG BASE N050007 001
AB + EQ 100MG BASE N050007 002
DOXYCYCLINE HYCLATE
XX + WEST WARD EQ 20MG BASE A065103 001 May 13, 2005
CAPSULE, DELAYED RELEASE; ORAL
DOXYCYCLINE HYCLATE
XX SANDOZ EQ 75MG BASE A065281 001 Dec 21, 2005
XX + EQ 100MG BASE A065281 002 Dec 21, 2005
INJECTABLE; INJECTION
DOXY 100
AP + APP PHARMS EQ 100MG BASE/VIAL A062475 001 Dec 09, 1983
DOXYCYCLINE
AP + BEDFORD EQ 100MG BASE/VIAL A062569 001 Mar 09, 1988
DOXY 200
XX + APP PHARMS EQ 200MG BASE/VIAL A062475 002 Dec 09, 1983
SYSTEM, EXTENDED RELEASE; PERIODONTAL

ATRIDOX

XX + TOLMAR 50MG N050751 001 Sep 03, 1998


TABLET; ORAL
DOXYCYCLINE HYCLATE
AB COREPHARMA EQ 20MG BASE A065182 001 May 13, 2005
AB IVAX SUB TEVA PHARMS EQ 20MG BASE A065163 001 May 13, 2005
AB EQ 100MG BASE A062505 001 Sep 11, 1984
AB LANNETT EQ 20MG BASE A065277 001 Nov 10, 2005
AB MUTUAL PHARM EQ 100MG BASE A062677 001 Jul 10, 1986
AB MUTUAL PHARMA EQ 20MG BASE A065134 001 May 13, 2005
AB VINTAGE PHARMS EQ 100MG BASE A062538 001 Apr 07, 1986
AB WATSON LABS EQ 100MG BASE A062421 001 Feb 02, 1983
AB WEST WARD EQ 100MG BASE A065095 001 Jul 02, 2003
PERIOSTAT
AB + GALDERMA LABS LP EQ 20MG BASE N050783 001 Feb 02, 2001
VIBRA-TABS
AB + PFIZER EQ 100MG BASE N050533 001
TABLET, DELAYED RELEASE; ORAL
DORYX
XX MAYNE PHARMA INTL EQ 75MG BASE N050795 001 May 06, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 144 (of 393)

DOXYCYCLINE HYCLATE
TABLET, DELAYED RELEASE; ORAL
DORYX
XX MAYNE PHARMA INTL EQ 100MG BASE N050795 002 May 06, 2005
XX + EQ 150MG BASE N050795 003 Jun 20, 2008

DRONABINOL
CAPSULE; ORAL
DRONABINOL
AB SVC PHARMA 2.5MG A078292 001 Jun 27, 2008
AB 5MG A078292 002 Jun 27, 2008
AB 10MG A078292 003 Jun 27, 2008
MARINOL
AB UNIMED 2.5MG N018651 001 May 31, 1985
AB + 5MG N018651 002 May 31, 1985
AB 10MG N018651 003 May 31, 1985

DRONEDARONE HYDROCHLORIDE
TABLET; ORAL

MULTAQ

XX + SANOFI AVENTIS US EQ 400MG BASE N022425 001 Jul 01, 2009

DROPERIDOL
INJECTABLE; INJECTION
DROPERIDOL
AP HOSPIRA 2.5MG/ML A071981 001 Feb 29, 1988
AP LUITPOLD 2.5MG/ML A072123 001 Oct 24, 1988
AP 2.5MG/ML A072335 001 Oct 24, 1988
INAPSINE
AP + AKORN INC 2.5MG/ML N016796 001

DROSPIRENONE; ESTRADIOL
TABLET; ORAL

ANGELIQ

XX + BAYER HLTHCARE 0.5MG;1MG N021355 002 Sep 28, 2005

DROSPIRENONE; ETHINYL ESTRADIOL


TABLET; ORAL
DROSPIRENONE AND ETHINYL ESTRADIOL
AB BARR 3MG;0.02MG A078515 001 Mar 30, 2009
YAZ
AB + BAYER HLTHCARE 3MG;0.02MG N021676 001 Mar 16, 2006
TABLET; ORAL-28
DROSPIRENONE AND ETHINYL ESTRADIOL
AB BARR 3MG;0.03MG A077527 001 May 09, 2008
YASMIN
AB + BAYER HLTHCARE 3MG;0.03MG N021098 001 May 11, 2001

DULOXETINE HYDROCHLORIDE
CAPSULE, DELAYED REL PELLETS; ORAL
CYMBALTA
XX LILLY EQ 20MG BASE N021427 001 Aug 03, 2004
XX EQ 30MG BASE N021427 002 Aug 03, 2004
XX EQ 40MG BASE N021427 003 Nov 19, 2009
XX + EQ 60MG BASE N021427 004 Aug 03, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 145 (of 393)

DUTASTERIDE
CAPSULE; ORAL

AVODART

XX + GLAXOSMITHKLINE 0.5MG N021319 001 Nov 20, 2001

DYPHYLLINE
TABLET; ORAL

LUFYLLIN

XX MEDA PHARMS 200MG


A084566 001

XX + 400MG A084566 002

ECHOTHIOPHATE IODIDE
FOR SOLUTION; OPHTHALMIC

PHOSPHOLINE IODIDE

XX + WYETH PHARMS INC 0.125% N011963 001

ECONAZOLE NITRATE
CREAM; TOPICAL
ECONAZOLE NITRATE
AB + ALTANA 1% A076075 001 Nov 26, 2002
AB PERRIGO NEW YORK 1% A076479 001 Jun 23, 2004
AB PRASCO 1% A076574 001 Dec 17, 2004
AB TARO 1% A076005 001 Nov 26, 2002

EDETATE CALCIUM DISODIUM


INJECTABLE; INJECTION

CALCIUM DISODIUM VERSENATE


XX + GRACEWAY 200MG/ML N008922 001

EDROPHONIUM CHLORIDE
INJECTABLE; INJECTION
EDROPHONIUM CHLORIDE
AP HOSPIRA 10MG/ML A040131 001 Feb 24, 1998
ENLON
AP BIONICHE PHARMA 10MG/ML A088873 001 Aug 06, 1985
TENSILON
AP + VALEANT PHARM INTL 10MG/ML
N007959 001
TENSILON PRESERVATIVE FREE

AP + VALEANT PHARM INTL 10MG/ML


N007959 002

EFAVIRENZ
CAPSULE; ORAL

SUSTIVA

XX BRISTOL MYERS SQUIBB 50MG


N020972 001 Sep 17, 1998
XX + 200MG N020972 003 Sep 17, 1998
TABLET; ORAL

SUSTIVA

XX + BRISTOL MYERS SQUIBB 600MG N021360 002 Feb 01, 2002

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE


TABLET; ORAL

ATRIPLA

XX + GILEAD 600MG;200MG;300MG N021937 001 Jul 12, 2006

EFLORNITHINE HYDROCHLORIDE
CREAM; TOPICAL

VANIQA

XX + SKINMEDICA 13.9% N021145 001 Jul 27, 2000


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 146 (of 393)

ELETRIPTAN HYDROBROMIDE
TABLET; ORAL
RELPAX
XX PFIZER IRELAND EQ 20MG BASE N021016 001 Dec 26, 2002
XX + EQ 40MG BASE N021016 002 Dec 26, 2002

ELTROMBOPAG OLAMINE
TABLET; ORAL
PROMACTA
XX GLAXOSMITHKLINE EQ 25MG ACID N022291 001 Nov 20, 2008
XX + EQ 50MG ACID N022291 002 Nov 20, 2008

EMEDASTINE DIFUMARATE
SOLUTION/DROPS; OPHTHALMIC

EMADINE

XX + ALCON 0.05% N020706 001 Dec 29, 1997

EMTRICITABINE
CAPSULE; ORAL

EMTRIVA

XX + GILEAD 200MG N021500 001 Jul 02, 2003


SOLUTION; ORAL

EMTRIVA

XX + GILEAD 10MG/ML N021896 001 Sep 28, 2005

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE


TABLET; ORAL

TRUVADA

XX + GILEAD 200MG;300MG N021752 001 Aug 02, 2004

ENALAPRIL MALEATE
TABLET; ORAL
ENALAPRIL MALEATE
AB APOTEX 2.5MG A075178 002 Mar 23, 2001
AB 5MG A075178 001 Mar 23, 2001
AB 10MG A075178 003 Mar 23, 2001
AB 20MG A075178 004 Mar 23, 2001
AB GENPHARM 2.5MG A075472 001 Aug 22, 2000
AB 5MG A075472 002 Aug 22, 2000
AB 10MG A075472 003 Aug 22, 2000
AB 20MG A075472 004 Aug 22, 2000
AB KRKA DD NOVO MESTO 2.5MG A075370 001 Aug 22, 2000
AB 5MG A075370 002 Aug 22, 2000
AB 10MG A075369 001 Aug 22, 2000
AB 20MG A075369 002 Aug 22, 2000
AB LEK PHARMS 2.5MG A075496 001 Aug 22, 2000
AB 5MG A075496 002 Aug 22, 2000
AB 10MG A075459 001 Aug 22, 2000
AB 20MG A075459 002 Aug 22, 2000
AB MYLAN 2.5MG A075480 001 Aug 22, 2000
AB 5MG A075480 002 Aug 22, 2000
AB 10MG A075480 003 Aug 22, 2000
AB 20MG A075480 004 Aug 22, 2000
AB RANBAXY 2.5MG A075556 001 Aug 22, 2000
AB 5MG A075556 002 Aug 22, 2000
AB 10MG A075556 003 Aug 22, 2000
AB 20MG A075556 004 Aug 22, 2000
AB SANDOZ 2.5MG A075621 001 Aug 22, 2000
AB 5MG A075621 002 Aug 22, 2000
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 147 (of 393)

ENALAPRIL MALEATE
TABLET; ORAL
ENALAPRIL MALEATE
AB SANDOZ 10MG A075621 003 Aug 22, 2000
AB 20MG A075621 004 Aug 22, 2000
AB TARO 2.5MG A075657 001 Jan 23, 2001
AB 5MG A075657 002 Jan 23, 2001
AB 10MG A075657 003 Jan 23, 2001
AB 20MG A075657 004 Jan 23, 2001
AB TEVA 2.5MG A075479 001 Aug 22, 2000
AB 5MG A075479 002 Aug 22, 2000
AB 10MG A075479 003 Aug 22, 2000
AB 20MG A075479 004 Aug 22, 2000
AB WATSON LABS 2.5MG A075501 001 Aug 22, 2000
AB 5MG A075501 002 Aug 22, 2000
AB 10MG A075501 003 Aug 22, 2000
AB 20MG A075501 004 Aug 22, 2000
AB WOCKHARDT 2.5MG A075483 001 Aug 22, 2000
AB 5MG A075483 002 Aug 22, 2000
AB 10MG A075483 003 Aug 22, 2000
AB 20MG A075483 004 Aug 22, 2000
VASOTEC
AB BIOVAIL LABS INTL 2.5MG N018998 005 Jul 26, 1988
AB 5MG N018998 001 Dec 24, 1985
AB 10MG N018998 002 Dec 24, 1985
AB + 20MG N018998 003 Dec 24, 1985

ENALAPRIL MALEATE; FELODIPINE


TABLET, EXTENDED RELEASE; ORAL

LEXXEL

XX + ASTRAZENECA 5MG;5MG N020668 001 Dec 27, 1996

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE


TABLET; ORAL
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
AB APOTEX INC 5MG;12.5MG A076486 001 Oct 27, 2004
AB 10MG;25MG A076486 002 Oct 27, 2004
AB DR REDDYS LABS LTD 5MG;12.5MG A075909 001 Oct 15, 2001
AB 10MG;25MG A075909 002 Oct 15, 2001
AB MYLAN 5MG;12.5MG A075624 001 Sep 18, 2001
AB 10MG;25MG A075624 002 Sep 18, 2001
AB SANDOZ 5MG;12.5MG A076116 001 Sep 19, 2001
AB 10MG;25MG A076116 002 Sep 19, 2001
AB TARO PHARM INDS 5MG;12.5MG A075788 001 Sep 18, 2001
AB 10MG;25MG A075788 002 Sep 18, 2001
AB TEVA 5MG;12.5MG A075727 001 Sep 18, 2001
AB 10MG;25MG A075727 002 Sep 18, 2001
VASERETIC
AB BIOVAIL LABS INTL 5MG;12.5MG N019221 003 Jul 12, 1995
AB + 10MG;25MG N019221 001 Oct 31, 1986

ENALAPRILAT
INJECTABLE; INJECTION
ENALAPRILAT
AP + BEDFORD 1.25MG/ML A075634 001 Aug 22, 2000
AP HIKMA FARMACEUTICA 1.25MG/ML A078687 001 Dec 23, 2008
AP + HOSPIRA 1.25MG/ML A075458 001 Aug 22, 2000
AP TEVA PARENTERAL 1.25MG/ML A075578 001 Aug 22, 2000
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 148 (of 393)

ENFLURANE
LIQUID; INHALATION
ENFLURANE
AN MINRAD 99.9% A074396 001 Jul 29, 1994
ETHRANE
AN + BAXTER HLTHCARE CORP 99.9% N017087 001

ENFUVIRTIDE
INJECTABLE; SUBCUTANEOUS

FUZEON

XX + ROCHE 90MG/VIAL N021481 001 Mar 13, 2003

ENOXAPARIN SODIUM
INJECTABLE; SUBCUTANEOUS
LOVENOX
XX SANOFI AVENTIS US 300MG/3ML (100MG/ML) N020164 009 Jan 23, 2003
LOVENOX (PRESERVATIVE FREE)
XX SANOFI AVENTIS US 30MG/0.3ML (100MG/ML) N020164 001 Mar 29, 1993
XX 40MG/0.4ML (100MG/ML) N020164 002 Jan 30, 1998
XX 60MG/0.6ML (100MG/ML) N020164 003 Mar 27, 1998
XX 80MG/0.8ML (100MG/ML) N020164 004 Mar 27, 1998
XX + 100MG/ML (100MG/ML) N020164 005 Mar 27, 1998
XX 120MG/0.8ML (150MG/ML) N020164 007 Jun 02, 2000
XX 150MG/ML (150MG/ML) N020164 008 Jun 02, 2000

ENTACAPONE
TABLET; ORAL

COMTAN

XX + ORION 200MG N020796 001 Oct 19, 1999

ENTECAVIR
SOLUTION; ORAL

BARACLUDE

XX + BRISTOL MYERS SQUIBB 0.05MG/ML N021798 001 Mar 29, 2005


TABLET; ORAL

BARACLUDE

XX BRISTOL MYERS SQUIBB 0.5MG


N021797 001 Mar 29, 2005
XX + 1MG
N021797 002 Mar 29, 2005

EPINASTINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC

ELESTAT

XX + ALLERGAN 0.05% N021565 001 Oct 16, 2003

EPINEPHRINE
INJECTABLE; IM-SC

TWINJECT 0.15

XX + SCIELE PHARMA INC EQ 0.15MG /DELIVERY N020800 002 May 28, 2004
TWINJECT 0.3
XX + SCIELE PHARMA INC EQ 0.3MG /DELIVERY N020800 001 May 30, 2003
INJECTABLE; INTRAMUSCULAR

EPIPEN

XX + MERIDIAN MEDCL TECHN 0.3MG/DELIVERY N019430 001 Dec 22, 1987


EPIPEN JR.
XX + MERIDIAN MEDCL TECHN 0.15MG/DELIVERY N019430 002 Dec 22, 1987
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 149 (of 393)

EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE


INJECTABLE; INJECTION

LIGNOSPAN FORTE

XX + DEPROCO EQ 0.02MG BASE/ML;2% A088389 001 Jan 22, 1985


LIGNOSPAN STANDARD
XX + DEPROCO EQ 0.01MG BASE/ML;2% A088390 001 Jan 22, 1985

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE


INJECTABLE; INJECTION

CITANEST FORTE DENTAL


XX + DENTSPLY PHARM 0.005MG/ML;4% N021383 001

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE


INJECTABLE; INJECTION
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
AP EASTMAN KODAK 0.01MG/ML;2% A040057 002 Feb 26, 1993
AP 0.02MG/ML;2% A040057 001 Feb 26, 1993
AP HOSPIRA 0.005MG/ML;0.5% A089635 001 Jun 21, 1988
AP 0.005MG/ML;1% A089649 001 Jun 21, 1988
AP 0.005MG/ML;1.5% A088571 001 Sep 13, 1985
AP 0.005MG/ML;1.5% A089645 001 Jun 21, 1988
AP 0.005MG/ML;2% A089651 001 Jun 21, 1988
AP 0.01MG/ML;1% A089644 001 Jun 21, 1988
AP 0.01MG/ML;2% A078772 001 May 12, 2008
AP 0.01MG/ML;2% A089646 001 Jun 21, 1988
AP 0.02MG/ML;2% A078772 002 May 12, 2008
OCTOCAINE
AP SEPTODONT 0.01MG/ML;2% A084048 001
AP + 0.02MG/ML;2% A084048 002
XYLOCAINE DENTAL WITH EPINEPHRINE
AP + DENTSPLY PHARM 0.01MG/ML;2% N021381 001
AP + 0.02MG/ML;2% N021381 002
XYLOCAINE W/ EPINEPHRINE
AP + APP PHARMS 0.005MG/ML;0.5% N006488 012
AP + 0.005MG/ML;1% N006488 018 Nov 13, 1986
AP + 0.005MG/ML;1.5% N006488 017
AP + 0.005MG/ML;2% N006488 019 Nov 13, 1986
AP + 0.01MG/ML;1% N006488 004
AP + 0.02MG/ML;2% N006488 005

EPIRUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION
ELLENCE
AP + PFIZER INC 200MG/100ML (2MG/ML) N050778 001 Sep 15, 1999
AP 50MG/25ML (2MG/ML) N050778 002 Sep 15, 1999
EPIRUBICIN HYDROCHLORIDE
AP ACTAVIS TOTOWA 10MG/5ML (2MG/ML) A065445 001 Sep 18, 2008
AP 50MG/25ML (2MG/ML) A065445 002 Sep 18, 2008
AP 200MG/100ML (2MG/ML) A065445 003 Sep 18, 2008
AP AKORN INC 50MG/25ML (2MG/ML) A090163 001 Jun 24, 2009
AP APP PHARMS 150MG/75ML (2MG/ML) A065408 003 Oct 15, 2007
AP 50MG/25ML (2MG/ML) A065408 002 Oct 15, 2007
AP 200MG/100ML (2MG/ML) A065408 004 Oct 15, 2007
AP 10MG/5ML (2MG/ML) A065408 001 Oct 15, 2007
AP BEDFORD 50MG/25ML (2MG/ML) A065289 001 Jun 27, 2007
AP 200MG/100ML (2MG/ML) A065289 002 Jun 27, 2007
AP EBEWE PHARMA 50MG/25ML (2MG/ML) A065339 001 Dec 22, 2009
AP 200MG/100ML (2MG/ML) A065339 002 Dec 22, 2009
AP FRESENIUS KABI ONCOL 50MG/25ML (2MG/ML) A065411 002 Aug 20, 2007
AP 200MG/100ML (2MG/ML) A065411 001 Aug 20, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 150 (of 393)

EPIRUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION
EPIRUBICIN HYDROCHLORIDE
AP GENERAMEDIX 50MG/25ML (2MG/ML) A065371 001 Nov 28, 2007
AP 200MG/100ML (2MG/ML) A065371 002 Nov 28, 2007
AP HOSPIRA 10MG/5ML (2MG/ML) A065343 001 Apr 19, 2007
AP 200MG/100ML (2MG/ML) A065343 004 Apr 19, 2007
AP 150MG/75ML (2MG/ML) A065343 003 Apr 19, 2007
AP 50MG/25ML (2MG/ML) A065343 002 Apr 19, 2007
AP TEVA PARENTERAL 50MG/25ML (2MG/ML) A065331 001 Aug 09, 2007
AP 200MG/100ML (2MG/ML) A065331 002 Aug 09, 2007
AP WATSON LABS 200MG/100ML (2MG/ML) A065361 002 Oct 22, 2007
AP 50MG/25ML (2MG/ML) A065361 001 Oct 22, 2007
INJECTABLE; IV (INFUSION)

EPIRUBICIN HYDROCHLORIDE

XX + HOSPIRA 50MG/VIAL N050807 001 Sep 15, 2006

EPLERENONE
TABLET; ORAL
EPLERENONE
AB APOTEX 25MG A078482 001 Jul 30, 2008
AB 50MG A078482 002 Jul 30, 2008
AB SANDOZ 25MG A078510 001 Aug 01, 2008
AB 50MG A078510 002 Aug 01, 2008
INSPRA
AB GD SEARLE LLC 25MG N021437 001 Sep 27, 2002
AB + 50MG N021437 002 Sep 27, 2002

EPOPROSTENOL SODIUM
INJECTABLE; INJECTION
EPOPROSTENOL SODIUM
AP TEVA PARENTERAL EQ 0.5MG BASE/VIAL A078396 001 Apr 23, 2008
AP EQ 1.5MG BASE/VIAL A078396 002 Apr 23, 2008
FLOLAN
AP + GLAXOSMITHKLINE EQ 0.5MG BASE/VIAL N020444 001 Sep 20, 1995
AP + EQ 1.5MG BASE/VIAL N020444 002 Sep 20, 1995
EPOPROSTENOL SODIUM
XX + ACTELION EQ 1.5MG BASE/VIAL N022260 001 Jun 27, 2008

EPROSARTAN MESYLATE
TABLET; ORAL
TEVETEN
XX ABBOTT EQ 400MG BASE N020738 005 Dec 22, 1997
XX + EQ 600MG BASE N020738 006 May 27, 1999

EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE


TABLET; ORAL
TEVETEN HCT
XX ABBOTT 600MG;12.5MG N021268 001 Nov 01, 2001
XX + 600MG;25MG N021268 002 Nov 01, 2001

EPTIFIBATIDE
INJECTABLE; INJECTION

INTEGRILIN

XX + SCHERING 2MG/ML N020718 001 May 18, 1998


XX + 75MG/100ML N020718 002 May 18, 1998
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 151 (of 393)

ERGOCALCIFEROL
CAPSULE; ORAL
DRISDOL
AA + SANOFI AVENTIS US 50,000 IU N003444 001
ERGOCALCIFEROL
AA ORIT LABS LLC 50,000 IU A040833 001 May 20, 2009
AA SUN PHARM INDS INC 50,000 IU A040865 001 Dec 29, 2009
VITAMIN D
AA BANNER PHARMACAPS 50,000 IU A080704 001

ERGOLOID MESYLATES
TABLET; ORAL
ERGOLOID MESYLATES
AB MUTUAL PHARM 1MG A081113 001 Oct 31, 1991
HYDERGINE
AB + NOVARTIS 1MG N017993 001
TABLET; SUBLINGUAL

ERGOLOID MESYLATES

XX WATSON LABS 0.5MG A087233 001


ERGOTAMINE TARTRATE
TABLET; SUBLINGUAL

ERGOMAR

XX + ROSEDALE THERAPEUTIC 2MG A087693 001 Feb 24, 1983

ERLOTINIB HYDROCHLORIDE
TABLET; ORAL
TARCEVA
XX OSI PHARMS EQ 25MG BASE N021743 001 Nov 18, 2004
XX EQ 100MG BASE N021743 002 Nov 18, 2004
XX + EQ 150MG BASE N021743 003 Nov 18, 2004

ERTAPENEM SODIUM
INJECTABLE; INTRAMUSCULAR, IV (INFUSION)

INVANZ

XX + MERCK EQ 1GM BASE/VIAL N021337 001 Nov 21, 2001

ERYTHROMYCIN
CAPSULE, DELAYED REL PELLETS; ORAL
ERYC
AB + HOSPIRA 250MG N050536 001
AB WARNER CHILCOTT 250MG A062338 001
ERYTHROMYCIN
AB ABBOTT 250MG A062746 001 Dec 22, 1986
GEL; TOPICAL
E-GLADES
AT STIEFEL LABS INC 2% A065009 001 Mar 18, 2002
ERYGEL
AT + MERZ PHARMS 2% N050617 001 Oct 21, 1987
ERYTHROMYCIN
AT ALTANA 2% A064184 001 Sep 30, 1997
AT PERRIGO 2% A063211 001 Jan 29, 1993
OINTMENT; OPHTHALMIC
ERYTHROMYCIN
AT BAUSCH AND LOMB 0.5% A064067 001 Jul 29, 1994
AT + FOUGERA 0.5% A062447 001 Sep 26, 1983
OINTMENT; TOPICAL

AKNE-MYCIN

XX + DOW PHARM SCIENCES 2% N050584 001 Jan 10, 1985


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 152 (of 393)

ERYTHROMYCIN
SOLUTION; TOPICAL
ERYTHRA-DERM
AT PADDOCK 2% A062687 001 Feb 05, 1988
ERYTHROMYCIN
AT + ALTANA 2% A064187 001 Sep 30, 1997
AT MORTON GROVE 2% A062825 001 Oct 23, 1987
AT PERRIGO NEW YORK 2% A063038 001 Jan 11, 1991
ERYTHRO-STATIN
AT HI TECH PHARMA 2% A064101 001 Oct 22, 1996
SWAB; TOPICAL
ERYTHROMYCIN
AT + ALTANA 2% A065320 001 Jul 25, 2006
AT + PERRIGO 2% A064126 001 Jul 03, 1996
TABLET; ORAL

ERYTHROMYCIN

XX ABBOTT 250MG A061621 001


XX + 500MG A061621 002


TABLET, COATED PARTICLES; ORAL
PCE
XX ABBOTT 333MG N050611 001 Sep 09, 1986
XX + 500MG N050611 002 Aug 22, 1990
TABLET, DELAYED RELEASE; ORAL

ERY-TAB

XX + ABBOTT 250MG A062298 001


XX + 333MG A062298 003 Mar 29, 1982
XX + 500MG A062298 002

ERYTHROMYCIN ETHYLSUCCINATE
GRANULE; ORAL
E.E.S.
AB ABBOTT EQ 200MG BASE/5ML N050207 001
ERYPED
AB ABBOTT EQ 200MG BASE/5ML N050207 003 Mar 30, 1987
ERYPED
XX + ABBOTT EQ 400MG BASE/5ML N050207 002
SUSPENSION; ORAL
E.E.S. 200
AB ABBOTT EQ 200MG BASE/5ML A061639 001
E.E.S. 400
AB + ABBOTT EQ 400MG BASE/5ML A061639 002
PEDIAMYCIN
AB ROSS LABS EQ 200MG BASE/5ML A062304 001
PEDIAMYCIN 400
AB ROSS LABS EQ 400MG BASE/5ML A062304 002
TABLET; ORAL
E.E.S. 400
XX + ABBOTT EQ 400MG BASE A061905 002 Aug 12, 1982

ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL


GRANULE; ORAL

ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL


XX + BARR EQ 200MG BASE/5ML;EQ 600MG BASE/5ML A062759 001 May 20, 1988

ERYTHROMYCIN LACTOBIONATE
INJECTABLE; INJECTION
ERYTHROCIN
AP HOSPIRA EQ 500MG BASE/VIAL A062638 001 Oct 31, 1986
AP + EQ 500MG BASE/VIAL N050609 001 Sep 24, 1986
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 153 (of 393)

ERYTHROMYCIN LACTOBIONATE
INJECTABLE; INJECTION
ERYTHROCIN
AP + HOSPIRA EQ 1GM BASE/VIAL A062638 002 Oct 31, 1986
ERYTHROMYCIN LACTOBIONATE
AP TEVA PARENTERAL EQ 500MG BASE/VIAL A063253 001 Jul 30, 1993
AP EQ 1GM BASE/VIAL A063253 002 Jul 30, 1993

ERYTHROMYCIN STEARATE
TABLET; ORAL

ERYTHROCIN STEARATE

XX ABBOTT EQ 250MG BASE A060359 001


XX + EQ 500MG BASE A060359 003

ESCITALOPRAM OXALATE
CAPSULE; ORAL
ESCITALOPRAM OXALATE
XX ALPHAPHARM EQ 5MG BASE A077660 001 Jul 31, 2007
XX EQ 10MG BASE A077660 002 Jul 31, 2007
XX + EQ 20MG BASE A077660 003 Jul 31, 2007
SOLUTION; ORAL

LEXAPRO

XX + FOREST LABS EQ 5MG BASE/5ML N021365 001 Nov 27, 2002


TABLET; ORAL
LEXAPRO
XX FOREST LABS EQ 5MG BASE N021323 001 Aug 14, 2002
XX EQ 10MG BASE N021323 002 Aug 14, 2002
XX + EQ 20MG BASE N021323 003 Aug 14, 2002

ESMOLOL HYDROCHLORIDE
INJECTABLE; INJECTION
BREVIBLOC
AP + BAXTER HLTHCARE CORP 10MG/ML N019386 006 Feb 25, 2003
ESMOLOL HYDROCHLORIDE
AP APP PHARMS 10MG/ML A076573 001 May 02, 2005
AP BEDFORD LABS 10MG/ML A076323 001 Aug 10, 2004
AP BIONICHE PHARMA 10MG/ML A076474 001 May 02, 2005
BREVIBLOC
XX + BAXTER HLTHCARE CORP 20MG/ML N019386 007 May 28, 2003
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE CORP 2GM/100ML N019386 005 Jan 27, 2003
BREVIBLOC IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE CORP 1GM/100ML N019386 004 Feb 16, 2001

ESOMEPRAZOLE MAGNESIUM
CAPSULE, DELAYED REL PELLETS; ORAL
NEXIUM
XX ASTRAZENECA EQ 20MG BASE N021153 001 Feb 20, 2001
XX + EQ 40MG BASE N021153 002 Feb 20, 2001
FOR SUSPENSION, DELAYED RELEASE; ORAL
NEXIUM
XX ASTRAZENECA EQ 10MG BASE/PACKET N022101 001 Feb 27, 2008
XX EQ 20MG BASE/PACKET N021957 001 Oct 20, 2006
XX + EQ 40MG BASE/PACKET N021957 002 Oct 20, 2006

ESOMEPRAZOLE SODIUM
INJECTABLE; INTRAVENOUS

NEXIUM IV

XX + ASTRAZENECA EQ 20MG BASE/VIAL N021689 001 Mar 31, 2005


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 154 (of 393)

ESOMEPRAZOLE SODIUM
INJECTABLE; INTRAVENOUS

NEXIUM IV

XX + ASTRAZENECA EQ 40MG BASE/VIAL N021689 002 Mar 31, 2005

ESTAZOLAM
TABLET; ORAL
ESTAZOLAM
AB PAR PHARM 1MG A074826 001 Jul 03, 1997
AB 2MG A074826 002 Jul 03, 1997
AB TEVA 1MG A074921 001 Jul 10, 1997
AB + 2MG A074921 002 Jul 10, 1997
AB WATSON LABS 1MG A074818 001 Aug 19, 1997
AB 2MG A074818 002 Aug 19, 1997

ESTRADIOL
CREAM; VAGINAL

ESTRACE

XX + WARNER CHILCOTT 0.01% A086069 001 Jan 31, 1984


FILM, EXTENDED RELEASE; TRANSDERMAL
CLIMARA
AB BAYER HLTHCARE 0.0375MG/24HR N020375 005 May 27, 2003
AB 0.06MG/24HR N020375 006 May 27, 2003
ESTRADIOL
AB MYLAN TECHNOLOGIES 0.0375MG/24HR A075182 004 Jul 20, 2006
AB 0.06MG/24HR A075182 005 Jul 20, 2006
VIVELLE
AB1 NOVARTIS 0.05MG/24HR N020323 002 Oct 28, 1994
AB1 0.1MG/24HR N020323 004 Oct 28, 1994
VIVELLE-DOT
AB1 NOVARTIS 0.05MG/24HR N020538 006 Jan 08, 1999
AB1 + 0.1MG/24HR N020538 008 Jan 08, 1999
CLIMARA
AB2 BAYER HLTHCARE 0.025MG/24HR N020375 004 Mar 05, 1999
AB2 0.05MG/24HR N020375 001 Dec 22, 1994
AB2 0.075MG/24HR N020375 003 Mar 23, 1998
AB2 + 0.1MG/24HR N020375 002 Dec 22, 1994
ESTRADIOL
AB2 MYLAN TECHNOLOGIES 0.025MG/24HR A075182 003 Jan 26, 2005
AB2 0.05MG/24HR A075182 006 Feb 24, 2000
AB2 0.075MG/24HR A075182 002 Jan 26, 2005
AB2 0.1MG/24HR A075182 001 Feb 24, 2000
ALORA
BX WATSON LABS 0.025MG/24HR N020655 004 Apr 05, 2002
BX 0.05MG/24HR N020655 001 Dec 20, 1996
BX 0.075MG/24HR N020655 002 Dec 20, 1996
BX 0.1MG/24HR N020655 003 Dec 20, 1996
ESTRADERM
BX NOVARTIS 0.05MG/24HR N019081 002 Sep 10, 1986
BX + 0.1MG/24HR N019081 003 Sep 10, 1986
VIVELLE-DOT
BX NOVARTIS 0.025MG/24HR N020538 009 May 03, 2002
BX 0.0375MG/24HR N020538 005 Jan 08, 1999
BX 0.075MG/24HR N020538 007 Jan 08, 1999
MENOSTAR
XX + BAYER HLTHCARE 0.014MG/24HR N021674 001 Jun 08, 2004
GEL; TRANSDERMAL
DIVIGEL
XX UPSHER SMITH 0.1% (0.25GM/PACKET) N022038 001 Jun 04, 2007
XX 0.1% (0.5GM/PACKET) N022038 002 Jun 04, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 155 (of 393)

ESTRADIOL
GEL; TRANSDERMAL

DIVIGEL

XX + UPSHER SMITH 0.1% (1GM/PACKET) N022038 003 Jun 04, 2007


GEL, METERED; TRANSDERMAL

ELESTRIN

XX + AZUR PHARMA II 0.06% (0.87GM/ACTIVATION) N021813 001 Dec 15, 2006


ESTROGEL
XX + ASCEND 0.06% (1.25GM/ACTIVATION) N021166 002 Feb 09, 2004
INSERT, EXTENDED RELEASE; VAGINAL

ESTRING

XX + PHARMACIA AND UPJOHN 0.0075MG/24HR N020472 001 Apr 26, 1996


SPRAY; TRANSDERMAL

EVAMIST

XX + KV PHARM 1.53MG/SPRAY N022014 001 Jul 27, 2007


TABLET; ORAL
ESTRACE
AB BRISTOL MYERS SQUIBB 0.5MG A081295 001 Jun 30, 1993
AB 1MG A084499 001
AB + 2MG A084500 001
ESTRADIOL
AB BARR 0.5MG A040197 001 Oct 22, 1997
AB 1MG A040197 002 Oct 22, 1997
AB 2MG A040197 003 Oct 22, 1997
AB MYLAN 0.5MG A040326 001 Apr 21, 1999
AB 1MG A040326 002 Apr 21, 1999
AB 2MG A040326 003 Apr 21, 1999
AB USL PHARMA 0.5MG A040297 001 Apr 17, 2002
AB 1MG A040297 002 Apr 17, 2002
AB 2MG A040297 003 Apr 17, 2002
AB WATSON LABS 0.5MG A040114 003 Mar 14, 1996
AB 1MG A040114 001 Mar 14, 1996
AB 2MG A040114 002 Mar 14, 1996
TABLET; VAGINAL
VAGIFEM
XX NOVO NORDISK INC 10MCG N020908 002 Nov 25, 2009
XX + 25MCG N020908 001 Mar 26, 1999

ESTRADIOL ACETATE
INSERT, EXTENDED RELEASE; VAGINAL
FEMRING
XX GALEN LTD EQ 0.05MG BASE/24HR N021367 001 Mar 20, 2003
XX + EQ 0.1MG BASE/24HR N021367 002 Mar 20, 2003
TABLET; ORAL
FEMTRACE
XX WARNER CHILCOTT 0.45MG N021633 001 Aug 20, 2004
XX 0.9MG N021633 002 Aug 20, 2004
XX + 1.8MG N021633 003 Aug 20, 2004

ESTRADIOL CYPIONATE
INJECTABLE; INJECTION
DEPO-ESTRADIOL
AO + PHARMACIA AND UPJOHN 5MG/ML A085470 003
ESTRADIOL CYPIONATE
AO WATSON LABS 5MG/ML A085620 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 156 (of 393)

ESTRADIOL HEMIHYDRATE
EMULSION; TOPICAL

ESTRASORB

XX + GRACEWAY 0.25% N021371 001 Oct 09, 2003

ESTRADIOL VALERATE
INJECTABLE; INJECTION
DELESTROGEN
AO + JHP PHARMS 10MG/ML N009402 002
AO + 20MG/ML N009402 004
AO + 40MG/ML N009402 003
ESTRADIOL VALERATE
AO SANDOZ 10MG/ML A040628 001 Oct 04, 2007
AO 20MG/ML A040628 002 Oct 04, 2007
AO 40MG/ML A040628 003 Oct 04, 2007
AO WATSON LABS 20MG/ML A083547 001
AO 40MG/ML A083714 001

ESTRADIOL; LEVONORGESTREL
FILM, EXTENDED RELEASE; TRANSDERMAL

CLIMARA PRO

XX + BAYER HLTHCARE 0.045MG/24HR;0.015MG/24HR N021258 001 Nov 21, 2003

ESTRADIOL; NORETHINDRONE ACETATE


FILM, EXTENDED RELEASE; TRANSDERMAL
COMBIPATCH
XX NOVARTIS 0.05MG/24HR;0.14MG/24HR N020870 001 Aug 07, 1998
XX + 0.05MG/24HR;0.25MG/24HR N020870 002 Aug 07, 1998
TABLET; ORAL
ACTIVELLA
AB + NOVO NORDISK INC 1MG;0.5MG N020907 001 Nov 18, 1998
ESTRADIOL AND NORETHINDRONE ACETATE
AB BRECKENRIDGE PHARM 1MG;0.5MG A078324 001 Apr 17, 2008
ACTIVELLA
XX NOVO NORDISK INC 0.5MG;0.1MG N020907 002 Dec 28, 2006

ESTRADIOL; NORGESTIMATE
TABLET; ORAL
ESTRADIOL AND NORGESTIMATE
AB BARR 1MG,1MG;N/A,0.09MG A076812 001 Apr 29, 2005
PREFEST
AB + DURAMED RES 1MG,1MG;N/A,0.09MG N021040 001 Oct 22, 1999

ESTRAMUSTINE PHOSPHATE SODIUM


CAPSULE; ORAL

EMCYT

XX + PHARMACIA AND UPJOHN EQ 140MG PHOSPHATE N018045 001

ESTROGENS, CONJUGATED
CREAM; TOPICAL, VAGINAL

PREMARIN

XX + WYETH PHARMS INC 0.625MG/GM N020216 001


INJECTABLE; INJECTION

PREMARIN

XX + WYETH PHARMS INC 25MG/VIAL N010402 001


TABLET; ORAL
PREMARIN
XX WYETH PHARMS INC 0.3MG N004782 003
XX 0.45MG N004782 006 Jul 16, 2003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 157 (of 393)

ESTROGENS, CONJUGATED
TABLET; ORAL

PREMARIN

XX + WYETH PHARMS INC 0.625MG N004782 004


XX + 0.9MG N004782 005 Jan 26, 1984
XX + 1.25MG N004782 001

ESTROGENS, CONJUGATED SYNTHETIC A


CREAM; VAGINAL

SYNTHETIC CONJUGATED ESTROGENS A


XX + DURAMED RES 0.625MG/GM N021788 001 Nov 28, 2008


TABLET; ORAL
CENESTIN
XX DURAMED 0.3MG N020992 001 Jun 21, 2002
XX 0.45MG N020992 005 Feb 05, 2004
XX 0.625MG N020992 002 Mar 24, 1999
XX 0.9MG N020992 003 Mar 24, 1999
XX + 1.25MG N020992 004 Mar 13, 2000

ESTROGENS, CONJUGATED SYNTHETIC B


TABLET; ORAL
ENJUVIA
XX DURAMED 0.3MG N021443 001 Dec 20, 2004
XX 0.45MG N021443 002 Dec 20, 2004
XX 0.625MG N021443 003 May 10, 2004
XX 0.9MG N021443 005 Apr 27, 2007
XX + 1.25MG N021443 004 May 10, 2004

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE


TABLET; ORAL-28

PREMPHASE 14/14

XX + WYETH PHARMS INC 0.625MG,0.625MG;N/A,5MG N020527 002 Nov 17, 1995


PREMPRO
XX + WYETH PHARMS INC 0.3MG;1.5MG N020527 005 Jun 04, 2003
XX + 0.45MG;1.5MG N020527 004 Mar 12, 2003
XX + 0.625MG;2.5MG N020527 001 Nov 17, 1995
XX + 0.625MG;5MG N020527 003 Jan 09, 1998

ESTROGENS, ESTERIFIED
TABLET; ORAL

MENEST

XX MONARCH PHARMS 0.3MG A084951 001


XX 0.625MG A084948 001


XX 1.25MG A084950 001


XX + 2.5MG A084949 001

ESTRONE
INJECTABLE; INJECTION

ESTRONE

XX + WATSON LABS 5MG/ML A085239 001

ESTROPIPATE
CREAM; VAGINAL

OGEN

XX + PHARMACIA AND UPJOHN 1.5MG/GM A084710 001


TABLET; ORAL
ESTROPIPATE
AB BARR 0.75MG A040135 001 Nov 27, 1996

AB 1.5MG A040135 002 Nov 27, 1996


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 158 (of 393)

ESTROPIPATE
TABLET; ORAL
ESTROPIPATE
AB BARR 3MG A040135 003 Nov 27, 1996
AB MYLAN 0.75MG A040359 001 Aug 26, 1999
AB 1.5MG A040359 002 Aug 26, 1999
AB WATSON LABS 0.75MG A081213 001 Sep 23, 1993
AB 1.5MG A081214 001 Sep 23, 1993
AB 3MG A081215 001 Sep 23, 1993
AB 6MG A081216 001 Sep 23, 1993
OGEN .625
AB PHARMACIA AND UPJOHN 0.75MG A083220 001
OGEN 1.25
AB PHARMACIA AND UPJOHN 1.5MG A083220 002
OGEN 2.5
AB + PHARMACIA AND UPJOHN 3MG A083220 003
OGEN 5
AB PHARMACIA AND UPJOHN 6MG A083220 004
ORTHO-EST
AB SUN PHARM INDS (IN) 0.75MG A089567 001 Feb 27, 1991
AB 1.5MG A089582 001 Jul 17, 1991

ESZOPICLONE
TABLET; ORAL
LUNESTA
XX SEPRACOR 1MG N021476 001 Dec 15, 2004
XX 2MG N021476 002 Dec 15, 2004
XX + 3MG N021476 003 Dec 15, 2004

ETHACRYNATE SODIUM
INJECTABLE; INJECTION

EDECRIN

XX + ATON EQ 50MG BASE/VIAL N016093 001

ETHACRYNIC ACID
TABLET; ORAL

EDECRIN

XX + ATON 25MG N016092 001

ETHAMBUTOL HYDROCHLORIDE
TABLET; ORAL
ETHAMBUTOL HYDROCHLORIDE
AB BARR 400MG A076057 001 Nov 26, 2001
AB LUPIN 100MG A078939 001 Jun 17, 2009
AB 400MG A078939 002 Jun 17, 2009
AB WEST WARD 100MG A075095 001 Nov 30, 1999
AB + 400MG A075095 002 Nov 30, 1999
MYAMBUTOL
AB STI PHARMA LLC 100MG N016320 001
AB 400MG N016320 003

ETHANOLAMINE OLEATE
INJECTABLE; INJECTION

ETHAMOLIN

XX + QOL MEDCL 50MG/ML N019357 001 Dec 22, 1988


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 159 (of 393)

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE


TABLET; ORAL-28
KELNOR
AB BARR 0.035MG;1MG A076785 001 May 23, 2005
ZOVIA 1/35E-28
AB WATSON LABS 0.035MG;1MG A072721 001 Dec 30, 1991
ZOVIA 1/50E-28
XX + WATSON LABS 0.05MG;1MG A072723 001 Dec 30, 1991

ETHINYL ESTRADIOL; ETONOGESTREL


RING; VAGINAL

NUVARING

XX + ORGANON USA INC 0.015MG;0.12MG N021187 001 Oct 03, 2001

ETHINYL ESTRADIOL; LEVONORGESTREL


TABLET; ORAL
QUASENSE
AB WATSON LABS 0.03MG;0.15MG A077101 001 Sep 06, 2006
SEASONALE
AB + DURAMED RES 0.03MG;0.15MG N021544 001 Sep 05, 2003
LOSEASONIQUE
XX DURAMED 0.02MG,0.01MG;0.1MG,N/A N022262 001 Oct 24, 2008
LYBREL
XX + WYETH PHARMS INC 0.02MG;0.09MG N021864 001 May 22, 2007
SEASONIQUE
XX + DURAMED RES 0.03MG,0.01MG;0.15MG,N/A N021840 001 May 25, 2006
TABLET; ORAL-28
ENPRESSE-28
AB DURAMED PHARMS BARR 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 A075809 002 Jul 16, 2001
25MG
LEVORA 0.15/30-28
AB WATSON LABS 0.03MG;0.15MG A073594 001 Dec 13, 1993
NORDETTE-28
AB + DURAMED 0.03MG;0.15MG N018782 001 Jul 21, 1982
PORTIA-28
AB BARR 0.03MG;0.15MG A075866 002 May 23, 2002
TRIVORA-28
AB + WATSON LABS 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 A074538 002 Dec 18, 1997
25MG
AVIANE-28
AB1 DURAMED PHARMS BARR 0.02MG;0.1MG A075796 001 Apr 30, 2001
LEVONORGESTREL AND ETHINYL ESTRADIOL
AB1 + WATSON LABS 0.02MG;0.1MG A076625 001 Nov 18, 2004
LESSINA-28
AB2 BARR 0.02MG;0.1MG A075803 002 Mar 20, 2002
LEVONORGESTREL AND ETHINYL ESTRADIOL
AB2 + WATSON LABS 0.02MG;0.1MG A077681 001 May 31, 2006

ETHINYL ESTRADIOL; NORELGESTROMIN


FILM, EXTENDED RELEASE; TRANSDERMAL

ORTHO EVRA

XX + ORTHO MCNEIL JANSSEN 0.02MG/24HR;0.15MG/24HR N021180 001 Nov 20, 2001

ETHINYL ESTRADIOL; NORETHINDRONE


TABLET; ORAL-21
NORETHIN 1/35E-21
AB WATSON LABS 0.035MG;1MG A071480 001 Apr 12, 1988
NORETHINDRONE AND ETHINYL ESTRADIOL
AB WATSON LABS 0.035MG;1MG A070685 001 Jan 29, 1987
NORINYL 1+35 21-DAY
AB WATSON LABS 0.035MG;1MG N017565 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 160 (of 393)

ETHINYL ESTRADIOL; NORETHINDRONE


TABLET; ORAL-21
NORTREL 1/35-21
AB BARR 0.035MG;1MG A072693 001 Feb 28, 1992
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)
XX WATSON LABS 0.035MG,0.035MG;0.5MG,1MG A071043 001 Apr 01, 1988
NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)
XX WATSON LABS 0.035MG,0.035MG;0.5MG,1MG A071041 001 Sep 24, 1991
NORTREL 7/7/7
XX BARR 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M A075478 001 Aug 30, 2002
G

TABLET; ORAL-28
ARANELLE
AB BARR 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG A076783 001 Sep 29, 2004
BALZIVA-28
AB BARR 0.035MG;0.4MG A076238 001 Apr 22, 2004
BREVICON 28-DAY
AB WATSON LABS 0.035MG;0.5MG N017743 001
MODICON 28
AB + ORTHO MCNEIL JANSSEN 0.035MG;0.5MG N017735 001
NORETHIN 1/35E-28
AB WATSON LABS 0.035MG;1MG A071481 001 Apr 12, 1988
NORETHINDRONE AND ETHINYL ESTRADIOL
AB WATSON LABS 0.035MG;0.5MG A070686 001 Jan 29, 1987
AB 0.035MG;1MG A070687 001 Jan 29, 1987
NORINYL 1+35 28-DAY
AB WATSON LABS 0.035MG;1MG N017565 002
NORTREL 0.5/35-28
AB BARR 0.035MG;0.5MG A072695 001 Feb 28, 1992
NORTREL 1/35-28
AB BARR 0.035MG;1MG A072696 001 Feb 28, 1992
NORTREL 7/7/7
AB BARR 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M A075478 002 Aug 30, 2002
G
ORTHO-NOVUM 1/35-28
AB + ORTHO MCNEIL JANSSEN 0.035MG;1MG N017919 002
ORTHO-NOVUM 7/7/7-28
AB + ORTHO MCNEIL JANSSEN 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M N018985 002 Apr 04, 1984
G
OVCON-35
AB + WARNER CHILCOTT 0.035MG;0.4MG N017716 001
TRI-NORINYL 28-DAY
AB + WATSON LABS 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG N018977 002 Apr 13, 1984
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)
XX WATSON LABS 0.035MG,0.035MG;0.5MG,1MG A071044 001 Apr 01, 1988
NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)
XX WATSON LABS 0.035MG,0.035MG;0.5MG,1MG A071042 001 Sep 24, 1991
OVCON-50
XX + WARNER CHILCOTT 0.05MG;1MG N017576 001
TABLET, CHEWABLE; ORAL-28

FEMCON FE

XX + WARNER CHILCOTT 0.035MG;0.4MG N021490 001 Nov 14, 2003

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE


TABLET; ORAL
FEMHRT
AB + WARNER CHILCOTT 0.005MG;1MG N021065 002 Oct 15, 1999
LOESTRIN 24 FE
AB + WARNER CHILCOTT 0.02MG;1MG N021871 001 Feb 17, 2006
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
AB BARR 0.005MG;1MG A076221 001 Nov 06, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 161 (of 393)

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE


TABLET; ORAL
FEMHRT
XX WARNER CHILCOTT 0.0025MG;0.5MG N021065 001 Jan 14, 2005
TABLET; ORAL-21
JUNEL 1.5/30
AB BARR 0.03MG;1.5MG A076381 001 May 30, 2003
JUNEL 1/20
AB BARR 0.02MG;1MG A076380 001 May 30, 2003
LOESTRIN 21 1.5/30
AB WARNER CHILCOTT 0.03MG;1.5MG N017875 001
LOESTRIN 21 1/20
AB WARNER CHILCOTT 0.02MG;1MG N017876 001
MICROGESTIN 1.5/30
AB WATSON LABS 0.03MG;1.5MG A075548 002 Jul 30, 2003
MICROGESTIN 1/20
AB WATSON LABS 0.02MG;1MG A075647 002 Jul 30, 2003
TRI-LEGEST 21
XX BARR 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG A076405 001 Oct 26, 2007
TABLET; ORAL-28
ESTROSTEP FE
AB + WARNER CHILCOTT 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG N020130 002 Oct 09, 1996
JUNEL FE 1.5/30
AB BARR 0.03MG;1.5MG A076064 001 Sep 18, 2003
JUNEL FE 1/20
AB BARR 0.02MG;1MG A076081 001 Sep 18, 2003
LOESTRIN FE 1.5/30
AB + WARNER CHILCOTT 0.03MG;1.5MG N017355 001
LOESTRIN FE 1/20
AB WARNER CHILCOTT 0.02MG;1MG N017354 001
MICROGESTIN FE 1.5/30
AB WATSON LABS 0.03MG;1.5MG A075548 001 Feb 05, 2001
MICROGESTIN FE 1/20
AB WATSON LABS 0.02MG;1MG A075647 001 Feb 05, 2001
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
AB TEVA PHARMS 0.02MG;1MG A077077 001 May 20, 2005
AB 0.03MG;1.5MG A077075 001 Apr 28, 2005
AB WATSON LABS 0.02MG;1MG A078267 001 Sep 01, 2009
TRI-LEGEST FE
AB BARR 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG A076105 001 Oct 26, 2007

ETHINYL ESTRADIOL; NORGESTIMATE


TABLET; ORAL-28
NORGESTIMATE AND ETHINYL ESTRADIOL
AB WATSON LABS 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, A076626 001 Aug 17, 2006
0.25MG
AB 0.035MG;0.25MG A076627 001 Aug 17, 2006
ORTHO CYCLEN-28
AB + ORTHO MCNEIL JANSSEN 0.035MG;0.25MG N019653 002 Dec 29, 1989
ORTHO TRI-CYCLEN
AB + ORTHO MCNEIL JANSSEN 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, N019697 001 Jul 03, 1992
0.25MG
ORTHO TRI-CYCLEN LO
AB + ORTHO MCNEIL JANSSEN 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG, N021241 001 Aug 22, 2002
0.25MG
PREVIFEM
AB TEVA PHARMS 0.035MG;0.25MG A076334 001 Jan 09, 2004
SPRINTEC
AB BARR 0.035MG;0.25MG A075804 001 Sep 25, 2002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 162 (of 393)

ETHINYL ESTRADIOL; NORGESTIMATE


TABLET; ORAL-28
TRI LO SPRINTEC
AB BARR 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG, A076784 001 Jun 29, 2009
0.25MG
TRI-PREVIFEM
AB TEVA PHARMS 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, A076335 001 Mar 26, 2004
0.25MG
TRI-SPRINTEC
AB BARR 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, A075808 001 Dec 29, 2003
0.25MG

ETHINYL ESTRADIOL; NORGESTREL


TABLET; ORAL-21
CRYSELLE
AB DURAMED PHARMS BARR 0.03MG;0.3MG A075840 001 Nov 30, 2001
LOW-OGESTREL-21
AB + WATSON LABS 0.03MG;0.3MG A075288 001 Jul 28, 1999
TABLET; ORAL-28
CRYSELLE
AB DURAMED PHARMS BARR 0.03MG;0.3MG A075840 002 Nov 30, 2001
LO/OVRAL-28
AB AKRIMAX PHARMS 0.03MG;0.3MG N017802 001
LOW-OGESTREL-28
AB WATSON LABS 0.03MG;0.3MG A075288 002 Jul 28, 1999
OGESTREL 0.5/50-28
XX + WATSON LABS 0.05MG;0.5MG A075406 002 Dec 15, 1999

ETHIODIZED OIL
OIL; INTRALYMPHATIC

ETHIODOL

XX SAVAGE LABS 99% N009190 001

ETHIONAMIDE
TABLET; ORAL

TRECATOR

XX + WYETH PHARMS INC 250MG N013026 002

ETHOSUXIMIDE
CAPSULE; ORAL
ETHOSUXIMIDE
AB BANNER PHARMACAPS 250MG A040430 001 Oct 28, 2002
AB COVENANT PHARMA INC 250MG A040686 001 May 28, 2008
ZARONTIN
AB + PARKE DAVIS 250MG N012380 001
SYRUP; ORAL
ETHOSUXIMIDE
AA MIKART 250MG/5ML A040506 001 Dec 22, 2003
AA PHARM ASSOC 250MG/5ML A040253 001 Nov 22, 2000
AA TEVA PHARMS 250MG/5ML A081306 001 Jul 30, 1993
ZARONTIN
AA + PARKE DAVIS 250MG/5ML A080258 001

ETHOTOIN
TABLET; ORAL

PEGANONE

XX + LUNDBECK INC 250MG N010841 001


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 163 (of 393)

ETIDRONATE DISODIUM
TABLET; ORAL
DIDRONEL
AB PROCTER AND GAMBLE 200MG N017831 001
AB + 400MG N017831 002
ETIDRONATE DISODIUM
AB MYLAN 200MG A075800 001 Jan 24, 2003
AB 400MG A075800 002 Jan 24, 2003

ETODOLAC
CAPSULE; ORAL
ETODOLAC
AB APOTEX 200MG A075419 001 Jul 28, 2000
AB 300MG A075419 002 Jul 28, 2000
AB TARO 200MG A075078 001 Apr 30, 1998
AB + 300MG A075078 002 Apr 30, 1998
AB TEVA 300MG A075126 002 Sep 16, 1999
TABLET; ORAL
ETODOLAC
AB ACTAVIS ELIZABETH 400MG A074819 001 Feb 28, 1997
AB APOTEX INC 400MG A076004 001 Dec 03, 2002
AB 500MG A076004 002 Dec 03, 2002
AB MYLAN 400MG A075104 001 Feb 06, 1998
AB 500MG A075104 002 Nov 20, 1998
AB SANDOZ 400MG A074903 001 Apr 11, 1997
AB 500MG A074903 002 Apr 19, 1999
AB TARO PHARM INDS 400MG A075074 001 Mar 11, 1998
AB + 500MG A075074 002 Apr 25, 2000
AB TEVA 400MG A075009 001 Nov 26, 1997
AB 500MG A075009 002 Dec 28, 1999
TABLET, EXTENDED RELEASE; ORAL
ETODOLAC
AB TARO 400MG A076174 001 Mar 13, 2003
AB 500MG A076174 002 Mar 13, 2003
AB 600MG A076174 003 Mar 13, 2003
AB TEVA 400MG A075665 003 Feb 05, 2001
AB 500MG A075665 002 Jul 31, 2000
AB + 600MG A075665 001 Jul 31, 2000

ETOMIDATE
INJECTABLE; INJECTION
AMIDATE
AP + HOSPIRA 2MG/ML N018227 001 Sep 07, 1982
ETOMIDATE
AP BEDFORD 2MG/ML A074593 001 Nov 04, 1996
AP PARENTA PHARMS 2MG/ML A078289 001 Jan 02, 2009
AP PHARMAFORCE 2MG/ML A078867 001 Dec 22, 2009

ETONOGESTREL
IMPLANT; IMPLANTATION

IMPLANON

XX + ORGANON USA INC 68MG/IMPLANT N021529 001 Jul 17, 2006

ETOPOSIDE
CAPSULE; ORAL

ETOPOSIDE

XX + MYLAN 50MG A075635 001 Sep 19, 2001


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 164 (of 393)

ETOPOSIDE
INJECTABLE; INJECTION
ETOPOSIDE
AP ACCORD HLTHCARE INC 20MG/ML A074513 001 Mar 14, 1996
AP APP PHARMS 20MG/ML A074983 001 Sep 30, 1998
AP BEDFORD 20MG/ML A074290 001 Jul 17, 1995
AP PHARMACHEMIE 20MG/ML A074227 001 Feb 22, 1996
AP TEVA PARENTERAL 20MG/ML A074284 001 Feb 10, 1994
AP 20MG/ML A074529 001 Jul 24, 1996
VEPESID
AP + BRISTOL MYERS SQUIBB 20MG/ML N018768 001 Nov 10, 1983

ETOPOSIDE PHOSPHATE
INJECTABLE; INJECTION

ETOPOPHOS PRESERVATIVE FREE


XX + BRISTOL MYERS SQUIBB EQ 100MG BASE/VIAL N020457 001 May 17, 1996

ETRAVIRINE
TABLET; ORAL

INTELENCE

XX + TIBOTEC 100MG N022187 001 Jan 18, 2008

EVEROLIMUS
TABLET; ORAL
AFINITOR
XX NOVARTIS 5MG N022334 001 Mar 30, 2009
XX + 10MG N022334 002 Mar 30, 2009

EXEMESTANE
TABLET; ORAL

AROMASIN

XX + PHARMACIA AND UPJOHN 25MG N020753 001 Oct 21, 1999

EXENATIDE SYNTHETIC
INJECTABLE; SUBCUTANEOUS

BYETTA

XX + AMYLIN 300MCG/1.2ML (250MCG/ML) N021773 001 Apr 28, 2005


XX + 600MCG/2.4ML (250MCG/ML) N021773 002 Apr 28, 2005

EZETIMIBE
TABLET; ORAL

ZETIA

XX + MSP SINGAPORE 10MG N021445 001 Oct 25, 2002

EZETIMIBE; SIMVASTATIN
TABLET; ORAL
VYTORIN
XX MSP SINGAPORE 10MG;10MG N021687 001 Jul 23, 2004
XX 10MG;20MG N021687 002 Jul 23, 2004
XX 10MG;40MG N021687 003 Jul 23, 2004
XX + 10MG;80MG N021687 004 Jul 23, 2004

FAMCICLOVIR
TABLET; ORAL
FAMCICLOVIR
AB TEVA PHARMS 125MG A077487 001 Aug 24, 2007
AB 250MG A077487 002 Aug 24, 2007
AB 500MG A077487 003 Aug 24, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 165 (of 393)

FAMCICLOVIR
TABLET; ORAL
FAMVIR
AB NOVARTIS 125MG N020363 003 Dec 11, 1995
AB 250MG N020363 001 Apr 26, 1996
AB + 500MG N020363 002 Jun 29, 1994

FAMOTIDINE
FOR SUSPENSION; ORAL

PEPCID

XX + SALIX PHARMS 40MG/5ML N019527 001 Feb 02, 1987


INJECTABLE; INJECTION
FAMOTIDINE
AP AKORN STRIDES 10MG/ML A078641 001 Jun 25, 2008
AP APP PHARMS 10MG/ML A075709 001 Apr 16, 2001
AP BAXTER HLTHCARE 10MG/ML A075488 001 Apr 16, 2001
AP 10MG/ML A075799 001 Apr 30, 2002
AP BEDFORD 10MG/ML A075651 001 Apr 16, 2001
AP 10MG/ML A075684 001 Apr 16, 2001
AP HOSPIRA 10MG/ML A075870 001 Nov 23, 2001
FAMOTIDINE PRESERVATIVE FREE
AP AKORN STRIDES 10MG/ML A078642 001 Jun 25, 2008
AP APOTEX INC 10MG/ML A076324 001 Nov 27, 2002
AP APP PHARMS 10MG/ML A075813 001 Apr 16, 2001
AP BAXTER HLTHCARE 10MG/ML A075486 001 Apr 16, 2001
AP 10MG/ML A075789 001 Apr 30, 2002
AP BEDFORD 10MG/ML A075622 001 Apr 16, 2001
AP BEN VENUE 10MG/ML A075825 001 Apr 17, 2001
FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK)
AP APOTEX INC 10MG/ML A076322 001 Nov 27, 2002
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 0.4MG/ML A075591 001 May 10, 2001
PEPCID
AP + MERCK 10MG/ML N019510 001 Nov 04, 1986
PEPCID PRESERVATIVE FREE
AP + MERCK 10MG/ML N019510 004 Nov 04, 1986
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER
AP + MERCK 0.4MG/ML N020249 001 Feb 18, 1994
TABLET; ORAL
FAMOTIDINE
AB ACTAVIS ELIZABETH 20MG A075650 001 Sep 14, 2001
AB 40MG A075650 002 Sep 14, 2001
AB ALEMBIC LTD 20MG A078916 001 May 22, 2009
AB 40MG A078916 002 May 22, 2009
AB APOTEX 20MG A075611 001 Jul 23, 2001
AB 40MG A075611 002 Jul 23, 2001
AB CARLSBAD 20MG A075805 001 Apr 16, 2001
AB 40MG A075805 002 Apr 16, 2001
AB DR REDDYS LABS LTD 20MG A075718 001 Apr 16, 2001
AB 40MG A075718 002 Apr 16, 2001
AB GENPHARM 20MG A075457 001 Apr 18, 2001
AB 40MG A075457 002 Apr 18, 2001
AB IVAX SUB TEVA PHARMS 20MG A075511 001 Apr 16, 2001
AB 40MG A075511 002 Apr 16, 2001
AB MYLAN 20MG A075704 001 Apr 16, 2001
AB 40MG A075704 002 Apr 16, 2001
AB PERRIGO 20MG A077352 002 Jul 27, 2005
AB 40MG A077352 001 Jul 27, 2005
AB SANDOZ 20MG A075607 001 May 10, 2001
AB 40MG A075607 002 May 10, 2001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 166 (of 393)

FAMOTIDINE
TABLET; ORAL
FAMOTIDINE
AB TEVA 20MG A075311 001 Apr 16, 2001
AB 40MG A075311 002 Apr 16, 2001
AB WATSON LABS 20MG A075062 002 Apr 16, 2001
AB 40MG A075062 001 Apr 16, 2001
AB WOCKHARDT 20MG A075786 001 Apr 16, 2001
AB 40MG A075786 002 Apr 16, 2001
PEPCID
AB MERCK 20MG N019462 001 Oct 15, 1986
AB + 40MG N019462 002 Oct 15, 1986
TABLET, ORALLY DISINTEGRATING; ORAL
FLUXID
XX SCHWARZ PHARMA 20MG N021712 001 Sep 24, 2004
XX + 40MG N021712 002 Sep 24, 2004

FEBUXOSTAT
TABLET; ORAL
ULORIC
XX TAKEDA PHARMS 40MG N021856 001 Feb 13, 2009
XX + 80MG N021856 002 Feb 13, 2009

FELBAMATE
SUSPENSION; ORAL

FELBATOL

XX + MEDA PHARMS 600MG/5ML N020189 003 Jul 29, 1993


TABLET; ORAL
FELBATOL
XX MEDA PHARMS 400MG N020189 001 Jul 29, 1993
XX + 600MG N020189 002 Jul 29, 1993

FELODIPINE
TABLET, EXTENDED RELEASE; ORAL
FELODIPINE
AB MUTUAL PHARM 2.5MG A075896 001 Nov 02, 2004
AB 5MG A075896 002 Nov 02, 2004
AB 10MG A075896 003 Nov 02, 2004
AB MYLAN 2.5MG A078855 001 Apr 17, 2008
AB 5MG A078855 002 Apr 17, 2008
AB + 10MG A078855 003 Apr 17, 2008

FENOFIBRATE
CAPSULE; ORAL
FENOFIBRATE (MICRONIZED)
AB IMPAX LABS 67MG A075868 001 Oct 27, 2003
AB 134MG A075868 002 Oct 27, 2003
AB 200MG A075868 003 Oct 27, 2003
AB TEVA 67MG A075753 001 Sep 03, 2002
AB 134MG A075753 002 Apr 09, 2002
AB + 200MG A075753 003 Apr 09, 2002
ANTARA (MICRONIZED)
XX OSCIENT 43MG N021695 001 Nov 30, 2004
XX + 130MG N021695 003 Nov 30, 2004
LIPOFEN
XX CIPHER PHARMS INC 50MG N021612 001 Jan 11, 2006
XX 100MG N021612 002 Jan 11, 2006
XX + 150MG N021612 003 Jan 11, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 167 (of 393)

FENOFIBRATE
TABLET; ORAL
FENOFIBRATE
AB IMPAX LABS 54MG A076509 001 Mar 26, 2008
AB 160MG A076509 002 Mar 26, 2008
AB MYLAN 54MG A076520 001 Oct 25, 2007
AB 160MG A076520 003 Oct 25, 2007
AB RANBAXY 54MG A076635 001 Oct 31, 2005
AB 160MG A076635 003 Oct 31, 2005
AB TEVA 54MG A076433 001 May 13, 2005
AB + 160MG A076433 002 May 13, 2005
TRIGLIDE
BX + SKYEPHARMA AG 160MG N021350 002 May 07, 2005
FENOFIBRATE
XX RANBAXY 107MG A076635 002 Oct 31, 2005
FENOGLIDE
XX SCIELE PHARMA INC 40MG N022118 001 Aug 10, 2007
XX + 120MG N022118 002 Aug 10, 2007
TRICOR
XX ABBOTT 48MG N021656 001 Nov 05, 2004
XX + 145MG N021656 002 Nov 05, 2004
TRIGLIDE
XX SKYEPHARMA AG 50MG N021350 001 May 07, 2005

FENOFIBRIC ACID
TABLET; ORAL
FIBRICOR
XX AR HOLDING CO INC 35MG N022418 001 Aug 14, 2009
XX + 105MG N022418 002 Aug 14, 2009

FENOLDOPAM MESYLATE
INJECTABLE; INJECTION
CORLOPAM
AP + HOSPIRA EQ 10MG BASE/ML N019922 001 Sep 23, 1997
FENOLDOPAM MESYLATE
AP BEDFORD LABS EQ 10MG BASE/ML A076582 001 Oct 12, 2004
AP PHARMAFORCE EQ 10MG BASE/ML A076656 001 Dec 01, 2003
AP SANDOZ EQ 10MG BASE/ML A077155 001 Feb 15, 2005
AP TEVA PARENTERAL EQ 10MG BASE/ML A077826 001 Mar 07, 2007

FENOPROFEN CALCIUM
CAPSULE; ORAL

NALFON

XX + PEDINOL EQ 200MG BASE N017604 003


XX EQ 400MG BASE N017604 004 Jul 21, 2009
TABLET; ORAL
FENOPROFEN CALCIUM
AB IVAX SUB TEVA PHARMS EQ 600MG BASE A072557 001 Aug 29, 1988
AB + MYLAN EQ 600MG BASE A072267 001 Aug 17, 1988

FENTANYL
FILM, EXTENDED RELEASE; TRANSDERMAL
DURAGESIC-100
AB ORTHO MCNEIL JANSSEN 100MCG/HR N019813 001 Aug 07, 1990
DURAGESIC-12
AB ORTHO MCNEIL JANSSEN 12.5MCG/HR N019813 005 Feb 04, 2005
DURAGESIC-25
AB + ORTHO MCNEIL JANSSEN 25MCG/HR N019813 004 Aug 07, 1990
DURAGESIC-50
AB ORTHO MCNEIL JANSSEN 50MCG/HR N019813 003 Aug 07, 1990
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 168 (of 393)

FENTANYL
FILM, EXTENDED RELEASE; TRANSDERMAL
DURAGESIC-75
AB ORTHO MCNEIL JANSSEN 75MCG/HR N019813 002 Aug 07, 1990
FENTANYL-100
AB ACTAVIS 100MCG/HR A077062 004 Aug 20, 2007
AB LAVIPHARM LABS 100MCG/HR A077051 004 Aug 04, 2006
AB MYLAN TECHNOLOGIES 100MCG/HR A076258 004 Jan 28, 2005
AB NOVEN 100MCG/HR A077775 004 Oct 16, 2009
AB TEVA PHARMS 100MCG/HR A077449 004 Oct 20, 2008
AB WATSON LABS 100MCG/HR A076709 004 Aug 20, 2007
FENTANYL-12
AB MYLAN TECHNOLOGIES 12.5MCG/HR A076258 005 Jan 23, 2007
FENTANYL-25
AB ACTAVIS 25MCG/HR A077062 001 Aug 20, 2007
AB LAVIPHARM LABS 25MCG/HR A077051 001 Aug 04, 2006
AB MYLAN TECHNOLOGIES 25MCG/HR A076258 001 Jan 28, 2005
AB NOVEN 25MCG/HR A077775 001 Oct 16, 2009
AB TEVA PHARMS 25MCG/HR A077449 001 Oct 20, 2008
AB WATSON LABS 25MCG/HR A076709 001 Aug 20, 2007
FENTANYL-50
AB ACTAVIS 50MCG/HR A077062 002 Aug 20, 2007
AB LAVIPHARM LABS 50MCG/HR A077051 002 Aug 04, 2006
AB MYLAN TECHNOLOGIES 50MCG/HR A076258 002 Jan 28, 2005
AB NOVEN 50MCG/HR A077775 002 Oct 16, 2009
AB TEVA PHARMS 50MCG/HR A077449 002 Oct 20, 2008
AB WATSON LABS 50MCG/HR A076709 002 Aug 20, 2007
FENTANYL-75
AB ACTAVIS 75MCG/HR A077062 003 Aug 20, 2007
AB LAVIPHARM LABS 75MCG/HR A077051 003 Aug 04, 2006
AB MYLAN TECHNOLOGIES 75MCG/HR A076258 003 Jan 28, 2005
AB NOVEN 75MCG/HR A077775 003 Oct 16, 2009
AB TEVA PHARMS 75MCG/HR A077449 003 Oct 20, 2008
AB WATSON LABS 75MCG/HR A076709 003 Aug 20, 2007

FENTANYL CITRATE
FILM; BUCCAL
ONSOLIS
XX MEDA PHARMS EQ 0.2MG BASE N022266 001 Jul 16, 2009
XX + EQ 0.4MG BASE N022266 002 Jul 16, 2009
XX EQ 0.6MG BASE N022266 003 Jul 16, 2009
XX EQ 0.8MG BASE N022266 004 Jul 16, 2009
XX EQ 1.2MG BASE N022266 005 Jul 16, 2009
INJECTABLE; INJECTION
FENTANYL CITRATE
AP HOSPIRA EQ 0.05MG BASE/ML N019115 001 Jan 12, 1985
FENTANYL CITRATE PRESERVATIVE FREE
AP + BAXTER HLTHCARE EQ 0.05MG BASE/ML N019101 001 Jul 11, 1984
AP HOSPIRA EQ 0.05MG BASE/ML A072786 001 Sep 24, 1991
SUBLIMAZE PRESERVATIVE FREE
AP + AKORN EQ 0.05MG BASE/ML N016619 001
TABLET; BUCCAL
FENTORA
XX CEPHALON EQ 0.1MG BASE N021947 001 Sep 25, 2006
XX EQ 0.2MG BASE N021947 002 Sep 25, 2006
XX + EQ 0.3MG BASE N021947 006 Mar 02, 2007
XX EQ 0.4MG BASE N021947 003 Sep 25, 2006
XX EQ 0.6MG BASE N021947 004 Sep 25, 2006
XX EQ 0.8MG BASE N021947 005 Sep 25, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 169 (of 393)

FENTANYL CITRATE
TROCHE/LOZENGE; TRANSMUCOSAL
ACTIQ
AB CEPHALON EQ 0.2MG BASE N020747 001 Nov 04, 1998
AB + EQ 0.4MG BASE N020747 002 Nov 04, 1998
AB EQ 0.6MG BASE N020747 003 Nov 04, 1998
AB EQ 0.8MG BASE N020747 004 Nov 04, 1998
AB EQ 1.2MG BASE N020747 005 Nov 04, 1998
AB EQ 1.6MG BASE N020747 006 Nov 04, 1998
FENTANYL CITRATE
AB BARR EQ 0.2MG BASE A077312 001 Oct 30, 2009
AB EQ 0.4MG BASE A077312 002 Oct 30, 2009
AB EQ 0.6MG BASE A077312 003 Oct 30, 2009
AB EQ 0.8MG BASE A077312 004 Oct 30, 2009
AB EQ 1.2MG BASE A077312 005 Oct 30, 2009
AB EQ 1.6MG BASE A077312 006 Oct 30, 2009
AB MALLINCKRODT EQ 0.2MG BASE A078907 001 Oct 30, 2009
AB EQ 0.4MG BASE A078907 002 Oct 30, 2009
AB EQ 0.6MG BASE A078907 003 Oct 30, 2009
AB EQ 0.8MG BASE A078907 004 Oct 30, 2009
AB EQ 1.2MG BASE A078907 005 Oct 30, 2009
AB EQ 1.6MG BASE A078907 006 Oct 30, 2009

FERRIC HEXACYANOFERRATE(II)
CAPSULE; ORAL

RADIOGARDASE (PRUSSIAN BLUE)


XX + HEYL CHEMISCH 500MG N021626 001 Oct 02, 2003

FERUMOXIDES
INJECTABLE; INJECTION

FERIDEX I.V.

XX + AMAG PHARMS INC EQ 11.2MG IRON/ML N020416 001 Aug 30, 1996

FERUMOXSIL
SUSPENSION; ORAL

GASTROMARK

XX + AMAG PHARMS INC EQ 0.175MG IRON/ML N020410 001 Dec 06, 1996

FERUMOXYTOL
SOLUTION; INTRAVENOUS

FERAHEME

XX + AMAG PHARMS INC EQ 510MG IRON/17ML (EQ 30MG IRON/ML) N022180 001 Jun 30, 2009

FESOTERODINE FUMARATE
TABLET, EXTENDED RELEASE; ORAL
TOVIAZ
XX PFIZER 4MG N022030 001 Oct 31, 2008
XX + 8MG N022030 002 Oct 31, 2008

FEXOFENADINE HYDROCHLORIDE
SUSPENSION; ORAL

ALLEGRA

XX + SANOFI AVENTIS US 30MG/5ML N021963 001 Oct 16, 2006


TABLET; ORAL
ALLEGRA
AB SANOFI AVENTIS US 30MG N020872 001 Feb 25, 2000
AB 60MG N020872 002 Feb 25, 2000
AB + 180MG N020872 004 Feb 25, 2000
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 170 (of 393)

FEXOFENADINE HYDROCHLORIDE
TABLET; ORAL
FEXOFENADINE HYDROCHLORIDE
AB BARR 30MG A076191 001 Aug 31, 2005
AB 60MG A076191 002 Aug 31, 2005
AB 180MG A076191 003 Aug 31, 2005
AB DR REDDYS LABS LTD 30MG A076502 001 Apr 11, 2006
AB 60MG A076502 002 Apr 11, 2006
AB 180MG A076502 003 Apr 11, 2006
AB MYLAN 30MG A077081 002 Apr 11, 2008
AB 60MG A077081 003 Apr 11, 2008
AB 180MG A077081 001 Apr 16, 2007
AB TEVA 30MG A076447 001 Sep 01, 2005
AB 60MG A076447 002 Sep 01, 2005
AB 180MG A076447 003 Sep 01, 2005
TABLET, ORALLY DISINTEGRATING; ORAL
ALLEGRA
XX + SANOFI AVENTIS US 30MG N021909 001 Jul 26, 2007

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE


TABLET, EXTENDED RELEASE; ORAL
ALLEGRA-D 12 HOUR
AB + SANOFI AVENTIS US 60MG;120MG N020786 001 Dec 24, 1997
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
AB BARR 60MG;120MG A076236 001 Apr 14, 2005
ALLEGRA D 24 HOUR
XX + SANOFI AVENTIS US 180MG;240MG N021704 001 Oct 19, 2004

FINASTERIDE
TABLET; ORAL
FINASTERIDE
AB ACTAVIS TOTOWA 5MG A077914 001 Mar 28, 2007
AB AUROBINDO PHARMA 5MG A078341 001 Oct 30, 2007
AB DR REDDYS LABS INC 1MG A076436 001 Jul 28, 2006
AB DR REDDYS LABS LTD 5MG A076437 001 Feb 28, 2007
AB GEDEON RICHTER USA 5MG A077251 001 Dec 22, 2006
AB MYLAN 5MG A077578 001 Dec 18, 2006
AB TEVA 5MG A076511 001 Dec 15, 2006
AB ZYDUS PHARMS USA INC 5MG A078900 001 Dec 28, 2009
PROPECIA
AB + MERCK 1MG N020788 001 Dec 19, 1997
PROSCAR
AB + MERCK 5MG N020180 001 Jun 19, 1992

FLAVOXATE HYDROCHLORIDE
TABLET; ORAL
FLAVOXATE HYDROCHLORIDE
AB HAMPTON LAINE LLC 100MG A076835 001 Nov 30, 2005
AB IMPAX PHARMS 100MG A076234 001 Aug 28, 2003
AB PADDOCK 100MG A076831 001 Dec 16, 2004
URISPAS
AB + ORTHO MCNEIL JANSSEN 100MG N016769 001

FLECAINIDE ACETATE
TABLET; ORAL
FLECAINIDE ACETATE
AB AMNEAL PHARM 50MG A075442 001 Jul 31, 2001
AB 100MG A075442 002 Jul 31, 2001
AB 150MG A075442 003 Jul 31, 2001
AB APOTEX INC 50MG A079164 001 Jul 09, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 171 (of 393)

FLECAINIDE ACETATE
TABLET; ORAL
FLECAINIDE ACETATE
AB APOTEX INC 100MG A079164 002 Jul 09, 2009
AB 150MG A079164 003 Jul 09, 2009
AB BARR 50MG A075882 001 Oct 28, 2002
AB 100MG A075882 002 Oct 28, 2002
AB 150MG A075882 003 Oct 28, 2002
AB RANBAXY 50MG A076421 001 Mar 28, 2003
AB 100MG A076421 002 Mar 28, 2003
AB 150MG A076421 003 Mar 28, 2003
AB ROXANE 50MG A076278 001 Jan 14, 2003
AB 100MG A076278 002 Jan 14, 2003
AB 150MG A076278 003 Jan 14, 2003
TAMBOCOR
AB GRACEWAY 50MG N018830 004 Aug 23, 1988
AB 100MG N018830 001 Oct 31, 1985
AB + 150MG N018830 003 Jun 03, 1988

FLOXURIDINE
INJECTABLE; INJECTION
FLOXURIDINE
AP APP PHARMS 500MG/VIAL A075837 001 Feb 22, 2001
AP + BEDFORD 500MG/VIAL A075387 001 Apr 16, 2000

FLUCONAZOLE
FOR SUSPENSION; ORAL
DIFLUCAN
AB PFIZER 50MG/5ML N020090 001 Dec 23, 1993
AB + 200MG/5ML N020090 002 Dec 23, 1993
FLUCONAZOLE
AB AUROBINDO PHARM 50MG/5ML A079150 001 Sep 18, 2009
AB 200MG/5ML A079150 002 Sep 18, 2009
AB IVAX SUB TEVA PHARMS 50MG/5ML A077523 001 Sep 12, 2007
AB 200MG/5ML A077523 002 Sep 12, 2007
AB RANBAXY 50MG/5ML A076332 001 Jul 29, 2004
AB 200MG/5ML A076332 002 Jul 29, 2004
AB ROXANE 50MG/5ML A076246 001 Jul 29, 2004
AB 200MG/5ML A076246 002 Jul 29, 2004
AB TARO PHARM INDS 50MG/5ML A076918 001 Dec 18, 2006
AB 200MG/5ML A076918 002 Dec 18, 2006
INJECTABLE; INJECTION
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + PFIZER 200MG/100ML (2MG/ML) N019950 003 Sep 29, 1992
AP + 400MG/200ML (2MG/ML) N019950 005 Jul 08, 1994
DIFLUCAN IN SODIUM CHLORIDE 0.9%
AP + PFIZER 200MG/100ML (2MG/ML) N019950 001 Jan 29, 1990
AP + 400MG/200ML (2MG/ML) N019950 006 Jan 29, 1990
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP + PFIZER 200MG/100ML (2MG/ML) N019950 002 Jan 29, 1990
AP + 400MG/200ML (2MG/ML) N019950 004 Jan 29, 1990
FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP ACS DOBFAR INFO SA 200MG/100ML (2MG/ML) A079104 001 Jul 30, 2009
AP 400MG/200ML (2MG/ML) A079104 002 Jul 30, 2009
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
AP APOTEX INC 200MG/100ML (2MG/ML) A076888 001 Mar 25, 2005
AP 400MG/200ML (2MG/ML) A076888 002 Mar 25, 2005
AP HOSPIRA 200MG/100ML (2MG/ML) A076304 001 Jul 29, 2004
AP 400MG/200ML (2MG/ML) A076304 002 Jul 29, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 172 (of 393)

FLUCONAZOLE
INJECTABLE; INJECTION
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
AP APP PHARMS 200MG/100ML (2MG/ML) A076145 001 Jul 29, 2004
AP 400MG/200ML (2MG/ML) A076145 002 Jul 29, 2004
AP BEDFORD 200MG/100ML (2MG/ML) A076087 001 Jul 29, 2004
AP 400MG/200ML (2MG/ML) A076087 003 Jul 29, 2004
AP HIKMA FARMACEUTICA 200MG/100ML (2MG/ML) A076736 001 Aug 23, 2005
AP TEVA PARENTERAL 200MG/100ML (2MG/ML) A076653 001 Jul 29, 2004
AP 400MG/200ML (2MG/ML) A076653 002 Jul 29, 2004
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 200MG/100ML (2MG/ML) A076766 001 Jul 29, 2004
AP 400MG/200ML (2MG/ML) A076766 002 Jul 29, 2004
AP BEDFORD LABS 200MG/100ML (2MG/ML) A078107 001 Jul 30, 2008
AP 400MG/200ML (2MG/ML) A078107 002 Jul 30, 2008
AP HOSPIRA 200MG/100ML (2MG/ML) A076303 001 Jul 29, 2004
AP 200MG/100ML (2MG/ML) A076617 001 Jul 29, 2004
AP 400MG/200ML (2MG/ML) A076303 002 Jul 29, 2004
AP 400MG/200ML (2MG/ML) A076617 002 Jul 29, 2004
AP TEVA PARENTERAL 200MG/100ML (2MG/ML) A076837 001 Jan 13, 2005
AP 400MG/200ML (2MG/ML) A076837 002 Jan 13, 2005
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
XX BEDFORD 100MG/50ML (2MG/ML) A076087 002 Sep 26, 2008
TABLET; ORAL
DIFLUCAN
AB PFIZER 50MG N019949 001 Jan 29, 1990
AB 100MG N019949 002 Jan 29, 1990
AB 150MG N019949 004 Jun 30, 1994
AB + 200MG N019949 003 Jan 29, 1990
FLUCONAZOLE
AB APOTEX 50MG A076665 001 Jul 29, 2004
AB 100MG A076665 002 Jul 29, 2004
AB 150MG A076665 003 Jul 29, 2004
AB 200MG A076665 004 Jul 29, 2004
AB AUROBINDO PHARMA 50MG A077731 001 Oct 07, 2008
AB 100MG A077731 002 Oct 07, 2008
AB 150MG A077731 003 Oct 07, 2008
AB 200MG A077731 004 Oct 07, 2008
AB GENPHARM 50MG A076042 001 Jul 29, 2004
AB 100MG A076042 002 Jul 29, 2004
AB 150MG A076042 003 Jul 29, 2004
AB 200MG A076042 004 Jul 29, 2004
AB GLENMARK GENERICS 50MG A077253 001 Jan 25, 2006
AB 100MG A077253 002 Jan 25, 2006
AB 150MG A077253 003 Jan 25, 2006
AB 200MG A077253 004 Jan 25, 2006
AB IVAX SUB TEVA PHARMS 50MG A076077 001 Jul 29, 2004
AB 100MG A076077 002 Jul 29, 2004
AB 150MG A076077 003 Jul 29, 2004
AB 200MG A076077 004 Jul 29, 2004
AB MYLAN 50MG A076351 001 Jul 29, 2004
AB 100MG A076351 002 Jul 29, 2004
AB 150MG A076351 003 Jul 29, 2004
AB 200MG A076351 004 Jul 29, 2004
AB RANBAXY 50MG A076386 001 Jul 29, 2004
AB 100MG A076386 002 Jul 29, 2004
AB 150MG A076386 003 Jul 29, 2004
AB 200MG A076386 004 Jul 29, 2004
AB TARO 50MG A076507 001 Jul 29, 2004
AB 100MG A076507 002 Jul 29, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 173 (of 393)

FLUCONAZOLE
TABLET; ORAL
FLUCONAZOLE
AB TARO 150MG A076507 003 Jul 29, 2004
AB 200MG A076507 004 Jul 29, 2004
AB TEVA 50MG A074681 001 Jul 29, 2004
AB 100MG A074681 002 Jul 29, 2004
AB 150MG A074681 003 Jul 29, 2004
AB 200MG A074681 004 Jul 29, 2004
AB UNIQUE PHARM LABS 50MG A076957 001 Sep 28, 2005
AB 100MG A076957 002 Sep 28, 2005
AB 200MG A076957 003 Sep 28, 2005
FLUCONAZOLE
BX DR REDDYS LABS INC 50MG A076658 001 Jul 29, 2004
BX 100MG A076658 002 Jul 29, 2004
BX 150MG A076658 003 Jul 29, 2004
BX 200MG A076658 004 Jul 29, 2004
BX PLIVA 50MG A076424 001 Jul 29, 2004
BX 100MG A076424 002 Jul 29, 2004
BX 150MG A076424 003 Jul 29, 2004
BX 200MG A076424 004 Jul 29, 2004

FLUCYTOSINE
CAPSULE; ORAL

ANCOBON

XX VALEANT 250MG N017001 001


XX + 500MG N017001 002

FLUDARABINE PHOSPHATE
INJECTABLE; INJECTION
FLUDARA
AP + GENZYME 50MG/VIAL N020038 001 Apr 18, 1991
FLUDARABINE PHOSPHATE
AP ACTAVIS TOTOWA 50MG/VIAL A078610 001 Feb 11, 2009
AP APP PHARMS 50MG/2ML (25MG/ML) A078393 001 Oct 15, 2007
AP 50MG/VIAL A078544 001 Oct 15, 2007
AP + EBEWE PHARMA 50MG/2ML (25MG/ML) N022137 001 Sep 21, 2007
AP HOSPIRA 50MG/VIAL A077790 001 Apr 06, 2007
AP TEVA PARENTERAL 50MG/VIAL A076349 001 Aug 28, 2003
AP + 50MG/2ML (25MG/ML) A076661 001 Apr 28, 2004
TABLET; ORAL

OFORTA

XX + SANOFI AVENTIS US 10MG N022273 001 Dec 18, 2008

FLUDEOXYGLUCOSE F-18
INJECTABLE; INTRAVENOUS

FLUDEOXYGLUCOSE F 18

XX + WEILL MEDCL COLL 10-100mCi/ML N021768 001 Aug 05, 2004


FLUDEOXYGLUCOSE F18
XX + FEINSTEIN 20-200mCi/ML N021870 001 Aug 19, 2005

FLUDROCORTISONE ACETATE
TABLET; ORAL
FLUDROCORTISONE ACETATE
AB BARR 0.1MG A040425 001 Jan 21, 2003
AB + IMPAX LABS 0.1MG A040431 001 Mar 18, 2002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 174 (of 393)

FLUMAZENIL
INJECTABLE; INJECTION
FLUMAZENIL
AP AKORN STRIDES 0.5MG/5ML (0.1MG/ML) A078595 001 May 13, 2008
AP 1MG/10ML (0.1MG/ML) A078595 002 May 13, 2008
AP APOTEX INC 0.5MG/5ML (0.1MG/ML) A076755 002 Oct 12, 2004
AP 1MG/10ML (0.1MG/ML) A076755 001 Oct 12, 2004
AP APP PHARMS 0.5MG/5ML (0.1MG/ML) A076955 002 Oct 12, 2004
AP 1MG/10ML (0.1MG/ML) A076955 001 Oct 12, 2004
AP BAXTER HLTHCARE 0.5MG/5ML (0.1MG/ML) A076787 002 Oct 12, 2004
AP 1MG/10ML (0.1MG/ML) A076787 001 Oct 12, 2004
AP BEDFORD LABS 0.5MG/5ML (0.1MG/ML) A076256 002 Oct 12, 2004
AP 1MG/10ML (0.1MG/ML) A076256 001 Oct 12, 2004
AP HIKMA FARMACEUTICA 0.5MG/5ML (0.1MG/ML) A078527 001 Mar 23, 2009
AP 1MG/10ML (0.1MG/ML) A078527 002 Mar 23, 2009
AP SANDOZ 1MG/10ML (0.1MG/ML) A077071 002 May 03, 2005
AP 0.5MG/5ML (0.1MG/ML) A077071 001 May 03, 2005
AP TEVA PARENTERAL 0.5MG/5ML (0.1MG/ML) A076589 002 Oct 12, 2004
AP 1MG/10ML (0.1MG/ML) A076589 001 Oct 12, 2004
ROMAZICON
AP + HLR 1MG/10ML (0.1MG/ML) N020073 001 Dec 20, 1991
AP 0.5MG/5ML (0.1MG/ML) N020073 002 Dec 20, 1991

FLUNISOLIDE
AEROSOL, METERED; INHALATION

AEROBID

XX + ROCHE PALO 0.25MG/INH N018340 001 Aug 17, 1984


AEROSPAN HFA
XX + FOREST LABS EQ 78MCG BASE/INH N021247 001 Jan 27, 2006
SPRAY, METERED; NASAL
FLUNISOLIDE
AB APOTEX INC 0.029MG/SPRAY A077436 001 Aug 09, 2007
AB + BAUSCH AND LOMB 0.025MG/SPRAY A074805 001 Feb 20, 2002
AB QPHARMA 0.025MG/SPRAY A077704 001 Aug 03, 2006
NASAREL
AB + TEVA GLOBAL 0.029MG/SPRAY N020409 001 Mar 08, 1995

FLUOCINOLONE ACETONIDE
CREAM; TOPICAL
FLUOCINOLONE ACETONIDE
AT FOUGERA 0.01% A088170 001 Dec 16, 1982
AT 0.025% A088169 001 Dec 16, 1982
AT TARO 0.025% A087104 001 Apr 27, 1982
SYNALAR
AT + MEDICIS 0.01% N012787 004
AT + 0.025% N012787 005
AT + 0.025% N012787 002
IMPLANT; INTRAVITREAL

RETISERT

XX + BAUSCH AND LOMB 0.59MG N021737 001 Apr 08, 2005


OIL; TOPICAL

DERMA-SMOOTHE/FS

XX + HILL DERMAC 0.01% N019452 002 Nov 09, 2005


XX + 0.01% N019452 001 Feb 03, 1988
OIL/DROPS; OTIC

DERMOTIC

XX + HILL DERMAC 0.01% N019452 003 Nov 09, 2005


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 175 (of 393)

FLUOCINOLONE ACETONIDE
OINTMENT; TOPICAL
FLUOCINOLONE ACETONIDE
AT FOUGERA 0.025% A088168 001 Dec 16, 1982
AT TARO 0.025% A040041 001 Sep 15, 1994
SYNALAR
AT + MEDICIS 0.025% N013960 001
SHAMPOO; TOPICAL

CAPEX

XX + GALDERMA LABS LP 0.01% N020001 001 Aug 27, 1990


SOLUTION; TOPICAL
FLUOCINOLONE ACETONIDE
AT FOUGERA 0.01% A088167 001 Dec 16, 1982
AT TARO 0.01% A089124 001 Sep 11, 1985
SYNALAR
AT + MEDICIS 0.01% N015296 001

FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN


CREAM; TOPICAL

TRI-LUMA

XX + GALDERMA LABS LP 0.01%;4%;0.05% N021112 001 Jan 18, 2002

FLUOCINONIDE
CREAM; TOPICAL
FLUOCINONIDE
AB1 ACTAVIS MID ATLANTIC 0.05% A073085 001 Feb 14, 1992
AB1 FOUGERA 0.05% A073030 001 Oct 17, 1994
AB1 TARO 0.05% N019117 001 Jun 26, 1984
AB1 TEVA 0.05% A072488 001 Feb 06, 1989
LIDEX
AB1 + MEDICIS 0.05% N016908 002
FLUOCINONIDE EMULSIFIED BASE
AB2 ALTANA 0.05% A076586 001 Jun 23, 2004
AB2 TARO 0.05% A072494 001 Jan 19, 1989
AB2 TEVA 0.05% A072490 001 Feb 07, 1989
LIDEX-E
AB2 + MEDICIS 0.05% N016908 003
VANOS
XX + MEDICIS 0.1% N021758 001 Feb 11, 2005
GEL; TOPICAL
FLUOCINONIDE
AB FOUGERA 0.05% A072933 001 Dec 30, 1994
AB TARO 0.05% A074935 001 Jul 29, 1997
AB TEVA 0.05% A072537 001 Feb 07, 1989
LIDEX
AB + MEDICIS 0.05% N017373 001
OINTMENT; TOPICAL
FLUOCINONIDE
AB ALTANA 0.05% A074905 001 Aug 26, 1997
AB TARO 0.05% A075008 001 Jun 30, 1999
AB TEVA 0.05% A073481 001 Dec 27, 1991
LIDEX
AB + MEDICIS 0.05% N016909 002
SOLUTION; TOPICAL
FLUOCINONIDE
AT ACTAVIS MID ATLANTIC 0.05% A071535 001 Dec 02, 1988
AT FOUGERA 0.05% A072934 001 Feb 27, 1995
AT TARO 0.05% A074799 001 Dec 31, 1996
AT TEVA 0.05% A072511 001 Feb 07, 1989
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 176 (of 393)

FLUOCINONIDE
SOLUTION; TOPICAL
LIDEX
AT + MEDICIS 0.05% N018849 001 Apr 06, 1984

FLUORESCEIN SODIUM
INJECTABLE; INTRAVENOUS
AK-FLUOR 10%
AP AKORN EQ 500MG BASE/5ML (EQ 100MG BASE/ML) N022186 001 Aug 08, 2008
FLUORESCITE
AP + ALCON EQ 500MG BASE/5ML (EQ 100MG BASE/ML) N021980 001 Mar 28, 2006
AK-FLUOR 25%
XX AKORN EQ 500MG BASE/2ML (EQ 250MG BASE/ML) N022186 002 Aug 08, 2008

FLUOROMETHOLONE
OINTMENT; OPHTHALMIC

FML

XX + ALLERGAN 0.1% N017760 001 Sep 04, 1985


SUSPENSION/DROPS; OPHTHALMIC

FML

XX + ALLERGAN 0.1% N016851 002 Jul 28, 1982


FML FORTE
XX ALLERGAN 0.25% N019216 001 Apr 23, 1986

FLUOROMETHOLONE ACETATE
SUSPENSION/DROPS; OPHTHALMIC

FLAREX

XX + ALCON 0.1% N019079 001 Feb 11, 1986

FLUOROURACIL
CREAM; TOPICAL
EFUDEX
AB + VALEANT PHARM INTL 5% N016831 003
FLUOROURACIL
AB SPEAR PHARMS 5% A077524 001 Apr 11, 2008
CARAC
XX + SANOFI AVENTIS US 0.5% N020985 001 Oct 27, 2000
FLUOROPLEX
XX + ALLERGAN HERBERT 1% N016988 001
INJECTABLE; INJECTION
FLUOROURACIL
AP + APP PHARMS 500MG/10ML (50MG/ML) A040279 002 Sep 30, 1998
AP + 1GM/20ML (50MG/ML) A040279 001 Sep 30, 1998
AP + 2.5GM/50ML (50MG/ML) A040278 001 Sep 30, 1998
AP + 5GM/100ML (50MG/ML) A040278 002 Sep 30, 1998
AP EBEWE PHARMA 500MG/10ML (50MG/ML) A040772 001 Aug 11, 2008
AP + GENERAMEDIX 500MG/10ML (50MG/ML) A040743 002 Apr 26, 2007
AP + 1GM/20ML (50MG/ML) A040743 001 Apr 26, 2007
AP + 2.5GM/50ML (50MG/ML) A040798 002 Apr 26, 2007
AP + 5GM/100ML (50MG/ML) A040798 001 Apr 26, 2007
AP + TEVA PARENTERAL 500MG/10ML (50MG/ML) A040333 001 Jan 27, 2000
AP + 2.5GM/50ML (50MG/ML) A040334 001 Feb 25, 2000
AP + 5GM/100ML (50MG/ML) A040334 002 Feb 25, 2000
AP + VALEANT 500MG/10ML (50MG/ML) N012209 001
SOLUTION; TOPICAL
EFUDEX
AT + VALEANT PHARM INTL 2% N016831 001
AT + 5% N016831 002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 177 (of 393)

FLUOROURACIL
SOLUTION; TOPICAL
FLUOROURACIL
AT TARO 2% A076526 001 Nov 05, 2003
AT 5% A076526 002 Nov 05, 2003

FLUOXETINE HYDROCHLORIDE
CAPSULE; ORAL
FLUOXETINE HYDROCHLORIDE
AB ALEMBIC LTD EQ 40MG BASE A090223 003 Mar 19, 2009
AB AUROBINDO PHARMA EQ 40MG BASE A078619 003 Jan 31, 2008
AB DR REDDYS LABS INC EQ 40MG BASE A075465 003 Aug 02, 2001
AB IVAX SUB TEVA PHARMS EQ 40MG BASE A075245 003 Sep 28, 2004
AB MYLAN EQ 40MG BASE A075207 003 May 25, 2007
AB RANBAXY EQ 40MG BASE A076990 001 Dec 13, 2004
AB SANDOZ EQ 40MG BASE A075049 003 Jan 29, 2002
AB TEVA EQ 40MG BASE A075452 003 Jan 29, 2002
AB WOCKHARDT EQ 40MG BASE A078143 003 Jan 16, 2008
PROZAC
AB + LILLY EQ 40MG BASE N018936 003 Jun 15, 1999
FLUOXETINE HYDROCHLORIDE
AB1 ALEMBIC LTD EQ 10MG BASE A090223 001 Mar 19, 2009
AB1 EQ 20MG BASE A090223 002 Mar 19, 2009
AB1 ALPHAPHARM EQ 10MG BASE A075577 001 Jan 29, 2002
AB1 EQ 20MG BASE A075577 002 Jan 29, 2002
AB1 AUROBINDO PHARMA EQ 10MG BASE A078619 001 Jan 31, 2008
AB1 EQ 20MG BASE A078619 002 Jan 31, 2008
AB1 BARR EQ 10MG BASE A074803 002 Jan 30, 2002
AB1 EQ 20MG BASE A074803 001 Aug 02, 2001
AB1 BEIJING DOUBLE CRANE EQ 10MG BASE A076165 001 Feb 01, 2002
AB1 EQ 20MG BASE A076165 002 Feb 01, 2002
AB1 DR REDDYS LABS INC EQ 10MG BASE A075465 001 Jan 29, 2002
AB1 EQ 20MG BASE A075465 002 Jan 29, 2002
AB1 IVAX SUB TEVA PHARMS EQ 10MG BASE A075245 002 Jan 31, 2002
AB1 EQ 20MG BASE A075245 001 Jan 31, 2002
AB1 LANDELA PHARM EQ 10MG BASE A075464 001 Jan 30, 2002
AB1 EQ 20MG BASE A075464 002 Jan 30, 2002
AB1 MALLINCKRODT EQ 10MG BASE A075658 001 Jan 29, 2002
AB1 EQ 20MG BASE A075658 002 Jan 29, 2002
AB1 MYLAN EQ 10MG BASE A075207 001 Jan 30, 2002
AB1 EQ 20MG BASE A075207 002 Jan 30, 2002
AB1 PLIVA EQ 10MG BASE A076001 001 Jan 29, 2002
AB1 EQ 20MG BASE A076001 002 Jan 29, 2002
AB1 SANDOZ EQ 10MG BASE A075049 001 Aug 02, 2001
AB1 EQ 20MG BASE A075049 002 Jan 29, 2002
AB1 TEVA EQ 10MG BASE A075452 001 Jan 29, 2002
AB1 EQ 20MG BASE A075452 002 Jan 29, 2002
AB1 WOCKHARDT EQ 10MG BASE A078143 001 Jan 16, 2008
AB1 EQ 20MG BASE A078143 002 Jan 16, 2008
PROZAC
AB1 LILLY EQ 10MG BASE N018936 006 Dec 23, 1992
AB1 EQ 20MG BASE N018936 001 Dec 29, 1987
FLUOXETINE HYDROCHLORIDE
AB2 MYLAN EQ 10MG BASE A078045 001 Nov 17, 2008
AB2 EQ 20MG BASE A078045 002 Nov 17, 2008
AB2 SANDOZ EQ 10MG BASE A077469 001 Nov 17, 2008
AB2 EQ 20MG BASE A077469 002 Nov 17, 2008
AB2 TEVA EQ 10MG BASE A076287 001 May 20, 2008
AB2 EQ 20MG BASE A076287 002 May 20, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 178 (of 393)

FLUOXETINE HYDROCHLORIDE
CAPSULE; ORAL
SARAFEM
AB2 LILLY EQ 10MG BASE N018936 007 Jul 06, 2000
AB2 + EQ 20MG BASE N018936 008 Jul 06, 2000
CAPSULE, DELAYED REL PELLETS; ORAL

PROZAC WEEKLY

XX + LILLY EQ 90MG BASE N021235 001 Feb 26, 2001


SOLUTION; ORAL
FLUOXETINE HYDROCHLORIDE
AA AUROBINDO PHARM EQ 20MG BASE/5ML A079209 001 Mar 20, 2009
AA MALLINCKRODT EQ 20MG BASE/5ML A075920 001 Jan 29, 2002
AA MORTON GROVE EQ 20MG BASE/5ML A075514 001 Aug 29, 2002
AA NOVEX EQ 20MG BASE/5ML A075292 001 Feb 07, 2002
AA PAR PHARM EQ 20MG BASE/5ML A076458 001 May 14, 2004
AA + PHARM ASSOC EQ 20MG BASE/5ML A076015 001 Jan 30, 2002
AA SILARX EQ 20MG BASE/5ML A077849 001 Feb 09, 2007
AA TEVA EQ 20MG BASE/5ML A075506 001 Aug 02, 2001
TABLET; ORAL
FLUOXETINE HYDROCHLORIDE
AB DR REDDYS LABS INC EQ 10MG BASE A076006 001 Jan 30, 2002
AB MYLAN EQ 10MG BASE A075755 001 Aug 02, 2001
AB TEVA EQ 10MG BASE A075872 001 Jan 29, 2002
FLUOXETINE HYDROCHLORIDE
XX + MYLAN EQ 20MG BASE A075755 002 Aug 02, 2001
SARAFEM
XX WARNER CHILCOTT EQ 10MG BASE N021860 001 May 19, 2006
XX EQ 15MG BASE N021860 002 May 19, 2006
XX + EQ 20MG BASE N021860 003 May 19, 2006

FLUOXETINE HYDROCHLORIDE; OLANZAPINE


CAPSULE; ORAL
SYMBYAX
XX LILLY EQ 25MG BASE;EQ 3MG BASE N021520 001 Apr 09, 2007
XX EQ 25MG BASE;EQ 6MG BASE N021520 002 Dec 24, 2003
XX EQ 25MG BASE;EQ 12MG BASE N021520 004 Dec 24, 2003
XX + EQ 50MG BASE;EQ 6MG BASE N021520 003 Dec 24, 2003
XX EQ 50MG BASE;EQ 12MG BASE N021520 005 Dec 24, 2003

FLUOXYMESTERONE
TABLET; ORAL

FLUOXYMESTERONE

XX + USL PHARMA 10MG A088342 001 Oct 21, 1983

FLUPHENAZINE DECANOATE
INJECTABLE; INJECTION
FLUPHENAZINE DECANOATE
AO APOTEX INC 25MG/ML A075918 001 Aug 17, 2001
AO APP PHARMS 25MG/ML A071413 001 Jul 14, 1987
AO + BEDFORD 25MG/ML A074531 001 Aug 30, 1996
AO TEVA PARENTERAL 25MG/ML A074795 001 Sep 10, 1996

FLUPHENAZINE HYDROCHLORIDE
CONCENTRATE; ORAL

FLUPHENAZINE HYDROCHLORIDE

XX + PHARM ASSOC 5MG/ML A074725 001 Sep 16, 1996


ELIXIR; ORAL

FLUPHENAZINE HYDROCHLORIDE

XX + PHARM ASSOC 2.5MG/5ML A040146 001 Aug 21, 1996


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 179 (of 393)

FLUPHENAZINE HYDROCHLORIDE
INJECTABLE; INJECTION

FLUPHENAZINE HYDROCHLORIDE

XX + APP PHARMS 2.5MG/ML A089556 001 Apr 16, 1987


TABLET; ORAL
FLUPHENAZINE HYDROCHLORIDE
AB LANNETT 1MG A089740 001 Aug 25, 1988
AB 2.5MG A089741 001 Aug 25, 1988
AB 5MG A089742 001 Aug 25, 1988
AB 10MG A089743 001 Aug 25, 1988
AB MYLAN 1MG A089804 002 Aug 12, 1988
AB 2.5MG A089804 003 Aug 12, 1988
AB 5MG A089804 004 Aug 12, 1988
AB + 10MG A089804 001 Aug 12, 1988
AB SANDOZ 1MG A089583 001 Oct 16, 1987
AB 2.5MG A089584 001 Oct 16, 1987
AB 5MG A089585 001 Oct 16, 1987
AB 10MG A089586 001 Oct 16, 1987

FLURANDRENOLIDE
CREAM; TOPICAL

CORDRAN SP

XX + WATSON PHARMS 0.025% N012806 003


XX + 0.05% N012806 002
LOTION; TOPICAL

CORDRAN

XX + WATSON LABS 0.05% N013790 001


OINTMENT; TOPICAL

CORDRAN

XX + WATSON PHARMS 0.025% N012806 004


XX + 0.05% N012806 001
TAPE; TOPICAL

CORDRAN

XX + WATSON PHARMS 0.004MG/SQ CM N016455 001

FLURAZEPAM HYDROCHLORIDE
CAPSULE; ORAL
DALMANE
AB VALEANT PHARM INTL 15MG N016721 001
AB + 30MG N016721 002
FLURAZEPAM HYDROCHLORIDE
AB MYLAN 15MG A070345 002 Nov 27, 1985
AB 30MG A070345 001 Nov 27, 1985
AB WATSON LABS 15MG A071205 001 Nov 25, 1986
AB 30MG A071068 001 Nov 25, 1986
AB 30MG A072369 001 Mar 30, 1989
AB WEST WARD 15MG A071107 001 Dec 08, 1986
AB 30MG A071108 001 Dec 08, 1986

FLURBIPROFEN
TABLET; ORAL
ANSAID
AB PHARMACIA AND UPJOHN 50MG N018766 002 Oct 31, 1988
AB + 100MG N018766 003 Oct 31, 1988
FLURBIPROFEN
AB CARACO 50MG A075058 001 Apr 27, 2001
AB 100MG A075058 002 Apr 27, 2001
AB MYLAN 50MG A074358 001 Jun 20, 1994
AB 100MG A074358 002 Jun 20, 1994
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 180 (of 393)

FLURBIPROFEN
TABLET; ORAL
FLURBIPROFEN
AB TEVA 100MG A074431 001 May 31, 1995

FLURBIPROFEN SODIUM
SOLUTION/DROPS; OPHTHALMIC
FLURBIPROFEN SODIUM
AT BAUSCH AND LOMB 0.03% A074447 001 Jan 04, 1995
OCUFEN
AT + ALLERGAN 0.03% N019404 001 Dec 31, 1986

FLUTAMIDE
CAPSULE; ORAL
FLUTAMIDE
AB GENPHARM 125MG A076224 001 May 09, 2003
AB IVAX SUB TEVA PHARMS 125MG A075780 001 Sep 19, 2001
AB PAR PHARM 125MG A075298 001 Sep 18, 2001
AB + SANDOZ 125MG A075818 001 Sep 18, 2001
AB WATSON LABS 125MG A075820 001 Sep 18, 2001

FLUTICASONE FUROATE
SPRAY, METERED; NASAL

VERAMYST

XX + GLAXOSMITHKLINE 0.0275MG/INH N022051 001 Apr 27, 2007

FLUTICASONE PROPIONATE
AEROSOL, METERED; INHALATION

FLOVENT HFA

XX + GLAXO GRP LTD 0.044MG/INH N021433 003 May 14, 2004


XX + 0.11MG/INH N021433 002 May 14, 2004
XX + 0.22MG/INH N021433 001 May 14, 2004
CREAM; TOPICAL
CUTIVATE
AB + ALTANA 0.05% N019958 001 Dec 18, 1990
FLUTICASONE PROPIONATE
AB ALTANA 0.05% A076451 001 May 14, 2004
AB G AND W LABS 0.05% A077055 001 Jun 30, 2006
AB KV PHARM 0.05% A076865 001 Sep 10, 2004
AB PERRIGO NEW YORK 0.05% A076793 001 May 14, 2004
AB TOLMAR 0.05% A076633 001 May 14, 2004
LOTION; TOPICAL

CUTIVATE

XX + NYCOMED US 0.05% N021152 001 Mar 31, 2005


OINTMENT; TOPICAL
CUTIVATE
AB + ALTANA 0.005% N019957 001 Dec 14, 1990
FLUTICASONE PROPIONATE
AB ALTANA 0.005% A076300 001 May 14, 2004
AB G AND W LABS 0.005% A077168 001 Mar 03, 2006
AB PERRIGO NEW YORK 0.005% A076668 001 May 14, 2004
POWDER; INHALATION

FLOVENT DISKUS 100

XX + GLAXOSMITHKLINE 0.1MG/INH N020833 002 Sep 29, 2000


FLOVENT DISKUS 250
XX + GLAXOSMITHKLINE 0.25MG/INH N020833 003 Sep 29, 2000
FLOVENT DISKUS 50
XX + GLAXOSMITHKLINE 0.05MG/INH N020833 001 Sep 29, 2000
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 181 (of 393)

FLUTICASONE PROPIONATE
SPRAY, METERED; NASAL
FLONASE
AB + GLAXOSMITHKLINE 0.05MG/SPRAY N020121 001 Oct 19, 1994
FLUTICASONE PROPIONATE
AB APOTEX INC 0.05MG/SPRAY A077538 001 Sep 12, 2007
AB HI TECH PHARMA 0.05MG/SPRAY A077570 001 Jan 16, 2008
AB ROXANE 0.05MG/SPRAY A076504 001 Feb 22, 2006

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE


AEROSOL, METERED; INHALATION

ADVAIR HFA

XX + GLAXOSMITHKLINE 0.045MG/INH;EQ 0.021MG BASE/INH N021254 001 Jun 08, 2006


XX + 0.115MG/INH;EQ 0.021MG BASE/INH N021254 002 Jun 08, 2006
XX + 0.23MG/INH;EQ 0.021MG BASE/INH N021254 003 Jun 08, 2006
POWDER; INHALATION

ADVAIR DISKUS 100/50

XX + GLAXOSMITHKLINE 0.1MG/INH;EQ 0.05MG BASE/INH N021077 001 Aug 24, 2000


ADVAIR DISKUS 250/50
XX + GLAXOSMITHKLINE 0.25MG/INH;EQ 0.05MG BASE/INH N021077 002 Aug 24, 2000
ADVAIR DISKUS 500/50
XX + GLAXOSMITHKLINE 0.5MG/INH;EQ 0.05MG BASE/INH N021077 003 Aug 24, 2000

FLUVASTATIN SODIUM
CAPSULE; ORAL

LESCOL

XX NOVARTIS EQ 20MG BASE


N020261 001 Dec 31, 1993
XX + EQ 40MG BASE N020261 002 Dec 31, 1993
TABLET, EXTENDED RELEASE; ORAL

LESCOL XL

XX + NOVARTIS 80MG N021192 001 Oct 06, 2000

FLUVOXAMINE MALEATE
CAPSULE, EXTENDED RELEASE; ORAL

LUVOX CR

XX JAZZ 100MG
N022033 001 Feb 28, 2008
XX + 150MG N022033 002 Feb 28, 2008
TABLET; ORAL
FLUVOXAMINE MALEATE
AB APOTEX 25MG A075902 001 May 07, 2001
AB 50MG A075902 002 May 07, 2001
AB 100MG A075902 003 May 07, 2001
AB BARR 25MG A075897 001 Jan 25, 2001
AB 50MG A075897 002 Jan 25, 2001
AB 100MG A075897 003 Jan 25, 2001
AB CARACO 25MG A075900 001 Feb 23, 2006
AB 50MG A075900 002 Feb 23, 2006
AB 100MG A075900 003 Feb 23, 2006
AB MYLAN 25MG A075889 001 Nov 29, 2000
AB 50MG A075889 002 Nov 29, 2000
AB 100MG A075889 003 Nov 29, 2000
AB SANDOZ 25MG A075888 001 Nov 29, 2000
AB 50MG A075888 002 Nov 29, 2000
AB + 100MG A075888 003 Nov 29, 2000
AB TEVA 25MG A075893 001 Sep 10, 2002
AB 50MG A075893 002 Sep 10, 2002
AB 100MG A075893 003 Sep 10, 2002
LUVOX
AB JAZZ 25MG N021519 001 Dec 20, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 182 (of 393)

FLUVOXAMINE MALEATE
TABLET; ORAL
LUVOX
AB JAZZ 50MG N021519 002 Dec 20, 2007
AB 100MG N021519 003 Dec 20, 2007

FOLIC ACID
INJECTABLE; INJECTION

FOLIC ACID

XX + APP PHARMS 5MG/ML A089202 001 Feb 18, 1986


TABLET; ORAL
FOLIC ACID
AA CADISTA PHARMS 1MG A040514 001 Jun 14, 2005
AA CONTRACT PHARMACAL 1MG A085061 001
AA EXCELLIUM 1MG A040796 001 Jan 12, 2009
AA INVAGEN PHARMS 1MG A090035 001 Jun 09, 2009
AA MUTUAL PHARM 1MG A040582 001 Jul 18, 2005
AA PHARMAX 1MG A040625 001 Jul 21, 2005
AA WEST WARD 1MG A080600 001

FOLLITROPIN ALFA/BETA
INJECTABLE; SUBCUTANEOUS

FOLLISTIM AQ

XX + ORGANON USA INC 75 IU/0.5ML N021273 001 Aug 26, 2005


XX + 150 IU/0.5ML N021273 002 Aug 26, 2005
XX + 300 IU/0.36ML N021211 001 Mar 23, 2004
XX + 600 IU/0.72ML N021211 002 Mar 23, 2004
XX + 900 IU/1.08ML N021211 004 Feb 11, 2005
GONAL-F
XX + EMD SERONO 450 IU/VIAL N020378 005 Mar 26, 2004
XX 1,050 IU/VIAL N020378 004 Feb 28, 2001
GONAL-F RFF
XX + EMD SERONO 75 IU/VIAL N021765 002 Mar 25, 2004
GONAL-F RFF PEN
XX + EMD SERONO 300 IU/0.5ML N021684 001 May 25, 2004
XX + 450 IU/0.75ML N021684 002 May 25, 2004
XX + 900 IU/1.5ML N021684 003 May 25, 2004

FOMEPIZOLE
INJECTABLE; INJECTION
ANTIZOL
AP + PALADIN LABS 1.5GM/1.5ML (1GM/ML) N020696 001 Dec 04, 1997
FOMEPIZOLE
AP GENERAMEDIX 1.5GM/1.5ML (1GM/ML) A079033 001 Apr 07, 2009
AP NAVINTA LLC 1.5GM/1.5ML (1GM/ML) A078537 001 Mar 06, 2008
AP PHARMAFORCE 1.5GM/1.5ML (1GM/ML) A078368 001 Dec 14, 2007
AP SYNERX PHARMA 1.5GM/1.5ML (1GM/ML) A078639 001 Mar 03, 2008

FONDAPARINUX SODIUM
INJECTABLE; SUBCUTANEOUS

ARIXTRA

XX + GLAXOSMITHKLINE 2.5MG/0.5ML N021345 001 Dec 07, 2001


XX + 5MG/0.4ML N021345 002 May 28, 2004
XX + 7.5MG/0.6ML N021345 003 May 28, 2004
XX + 10MG/0.8ML N021345 004 May 28, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 183 (of 393)

FORMOTEROL FUMARATE
POWDER; INHALATION

FORADIL

XX + NOVARTIS 0.012MG/INH N020831 001 Feb 16, 2001


FORADIL CERTIHALER
XX + NOVARTIS 0.0085MG/INH N021592 001 Dec 15, 2006
SOLUTION; INHALATION

PERFOROMIST

XX + DEY LP 0.02MG/2ML N022007 001 May 11, 2007

FOSAMPRENAVIR CALCIUM
SUSPENSION; ORAL

LEXIVA

XX + VIIV HLTHCARE EQ 50MG BASE/ML N022116 001 Jun 14, 2007


TABLET; ORAL

LEXIVA

XX + VIIV HLTHCARE EQ 700MG BASE N021548 001 Oct 20, 2003

FOSAPREPITANT DIMEGLUMINE
POWDER; INTRAVENOUS

EMEND

XX + MERCK AND CO INC EQ 115MG BASE/VIAL N022023 001 Jan 25, 2008

FOSCARNET SODIUM
INJECTABLE; INJECTION
FOSCARNET SODIUM
AP HOSPIRA 2.4GM/100ML A077174 001 May 31, 2005
FOSCAVIR
AP + ASTRAZENECA 2.4GM/100ML N020068 001 Sep 27, 1991

FOSFOMYCIN TROMETHAMINE
FOR SUSPENSION; ORAL

MONUROL

XX + ZAMBON SPA EQ 3GM BASE/PACKET N050717 001 Dec 19, 1996

FOSINOPRIL SODIUM
TABLET; ORAL
FOSINOPRIL SODIUM
AB APOTEX INC 10MG A076906 001 May 17, 2005
AB 20MG A076906 002 May 17, 2005
AB 40MG A076906 003 May 17, 2005
AB COBALT 10MG A077531 001 Aug 31, 2006
AB 20MG A077531 002 Aug 31, 2006
AB 40MG A077531 003 Aug 31, 2006
AB INVAGEN PHARMS 10MG A077222 001 Apr 20, 2005
AB 20MG A077222 002 Apr 20, 2005
AB 40MG A077222 003 Apr 20, 2005
AB RANBAXY 10MG A076580 001 Apr 23, 2004
AB 20MG A076580 002 Apr 23, 2004
AB 40MG A076580 003 Apr 23, 2004
AB SANDOZ 10MG A076483 001 Apr 23, 2004
AB 20MG A076483 002 Apr 23, 2004
AB 40MG A076483 003 Apr 23, 2004
AB TEVA 10MG A076139 001 Nov 25, 2003
AB 20MG A076139 002 Nov 25, 2003
AB + 40MG A076139 003 Nov 25, 2003
AB WATSON LABS 10MG A076987 001 Dec 23, 2004
AB 20MG A076987 002 Dec 23, 2004
AB 40MG A076987 003 Dec 23, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 184 (of 393)

FOSINOPRIL SODIUM
TABLET; ORAL
FOSINOPRIL SODIUM
AB WATSON LABS FLORIDA 10MG A076620 001 Oct 15, 2004
AB 20MG A076620 002 Oct 15, 2004
AB 40MG A076620 003 Oct 15, 2004
MONOPRIL
AB BRISTOL MYERS SQUIBB 10MG N019915 002 May 16, 1991
AB 20MG N019915 003 May 16, 1991
AB + 40MG N019915 004 Mar 28, 1995

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE


TABLET; ORAL
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
AB AUROBINDO PHARMA 10MG;12.5MG A079245 001 Jul 09, 2009
AB 20MG;12.5MG A079245 002 Jul 09, 2009
AB INVAGEN PHARMS 10MG;12.5MG A090228 001 Jul 09, 2009
AB 20MG;12.5MG A090228 002 Jul 09, 2009
AB MYLAN 10MG;12.5MG A077705 001 Aug 14, 2006
AB 20MG;12.5MG A077705 002 Aug 14, 2006
AB RANBAXY 10MG;12.5MG A076739 001 Dec 17, 2004
AB 20MG;12.5MG A076739 002 Dec 17, 2004
AB SANDOZ 10MG;12.5MG A076961 001 Sep 28, 2005
AB 20MG;12.5MG A076961 002 Sep 28, 2005
AB WATSON LABS FLORIDA 10MG;12.5MG A076608 001 Dec 03, 2004
AB 20MG;12.5MG A076608 002 Dec 03, 2004

FOSPHENYTOIN SODIUM
INJECTABLE; INJECTION
CEREBYX
AP + PARKE DAVIS EQ 50MG PHENYTOIN NA/ML N020450 001 Aug 05, 1996
FOSPHENYTOIN SODIUM
AP AKORN STRIDES EQ 50MG PNENYTOIN NA/ML A078476 001 Mar 18, 2008
AP APOTEX INC EQ 50MG PHENYTOIN NA/ML A078126 001 Aug 06, 2007
AP APP PHARMS EQ 50MG PHENYTOIN NA/ML A078052 001 Aug 06, 2007
AP BAXTER HLTHCARE EQ 50MG PHENYTOIN NA/ML A077989 001 Aug 06, 2007
AP BEDFORD EQ 50MG PHENYTOIN NA/ML A077481 001 Aug 06, 2007
AP HIKMA FARMACEUTICA EQ 50MG PHENYTOIN NA/ML A078765 001 Dec 02, 2009
AP HOSPIRA EQ 50MG PHENYTOIN NA/ML A078158 001 Aug 06, 2007
AP IV THERAP EQ 50MG PHENYTOIN NA/ML A078277 001 Aug 06, 2007
AP SUN PHARM INDS EQ 50MG PHENYTOIN NA/ML A078417 001 Mar 18, 2008
AP TEVA PARENTERAL EQ 50MG PHENYTOIN NA/ML A076886 001 Aug 06, 2007
AP WOCKHARDT EQ 50MG PHENYTOIN NA/ML A078137 001 Aug 06, 2007

FOSPROPOFOL DISODIUM
SOLUTION; INTRAVENOUS

LUSEDRA

XX + EISAI INC 1050MG/30ML (35MG/ML) N022244 001 Dec 12, 2008

FROVATRIPTAN SUCCINATE
TABLET; ORAL

FROVA

XX + ENDO PHARMS EQ 2.5MG BASE N021006 001 Nov 08, 2001

FULVESTRANT
INJECTABLE; INTRAMUSCULAR

FASLODEX

XX + ASTRAZENECA 50MG/ML N021344 001 Apr 25, 2002


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 185 (of 393)

FUROSEMIDE
INJECTABLE; INJECTION
FUROSEMIDE
AP APP PHARMS 10MG/ML N018902 001 May 22, 1984
AP HOSPIRA 10MG/ML A070578 001 Jul 08, 1987
AP 10MG/ML A075241 001 May 28, 1999
AP 10MG/ML N018667 001 May 28, 1982
AP INTL MEDICATION 10MG/ML N018025 001
AP + LUITPOLD 10MG/ML N018579 001 Nov 30, 1983
AP WOCKHARDT 10MG/ML A077941 001 Mar 22, 2007
SOLUTION; ORAL
FUROSEMIDE
AA MORTON GROVE 10MG/ML A070655 001 Oct 02, 1987
AA + ROXANE 10MG/ML A070434 001 Apr 22, 1987
FUROSEMIDE
XX ROXANE 40MG/5ML A070433 001 Apr 22, 1987
TABLET; ORAL
FUROSEMIDE
AB DAVA PHARMS INC 20MG N018415 001 Jul 27, 1982
AB 40MG N018415 002 Jul 27, 1982
AB 80MG N018415 003 Nov 26, 1984
AB EXCELLIUM 20MG A077293 001 Nov 09, 2005
AB 40MG A077293 002 Nov 09, 2005
AB 80MG A077293 003 Nov 09, 2005
AB IPCA LABS LTD 20MG A078010 001 Sep 18, 2006
AB 40MG A078010 002 Sep 18, 2006
AB 80MG A078010 003 Sep 18, 2006
AB IVAX SUB TEVA PHARMS 20MG N018413 001 Nov 30, 1983
AB 40MG N018413 002 Nov 30, 1983
AB MYLAN 20MG N018487 001
AB 40MG N018487 002
AB 80MG A070082 001 Oct 29, 1986
AB ROXANE 20MG N018823 001 Nov 10, 1983
AB 40MG N018823 002 Nov 10, 1983
AB 80MG A070086 001 Jan 24, 1986
AB SANDOZ 20MG N018569 002
AB 40MG N018569 001
AB 80MG N018569 005 Aug 14, 1984
AB VINTAGE PHARMS 20MG A076796 001 Mar 26, 2004
AB 40MG A076796 002 Mar 26, 2004
AB 80MG A076796 003 Mar 26, 2004
AB WATSON LABS 20MG A070412 001 Feb 26, 1986
AB 20MG A070449 001 Nov 22, 1985
AB 20MG A071379 001 Jan 02, 1987
AB 40MG A070450 001 Nov 22, 1985
AB 80MG A070528 001 Jan 07, 1986
AB 80MG A071594 001 Feb 09, 1988
LASIX
AB SANOFI AVENTIS US 20MG N016273 002
AB 40MG N016273 001
AB + 80MG N016273 003

GABAPENTIN
CAPSULE; ORAL
GABAPENTIN
AB ACTAVIS ELIZABETH 100MG A075350 001 Sep 12, 2003
AB 300MG A075350 002 Sep 12, 2003
AB 400MG A075350 003 Sep 12, 2003
AB AMNEAL PHARMS NY 100MG A078428 001 Jul 25, 2007
AB 300MG A078428 002 Jul 25, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 186 (of 393)

GABAPENTIN
CAPSULE; ORAL
GABAPENTIN
AB AMNEAL PHARMS NY 400MG A078428 003 Jul 25, 2007
AB APOTEX INC 100MG A075360 001 Apr 06, 2005
AB 300MG A075360 002 Apr 06, 2005
AB 400MG A075360 003 Apr 06, 2005
AB AUROBINDO PHARM 100MG A078787 001 Jan 31, 2008
AB 300MG A078787 002 Jan 31, 2008
AB 400MG A078787 003 Jan 31, 2008
AB HIKMA 100MG A078150 001 Sep 25, 2007
AB 300MG A078150 002 Sep 25, 2007
AB 400MG A078150 003 Sep 25, 2007
AB INVAGEN PHARMS 100MG A090705 001 Dec 30, 2009
AB 300MG A090705 002 Dec 30, 2009
AB 400MG A090705 003 Dec 30, 2009
AB RANBAXY 100MG A076606 001 Oct 07, 2005
AB 300MG A076606 002 Oct 07, 2005
AB 400MG A076606 003 Oct 07, 2005
AB SANDOZ 100MG A075539 001 Apr 06, 2005
AB 300MG A075539 002 Apr 06, 2005
AB 400MG A075539 003 Apr 06, 2005
AB SUN PHARM INDS LTD 100MG A077242 001 Aug 24, 2006
AB 300MG A077242 002 Aug 24, 2006
AB 400MG A077242 003 Aug 24, 2006
AB TEVA PHARMS 100MG A075435 001 Oct 08, 2004
AB 300MG A075435 002 Oct 08, 2004
AB 400MG A075435 003 Oct 08, 2004
AB WATSON LABS 100MG A075485 003 May 11, 2007
AB 300MG A075485 002 May 11, 2007
AB 400MG A075485 001 May 11, 2007
NEURONTIN
AB PFIZER PHARMS 100MG N020235 001 Dec 30, 1993
AB 300MG N020235 002 Dec 30, 1993
AB + 400MG N020235 003 Dec 30, 1993
SOLUTION; ORAL

NEURONTIN

XX + PARKE DAVIS 250MG/5ML N021129 001 Mar 02, 2000


TABLET; ORAL
GABAPENTIN
AB ACTAVIS ELIZABETH 600MG A075694 001 Oct 21, 2004
AB 800MG A075694 002 Oct 21, 2004
AB APOTEX INC 100MG A077894 001 Oct 10, 2006
AB 300MG A077894 002 Oct 10, 2006
AB 400MG A077894 003 Oct 10, 2006
AB 600MG A077661 004 Sep 13, 2006
AB 800MG A077661 005 Sep 13, 2006
AB GLENMARK GENERICS 600MG A077662 001 Aug 18, 2006
AB 800MG A077662 002 Aug 18, 2006
AB IVAX SUB TEVA PHARMS 100MG A076017 001 Apr 28, 2004
AB 300MG A076017 002 Apr 28, 2004
AB 400MG A076017 003 Apr 28, 2004
AB 600MG A076017 004 Apr 29, 2005
AB 800MG A076017 005 Apr 29, 2005
AB SANDOZ 600MG A076877 001 Jul 06, 2006
AB 800MG A076877 002 Jul 06, 2006
AB SUN PHARM INDS LTD 600MG A077525 001 Aug 24, 2006
AB 800MG A077525 002 Aug 24, 2006
AB TEVA 600MG A075827 001 Dec 15, 2004
AB 800MG A075827 002 Dec 15, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 187 (of 393)

GABAPENTIN
TABLET; ORAL
NEURONTIN
AB PFIZER PHARMS 600MG N020882 001 Oct 09, 1998
AB + 800MG N020882 002 Oct 09, 1998

GADOBENATE DIMEGLUMINE
INJECTABLE; INTRAVENOUS

MULTIHANCE

XX + BRACCO 2.645GM/5ML (529MG/ML) N021357 001 Nov 23, 2004


XX + 5.29GM/10ML (529MG/ML) N021357 002 Nov 23, 2004
XX + 7.935GM/15ML (529MG/ML) N021357 003 Nov 23, 2004
XX + 10.58GM/20ML (529MG/ML) N021357 004 Nov 23, 2004
MULTIHANCE MULTIPACK
XX + BRACCO 26.45GM/50ML (529MG/ML) N021358 001 Nov 23, 2004
XX + 52.9GM/100ML (529MG/ML) N021358 002 Nov 23, 2004

GADODIAMIDE
INJECTABLE; INJECTION

OMNISCAN

XX + GE HEALTHCARE 287MG/ML N020123 001 Jan 08, 1993


XX + 28.7GM/100ML (287MG/ML) N022066 002 Sep 05, 2007

GADOFOSVESET TRISODIUM
SOLUTION; INTRAVENOUS
ABLAVAR
XX LANTHEUS MEDCL 2440MG/10ML (244MG/ML) N021711 001 Dec 22, 2008
XX + 3660MG/15ML (244MG/ML) N021711 002 Dec 22, 2008

GADOPENTETATE DIMEGLUMINE
INJECTABLE; INJECTION

MAGNEVIST

XX + BAYER HLTHCARE 469.01MG/ML N019596 001 Jun 02, 1988


XX + 469.01MG/ML N021037 001 Mar 10, 2000

GADOTERIDOL
INJECTABLE; INJECTION

PROHANCE

XX + BRACCO 279.3MG/ML N020131 001 Nov 16, 1992


PROHANCE MULTIPACK
XX + BRACCO 279.3MG/ML N021489 001 Oct 09, 2003

GADOVERSETAMIDE
INJECTABLE; INJECTION

OPTIMARK

XX + MALLINCKRODT 1654.5MG/5ML (330.9MG/ML) N020937 001 Dec 08, 1999


XX + 3309MG/10ML (330.9MG/ML) N020937 002 Dec 08, 1999
XX + 4963.5MG/15ML (330.9MG/ML) N020937 003 Dec 08, 1999
XX + 6618MG/20ML (330.9MG/ML) N020937 004 Dec 08, 1999
XX + 16.545GM/50ML (330.9MG/ML) N020975 001 Dec 08, 1999
OPTIMARK IN PLASTIC CONTAINER
XX + MALLINCKRODT 1654.5MG/5ML (330.9MG/ML) N020976 001 Dec 08, 1999
XX + 3309MG/10ML (330.9MG/ML) N020976 002 Dec 08, 1999
XX + 4963.5MG/15ML (330.9MG/ML) N020976 003 Dec 08, 1999
XX + 6618MG/20ML (330.9MG/ML) N020976 004 Dec 08, 1999
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 188 (of 393)

GADOXETATE DISODIUM
SOLUTION; INTRAVENOUS

EOVIST

XX + BAYER HLTHCARE 1.8143GM/10ML (181.43MG/ML) N022090 001 Jul 03, 2008

GALANTAMINE HYDROBROMIDE
CAPSULE, EXTENDED RELEASE; ORAL
GALANTAMINE HYDROBROMIDE
AB BARR EQ 8MG BASE A078189 001 Sep 15, 2008
AB EQ 16MG BASE A078189 002 Sep 15, 2008
AB EQ 24MG BASE A078189 003 Sep 15, 2008
AB IMPAX LABS EQ 8MG BASE A078484 001 May 27, 2009
AB EQ 16MG BASE A078484 002 May 27, 2009
AB EQ 24MG BASE A078484 003 May 27, 2009
AB WATSON LABS EQ 8MG BASE A079028 001 Dec 15, 2008
AB EQ 16MG BASE A079028 002 Dec 15, 2008
AB EQ 24MG BASE A079028 003 Dec 15, 2008
RAZADYNE ER
AB + ORTHO MCNEIL JANSSEN EQ 8MG BASE N021615 001 Apr 01, 2005
AB EQ 16MG BASE N021615 002 Apr 01, 2005
AB EQ 24MG BASE N021615 003 Apr 01, 2005
SOLUTION; ORAL
GALANTAMINE HYDROBROMIDE
AA ROXANE 4MG/ML A078185 001 Jan 30, 2009
RAZADYNE
AA + ORTHO MCNEIL JANSSEN 4MG/ML N021224 001 Jun 22, 2001
TABLET; ORAL
GALANTAMINE HYDROBROMIDE
AB ACTAVIS ELIZABETH EQ 4MG BASE A077585 001 Sep 15, 2009
AB EQ 8MG BASE A077585 002 Sep 15, 2009
AB EQ 12MG BASE A077585 003 Sep 15, 2009
AB BARR EQ 4MG BASE A077605 001 Aug 28, 2008
AB EQ 8MG BASE A077605 002 Aug 28, 2008
AB EQ 12MG BASE A077605 003 Aug 28, 2008
AB BEJING YABAO EQ 4MG BASE A077604 001 Feb 06, 2009
AB EQ 8MG BASE A077604 002 Feb 06, 2009
AB EQ 12MG BASE A077604 003 Feb 06, 2009
AB DR REDDYS LABS LTD EQ 4MG BASE A077593 001 Sep 11, 2008
AB EQ 8MG BASE A077593 002 Sep 11, 2008
AB EQ 12MG BASE A077593 003 Sep 11, 2008
AB MYLAN EQ 4MG BASE A077590 001 May 29, 2009
AB EQ 4MG BASE A077603 001 Aug 28, 2008
AB EQ 8MG BASE A077590 002 May 29, 2009
AB EQ 8MG BASE A077603 002 Aug 28, 2008
AB EQ 12MG BASE A077590 003 May 29, 2009
AB EQ 12MG BASE A077603 003 Aug 28, 2008
AB ROXANE EQ 4MG BASE A077608 001 Feb 11, 2009
AB EQ 8MG BASE A077608 002 Feb 11, 2009
AB EQ 12MG BASE A077608 003 Feb 11, 2009
AB SANDOZ EQ 4MG BASE A077589 001 Jun 22, 2009
AB EQ 8MG BASE A077589 002 Jun 22, 2009
AB EQ 12MG BASE A077589 003 Jun 22, 2009
AB TEVA PHARMS EQ 4MG BASE A077587 001 Jul 09, 2009
AB EQ 8MG BASE A077587 002 Jul 09, 2009
AB EQ 12MG BASE A077587 003 Jul 09, 2009
RAZADYNE
AB + ORTHO MCNEIL JANSSEN EQ 4MG BASE N021169 001 Feb 28, 2001
AB EQ 8MG BASE N021169 002 Feb 28, 2001
AB EQ 12MG BASE N021169 003 Feb 28, 2001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 189 (of 393)

GALLIUM CITRATE, GA-67


INJECTABLE; INJECTION
GALLIUM CITRATE GA 67
BS LANTHEUS MEDCL 2mCi/ML N017478 001
BS MALLINCKRODT 2mCi/ML N018058 001

GALLIUM NITRATE
INJECTABLE; INJECTION

GANITE

XX + GENTA 25MG/ML N019961 002 Jan 17, 1991

GANCICLOVIR
CAPSULE; ORAL

GANCICLOVIR

XX RANBAXY
250MG A076457 001 Jun 27, 2003
XX +
500MG A076457 002 Jun 27, 2003
GEL; OPHTHALMIC

ZIRGAN

XX + SIRION THERAP 0.15% N022211 001 Sep 15, 2009


IMPLANT; IMPLANTATION

VITRASERT

XX + BAUSCH AND LOMB 4.5MG N020569 001 Mar 04, 1996

GANCICLOVIR SODIUM
INJECTABLE; INJECTION
GANCICLOVIR SODIUM
XX BEDFORD EQ 500MG BASE/VIAL A076222 001 Jul 16, 2003

GANIRELIX ACETATE
INJECTABLE; INJECTION

GANIRELIX ACETATE INJECTION

XX + ORGANON USA INC EQ 250MCG BASE/0.5ML N021057 001 Jul 29, 1999

GATIFLOXACIN
SOLUTION/DROPS; OPHTHALMIC

ZYMAR

XX + ALLERGAN 0.3% N021493 001 Mar 28, 2003

GEFITINIB
TABLET; ORAL

IRESSA

XX + ASTRAZENECA 250MG N021399 001 May 05, 2003

GEMCITABINE HYDROCHLORIDE
INJECTABLE; INJECTION
GEMCITABINE HYDROCHLORIDE
AP TEVA PARENTERAL EQ 200MG BASE/VIAL A077983 002 May 04, 2007
AP EQ 1GM BASE/VIAL A077983 001 Dec 18, 2008
GEMZAR
AP + LILLY EQ 200MG BASE/VIAL N020509 001 May 15, 1996
AP + EQ 1GM BASE/VIAL N020509 002 May 15, 1996

GEMFIBROZIL
TABLET; ORAL
GEMFIBROZIL
AB APOTEX 600MG A075034 001 Jul 20, 1998
AB IMPAX PHARMS 600MG A078207 001 Jun 01, 2007
AB INVAGEN PHARMS 600MG A077836 001 Jul 27, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 190 (of 393)

GEMFIBROZIL
TABLET; ORAL
GEMFIBROZIL
AB PERRIGO R AND D 600MG A078012 001 Mar 26, 2007
AB SUN PHARM INDS INC 600MG A079239 001 Dec 29, 2008
AB TEVA 600MG A074256 001 Oct 31, 1993
AB WATSON LABS 600MG A074442 001 Apr 28, 1995
LOPID
AB + PFIZER PHARMS 600MG N018422 003 Nov 20, 1986

GEMIFLOXACIN MESYLATE
TABLET; ORAL

FACTIVE

XX + OSCIENT EQ 320MG BASE N021158 001 Apr 04, 2003

GEMTUZUMAB OZOGAMICIN
INJECTABLE; INJECTION

MYLOTARG

XX + WYETH PHARMS INC 5MG/VIAL N021174 001 May 17, 2000

GENTAMICIN SULFATE
CREAM; TOPICAL
GENTAMICIN SULFATE
AT + FOUGERA EQ 0.1% BASE A062531 001 Jul 05, 1984
AT PERRIGO NEW YORK EQ 0.1% BASE A062307 001
AT TARO EQ 0.1% BASE A062427 001 May 26, 1983
INJECTABLE; INJECTION
GENTAMICIN SULFATE
AP + APP PHARMS EQ 10MG BASE/ML A062356 001 Mar 04, 1982
AP + EQ 40MG BASE/ML A062356 002 Mar 04, 1982
AP EQ 40MG BASE/ML A062366 001 Aug 04, 1983
AP HOSPIRA EQ 10MG BASE/ML A062420 001 Aug 15, 1983
AP EQ 10MG BASE/ML A062612 004 Feb 20, 1986
AP EQ 40MG BASE/ML A062420 002 Aug 15, 1983
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP + B BRAUN EQ 0.8MG BASE/ML A062814 001 Aug 28, 1987
AP + EQ 1.2MG BASE/ML A062814 002 Aug 28, 1987
AP + EQ 1.4MG BASE/ML A062814 003 Aug 28, 1987
AP + EQ 1.6MG BASE/ML A062814 004 Aug 28, 1987
AP + EQ 1.8MG BASE/ML A062814 005 Aug 28, 1987
AP + EQ 2MG BASE/ML A062814 006 Aug 28, 1987
AP + EQ 2.4MG BASE/ML A062814 007 Aug 28, 1987
AP + EQ 40MG BASE/100ML A062814 008 Aug 28, 1987
AP + EQ 60MG BASE/100ML A062814 009 Aug 28, 1987
AP + EQ 70MG BASE/100ML A062814 010 Aug 28, 1987
AP + EQ 80MG BASE/100ML A062814 011 Aug 28, 1987
AP + EQ 90MG BASE/100ML A062814 012 Aug 28, 1987
AP + EQ 100MG BASE/100ML A062814 013 Aug 28, 1987
AP + EQ 120MG BASE/100ML A062814 014 Aug 28, 1987
AP HOSPIRA EQ 1.2MG BASE/ML A062414 001 Aug 15, 1983
AP EQ 1.4MG BASE/ML A062414 002 Aug 15, 1983
AP EQ 1.6MG BASE/ML A062414 003 Aug 15, 1983
AP EQ 1.8MG BASE/ML A062414 004 Aug 15, 1983
AP EQ 2MG BASE/ML A062414 005 Aug 15, 1983
AP EQ 60MG BASE/100ML A062414 006 Aug 15, 1983
AP EQ 70MG BASE/100ML A062414 007 Aug 15, 1983
AP EQ 80MG BASE/100ML A062414 008 Aug 15, 1983
AP EQ 90MG BASE/100ML A062414 009 Aug 15, 1983
AP EQ 100MG BASE/100ML A062414 010 Aug 15, 1983
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 191 (of 393)

GENTAMICIN SULFATE
INJECTABLE; INJECTION
ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER
AP BAXTER HLTHCARE EQ 0.8MG BASE/ML A062373 001 Sep 07, 1982
AP EQ 1.2MG BASE/ML A062373 007 Sep 07, 1982
AP EQ 1.6MG BASE/ML A062373 008 Sep 07, 1982
AP EQ 2MG BASE/ML A062373 009 Sep 07, 1982
AP EQ 2.4MG BASE/ML A062373 010 Sep 07, 1982
AP EQ 40MG BASE/100ML A062373 003 Sep 07, 1982
AP EQ 60MG BASE/100ML A062373 004 Sep 07, 1982
AP EQ 80MG BASE/100ML A062373 002 Sep 07, 1982
AP EQ 100MG BASE/100ML A062373 005 Sep 07, 1982
AP EQ 120MG BASE/100ML A062373 006 Sep 07, 1982
OINTMENT; OPHTHALMIC
GENTAMICIN SULFATE
AT + AKORN EQ 0.3% BASE A064093 001 Aug 31, 1995
AT ALTANA EQ 0.3% BASE A065024 001 Jul 30, 2004
OINTMENT; TOPICAL
GENTAMICIN SULFATE
AT FOUGERA EQ 0.1% BASE A062533 001 Oct 05, 1984
AT + PERRIGO NEW YORK EQ 0.1% BASE A062351 001 Feb 18, 1982
AT TARO EQ 0.1% BASE A062477 001 Dec 23, 1983
SOLUTION/DROPS; OPHTHALMIC
GENOPTIC
AT ALLERGAN EQ 0.3% BASE A062452 001 Oct 10, 1984
GENTAK
AT AKORN EQ 0.3% BASE A064163 001 Oct 12, 2001
GENTAMICIN SULFATE
AT AKORN EQ 0.3% BASE A062635 001 Jan 08, 1987
AT ALTANA EQ 0.3% BASE A065121 001 Jan 30, 2004
AT + BAUSCH AND LOMB EQ 0.3% BASE A064048 001 May 11, 1994
AT FALCON PHARMS EQ 0.3% BASE A062196 001

GENTAMICIN SULFATE; PREDNISOLONE ACETATE


OINTMENT; OPHTHALMIC

PRED-G

XX + ALLERGAN EQ 0.3% BASE;0.6% N050612 001 Dec 01, 1989


SUSPENSION/DROPS; OPHTHALMIC

PRED-G

XX + ALLERGAN EQ 0.3% BASE;1% N050586 001 Jun 10, 1988

GLATIRAMER ACETATE
INJECTABLE; SUBCUTANEOUS

COPAXONE

XX + TEVA 20MG/ML N020622 002 Feb 12, 2002

GLIMEPIRIDE
TABLET; ORAL
AMARYL
AB + SANOFI AVENTIS US 1MG N020496 001 Nov 30, 1995
AB 2MG N020496 002 Nov 30, 1995
AB 4MG N020496 003 Nov 30, 1995
GLIMEPIRIDE
AB ACCORD HLTHCARE 1MG A078181 001 Aug 23, 2007
AB 2MG A078181 002 Aug 23, 2007
AB 4MG A078181 003 Aug 23, 2007
AB CARLSBAD 1MG A077911 001 Sep 22, 2009
AB 2MG A077911 002 Sep 22, 2009
AB 4MG A077911 003 Sep 22, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 192 (of 393)

GLIMEPIRIDE
TABLET; ORAL
GLIMEPIRIDE
AB COBALT 1MG A077280 001 Feb 03, 2006
AB 2MG A077280 002 Feb 03, 2006
AB 4MG A077280 003 Feb 03, 2006
AB COREPHARMA 1MG A077274 001 Oct 06, 2005
AB 2MG A077274 002 Oct 06, 2005
AB 4MG A077274 003 Oct 06, 2005
AB DR REDDYS LABS LTD 1MG A077091 001 Oct 06, 2005
AB 2MG A077091 002 Oct 06, 2005
AB 4MG A077091 003 Oct 06, 2005
AB GENPHARM 1MG A077486 001 Feb 10, 2006
AB 2MG A077486 002 Feb 10, 2006
AB 4MG A077486 003 Feb 10, 2006
AB INVAGEN PHARMS 1MG A077295 001 Oct 06, 2005
AB 2MG A077295 002 Oct 06, 2005
AB 4MG A077295 003 Oct 06, 2005
AB MYLAN 1MG A077624 001 Nov 28, 2005
AB 2MG A077624 002 Nov 28, 2005
AB 4MG A077624 003 Nov 28, 2005
AB RANBAXY 1MG A076875 001 Oct 06, 2005
AB 2MG A076875 002 Oct 06, 2005
AB 4MG A076875 003 Oct 06, 2005
AB TEVA 1MG A076802 001 Oct 06, 2005
AB 2MG A076802 002 Oct 06, 2005
AB 4MG A076802 003 Oct 06, 2005
GLIMEPIRIDE
XX RANBAXY 8MG A076875 004 Oct 06, 2005

GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE


TABLET; ORAL

DUETACT

XX + TAKEDA GLOBAL 2MG;30MG N021925 001 Jul 28, 2006


XX 4MG;30MG N021925 002 Jul 28, 2006

GLIMEPIRIDE; ROSIGLITAZONE MALEATE


TABLET; ORAL

AVANDARYL

XX + SB PHARMCO 1MG;4MG N021700 001 Nov 23, 2005


XX 2MG;4MG N021700 002 Nov 23, 2005
XX 2MG;8MG N021700 004 Mar 30, 2007
XX 4MG;4MG N021700 003 Nov 23, 2005
XX 4MG;8MG N021700 005 Mar 30, 2007

GLIPIZIDE
TABLET; ORAL
GLIPIZIDE
AB ALPHAPHARM 5MG A074438 001 Jun 20, 1995
AB 10MG A074438 002 Jun 20, 1995
AB APOTEX 5MG A075795 001 Jun 13, 2001
AB 10MG A075795 002 Jun 13, 2001
AB CARACO 5MG A077820 001 Jul 11, 2006
AB 10MG A077820 002 Jul 11, 2006
AB IVAX SUB TEVA PHARMS 5MG A074497 001 Aug 31, 1995
AB 10MG A074497 002 Aug 31, 1995
AB KALI LABS 5MG A074550 001 Sep 11, 1997
AB 10MG A074550 002 Sep 11, 1997
AB MYLAN 5MG A074226 001 May 10, 1994
AB 10MG A074226 002 May 10, 1994
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 193 (of 393)

GLIPIZIDE
TABLET; ORAL
GLIPIZIDE
AB SANDOZ 5MG A074305 001 Apr 07, 1995
AB 10MG A074305 002 Apr 07, 1995
AB WATSON LABS 5MG A074223 001 Feb 27, 1995
AB 5MG A074370 001 Nov 22, 1994
AB 10MG A074223 002 Feb 27, 1995
AB 10MG A074370 002 Nov 22, 1994
GLUCOTROL
AB PFIZER 5MG N017783 001 May 08, 1984
AB + 10MG N017783 002 May 08, 1984
TABLET, EXTENDED RELEASE; ORAL
GLIPIZIDE
AB WATSON LABS 2.5MG A076467 003 Mar 27, 2006
AB 5MG A076467 001 Sep 08, 2003
AB 10MG A076467 002 Nov 07, 2003
GLUCOTROL XL
AB PFIZER 2.5MG N020329 003 Aug 10, 1999
AB 5MG N020329 001 Apr 26, 1994
AB + 10MG N020329 002 Apr 26, 1994

GLIPIZIDE; METFORMIN HYDROCHLORIDE


TABLET; ORAL
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
AB CARACO 2.5MG;250MG A077620 001 Jan 11, 2008
AB 2.5MG;500MG A077620 002 Jan 11, 2008
AB 5MG;500MG A077620 003 Jan 11, 2008
AB COREPHARMA 2.5MG;250MG A077507 001 Oct 27, 2005
AB 2.5MG;500MG A077507 002 Oct 27, 2005
AB 5MG;500MG A077507 003 Oct 27, 2005
AB MYLAN 2.5MG;250MG A078083 001 Apr 12, 2007
AB 2.5MG;500MG A078083 002 Apr 12, 2007
AB 5MG;500MG A078083 003 Apr 12, 2007
AB TEVA PHARMS 2.5MG;250MG A077270 001 Oct 28, 2005
AB 2.5MG;500MG A077270 002 Oct 28, 2005
AB 5MG;500MG A077270 003 Oct 28, 2005
METAGLIP
AB BRISTOL MYERS SQUIBB 2.5MG;250MG N021460 001 Oct 21, 2002
AB 2.5MG;500MG N021460 002 Oct 21, 2002
AB + 5MG;500MG N021460 003 Oct 21, 2002

GLUCAGON HYDROCHLORIDE RECOMBINANT


INJECTABLE; INJECTION

GLUCAGEN

XX + NOVO NORDISK EQ 1MG BASE/VIAL N020918 001 Jun 22, 1998

GLUCAGON RECOMBINANT
INJECTABLE; INJECTION

GLUCAGON

XX + LILLY 1MG/VIAL N020928 001 Sep 11, 1998

GLUTAMINE
FOR SOLUTION; ORAL

NUTRESTORE

XX + NUTRITIONAL RESTART 5GM/PACKET N021667 001 Jun 10, 2004


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 194 (of 393)

GLYBURIDE
TABLET; ORAL
GLYBURIDE
AB ACTAVIS TOTOWA 1.5MG A075947 001 Nov 14, 2002
AB 3MG A075947 002 Nov 14, 2002
AB 6MG A075947 003 Nov 14, 2002
AB AUROBINDO PHARMA 1.25MG A077537 001 Oct 18, 2007
AB 2.5MG A077537 002 Oct 18, 2007
AB 5MG A077537 003 Oct 18, 2007
AB COREPHARMA 1.25MG A076257 001 Jun 27, 2002
AB 2.5MG A076257 002 Jun 27, 2002
AB 5MG A076257 003 Jun 27, 2002
AB TEVA 1.25MG A074388 001 Aug 29, 1995
AB 2.5MG A074388 002 Aug 29, 1995
AB + 5MG A074388 003 Aug 29, 1995
GLYBURIDE (MICRONIZED)
AB DAVA PHARMS INC 1.5MG A074591 001 Dec 22, 1997
AB 3MG A074591 002 Dec 22, 1997
AB 4.5MG A074591 003 Dec 22, 1997
AB 6MG A074591 004 Dec 22, 1997
AB HIKMA 1.5MG A075890 001 Jul 31, 2003
AB 3MG A075890 002 Jul 31, 2003
AB 6MG A075890 003 Jul 31, 2003
AB MYLAN 1.5MG A074792 001 Jun 26, 1998
AB 3MG A074792 002 Jun 26, 1998
AB 6MG A074792 003 Aug 17, 1999
AB TEVA 1.5MG A074686 001 Apr 20, 1999
AB 3MG A074686 002 Apr 20, 1999
AB 4.5MG A074686 003 Apr 20, 1999
AB 6MG A074686 004 Apr 20, 1999
GLYNASE
AB PHARMACIA AND UPJOHN 1.5MG N020051 001 Mar 04, 1992
AB 3MG N020051 002 Mar 04, 1992
AB + 6MG N020051 004 Sep 24, 1993
DIABETA
BX SANOFI AVENTIS US 1.25MG N017532 001 May 01, 1984
BX 2.5MG N017532 002 May 01, 1984
BX + 5MG N017532 003 May 01, 1984

GLYBURIDE; METFORMIN HYDROCHLORIDE


TABLET; ORAL
GLUCOVANCE
AB BRISTOL MYERS SQUIBB 1.25MG;250MG N021178 001 Jul 31, 2000
AB + 2.5MG;500MG N021178 002 Jul 31, 2000
AB 5MG;500MG N021178 003 Jul 31, 2000
GLYBURIDE AND METFORMIN HYDROCHLORIDE
AB ACTAVIS ELIZABETH 1.25MG;250MG A076716 001 Jun 28, 2005
AB 2.5MG;500MG A076716 002 Jun 28, 2005
AB 5MG;500MG A076716 003 Jun 28, 2005
AB AUROBINDO PHARMA 1.25MG;250MG A077870 001 Nov 14, 2007
AB 2.5MG;500MG A077870 002 Nov 14, 2007
AB 5MG;500MG A077870 003 Nov 14, 2007
AB COREPHARMA 1.25MG;250MG A076731 001 Nov 19, 2004
AB 2.5MG;500MG A076731 002 Nov 19, 2004
AB 5MG;500MG A076731 003 Nov 19, 2004
AB DR REDDYS LABS INC 1.25MG;250MG A079009 001 Jun 03, 2009
AB 2.5MG;500MG A079009 002 Jun 03, 2009
AB 5MG;500MG A079009 003 Jun 03, 2009
AB IVAX SUB TEVA PHARMS 1.25MG;250MG A076345 001 Feb 18, 2004
AB 2.5MG;500MG A076345 002 Feb 18, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 195 (of 393)

GLYBURIDE; METFORMIN HYDROCHLORIDE


TABLET; ORAL
GLYBURIDE AND METFORMIN HYDROCHLORIDE
AB IVAX SUB TEVA PHARMS 5MG;500MG A076345 003 Feb 18, 2004
AB TEVA 1.25MG;250MG A076821 001 Jan 27, 2005
AB 2.5MG;500MG A076821 002 Jan 27, 2005
AB 5MG;500MG A076821 003 Jan 27, 2005

GLYCINE
SOLUTION; IRRIGATION
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 1.5GM/100ML N017865 001
GLYCINE 1.5% IN PLASTIC CONTAINER
AT B BRAUN 1.5GM/100ML N016784 001
AT HOSPIRA 1.5GM/100ML N018315 001

GLYCOPYRROLATE
INJECTABLE; INJECTION
GLYCOPYRROLATE
AP LUITPOLD 0.2MG/ML A089335 001 Jul 23, 1986
ROBINUL
AP + BAXTER HLTHCARE 0.2MG/ML N017558 001
TABLET; ORAL
GLYCOPYRROLATE
AA COREPHARMA 1MG A040568 001 Dec 22, 2004
AA 2MG A040568 002 Dec 22, 2004
AA DR REDDYS LABS LTD 1MG A040847 001 Mar 21, 2008
AA 2MG A040847 002 Mar 21, 2008
AA KALI LABS 1MG A040653 001 Aug 31, 2006
AA 2MG A040653 002 Aug 31, 2006
AA RANBAXY 1MG A040844 001 Aug 18, 2009
AA 2MG A040844 002 Aug 18, 2009
AA VINTAGE 1MG A040821 001 Dec 29, 2008
AA 2MG A040821 002 Dec 29, 2008
AA WEST WARD 1MG A040836 001 Mar 05, 2009
AA 2MG A040836 002 Mar 05, 2009
ROBINUL
AA + SCIELE PHARMA INC 1MG N012827 001
ROBINUL FORTE
AA + SCIELE PHARMA INC 2MG N012827 002

GONADOTROPIN, CHORIONIC
INJECTABLE; INJECTION
CHORIONIC GONADOTROPIN
AP + APP PHARMS 10,000 UNITS/VIAL N017067 002
AP + FERRING 10,000 UNITS/VIAL N017016 007
PREGNYL
AP + ORGANON USA INC 10,000 UNITS/VIAL N017692 001

GOSERELIN ACETATE
IMPLANT; IMPLANTATION

ZOLADEX

XX + ASTRAZENECA EQ 3.6MG BASE N019726 001 Dec 29, 1989


XX + EQ 10.8MG BASE N020578 001 Jan 11, 1996

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


SOLUTION/DROPS; OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
AT + BAUSCH AND LOMB 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A064047 001 Jan 31, 1996
UNITS/ML
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 196 (of 393)

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


SOLUTION/DROPS; OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
AT PHARMAFORCE 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A065187 001 Oct 28, 2005
UNITS/ML
NEOSPORIN
AT + MONARCH PHARMS 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A060582 001
UNITS/ML

GRANISETRON
FILM, EXTENDED RELEASE; TRANSDERMAL

SANCUSO

XX + STRAKAN 3.1MG/24HR N022198 001 Sep 12, 2008

GRANISETRON HYDROCHLORIDE
INJECTABLE; INJECTION
GRANISETRON HYDROCHLORIDE
AP AKORN INC EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A079119 001 Sep 10, 2009
AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A079078 002 Sep 14, 2009
AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) A079078 001 Sep 14, 2009
AP APOTEX CORP EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A078197 001 Dec 31, 2007
AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) A078198 001 Jun 30, 2008
AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A078198 002 Jun 30, 2008
AP APP PHARMS EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A078522 001 Dec 31, 2007
AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A078090 001 Jun 30, 2008
AP BAXTER HLTHCARE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A077177 001 Dec 31, 2007
AP BEDFORD LABS EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A077913 001 Jun 26, 2008
AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A077186 001 Jun 30, 2008
AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) A077187 001 Jun 30, 2008
AP DR REDDYS LABS INC EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A078863 001 Jun 30, 2008
AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A078880 001 Jun 30, 2008
AP EBEWE PHARMA EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A078808 001 Apr 29, 2008
AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) A078835 001 Jun 30, 2008
AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A078835 002 Jun 30, 2008
AP SANDOZ EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A078534 001 Apr 30, 2009
AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) A078531 001 Apr 30, 2009
AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A078531 002 Apr 30, 2009
AP TEVA PARENTERAL EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A078392 001 Dec 31, 2007
AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) A077963 001 Jan 03, 2008
AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A077297 001 Jun 30, 2008
AP WATSON LABS EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A078262 001 Dec 31, 2007
AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) A078258 001 Jun 30, 2008
AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A078258 002 Jun 30, 2008
AP WOCKHARDT USA EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A078566 001 Feb 29, 2008
AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) A078564 001 Jun 30, 2008
AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A078565 001 Jun 30, 2008
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
AP APP PHARMS EQ 1MG BASE/ML (EQ 1MG BASE/ML) A078096 001 Jun 30, 2008
AP DR REDDYS LABS INC EQ 1MG BASE/ML (EQ 1MG BASE/ML) A078863 002 Jun 30, 2008
AP TEVA PARENTERAL EQ 1MG BASE/ML (EQ 1MG BASE/ML) A077165 001 Dec 31, 2007
GRANISTERON HYDROCHLORIDE
AP HIKMA FARMACEUTICA EQ 1MG BASE/ML (EQ 1MG BASE/ML) A078629 001 Dec 23, 2009
AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A078629 002 Dec 23, 2009
KYTRIL
AP + ROCHE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) N020239 003 Sep 17, 2004
AP + EQ 1MG BASE/ML (EQ 1MG BASE/ML) N020239 004 Mar 11, 1994
AP + EQ 4MG BASE/4ML (EQ 1MG BASE/ML) N020239 002 Mar 11, 1994
SOLUTION; ORAL

GRANISETRON HYDROCHLORIDE

XX + CYPRESS PHARM EQ 2MG BASE/10ML A078334 001 Feb 28, 2008


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 197 (of 393)

GRANISETRON HYDROCHLORIDE
TABLET; ORAL
GRANISETRON HYDROCHLORIDE
AB APOTEX INC EQ 1MG BASE A078843 001 Feb 27, 2008
AB BARR EQ 1MG BASE A078221 001 Dec 31, 2007
AB CIPLA LTD EQ 1MG BASE A078037 001 Feb 27, 2008
AB COREPHARMA EQ 1MG BASE A078260 001 Dec 31, 2007
AB DR REDDYS LABS LTD EQ 1MG BASE A078846 001 Feb 27, 2009
AB MYLAN EQ 1MG BASE A078725 001 Jan 30, 2008
AB NATCO PHARMA EQ 1MG BASE A078969 001 Jun 22, 2009
AB ORCHID HLTHCARE EQ 1MG BASE A078678 001 Feb 13, 2008
AB ROXANE EQ 1MG BASE A077842 001 Dec 31, 2007
AB TEVA PHARMS EQ 1MG BASE A078080 001 Dec 31, 2007
KYTRIL
AB + ROCHE EQ 1MG BASE N020305 001 Mar 16, 1995

GRISEOFULVIN, MICROCRYSTALLINE
SUSPENSION; ORAL
GRIFULVIN V
AB + ORTHONEUTROGENA 125MG/5ML A062483 001 Jan 26, 1984
GRISEOFULVIN
AB ACTAVIS MID ATLANTIC 125MG/5ML A065394 001 Jul 06, 2007
AB IVAX SUB TEVA PHARMS 125MG/5ML A065354 001 Sep 10, 2007
AB PERRIGO CO TENNESSEE 125MG/5ML A065200 001 Mar 02, 2005
TABLET; ORAL

GRIFULVIN V

XX + ORTHONEUTROGENA 500MG A062279 003

GRISEOFULVIN, ULTRAMICROCRYSTALLINE
TABLET; ORAL

GRIS-PEG

XX PEDINOL 125MG N050475 001


XX + 250MG N050475 002

GUANABENZ ACETATE
TABLET; ORAL
GUANABENZ ACETATE
XX IVAX SUB TEVA PHARMS EQ 4MG BASE A074149 001 Apr 07, 1995
XX + EQ 8MG BASE A074149 002 Apr 07, 1995

GUANFACINE HYDROCHLORIDE
TABLET; ORAL
GUANFACINE HYDROCHLORIDE
AB ACTAVIS TOTOWA EQ 1MG BASE A074673 001 Feb 28, 1997
AB EQ 2MG BASE A074673 002 Feb 28, 1997
AB AMNEAL PHARM EQ 1MG BASE A075109 001 Nov 25, 1998
AB EQ 2MG BASE A075109 002 Nov 25, 1998
AB MYLAN EQ 1MG BASE A074796 001 Jan 27, 1997
AB EQ 2MG BASE A074796 002 Jan 27, 1997
AB WATSON LABS EQ 1MG BASE A074145 001 Oct 17, 1995
AB EQ 2MG BASE A074145 002 Oct 17, 1995
TENEX
AB PROMIUS PHARMA EQ 1MG BASE N019032 001 Oct 27, 1986
AB + EQ 2MG BASE N019032 002 Nov 07, 1988
TABLET, EXTENDED RELEASE; ORAL
INTUNIV
XX SHIRE EQ 1MG BASE N022037 001 Sep 02, 2009
XX EQ 2MG BASE N022037 002 Sep 02, 2009
XX EQ 3MG BASE N022037 003 Sep 02, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 198 (of 393)

GUANFACINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL

INTUNIV

XX + SHIRE EQ 4MG BASE N022037 004 Sep 02, 2009

GUANIDINE HYDROCHLORIDE
TABLET; ORAL

GUANIDINE HYDROCHLORIDE

XX SCHERING 125MG N001546 001


HALCINONIDE
CREAM; TOPICAL

HALOG

XX + RANBAXY 0.1% N017556 001


OINTMENT; TOPICAL

HALOG

XX + RANBAXY 0.1% N017824 001


SOLUTION; TOPICAL

HALOG

XX RANBAXY 0.1% N017823 001


HALOBETASOL PROPIONATE
CREAM; TOPICAL
HALOBETASOL PROPIONATE
AB ALTANA 0.05% A077001 001 Dec 16, 2004
AB G AND W LABS 0.05% A078162 001 Apr 24, 2007
AB PERRIGO ISRAEL 0.05% A077123 001 Dec 16, 2004
AB TARO 0.05% A077227 001 Aug 04, 2005
ULTRAVATE
AB + RANBAXY 0.05% N019967 001 Dec 27, 1990
OINTMENT; TOPICAL
HALOBETASOL PROPIONATE
AB ACTAVIS MID ATLANTIC 0.05% A077109 001 Jun 14, 2005
AB ALTANA 0.05% A076903 001 Dec 16, 2004
AB G AND W LABS 0.05% A077721 001 Sep 07, 2006
AB PERRIGO 0.05% A076872 001 Dec 16, 2004
AB TARO 0.05% A076994 001 Dec 16, 2004
ULTRAVATE
AB + RANBAXY 0.05% N019968 001 Dec 17, 1990

HALOPERIDOL
TABLET; ORAL
HALOPERIDOL
AB MYLAN 0.5MG A070278 006 Jun 10, 1986
AB 1MG A070278 004 Jun 10, 1986
AB 2MG A070278 001 Jun 10, 1986
AB 5MG A070278 005 Jun 10, 1986
AB 10MG A070278 002 Jul 16, 2009
AB 20MG A070278 003 Jul 16, 2009
AB SANDOZ 0.5MG A071206 001 Nov 17, 1986
AB 1MG A071207 001 Nov 17, 1986
AB + 2MG A071208 001 Nov 17, 1986
AB 5MG A071209 001 Nov 17, 1986
AB 10MG A071210 001 Mar 11, 1988
AB 20MG A071211 001 Mar 11, 1988
AB ZYDUS PHARMS USA 5MG A077580 003 Nov 29, 2007
AB 10MG A077580 004 Nov 29, 2007
AB 20MG A077580 005 Nov 29, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 199 (of 393)

HALOPERIDOL DECANOATE
INJECTABLE; INJECTION
HALDOL
AO + ORTHO MCNEIL JANSSEN EQ 50MG BASE/ML N018701 001 Jan 14, 1986
AO + EQ 100MG BASE/ML N018701 002 Jan 31, 1997
HALOPERIDOL DECANOATE
AO APOTEX INC EQ 50MG BASE/ML A075440 001 Feb 28, 2000
AO EQ 100MG BASE/ML A075440 002 Feb 28, 2000
AO APP PHARMS EQ 50MG BASE/ML A074893 001 Dec 19, 1997
AO EQ 100MG BASE/ML A074893 002 Dec 19, 1997
AO BEDFORD EQ 50MG BASE/ML A074811 001 Jan 30, 1998
AO EQ 100MG BASE/ML A075305 001 Sep 28, 1998
AO TEVA PARENTERAL EQ 50MG BASE/ML A075393 001 May 11, 1999
AO EQ 100MG BASE/ML A075393 002 May 11, 1999

HALOPERIDOL LACTATE
CONCENTRATE; ORAL
HALOPERIDOL
AA PHARM ASSOC EQ 2MG BASE/ML A073037 001 Feb 26, 1993
AA SILARX EQ 2MG BASE/ML A073364 001 Sep 28, 1993
AA + TEVA PHARMS EQ 2MG BASE/ML A071617 001 Dec 01, 1988
INJECTABLE; INJECTION
HALDOL
AP + ORTHO MCNEIL JANSSEN EQ 5MG BASE/ML N015923 001
HALOPERIDOL
AP AKORN STRIDES EQ 5MG BASE/ML A078347 001 Sep 14, 2009
AP APOTEX INC EQ 5MG BASE/ML A076791 001 Aug 25, 2004
AP EQ 5MG BASE/ML A076828 001 Aug 25, 2004
AP APP PHARMS EQ 5MG BASE/ML A075689 001 Mar 09, 2001
AP BEDFORD EQ 5MG BASE/ML A075858 001 Jun 18, 2001
AP GLAND PHARMA LTD EQ 5MG BASE/ML A076774 001 Aug 25, 2004
AP TEVA PARENTERAL EQ 5MG BASE/ML A076035 001 Aug 29, 2001

HEPARIN SODIUM
INJECTABLE; INJECTION
HEPARIN SODIUM
AP + APP PHARMS 1,000 UNITS/ML N017029 001
AP + 5,000 UNITS/ML N017651 006
AP + 10,000 UNITS/ML N017029 003
AP + 20,000 UNITS/ML N017029 004
AP + BAXTER HLTHCARE 1,000 UNITS/ML N017037 001
AP + 5,000 UNITS/ML N017037 002
AP + 10,000 UNITS/ML N017037 003
AP HOSPIRA 5,000 UNITS/ML A088100 001 Apr 28, 1983
AP HOSPIRA INC 1,000 UNITS/ML A090571 001 Aug 31, 2009
AP 5,000 UNITS/ML A090571 002 Aug 31, 2009
AP 10,000 UNITS/ML A090571 003 Aug 31, 2009
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 200 UNITS/100ML N018609 001 Apr 28, 1982
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 200 UNITS/100ML N019953 001 Jul 20, 1992
AP HOSPIRA 200 UNITS/100ML N018916 010 Jun 23, 1989
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
AP HOSPIRA 10,000 UNITS/100ML N019339 003 Mar 27, 1985
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 200 UNITS/100ML N018609 002 Apr 28, 1982
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP HOSPIRA 200 UNITS/100ML N018916 011 Jun 23, 1989
HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 4,000 UNITS/100ML N018814 001 Oct 31, 1983
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 200 (of 393)

HEPARIN SODIUM
INJECTABLE; INJECTION
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 4,000 UNITS/100ML N019952 001 Jul 20, 1992
AP HOSPIRA 4,000 UNITS/100ML N019805 001 Jan 25, 1989
HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5,000 UNITS/100ML N018814 003 Jul 09, 1985
AP 10,000 UNITS/100ML N018814 004 Jul 02, 1987
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 5,000 UNITS/100ML N019952 004 Jul 20, 1992
AP 10,000 UNITS/100ML N019952 005 Jul 20, 1992
AP HOSPIRA 5,000 UNITS/100ML N019339 004 Mar 27, 1985
AP 5,000 UNITS/100ML N019805 002 Jan 25, 1989
AP 10,000 UNITS/100ML N019339 002 Mar 27, 1985
HEPARIN SODIUM IN PLASTIC CONTAINER
AP + APP PHARMS 1,000 UNITS/ML N017029 013 Dec 05, 1985
AP + 5,000 UNITS/ML N017029 014 Dec 05, 1985
AP + 10,000 UNITS/ML N017029 015 Dec 05, 1985
AP + 20,000 UNITS/ML N017029 016 Dec 05, 1985
HEPARIN SODIUM PRESERVATIVE FREE
AP + APP PHARMS 1,000 UNITS/ML N017029 010 Apr 28, 1986
AP + HOSPIRA 10,000 UNITS/ML A089522 001 May 04, 1987
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
XX HOSPIRA 5,000 UNITS/100ML N019339 001 Mar 27, 1985
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
XX HOSPIRA 5,000 UNITS/100ML N018916 006 Jan 31, 1984
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
XX HOSPIRA 5,000 UNITS/100ML N018916 007 Jan 31, 1984
XX 10,000 UNITS/100ML N018916 008 Jan 31, 1984
HEPARIN SODIUM PRESERVATIVE FREE
XX + HOSPIRA 2,000 UNITS/ML N005264 013 Apr 07, 1986
XX + 2,500 UNITS/ML N005264 014 Apr 07, 1986

HEXACHLOROPHENE
EMULSION; TOPICAL

PHISOHEX

XX + SANOFI AVENTIS US 3% N006882 001


SPONGE; TOPICAL
PRE-OP
AT + DAVIS AND GECK 480MG N017433 001
PRE-OP II
AT DAVIS AND GECK 480MG N017433 002

HISTRELIN ACETATE
IMPLANT; SUBCUTANEOUS

SUPPRELIN LA

XX + ENDO PHARM 50MG N022058 001 May 03, 2007


VANTAS
XX + ENDO PHARM 50MG N021732 001 Oct 12, 2004

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE


SYRUP; ORAL
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
AA ACTAVIS MID ATLANTIC 1.5MG/5ML;5MG/5ML A088017 001 Jul 05, 1983
AA + HI TECH PHARMA 1.5MG/5ML;5MG/5ML A040613 001 Feb 08, 2008
AA MORTON GROVE 1.5MG/5ML;5MG/5ML A088008 001 Mar 03, 1983
TABLET; ORAL

TUSSIGON

XX + KING PHARMS 1.5MG;5MG A088508 001 Jul 30, 1985


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 201 (of 393)

HYALURONIDASE
INJECTABLE; INJECTION

AMPHADASE

XX + AMPHASTAR PHARM 150 UNITS/ML N021665 001 Oct 26, 2004


HYDASE
XX + PRIMAPHARM 150 UNITS/ML N021716 001 Oct 25, 2005
VITRASE
XX + ISTA PHARMS 200 UNITS/VIAL N021640 002 Dec 02, 2004

HYALURONIDASE RECOMBINANT HUMAN


INJECTABLE; INJECTION

HYLENEX RECOMBINANT

XX + HALOZYME THERAP 150 UNITS/ML N021859 001 Dec 02, 2005

HYDRALAZINE HYDROCHLORIDE
INJECTABLE; INJECTION
HYDRALAZINE HYDROCHLORIDE
AP AKORN 20MG/ML A040730 001 Apr 21, 2009
AP APP PHARMS 20MG/ML A040388 001 Mar 13, 2001
AP + LUITPOLD 20MG/ML A040136 001 Jun 30, 1997
TABLET; ORAL
HYDRALAZINE HYDROCHLORIDE
AA GLENMARK PHARMS LTD 10MG A090527 001 May 27, 2009
AA 25MG A090527 002 May 27, 2009
AA 50MG A090527 003 May 27, 2009
AA 100MG A090527 004 May 27, 2009
AA HERITAGE PHARMS INC 25MG A086242 003
AA 50MG A086242 002
AA HETERO DRUGS LTD 10MG A040901 001 Sep 12, 2008
AA 25MG A040901 002 Sep 12, 2008
AA 50MG A040901 003 Sep 12, 2008
AA 100MG A040901 004 Sep 12, 2008
AA INVAGEN PHARMS 10MG A090255 001 Dec 15, 2008
AA 25MG A090255 002 Dec 15, 2008
AA 50MG A090255 003 Dec 15, 2008
AA 100MG A090255 004 Dec 15, 2008
AA PAR PHARM 10MG A087836 001 Oct 05, 1982
AA 25MG A086961 002
AA 50MG A086962 001
AA 100MG A088391 001 Sep 27, 1983
AA + PLIVA 10MG A089097 001 Dec 18, 1985
AA + 25MG A088467 001 May 01, 1984
AA + 50MG A088468 001 May 01, 1984
AA + 100MG A089098 001 Dec 18, 1985
AA WATSON LABS 25MG A084504 001
AA 50MG A084503 001

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE


CAPSULE; ORAL
HYDRA-ZIDE
XX PAR PHARM 25MG;25MG A088957 001 Oct 21, 1985
XX + 50MG;50MG A088946 001 Oct 21, 1985

HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE


TABLET; ORAL

BIDIL

XX + NITROMED 37.5MG;20MG N020727 001 Jun 23, 2005


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 202 (of 393)

HYDROCHLOROTHIAZIDE
CAPSULE; ORAL
HYDROCHLOROTHIAZIDE
AB APOTEX 12.5MG A078389 001 May 16, 2008
AB AUROBINDO PHARMA 12.5MG A078164 001 Sep 18, 2007
AB CADISTA PHARMS 12.5MG A078391 001 Feb 11, 2008
AB IPCA LABS LTD 12.5MG A079237 001 Apr 02, 2009
AB IVAX SUB TEVA PHARMS 12.5MG A077005 001 Jul 13, 2005
AB MYLAN 12.5MG A075640 001 Jan 28, 2000
AB VINTAGE PHARMS 12.5MG A075907 001 Sep 17, 2002
AB WEST WARD 12.5MG A077885 001 Nov 26, 2007
MICROZIDE
AB + WATSON LABS 12.5MG N020504 001 Dec 27, 1996
TABLET; ORAL
HYDROCHLOROTHIAZIDE
AB ACTAVIS ELIZABETH 12.5MG A040707 001 Feb 27, 2007
AB 25MG A085054 002
AB 50MG A085208 001
AB APOTEX 25MG A040774 001 Oct 03, 2007
AB 50MG A040774 002 Oct 03, 2007
AB AUROBINDO PHARMA 25MG A040780 001 Jul 20, 2007
AB 50MG A040780 002 Jul 20, 2007
AB CADISTA PHARMS 25MG A040809 001 Sep 04, 2007
AB 50MG A040809 002 Sep 04, 2007
AB CARACO 12.5MG A040857 001 May 30, 2008
AB 25MG A040810 001 Mar 27, 2007
AB 50MG A040810 002 Mar 27, 2007
AB DAVA PHARMS INC 25MG A087059 001
AB 50MG A087068 001
AB EXCELLIUM 25MG A040702 001 Mar 16, 2007
AB 50MG A040702 002 Mar 16, 2007
AB HERITAGE PHARMS INC 25MG A085182 002
AB 50MG A085182 001
AB IPCA LABS LTD 12.5MG A040807 001 Jul 20, 2007
AB 25MG A040807 002 Jul 20, 2007
AB 50MG A040807 003 Jul 20, 2007
AB IVAX SUB TEVA PHARMS 25MG A083177 001
AB 50MG A083177 002
AB LANNETT 25MG A084325 001
AB 50MG A084324 001
AB MYLAN 12.5MG A040770 001 Jan 23, 2007
AB 25MG A040735 002 Jan 23, 2007
AB + 50MG A040735 003 Jan 23, 2007
AB SANDOZ 50MG A085219 001
AB UNICHEM 25MG A040907 001 Aug 15, 2008
AB 50MG A040907 002 Aug 15, 2008
AB VINTAGE PHARMS 25MG A040412 001 Mar 29, 2002
AB 50MG A040412 002 Mar 29, 2002
AB WATSON LABS 25MG A081189 001 Jan 24, 1992
AB WEST WARD 25MG A084878 002 Jul 12, 2006
AB 50MG A084878 001
ORETIC
AB ABBOTT 50MG N011971 002

HYDROCHLOROTHIAZIDE; IRBESARTAN
TABLET; ORAL
AVALIDE
XX SANOFI AVENTIS US 12.5MG;150MG N020758 002 Sep 30, 1997
XX 12.5MG;300MG N020758 003 Aug 31, 1998
XX + 25MG;300MG N020758 004 Mar 15, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 203 (of 393)

HYDROCHLOROTHIAZIDE; LISINOPRIL
TABLET; ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDE
AB ACTAVIS ELIZABETH 12.5MG;10MG A076230 001 Jul 01, 2002
AB 12.5MG;20MG A076230 002 Jul 01, 2002
AB 25MG;20MG A076230 003 Jul 01, 2002
AB APOTEX INC 12.5MG;10MG A076674 001 Oct 05, 2004
AB 12.5MG;20MG A076674 002 Oct 05, 2004
AB 25MG;20MG A076674 003 Oct 05, 2004
AB AUROBINDO 12.5MG;10MG A077606 001 Mar 14, 2006
AB 12.5MG;20MG A077606 002 Mar 14, 2006
AB 25MG;20MG A077606 003 Mar 14, 2006
AB IVAX SUB TEVA PHARMS 12.5MG;10MG A075776 001 Jul 01, 2002
AB 12.5MG;20MG A075776 002 Jul 01, 2002
AB 25MG;20MG A075776 003 Jul 01, 2002
AB LUPIN 12.5MG;10MG A077912 001 Sep 27, 2006
AB 12.5MG;20MG A077912 002 Sep 27, 2006
AB 25MG;20MG A077912 003 Sep 27, 2006
AB MYLAN 12.5MG;10MG A076113 001 Jul 01, 2002
AB 12.5MG;20MG A076113 002 Jul 01, 2002
AB 25MG;20MG A076113 003 Jul 01, 2002
AB RANBAXY 12.5MG;10MG A076007 001 Jul 01, 2002
AB 12.5MG;20MG A076007 002 Jul 01, 2002
AB 25MG;20MG A076007 003 Jul 01, 2002
AB SANDOZ 12.5MG;10MG A076262 001 Jul 01, 2002
AB 12.5MG;20MG A076262 002 Jul 01, 2002
AB 25MG;20MG A076262 003 Jul 01, 2002
AB TEVA 12.5MG;10MG A075869 001 Jul 01, 2002
AB 12.5MG;20MG A075869 002 Jul 01, 2002
AB 25MG;20MG A075869 003 Jul 01, 2002
AB WATSON LABS 12.5MG;10MG A076194 003 Jul 01, 2002
AB 12.5MG;20MG A076194 001 Jul 01, 2002
AB 25MG;20MG A076194 002 Jul 01, 2002
AB WEST WARD 12.5MG;10MG A076265 001 Jul 08, 2002
AB 12.5MG;20MG A076265 002 Jul 08, 2002
AB 25MG;20MG A076265 003 Jul 08, 2002
PRINZIDE
AB MERCK 12.5MG;10MG N019778 003 Nov 18, 1993
AB 12.5MG;20MG N019778 001 Feb 16, 1989
ZESTORETIC
AB ASTRAZENECA 12.5MG;10MG N019888 003 Nov 18, 1993
AB + 12.5MG;20MG N019888 001 Sep 20, 1990
AB + 25MG;20MG N019888 002 Jul 20, 1989

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM


TABLET; ORAL
HYZAAR
XX MERCK 12.5MG;50MG N020387 001 Apr 28, 1995
XX 12.5MG;100MG N020387 003 Oct 20, 2005
XX + 25MG;100MG N020387 002 Nov 10, 1998

HYDROCHLOROTHIAZIDE; METHYLDOPA
TABLET; ORAL
METHYLDOPA AND HYDROCHLOROTHIAZIDE
XX MYLAN 15MG;250MG A070264 001 Jan 23, 1986
XX + 25MG;250MG A070265 001 Jan 23, 1986
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 204 (of 393)

HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE


TABLET; ORAL
LOPRESSOR HCT
AB NOVARTIS 25MG;50MG N018303 001 Dec 31, 1984
AB + 25MG;100MG N018303 002 Dec 31, 1984
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
AB MYLAN 25MG;50MG A076792 001 Aug 20, 2004
AB 25MG;100MG A076792 002 Aug 20, 2004
AB 50MG;100MG A076792 003 Aug 20, 2004

HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE


TABLET; ORAL
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
AB PADDOCK 12.5MG;7.5MG A090096 001 Sep 25, 2008
AB 12.5MG;15MG A090096 002 Sep 25, 2008
AB 25MG;15MG A090096 003 Sep 25, 2008
AB TEVA 12.5MG;7.5MG A076980 001 Mar 07, 2007
AB 12.5MG;15MG A076980 003 Mar 07, 2007
AB 25MG;15MG A076980 002 Mar 07, 2007
UNIRETIC
AB SCHWARZ PHARMA 12.5MG;7.5MG N020729 001 Jun 27, 1997
AB 12.5MG;15MG N020729 003 Feb 14, 2002
AB + 25MG;15MG N020729 002 Jun 27, 1997

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL


TABLET; ORAL
BENICAR HCT
XX DAIICHI SANKYO 12.5MG;20MG N021532 002 Jun 05, 2003
XX 12.5MG;40MG N021532 003 Jun 05, 2003
XX + 25MG;40MG N021532 005 Jun 05, 2003

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE


TABLET; ORAL
INDERIDE-40/25
AB + AKRIMAX PHARMS 25MG;40MG N018031 001
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
AB MYLAN 25MG;40MG A070946 001 Mar 04, 1987
AB + 25MG;80MG A070947 001 Apr 01, 1987
AB PLIVA 25MG;40MG A072042 001 Mar 14, 1988
AB 25MG;80MG A072043 001 Mar 14, 1988
AB WATSON LABS 25MG;40MG A070301 001 Apr 18, 1986
AB 25MG;80MG A070305 001 Apr 18, 1986

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE


TABLET; ORAL
ACCURETIC
AB PFIZER PHARMS 12.5MG;EQ 10MG BASE N020125 001 Dec 28, 1999
AB 12.5MG;EQ 20MG BASE N020125 002 Dec 28, 1999
AB + 25MG;EQ 20MG BASE N020125 003 Dec 28, 1999
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
AB AUROBINDO PHARMA 12.5MG;EQ 10MG BASE A078450 001 Aug 24, 2007
AB 12.5MG;EQ 20MG BASE A078450 002 Aug 24, 2007
AB 25MG;EQ 20MG BASE A078450 003 Aug 24, 2007
AB MYLAN 12.5MG;EQ 10MG BASE A077093 001 Mar 28, 2005
AB 12.5MG;EQ 20MG BASE A077093 002 Mar 28, 2005
AB 25MG;EQ 20MG BASE A077093 003 Mar 28, 2005
AB RANBAXY 12.5MG;EQ 10MG BASE A078211 001 Mar 04, 2009
AB 12.5MG;EQ 20MG BASE A078211 002 Mar 04, 2009
AB 25MG;EQ 20MG BASE A078211 003 Mar 04, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 205 (of 393)

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE


TABLET; ORAL
QUINARETIC
AB ACTAVIS TOTOWA 12.5MG;EQ 10MG BASE A076374 001 Mar 31, 2004
AB 12.5MG;EQ 20MG BASE A076374 002 Mar 31, 2004
AB 25MG;EQ 20MG BASE A076374 003 Mar 31, 2004

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
TABLET; ORAL
ALDACTAZIDE
AB GD SEARLE LLC 25MG;25MG N012616 004 Dec 30, 1982
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
AB MUTUAL PHARM 25MG;25MG A089534 001 Jul 02, 1987
AB MYLAN 25MG;25MG A086513 001
AB WATSON LABS 25MG;25MG A087398 001
ALDACTAZIDE
XX + GD SEARLE LLC 50MG;50MG N012616 005 Dec 30, 1982

HYDROCHLOROTHIAZIDE; TELMISARTAN
TABLET; ORAL
MICARDIS HCT
XX BOEHRINGER INGELHEIM 12.5MG;40MG N021162 001 Nov 17, 2000
XX 12.5MG;80MG N021162 002 Nov 17, 2000
XX + 25MG;80MG N021162 003 Apr 19, 2004

HYDROCHLOROTHIAZIDE; TRIAMTERENE
CAPSULE; ORAL
DYAZIDE
AB + GLAXOSMITHKLINE 25MG;37.5MG N016042 003 Mar 03, 1994
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
AB DURAMED PHARMS BARR 25MG;37.5MG A075052 001 Jun 18, 1999
AB IVAX SUB TEVA PHARMS 25MG;50MG A074259 001 Mar 30, 1995
AB MYLAN 25MG;37.5MG A074701 001 Jun 07, 1996
AB SANDOZ 25MG;37.5MG A074821 001 Jun 05, 1997
AB + 25MG;50MG A073191 001 Jul 31, 1991
TABLET; ORAL
MAXZIDE
AB + MYLAN BERTEK 50MG;75MG N019129 001 Oct 22, 1984
MAXZIDE-25
AB MYLAN BERTEK 25MG;37.5MG N019129 003 May 13, 1988
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
AB APOTEX INC 25MG;37.5MG A071251 002 May 05, 1998
AB 50MG;75MG A071251 001 Apr 17, 1988
AB PLIVA 25MG;37.5MG A074026 001 Apr 26, 1996
AB 50MG;75MG A073467 001 Jan 31, 1996
AB SANDOZ 25MG;37.5MG A073281 001 Apr 30, 1992
AB 50MG;75MG A072011 001 Jun 17, 1988
AB WATSON LABS 25MG;37.5MG A073449 001 Sep 23, 1993
AB 50MG;75MG A071851 001 Nov 30, 1988
AB 50MG;75MG A071969 001 Apr 17, 1988

HYDROCHLOROTHIAZIDE; VALSARTAN
TABLET; ORAL
DIOVAN HCT
XX NOVARTIS 12.5MG;80MG N020818 001 Mar 06, 1998
XX 12.5MG;160MG N020818 002 Mar 06, 1998
XX 12.5MG;320MG N020818 004 Apr 28, 2006
XX 25MG;160MG N020818 003 Jan 17, 2002
XX + 25MG;320MG N020818 005 Apr 28, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 206 (of 393)

HYDROCODONE BITARTRATE; IBUPROFEN


TABLET; ORAL
HYDROCODONE BITARTRATE AND IBUPROFEN
AB AMNEAL PHARMS NY 5MG;200MG A076642 002 Mar 18, 2004
AB 7.5MG;200MG A076642 001 Oct 12, 2004
AB TEVA 7.5MG;200MG A076023 001 Apr 11, 2003
AB VINTAGE PHARMS 5MG;200MG A077727 001 Nov 06, 2006
AB 7.5MG;200MG A077723 001 Nov 06, 2006
AB 10MG;200MG A077723 002 Nov 06, 2006
AB WATSON LABS FLORIDA 7.5MG;200MG A076604 001 Dec 31, 2003
VICOPROFEN
AB + ABBOTT 7.5MG;200MG N020716 001 Sep 23, 1997
REPREXAIN
XX AMNEAL PHARMS NY 2.5MG;200MG A076642 003 Oct 19, 2007
XX 10MG;200MG A076642 004 Oct 19, 2007

HYDROCORTISONE
CREAM; TOPICAL
ALA-CORT
AT DEL RAY LABS 1% A080706 006
ANUSOL HC
AT SALIX PHARMS 2.5% A088250 001 Jun 06, 1984
HYDROCORTISONE
AT ACTAVIS MID ATLANTIC 1% A087795 001 May 03, 1983
AT 2.5% A089682 001 Mar 10, 1988
AT FOUGERA 1% A080693 003
AT 2.5% A089414 001 Dec 16, 1986
AT PERRIGO NEW YORK 2.5% A085025 001
AT TARO 1% A086155 001
AT 2.5% A088799 001 Nov 09, 1984
AT VINTAGE PHARMS 2.5% A040503 001 Mar 12, 2004
HYTONE
AT + SANOFI AVENTIS US 1% A080472 003
AT + 2.5% A080472 004
SYNACORT
AT MEDICIS 1% A087458 001
AT 2.5% A087457 001
ENEMA; RECTAL
COLOCORT
AB PADDOCK 100MG/60ML A075172 001 Dec 03, 1999
CORTENEMA
AB + ANI PHARMS 100MG/60ML N016199 001
HYDROCORTISONE
AB TEVA PHARMS 100MG/60ML A074171 001 May 27, 1994
LOTION; TOPICAL
ALA-CORT
AT DEL RAY LABS 1% A083201 001
HYDROCORTISONE
AT ALTANA 2.5% A040351 001 Jul 25, 2000
AT TARO 2.5% A040247 001 Jul 23, 1999
AT VINTAGE PHARMS 2.5% A040417 001 Jul 30, 2003
HYTONE
AT + SANOFI AVENTIS US 1% A080473 003
AT + 2.5% A080473 004 Nov 30, 1982
NUTRACORT
AT CORIA 1% A080443 003
AT 2.5% A087644 001 Aug 24, 1982
STIE-CORT
AT PERRIGO 1% A089066 001 Nov 25, 1985
AT 2.5% A089074 001 Nov 26, 1985
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 207 (of 393)

HYDROCORTISONE
LOTION; TOPICAL

ALA-SCALP

XX DEL RAY LABS 2% A083231 001


OINTMENT; TOPICAL
HYDROCORTISONE
AT ACTAVIS MID ATLANTIC 1% A087796 001 Oct 13, 1982
AT ALTANA 1% A080692 001
AT FOUGERA 2.5% A081203 001 May 28, 1993
AT PERRIGO NEW YORK 2.5% A085027 001
AT TARO 1% A086257 001
AT 2.5% A040310 001 Dec 29, 2000
HYDROCORTISONE IN ABSORBASE
AT CAROLINA MEDCL 1% A088138 001 Sep 06, 1985
POWDER; FOR RX COMPOUNDING

HYDRO-RX

XX + X GEN PHARMS 100% A085982 001


TABLET; ORAL
CORTEF
AB PHARMACIA AND UPJOHN 5MG N008697 003
AB 10MG N008697 001
AB + 20MG N008697 002
HYDROCORTISONE
AB STIEFEL GSK 5MG A040646 001 Mar 30, 2007
AB 10MG A040646 002 Mar 30, 2007
AB 20MG A040646 003 Mar 30, 2007
AB VINTAGE 5MG A040761 001 Jul 16, 2007
AB 10MG A040761 002 Jul 16, 2007
AB 20MG A040761 003 Jul 16, 2007
HYDROCORTISONE
BP WEST WARD 20MG A083365 001

HYDROCORTISONE ACETATE
AEROSOL, METERED; RECTAL

CORTIFOAM

XX + SCHWARZ PHARMA 10% N017351 001 Feb 10, 1982


CREAM; TOPICAL

HYDROCORTISONE ACETATE

XX + FERNDALE LABS 2.5% A040259 001 Jul 29, 1999


MICORT-HC
XX + FERNDALE LABS 2% A040398 001 Mar 29, 2002
XX 2.5% A040396 001 Feb 27, 2001
PASTE; TOPICAL

ORABASE HCA

XX COLGATE 0.5% A083205 001


POWDER; FOR RX COMPOUNDING

HYDROCORTISONE ACETATE

XX X GEN PHARMS 100% A085981 001


HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


CREAM; TOPICAL

CORTISPORIN

XX + MONARCH PHARMS 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM N050218 001 Aug 09, 1985

HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE


AEROSOL, METERED; TOPICAL
EPIFOAM
BX SCHWARZ PHARMA 1%;1% A086457 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 208 (of 393)

HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE


AEROSOL, METERED; TOPICAL
PROCTOFOAM HC
BX UCB INC 1%;1% A086195 001
CREAM; TOPICAL

PRAMOSONE

XX FERNDALE LABS 0.5%;1% A083778 001


XX 1%;1% A085368 001


LOTION; TOPICAL

PRAMOSONE

XX FERNDALE LABS 1%;1% A085980 001


XX 2.5%;1% A085979 001


HYDROCORTISONE ACETATE; UREA


CREAM; TOPICAL
CARMOL HC
AT + NYCOMED US 1%;10% A080505 001
U-CORT
AT TARO 1%;10% A089472 001 Jun 13, 1988

HYDROCORTISONE BUTYRATE
CREAM; TOPICAL
HYDROCORTISONE BUTYRATE
AB TARO PHARM INDS 0.1% A076654 001 Aug 03, 2005
LOCOID
AB + TRIAX PHARMS LLC 0.1% N018514 001 Mar 31, 1982
LOCOID LIPOCREAM
XX + TRIAX PHARMS LLC 0.1% N020769 001 Sep 08, 1997
LOTION; TOPICAL

LOCOID

XX + TRIAX PHARMS LLC 0.1% N022076 001 May 18, 2007


OINTMENT; TOPICAL
HYDROCORTISONE BUTYRATE
AB TARO 0.1% A076842 001 Dec 27, 2004
LOCOID
AB + TRIAX PHARMS LLC 0.1% N018652 001 Oct 29, 1982
SOLUTION; TOPICAL
HYDROCORTISONE BUTYRATE
AT TARO PHARM INDS 0.1% A076364 001 Jan 14, 2004
LOCOID
AT + TRIAX PHARMS LLC 0.1% N019116 001 Feb 25, 1987

HYDROCORTISONE PROBUTATE
CREAM; TOPICAL

PANDEL

XX + SAVAGE LABS 0.1% N020453 001 Feb 28, 1997

HYDROCORTISONE SODIUM SUCCINATE


INJECTABLE; INJECTION
A-HYDROCORT
AP HOSPIRA EQ 100MG BASE/VIAL A040666 001 Apr 06, 2006
AP EQ 250MG BASE/VIAL A085930 001
AP EQ 500MG BASE/VIAL A085931 001
AP EQ 1GM BASE/VIAL A085932 001
SOLU-CORTEF
AP + PHARMACIA AND UPJOHN EQ 100MG BASE/VIAL N009866 001
AP + EQ 250MG BASE/VIAL N009866 002
AP + EQ 500MG BASE/VIAL N009866 003
AP + EQ 1GM BASE/VIAL N009866 004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 209 (of 393)

HYDROCORTISONE VALERATE
CREAM; TOPICAL
HYDROCORTISONE VALERATE
AB PERRIGO NEW YORK 0.2% A075666 001 May 24, 2000
AB TARO 0.2% A075042 001 Aug 25, 1998
WESTCORT
AB + RANBAXY 0.2% N017950 001
OINTMENT; TOPICAL
HYDROCORTISONE VALERATE
AB ALTANA 0.2% A075085 001 Jul 31, 2001
AB TARO 0.2% A075043 001 Aug 25, 1998
WESTCORT
AB + RANBAXY 0.2% N018726 001 Aug 08, 1983

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


SOLUTION/DROPS; OTIC
CORTISPORIN
AT + MONARCH PHARMS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N050479 001
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
AT ALCON 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062423 001 Aug 25, 1983
AT BAUSCH AND LOMB 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A064053 001 Dec 29, 1995
AT PHARMAFORCE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A065216 001 Oct 31, 2005
SUSPENSION/DROPS; OPHTHALMIC

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

XX + ALCON UNIVERSAL 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062874 001 May 11, 1988
SUSPENSION/DROPS; OTIC
CORTISPORIN
AT + MONARCH PHARMS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A060613 001
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
AT ALCON UNIVERSAL 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062488 001 Nov 06, 1985
AT PHARMAFORCE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A065219 001 May 01, 2006
OTICAIR
AT BAUSCH AND LOMB 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A064065 001 Aug 28, 1996
PEDIOTIC
AT MONARCH PHARMS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062822 001 Sep 29, 1987

HYDROFLUMETHIAZIDE
TABLET; ORAL
HYDROFLUMETHIAZIDE
AB PAR PHARM 50MG A088850 001 May 31, 1985
SALURON
AB + SHIRE 50MG N011949 001

HYDROMORPHONE HYDROCHLORIDE
INJECTABLE; INJECTION
DILAUDID-HP
AP + PURDUE PHARM PRODS 10MG/ML N019034 001 Jan 11, 1984
HYDROMORPHONE HYDROCHLORIDE
AP BARR 10MG/ML A076444 001 Apr 25, 2003
AP HOSPIRA 10MG/ML A074598 001 Jun 19, 1997
AP HOSPIRA INC 10MG/ML A078591 001 Jun 17, 2008
DILAUDID
XX + PURDUE PHARM PRODS 1MG/ML N019034 003 Apr 30, 2009
XX + 2MG/ML N019034 004 Apr 30, 2009
XX + 4MG/ML N019034 005 Apr 30, 2009
DILAUDID-HP
XX + PURDUE PHARM PRODS 250MG/VIAL N019034 002 Aug 04, 1994
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 210 (of 393)

HYDROMORPHONE HYDROCHLORIDE
SOLUTION; ORAL
DILAUDID
AA + PURDUE PHARM PRODS 5MG/5ML N019891 001 Dec 07, 1992
HYDROMORPHONE HYDROCHLORIDE
AA ROXANE 5MG/5ML A074653 001 Jul 29, 1998
TABLET; ORAL
DILAUDID
AB PURDUE PHARM PRODS 2MG N019892 003 Nov 09, 2007
AB 4MG N019892 002 Nov 09, 2007
AB + 8MG N019892 001 Dec 07, 1992
HYDROMORPHONE HYDROCHLORIDE
AB ACTAVIS TOTOWA 8MG A076723 001 Oct 18, 2005
AB KV PHARM 2MG A077311 001 Nov 09, 2005
AB 4MG A077311 002 Nov 09, 2005
AB 8MG A077311 003 Nov 09, 2005
AB LANNETT 2MG A078439 001 Dec 09, 2009
AB 4MG A078439 002 Dec 09, 2009
AB 8MG A077471 001 Dec 09, 2009
AB MALLINCKRODT 8MG A076855 001 Dec 23, 2004
AB ROXANE 4MG A074597 003 May 29, 2009
AB 8MG A074597 001 Jul 29, 1998
AB TYCO HLTHCARE 2MG A078273 001 Sep 19, 2007
AB 4MG A078273 002 Sep 19, 2007

HYDROXOCOBALAMIN
INJECTABLE; INJECTION

CYANOKIT

XX + MERCK SANTE SAS 2.5GM/VIAL (5GM/KIT) N022041 002 Dec 15, 2006
HYDROXOCOBALAMIN
XX + WATSON LABS 1MG/ML A085998 001

HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE


SOLUTION/DROPS; OPHTHALMIC

PAREMYD

XX + AKORN 1%;0.25% N019261 001 Jan 30, 1992

HYDROXYCHLOROQUINE SULFATE
TABLET; ORAL
HYDROXYCHLOROQUINE SULFATE
AB IPCA LABS LTD 200MG A040766 001 Jun 14, 2007
AB MYLAN 200MG A040274 001 May 29, 1998
AB SANDOZ 200MG A040104 001 Nov 30, 1995
AB 200MG A040150 001 Jan 27, 1996
AB TEVA PHARMS 200MG A040081 001 Sep 30, 1994
AB WATSON LABS 200MG A040133 001 Nov 30, 1995
AB WEST WARD 200MG A040760 001 Aug 15, 2007
AB ZYDUS PHARMS USA INC 200MG A040657 001 Sep 21, 2007
PLAQUENIL
AB + SANOFI AVENTIS US 200MG N009768 001

HYDROXYPROPYL CELLULOSE
INSERT; OPHTHALMIC

LACRISERT

XX + ATON 5MG N018771 001


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 211 (of 393)

HYDROXYUREA
CAPSULE; ORAL
HYDREA
AB + BRISTOL MYERS SQUIBB 500MG N016295 001
HYDROXYUREA
AB BARR 500MG A075143 001 Oct 16, 1998
AB PAR PHARM 500MG A075340 001 Feb 24, 1999
DROXIA
XX BRISTOL MYERS SQUIBB 200MG N016295 002 Feb 25, 1998
XX 300MG N016295 003 Feb 25, 1998
XX 400MG N016295 004 Feb 25, 1998

HYDROXYZINE HYDROCHLORIDE
INJECTABLE; INJECTION
HYDROXYZINE HYDROCHLORIDE
AP + APP PHARMS 25MG/ML A087329 001
AP + 50MG/ML A087329 002
AP LUITPOLD 25MG/ML A087408 001
AP 50MG/ML A087408 002
SYRUP; ORAL
HYDROXYZINE HYDROCHLORIDE
AA + HI TECH PHARMA 10MG/5ML A040010 001 Oct 28, 1994
AA + MORTON GROVE 10MG/5ML A087294 001 Apr 12, 1982
AA + VINTAGE PHARMS 10MG/5ML A040391 001 Apr 10, 2002
TABLET; ORAL
HYDROXYZINE HYDROCHLORIDE
AB ACTAVIS TOTOWA 10MG A040600 001 Dec 28, 2004
AB 25MG A040602 001 Dec 28, 2004
AB 50MG A040604 001 Dec 28, 2004
AB AMNEAL PHARM 10MG A040808 001 Sep 24, 2008
AB 25MG A040808 002 Sep 24, 2008
AB 50MG A040808 003 Sep 24, 2008
AB ANDAPHARM 10MG A040804 001 Jun 30, 2008
AB 25MG A040804 002 Jun 30, 2008
AB 50MG A040804 003 Jun 30, 2008
AB HETERO DRUGS LTD 10MG A040805 001 May 29, 2008
AB 25MG A040805 002 May 29, 2008
AB 50MG A040805 003 May 29, 2008
AB INVAGEN PHARMS 10MG A040812 001 Mar 12, 2008
AB 25MG A040812 002 Mar 12, 2008
AB 50MG A040812 003 Mar 12, 2008
AB KVK TECH 10MG A040786 001 Mar 20, 2007
AB 25MG A040787 001 Mar 20, 2007
AB 50MG A040788 001 Mar 20, 2007
AB MUTUAL PHARM 10MG A089381 001 May 19, 1986
AB 25MG A089382 001 May 19, 1986
AB 50MG A089383 001 May 19, 1986
AB NORTHSTAR HLTHCARE 10MG A040841 001 Mar 31, 2008
AB 25MG A040842 001 Mar 31, 2008
AB 50MG A040840 001 Mar 31, 2008
AB + PLIVA 10MG A088617 001 Jan 10, 1986
AB + 25MG A088618 001 Jan 10, 1986
AB + 50MG A088619 001 Jan 10, 1986
AB SUN PHARM INDS INC 10MG A040899 001 Jun 10, 2008
AB 25MG A040899 002 Jun 10, 2008
AB 50MG A040899 003 Jun 10, 2008
AB VINTAGE PHARMS 10MG A040579 001 May 27, 2005
AB 25MG A040574 001 May 27, 2005
AB 50MG A040580 001 May 27, 2005
AB WATSON LABS 10MG A081149 001 Mar 18, 1994
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 212 (of 393)

HYDROXYZINE HYDROCHLORIDE
TABLET; ORAL
HYDROXYZINE HYDROCHLORIDE
AB WATSON LABS 10MG A088348 001 Sep 15, 1983
AB 25MG A081150 001 Mar 18, 1994
AB 25MG A088349 001 Sep 15, 1983
AB 50MG A081151 001 Mar 18, 1994
AB 50MG A088350 001 Sep 15, 1983

HYDROXYZINE PAMOATE
CAPSULE; ORAL
HYDROXYZINE PAMOATE
AB BARR EQ 25MG HCL A088496 001 Jun 15, 1984
AB EQ 50MG HCL A088487 001 Jun 15, 1984
AB IVAX PHARMS EQ 25MG HCL A087761 001 Mar 05, 1982
AB EQ 50MG HCL A087760 001 Mar 05, 1982
AB SANDOZ EQ 25MG HCL A087479 001
AB EQ 50MG HCL A086183 001
AB WATSON LABS EQ 25MG HCL A040156 001 Jul 15, 1996
AB EQ 25MG HCL A081165 001 Jul 31, 1991
AB EQ 50MG HCL A040156 002 Jul 15, 1996
VISTARIL
AB PFIZER EQ 25MG HCL N011459 002
AB + EQ 50MG HCL N011459 004
HYDROXYZINE PAMOATE
XX BARR EQ 100MG HCL A088488 001 Jun 15, 1984
SUSPENSION; ORAL

VISTARIL

XX + PFIZER EQ 25MG HCL/5ML N011795 001

IBANDRONATE SODIUM
INJECTABLE; INTRAVENOUS

BONIVA

XX + ROCHE EQ 3MG BASE/3ML N021858 001 Jan 06, 2006


TABLET; ORAL

BONIVA

XX + ROCHE EQ 150MG BASE N021455 002 Mar 24, 2005

IBUPROFEN
SOLUTION; INTRAVENOUS
CALDOLOR
XX CUMBERLAND PHARMS 400MG/4ML (100MG/ML) N022348 001 Jun 11, 2009
XX + 800MG/8ML (100MG/ML) N022348 002 Jun 11, 2009
SUSPENSION; ORAL
IBUPROFEN
AB + ACTAVIS MID ATLANTIC 100MG/5ML A074978 001 Mar 25, 1998
AB PERRIGO R AND D 100MG/5ML A076925 001 Sep 23, 2004
TABLET; ORAL
IBUPROFEN
AB AMNEAL PHARMS NY 400MG A071334 001 Nov 25, 1986
AB 400MG A078558 001 Jun 18, 2007
AB 600MG A071335 001 Nov 25, 1986
AB 600MG A078558 002 Jun 18, 2007
AB 800MG A071935 001 Oct 13, 1987
AB 800MG A078558 003 Jun 18, 2007
AB DR REDDYS LA 400MG A075682 001 Nov 14, 2001
AB 600MG A075682 002 Nov 14, 2001
AB + 800MG A075682 003 Nov 14, 2001
AB DR REDDYS LABS INC 400MG A076112 001 Oct 31, 2001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 213 (of 393)

IBUPROFEN
TABLET; ORAL
IBUPROFEN
AB DR REDDYS LABS INC 600MG A076112 002 Oct 31, 2001
AB 800MG A076112 003 Oct 31, 2001
AB LEINER 400MG A071267 001 Oct 15, 1986
AB 600MG A071268 001 Oct 15, 1986
AB 800MG A072300 001 Jul 01, 1988
AB NORTHSTAR HLTHCARE 400MG A078132 001 Sep 10, 2007
AB 600MG A078132 002 Sep 10, 2007
AB 800MG A078132 003 Sep 10, 2007
AB OHM LABS 400MG A070818 001 Dec 26, 1985
AB PERRIGO R AND D 400MG A077114 001 Jul 18, 2005
AB 600MG A077114 002 Jul 18, 2005
AB 800MG A077114 003 Jul 18, 2005
AB SHASUN USA 400MG A078329 001 Feb 05, 2009
AB 600MG A078329 002 Feb 05, 2009
AB 800MG A078329 003 Feb 05, 2009
AB VINTAGE PHARMS 300MG A071230 001 Oct 22, 1986
AB 400MG A071231 001 Oct 22, 1986
AB 400MG A071644 001 Feb 01, 1988
AB 600MG A071232 001 Oct 22, 1986
AB 800MG A072004 001 Nov 18, 1987
AB WATSON LABS 400MG A070436 001 Aug 21, 1985
AB 600MG A070437 001 Aug 21, 1985
IBUPROHM
AB OHM LABS 400MG A070469 001 Aug 29, 1985
IBU-TAB
AB ALRA 400MG A071058 001 Aug 11, 1988
AB 600MG A071059 001 Aug 11, 1988

IBUPROFEN LYSINE
INJECTABLE; INTRAVENOUS

NEOPROFEN

XX + LUNDBECK INC EQ 20MG BASE/2ML (EQ 10MG BASE/ML) N021903 001 Apr 13, 2006

IBUPROFEN; OXYCODONE HYDROCHLORIDE


TABLET; ORAL
COMBUNOX
AB + FOREST LABS 400MG;5MG N021378 001 Nov 26, 2004
OXYCODONE HYDROCHLORIDE AND IBUPROFEN
AB ACTAVIS ELIZABETH 400MG;5MG A078769 001 Jan 04, 2008
AB BARR 400MG;5MG A078316 001 Nov 29, 2007
AB WATSON LABS 400MG;5MG A078394 001 Nov 26, 2007

IBUTILIDE FUMARATE
INJECTABLE; INJECTION
CORVERT
AP + PHARMACIA AND UPJOHN 0.1MG/ML N020491 001 Dec 28, 1995
IBUTILIDE FUMARATE
AP BIONICHE PHARMA USA 0.1MG/ML A090643 001 Jan 11, 2010
AP GENERAMEDIX 0.1MG/ML A090924 001 Jan 11, 2010
AP PHARMAFORCE 0.1MG/ML A090240 001 Jan 11, 2010

ICODEXTRIN
SOLUTION; INTRAPERITONEAL

EXTRANEAL

XX + BAXTER HLTHCARE 7.5GM/100ML N021321 001 Dec 20, 2002


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 214 (of 393)

IDARUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION

IDAMYCIN PFS

AP + PHARMACIA AND UPJOHN 1MG/ML N050734 001 Feb 17, 1997


IDARUBICIN HYDROCHLORIDE
AP APP PHARMS 1MG/ML A065440 001 Aug 04, 2009
AP BEDFORD LABS 1MG/ML A065275 001 Dec 14, 2006
AP 1MG/ML A065288 001 May 15, 2007
IDARUBICIN HYDROCHLORIDE PFS
AP TEVA PARENTERAL 1MG/ML A065036 001 May 01, 2002
IDARUBICIN HYDROCHLORIDE
XX + TEVA PARENTERAL 5MG/VIAL A065037 003 May 01, 2002
XX + 10MG/VIAL A065037 002 May 01, 2002
XX + 20MG/VIAL A065037 001 May 01, 2002

IDOXURIDINE
SOLUTION/DROPS; OPHTHALMIC
DENDRID
AT + ALCON 0.1% N014169 001
HERPLEX
AT + ALLERGAN 0.1% N013935 002

IFOSFAMIDE
INJECTABLE; INJECTION
IFOSFAMIDE
AP + APP PHARMS 1GM/VIAL A076078 001 May 28, 2002
AP 1GM/VIAL A090181 001 Sep 22, 2009
AP + 3GM/VIAL A076078 002 May 28, 2002
AP 3GM/VIAL A090181 002 Sep 22, 2009
IFOSFAMIDE
XX + TEVA PARENTERAL 1GM/20ML (50MG/ML) A076657 001 Apr 04, 2007
XX + 3GM/60ML (50MG/ML) A076657 002 Apr 04, 2007

IFOSFAMIDE; MESNA
INJECTABLE; INJECTION

IFEX/MESNEX KIT

XX + BAXTER HLTHCARE 1GM/VIAL;100MG/ML N019763 003 Oct 10, 1992


XX + 3GM/VIAL;100MG/ML N019763 004 Oct 10, 1992
INJECTABLE; INTRAVENOUS

IFOSFAMIDE/MESNA KIT

XX + TEVA PARENTERAL 1GM/20ML;1GM/10ML (50MG/ML;100MG/ML) A075874 001 Feb 26, 2002


XX + 3GM/60ML;1GM/10ML (50MG/ML;100MG/ML) A075874 002 Feb 26, 2002

ILOPERIDONE
TABLET; ORAL
FANAPT
XX VANDA PHARMS INC 1MG N022192 001 May 06, 2009
XX 2MG N022192 002 May 06, 2009
XX 4MG N022192 003 May 06, 2009
XX 6MG N022192 004 May 06, 2009
XX 8MG N022192 005 May 06, 2009
XX 10MG N022192 006 May 06, 2009
XX + 12MG N022192 007 May 06, 2009

ILOPROST
SOLUTION; INHALATION

VENTAVIS

XX + ACTELION PHARMS LTD 10MCG/ML (10MCG/ML) N021779 002 Dec 08, 2005
XX + 20MCG/2ML (10MCG/ML) N021779 001 Dec 29, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 215 (of 393)

IMATINIB MESYLATE
TABLET; ORAL
GLEEVEC
XX NOVARTIS EQ 100MG BASE N021588 001 Apr 18, 2003
XX + EQ 400MG BASE N021588 002 Apr 18, 2003

IMIGLUCERASE
INJECTABLE; INJECTION
CEREZYME
XX GENZYME 200 UNITS/VIAL N020367 001 May 23, 1994
XX + 400 UNITS/VIAL N020367 002 Sep 22, 1999

IMIPRAMINE HYDROCHLORIDE
TABLET; ORAL
IMIPRAMINE HYDROCHLORIDE
AB ACTAVIS TOTOWA 10MG A040753 001 Feb 28, 2008
AB 25MG A040752 001 Feb 28, 2008
AB 50MG A040751 001 Feb 28, 2008
AB MUTUAL PHARM 10MG A081048 001 Jun 05, 1990
AB 25MG A081049 001 Jun 05, 1990
AB 50MG A081050 001 Jun 05, 1990
AB PAR PHARM 10MG A088292 001 Oct 21, 1983
AB 10MG A089422 001 Jul 14, 1987
AB 25MG A088262 001 Oct 21, 1983
AB SANDOZ 10MG A084936 002
AB 25MG A083745 001
AB 50MG A084937 001
TOFRANIL
AB TYCO HLTHCARE 10MG A087844 001 May 22, 1984
AB 25MG A087845 001 May 22, 1984
AB + 50MG A087846 001 May 22, 1984

IMIPRAMINE PAMOATE
CAPSULE; ORAL

TOFRANIL-PM

XX + TYCO HLTHCARE EQ 75MG HCL N017090 001


XX EQ 100MG HCL N017090 004


XX EQ 125MG HCL N017090 003


XX EQ 150MG HCL N017090 002


IMIQUIMOD
CREAM; TOPICAL

ALDARA

XX + GRACEWAY 5% N020723 001 Feb 27, 1997

INAMRINONE LACTATE
INJECTABLE; INJECTION
AMRINONE LACTATE
AP BAXTER HLTHCARE CORP EQ 5MG BASE/ML A075542 001 May 10, 2000
AP + BEDFORD EQ 5MG BASE/ML A075513 001 May 09, 2000

INDAPAMIDE
TABLET; ORAL
INDAPAMIDE
AB ACTAVIS ELIZABETH 1.25MG A074722 001 Jun 17, 1996
AB 2.5MG A074722 002 Jun 17, 1996
AB ALPHAPHARM 1.25MG A075105 001 Jul 23, 1998
AB 2.5MG A075105 002 Jul 23, 1998
AB IVAX SUB TEVA PHARMS 1.25MG A074299 002 Apr 29, 1996
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 216 (of 393)

INDAPAMIDE
TABLET; ORAL
INDAPAMIDE
AB IVAX SUB TEVA PHARMS 2.5MG A074299 001 Jul 27, 1995
AB MYLAN 1.25MG A074461 002 Mar 26, 1997
AB + 2.5MG A074461 001 Mar 27, 1996
AB SANDOZ 1.25MG A074594 001 May 23, 1996
AB 2.5MG A074594 002 May 23, 1996
AB WATSON LABS 1.25MG A074585 001 Sep 26, 1996
AB 2.5MG A074585 002 Sep 26, 1996

INDINAVIR SULFATE
CAPSULE; ORAL
CRIXIVAN
XX MERCK SHARP DOHME EQ 100MG BASE N020685 006 Apr 19, 2000
XX EQ 200MG BASE N020685 003 Mar 13, 1996
XX + EQ 400MG BASE N020685 001 Mar 13, 1996

INDIUM IN-111 CHLORIDE


INJECTABLE; INJECTION

INDICLOR

XX + GE HEALTHCARE 2mCi/0.2ML N019862 001 Dec 29, 1992


INDIUM IN 111 CHLORIDE
XX + MALLINCKRODT 5mCi/0.5ML N019841 001 Sep 27, 1994

INDIUM IN-111 OXYQUINOLINE


INJECTABLE; INJECTION

INDIUM IN-111 OXYQUINOLINE


XX + GE HEALTHCARE 1mCi/ML N019044 001 Dec 24, 1985

INDIUM IN-111 PENTETATE DISODIUM


INJECTABLE; INTRATHECAL

MPI INDIUM DTPA IN 111


XX + GE HEALTHCARE 1mCi/ML N017707 001 Feb 18, 1982

INDIUM IN-111 PENTETREOTIDE KIT


INJECTABLE; INJECTION

OCTREOSCAN

XX + MALLINCKRODT 3mCi/ML N020314 001 Jun 02, 1994

INDOCYANINE GREEN
INJECTABLE; INJECTION
IC-GREEN
AP + AKORN 25MG/VIAL N011525 001
INDOCYANINE GREEN
AP PULSION MEDCL 25MG/VIAL A040811 001 Nov 21, 2007

INDOMETHACIN
CAPSULE; ORAL
INDOMETHACIN
AB IVAX SUB TEVA PHARMS 25MG A070719 001 Feb 12, 1986
AB 50MG A070756 001 Feb 12, 1986
AB MYLAN 25MG N018858 001 Apr 20, 1984
AB + 50MG A070624 001 Sep 04, 1985
AB SANDOZ 25MG A070673 001 Apr 29, 1987
AB 50MG A070674 001 Apr 29, 1987
CAPSULE, EXTENDED RELEASE; ORAL
INDOCIN SR
AB + SANDOZ 75MG A074464 001 May 28, 1998
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 217 (of 393)

INDOMETHACIN
CAPSULE, EXTENDED RELEASE; ORAL
INDOMETHACIN
AB AVANTHI INC 75MG A079175 001 Mar 06, 2009
SUPPOSITORY; RECTAL

INDOMETHACIN

XX + G AND W LABS 50MG A073314 001 Aug 31, 1992


SUSPENSION; ORAL

INDOCIN

XX + IROKO PHARMS 25MG/5ML N018332 001 Oct 10, 1985

INDOMETHACIN SODIUM
INJECTABLE; INJECTION
INDOCIN
AP + LUNDBECK INC EQ 1MG BASE/VIAL N018878 001 Jan 30, 1985
INDOMETHACIN SODIUM
AP BEDFORD EQ 1MG BASE/VIAL A078713 001 Jul 16, 2008

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT


INJECTABLE; SUBCUTANEOUS

NOVOLOG MIX 70/30


XX + NOVO NORDISK INC 70 UNITS/ML;30 UNITS/ML N021172 001 Nov 01, 2001

INSULIN ASPART RECOMBINANT


INJECTABLE; SUBCUTANEOUS

NOVOLOG

XX + NOVO NORDISK INC 100 UNITS/ML N020986 001 Jun 07, 2000

INSULIN DETEMIR RECOMBINANT


INJECTABLE; SUBCUTANEOUS

LEVEMIR

XX + NOVO NORDISK INC 100 UNITS/ML N021536 001 Jun 16, 2005

INSULIN GLARGINE RECOMBINANT


INJECTABLE; INJECTION

LANTUS

XX + SANOFI AVENTIS US 100 UNITS/ML N021081 001 Apr 20, 2000

INSULIN GLULISINE RECOMBINANT


INJECTABLE; IV (INFUSION)-SC

APIDRA

XX + SANOFI AVENTIS US 1000 UNITS/10ML (100 UNITS/ML) N021629 001 Apr 16, 2004
XX + 300 UNITS/3ML (100 UNITS/ML) N021629 002 Dec 20, 2005
INJECTABLE; SUBCUTANEOUS
APIDRA SOLOSTAR
XX SANOFI AVENTIS US 300 UNITS/3ML N021629 003 Feb 24, 2009

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT


INJECTABLE; INJECTION

HUMALOG MIX 50/50

XX + LILLY 50 UNITS/ML;50 UNITS/ML N021018 001 Dec 22, 1999


HUMALOG MIX 50/50 KWIKPEN
XX + LILLY 50 UNITS/ML;50 UNITS/ML N021018 002 Sep 06, 2007
HUMALOG MIX 75/25
XX + LILLY 75 UNITS/ML;25 UNITS/ML N021017 001 Dec 22, 1999
HUMALOG MIX 75/25 KWIKPEN
XX + LILLY 75 UNITS/ML;25 UNITS/ML N021017 002 Sep 06, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 218 (of 393)

INSULIN LISPRO RECOMBINANT


INJECTABLE; INJECTION

HUMALOG

XX + LILLY 100 UNITS/ML N020563 001 Jun 14, 1996


HUMALOG KWIKPEN
XX + LILLY 100 UNITS/ML N020563 003 Sep 06, 2007
HUMALOG PEN
XX + LILLY 100 UNITS/ML N020563 002 Aug 06, 1998

INSULIN RECOMBINANT HUMAN


INJECTABLE; INJECTION

HUMULIN R

XX + LILLY 500 UNITS/ML N018780 004 Mar 31, 1994

IOBENGUANE SULFATE I 123


SOLUTION; INTRAVENOUS

ADREVIEW

XX + GE HEALTHCARE 10MCI/5ML (2MCI/ML) N022290 001 Sep 19, 2008

IODIPAMIDE MEGLUMINE
INJECTABLE; INJECTION

CHOLOGRAFIN MEGLUMINE

XX + BRACCO 52% N009321 003

IODIXANOL
INJECTABLE; INJECTION

VISIPAQUE 270

XX + GE HEALTHCARE 55% N020351 001 Mar 22, 1996


XX 55% N020808 001 Aug 29, 1997
VISIPAQUE 320
XX + GE HEALTHCARE 65.2% N020351 002 Mar 22, 1996
XX 65.2% N020808 002 Aug 29, 1997

IOHEXOL
INJECTABLE; INJECTION

OMNIPAQUE 140

XX + GE HEALTHCARE 30.2% N018956 005 Nov 30, 1988


SOLUTION; INJECTION, ORAL

OMNIPAQUE 350

XX + GE HEALTHCARE 75.5% N018956 004 Dec 26, 1985


XX 75.5% N020608 003 Oct 24, 1995
SOLUTION; INJECTION, ORAL, RECTAL

OMNIPAQUE 180

XX + GE HEALTHCARE 38.8% N018956 001 Dec 26, 1985


OMNIPAQUE 240
XX + GE HEALTHCARE 51.8% N018956 002 Dec 26, 1985
XX 51.8% N020608 001 Oct 24, 1995
OMNIPAQUE 300
XX + GE HEALTHCARE 64.7% N018956 003 Dec 26, 1985
XX 64.7% N020608 002 Oct 24, 1995

IOPAMIDOL
INJECTABLE; INJECTION
IOPAMIDOL-200
AP HOSPIRA 41% A074898 001 Dec 30, 1997
IOPAMIDOL-200 IN PLASTIC CONTAINER
AP HOSPIRA 41% A074636 001 Dec 30, 1997
IOPAMIDOL-250
AP APP PHARMS 51% A074679 001 Apr 02, 1997
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 219 (of 393)

IOPAMIDOL
INJECTABLE; INJECTION
IOPAMIDOL-250
AP HOSPIRA 51% A074898 002 Dec 30, 1997
AP 51% A075005 001 Feb 24, 1998
IOPAMIDOL-250 IN PLASTIC CONTAINER
AP HOSPIRA 51% A074636 002 Dec 30, 1997
IOPAMIDOL-300
AP APP PHARMS 61% A074679 002 Apr 02, 1997
AP HOSPIRA 61% A074898 003 Dec 30, 1997
AP 61% A075005 002 Feb 24, 1998
IOPAMIDOL-300 IN PLASTIC CONTAINER
AP HOSPIRA 61% A074636 003 Dec 30, 1997
AP 61% A074637 001 Apr 03, 1997
IOPAMIDOL-370
AP APP PHARMS 76% A074679 003 Apr 02, 1997
AP HOSPIRA 76% A074898 004 Dec 30, 1997
AP 76% A075005 003 Feb 24, 1998
IOPAMIDOL-370 IN PLASTIC CONTAINER
AP HOSPIRA 76% A074636 004 Dec 30, 1997
ISOVUE-200
AP + BRACCO 41% N018735 006 Jul 07, 1987
ISOVUE-250
AP + BRACCO 51% N018735 007 Jul 06, 1992
AP + 51% N020327 002 Oct 12, 1994
ISOVUE-300
AP + BRACCO 61% N018735 002 Dec 31, 1985
AP + 61% N020327 003 Oct 12, 1994
ISOVUE-370
AP + BRACCO 76% N018735 003 Dec 31, 1985
AP + 76% N020327 004 Oct 12, 1994
ISOVUE-M 200
XX + BRACCO 41% N018735 001 Dec 31, 1985
ISOVUE-M 300
XX + BRACCO 61% N018735 004 Dec 31, 1985

IOPROMIDE
INJECTABLE; INJECTION

ULTRAVIST (PHARMACY BULK)


XX + BAYER HLTHCARE 49.9% N021425 003 Mar 12, 2004


XX + 62.3% N021425 001 Sep 20, 2002
XX + 76.9% N021425 002 Sep 20, 2002
ULTRAVIST 150
XX + BAYER HLTHCARE 31.2% N020220 004 May 10, 1995
ULTRAVIST 240
XX + BAYER HLTHCARE 49.9% N020220 003 May 10, 1995
ULTRAVIST 300
XX + BAYER HLTHCARE 62.3% N020220 002 May 10, 1995
ULTRAVIST 300 IN PLASTIC CONTAINER
XX + BAYER HLTHCARE 62.3% N020220 005 Nov 18, 2008
ULTRAVIST 370
XX + BAYER HLTHCARE 76.9% N020220 001 May 10, 1995

IOTHALAMATE MEGLUMINE
INJECTABLE; INJECTION

CONRAY

XX + MALLINCKRODT 60% N013295 001


CONRAY 30

XX + MALLINCKRODT 30% N016983 001


CONRAY 43

XX + MALLINCKRODT 43% N013295 002


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 220 (of 393)

IOTHALAMATE MEGLUMINE
SOLUTION; INTRAVESICAL

CYSTO-CONRAY II

XX MALLINCKRODT 17.2% N017057 002


IOVERSOL
INJECTABLE; INJECTION

OPTIRAY 160

XX + MALLINCKRODT 34% N019710 003 Dec 30, 1988


OPTIRAY 240
XX + MALLINCKRODT 51% N019710 002 Dec 30, 1988
OPTIRAY 300
XX + MALLINCKRODT 64% N019710 004 Jan 22, 1992
XX + 64% N020923 004 May 13, 1999
OPTIRAY 320
XX + MALLINCKRODT 68% N019710 001 Dec 30, 1988
OPTIRAY 350
XX + MALLINCKRODT 74% N019710 005 Jan 22, 1992
XX + 74% N020923 003 May 28, 1998

IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM


INJECTABLE; INJECTION

HEXABRIX

XX + GUERBET 39.3%;19.6% N018905 002 Jul 26, 1985

IOXILAN
INJECTABLE; INJECTION
OXILAN-300
XX GUERBET 62% N020316 001 Dec 21, 1995
OXILAN-350
XX GUERBET 73% N020316 002 Dec 21, 1995

IPRATROPIUM BROMIDE
AEROSOL, METERED; INHALATION

ATROVENT HFA

XX + BOEHRINGER INGELHEIM 0.021MG/INH N021527 001 Nov 27, 2004


SOLUTION; INHALATION
IPRATROPIUM BROMIDE
AN ACTAVIS MID ATLANTIC 0.02% A075111 001 Apr 22, 1999
AN BAUSCH AND LOMB 0.02% A075835 001 Oct 15, 2001
AN COBALT LABS INC 0.02% A076291 001 May 09, 2005
AN + DEY 0.02% A074755 001 Jan 10, 1997
AN HOLOPACK INTL 0.02% A075693 001 Jan 26, 2001
AN LANDELA PHARM 0.02% A077072 001 Jul 19, 2005
AN NEPHRON 0.02% A075562 001 Sep 27, 2001
AN NOVEX 0.02% A075441 001 Mar 28, 2001
AN TEVA PARENTERAL 0.02% A075313 001 Feb 07, 2000
SPRAY, METERED; NASAL
ATROVENT
AB + BOEHRINGER INGELHEIM 0.021MG/SPRAY N020393 001 Oct 20, 1995
AB + 0.042MG/SPRAY N020394 001 Oct 20, 1995
IPRATROPIUM BROMIDE
AB BAUSCH AND LOMB 0.021MG/SPRAY A076025 001 Mar 31, 2003
AB 0.042MG/SPRAY A076103 001 Mar 31, 2003
AB DEY 0.021MG/SPRAY A075552 001 Mar 31, 2003
AB 0.042MG/SPRAY A075553 001 Mar 31, 2003
AB NOVEX 0.021MG/SPRAY A076156 001 Apr 18, 2003
AB 0.042MG/SPRAY A076155 001 Apr 18, 2003
AB ROXANE 0.021MG/SPRAY A076664 001 Nov 05, 2003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 221 (of 393)

IPRATROPIUM BROMIDE
SPRAY, METERED; NASAL
IPRATROPIUM BROMIDE
AB ROXANE 0.042MG/SPRAY A076598 001 Nov 05, 2003

IRBESARTAN
TABLET; ORAL
AVAPRO
XX SANOFI AVENTIS US 75MG N020757 001 Sep 30, 1997
XX 150MG N020757 002 Sep 30, 1997
XX + 300MG N020757 003 Sep 30, 1997

IRINOTECAN HYDROCHLORIDE
INJECTABLE; INJECTION
CAMPTOSAR
AP + PFIZER INC 40MG/2ML (20MG/ML) N020571 001 Jun 14, 1996
AP + 100MG/5ML (20MG/ML) N020571 002 Jun 14, 1996
IRINOTECAN HYDROCHLORIDE
AP ACCORD HLTHCARE 40MG/2ML (20MG/ML) A079068 001 Nov 21, 2008
AP 100MG/5ML (20MG/ML) A079068 002 Nov 21, 2008
AP ACTAVIS TOTOWA 40MG/2ML (20MG/ML) A078589 001 Feb 27, 2008
AP 100MG/5ML (20MG/ML) A078589 002 Feb 27, 2008
AP AKORN 40MG/2ML (20MG/ML) A090726 001 Sep 16, 2009
AP 100MG/5ML (20MG/ML) A090726 002 Sep 16, 2009
AP APP PHARMS 40MG/2ML (20MG/ML) A077776 001 Feb 27, 2008
AP 100MG/5ML (20MG/ML) A077776 002 Feb 27, 2008
AP BEDFORD LABS 40MG/2ML (20MG/ML) A078753 001 Dec 24, 2008
AP 100MG/5ML (20MG/ML) A078753 002 Dec 24, 2008
AP EBEWE PHARMA 40MG/2ML (20MG/ML) A090137 001 Nov 12, 2009
AP 100MG/5ML (20MG/ML) A090137 002 Nov 12, 2009
AP FRESENIUS KABI ONCOL 40MG/2ML (20MG/ML) A078188 001 Feb 27, 2008
AP 100MG/5ML (20MG/ML) A078188 002 Feb 27, 2008
AP HOSPIRA 40MG/2ML (20MG/ML) A077915 001 Feb 27, 2008
AP 100MG/5ML (20MG/ML) A077915 002 Feb 27, 2008
AP + 500MG/25ML (20MG/ML) A078796 001 Feb 27, 2008
AP PHARMAFORCE 40MG/2ML (20MG/ML) A090016 001 Jan 28, 2009
AP 100MG/5ML (20MG/ML) A090016 002 Jan 28, 2009
AP PLIVA LACHEMA 40MG/2ML (20MG/ML) A078122 001 Oct 31, 2008
AP 100MG/5ML (20MG/ML) A078122 002 Oct 31, 2008
AP SANDOZ 40MG/2ML (20MG/ML) A077994 001 Feb 27, 2008
AP 100MG/5ML (20MG/ML) A077994 002 Feb 27, 2008
AP SUN PHARMA GLOBAL 40MG/2ML (20MG/ML) A078805 001 Apr 21, 2008
AP 100MG/5ML (20MG/ML) A078805 002 Apr 21, 2008
AP TEVA PARENTERAL 40MG/2ML (20MG/ML) A077260 001 Feb 27, 2008
AP 100MG/5ML (20MG/ML) A077260 002 Feb 27, 2008
AP 500MG/25ML (20MG/ML) A090101 001 Nov 26, 2008
AP WATSON LABS 40MG/2ML (20MG/ML) A077219 001 Feb 20, 2008
AP 100MG/5ML (20MG/ML) A077219 002 Feb 20, 2008

IRON DEXTRAN
INJECTABLE; INJECTION
DEXFERRUM
BP LUITPOLD EQ 50MG IRON/ML A040024 001 Feb 23, 1996
INFED
BP + WATSON LABS (UTAH) EQ 50MG IRON/ML N017441 001
PROFERDEX
BP NEW RIVER EQ 50MG IRON/ML N017807 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 222 (of 393)

IRON SUCROSE
INJECTABLE; INTRAVENOUS

VENOFER

XX + LUITPOLD EQ 100MG BASE/5ML (EQ 20MG BASE/ML) N021135 001 Nov 06, 2000
XX EQ 200MG BASE/10ML (EQ 20MG BASE/ML) N021135 004 Feb 09, 2007

ISOCARBOXAZID
TABLET; ORAL

MARPLAN

XX + VALIDUS PHARMS INC 10MG N011961 001

ISOFLURANE
LIQUID; INHALATION
FORANE
AN + BAXTER HLTHCARE CORP 99.9% N017624 001
ISOFLURANE
AN HALOCARBON PRODS 99.9% A075225 001 Oct 20, 1999
AN HOSPIRA 99.9% A074097 001 Jan 25, 1993
AN MINRAD 99.9% A074416 001 Sep 30, 1994
AN RHODIA 99.9% A074502 001 Jun 27, 1995

ISONIAZID
INJECTABLE; INJECTION

ISONIAZID

XX + SANDOZ 100MG/ML A040648 001 Jul 05, 2005


SYRUP; ORAL

ISONIAZID

XX + CAROLINA MEDCL 50MG/5ML A088235 001 Nov 10, 1983


TABLET; ORAL
ISONIAZID
AA BARR 100MG A080936 001
AA 300MG A080937 002
AA MIKART 100MG A040090 001 Jun 26, 1997
AA 300MG A040090 002 Jun 26, 1997
AA + SANDOZ 100MG N008678 002
AA + 300MG N008678 003
AA WATSON LABS 300MG A080521 001
AA WEST WARD 100MG A080212 001
AA 300MG A087425 001

ISONIAZID; PYRAZINAMIDE; RIFAMPIN


TABLET; ORAL

RIFATER

XX + SANOFI AVENTIS US 50MG;300MG;120MG N050705 001 May 31, 1994

ISONIAZID; RIFAMPIN
CAPSULE; ORAL
RIFAMATE
AB + SANOFI AVENTIS US 150MG;300MG A061884 001
RIFAMPIN AND ISONIAZID
AB WESTWARD 150MG;300MG A065221 001 Jul 29, 2005

ISOPROTERENOL HYDROCHLORIDE
INJECTABLE; INJECTION
ISOPROTERENOL HYDROCHLORIDE
AP INTL MEDICATION 0.2MG/ML A083724 001
ISUPREL
AP + HOSPIRA 0.2MG/ML N010515 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 223 (of 393)

ISOSORBIDE DINITRATE
CAPSULE, EXTENDED RELEASE; ORAL

DILATRATE-SR

XX + SCHWARZ PHARMA 40MG N019790 001 Sep 02, 1988


TABLET; ORAL
ISORDIL
AB BIOVAIL 5MG N012093 007 Jul 29, 1988
AB 10MG N012093 002 Jul 29, 1988
AB 20MG N012093 006 Jul 29, 1988
AB + 30MG N012093 005 Jul 29, 1988
ISOSORBIDE DINITRATE
AB PAR PHARM 5MG A086923 001 Mar 12, 1987
AB 10MG A086925 001 Mar 12, 1987
AB 20MG A087537 001 Oct 02, 1987
AB 30MG A087946 001 Jan 12, 1988
AB SANDOZ 5MG A086221 001 Jan 07, 1988
AB 10MG A086223 001 Jan 07, 1988
AB 20MG A089367 001 Apr 07, 1988
AB WATSON LABS 5MG A086034 001 Jan 06, 1988
AB 10MG A086032 001 Jan 07, 1988
AB WEST WARD 5MG A086067 001 Oct 29, 1987
AB 10MG A086066 001 Oct 29, 1987
AB 20MG A088088 001 Nov 02, 1987
AB 30MG A040591 001 Jan 10, 2007
ISORDIL
XX + BIOVAIL 40MG N012093 001 Jul 29, 1988
TABLET; SUBLINGUAL
ISOSORBIDE DINITRATE
AB WATSON LABS 2.5MG A086033 001 Feb 26, 1988
AB + 5MG A086031 001 Sep 29, 1987
AB WEST WARD 2.5MG A086054 001 Oct 29, 1987
AB 5MG A086055 001 Nov 02, 1987
TABLET, EXTENDED RELEASE; ORAL
ISOSORBIDE DINITRATE
AB COREPHARMA 40MG A040723 001 Mar 17, 2008
AB + INWOOD LABS 40MG A040009 001 Dec 30, 1998

ISOSORBIDE MONONITRATE
TABLET; ORAL
ISMO
AB PROMIUS PHARMA 20MG N019091 001 Dec 30, 1991
ISOSORBIDE MONONITRATE
AB ACTAVIS ELIZABETH 10MG A075037 002 Oct 30, 1998
AB 20MG A075037 001 Oct 30, 1998
AB TEVA 20MG A075147 001 Nov 27, 1998
AB WEST WARD 20MG A075361 001 Oct 05, 2000
MONOKET
AB SCHWARZ 10MG N020215 002 Jun 30, 1993
AB + 20MG N020215 001 Jun 30, 1993
TABLET, EXTENDED RELEASE; ORAL
ISOSORBIDE MONONITRATE
AB ACTAVIS ELIZABETH 30MG A075306 001 Dec 31, 1998
AB 60MG A075306 002 Dec 31, 1998
AB BRIGHTSTONE 60MG A075166 001 Oct 07, 1999
AB DEXCEL LTD 60MG A075522 001 Apr 17, 2000
AB ELAN PHARM 60MG A075041 001 Sep 22, 1998
AB KREMERS URBAN 30MG A075155 002 Jan 13, 2000
AB 60MG A075155 001 Oct 30, 1998
AB + 120MG A075155 003 Aug 04, 2000
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 224 (of 393)

ISOSORBIDE MONONITRATE
TABLET, EXTENDED RELEASE; ORAL
ISOSORBIDE MONONITRATE
AB KV PHARM 30MG A075395 001 Mar 16, 2000
AB 60MG A075395 002 Mar 16, 2000
AB 120MG A075395 003 Mar 16, 2000
AB WEST WARD 30MG A076813 002 Mar 30, 2006
AB 60MG A076813 001 Jan 07, 2005

ISOSULFAN BLUE
INJECTABLE; INJECTION

LYMPHAZURIN

XX + US SURGCL 1% N018310 001

ISOTRETINOIN
CAPSULE; ORAL
AMNESTEEM
AB GENPHARM 10MG A075945 001 Nov 08, 2002
AB + 20MG A075945 002 Nov 08, 2002
AB + 40MG A075945 003 Nov 08, 2002
CLARAVIS
AB BARR 10MG A076356 001 Apr 11, 2003
AB 20MG A076135 002 Apr 11, 2003
AB 30MG A076135 003 May 11, 2006
AB 40MG A076135 001 Apr 11, 2003
SOTRET
AB RANBAXY 10MG A076041 001 Dec 24, 2002
AB 20MG A076041 002 Dec 24, 2002
AB 30MG A076503 001 Jun 20, 2003
AB 40MG A076041 003 Dec 24, 2002

ISRADIPINE
CAPSULE; ORAL
ISRADIPINE
AB ACTAVIS TOTOWA 2.5MG A077169 001 Apr 24, 2006
AB 5MG A077169 002 Apr 24, 2006
AB COBALT LABS INC 2.5MG A077317 001 Jan 05, 2006
AB + 5MG A077317 002 Jan 05, 2006
TABLET, EXTENDED RELEASE; ORAL
DYNACIRC CR
XX SMITHKLINE BEECHAM 5MG N020336 001 Jun 01, 1994
XX + 10MG N020336 002 Jun 01, 1994

ITRACONAZOLE
CAPSULE; ORAL
ITRACONAZOLE
AB SANDOZ 100MG A076104 001 May 28, 2004
SPORANOX
AB + ORTHO MCNEIL JANSSEN 100MG N020083 001 Sep 11, 1992
INJECTABLE; INJECTION

SPORANOX

XX + ORTHO MCNEIL JANSSEN 10MG/ML N020966 001 Mar 30, 1999


SOLUTION; ORAL

SPORANOX

XX + ORTHO MCNEIL JANSSEN 10MG/ML N020657 001 Feb 21, 1997


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 225 (of 393)

IVERMECTIN
TABLET; ORAL

STROMECTOL

XX + MERCK 3MG N050742 002 Oct 08, 1998

IXABEPILONE
INJECTABLE; IV (INFUSION)

IXEMPRA KIT

XX + BRISTOL MYERS SQUIBB 15MG/VIAL N022065 001 Oct 16, 2007


XX + 45MG/VIAL N022065 002 Oct 16, 2007

KANAMYCIN SULFATE
INJECTABLE; INJECTION
KANAMYCIN SULFATE
XX APP PHARMS EQ 500MG BASE/2ML A065111 001 Dec 17, 2002
XX + EQ 1GM BASE/3ML A065111 002 Dec 17, 2002

KETAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
KETALAR
AP + JHP PHARMS EQ 10MG BASE/ML N016812 001
AP + EQ 50MG BASE/ML N016812 002
AP + EQ 100MG BASE/ML N016812 003
KETAMINE HYDROCHLORIDE
AP BEDFORD EQ 50MG BASE/ML A074524 001 Mar 22, 1996
AP EQ 100MG BASE/ML A074524 002 Mar 22, 1996
AP BIONICHE PHARMA EQ 10MG BASE/ML A076092 001 Sep 30, 2008
AP EQ 50MG BASE/ML A076092 002 Dec 28, 2001
AP EQ 100MG BASE/ML A076092 003 Oct 25, 2002
AP HOSPIRA EQ 50MG BASE/ML A074549 001 Jun 27, 1996
AP EQ 100MG BASE/ML A074549 002 Jun 27, 1996

KETOCONAZOLE
AEROSOL, FOAM; TOPICAL

EXTINA

XX + STIEFEL LABS INC 2% N021738 001 Jun 12, 2007


CREAM; TOPICAL
KETOCONAZOLE
AB ALTANA 2% A076294 001 Apr 28, 2004
AB + TEVA 2% A075581 001 Apr 25, 2000
KETOZOLE
AB TARO 2% A075638 001 Dec 18, 2002
GEL; TOPICAL

XOLEGEL

XX + STIEFEL LABS INC 2% N021946 001 Jul 28, 2006


SHAMPOO; TOPICAL
KETOCONAZOLE
AB PERRIGO NEW YORK 2% A076419 001 Jan 07, 2004
AB TOLMAR 2% A076942 001 Apr 11, 2005
NIZORAL
AB + ORTHO MCNEIL JANSSEN 2% N019927 001 Aug 31, 1990
TABLET; ORAL
KETOCONAZOLE
AB APOTEX 200MG A075912 001 Jan 10, 2002
AB MUTUAL PHARMA 200MG A075314 001 Jun 15, 1999
AB MYLAN 200MG A075597 001 Dec 23, 1999
AB PLIVA 200MG A075362 001 Jun 15, 1999
AB TARO 200MG A075319 001 Jun 15, 1999
AB TEVA 200MG A075273 001 Jun 15, 1999
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 226 (of 393)

KETOCONAZOLE
TABLET; ORAL
NIZORAL
AB + ORTHO MCNEIL JANSSEN 200MG N018533 001

KETOPROFEN
CAPSULE; ORAL
KETOPROFEN
AB HERITAGE PHARMS INC 50MG A074014 002 Jan 29, 1993
AB 75MG A074014 003 Jan 29, 1993
AB MYLAN 50MG A074035 002 Dec 31, 1996
AB 75MG A074035 003 Dec 31, 1996
AB TEVA 50MG A073516 001 Dec 22, 1992
AB + 75MG A073517 001 Dec 22, 1992
KETOPROFEN
XX HERITAGE PHARMS INC 25MG A074014 001 Jan 29, 1993
CAPSULE, EXTENDED RELEASE; ORAL
KETOPROFEN
AB ELAN PHARM 200MG A074879 001 Dec 10, 1997
AB MYLAN 100MG A075679 003 Feb 20, 2002
AB 150MG A075679 002 Feb 20, 2002
AB + 200MG A075679 001 Feb 20, 2002
AB WATSON LABS FLORIDA 100MG A075270 002 Mar 24, 1999
AB 150MG A075270 003 Mar 24, 1999
AB 200MG A075270 001 Mar 24, 1999

KETOROLAC TROMETHAMINE
INJECTABLE; INJECTION
KETOROLAC TROMETHAMINE
AP AKORN STRIDES 15MG/ML A078299 001 Jul 16, 2007
AP 30MG/ML A078299 002 Jul 16, 2007
AP APOTEX INC 15MG/ML A075631 002 Jun 29, 2001
AP 30MG/ML A075631 001 Jun 29, 2001
AP APP PHARMS 15MG/ML A075784 001 Jan 11, 2002
AP 30MG/ML A075784 002 Jan 11, 2002
AP BAXTER HLTHCARE 15MG/ML A075772 001 Jul 21, 2004
AP 30MG/ML A075772 002 Jul 21, 2004
AP BAXTER HLTHCARE CORP 15MG/ML A075299 001 Nov 03, 1999
AP 30MG/ML A075299 002 Nov 03, 1999
AP + BEDFORD 15MG/ML A075222 001 Apr 26, 1999
AP + 30MG/ML A075222 002 Apr 26, 1999
AP + 30MG/ML A075228 001 Apr 26, 1999
AP HOSPIRA 15MG/ML A074802 001 Jun 05, 1997
AP 15MG/ML A074993 001 Jan 27, 1999
AP 30MG/ML A074802 002 Jun 05, 1997
AP 30MG/ML A074993 002 Jan 27, 1999
AP LUITPOLD 15MG/ML A078145 001 Jan 14, 2008
AP 30MG/ML A078145 002 Jan 14, 2008
AP SANDOZ 15MG/ML A076271 001 Oct 06, 2004
AP 30MG/ML A076271 002 Oct 06, 2004
AP SUN PHARMA GLOBAL 15MG/ML A078737 001 Oct 06, 2008
AP 30MG/ML A078737 002 Oct 06, 2008
AP WOCKHARDT 15MG/ML A077942 001 Mar 27, 2007
AP 30MG/ML A077942 002 Mar 27, 2007
AP 30MG/ML A077943 001 Mar 27, 2007
SOLUTION/DROPS; OPHTHALMIC
ACULAR
AT + ALLERGAN 0.5% N019700 001 Nov 09, 1992
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 227 (of 393)

KETOROLAC TROMETHAMINE
SOLUTION/DROPS; OPHTHALMIC
ACULAR LS
AT + ALLERGAN 0.4% N021528 001 May 30, 2003
KETOROLAC TROMETHAMINE
AT AKORN 0.4% A078399 001 Nov 05, 2009
AT 0.5% A078434 001 Nov 05, 2009
AT ALCON 0.4% A078721 001 Nov 05, 2009
AT 0.5% A076583 001 Nov 05, 2009
AT APOTEX INC 0.4% A077308 001 Nov 05, 2009
AT 0.5% A076109 001 Nov 05, 2009
AT SUN PHARMA GLOBAL 0.5% A090017 001 Nov 05, 2009
ACULAR PRESERVATIVE FREE
XX + ALLERGAN 0.5% N020811 001 Nov 03, 1997
ACUVAIL
XX + ALLERGAN 0.45% N022427 001 Jul 22, 2009
TABLET; ORAL
KETOROLAC TROMETHAMINE
AB + MYLAN 10MG A074761 001 May 16, 1997
AB PLIVA 10MG A075284 001 Jun 23, 1999
AB TEVA 10MG A074754 001 May 16, 1997

LABETALOL HYDROCHLORIDE
INJECTABLE; INJECTION
LABETALOL HYDROCHLORIDE
AP APOTEX INC 5MG/ML A076051 001 Jul 05, 2002
AP BEDFORD 5MG/ML A075303 001 May 28, 1999
AP + HOSPIRA 5MG/ML A075239 001 Nov 29, 1999
AP + 5MG/ML A075240 001 Nov 29, 1999
AP TAYLOR 5MG/ML A075431 001 Nov 29, 1999
AP 5MG/ML A075524 001 Nov 29, 1999
TABLET; ORAL
LABETALOL HYDROCHLORIDE
AB IVAX SUB TEVA PHARMS 100MG A074787 001 Aug 03, 1998
AB 200MG A074787 002 Aug 03, 1998
AB 300MG A074787 003 Aug 03, 1998
AB SANDOZ 100MG A075113 001 Aug 04, 1998
AB 200MG A075113 002 Aug 04, 1998
AB 300MG A075113 003 Aug 04, 1998
AB WATSON LABS 100MG A075133 001 Aug 03, 1998
AB 200MG A075133 002 Aug 03, 1998
AB 300MG A075133 003 Aug 03, 1998
TRANDATE
AB PROMETHEUS LABS 100MG N018716 001 May 24, 1985
AB 200MG N018716 002 Aug 01, 1984
AB + 300MG N018716 003 Aug 01, 1984

LACOSAMIDE
SOLUTION; INTRAVENOUS

VIMPAT

XX + SCHWARZ BIOSCIENCES 200MG/20ML (10MG/ML) N022254 001 Oct 28, 2008


TABLET; ORAL
VIMPAT
XX SCHWARZ BIOSCIENCES 50MG N022253 001 Oct 28, 2008
XX 100MG N022253 002 Oct 28, 2008
XX 150MG N022253 003 Oct 28, 2008
XX + 200MG N022253 004 Oct 28, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 228 (of 393)

LACTULOSE
FOR SOLUTION; ORAL

LACTULOSE

XX + INALCO 10GM/PACKET A074712 001 Dec 10, 1997


XX + 20GM/PACKET A074712 002 Dec 10, 1997
SOLUTION; ORAL
CONSTILAC
AA ALRA 10GM/15ML A071054 001 Jul 26, 1988
CONSTULOSE
AA + ACTAVIS MID ATLANTIC 10GM/15ML A070288 001 Aug 15, 1988
LACTULOSE
AA ANI PHARMS 10GM/15ML A078430 001 Nov 28, 2007
AA HI TECH PHARMA 10GM/15ML A074076 001 Jul 03, 1995
AA MORTON GROVE 10GM/15ML A074602 001 Nov 14, 1996
AA NOVEX 10GM/15ML A075911 001 Feb 21, 2002
AA PHARM ASSOC 10GM/15ML A074623 001 Jul 30, 1996
AA ROXANE 10GM/15ML A073591 001 May 29, 1992
AA VINTAGE PHARMS 10GM/15ML A075993 001 Jul 26, 2001
AA VISTAPHARM 10GM/15ML A074138 001 Sep 30, 1992
SOLUTION; ORAL, RECTAL
CHOLAC
AA ALRA 10GM/15ML A071331 001 Jul 26, 1988
ENULOSE
AA + ACTAVIS MID ATLANTIC 10GM/15ML A071548 001 Aug 15, 1988
GENERLAC
AA MORTON GROVE PHARMS 10GM/15ML A074603 001 Oct 31, 1996
LACTULOSE
AA ANI PHARMS 10GM/15ML A090426 001 Nov 21, 2008
AA HI TECH PHARMA 10GM/15ML A074077 001 Jul 03, 1995
AA NOVEX 10GM/15ML A076645 001 Jul 28, 2003

LAMIVUDINE
SOLUTION; ORAL

EPIVIR

XX + VIIV HLTHCARE 10MG/ML N020596 001 Nov 17, 1995


EPIVIR-HBV
XX + GLAXOSMITHKLINE 5MG/ML N021004 001 Dec 08, 1998
TABLET; ORAL
EPIVIR
XX VIIV HLTHCARE 150MG N020564 001 Nov 17, 1995
XX + 300MG N020564 003 Jun 24, 2002
EPIVIR-HBV
XX + GLAXOSMITHKLINE 100MG N021003 001 Dec 08, 1998

LAMIVUDINE; ZIDOVUDINE
TABLET; ORAL

COMBIVIR

XX + VIIV HLTHCARE 150MG;300MG N020857 001 Sep 26, 1997

LAMOTRIGINE
TABLET; ORAL
LAMICTAL
AB + GLAXOSMITHKLINE 25MG N020241 005 Dec 27, 1994
AB 100MG N020241 001 Dec 27, 1994
AB 150MG N020241 002 Dec 27, 1994
AB 200MG N020241 003 Dec 27, 1994
LAMOTRIGINE
AB APOTEX INC 25MG A078625 001 Jan 27, 2009
AB 100MG A078625 002 Jan 27, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 229 (of 393)

LAMOTRIGINE
TABLET; ORAL
LAMOTRIGINE
AB APOTEX INC 150MG A078625 003 Jan 27, 2009
AB 200MG A078625 004 Jan 27, 2009
AB AUROBINDO PHARMA 25MG A078956 001 Jan 27, 2009
AB 100MG A078956 002 Jan 27, 2009
AB 150MG A078956 003 Jan 27, 2009
AB 200MG A078956 004 Jan 27, 2009
AB CADISTA PHARMS 25MG A079132 001 Jan 27, 2009
AB 100MG A079132 002 Jan 27, 2009
AB 150MG A079132 003 Jan 27, 2009
AB 200MG A079132 004 Jan 27, 2009
AB DR REDDYS LABS LTD 25MG A076708 001 Jan 27, 2009
AB 100MG A076708 002 Jan 27, 2009
AB 150MG A076708 003 Jan 27, 2009
AB 200MG A076708 004 Jan 27, 2009
AB MATRIX LABS LTD 25MG A078443 001 Feb 11, 2009
AB 100MG A078443 002 Feb 11, 2009
AB 150MG A078443 003 Feb 11, 2009
AB 200MG A078443 004 Feb 11, 2009
AB MYLAN 25MG A077420 001 Jan 27, 2009
AB 100MG A077420 002 Jan 27, 2009
AB 150MG A077420 003 Jan 27, 2009
AB 200MG A077420 004 Jan 27, 2009
AB ROXANE 25MG A077392 001 Jan 27, 2009
AB 100MG A077392 002 Jan 27, 2009
AB 150MG A077392 003 Jan 27, 2009
AB 200MG A077392 004 Jan 27, 2009
AB SANDOZ 25MG A078645 001 Jan 27, 2009
AB 100MG A078645 002 Jan 27, 2009
AB 150MG A078645 003 Jan 27, 2009
AB 200MG A078645 004 Jan 27, 2009
AB TARO PHARM INDS 25MG A078525 001 Jan 27, 2009
AB 100MG A078525 002 Jan 27, 2009
AB 150MG A078525 003 Jan 27, 2009
AB 200MG A078525 004 Jan 27, 2009
AB TEVA 25MG A076388 001 Aug 30, 2006
AB 100MG A076388 002 Aug 30, 2006
AB 150MG A076388 003 Aug 30, 2006
AB 200MG A076388 004 Aug 30, 2006
AB TORRENT PHARMS 25MG A078947 001 Jan 27, 2009
AB 100MG A078947 002 Jan 27, 2009
AB 150MG A078947 003 Jan 27, 2009
AB 200MG A078947 004 Jan 27, 2009
AB UPSHER SMITH 25MG A078310 001 Feb 04, 2009
AB 100MG A078310 002 Feb 04, 2009
AB 150MG A078310 003 Feb 04, 2009
AB 200MG A078310 004 Feb 04, 2009
AB WOCKHARDT 25MG A078982 001 Jan 27, 2009
AB 100MG A078982 002 Jan 27, 2009
AB 150MG A078982 003 Jan 27, 2009
AB 200MG A078982 004 Jan 27, 2009
AB ZYDUS PHARMS USA 25MG A077633 001 Jan 27, 2009
AB 100MG A077633 003 Jan 27, 2009
AB 150MG A077633 004 Jan 27, 2009
AB 200MG A077633 005 Jan 27, 2009
LAMOTRIGINE
XX ZYDUS PHARMS USA 50MG A077633 002 Jan 27, 2009
XX 250MG A077633 006 Jan 27, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 230 (of 393)

LAMOTRIGINE
TABLET, CHEWABLE; ORAL
LAMICTAL CD
AB GLAXOSMITHKLINE 2MG N020764 004 Sep 08, 2000
AB 5MG N020764 001 Aug 24, 1998
AB + 25MG N020764 002 Aug 24, 1998
LAMOTRIGINE
AB AUROBINDO PHARMA 5MG A090401 002 Nov 04, 2009
AB 25MG A090401 003 Nov 04, 2009
AB COBALT LABS INC 2MG A076928 001 Jan 22, 2009
AB 5MG A076928 002 Jan 22, 2009
AB 25MG A076928 003 Jan 22, 2009
AB DR REDDYS LABS LTD 5MG A076701 001 Jan 22, 2009
AB 25MG A076701 002 Jan 22, 2009
AB GLENMARK GENERICS 5MG A079099 001 Feb 19, 2009
AB 25MG A079099 002 Feb 19, 2009
AB MYLAN 5MG A076630 001 Jan 22, 2009
AB 25MG A076630 002 Jan 22, 2009
AB TARO 5MG A079204 001 Feb 04, 2009
AB 25MG A079204 002 Feb 04, 2009
AB TEVA 5MG A076420 001 Jun 21, 2006
AB 25MG A076420 002 Jun 21, 2006
AB ZYDUS PHARMS USA INC 5MG A078009 002 Jan 22, 2009
AB 25MG A078009 003 Jan 22, 2009
TABLET, EXTENDED RELEASE; ORAL
LAMICTAL XR
XX SMITHKLINE BEECHAM 25MG N022115 001 May 29, 2009
XX + 50MG N022115 002 May 29, 2009
XX 100MG N022115 003 May 29, 2009
XX 200MG N022115 004 May 29, 2009
TABLET, ORALLY DISINTEGRATING; ORAL
LAMICTAL ODT
XX SMITHKLINE BEECHAM 25MG N022251 001 May 08, 2009
XX + 50MG N022251 002 May 08, 2009
XX 100MG N022251 003 May 08, 2009
XX 200MG N022251 004 May 08, 2009

LANREOTIDE ACETATE
INJECTABLE; SUBCUTANEOUS

SOMATULINE DEPOT

XX + BEAUFOUR IPSEN EQ 60MG BASE N022074 001 Aug 30, 2007


XX + EQ 90MG BASE N022074 002 Aug 30, 2007
XX + EQ 120MG BASE N022074 003 Aug 30, 2007

LANSOPRAZOLE
CAPSULE, DELAYED REL PELLETS; ORAL
LANSOPRAZOLE
AB MATRIX LABS LTD 15MG A090763 001 Nov 10, 2009
AB 30MG A090763 002 Nov 10, 2009
AB TEVA PHARMS 15MG A077255 001 Nov 10, 2009
AB 30MG A077255 002 Nov 10, 2009
PREVACID
AB TAKEDA PHARMS NA 15MG N020406 001 May 10, 1995
AB + 30MG N020406 002 May 10, 1995
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING; ORAL
PREVACID
XX TAKEDA PHARMS NA 15MG N021428 001 Aug 30, 2002
XX + 30MG N021428 002 Aug 30, 2002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 231 (of 393)

LANTHANUM CARBONATE
TABLET, CHEWABLE; ORAL
FOSRENOL
XX SHIRE EQ 500MG BASE N021468 002 Oct 26, 2004
XX EQ 750MG BASE N021468 003 Nov 23, 2005
XX + EQ 1GM BASE N021468 004 Nov 23, 2005

LAPATINIB DITOSYLATE
TABLET; ORAL

TYKERB

XX + SMITHKLINE BEECHAM EQ 250MG BASE N022059 001 Mar 13, 2007

LATANOPROST
SOLUTION/DROPS; OPHTHALMIC

XALATAN

XX + PHARMACIA AND UPJOHN 0.005% N020597 001 Jun 05, 1996

LEFLUNOMIDE
TABLET; ORAL
ARAVA
AB SANOFI AVENTIS US 10MG N020905 001 Sep 10, 1998
AB + 20MG N020905 002 Sep 10, 1998
LEFLUNOMIDE
AB APOTEX INC 10MG A077090 001 Sep 13, 2005
AB 20MG A077090 002 Sep 13, 2005
AB BARR 10MG A077083 001 Sep 13, 2005
AB 20MG A077083 002 Sep 13, 2005
AB HERITAGE PHARMS INC 10MG A077086 001 Sep 13, 2005
AB 20MG A077086 002 Sep 13, 2005
AB SANDOZ 10MG A077087 001 Sep 13, 2005
AB 20MG A077087 002 Sep 13, 2005
AB TEVA PHARMS 10MG A077084 001 Sep 13, 2005
AB 20MG A077084 002 Sep 13, 2005
ARAVA
XX + SANOFI AVENTIS US 100MG N020905 003 Sep 10, 1998

LENALIDOMIDE
CAPSULE; ORAL
REVLIMID
XX CELGENE 5MG N021880 001 Dec 27, 2005
XX 10MG N021880 002 Dec 27, 2005
XX 15MG N021880 003 Jun 29, 2006
XX + 25MG N021880 004 Jun 29, 2006

LEPIRUDIN RECOMBINANT
INJECTABLE; INJECTION

REFLUDAN

XX + BAYER HLTHCARE 50MG/VIAL N020807 001 Mar 06, 1998

LETROZOLE
TABLET; ORAL
FEMARA
AB + NOVARTIS PHARMS 2.5MG N020726 001 Jul 25, 1997
LETROZOLE
AB MYLAN 2.5MG A078190 001 Dec 24, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 232 (of 393)

LEUCOVORIN CALCIUM
INJECTABLE; INJECTION
LEUCOVORIN CALCIUM
AP + BEDFORD EQ 50MG BASE/VIAL A089384 001 Sep 14, 1987
AP + EQ 100MG BASE/VIAL A089717 001 Mar 28, 1988
AP + HOSPIRA EQ 350MG BASE/VIAL N008107 005 Apr 05, 1989
AP TEVA PARENTERAL EQ 50MG BASE/VIAL A081278 001 Sep 28, 1993
AP EQ 100MG BASE/VIAL A081277 001 Sep 28, 1993
AP EQ 350MG BASE/VIAL A040174 001 Jun 12, 1997
LEUCOVORIN CALCIUM PRESERVATIVE FREE
AP APP PHARMS EQ 200MG BASE/VIAL A040258 001 Feb 26, 1999
AP + BEDFORD EQ 200MG BASE/VIAL A040056 001 May 23, 1995
AP EQ 350MG BASE/VIAL A040335 001 Apr 20, 2000
AP LUITPOLD EQ 50MG BASE/VIAL A040338 001 Jan 31, 2001
LEUCOVORIN CALCIUM PRESERVATIVE FREE
XX + APP PHARMS EQ 500MG BASE/VIAL A040286 001 Feb 26, 1999
XX + BEDFORD EQ 10MG BASE/ML A040347 001 Apr 25, 2000
TABLET; ORAL
LEUCOVORIN CALCIUM
AB BARR EQ 5MG BASE A071198 001 Sep 24, 1987
AB EQ 25MG BASE A071199 001 Sep 24, 1987
AB ROXANE EQ 5MG BASE A072733 001 Feb 22, 1993
AB EQ 15MG BASE A072735 001 Feb 22, 1993
AB + EQ 25MG BASE A072736 001 Feb 22, 1993
AB SANDOZ EQ 15MG BASE A075327 001 Mar 24, 1999
LEUCOVORIN CALCIUM
XX ROXANE EQ 10MG BASE A072734 001 Feb 22, 1993

LEUPROLIDE ACETATE
INJECTABLE; INJECTION
LEUPROLIDE ACETATE
AP BEDFORD LABS 1MG/0.2ML A074728 001 Aug 04, 1998
AP GENZYME 1MG/0.2ML A075721 001 Nov 29, 2001
AP SUN PHARMA GLOBAL 1MG/0.2ML A078885 001 Mar 09, 2009
AP TEVA PARENTERAL 1MG/0.2ML A075471 001 Oct 25, 2000
LUPRON
AP + ABBOTT LABS 1MG/0.2ML N019010 001 Apr 09, 1985
LUPRON DEPOT
XX + ABBOTT LABS 3.75MG/VIAL N020011 001 Oct 22, 1990
XX + 7.5MG/VIAL N019732 001 Jan 26, 1989
XX + 22.5MG/VIAL N020517 001 Dec 22, 1995
LUPRON DEPOT-3
XX + ABBOTT LABS 11.25MG/VIAL N020708 001 Mar 07, 1997
LUPRON DEPOT-4
XX + ABBOTT LABS 30MG/VIAL N020517 002 May 30, 1997
LUPRON DEPOT-PED
XX + ABBOTT LABS 7.5MG/VIAL N020263 002 Apr 16, 1993
XX + 11.25MG/VIAL N020263 005 Jan 21, 1994
XX + 15MG/VIAL N020263 006 Jan 21, 1994
INJECTABLE; SUBCUTANEOUS

ELIGARD

XX + TOLMAR THERAP 7.5MG/VIAL N021343 001 Jan 23, 2002


XX + 22.5MG/VIAL N021379 001 Jul 24, 2002
XX + 30MG/VIAL N021488 001 Feb 13, 2003
XX + 45MG/VIAL N021731 001 Dec 14, 2004

LEVALBUTEROL HYDROCHLORIDE
SOLUTION; INHALATION
LEVALBUTEROL HYDROCHLORIDE
AN BREATH LTD EQ 0.0103% BASE A077756 003 Apr 09, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 233 (of 393)

LEVALBUTEROL HYDROCHLORIDE
SOLUTION; INHALATION
LEVALBUTEROL HYDROCHLORIDE
AN BREATH LTD EQ 0.021% BASE A077756 001 Apr 09, 2008
AN EQ 0.042% BASE A077756 002 Apr 09, 2008
AN DEY EQ 0.25% BASE A078309 001 Mar 20, 2009
XOPENEX
AN + SEPRACOR EQ 0.0103% BASE N020837 003 Jan 30, 2002
AN + EQ 0.021% BASE N020837 001 Mar 25, 1999
AN + EQ 0.042% BASE N020837 002 Mar 25, 1999
AN + EQ 0.25% BASE N020837 004 Jul 18, 2003

LEVALBUTEROL TARTRATE
AEROSOL, METERED; INHALATION

XOPENEX HFA

XX + SEPRACOR EQ 0.045MG BASE/INH N021730 001 Mar 11, 2005

LEVETIRACETAM
INJECTABLE; IV (INFUSION)

KEPPRA

XX + UCB INC 500MG/5ML (100MG/ML) N021872 001 Jul 31, 2006


SOLUTION; ORAL
KEPPRA
AA + UCB INC 100MG/ML N021505 001 Jul 15, 2003
LEVETIRACETAM
AA ACTAVIS MID ATLANTIC 100MG/ML A078976 001 Jan 15, 2009
AA AMNEAL PHARMS 100MG/ML A090992 001 Oct 27, 2009
AA AUROBINDO PHARM 100MG/ML A079063 001 Jan 15, 2009
AA CYPRESS PHARM 100MG/ML A079120 001 Jan 16, 2009
AA ROXANE 100MG/ML A078582 001 Jan 15, 2009
AA SILARX 100MG/ML A090263 001 Apr 03, 2009
AA TARO 100MG/ML A078774 001 Feb 10, 2009
AA TOLMAR 100MG/ML A079107 001 Jan 15, 2009
TABLET; ORAL
KEPPRA
AB UCB INC 250MG N021035 001 Nov 30, 1999
AB 500MG N021035 002 Nov 30, 1999
AB 750MG N021035 003 Nov 30, 1999
AB + 1GM N021035 004 Jan 06, 2006
LEVETIRACETAM
AB APOTEX INC 250MG A078869 001 Mar 13, 2009
AB 500MG A078869 002 Mar 13, 2009
AB 750MG A078869 003 Mar 13, 2009
AB 1GM A078869 004 Mar 13, 2009
AB AUROBINDO PHARMA 250MG A078993 001 Jan 15, 2009
AB 500MG A078993 002 Jan 15, 2009
AB 750MG A078993 003 Jan 15, 2009
AB 1GM A078993 004 Jan 15, 2009
AB BOCA PHARMA 250MG A077319 001 Mar 20, 2009
AB 500MG A077319 002 Mar 20, 2009
AB 750MG A077319 003 Mar 20, 2009
AB COBALT LABS INC 250MG A077384 001 Jan 15, 2009
AB 500MG A077384 002 Jan 15, 2009
AB 750MG A077384 003 Jan 15, 2009
AB 1GM A078797 001 Jan 15, 2009
AB DR REDDYS LABS LTD 250MG A076920 001 Jan 15, 2009
AB 500MG A076920 002 Jan 15, 2009
AB 750MG A076920 003 Jan 15, 2009
AB 1GM A078904 001 Jan 15, 2009
AB INVAGEN PHARMS 250MG A078234 001 Jan 15, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 234 (of 393)

LEVETIRACETAM
TABLET; ORAL
LEVETIRACETAM
AB INVAGEN PHARMS 500MG A078234 002 Jan 15, 2009
AB 750MG A078234 003 Jan 15, 2009
AB LUPIN 250MG A078154 001 Jan 15, 2009
AB 500MG A078154 002 Jan 15, 2009
AB 750MG A078154 003 Jan 15, 2009
AB 1GM A090025 001 Jan 15, 2009
AB MYLAN 250MG A076919 001 Nov 04, 2008
AB 500MG A076919 002 Nov 04, 2008
AB 750MG A076919 003 Nov 04, 2008
AB 1GM A090261 001 Dec 08, 2009
AB ORCHID HLTHCARE 250MG A078526 001 Jan 15, 2009
AB 500MG A078526 002 Jan 15, 2009
AB 750MG A078526 003 Jan 15, 2009
AB ROXANE 250MG A078042 001 Jan 15, 2009
AB 500MG A078042 002 Jan 15, 2009
AB 750MG A078042 003 Jan 15, 2009
AB 1GM A078042 004 Jan 15, 2009
AB SANDOZ 250MG A077324 001 Jan 15, 2009
AB 500MG A077324 002 Jan 15, 2009
AB 750MG A077324 003 Jan 15, 2009
AB 1GM A077324 004 Jan 15, 2009
AB SOLCO HLTHCARE 250MG A078106 001 Feb 10, 2009
AB 500MG A078106 002 Feb 10, 2009
AB 750MG A078106 003 Feb 10, 2009
AB 1GM A078106 004 Feb 10, 2009
AB TEVA PHARMS 250MG A078101 001 Jan 15, 2009
AB 500MG A078101 002 Jan 15, 2009
AB 750MG A078101 003 Jan 15, 2009
AB 1GM A078101 004 Jan 15, 2009
AB TORRENT PHARMS 250MG A078858 001 Jan 15, 2009
AB 500MG A078858 002 Jan 15, 2009
AB 750MG A078858 003 Jan 15, 2009
AB 1GM A078858 004 Jan 15, 2009
AB WOCKHARDT 250MG A079042 001 Jan 15, 2009
AB 500MG A079042 002 Jan 15, 2009
AB 750MG A079042 003 Jan 15, 2009
AB 1GM A079042 004 Jan 15, 2009
AB ZYDUS PHARMS USA INC 250MG A078918 001 Apr 29, 2009
AB 1GM A078918 002 Apr 29, 2009
TABLET, EXTENDED RELEASE; ORAL
KEPPRA XR
XX UCB INC 500MG N022285 001 Sep 12, 2008
XX + 750MG N022285 002 Feb 12, 2009

LEVOBUNOLOL HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
AKBETA
AT AKORN 0.25% A074779 001 Oct 29, 1996
AT 0.5% A074780 001 Oct 29, 1996
BETAGAN
AT + ALLERGAN 0.25% N019814 001 Jun 28, 1989
AT + 0.5% N019219 002 Dec 19, 1985
LEVOBUNOLOL HYDROCHLORIDE
AT BAUSCH AND LOMB 0.25% A074307 001 Mar 04, 1994
AT 0.5% A074326 001 Mar 04, 1994
AT FALCON PHARMS 0.25% A074851 001 Oct 28, 1996
AT 0.5% A074850 001 Oct 28, 1996
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 235 (of 393)

LEVOBUNOLOL HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
LEVOBUNOLOL HYDROCHLORIDE
AT NOVEX 0.25% A075473 001 Aug 03, 2000
AT 0.5% A075475 001 Aug 03, 2000

LEVOCARNITINE
INJECTABLE; INJECTION
CARNITOR
AP + SIGMA TAU 200MG/ML N020182 001 Dec 16, 1992
LEVOCARNITINE
AP BEDFORD 200MG/ML A075567 001 Mar 29, 2001
AP LUITPOLD 200MG/ML A075861 001 Jun 22, 2001
AP TEVA PARENTERAL 200MG/ML A075881 001 Mar 29, 2001
SOLUTION; ORAL
CARNITOR
AA + SIGMA TAU 1GM/10ML N019257 001 Apr 10, 1986
CARNITOR SF
AA SIGMA TAU 1GM/10ML N019257 002 Mar 28, 2007
LEVOCARNITINE
AA HI TECH PHARMA 1GM/10ML A077399 001 Oct 25, 2007
AA LYNE 1GM/10ML A076851 001 Aug 10, 2004
TABLET; ORAL
CARNITOR
AB + SIGMA TAU 330MG N018948 001 Dec 27, 1985
LEVOCARNITINE
AB COREPHARMA 330MG A076858 001 Sep 20, 2004

LEVOCETIRIZINE DIHYDROCHLORIDE
SOLUTION; ORAL

XYZAL

XX + UCB INC 2.5MG/5ML N022157 001 Jan 28, 2008


TABLET; ORAL

XYZAL

XX + UCB INC 5MG N022064 001 May 25, 2007

LEVOFLOXACIN
INJECTABLE; INJECTION

LEVAQUIN

XX + ORTHO MCNEIL PHARM EQ 500MG/20ML (EQ 25MG/ML) N020635 001 Dec 20, 1996
XX + EQ 750MG/30ML (EQ 25MG/ML) N020635 004 Dec 20, 1996
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
XX + ORTHO MCNEIL PHARM EQ 250MG/50ML (EQ 5MG/ML) N020635 002 Dec 20, 1996
XX + EQ 500MG/100ML (EQ 5MG/ML) N020635 003 Dec 20, 1996
XX + EQ 750MG/150ML (EQ 5MG/ML) N020635 005 Dec 20, 1996
SOLUTION; ORAL

LEVAQUIN

XX + ORTHO MCNEIL JANSSEN 250MG/10ML N021721 001 Oct 21, 2004


SOLUTION/DROPS; OPHTHALMIC

IQUIX

XX + SANTEN 1.5% N021571 001 Mar 01, 2004


QUIXIN
XX + SANTEN 0.5% N021199 001 Aug 18, 2000
TABLET; ORAL
LEVAQUIN
XX ORTHO MCNEIL JANSSEN 250MG N020634 001 Dec 20, 1996
XX 500MG N020634 002 Dec 20, 1996
XX + 750MG N020634 003 Sep 08, 2000
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 236 (of 393)

LEVOLEUCOVORIN CALCIUM
POWDER; IV (INFUSION)

FUSILEV

XX + SPECTRUM PHARMS EQ 50MG BASE/VIAL N020140 001 Mar 07, 2008

LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE


INJECTABLE; INJECTION
ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN
AP NOVOCOL 0.05MG/ML;2% A084697 001
SCANDONEST L
AP DEPROCO 0.05MG/ML;2% A088388 001 Oct 10, 1984

LEVONORGESTREL
INTRAUTERINE DEVICE; INTRAUTERINE

MIRENA

XX + BAYER HLTHCARE 52MG N021225 001 Dec 06, 2000


TABLET; ORAL
LEVONORGESTREL
AB WATSON LABS 0.75MG A078665 001 Aug 28, 2009
AB 0.75MG A078666 001 Jun 24, 2009
PLAN B
AB + DURAMED 0.75MG N021045 002 Aug 24, 2006
PLAN B ONE-STEP
XX + DURAMED 1.5MG N021998 001 Jul 10, 2009

LEVORPHANOL TARTRATE
TABLET; ORAL
LEVO-DROMORAN
AB + VALEANT PHARM INTL 2MG N008720 001 Dec 19, 1991
LEVORPHANOL TARTRATE
AB ROXANE 2MG A074278 001 Mar 31, 2000

LEVOTHYROXINE SODIUM**

**Refer to Preface Section 1.8 Levothyroxine Sodium for amplifying information**


TABLET; ORAL
LEVO-T
--> ALARA PHARM --> AB2,AB3 0.025MG N021342 001 Mar 01, 2002
--> --> AB2,AB3 0.05MG N021342 002 Mar 01, 2002
--> --> AB2,AB3 0.075MG N021342 003 Mar 01, 2002
--> --> AB2,AB3 0.088MG N021342 004 Mar 01, 2002
--> --> AB2,AB3 0.1MG N021342 005 Mar 01, 2002
--> --> AB2,AB3 0.112MG N021342 006 Mar 01, 2002
--> --> AB2,AB3 0.125MG N021342 007 Mar 01, 2002
--> --> AB2,AB3 0.137MG N021342 012 Dec 08, 2003
--> --> AB2,AB3 0.15MG N021342 008 Mar 01, 2002
--> --> AB2,AB3 0.175MG N021342 009 Mar 01, 2002
--> --> AB2,AB3 0.2MG N021342 010 Mar 01, 2002
--> + --> AB2,AB3 0.3MG N021342 011 Mar 01, 2002
LEVOTHYROXINE SODIUM
--> MERCK KGAA --> AB2,AB3 0.025MG A076752 001 Jun 16, 2005
--> --> AB2,AB3 0.05MG A076752 002 Jun 16, 2005
--> --> AB2,AB3 0.075MG A076752 003 Jun 16, 2005
--> --> AB2,AB3 0.088MG A076752 004 Jun 16, 2005
--> --> AB2,AB3 0.1MG A076752 005 Jun 16, 2005
--> --> AB2,AB3 0.112MG A076752 006 Jun 16, 2005
--> --> AB2,AB3 0.125MG A076752 007 Jun 16, 2005
--> --> AB2,AB3 0.15MG A076752 008 Jun 16, 2005
--> --> AB2,AB3 0.175MG A076752 009 Jun 16, 2005
--> --> AB2,AB3 0.2MG A076752 010 Jun 16, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 237 (of 393)

LEVOTHYROXINE SODIUM**

**Refer to Preface Section 1.8 Levothyroxine Sodium for amplifying information**


TABLET; ORAL
LEVOTHYROXINE SODIUM
--> MERCK KGAA --> AB2,AB3 0.3MG A076752 011 Jun 16, 2005
--> MYLAN --> AB1,AB2,AB3,AB4 0.025MG A076187 001 Jun 05, 2002
--> --> AB1,AB2,AB3,AB4 0.05MG A076187 002 Jun 05, 2002
--> --> AB1,AB2,AB3,AB4 0.075MG A076187 003 Jun 05, 2002
--> --> AB1,AB2,AB3,AB4 0.088MG A076187 004 Jun 05, 2002
--> --> AB1,AB2,AB3,AB4 0.1MG A076187 005 Jun 05, 2002
--> --> AB1,AB2,AB3,AB4 0.112MG A076187 006 Jun 05, 2002
--> --> AB1,AB2,AB3,AB4 0.125MG A076187 007 Jun 05, 2002
--> --> AB1,AB2,AB3,AB4 0.137MG A076187 012 Dec 13, 2006
--> --> AB1,AB2,AB3,AB4 0.15MG A076187 008 Jun 05, 2002
--> --> AB1,AB2,AB3,AB4 0.175MG A076187 009 Jun 05, 2002
--> --> AB1,AB2,AB3,AB4 0.2MG A076187 010 Jun 05, 2002
--> --> AB1,AB2,AB3,AB4 0.3MG A076187 011 Jun 05, 2002
LEVOXYL
--> KING PHARMS --> AB1,AB3 0.025MG N021301 001 May 25, 2001
--> --> AB1,AB3 0.05MG N021301 002 May 25, 2001
--> --> AB1,AB3 0.075MG N021301 003 May 25, 2001
--> --> AB1,AB3 0.088MG N021301 004 May 25, 2001
--> --> AB1,AB3 0.1MG N021301 005 May 25, 2001
--> --> AB1,AB3 0.112MG N021301 006 May 25, 2001
--> --> AB1,AB3 0.125MG N021301 007 May 25, 2001
--> --> AB1,AB3 0.137MG N021301 008 May 25, 2001
--> --> AB1,AB3 0.15MG N021301 009 May 25, 2001
--> --> AB1,AB3 0.175MG N021301 010 May 25, 2001
--> + --> AB1,AB3 0.2MG N021301 011 May 25, 2001
SYNTHROID
--> ABBOTT --> AB1,AB2 0.025MG N021402 001 Jul 24, 2002
--> --> AB1,AB2 0.05MG N021402 002 Jul 24, 2002
--> --> AB1,AB2 0.075MG N021402 003 Jul 24, 2002
--> --> AB1,AB2 0.088MG N021402 004 Jul 24, 2002
--> --> AB1,AB2 0.1MG N021402 005 Jul 24, 2002
--> --> AB1,AB2 0.112MG N021402 006 Jul 24, 2002
--> --> AB1,AB2 0.125MG N021402 007 Jul 24, 2002
--> --> AB1,AB2 0.137MG N021402 008 Jul 24, 2002
--> --> AB1,AB2 0.15MG N021402 009 Jul 24, 2002
--> --> AB1,AB2 0.175MG N021402 010 Jul 24, 2002
--> --> AB1,AB2 0.2MG N021402 012 Jul 24, 2002
--> + --> AB1,AB2 0.3MG N021402 011 Jul 24, 2002
UNITHROID
--> STEVENS J --> AB1,AB2,AB3 0.025MG N021210 001 Aug 21, 2000
--> --> AB1,AB2,AB3 0.05MG N021210 002 Aug 21, 2000
--> --> AB1,AB2,AB3 0.075MG N021210 003 Aug 21, 2000
--> --> AB1,AB2,AB3 0.088MG N021210 004 Aug 21, 2000
--> --> AB1,AB2,AB3 0.1MG N021210 005 Aug 21, 2000
--> --> AB1,AB2,AB3 0.112MG N021210 006 Aug 21, 2000
--> --> AB1,AB2,AB3 0.125MG N021210 007 Aug 21, 2000
--> --> AB1,AB2,AB3 0.137MG N021210 012 Feb 08, 2008
--> --> AB1,AB2,AB3 0.15MG N021210 008 Aug 21, 2000
--> --> AB1,AB2,AB3 0.175MG N021210 009 Aug 21, 2000
--> --> AB1,AB2,AB3 0.2MG N021210 010 Aug 21, 2000
--> + --> AB1,AB2,AB3 0.3MG N021210 011 Aug 21, 2000
LEVOTHROID
AB4 LLOYD 0.025MG N021116 001 Oct 24, 2002
AB4 0.05MG N021116 002 Oct 24, 2002
AB4 0.075MG N021116 003 Oct 24, 2002
AB4 0.088MG N021116 010 Oct 24, 2002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 238 (of 393)

LEVOTHYROXINE SODIUM**

**Refer to Preface Section 1.8 Levothyroxine Sodium for amplifying information**


TABLET; ORAL
LEVOTHROID
AB4 LLOYD 0.1MG N021116 004 Oct 24, 2002
AB4 0.112MG N021116 011 Oct 24, 2002
AB4 0.125MG N021116 005 Oct 24, 2002
AB4 0.137MG N021116 012 Dec 07, 2004
AB4 0.15MG N021116 006 Oct 24, 2002
AB4 0.175MG N021116 007 Oct 24, 2002
AB4 0.2MG N021116 008 Oct 24, 2002
AB4 + 0.3MG N021116 009 Oct 24, 2002

LIDOCAINE
OINTMENT; TOPICAL
LIDOCAINE
AT + FOUGERA 5% A080198 001
AT TARO 5% A086724 001
PATCH; TOPICAL

LIDODERM

XX + TEIKOKU PHARMA USA 5% N020612 001 Mar 19, 1999

LIDOCAINE HYDROCHLORIDE
GEL; OPHTHALMIC

AKTEN

XX + AKORN 3.5% N022221 001 Oct 07, 2008


INJECTABLE; INJECTION
LIDOCAINE HYDROCHLORIDE
AP HOSPIRA 0.5% A088328 001 May 17, 1984
AP 1% A040013 001 Jun 23, 1995
AP 1% A083158 001
AP 1% A088329 001 May 17, 1984
AP 2% A040078 001 Jun 23, 1995
AP 2% A083158 002
AP 2% A088294 001 May 17, 1984
AP 20% A083158 003
AP INTL MEDICATION 1% A083173 001
AP 2% A083173 002
AP LUITPOLD 1% A080850 001
AP 2% A083198 001
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 200MG/100ML N019830 002 Apr 08, 1992
AP BAXTER HLTHCARE 200MG/100ML N018461 002
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 400MG/100ML N019830 003 Apr 08, 1992
AP BAXTER HLTHCARE 400MG/100ML N018461 003
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP HOSPIRA 400MG/100ML N018388 002
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 800MG/100ML N019830 004 Apr 08, 1992
AP BAXTER HLTHCARE 800MG/100ML N018461 004 Feb 22, 1982
LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP HOSPIRA 800MG/100ML N018388 003 Nov 05, 1982
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
AP APP PHARMS 1% A088586 001 Jul 24, 1985
AP HOSPIRA 0.5% A088325 001 Jul 31, 1984
AP 1% A088299 001 Jul 31, 1984
AP 2% A088327 001 Jul 31, 1984
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
AP ABRAXIS PHARM 2% N017584 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 239 (of 393)

LIDOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
AP ABRAXIS PHARM 4% N017584 002
AP APP PHARMS 1% A080404 002
AP 2% A080404 003
AP HOSPIRA 1% A080408 001
AP 1.5% A080408 002
AP 4% A088295 001 May 17, 1984
AP INTL MEDICATION 20% N017702 001
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER
AP HOSPIRA 1% A040302 001 Sep 28, 1998
AP 2% A040302 002 Sep 28, 1998
LIDOPEN
AP MERIDIAN MEDCL TECHN 10% N017549 001
XYLOCAINE
AP + APP PHARMS 0.5% N006488 008
AP + 1% N006488 007
AP + 1.5% N006488 010
AP + 2% N006488 002
XYLOCAINE 4% PRESERVATIVE FREE
AP + APP PHARMS 4% N010417 001
XYLOCAINE DENTAL
AP + DENTSPLY PHARM 2% N021380 001
XYLOCAINE PRESERVATIVE FREE
AP APP PHARMS 1% N016801 005 Jan 19, 1988
AP + 2% N016801 001
AP 4% N016801 002
AP + 10% N016801 003
AP + 20% N016801 004
INJECTABLE; SPINAL

LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%

XX + HOSPIRA 5% A083914 001


JELLY; TOPICAL
ANESTACON
AT POLYMEDICA 2% A080429 001
LIDOCAINE HYDROCHLORIDE
AT AKORN 2% A040433 001 Feb 12, 2003
AT INTL MEDICATION 2% A086283 001
AT TEVA PHARMS 2% A081318 001 Apr 29, 1993
XYLOCAINE
AT + APP PHARMS 2% N008816 001
SOLUTION; ORAL
LIDOCAINE HYDROCHLORIDE
AT HI TECH PHARMA 2% A040014 001 Jul 10, 1995
AT MORTON GROVE 2% A087872 001 Nov 18, 1982
LIDOCAINE HYDROCHLORIDE VISCOUS
AT ACTAVIS MID ATLANTIC 2% A086578 001
AT VINTAGE 2% A040708 001 Feb 27, 2007
LIDOCAINE VISCOUS
AT ROXANE 2% A088802 001 Apr 26, 1985
XYLOCAINE VISCOUS
AT + APP PHARMS 2% N009470 001
SOLUTION; TOPICAL
LARYNG-O-JET KIT
AT INTL MEDICATION 4% A086364 001
LIDOCAINE HYDROCHLORIDE
AT MORTON GROVE 4% A087881 001 Nov 18, 1982
AT ROXANE 4% A088803 001 Apr 03, 1985
AT VINTAGE 4% A040710 001 Feb 27, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 240 (of 393)

LIDOCAINE HYDROCHLORIDE
SOLUTION; TOPICAL
LTA II KIT
AT HOSPIRA 4% A080409 001
XYLOCAINE 4% PRESERVATIVE FREE
AT + APP PHARMS 4% N010417 002
PEDIATRIC LTA KIT
XX HOSPIRA 2% A085995 001

LIDOCAINE; PRILOCAINE
CREAM; TOPICAL
EMLA
AB + APP PHARMS 2.5%;2.5% N019941 001 Dec 30, 1992
LIDOCAINE AND PRILOCAINE
AB ALTANA 2.5%;2.5% A076453 001 Aug 18, 2003
AB HI TECH PHARMA 2.5%;2.5% A076290 001 Sep 25, 2003
AB TOLMAR 2.5%;2.5% A076320 001 Aug 27, 2003
GEL; PERIODONTAL

ORAQIX

XX + DENTSPLY PHARM 2.5%;2.5% N021451 001 Dec 19, 2003

LIDOCAINE; TETRACAINE
CREAM; TOPICAL

LIDOCAINE AND TETRACAINE


XX + GALDERMA LABS LP 7%;7% N021717 001 Jun 29, 2006


PATCH; TOPICAL

SYNERA

XX + ZARS PHARM 70MG;70MG N021623 001 Jun 23, 2005

LINCOMYCIN HYDROCHLORIDE
INJECTABLE; INJECTION

LINCOCIN

XX + PHARMACIA AND UPJOHN EQ 300MG BASE/ML N050317 001

LINDANE
LOTION; TOPICAL

LINDANE

XX + MORTON GROVE 1% A088190 001 Aug 16, 1984


SHAMPOO; TOPICAL
LINDANE
AT MORTON GROVE 1% A088191 001 Sep 18, 1984
AT + OLTA PHARMS 1% A087266 001

LINEZOLID
FOR SUSPENSION; ORAL

ZYVOX

XX + PHARMACIA AND UPJOHN 100MG/5ML N021132 001 Apr 18, 2000


INJECTABLE; INJECTION

ZYVOX

XX + PHARMACIA AND UPJOHN 200MG/100ML N021131 001 Apr 18, 2000


TABLET; ORAL

ZYVOX

XX + PHARMACIA AND UPJOHN 600MG N021130 002 Apr 18, 2000

LIOTHYRONINE SODIUM
INJECTABLE; INJECTION
LIOTHYRONINE SODIUM
AP X GEN PHARMS EQ 0.01MG BASE/ML A076923 001 Aug 17, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 241 (of 393)

LIOTHYRONINE SODIUM
INJECTABLE; INJECTION
TRIOSTAT
AP + JHP PHARMS EQ 0.01MG BASE/ML N020105 001 Dec 31, 1991
TABLET; ORAL
CYTOMEL
AB KING PHARMS EQ 0.005MG BASE N010379 001
AB EQ 0.025MG BASE N010379 002
AB + EQ 0.05MG BASE N010379 003
LIOTHYRONINE SODIUM
AB COASTAL PHARMS EQ 0.005MG BASE A090097 001 Mar 20, 2009
AB EQ 0.025MG BASE A090097 002 Mar 20, 2009
AB EQ 0.05MG BASE A090097 003 Mar 20, 2009
AB MYLAN EQ 0.005MG BASE A090326 001 Jul 14, 2009
AB EQ 0.025MG BASE A090326 002 Jul 14, 2009
AB EQ 0.05MG BASE A090326 003 Jul 14, 2009

LIOTRIX (T4;T3)
TABLET; ORAL

THYROLAR-0.25

XX FOREST LABS 0.0125MG;0.0031MG N016807 001


THYROLAR-0.5

XX FOREST LABS 0.025MG;0.0063MG N016807 005


THYROLAR-1

XX FOREST LABS 0.05MG;0.0125MG N016807 004


THYROLAR-2

XX FOREST LABS 0.1MG;0.025MG N016807 002


THYROLAR-3

XX + FOREST LABS 0.15MG;0.0375MG N016807 003

LISDEXAMFETAMINE DIMESYLATE
CAPSULE; ORAL
VYVANSE
XX SHIRE DEVELOPMENT 20MG N021977 004 Dec 10, 2007
XX 30MG N021977 001 Feb 23, 2007
XX 40MG N021977 005 Dec 10, 2007
XX 50MG N021977 002 Feb 23, 2007
XX 60MG N021977 006 Dec 10, 2007
XX + 70MG N021977 003 Feb 23, 2007

LISINOPRIL
TABLET; ORAL
LISINOPRIL
AB ACTAVIS ELIZABETH 2.5MG A076180 001 Jul 01, 2002
AB 5MG A076180 002 Jul 01, 2002
AB 10MG A076180 003 Jul 01, 2002
AB 20MG A076164 001 Jul 01, 2002
AB 30MG A076164 002 Jul 01, 2002
AB 40MG A076164 003 Jul 01, 2002
AB APOTEX INC 2.5MG A076102 001 Sep 30, 2002
AB 5MG A076102 002 Sep 30, 2002
AB 10MG A076102 003 Sep 30, 2002
AB 20MG A076102 004 Sep 30, 2002
AB 30MG A076102 005 Sep 30, 2002
AB 40MG A076102 006 Sep 30, 2002
AB AUROBINDO 2.5MG A077622 001 Feb 22, 2006
AB 5MG A077622 002 Feb 22, 2006
AB 10MG A077622 003 Feb 22, 2006
AB 20MG A077622 004 Feb 22, 2006
AB 30MG A077622 005 Feb 22, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 242 (of 393)

LISINOPRIL
TABLET; ORAL
LISINOPRIL
AB AUROBINDO 40MG A077622 006 Feb 22, 2006
AB IVAX SUB TEVA PHARMS 2.5MG A075752 001 Jul 01, 2002
AB 5MG A075752 002 Jul 01, 2002
AB 10MG A075752 003 Jul 01, 2002
AB 20MG A075752 004 Jul 01, 2002
AB 30MG A075752 005 Jul 01, 2002
AB 40MG A075752 006 Jul 01, 2002
AB LEK PHARMS 2.5MG A075999 001 Jul 01, 2002
AB 5MG A075999 002 Jul 01, 2002
AB 10MG A075999 003 Jul 01, 2002
AB 20MG A075999 004 Jul 01, 2002
AB 30MG A075999 005 Jul 01, 2002
AB 40MG A075999 006 Jul 01, 2002
AB LUPIN 2.5MG A077321 001 Sep 09, 2005
AB 5MG A077321 002 Sep 09, 2005
AB 10MG A077321 003 Sep 09, 2005
AB 20MG A077321 004 Sep 09, 2005
AB 30MG A077321 005 Sep 09, 2005
AB 40MG A077321 006 Sep 09, 2005
AB MYLAN 2.5MG A076071 001 Jul 01, 2002
AB 5MG A076071 002 Jul 01, 2002
AB 10MG A076071 003 Jul 01, 2002
AB 20MG A076071 004 Jul 01, 2002
AB 30MG A076071 005 Jul 01, 2002
AB 40MG A076071 006 Jul 01, 2002
AB RANBAXY 2.5MG A075944 001 Jul 01, 2002
AB 5MG A075944 002 Jul 01, 2002
AB 10MG A075944 003 Jul 01, 2002
AB 20MG A075944 004 Jul 01, 2002
AB 30MG A075944 006 Feb 11, 2003
AB 40MG A075944 005 Jul 01, 2002
AB SANDOZ 2.5MG A075903 001 Jul 01, 2002
AB 2.5MG A075994 001 Jul 01, 2002
AB 5MG A075903 002 Jul 01, 2002
AB 5MG A075994 002 Jul 01, 2002
AB 10MG A075903 003 Jul 01, 2002
AB 10MG A075994 003 Jul 01, 2002
AB 20MG A075903 004 Jul 01, 2002
AB 20MG A075994 004 Jul 01, 2002
AB 30MG A075903 005 Jul 01, 2002
AB 30MG A075994 005 Jul 01, 2002
AB 40MG A075903 006 Jul 01, 2002
AB 40MG A075994 006 Jul 01, 2002
AB TEVA 2.5MG A075783 001 Jul 01, 2002
AB 5MG A075783 002 Jul 01, 2002
AB 10MG A075783 003 Jul 01, 2002
AB 20MG A075783 004 Jul 01, 2002
AB 30MG A075783 005 Jul 01, 2002
AB 40MG A075783 006 Jul 01, 2002
AB VINTAGE 2.5MG A075743 001 Jul 01, 2002
AB 5MG A075743 002 Jul 01, 2002
AB 10MG A075743 003 Jul 01, 2002
AB 20MG A075743 004 Jul 01, 2002
AB 30MG A075743 005 Jul 01, 2002
AB 40MG A075743 006 Jul 01, 2002
AB WATSON LABS 2.5MG A076059 001 Jul 01, 2002
AB 5MG A076059 002 Jul 01, 2002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 243 (of 393)

LISINOPRIL
TABLET; ORAL
LISINOPRIL
AB WATSON LABS 10MG A076059 003 Jul 01, 2002
AB 20MG A076059 004 Jul 01, 2002
AB 30MG A076059 005 Jul 01, 2002
AB 40MG A076059 006 Jul 01, 2002
AB WEST WARD 2.5MG A076063 001 Jul 01, 2002
AB 5MG A076063 002 Jul 01, 2002
AB 10MG A076063 003 Jul 01, 2002
AB 20MG A076063 004 Jul 01, 2002
AB 30MG A076063 006 Jun 27, 2003
AB 40MG A076063 005 Jul 01, 2002
AB WOCKHARDT 2.5MG A078402 001 Apr 19, 2007
AB 5MG A078402 002 Apr 19, 2007
AB 10MG A078402 003 Apr 19, 2007
AB 20MG A078402 004 Apr 19, 2007
AB 30MG A078402 005 Apr 19, 2007
AB 40MG A078402 006 Apr 19, 2007
PRINIVIL
AB MERCK 5MG N019558 001 Dec 29, 1987
AB 10MG N019558 002 Dec 29, 1987
AB 20MG N019558 003 Dec 29, 1987
AB 40MG N019558 004 Oct 25, 1988
ZESTRIL
AB ASTRAZENECA 2.5MG N019777 005 Apr 29, 1993
AB 5MG N019777 001 May 19, 1988
AB 10MG N019777 002 May 19, 1988
AB 20MG N019777 003 May 19, 1988
AB 30MG N019777 006 Jan 20, 1999
AB + 40MG N019777 004 May 19, 1988

LITHIUM CARBONATE
CAPSULE; ORAL
ESKALITH
AB NOVEN THERAP 300MG N016860 001
LITHIUM CARBONATE
AB ALEMBIC LTD 150MG A079159 001 Jan 12, 2009
AB 300MG A079159 002 Jan 12, 2009
AB 600MG A079159 003 Jan 12, 2009
AB APOTEX INC 300MG A076795 001 Nov 22, 2004
AB GLENMARK GENERICS 150MG A079139 001 Feb 03, 2009
AB 300MG A079139 002 Feb 03, 2009
AB 600MG A079139 003 Feb 03, 2009
AB HETERO DRUGS LTD 150MG A090702 001 Sep 25, 2009
AB 300MG A090702 002 Sep 25, 2009
AB 600MG A090702 003 Sep 25, 2009
AB ROXANE 150MG N017812 002 Jan 28, 1987
AB 300MG N017812 001
AB + 600MG N017812 003 Jan 28, 1987
AB WEST WARD 150MG A076243 002 Feb 24, 2003
AB 300MG A076243 001 Jun 27, 2002
AB 600MG A078763 001 Apr 15, 2008
TABLET; ORAL

LITHIUM CARBONATE

XX + ROXANE 300MG N018558 001 Jan 29, 1982


TABLET, EXTENDED RELEASE; ORAL
LITHIUM CARBONATE
AB ROXANE 300MG A076832 001 Oct 28, 2004
AB + 450MG A076691 001 Jan 05, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 244 (of 393)

LITHIUM CARBONATE
TABLET, EXTENDED RELEASE; ORAL
LITHIUM CARBONATE
AB WEST WARD 450MG A076490 001 Jun 17, 2003
LITHOBID
AB + NOVEN THERAP 300MG N018027 001

LITHIUM CITRATE
SYRUP; ORAL
LITHIUM CITRATE
AA MORTON GROVE EQ 300MG CARBONATE/5ML A070755 001 May 21, 1986
AA + ROXANE EQ 300MG CARBONATE/5ML N018421 001

LODOXAMIDE TROMETHAMINE
SOLUTION/DROPS; OPHTHALMIC

ALOMIDE

XX + ALCON EQ 0.1% BASE N020191 001 Sep 23, 1993

LOMUSTINE
CAPSULE; ORAL

CEENU

XX BRISTOL MYERS SQUIBB 10MG N017588 001


XX 40MG N017588 002


XX + 100MG N017588 003

LOPERAMIDE HYDROCHLORIDE
CAPSULE; ORAL
IMODIUM
AB + MCNEIL CONS 2MG N017694 001
LOPERAMIDE HYDROCHLORIDE
AB MYLAN 2MG A072741 001 Sep 18, 1991
AB TEVA 2MG A073192 001 Apr 30, 1992

LOPINAVIR; RITONAVIR
CAPSULE; ORAL

KALETRA

XX + ABBOTT 133.3MG;33.3MG N021226 001 Sep 15, 2000


SOLUTION; ORAL

KALETRA

XX + ABBOTT 80MG/ML;20MG/ML N021251 001 Sep 15, 2000


TABLET; ORAL
KALETRA
XX ABBOTT 100MG;25MG N021906 002 Nov 09, 2007
XX + 200MG;50MG N021906 001 Oct 28, 2005

LORAZEPAM
CONCENTRATE; ORAL
LORAZEPAM
AA AMNEAL PHARMS 2MG/ML A091383 001 Dec 23, 2009
AA PADDOCK LABS 2MG/ML A079244 001 Apr 28, 2009
LORAZEPAM INTENSOL
AA + ROXANE 2MG/ML A072755 001 Jun 28, 1991
INJECTABLE; INJECTION
ATIVAN
AP + BAXTER HLTHCARE CORP 2MG/ML N018140 001
AP + 4MG/ML N018140 002
LORAZEPAM
AP BEDFORD 2MG/ML A077076 001 Jul 13, 2005
AP 4MG/ML A077076 002 Jul 13, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 245 (of 393)

LORAZEPAM
INJECTABLE; INJECTION
LORAZEPAM
AP HOSPIRA 2MG/ML A074243 001 Apr 12, 1994
AP 2MG/ML A074282 001 May 27, 1994
AP 2MG/ML A074300 001 Apr 12, 1994
AP 4MG/ML A074243 002 Apr 12, 1994
AP 4MG/ML A074282 002 May 27, 1994
AP INTL MEDICATION SYS 2MG/ML A076150 001 Nov 15, 2004
AP WATSON LABS 2MG/ML A074276 001 Apr 15, 1994
AP 4MG/ML A074276 002 Apr 15, 1994
LORAZEPAM PRESERVATIVE FREE
AP BEDFORD LABS 2MG/ML A077074 001 Jul 13, 2005
AP 4MG/ML A077074 002 Jul 13, 2005
TABLET; ORAL
ATIVAN
AB BIOVAIL 0.5MG N017794 001
AB 1MG N017794 002
AB + 2MG N017794 003
LORAZEPAM
AB ACTAVIS ELIZABETH 0.5MG A071403 001 Apr 21, 1987
AB 1MG A071404 001 Apr 21, 1987
AB 2MG A071141 001 Apr 21, 1987
AB EXCELLIUM 0.5MG A078203 001 Jul 30, 2007
AB 1MG A078203 002 Jul 30, 2007
AB 2MG A078203 003 Jul 30, 2007
AB IVAX SUB TEVA PHARMS 0.5MG A077396 001 Dec 13, 2006
AB 1MG A077396 002 Dec 13, 2006
AB 2MG A077396 003 Dec 13, 2006
AB MUTUAL PHARM 0.5MG A072553 001 Mar 29, 1991
AB 1MG A072554 001 Mar 29, 1991
AB 2MG A072555 001 Mar 29, 1991
AB MYLAN 0.5MG A071589 001 Oct 13, 1987
AB 0.5MG A077657 001 Mar 16, 2006
AB 1MG A071590 001 Oct 13, 1987
AB 1MG A077657 002 Mar 16, 2006
AB 2MG A071591 001 Oct 13, 1987
AB 2MG A077657 003 Mar 16, 2006
AB RANBAXY 0.5MG A076045 001 Aug 29, 2001
AB 1MG A076045 002 Aug 29, 2001
AB 2MG A076045 003 Aug 29, 2001
AB SANDOZ 0.5MG A071193 001 Apr 15, 1988
AB 1MG A071194 001 Apr 15, 1988
AB 2MG A071195 001 Apr 15, 1988
AB VINTAGE PHARMS 0.5MG A077754 001 May 10, 2006
AB 1MG A077754 002 May 10, 2006
AB 2MG A077754 003 May 10, 2006
AB WATSON LABS 0.5MG A072926 001 Oct 31, 1991
AB 1MG A071118 001 Jul 24, 1986
AB 1MG A072927 001 Oct 31, 1991
AB 2MG A072928 001 Oct 31, 1991

LOSARTAN POTASSIUM
TABLET; ORAL
COZAAR
XX MERCK 25MG N020386 001 Apr 14, 1995
XX 50MG N020386 002 Apr 14, 1995
XX + 100MG N020386 003 Oct 13, 1998
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 246 (of 393)

LOTEPREDNOL ETABONATE
SUSPENSION/DROPS; OPHTHALMIC

ALREX

XX + BAUSCH AND LOMB 0.2% N020803 001 Mar 09, 1998


LOTEMAX
XX + BAUSCH AND LOMB 0.5% N020583 001 Mar 09, 1998

LOTEPREDNOL ETABONATE; TOBRAMYCIN


SUSPENSION/DROPS; OPHTHALMIC

ZYLET

XX + BAUSCH AND LOMB 0.5%;0.3% N050804 001 Dec 14, 2004

LOVASTATIN
TABLET; ORAL
LOVASTATIN
AB ACTAVIS ELIZABETH 10MG A075828 001 Dec 17, 2001
AB 20MG A075828 002 Dec 17, 2001
AB 40MG A075828 003 Dec 17, 2001
AB APOTEX INC 10MG A077748 001 Feb 28, 2007
AB 20MG A077748 002 Feb 28, 2007
AB 40MG A077748 003 Feb 28, 2007
AB CARLSBAD 10MG A075991 001 Jun 05, 2002
AB 20MG A075991 002 Jun 05, 2002
AB 40MG A075991 003 Jun 05, 2002
AB LUPIN 10MG A078296 001 Mar 14, 2008
AB 20MG A078296 002 Nov 01, 2007
AB 40MG A078296 003 Nov 01, 2007
AB MUTUAL PHARM 10MG A077520 001 Apr 14, 2006
AB 20MG A077520 002 Apr 14, 2006
AB 40MG A077520 003 Apr 14, 2006
AB MYLAN 10MG A075451 001 Dec 17, 2001
AB 10MG A075935 001 Dec 17, 2001
AB 20MG A075451 002 Dec 17, 2001
AB 20MG A075935 002 Dec 17, 2001
AB 40MG A075451 003 Dec 17, 2001
AB 40MG A075935 003 Dec 17, 2001
AB SANDOZ 10MG A075300 001 Dec 17, 2001
AB 10MG A075636 001 Dec 17, 2001
AB 20MG A075300 002 Dec 17, 2001
AB 20MG A075636 002 Dec 17, 2001
AB 40MG A075300 003 Dec 17, 2001
AB 40MG A075636 003 Dec 17, 2001
AB TEVA 10MG A075551 003 Dec 17, 2001
AB 20MG A075551 002 Dec 17, 2001
AB 40MG A075551 001 Dec 17, 2001
MEVACOR
AB MERCK 20MG N019643 003 Aug 31, 1987
AB + 40MG N019643 004 Dec 14, 1988
TABLET, EXTENDED RELEASE; ORAL
ALTOPREV
XX ANDRX LABS LLC 20MG N021316 002 Jun 26, 2002
XX 40MG N021316 003 Jun 26, 2002
XX + 60MG N021316 004 Jun 26, 2002

LOVASTATIN; NIACIN
TABLET, EXTENDED RELEASE; ORAL

ADVICOR

XX + ABBOTT 20MG;500MG N021249 001 Dec 17, 2001


XX + 20MG;750MG N021249 002 Dec 17, 2001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 247 (of 393)

LOVASTATIN; NIACIN
TABLET, EXTENDED RELEASE; ORAL

ADVICOR

XX + ABBOTT 20MG;1GM N021249 003 Dec 17, 2001


XX + 40MG;1GM N021249 004 Apr 27, 2006

LOXAPINE SUCCINATE
CAPSULE; ORAL
LOXAPINE SUCCINATE
AB MYLAN EQ 5MG BASE A076762 001 Nov 01, 2004
AB EQ 10MG BASE A076762 002 Nov 01, 2004
AB EQ 25MG BASE A076762 003 Nov 01, 2004
AB EQ 50MG BASE A076762 004 Nov 01, 2004
AB WATSON LABS EQ 5MG BASE A072204 001 Jun 15, 1988
AB EQ 10MG BASE A072205 001 Jun 15, 1988
AB + EQ 25MG BASE A072206 001 Jun 15, 1988
AB EQ 50MG BASE A072062 001 Jun 15, 1988

LUBIPROSTONE
CAPSULE; ORAL
AMITIZA
XX SUCAMPO PHARMS 8MCG N021908 002 Apr 29, 2008
XX + 24MCG N021908 001 Jan 31, 2006

LUTROPIN ALFA
INJECTABLE; SUBCUTANEOUS

LUVERIS

XX + EMD SERONO 75 IU/VIAL N021322 001 Oct 08, 2004

MAFENIDE ACETATE
CREAM; TOPICAL

SULFAMYLON

XX + UDL LABS EQ 85MG BASE/GM N016763 001


FOR SOLUTION; TOPICAL

SULFAMYLON

XX + UDL LABS 5% N019832 003 Jun 05, 1998

MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE


INJECTABLE; INJECTION
PLASMA-LYTE 56 IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 32MG/100ML;128MG/100ML;234MG/100ML N019047 001 Jun 15, 1984

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM


ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE; INJECTION

ISOLYTE S PH 7.4 IN PLASTIC CONTAINER


XX + B BRAUN 30MG/100ML;37MG/100ML;0.82MG/100ML;370M N019696 001 Sep 29, 1989


G/100ML;530MG/100ML;500MG/100ML;12MG/10
0ML

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM


GLUCONATE
INJECTABLE; INJECTION
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 30MG/100ML;37MG/100ML;368MG/100ML;526MG N017378 001
/100ML;502MG/100ML
PLASMA-LYTE A IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 30MG/100ML;37MG/100ML;368MG/100ML;526MG N017378 002 Nov 22, 1982
/100ML;502MG/100ML
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 248 (of 393)

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM


GLUCONATE
INJECTABLE; INJECTION
ISOLYTE S IN PLASTIC CONTAINER
XX B BRAUN 30MG/100ML;37MG/100ML;370MG/100ML;530MG N019711 001 Sep 29, 1989
/100ML;500MG/100ML
NORMOSOL-R IN PLASTIC CONTAINER
XX HOSPIRA 30MG/100ML;37MG/100ML;222MG/100ML;526MG N017586 001
/100ML;502MG/100ML

SOLUTION; IRRIGATION
PHYSIOLYTE IN PLASTIC CONTAINER
XX B BRAUN 30MG/100ML;37MG/100ML;370MG/100ML;530MG N019024 001 Jun 08, 1984
/100ML;500MG/100ML
PHYSIOSOL IN PLASTIC CONTAINER
XX HOSPIRA 30MG/100ML;37MG/100ML;222MG/100ML;526MG N017637 002 Jul 08, 1982
/100ML;502MG/100ML
PHYSIOSOL PH 7.4 IN PLASTIC CONTAINER
XX HOSPIRA 30MG/100ML;37MG/100ML;222MG/100ML;526MG N018406 002 Jul 08, 1982
/100ML;502MG/100ML

MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE


SOLUTION; INJECTION

NORMOCARB HF 25

XX + DIALYSIS SUPS 0.21GM/100ML;2.8GM/100ML;9.07GM/100ML N021910 001 Jul 26, 2006


NORMOCARB HF 35
XX + DIALYSIS SUPS 0.21GM/100ML;3.97GM/100ML;8.3GM/100ML N021910 002 Jul 26, 2006

MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE


TABLET; ORAL
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
XX SANTARUS 343MG;20MG;750MG N022456 001 Dec 04, 2009
XX + 343MG;40MG;750MG N022456 002 Dec 04, 2009
TABLET, CHEWABLE; ORAL
ZEGERID
XX SANTARUS 700MG;20MG;600MG N021850 001 Mar 24, 2006
XX + 700MG;40MG;600MG N021850 002 Mar 24, 2006

MAGNESIUM SULFATE
INJECTABLE; INJECTION
MAGNESIUM SULFATE
AP + ABRAXIS PHARM 500MG/ML N019316 001 Sep 08, 1986
AP HOSPIRA 500MG/ML A075151 001 Apr 25, 2000
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
XX + HOSPIRA 1GM/100ML N020488 001 Jul 11, 1995
XX + 2GM/100ML N020488 002 Jul 11, 1995
MAGNESIUM SULFATE IN PLASTIC CONTAINER
XX HOSPIRA 2GM/50ML (40MG/ML) N020309 003 Jan 26, 2007
XX + 4GM/100ML (40MG/ML) N020309 001 Jun 24, 1994
XX + 4GM/50ML (80MG/ML) N020309 002 Jun 24, 1994

MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM


CHLORIDE; SODIUM PHOSPHATE
SOLUTION; IRRIGATION
TIS-U-SOL
AT BAXTER HLTHCARE 20MG/100ML;40MG/100ML;6.25MG/100ML;800M N018508 001 Feb 19, 1982
G/100ML;8.75MG/100ML
TIS-U-SOL IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 20MG/100ML;40MG/100ML;6.25MG/100ML;800M N018336 001
G/100ML;8.75MG/100ML
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 249 (of 393)

MALATHION
LOTION; TOPICAL
MALATHION
AT SYNERX PHARMA 0.5% A078743 001 Mar 06, 2009
OVIDE
AT + TARO PHARMS NORTH 0.5% N018613 001 Aug 02, 1982

MANGANESE CHLORIDE
INJECTABLE; INJECTION
MANGANESE CHLORIDE IN PLASTIC CONTAINER
XX HOSPIRA EQ 0.1MG MANGANESE/ML N018962 001 Jun 26, 1986

MANNITOL
INJECTABLE; INJECTION
MANNITOL 10%
AP B BRAUN 10GM/100ML N016080 002
MANNITOL 10% IN PLASTIC CONTAINER
AP B BRAUN 10GM/100ML N020006 002 Jul 26, 1993
AP HOSPIRA 10GM/100ML N019603 002 Jan 08, 1987
MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER
AP B BRAUN 10GM/100ML N016080 006
MANNITOL 15%
AP B BRAUN 15GM/100ML N016080 003
MANNITOL 15% IN PLASTIC CONTAINER
AP B BRAUN 15GM/100ML N020006 003 Jul 26, 1993
AP HOSPIRA 15GM/100ML N019603 003 Jan 08, 1990
MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%
AP B BRAUN 15GM/100ML N016080 005
MANNITOL 20%
AP B BRAUN 20GM/100ML N014738 001
AP 20GM/100ML N016080 004
MANNITOL 20% IN PLASTIC CONTAINER
AP B BRAUN 20GM/100ML N020006 004 Jul 26, 1993
AP HOSPIRA 20GM/100ML N019603 004 Jan 08, 1990
MANNITOL 25%
AP APP PHARMS 12.5GM/50ML A080677 001
AP HOSPIRA 12.5GM/50ML N016269 006 Aug 25, 1994
AP INTL MEDICATION 12.5GM/50ML A083051 001
AP LUITPOLD 12.5GM/50ML A087409 001 Jan 21, 1982
MANNITOL 5%
AP B BRAUN 5GM/100ML N016080 001
MANNITOL 5% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML N020006 001 Jul 26, 1993
AP HOSPIRA 5GM/100ML N019603 001 Jan 08, 1987
MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%
AP B BRAUN 5GM/100ML N016080 007
OSMITROL 10% IN WATER
AP BAXTER HLTHCARE 10GM/100ML N013684 002
OSMITROL 10% IN WATER IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 10GM/100ML N013684 006
OSMITROL 15% IN WATER
AP BAXTER HLTHCARE 15GM/100ML N013684 004
OSMITROL 15% IN WATER IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 15GM/100ML N013684 008
OSMITROL 20% IN WATER
AP BAXTER HLTHCARE 20GM/100ML N013684 003
OSMITROL 20% IN WATER IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20GM/100ML N013684 007
OSMITROL 5% IN WATER
AP BAXTER HLTHCARE 5GM/100ML N013684 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 250 (of 393)

MANNITOL
INJECTABLE; INJECTION
OSMITROL 5% IN WATER IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML N013684 005
SOLUTION; IRRIGATION

RESECTISOL IN PLASTIC CONTAINER


XX B BRAUN 5GM/100ML N016772 002


MANNITOL; SORBITOL
SOLUTION; IRRIGATION

SORBITOL-MANNITOL IN PLASTIC CONTAINER


XX HOSPIRA 540MG/100ML;2.7GM/100ML N018316 001


MAPROTILINE HYDROCHLORIDE
TABLET; ORAL
MAPROTILINE HYDROCHLORIDE
XX MYLAN 25MG A072285 002 Oct 03, 1988
XX + 50MG A072285 001 Oct 03, 1988
XX 75MG A072285 003 Oct 03, 1988

MARAVIROC
TABLET; ORAL
SELZENTRY
XX VIIV HLTHCARE 150MG N022128 001 Aug 06, 2007
XX + 300MG N022128 002 Aug 06, 2007

MEBENDAZOLE
TABLET, CHEWABLE; ORAL

MEBENDAZOLE

XX + TEVA PHARMS 100MG A073580 001 Jan 04, 1995

MECASERMIN RECOMBINANT
INJECTABLE; SUBCUTANEOUS

INCRELEX

XX + TERCICA 40MG/4ML (10MG/ML) N021839 001 Aug 30, 2005

MECHLORETHAMINE HYDROCHLORIDE
INJECTABLE; INJECTION

MUSTARGEN

XX + LUNDBECK INC 10MG/VIAL N006695 001

MECLIZINE HYDROCHLORIDE
TABLET; ORAL
ANTIVERT
AA + PFIZER 12.5MG N010721 006
AA + 25MG N010721 004
MECLIZINE HYDROCHLORIDE
AA PAR PHARM 12.5MG A087127 001
AA 25MG A087128 001
AA 50MG A089674 001 Mar 31, 1988
AA SANDOZ 12.5MG A084843 002 May 22, 1989
AA 25MG A084092 003 May 22, 1989
AA VINTAGE PHARMS 12.5MG A040179 001 Jan 30, 1997
AA 25MG A040179 002 Jan 30, 1997
AA WATSON LABS 25MG A085740 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 251 (of 393)

MECLOFENAMATE SODIUM
CAPSULE; ORAL
MECLOFENAMATE SODIUM
AB MYLAN EQ 50MG BASE A071081 002 Sep 03, 1986
AB + EQ 100MG BASE A071081 001 Sep 03, 1986
AB WATSON LABS EQ 50MG BASE A071468 001 Apr 15, 1987
AB EQ 100MG BASE A071469 001 Apr 15, 1987

MEDROXYPROGESTERONE ACETATE
INJECTABLE; INJECTION
DEPO-PROVERA
AB + PHARMACIA AND UPJOHN 150MG/ML N020246 001 Oct 29, 1992
MEDROXYPROGESTERONE ACETATE
AB SANDOZ 150MG/ML A078711 001 May 20, 2009
AB TEVA PARENTERAL 150MG/ML A076552 001 Oct 27, 2004
AB 150MG/ML A076553 001 Jul 28, 2004
DEPO-PROVERA
XX + PHARMACIA AND UPJOHN 400MG/ML N012541 003
INJECTABLE; SUBCUTANEOUS

DEPO-SUBQ PROVERA 104


XX + PHARMACIA AND UPJOHN 104MG/0.65ML N021583 001 Dec 17, 2004


TABLET; ORAL
MEDROXYPROGESTERONE ACETATE
AB BARR 2.5MG A040159 001 Aug 09, 1996
AB 5MG A040159 002 Aug 09, 1996
AB 10MG A040159 003 Aug 09, 1996
PROVERA
AB PHARMACIA AND UPJOHN 2.5MG N011839 001
AB 5MG N011839 003
AB + 10MG N011839 004
MEDROXYPROGESTERONE ACETATE
BP USL PHARMA 10MG A088484 001 Jul 26, 1984

MEFENAMIC ACID
CAPSULE; ORAL

PONSTEL

XX + SCIELE PHARMA INC 250MG N015034 003

MEFLOQUINE HYDROCHLORIDE
TABLET; ORAL
MEFLOQUINE HYDROCHLORIDE
AB BARR 250MG A076392 001 Dec 29, 2003
AB ROXANE 250MG A076523 001 Oct 01, 2004
AB + SANDOZ 250MG A076175 001 Feb 20, 2002

MEGESTROL ACETATE
SUSPENSION; ORAL
MEGACE
AB + BRISTOL MYERS SQUIBB 40MG/ML N020264 001 Sep 10, 1993
MEGESTROL ACETATE
AB APOTEX INC 40MG/ML A077404 001 Feb 16, 2006
AB MORTON GROVE 40MG/ML A076721 001 Nov 01, 2004
AB PAR PHARM 40MG/ML A075671 001 Jul 25, 2001
AB ROXANE 40MG/ML A075997 001 Feb 15, 2002
AB TEVA PHARMS 40MG/ML A075681 001 May 05, 2003
MEGACE ES
XX + PAR PHARM 125MG/ML N021778 001 Jul 05, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 252 (of 393)

MEGESTROL ACETATE
TABLET; ORAL
MEGACE
AB BRISTOL MYERS SQUIBB 20MG N016979 001
AB + 40MG N016979 002
MEGESTROL ACETATE
AB BARR 20MG A074621 002 Aug 16, 1996
AB 40MG A074621 001 Nov 30, 1995
AB PAR PHARM 20MG A072422 001 Aug 08, 1988
AB 40MG A072423 001 Aug 08, 1988
AB ROXANE 20MG A074458 001 Sep 29, 1995
AB 40MG A074458 002 Sep 29, 1995

MELOXICAM
SUSPENSION; ORAL

MOBIC

XX + BOEHRINGER INGELHEIM 7.5MG/5ML N021530 001 Jun 01, 2004


TABLET; ORAL
MELOXICAM
AB ACTAVIS TOTOWA 7.5MG A077938 001 Jul 19, 2006
AB 15MG A077938 002 Jul 19, 2006
AB APOTEX INC 7.5MG A077882 001 Jul 20, 2006
AB 15MG A077882 002 Jul 20, 2006
AB AUROBINDO PHARMA 7.5MG A078008 001 Oct 02, 2006
AB 15MG A078008 002 Oct 02, 2006
AB BEIJING DOUBLE CRANE 7.5MG A078039 001 Dec 14, 2006
AB 15MG A078039 002 Dec 14, 2006
AB BEJING YABAO 7.5MG A077933 001 Jul 19, 2006
AB 15MG A077933 002 Jul 19, 2006
AB BRECKENRIDGE PHARM 7.5MG A077920 001 Jul 19, 2006
AB 15MG A077920 002 Jul 19, 2006
AB CARACO 7.5MG A077937 001 Jul 19, 2006
AB 15MG A077937 002 Jul 19, 2006
AB CARLSBAD 7.5MG A077918 001 Dec 07, 2006
AB 15MG A077918 002 Dec 07, 2006
AB COREPHARMA 7.5MG A077930 001 Jul 19, 2006
AB 15MG A077930 002 Jul 19, 2006
AB DR REDDYS LABS INC 7.5MG A077931 001 Jul 25, 2006
AB 15MG A077931 002 Jul 25, 2006
AB GENPHARM 7.5MG A077934 001 Jul 20, 2006
AB 15MG A077934 002 Jul 20, 2006
AB GLENMARK GENERICS 7.5MG A077932 001 Jul 19, 2006
AB 15MG A077932 002 Jul 19, 2006
AB LUPIN PHARMS 7.5MG A077944 001 Jul 19, 2006
AB 15MG A077944 002 Jul 19, 2006
AB MYLAN 7.5MG A077923 001 Jul 19, 2006
AB 15MG A077923 002 Jul 19, 2006
AB STRIDES ARCOLAB LTD 7.5MG A077928 001 May 13, 2009
AB 15MG A077928 002 May 13, 2009
AB TARO 7.5MG A078102 001 Nov 07, 2006
AB 15MG A078102 002 Nov 07, 2006
AB TEVA PHARMS 7.5MG A077936 001 Jul 19, 2006
AB 15MG A077936 002 Jul 19, 2006
AB UNICHEM 7.5MG A077927 001 Dec 20, 2006
AB 15MG A077927 002 Dec 20, 2006
AB WATSON LABS 7.5MG A077929 001 Jul 19, 2006
AB 15MG A077929 002 Jul 19, 2006
AB ZYDUS PHARMS USA 7.5MG A077921 001 Jul 19, 2006
AB 15MG A077921 002 Jul 19, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 253 (of 393)

MELOXICAM
TABLET; ORAL
MOBIC
AB BOEHRINGER INGELHEIM 7.5MG N020938 001 Apr 13, 2000
AB + 15MG N020938 002 Aug 23, 2000

MELPHALAN
TABLET; ORAL

ALKERAN

XX + GLAXOSMITHKLINE 2MG N014691 002

MELPHALAN HYDROCHLORIDE
INJECTABLE; INJECTION
ALKERAN
AP + GLAXOSMITHKLINE EQ 50MG BASE/VIAL N020207 001 Nov 18, 1992
MELPHALAN HYDROCHLORIDE
AP GENERAMEDIX EQ 50MG BASE/VIAL A090299 001 Oct 27, 2009
AP SYNERX EQ 50MG BASE/VIAL A090270 001 Jun 09, 2009

MEMANTINE HYDROCHLORIDE
SOLUTION; ORAL

NAMENDA

XX + FOREST LABS 2MG/ML N021627 001 Apr 18, 2005


TABLET; ORAL
NAMENDA
XX FOREST LABS 5MG N021487 001 Oct 16, 2003
XX + 10MG N021487 002 Oct 16, 2003

MENOTROPINS (FSH;LH)
INJECTABLE; IM-SC

REPRONEX

XX + FERRING 75 IU/VIAL;75 IU/VIAL N021047 001 Aug 27, 1999


INJECTABLE; SUBCUTANEOUS

MENOPUR

XX + FERRING 75 IU/VIAL;75 IU/VIAL N021663 001 Oct 29, 2004

MEPENZOLATE BROMIDE
TABLET; ORAL

CANTIL

XX + SANOFI AVENTIS US 25MG N010679 003

MEPERIDINE HYDROCHLORIDE
INJECTABLE; INJECTION
DEMEROL
AP + HOSPIRA 25MG/ML N021171 001
AP + 50MG/ML N021171 002
AP + 75MG/ML N021171 003
AP + 100MG/ML N021171 004
MEPERIDINE HYDROCHLORIDE
AP BAXTER HLTHCARE CORP 25MG/ML A080455 007
AP 50MG/ML A080455 008
AP 75MG/ML A080455 009
AP 100MG/ML A080455 010
AP ELKINS SINN 25MG/ML A080445 001
AP 50MG/ML A080445 002
AP 75MG/ML A080445 003
AP 100MG/ML A080445 004
AP WATSON LABS 50MG/ML A073444 001 Mar 17, 1992
AP 100MG/ML A073445 001 Mar 17, 1992
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 254 (of 393)

MEPERIDINE HYDROCHLORIDE
INJECTABLE; INJECTION
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
AP ASTRAZENECA 10MG/ML A081002 001 Jul 30, 1993
AP + HOSPIRA 10MG/ML A088432 001 Aug 16, 1984
AP INTL MEDICATION 10MG/ML A081309 001 Aug 30, 1993
AP WATSON LABS 10MG/ML A073443 001 Mar 17, 1992
SYRUP; ORAL
DEMEROL
AA + SANOFI AVENTIS US 50MG/5ML N005010 005
MEPERIDINE HYDROCHLORIDE
AA ROXANE 50MG/5ML A088744 001 Jan 30, 1985
TABLET; ORAL
DEMEROL
AA + SANOFI AVENTIS US 50MG N005010 001
AA + 100MG N005010 004
MEPERIDINE HYDROCHLORIDE
AA ACTAVIS TOTOWA 50MG A040331 001 May 28, 1999
AA 100MG A040331 002 May 28, 1999
AA BARR 50MG A088639 001 Jul 02, 1984
AA 100MG A088640 001 Sep 19, 1984
AA CARACO 50MG A040446 001 Aug 08, 2002
AA 100MG A040446 002 Aug 08, 2002
AA MALLINCKRODT 50MG A040352 001 Jun 13, 2000
AA 100MG A040352 002 Jun 13, 2000
AA MIKART 50MG A040893 001 Jun 24, 2009
AA 100MG A040893 003 Jun 24, 2009
AA ROXANE 50MG A040110 001 Mar 12, 1997
AA 100MG A040110 002 Mar 12, 1997
AA VINTAGE PHARMS 50MG A040191 001 Dec 17, 1998
AA 100MG A040191 002 Dec 17, 1998
AA WATSON LABS 50MG A040186 001 Jun 30, 1997
AA 100MG A040186 002 Jun 30, 1997
MEPERIDINE HYDROCHLORIDE
XX MIKART 75MG A040893 002 Jun 24, 2009
XX 150MG A040893 004 Jun 24, 2009

MEPIVACAINE HYDROCHLORIDE
INJECTABLE; INJECTION
CARBOCAINE
AP + HOSPIRA 1% N012250 001
AP + 1.5% N012250 005
AP + 2% N012250 002
ISOCAINE HYDROCHLORIDE
AP + NOVOCOL 3% A080925 001
MEPIVACAINE HYDROCHLORIDE
AP HOSPIRA INC 3% A040806 001 Apr 28, 2008
AP WATSON LABS 1% A088769 001 Nov 20, 1984
AP 2% A088770 001 Nov 20, 1984
POLOCAINE
AP APP PHARMS 1% A089407 001 Dec 01, 1986
AP 2% A089410 001 Dec 01, 1986
AP DENTSPLY PHARM 3% A088653 001 Aug 21, 1984
POLOCAINE-MPF
AP APP PHARMS 1% A089406 001 Dec 01, 1986
AP 1.5% A089408 001 Dec 01, 1986
AP 2% A089409 001 Dec 01, 1986
SCANDONEST PLAIN
AP + DEPROCO 3% A088387 001 Oct 10, 1984
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 255 (of 393)

MEPROBAMATE
TABLET; ORAL
MEPROBAMATE
AA ALEMBIC LTD 200MG A090122 001 Feb 18, 2009
AA 400MG A090122 002 Feb 18, 2009
AA INVAGEN PHARMS 200MG A040797 001 Feb 27, 2008
AA 400MG A040797 002 Feb 27, 2008
AA + WATSON LABS 200MG A083304 001
AA + 400MG A083308 001

MEQUINOL; TRETINOIN
SOLUTION; TOPICAL

SOLAGE

XX + STIEFEL LABS INC 2%;0.01% N020922 001 Dec 10, 1999

MERCAPTOPURINE
TABLET; ORAL
MERCAPTOPURINE
AB MYLAN 50MG A040594 001 Jul 01, 2005
AB PROMETHEUS LABS 50MG A040461 001 Feb 11, 2004
AB ROXANE 50MG A040528 001 Feb 13, 2004
PURINETHOL
AB + TEVA 50MG N009053 002

MEROPENEM
INJECTABLE; INJECTION

MERREM I.V.

XX + ASTRAZENECA 500MG/VIAL N050706 003 Jun 21, 1996


XX + 1GM/VIAL N050706 001 Jun 21, 1996

MESALAMINE
CAPSULE, EXTENDED RELEASE; ORAL

APRISO

XX + SALIX PHARMS 375MG N022301 001 Oct 31, 2008


PENTASA
XX SHIRE 250MG N020049 001 May 10, 1993
XX + 500MG N020049 002 Jul 08, 2004
ENEMA; RECTAL
MESALAMINE
AB PERRIGO ISRAEL 4GM/60ML A076751 001 Sep 17, 2004
AB TEVA 4GM/60ML A076841 001 Sep 30, 2004
ROWASA
AB + ALAVEN PHARM 4GM/60ML N019618 001 Dec 24, 1987
SFROWASA
AB ALAVEN PHARM 4GM/60ML N019618 002 Jun 20, 2008
SUPPOSITORY; RECTAL

CANASA

XX + AXCAN SCANDIPHARM 1GM N021252 002 Nov 05, 2004


TABLET, DELAYED RELEASE; ORAL

ASACOL

XX + PROCTER AND GAMBLE 400MG N019651 001 Jan 31, 1992


ASACOL HD
XX + PROCTER AND GAMBLE 800MG N021830 001 May 29, 2008
LIALDA
XX + SHIRE 1.2GM N022000 001 Jan 16, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 256 (of 393)

MESNA
INJECTABLE; INTRAVENOUS
MESNA
AP APP PHARMS 100MG/ML A075811 001 Apr 26, 2001
AP BEDFORD 100MG/ML A075739 001 Jan 09, 2004
AP TEVA PARENTERAL 100MG/ML A075764 001 Apr 27, 2001
MESNEX
AP + BAXTER HLTHCARE 100MG/ML N019884 001 Dec 30, 1988
TABLET; ORAL

MESNEX

XX + BAXTER HLTHCARE 400MG N020855 001 Mar 21, 2002

MESTRANOL; NORETHINDRONE
TABLET; ORAL-28

NORINYL 1+50 28-DAY

XX + WATSON LABS 0.05MG;1MG N016659 001

METAPROTERENOL SULFATE
SOLUTION; INHALATION
METAPROTERENOL SULFATE
AN + DEY 0.4% A071786 001 Aug 05, 1988
AN + 0.6% A070804 001 Aug 17, 1987
AN MORTON GROVE 0.4% A075586 001 May 30, 2002
AN 0.6% A075586 002 May 30, 2002
AN NEPHRON 0.4% A071855 001 Jul 14, 1988
AN 0.6% A071726 001 Jul 14, 1988
AN NOVEX 0.4% A075402 001 Feb 28, 2001
AN 0.6% A075403 001 Feb 28, 2001
SYRUP; ORAL
METAPROTERENOL SULFATE
AA NOVEX 10MG/5ML A075235 001 Jan 27, 2000
AA + SILARX 10MG/5ML A073632 001 Jul 22, 1992
TABLET; ORAL
METAPROTERENOL SULFATE
AB PAR PHARM 10MG A072024 001 Jun 28, 1988
AB + 20MG A072025 001 Jun 28, 1988
AB WATSON LABS 10MG A073013 001 Jan 31, 1991
AB 20MG A072795 001 Jan 31, 1991

METARAMINOL BITARTRATE
INJECTABLE; INJECTION

METARAMINOL BITARTRATE

XX + APP PHARMS EQ 10MG BASE/ML A080722 001

METAXALONE
TABLET; ORAL

SKELAXIN

XX + KING PHARMS 800MG N013217 003 Aug 30, 2002

METFORMIN HYDROCHLORIDE
SOLUTION; ORAL

RIOMET

XX + RANBAXY 500MG/5ML N021591 001 Sep 11, 2003


TABLET; ORAL
GLUCOPHAGE
AB BRISTOL MYERS SQUIBB 500MG N020357 001 Mar 03, 1995
AB 850MG N020357 002 Mar 03, 1995
AB + 1GM N020357 005 Nov 05, 1998
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 257 (of 393)

METFORMIN HYDROCHLORIDE
TABLET; ORAL
METFORMIN HYDROCHLORIDE
AB ALPHAPHARM 500MG A075969 001 Jan 29, 2002
AB 850MG A075969 002 Jan 29, 2002
AB 1GM A075969 003 Jan 29, 2002
AB ALVOGEN 500MG A076033 001 Jan 24, 2002
AB 850MG A076033 002 Jan 24, 2002
AB 1GM A076033 003 Jan 24, 2002
AB AMNEAL PHARMS NY 500MG A077880 001 Jun 05, 2006
AB 850MG A077880 002 Jun 05, 2006
AB 1GM A077880 003 Jun 05, 2006
AB APOTEX 500MG A075984 001 Apr 23, 2002
AB 850MG A075984 002 Apr 23, 2002
AB 1GM A075984 003 Apr 23, 2002
AB AUROBINDO 500MG A077095 001 Jan 14, 2005
AB 850MG A077095 002 Jan 14, 2005
AB 1GM A077095 003 Jan 14, 2005
AB CARACO 500MG A075967 001 Jan 29, 2002
AB 850MG A075967 002 Jan 29, 2002
AB 1GM A075967 003 Jan 29, 2002
AB DR REDDYS LABS INC 500MG A077787 001 Aug 23, 2006
AB 850MG A077787 002 Aug 23, 2006
AB 1GM A077787 003 Aug 23, 2006
AB GENPHARM 500MG A075973 001 Jan 25, 2002
AB 850MG A075973 002 Jan 25, 2002
AB 1GM A075973 003 Jan 25, 2002
AB GLENMARK GENERICS 500MG A078170 001 May 23, 2008
AB 850MG A078170 002 May 23, 2008
AB 1GM A078170 003 May 23, 2008
AB GOLDLINE 500MG A075972 001 Jan 24, 2002
AB 625MG A075972 005 Jan 24, 2002
AB 750MG A075972 004 Jan 24, 2002
AB 850MG A075972 002 Jan 24, 2002
AB 1GM A075972 003 Jan 24, 2002
AB INDICUS PHARMA 500MG A079148 001 Nov 25, 2008
AB 850MG A079148 002 Nov 25, 2008
AB 1GM A079148 003 Nov 25, 2008
AB IPCA LABS LTD 500MG A078422 001 Aug 06, 2007
AB 850MG A078422 002 Aug 06, 2007
AB 1GM A078422 003 Aug 06, 2007
AB MUTUAL PHARMA 500MG A076038 001 Feb 21, 2002
AB 850MG A076038 002 Feb 21, 2002
AB 1GM A076038 003 Feb 21, 2002
AB MYLAN 500MG A075976 001 Jan 24, 2002
AB 850MG A075976 002 Jan 24, 2002
AB 1GM A075976 003 Jan 24, 2002
AB PROVIDENT PHARM 500MG A077853 001 Jul 28, 2006
AB 850MG A077853 002 Jul 28, 2006
AB 1GM A077853 003 Jul 28, 2006
AB SANDOZ 500MG A075965 001 Jan 25, 2002
AB 500MG A075985 001 Jan 25, 2002
AB 850MG A075965 002 Jan 25, 2002
AB 850MG A075985 002 Jan 25, 2002
AB 1GM A075965 003 Jan 25, 2002
AB 1GM A075985 003 Jan 25, 2002
AB TEVA 500MG A075978 001 Jan 25, 2002
AB 850MG A075978 002 Jan 25, 2002
AB 1GM A075978 003 Nov 05, 2002
AB TORRENT PHARMS 500MG A077711 001 Jan 24, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 258 (of 393)

METFORMIN HYDROCHLORIDE
TABLET; ORAL
METFORMIN HYDROCHLORIDE
AB TORRENT PHARMS 850MG A077711 002 Jan 24, 2007
AB 1GM A077711 003 Jan 24, 2007
AB WATSON LABS 500MG A075979 001 Jan 24, 2002
AB 850MG A075979 002 Jan 24, 2002
AB 1GM A075979 003 Jan 24, 2002
AB WATSON LABS FLORIDA 500MG A075961 001 Jan 25, 2002
AB 850MG A075961 002 Jan 25, 2002
AB 1GM A075961 003 Jan 25, 2002
AB ZENITH GOLDLINE 500MG A075975 001 Jan 24, 2002
AB 625MG A075975 004 Jan 24, 2002
AB 750MG A075975 005 Jan 24, 2002
AB 850MG A075975 002 Jan 24, 2002
AB 1GM A075975 003 Jan 24, 2002
AB ZYDUS PHARMS USA 500MG A077064 001 Apr 18, 2005
AB 850MG A077064 002 Apr 18, 2005
AB 1GM A077064 003 Apr 18, 2005
TABLET, EXTENDED RELEASE; ORAL
GLUCOPHAGE XR
AB BRISTOL MYERS SQUIBB 500MG N021202 001 Oct 13, 2000
AB + 750MG N021202 004 Apr 11, 2003
METFORMIN HYDROCHLORIDE
AB ACTAVIS ELIZABETH 500MG A076450 001 Oct 01, 2004
AB 750MG A076878 001 Apr 13, 2005
AB AMNEAL PHARMS NY 500MG A078596 001 Jan 03, 2008
AB 750MG A078596 002 Jan 03, 2008
AB APOTEX INC 500MG A076706 001 Dec 14, 2004
AB 750MG A076706 002 Dec 29, 2005
AB BARR 750MG A076863 001 Oct 14, 2004
AB COBALT 500MG A076818 001 Dec 14, 2004
AB IMPAX LABS 500MG A076249 001 Jul 30, 2004
AB 750MG A076985 001 Sep 13, 2005
AB IVAX SUB TEVA PHARMS 500MG A076545 001 Dec 01, 2003
AB MYLAN 500MG A076650 001 Sep 13, 2005
AB 750MG A077113 001 Sep 08, 2005
AB NEUROSCI INC 500MG A078321 001 Apr 17, 2008
AB 750MG A078321 002 Apr 17, 2008
AB NOSTRUM 500MG A076756 001 Jul 26, 2006
AB RANBAXY 500MG A076413 001 Jun 18, 2004
AB 750MG A077211 001 Jun 29, 2005
AB SANDOZ 500MG A076873 001 Dec 14, 2004
AB SUN PHARM INDS (IN) 500MG A077336 001 Feb 09, 2006
AB 750MG A077336 002 Feb 09, 2006
AB TEVA 500MG A076269 001 Jun 18, 2004
AB 750MG A076864 001 Apr 12, 2005
AB TORRENT PHARM 500MG A090014 001 Dec 30, 2009
AB WATSON LABS FLORIDA 500MG A076172 001 Jun 16, 2004
AB 750MG A076869 001 Apr 12, 2005
AB ZYDUS PHARMS USA 500MG A077060 001 Apr 20, 2005
AB 750MG A077078 001 Apr 21, 2005
FORTAMET
BX ANDRX LABS LLC 500MG N021574 001 Apr 27, 2004
BX + 1GM N021574 002 Apr 27, 2004
GLUMETZA
BX DEPOMED INC 500MG N021748 001 Jun 03, 2005
BX + 1GM N021748 002 Jun 03, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 259 (of 393)

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE


TABLET; ORAL
ACTOPLUS MET
XX TAKEDA GLOBAL 500MG;EQ 15MG BASE N021842 001 Aug 29, 2005
XX + 850MG;EQ 15MG BASE N021842 002 Aug 29, 2005
TABLET, EXTENDED RELEASE; ORAL
ACTOPLUS MET XR
XX TAKEDA GLOBAL 1GM;EQ 15MG BASE N022024 001 May 12, 2009
XX + 1GM;EQ 30MG BASE N022024 002 May 12, 2009

METFORMIN HYDROCHLORIDE; REPAGLINIDE


TABLET; ORAL
PRANDIMET
XX NOVO NORDISK INC 500MG;1MG N022386 001 Jun 23, 2008
XX + 500MG;2MG N022386 002 Jun 23, 2008

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE


TABLET; ORAL
AVANDAMET
XX SB PHARMCO 500MG;EQ 1MG BASE N021410 001 Oct 10, 2002
XX 500MG;EQ 2MG BASE N021410 002 Oct 10, 2002
XX 500MG;EQ 4MG BASE N021410 003 Oct 10, 2002
XX 1GM;EQ 2MG BASE N021410 004 Aug 25, 2003
XX + 1GM;EQ 4MG BASE N021410 005 Aug 25, 2003

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE


TABLET; ORAL
JANUMET
XX MERCK 500MG;EQ 50MG BASE N022044 001 Mar 30, 2007
XX + 1GM;EQ 50MG BASE N022044 002 Mar 30, 2007

METHACHOLINE CHLORIDE
FOR SOLUTION; INHALATION

PROVOCHOLINE

XX + METHAPHARM 100MG/VIAL N019193 001 Oct 31, 1986

METHADONE HYDROCHLORIDE
CONCENTRATE; ORAL
METHADONE HYDROCHLORIDE
AA ROXANE 10MG/ML A040180 001 Apr 30, 1998
AA VISTAPHARM 10MG/ML A040088 001 Nov 30, 1994
METHADONE HYDROCHLORIDE INTENSOL
AA ROXANE 10MG/ML A089897 001 Sep 06, 1988
METHADOSE
AA + MALLINCKRODT 10MG/ML N017116 002
INJECTABLE; INJECTION

DOLOPHINE HYDROCHLORIDE

XX + XANODYNE PHARM 10MG/ML N021624 001


POWDER; FOR RX COMPOUNDING

METHADONE HYDROCHLORIDE

XX MALLINCKRODT 50GM/BOT N006383 002


XX 100GM/BOT N006383 003


XX 500GM/BOT N006383 004


SOLUTION; ORAL

METHADONE HYDROCHLORIDE

XX + ROXANE 5MG/5ML A087393 001


XX + 10MG/5ML A087997 001 Aug 30, 1982
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 260 (of 393)

METHADONE HYDROCHLORIDE
TABLET; ORAL
DOLOPHINE HYDROCHLORIDE
AA + ROXANE 5MG N006134 002
AA + 10MG N006134 010
METHADONE HYDROCHLORIDE
AA MALLINCKRODT 5MG A040517 001 Apr 27, 2004
AA 10MG A040517 002 Apr 27, 2004
AA 40MG A077142 001 Jul 12, 2005
AA + ROXANE 40MG N017058 001
AA SANDOZ 10MG A040241 002 May 29, 1998
AA 40MG A075082 001 Mar 25, 1998
AA THE PHARMANETWORK 10MG A090635 001 Nov 25, 2009
METHADOSE
AA MALLINCKRODT 5MG A040050 001 Apr 15, 1993
AA 10MG A040050 002 Apr 15, 1993
AA 40MG A074184 001 Apr 29, 1993

METHAMPHETAMINE HYDROCHLORIDE
TABLET; ORAL

DESOXYN

XX + LUNDBECK INC 5MG N005378 002

METHAZOLAMIDE
TABLET; ORAL
METHAZOLAMIDE
AB MIKART 25MG A040062 001 Jan 27, 1994
AB + 50MG A040062 002 Jan 27, 1994
AB SANDOZ 25MG A040036 001 Jun 30, 1993
AB 50MG A040036 002 Jun 30, 1993
AB TEVA PHARMS 25MG A040001 001 Jun 30, 1993
AB 50MG A040001 002 Jun 30, 1993

METHENAMINE HIPPURATE
TABLET; ORAL
HIPREX
AB + SANOFI AVENTIS US 1GM N017681 001
METHENAMINE HIPPURATE
AB COREPHARMA 1GM A076411 001 Jun 20, 2003
UREX
AB VATRING PHARMS 1GM N016151 001

METHIMAZOLE
TABLET; ORAL
METHIMAZOLE
AB ACTAVIS TOTOWA 5MG A040734 001 Dec 14, 2007
AB 10MG A040734 002 Dec 14, 2007
AB CARACO 5MG A040870 001 Sep 25, 2007
AB 10MG A040870 002 Sep 25, 2007
AB CEDAR PHARMS 5MG A040547 001 Feb 18, 2005
AB 10MG A040547 002 Feb 18, 2005
AB MYLAN 5MG A040350 001 Mar 29, 2000
AB + 10MG A040350 002 Mar 29, 2000
AB SANDOZ 5MG A040411 001 Mar 27, 2001
AB 10MG A040411 002 Mar 27, 2001
TAPAZOLE
AB KING PHARMS 5MG A040320 001 Mar 31, 2000
AB 10MG A040320 002 Mar 31, 2000
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 261 (of 393)

METHOCARBAMOL
INJECTABLE; INJECTION
METHOCARBAMOL
AP WATSON LABS 100MG/ML A086459 001
ROBAXIN
AP + BAXTER HLTHCARE CORP 100MG/ML N011790 001
TABLET; ORAL
METHOCARBAMOL
AA HETERO DRUGS 500MG A090200 001 Nov 06, 2009
AA 750MG A090200 002 Nov 06, 2009
AA LANNETT 500MG A084756 002 Mar 31, 2003
AA 750MG A084756 001
AA SANDOZ 500MG A084616 001
AA 750MG A084615 001
AA VINTAGE PHARMS 500MG A040489 001 Jan 29, 2003
AA 750MG A040489 002 Jan 29, 2003
AA WATSON LABS 500MG A084277 001
AA 500MG A085180 001
AA 750MG A084276 002
AA 750MG A085192 001
AA WEST WARD 500MG A085159 001
AA 750MG A085123 001
ROBAXIN
AA + SCHWARZ PHARMA 500MG N011011 004
ROBAXIN-750
AA + SCHWARZ PHARMA 750MG N011011 006

METHOHEXITAL SODIUM
INJECTABLE; INJECTION

BREVITAL SODIUM

XX + JHP PHARMS 500MG/VIAL N011559 001


XX + 2.5GM/VIAL N011559 002

METHOTREXATE SODIUM
INJECTABLE; INJECTION
METHOTREXATE SODIUM
AP + APP PHARMS EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A040263 001 Feb 26, 1999
AP + EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A040263 002 Feb 26, 1999
AP + HOSPIRA EQ 50MG BASE/2ML (EQ 25MG BASE/ML) N011719 010 Dec 15, 2004
METHOTREXATE SODIUM PRESERVATIVE FREE
AP + BEDFORD EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A089340 001 Sep 16, 1986
AP + EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A089343 001 Sep 16, 1986
AP EBEWE PHARMA EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A090039 001 Mar 31, 2009
AP EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A090039 002 Mar 31, 2009
AP EQ 1GM BASE/40ML (EQ 25MG BASE/ML) A090029 001 Mar 31, 2009
AP + GENERAMEDIX EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A040767 001 Apr 30, 2007
AP + EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A040768 001 Apr 30, 2007
AP + EQ 1GM BASE/40ML (EQ 25MG BASE/ML) A040716 001 Apr 30, 2007
AP + HOSPIRA EQ 1GM BASE/40ML (EQ 25MG BASE/ML) N011719 012 Apr 13, 2005
AP PHARMACHEMIE BV EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A040850 001 Jan 11, 2010
AP EQ 250MG/10ML (EQ 25MG BASE/ML) A040853 001 Jan 11, 2010
AP EQ 1GM BASE/40ML (EQ 25MG BASE/ML) A040843 001 Jan 11, 2010
METHOTREXATE SODIUM
XX + BEDFORD EQ 100MG BASE/4ML (EQ 25MG BASE/ML) A089341 001 Sep 16, 1986
XX + EQ 200MG BASE/8ML (EQ 25MG BASE/ML) A089342 001 Sep 16, 1986
METHOTREXATE SODIUM PRESERVATIVE FREE
XX + BEDFORD EQ 1GM BASE/VIAL A040632 001 Aug 12, 2005
TABLET; ORAL
METHOTREXATE SODIUM
AB BARR EQ 2.5MG BASE A081099 001 Oct 15, 1990
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 262 (of 393)

METHOTREXATE SODIUM
TABLET; ORAL
METHOTREXATE SODIUM
AB + DAVA PHARMS INC EQ 2.5MG BASE N008085 002
AB MYLAN EQ 2.5MG BASE A081235 001 May 15, 1992
AB ROXANE EQ 2.5MG BASE A040054 001 Aug 01, 1994
TREXALL
XX BARR EQ 5MG BASE A040385 001 Mar 21, 2001
XX EQ 7.5MG BASE A040385 002 Mar 21, 2001
XX EQ 10MG BASE A040385 003 Mar 21, 2001
XX + EQ 15MG BASE A040385 004 Mar 21, 2001

METHOXSALEN
CAPSULE; ORAL

8-MOP

XX + VALEANT PHARM INTL 10MG N009048 001


OXSORALEN-ULTRA

XX + VALEANT PHARM INTL 10MG N019600 001 Oct 30, 1986


INJECTABLE; INJECTION

UVADEX

XX + THERAKOS 0.02MG/ML N020969 001 Feb 25, 1999


LOTION; TOPICAL

OXSORALEN

XX + VALEANT PHARM INTL 1% N009048 002

METHSCOPOLAMINE BROMIDE
TABLET; ORAL
METHSCOPOLAMINE BROMIDE
AA BOCA PHARMA 2.5MG A040624 001 Dec 28, 2006
AA 5MG A040624 002 Dec 28, 2006
PAMINE
AA + NYCOMED US 2.5MG N008848 001
PAMINE FORTE
AA + NYCOMED US 5MG N008848 002 Mar 25, 2003

METHSUXIMIDE
CAPSULE; ORAL

CELONTIN

XX PARKE DAVIS 150MG N010596 007


XX + 300MG N010596 008

METHYCLOTHIAZIDE
TABLET; ORAL
ENDURON
AB + ABBOTT 5MG N012524 004
METHYCLOTHIAZIDE
AB MYLAN 5MG A087672 001 Aug 17, 1982
AB WATSON LABS 5MG A088724 001 Sep 06, 1984
ENDURON

XX ABBOTT 2.5MG N012524 001


METHYL AMINOLEVULINATE HYDROCHLORIDE


CREAM; TOPICAL

METVIXIA

XX + GALDERMA LABS LP EQ 16.8% BASE N021415 001 Jul 27, 2004


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 263 (of 393)

METHYLDOPA
TABLET; ORAL
METHYLDOPA
AB ACCORD HLTH 250MG A070084 001 Oct 15, 1985
AB 500MG A070085 001 Oct 15, 1985
AB IVAX SUB TEVA PHARMS 250MG A070098 001 Feb 20, 1986
AB 500MG A070343 001 Feb 20, 1986
AB MYLAN 250MG A070075 001 Apr 18, 1985
AB + 500MG A070076 001 Apr 18, 1985
AB WATSON LABS 500MG A070625 001 Jun 06, 1986

METHYLDOPATE HYDROCHLORIDE
INJECTABLE; INJECTION
METHYLDOPATE HYDROCHLORIDE
AP + LUITPOLD 50MG/ML A071279 001 Oct 02, 1987
AP TEVA PARENTERAL 50MG/ML A072974 001 Nov 22, 1991

METHYLERGONOVINE MALEATE
INJECTABLE; INJECTION
METHERGINE
AP + NOVARTIS 0.2MG/ML N006035 004
METHYLERGONOVINE MALEATE
AP PHARMAFORCE 0.2MG/ML A090193 001 Nov 24, 2008
TABLET; ORAL

METHERGINE

XX + NOVARTIS 0.2MG N006035 003

METHYLNALTREXONE BROMIDE
SOLUTION; SUBCUTANEOUS

RELISTOR

XX + PROGENICS 12MG/0.6ML (12MG/0.6ML) N021964 001 Apr 24, 2008

METHYLPHENIDATE
FILM, EXTENDED RELEASE; TRANSDERMAL
DAYTRANA
XX SHIRE 10MG/9HR (1.1MG/HR) N021514 001 Apr 06, 2006
XX 15MG/9HR (1.6MG/HR) N021514 002 Apr 06, 2006
XX 20MG/9HR (2.2MG/HR) N021514 003 Apr 06, 2006
XX + 30MG/9HR (3.3MG/HR) N021514 004 Apr 06, 2006

METHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
METADATE CD
BX UCB INC 10MG N021259 003 May 27, 2003
BX 20MG N021259 001 Apr 03, 2001
BX 30MG N021259 002 Jun 19, 2003
BX 40MG N021259 004 Feb 19, 2006
RITALIN LA
BX NOVARTIS 10MG N021284 004 Apr 10, 2004
BX 20MG N021284 001 Jun 05, 2002
BX 30MG N021284 002 Jun 05, 2002
BX + 40MG N021284 003 Jun 05, 2002
METADATE CD
XX UCB INC 50MG N021259 005 Feb 19, 2006
XX + 60MG N021259 006 Feb 19, 2006
SOLUTION; ORAL

METHYLIN

XX + MALLINCKRODT 5MG/5ML N021419 001 Dec 19, 2002


XX + 10MG/5ML N021419 002 Dec 19, 2002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 264 (of 393)

METHYLPHENIDATE HYDROCHLORIDE
TABLET; ORAL
METHYLPHENIDATE HYDROCHLORIDE
AB ACTAVIS ELIZABETH 5MG A040321 001 Feb 05, 2002
AB 10MG A040321 002 Feb 05, 2002
AB 20MG A040321 003 Feb 05, 2002
AB MALLINCKRODT 5MG A040300 001 Nov 27, 1998
AB 10MG A040300 002 Nov 27, 1998
AB 20MG A040300 003 Nov 27, 1998
AB UCB INC 5MG A086429 001
AB 10MG A085799 001
AB 20MG A086428 001
AB WATSON LABS 5MG A040220 001 Aug 29, 1997
AB 10MG A040220 002 Aug 29, 1997
AB 20MG A040220 003 Aug 29, 1997
RITALIN
AB NOVARTIS 5MG N010187 003
AB 10MG N010187 006
AB + 20MG N010187 010
TABLET, CHEWABLE; ORAL
METHYLIN
XX MALLINCKRODT 2.5MG N021475 001 Apr 15, 2003
XX 5MG N021475 002 Apr 15, 2003
XX + 10MG N021475 003 Apr 15, 2003
TABLET, EXTENDED RELEASE; ORAL
METADATE ER
AB UCB INC 10MG A040306 001 Oct 20, 1999
AB + 20MG A089601 001 Jun 01, 1988
METHYLIN ER
AB MALLINCKRODT 10MG A075629 001 May 09, 2000
AB 20MG A075629 002 May 09, 2000
METHYLPHENIDATE HYDROCHLORIDE
AB ACTAVIS ELIZABETH 20MG A075450 001 Dec 21, 2001
AB WATSON LABS 20MG A040410 001 Feb 09, 2001
RITALIN-SR
AB NOVARTIS 20MG N018029 001 Mar 30, 1982
CONCERTA
XX ORTHO MCNEIL JANSSEN 18MG N021121 001 Aug 01, 2000
XX 27MG N021121 004 Apr 01, 2002
XX 36MG N021121 002 Aug 01, 2000
XX + 54MG N021121 003 Dec 08, 2000

METHYLPREDNISOLONE
TABLET; ORAL
MEDROL
AB PHARMACIA AND UPJOHN 4MG N011153 001
AB 8MG N011153 004
AB 16MG N011153 003
AB + 32MG N011153 006
METHYLPREDNISOLONE
AB CADISTA PHARMS 4MG A040189 001 Oct 31, 1997
AB 8MG A040189 002 Oct 31, 1997
AB 16MG A040189 003 Jul 20, 2007
AB 32MG A040189 004 Jul 20, 2007
AB DURAMED PHARMS BARR 4MG A088497 001 Feb 21, 1984
AB SANDOZ 4MG A040194 001 Oct 31, 1997
AB VINTAGE PHARMS 4MG A040183 001 Dec 22, 1998
AB WATSON LABS 4MG A040232 001 Oct 16, 1997
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 265 (of 393)

METHYLPREDNISOLONE ACETATE
INJECTABLE; INJECTION
DEPO-MEDROL
AB + PHARMACIA AND UPJOHN 40MG/ML N011757 001
AB + 80MG/ML N011757 004
METHYLPREDNISOLONE ACETATE
AB SANDOZ 40MG/ML A040719 001 Jan 29, 2009
AB 40MG/ML A040794 001 Mar 05, 2009
AB 80MG/ML A040719 002 Jan 29, 2009
AB 80MG/ML A040794 002 Mar 05, 2009
AB TEVA PARENTERAL 40MG/ML A040557 001 Feb 23, 2005
AB 40MG/ML A040620 001 Oct 27, 2006
AB 80MG/ML A040557 002 Feb 23, 2005
AB 80MG/ML A040620 002 Oct 27, 2006
DEPO-MEDROL
XX + PHARMACIA AND UPJOHN 20MG/ML N011757 002

METHYLPREDNISOLONE SODIUM SUCCINATE


INJECTABLE; INJECTION
A-METHAPRED
AP HEMOPHARM USA EQ 40MG BASE/VIAL A040793 001 Nov 25, 2008
AP EQ 125MG BASE/VIAL A040827 001 Nov 25, 2008
AP HOSPIRA EQ 40MG BASE/VIAL A040664 001 Dec 20, 2005
AP EQ 125MG BASE/VIAL A040665 001 Dec 20, 2005
AP EQ 500MG BASE/VIAL A089173 001 Aug 18, 1987
AP EQ 1GM BASE/VIAL A089174 001 Aug 18, 1987
METHYLPREDNISOLONE SODIUM SUCCINATE
AP APP PHARMS EQ 40MG BASE/VIAL A040583 001 Jul 30, 2004
AP EQ 125MG BASE/VIAL A040583 002 Jul 30, 2004
AP EQ 1GM BASE/VIAL A040612 001 Aug 12, 2004
AP BEDFORD LABS EQ 40MG BASE/VIAL A040662 001 Feb 21, 2007
AP EQ 125MG BASE/VIAL A040641 002 Feb 21, 2007
AP EQ 500MG BASE/VIAL A040641 003 Feb 21, 2007
AP EQ 500MG BASE/VIAL A040709 001 Feb 21, 2007
AP EQ 1GM BASE/VIAL A040641 004 Feb 21, 2007
AP EQ 1GM BASE/VIAL A040709 002 Feb 21, 2007
AP TEVA PARENTERAL EQ 125MG BASE/VIAL A081266 001 Nov 30, 1992
SOLU-MEDROL
AP + PHARMACIA AND UPJOHN EQ 40MG BASE/VIAL N011856 003
AP + EQ 125MG BASE/VIAL N011856 004
AP + EQ 500MG BASE/VIAL N011856 005
AP + EQ 1GM BASE/VIAL N011856 006
SOLU-MEDROL
XX + PHARMACIA AND UPJOHN EQ 2GM BASE/VIAL N011856 007 Feb 27, 1985

METHYLTESTOSTERONE
CAPSULE; ORAL

TESTRED

XX + VALEANT PHARM INTL 10MG A083976 001


TABLET; ORAL
ANDROID 10
BP VALEANT PHARM INTL 10MG A086450 001
ANDROID 25
BP + VALEANT PHARM INTL 25MG A087147 001
METHYLTESTOSTERONE
BP IMPAX LABS 10MG A080767 002
BP 25MG A084310 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 266 (of 393)

METIPRANOLOL HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
METIPRANOLOL
AT FALCON PHARMS 0.3% A075720 001 Aug 06, 2001
OPTIPRANOLOL
AT + BAUSCH AND LOMB 0.3% N019907 001 Dec 29, 1989

METOCLOPRAMIDE HYDROCHLORIDE
INJECTABLE; INJECTION
METOCLOPRAMIDE HYDROCHLORIDE
AP HOSPIRA EQ 5MG BASE/ML A073117 001 Jan 17, 1991
AP EQ 5MG BASE/ML A073118 001 Jan 17, 1991
AP EQ 5MG BASE/ML A074147 001 Aug 02, 1996
AP TEVA PARENTERAL EQ 5MG BASE/ML A073135 001 Nov 27, 1991
REGLAN
AP + BAXTER HLTHCARE CORP EQ 5MG BASE/ML N017862 001
SOLUTION; ORAL
METOCLOPRAMIDE HYDROCHLORIDE
AA ANI PHARMS EQ 5MG BASE/5ML A071402 001 Jun 25, 1993
AA + MORTON GROVE EQ 5MG BASE/5ML A074703 001 Oct 31, 1997
AA PHARM ASSOC EQ 5MG BASE/5ML A072744 001 May 28, 1991
AA SILARX EQ 5MG BASE/5ML A073680 001 Oct 27, 1992
AA VISTAPHARM EQ 5MG BASE/5ML A075051 001 Jan 26, 2001
TABLET; ORAL
METOCLOPRAMIDE HYDROCHLORIDE
AB ACTAVIS ELIZABETH EQ 10MG BASE A070581 001 Oct 17, 1985
AB IPCA LABS LTD EQ 5MG BASE A078807 001 Jun 12, 2008
AB EQ 10MG BASE A078807 002 Jun 12, 2008
AB MUTUAL PHARM EQ 5MG BASE A071536 002 Jan 16, 1997
AB NORTHSTAR HLTHCARE EQ 5MG BASE A078374 001 Nov 30, 2007
AB EQ 10MG BASE A078374 002 Nov 30, 2007
AB SANDOZ EQ 10MG BASE A074478 002 Oct 05, 1995
AB TEVA EQ 5MG BASE A072801 001 Jun 15, 1993
AB EQ 10MG BASE A070184 001 Jul 29, 1985
AB VINTAGE PHARMS EQ 5MG BASE A077878 001 Aug 28, 2006
AB EQ 10MG BASE A077878 002 Aug 28, 2006
AB WATSON LABS EQ 5MG BASE A072750 001 Dec 28, 1995
AB EQ 10MG BASE A070511 001 Jan 22, 1986
AB EQ 10MG BASE A071250 001 Feb 03, 1988
REGLAN
AB ALAVEN PHARM EQ 5MG BASE N017854 002 May 05, 1987
AB + EQ 10MG BASE N017854 001
TABLET, ORALLY DISINTEGRATING; ORAL
METOZOLV ODT
XX SALIX PHARMS EQ 5MG BASE N022246 001 Sep 04, 2009
XX EQ 10MG BASE N022246 002 Sep 04, 2009

METOLAZONE
TABLET; ORAL
METOLAZONE
AB MYLAN 2.5MG A076698 001 Dec 23, 2003
AB 5MG A076698 002 Oct 19, 2004
AB 10MG A076698 003 Oct 19, 2004
AB SANDOZ 2.5MG A076732 001 Dec 19, 2003
AB 5MG A076466 001 Dec 19, 2003
AB 10MG A076466 002 Dec 19, 2003
AB TEVA 2.5MG A076600 001 Jan 06, 2004
AB 5MG A076833 001 Mar 01, 2004
AB 10MG A075543 003 Dec 24, 2003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 267 (of 393)

METOLAZONE
TABLET; ORAL
ZAROXOLYN
AB UCB INC 2.5MG N017386 001
AB + 5MG N017386 002
AB + 10MG N017386 003

METOPROLOL SUCCINATE
TABLET, EXTENDED RELEASE; ORAL
METOPROLOL SUCCINATE
AB KV PHARM EQ 25MG TARTRATE A077779 001 Mar 20, 2008
AB EQ 50MG TARTRATE A077176 001 May 14, 2008
AB EQ 100MG TARTRATE A076640 002 May 18, 2007
AB EQ 200MG TARTRATE A076640 001 May 18, 2007
AB SANDOZ EQ 25MG TARTRATE A076969 001 Jul 31, 2006
AB EQ 50MG TARTRATE A076969 002 May 18, 2007
AB EQ 100MG TARTRATE A076969 003 Mar 20, 2008
AB EQ 200MG TARTRATE A076969 004 Mar 20, 2008
AB WATSON LABS FLORIDA EQ 25MG TARTRATE A077118 001 Aug 03, 2009
AB EQ 50MG TARTRATE A076862 001 Aug 03, 2009
TOPROL-XL
AB ASTRAZENECA EQ 25MG TARTRATE N019962 004 Feb 05, 2001
AB + EQ 50MG TARTRATE N019962 001 Jan 10, 1992
AB EQ 100MG TARTRATE N019962 002 Jan 10, 1992
AB + EQ 200MG TARTRATE N019962 003 Jan 10, 1992

METOPROLOL TARTRATE
INJECTABLE; INJECTION
LOPRESSOR
AP + NOVARTIS 1MG/ML N018704 001 Mar 30, 1984
METOPROLOL TARTRATE
AP BEDFORD LABS 1MG/ML A076495 001 Jul 07, 2003
AP HIKMA FARMACEUTICA 1MG/ML A077761 001 May 30, 2007
AP HOSPIRA 1MG/ML A074133 001 Dec 21, 1993
AP 1MG/ML A075160 001 Jul 06, 1998
AP 1MG/ML A078085 001 Apr 29, 2008
AP LUITPOLD 1MG/ML A090386 001 Sep 30, 2009
AP SANDOZ 1MG/ML A077360 001 Oct 02, 2007
AP WATSON LABS 1MG/ML A074032 001 Dec 21, 1993
TABLET; ORAL
LOPRESSOR
AB NOVARTIS 50MG N017963 001
AB 100MG N017963 002
METOPROLOL TARTRATE
AB AUROBINDO PHARMA 25MG A077739 001 Sep 11, 2007
AB 50MG A077739 002 Sep 11, 2007
AB 100MG A077739 003 Sep 11, 2007
AB CARACO 25MG A076670 001 Jan 15, 2004
AB 50MG A074644 001 Dec 10, 1996
AB 100MG A074644 002 Dec 10, 1996
AB IPCA LABS LTD 25MG A078459 001 Jun 17, 2008
AB 50MG A078459 002 Jun 17, 2008
AB 100MG A078459 003 Jun 17, 2008
AB MUTUAL PHARM 25MG A073654 002 Jul 15, 2009
AB 50MG A073653 001 Dec 21, 1993
AB 100MG A073654 001 Dec 21, 1993
AB MYLAN 25MG A076704 001 Jan 16, 2004
AB 50MG A076704 002 Jan 16, 2004
AB + 100MG A076704 003 Jan 16, 2004
AB SANDOZ 50MG A073288 001 Mar 25, 1994
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 268 (of 393)

METOPROLOL TARTRATE
TABLET; ORAL
METOPROLOL TARTRATE
AB SANDOZ 100MG A073289 001 Mar 25, 1994
AB TEVA 50MG A074141 001 Jan 31, 1995
AB 100MG A074141 002 Jan 31, 1995
AB WATSON LABS 50MG A074217 001 May 27, 1994
AB 100MG A074217 002 May 27, 1994

METRONIDAZOLE
CAPSULE; ORAL
FLAGYL
AB + GD SEARLE LLC 375MG N020334 001 May 03, 1995
METRONIDAZOLE
AB ALEMBIC LTD 375MG A079065 001 Jun 23, 2009
AB KALI LABS 375MG A076522 001 Jan 29, 2004
CREAM; TOPICAL
METROCREAM
AB + GALDERMA LABS LP 0.75% N020531 001 Sep 20, 1995
METRONIDAZOLE
AB ALTANA 0.75% A076408 001 May 28, 2004
AB G AND W LABS 0.75% A077549 001 Dec 19, 2007
NORITATE
XX + SANOFI AVENTIS US 1% N020743 001 Sep 26, 1997
GEL; TOPICAL
METROGEL
AB + GALDERMA LABS LP 0.75% N019737 001 Nov 22, 1988
METRONIDAZOLE
AB ALTANA 0.75% A077018 001 Jun 06, 2006
AB TARO 0.75% A077819 001 Jul 18, 2006
AB TOLMAR 0.75% A077547 001 Jul 13, 2006
METROGEL
XX + GALDERMA LABS LP 1% N021789 001 Jun 30, 2005
GEL; VAGINAL
METROGEL-VAGINAL
AB + GRACEWAY 0.75% N020208 001 Aug 17, 1992
METRONIDAZOLE
AB TOLMAR 0.75% A077264 001 Oct 31, 2006
VANDAZOLE
BX TEVA PHARMS 0.75% N021806 001 May 20, 2005
INJECTABLE; INJECTION
FLAGYL I.V. RTU IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 500MG/100ML N018657 001
AP + GD SEARLE LLC 500MG/100ML N018353 002
METRO I.V. IN PLASTIC CONTAINER
AP + B BRAUN 500MG/100ML N018900 001 Sep 29, 1983
METRONIDAZOLE IN PLASTIC CONTAINER
AP CLARIS LIFESCIENCES 500MG/100ML A078084 001 Mar 31, 2008
AP + HOSPIRA 500MG/100ML N018890 002 Nov 18, 1983
LOTION; TOPICAL
METROLOTION
AB + GALDERMA LABS LP 0.75% N020901 001 Nov 24, 1998
METRONIDAZOLE
AB ALTANA 0.75% A077197 001 May 24, 2006
TABLET; ORAL
FLAGYL
AB GD SEARLE LLC 250MG N012623 001
AB + 500MG N012623 003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 269 (of 393)

METRONIDAZOLE
TABLET; ORAL
METRONIDAZOLE
AB ALEMBIC LTD 250MG A079067 001 Mar 13, 2009
AB 500MG A079067 002 Mar 13, 2009
AB IVAX SUB TEVA PHARMS 250MG N018517 001
AB 500MG N018517 002 May 05, 1982
AB MUTUAL PHARM 250MG A070772 001 Jul 16, 1986
AB 500MG A070773 001 Jul 16, 1986
AB PLIVA 250MG A070027 001 Nov 06, 1984
AB 500MG A070033 001 Dec 06, 1984
AB SANDOZ 250MG N018620 001 Mar 04, 1982
AB 500MG N018620 002 Jun 02, 1983
AB TEVA 500MG A070044 001 Feb 08, 1985
AB WATSON LABS 250MG A070035 001 Dec 20, 1984
AB 250MG N018764 001 Sep 17, 1982
AB 500MG N018764 002 Dec 20, 1982
TABLET, EXTENDED RELEASE; ORAL

FLAGYL ER

XX + GD SEARLE LLC 750MG N020868 001 Nov 26, 1997

METRONIDAZOLE HYDROCHLORIDE
INJECTABLE; INJECTION

FLAGYL I.V.

XX + GD SEARLE LLC EQ 500MG BASE/VIAL N018353 001

METYRAPONE
CAPSULE; ORAL

METOPIRONE

XX + NOVARTIS 250MG N012911 002 Aug 09, 1996

METYROSINE
CAPSULE; ORAL

DEMSER

XX + ATON 250MG N017871 001

MEXILETINE HYDROCHLORIDE
CAPSULE; ORAL
MEXILETINE HYDROCHLORIDE
AB TEVA 150MG A074377 001 May 16, 1995
AB 200MG A074377 002 May 16, 1995
AB + 250MG A074377 003 May 16, 1995
AB WATSON LABS 150MG A074711 001 Feb 26, 1997
AB 150MG A074865 001 Apr 13, 1998
AB 200MG A074711 002 Feb 26, 1997
AB 200MG A074865 002 Apr 13, 1998
AB 250MG A074711 003 Feb 26, 1997
AB 250MG A074865 003 Apr 13, 1998

MICAFUNGIN SODIUM
INJECTABLE; IV (INFUSION)

MYCAMINE

XX + ASTELLAS 50MG/VIAL N021506 002 Mar 16, 2005


XX 100MG/VIAL N021506 003 Jun 27, 2006

MICONAZOLE NITRATE
SUPPOSITORY; VAGINAL
MICONAZOLE NITRATE
AB ACTAVIS MID ATLANTIC 200MG A073508 001 Nov 19, 1993
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 270 (of 393)

MICONAZOLE NITRATE
SUPPOSITORY; VAGINAL
MONISTAT 3
AB + PERSONAL PRODS 200MG N018888 001 Aug 15, 1984

MICONAZOLE NITRATE; PETROLATUM, WHITE; ZINC OXIDE


OINTMENT; TOPICAL

VUSION

XX + STIEFEL LABS INC 0.25%;81.35%;15% N021026 001 Feb 16, 2006

MIDAZOLAM HYDROCHLORIDE
INJECTABLE; INJECTION
MIDAZOLAM HYDROCHLORIDE
AP APOTEX INC EQ 1MG BASE/ML A075637 001 Oct 31, 2000
AP EQ 5MG BASE/ML A075637 002 Oct 31, 2000
AP APP PHARMS EQ 1MG BASE/ML A075154 002 Jun 20, 2000
AP EQ 5MG BASE/ML A075154 001 Jun 20, 2000
AP BAXTER HLTHCARE EQ 1MG BASE/ML A075243 001 Jun 20, 2000
AP EQ 5MG BASE/ML A075243 002 Jun 20, 2000
AP BAXTER HLTHCARE CORP EQ 1MG BASE/ML A075324 001 Jun 20, 2000
AP EQ 5MG BASE/ML A075324 002 Jun 20, 2000
AP BEDFORD EQ 1MG BASE/ML A075247 002 Jun 23, 2000
AP EQ 5MG BASE/ML A075247 001 Jun 23, 2000
AP BEN VENUE EQ 1MG BASE/ML A075421 002 Jun 20, 2000
AP EQ 5MG BASE/ML A075421 001 Jun 20, 2000
AP + HOSPIRA EQ 1MG BASE/ML A075293 001 Jun 20, 2000
AP EQ 1MG BASE/ML A075409 002 Jun 20, 2000
AP EQ 1MG BASE/ML A075856 001 Jun 13, 2002
AP + EQ 5MG BASE/ML A075293 002 Jun 20, 2000
AP EQ 5MG BASE/ML A075856 002 Jun 13, 2002
AP INTL MEDICATED EQ 1MG BASE/ML A076144 001 Jan 26, 2005
AP EQ 5MG BASE/ML A076144 002 Jan 26, 2005
AP INTL MEDICATION EQ 1MG BASE/ML A076020 001 Jul 16, 2004
AP EQ 5MG BASE/ML A076020 002 Jul 16, 2004
AP TAYLOR EQ 1MG BASE/ML A075494 001 Jun 30, 2000
AP EQ 5MG BASE/ML A075481 001 Jun 30, 2000
AP EQ 5MG BASE/ML A075494 002 Jun 30, 2000
AP WOCKHARDT EQ 1MG BASE/ML A078141 001 May 30, 2008
AP EQ 1MG BASE/ML A078511 001 Nov 10, 2008
AP EQ 5MG BASE/ML A078141 002 May 30, 2008
AP EQ 5MG BASE/ML A078511 002 Nov 10, 2008
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
AP + HOSPIRA EQ 1MG BASE/ML A075857 001 Jul 22, 2002
AP + EQ 5MG BASE/ML A075857 002 Jul 22, 2002
SYRUP; ORAL
MIDAZOLAM HYDROCHLORIDE
AA APOTEX INC EQ 2MG BASE/ML A077115 001 Sep 09, 2005
AA HI TECH PHARMA EQ 2MG BASE/ML A075958 001 Sep 04, 2003
AA PADDOCK EQ 2MG BASE/ML A076379 001 May 02, 2005
AA RANBAXY EQ 2MG BASE/ML A076058 001 Mar 15, 2002
AA + ROXANE EQ 2MG BASE/ML A075873 001 Apr 30, 2002

MIDODRINE HYDROCHLORIDE
TABLET; ORAL
MIDODRINE HYDROCHLORIDE
AB APOTEX INC 2.5MG A077746 001 Sep 12, 2006
AB 5MG A077746 002 Sep 12, 2006
AB 10MG A077746 003 Sep 12, 2006
AB IMPAX PHARMS 2.5MG A076449 001 May 27, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 271 (of 393)

MIDODRINE HYDROCHLORIDE
TABLET; ORAL
MIDODRINE HYDROCHLORIDE
AB IMPAX PHARMS 5MG A076449 002 May 27, 2004
AB 10MG A076449 003 Dec 16, 2005
AB MYLAN 2.5MG A076577 001 Sep 10, 2003
AB 5MG A076577 002 Sep 10, 2003
AB 10MG A076577 003 Sep 10, 2003
AB SANDOZ 2.5MG A076514 001 Sep 11, 2003
AB 5MG A076514 002 Sep 11, 2003
AB 10MG A076514 003 Jul 02, 2004
ORVATEN
AB UPSHER SMITH 2.5MG A076725 001 Nov 03, 2004
AB 5MG A076725 002 Nov 03, 2004
AB 10MG A076725 003 Nov 03, 2004
PROAMATINE
AB SHIRE 2.5MG N019815 001 Sep 06, 1996
AB + 5MG N019815 002 Sep 06, 1996
AB 10MG N019815 003 Mar 20, 2002

MIFEPRISTONE
TABLET; ORAL

MIFEPREX

XX + DANCO LABS LLC 200MG N020687 001 Sep 28, 2000

MIGLITOL
TABLET; ORAL
GLYSET
XX PHARMACIA AND UPJOHN 25MG N020682 001 Dec 18, 1996
XX 50MG N020682 002 Dec 18, 1996
XX + 100MG N020682 003 Dec 18, 1996

MIGLUSTAT
CAPSULE; ORAL

ZAVESCA

XX + ACTELION PHARMS LTD 100MG N021348 001 Jul 31, 2003

MILNACIPRAN HYDROCHLORIDE
TABLET; ORAL
SAVELLA
XX CYPRESS BIOSCIENCE 12.5MG N022256 001 Jan 14, 2009
XX 25MG N022256 002 Jan 14, 2009
XX 50MG N022256 003 Jan 14, 2009
XX + 100MG N022256 004 Jan 14, 2009

MILRINONE LACTATE
INJECTABLE; INJECTION
MILRINONE LACTATE
AP APOTEX INC EQ 1MG BASE/ML A076427 001 Sep 21, 2004
AP APP PHARMS EQ 1MG BASE/ML A075936 001 May 28, 2002
AP BAXTER HLTHCARE EQ 1MG BASE/ML A075530 001 May 28, 2002
AP + BEDFORD EQ 1MG BASE/ML A075660 001 May 28, 2002
AP GLAND PHARMA LTD EQ 1MG BASE/ML A077190 001 Oct 31, 2006
AP HOSPIRA EQ 1MG BASE/ML A075884 001 May 28, 2002
AP INTL MEDICATED EQ 1MG BASE/ML A076013 001 Aug 02, 2002
MILRINONE LACTATE IN DEXTROSE 5%
AP APOTEX INC EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A077151 002 Jul 20, 2005
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
AP APOTEX INC EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A077151 001 Jul 20, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 272 (of 393)

MILRINONE LACTATE
INJECTABLE; INJECTION
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A076414 001 Aug 18, 2004
AP BAXTER HLTHCARE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A075834 001 May 28, 2002
AP EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A075834 002 May 28, 2002
AP BEDFORD LABS EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A078113 001 May 21, 2008
AP EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A078113 002 May 21, 2008
AP HOSPIRA EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A075885 001 May 28, 2002
AP EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A075885 002 May 28, 2002
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + SANOFI AVENTIS US EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) N020343 003 Aug 09, 1994
AP + EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) N020343 004 Aug 09, 1994

MINOCYCLINE HYDROCHLORIDE
CAPSULE; ORAL
DYNACIN
AB MEDICIS EQ 75MG BASE A063067 002 Sep 15, 1999
AB EQ 100MG BASE A063067 001 Jul 31, 1990
MINOCIN
AB TRIAX PHARMS LLC EQ 50MG BASE N050649 001 May 31, 1990
AB EQ 100MG BASE N050649 002 May 31, 1990
MINOCYCLINE HYDROCHLORIDE
AB AUROBINDO PHARMA EQ 50MG BASE A065470 001 Mar 11, 2008
AB EQ 75MG BASE A065470 002 Mar 11, 2008
AB EQ 100MG BASE A065470 003 Mar 11, 2008
AB IMPAX LABS EQ 50MG BASE A065005 001 Mar 23, 1999
AB EQ 75MG BASE A065005 003 Apr 18, 2001
AB EQ 100MG BASE A065005 002 Mar 23, 1999
AB RANBAXY EQ 50MG BASE A065062 001 Nov 30, 2000
AB EQ 75MG BASE A065062 002 Nov 30, 2000
AB EQ 100MG BASE A065062 003 Nov 30, 2000
AB TEVA EQ 50MG BASE A063011 001 Mar 02, 1992
AB EQ 75MG BASE A063009 002 Aug 12, 2003
AB + EQ 100MG BASE A063009 001 Mar 02, 1992
AB WATSON LABS EQ 50MG BASE A063181 001 Dec 30, 1991
AB EQ 75MG BASE A063065 002 Jun 10, 1999
AB EQ 100MG BASE A063065 001 Dec 30, 1991
INJECTABLE; INJECTION

MINOCIN

XX + TRIAX PHARMS LLC EQ 100MG BASE/VIAL N050444 001


POWDER, EXTENDED RELEASE; DENTAL

ARESTIN

XX + ORAPHARMA EQ 1MG BASE N050781 001 Feb 16, 2001


TABLET; ORAL
MINOCYCLINE HYDROCHLORIDE
AB DR REDDYS LABS LTD EQ 50MG BASE A065436 001 Dec 26, 2007
AB EQ 75MG BASE A065436 002 Dec 26, 2007
AB EQ 100MG BASE A065436 003 Dec 26, 2007
AB MEDICIS EQ 50MG BASE A065131 001 Apr 16, 2003
AB EQ 75MG BASE A065131 002 Apr 16, 2003
AB + EQ 100MG BASE A065131 003 Apr 16, 2003
AB RANBAXY EQ 50MG BASE A065156 001 Jan 06, 2004
AB EQ 75MG BASE A065156 002 Jan 06, 2004
AB EQ 100MG BASE A065156 003 Jan 06, 2004
TABLET, EXTENDED RELEASE; ORAL
MINOCYCLINE HYDROCHLORIDE
AB BARR EQ 45MG BASE A065485 001 Mar 17, 2009
AB EQ 90MG BASE A065485 002 Mar 17, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 273 (of 393)

MINOCYCLINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL
MINOCYCLINE HYDROCHLORIDE
AB BARR EQ 135MG BASE A065485 003 Mar 17, 2009
AB IMPAX LABS INC EQ 45MG BASE A090024 001 Feb 03, 2009
AB EQ 90MG BASE A090024 002 Feb 03, 2009
AB EQ 135MG BASE A090024 003 Feb 03, 2009
AB SANDOZ EQ 45MG BASE A090422 001 Aug 13, 2009
AB EQ 90MG BASE A090422 002 Aug 13, 2009
AB EQ 135MG BASE A090422 003 Aug 13, 2009
SOLODYN
AB MEDICIS EQ 45MG BASE N050808 001 May 08, 2006
AB EQ 90MG BASE N050808 002 May 08, 2006
AB + EQ 135MG BASE N050808 003 May 08, 2006
SOLODYN
XX MEDICIS EQ 65MG BASE N050808 004 Jul 23, 2009
XX EQ 115MG BASE N050808 005 Jul 23, 2009

MINOXIDIL
TABLET; ORAL
MINOXIDIL
AB MUTUAL PHARM 2.5MG A072708 001 Dec 14, 1995
AB 10MG A072709 001 Dec 14, 1995
AB PAR PHARM 2.5MG A071826 001 Nov 14, 1988
AB 10MG A071839 001 Nov 14, 1988
AB WATSON LABS 2.5MG A071344 001 Mar 03, 1987
AB + 10MG A071345 001 Mar 03, 1987

MIRTAZAPINE
TABLET; ORAL
MIRTAZAPINE
AB ACTAVIS ELIZABETH 15MG A076308 001 Jun 20, 2003
AB 30MG A076308 002 Jun 20, 2003
AB 45MG A076308 003 Jun 20, 2003
AB ACTAVIS TOTOWA 15MG A076241 001 Jun 25, 2003
AB 30MG A076241 002 Jun 25, 2003
AB 45MG A076241 003 Jun 25, 2003
AB ALPHAPHARM 15MG A076176 001 Jun 19, 2003
AB 30MG A076176 002 Jun 19, 2003
AB 45MG A076176 003 Jun 19, 2003
AB APOTEX INC 15MG A077666 001 Aug 22, 2007
AB 30MG A077666 002 Aug 22, 2007
AB 45MG A077666 003 Aug 22, 2007
AB AUROBINDO 7.5MG A076921 001 Oct 22, 2004
AB 15MG A076921 002 Oct 22, 2004
AB 30MG A076921 003 Oct 22, 2004
AB 45MG A076921 004 Oct 22, 2004
AB CARACO 7.5MG A076541 004 Apr 22, 2004
AB 15MG A076541 001 Apr 22, 2004
AB 30MG A076541 002 Apr 22, 2004
AB 45MG A076541 003 Apr 22, 2004
AB MYLAN 15MG A076122 001 Jun 19, 2003
AB 30MG A076122 002 Jun 19, 2003
AB 45MG A076122 003 Jun 19, 2003
AB SANDOZ 15MG A076219 001 Jun 19, 2003
AB 30MG A076219 002 Jun 19, 2003
AB 45MG A076219 003 Jun 19, 2003
AB TEVA 15MG A076119 001 Jan 24, 2003
AB 30MG A076119 002 Jan 24, 2003
AB 45MG A076119 003 Jun 19, 2003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 274 (of 393)

MIRTAZAPINE
TABLET; ORAL
MIRTAZAPINE
AB WATSON LABS 15MG A076312 001 Jun 19, 2003
AB 30MG A076312 002 Jun 19, 2003
AB 45MG A076312 003 Jun 19, 2003
AB WATSON LABS FLORIDA 15MG A076336 001 Jun 20, 2003
AB 30MG A076336 002 Jun 20, 2003
AB 45MG A076336 003 Jun 20, 2003
REMERON
AB + ORGANON USA INC 15MG N020415 001 Jun 14, 1996
AB 30MG N020415 002 Jun 14, 1996
AB 45MG N020415 003 Mar 17, 1997
TABLET, ORALLY DISINTEGRATING; ORAL
MIRTAZAPINE
AB ACTAVIS TOTOWA 15MG A076689 001 Aug 31, 2005
AB 30MG A076689 002 Aug 31, 2005
AB 45MG A076689 003 Aug 31, 2005
AB AUROBINDO PHARMA LTD 15MG A077376 002 Dec 08, 2005
AB 30MG A077376 003 Dec 08, 2005
AB 45MG A077376 004 Feb 28, 2006
AB TEVA 15MG A076901 001 Jun 28, 2005
AB 30MG A076901 002 Jun 28, 2005
AB 45MG A076901 003 Jun 28, 2005
AB WATSON LABS 15MG A076307 001 Dec 17, 2003
AB 30MG A076307 002 Dec 17, 2003
AB 45MG A076307 003 Feb 28, 2006
REMERON SOLTAB
AB + ORGANON USA INC 15MG N021208 001 Jan 12, 2001
AB 30MG N021208 002 Jan 12, 2001
AB 45MG N021208 003 Jan 12, 2001

MISOPROSTOL
TABLET; ORAL
CYTOTEC
AB GD SEARLE LLC 0.1MG N019268 003 Sep 21, 1990
AB + 0.2MG N019268 001 Dec 27, 1988
MISOPROSTOL
AB IVAX SUB TEVA PHARMS 0.1MG A076095 001 Jul 10, 2002
AB 0.2MG A076095 002 Jul 10, 2002

MITOMYCIN
INJECTABLE; INJECTION
MITOMYCIN
AP ACCORD HLTHCARE 5MG/VIAL A064144 001 Apr 30, 1998
AP 20MG/VIAL A064144 002 Apr 30, 1998
AP 40MG/VIAL A064144 003 Aug 11, 2009
AP BAXTER HLTHCARE 5MG/VIAL A064180 001 Dec 23, 1999
AP 20MG/VIAL A064180 002 Dec 23, 1999
AP BEDFORD 5MG/VIAL A064117 001 Apr 19, 1995
AP 20MG/VIAL A064117 002 Apr 19, 1995
MUTAMYCIN
AP + BRISTOL MYERS 5MG/VIAL A062336 001
AP + 20MG/VIAL A062336 002
AP + 40MG/VIAL A062336 003 Mar 10, 1988

MITOTANE
TABLET; ORAL

LYSODREN

XX + BRISTOL MYERS SQUIBB 500MG N016885 001


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 275 (of 393)

MITOXANTRONE HYDROCHLORIDE
INJECTABLE; INJECTION
MITOXANTRONE HYDROCHLORIDE
AP APP PHARMS EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A077496 001 Apr 11, 2006
AP EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A077496 002 Apr 11, 2006
AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A077496 003 Apr 11, 2006
AP BEDFORD EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A076611 001 Apr 11, 2006
AP EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A076611 002 Apr 11, 2006
AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A076611 003 Apr 11, 2006
AP FRESENIUS KABI ONCOL EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A078606 001 May 14, 2008
AP EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A078606 002 May 14, 2008
AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A078606 003 May 14, 2008
AP GENERAMEDIX EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A078980 001 Apr 13, 2009
AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A078980 002 Apr 13, 2009
AP HOSPIRA EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A076871 001 Apr 11, 2006
AP EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A076871 002 Apr 11, 2006
AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A076871 003 Apr 11, 2006
AP TEVA PARENTERAL EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A077356 001 Apr 11, 2006
AP EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A077356 002 Apr 11, 2006
AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A077356 003 Apr 11, 2006
NOVANTRONE
AP + EMD SERONO EQ 20MG BASE/10ML (EQ 2MG BASE/ML) N019297 001 Dec 23, 1987

MIVACURIUM CHLORIDE
INJECTABLE; INJECTION

MIVACURIUM CHLORIDE

XX + EBEWE PARENTA EQ 2MG BASE/ML A078562 001 Apr 30, 2009

MODAFINIL
TABLET; ORAL
PROVIGIL
XX CEPHALON 100MG N020717 001 Dec 24, 1998
XX + 200MG N020717 002 Dec 24, 1998

MOEXIPRIL HYDROCHLORIDE
TABLET; ORAL
MOEXIPRIL HYDROCHLORIDE
AB APOTEX INC 7.5MG A078454 001 Jun 02, 2008
AB 15MG A078454 002 Jun 02, 2008
AB PADDOCK 7.5MG A077536 001 Nov 30, 2006
AB 15MG A077536 002 Nov 30, 2006
AB TEVA 7.5MG A076204 001 May 08, 2003
AB 15MG A076204 002 May 08, 2003
UNIVASC
AB SCHWARZ PHARMA 7.5MG N020312 001 Apr 19, 1995
AB + 15MG N020312 002 Apr 19, 1995

MOLINDONE HYDROCHLORIDE
TABLET; ORAL

MOBAN

XX ENDO PHARMS 5MG N017111 004


XX 10MG N017111 005


XX + 25MG N017111 006


XX + 50MG N017111 007

MOMETASONE FUROATE
CREAM; TOPICAL
ELOCON
AB + SCHERING 0.1% N019625 001 May 06, 1987
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 276 (of 393)

MOMETASONE FUROATE
CREAM; TOPICAL
MOMETASONE FUROATE
AB ALTANA 0.1% A076171 001 Apr 08, 2005
AB G AND W LABS 0.1% A077447 001 May 22, 2006
AB GLENMARK GENERICS 0.1% A078541 001 May 28, 2008
AB TARO 0.1% A076679 001 Dec 21, 2004
AB TOLMAR 0.1% A076591 001 Apr 18, 2007
LOTION; TOPICAL
ELOCON
AB + SCHERING 0.1% N019796 001 Mar 30, 1989
MOMETASONE FUROATE
AB G AND W LABS 0.1% A077678 001 Nov 21, 2007
AB NYCOMED US 0.1% A075919 001 Nov 29, 2007
AB PERRIGO 0.1% A077180 001 Apr 06, 2005
AB TARO 0.1% A076788 001 Mar 15, 2006
AB TOLMAR 0.1% A076499 001 Nov 21, 2007
OINTMENT; TOPICAL
ELOCON
AB + SCHERING 0.1% N019543 001 Apr 30, 1987
MOMETASONE FUROATE
AB ALTANA 0.1% A077061 001 Mar 28, 2005
AB G AND W LABS 0.1% A077401 001 Jun 20, 2006
AB GLENMARK GENERICS 0.1% A078571 001 May 28, 2008
AB PERRIGO NEW YORK 0.1% A076067 001 Mar 18, 2002
AB TARO 0.1% A076624 001 Dec 03, 2004
AB TOLMAR 0.1% A076481 001 Nov 14, 2003
POWDER; INHALATION
ASMANEX TWISTHALER
XX SCHERING 0.11MG/INH N021067 002 Feb 01, 2008
XX + 0.22MG/INH N021067 001 Mar 30, 2005

MOMETASONE FUROATE MONOHYDRATE


SPRAY, METERED; NASAL

NASONEX

XX + SCHERING PLOUGH EQ 0.05MG BASE/SPRAY N020762 001 Oct 01, 1997

MONTELUKAST SODIUM
GRANULE; ORAL

SINGULAIR

XX + MERCK EQ 4MG BASE/PACKET N021409 001 Jul 26, 2002


TABLET; ORAL

SINGULAIR

XX + MERCK EQ 10MG BASE N020829 002 Feb 20, 1998


TABLET, CHEWABLE; ORAL
SINGULAIR
XX MERCK EQ 4MG BASE N020830 002 Mar 03, 2000
XX + EQ 5MG BASE N020830 001 Feb 20, 1998

MORPHINE SULFATE
CAPSULE, EXTENDED RELEASE; ORAL
AVINZA
BX KING PHARMS 30MG N021260 001 Mar 20, 2002
BX 60MG N021260 002 Mar 20, 2002
KADIAN
BX ACTAVIS ELIZABETH 30MG N020616 004 Mar 09, 2001
BX 60MG N020616 005 Mar 09, 2001
AVINZA
XX KING PHARMS 45MG N021260 005 Dec 18, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 277 (of 393)

MORPHINE SULFATE
CAPSULE, EXTENDED RELEASE; ORAL
AVINZA
XX KING PHARMS 75MG N021260 006 Dec 18, 2008
XX 90MG N021260 003 Mar 20, 2002
XX + 120MG N021260 004 Mar 20, 2002
KADIAN
XX + ACTAVIS ELIZABETH 10MG N020616 008 Apr 20, 2007
XX 20MG N020616 001 Jul 03, 1996
XX 50MG N020616 002 Jul 03, 1996
XX + 80MG N020616 006 Oct 27, 2006
XX + 100MG N020616 003 Jul 03, 1996
XX 200MG N020616 007 Feb 27, 2007
INJECTABLE; INJECTION
ASTRAMORPH PF
AP APP PHARMS 0.5MG/ML A071050 001 Oct 07, 1986
AP 0.5MG/ML A071051 001 Oct 07, 1986
AP 1MG/ML A071052 001 Oct 07, 1986
AP 1MG/ML A071053 001 Oct 07, 1986
DURAMORPH PF
AP + BAXTER HLTHCARE 0.5MG/ML N018565 001 Sep 18, 1984
AP + 1MG/ML N018565 002 Sep 18, 1984
MORPHINE SULFATE
AP HOSPIRA 0.5MG/ML A071849 001 May 11, 1988
AP 0.5MG/ML A073509 001 Sep 30, 1992
AP 1MG/ML A071850 001 May 11, 1988
AP 1MG/ML A073510 001 Sep 30, 1992
AP + 1MG/ML N019916 001 Oct 30, 1992
AP WATSON LABS 0.5MG/ML A073373 001 Sep 30, 1991
AP 0.5MG/ML A073375 001 Sep 30, 1991
AP 1MG/ML A073374 001 Sep 30, 1991
AP 1MG/ML A073376 001 Sep 30, 1991
INFUMORPH
XX + BAXTER HLTHCARE 10MG/ML N018565 003 Jul 19, 1991
XX + 25MG/ML N018565 004 Jul 19, 1991
MORPHINE SULFATE
XX + HOSPIRA 5MG/ML N019916 002 Oct 27, 2006
XX + MERIDIAN MEDCL TECHN 15MG/ML N019999 001 Jul 12, 1990
INJECTABLE, LIPOSOMAL; EPIDURAL
DEPODUR
XX PACIRA PHARMS INC 10MG/ML (10MG/ML) N021671 001 May 18, 2004
XX + 15MG/1.5ML (10MG/ML) N021671 002 May 18, 2004
SOLUTION; ORAL
MORPHINE SULFATE
XX ROXANE 10MG/5ML N022195 001 Mar 17, 2008
XX + 20MG/5ML N022195 002 Mar 17, 2008
TABLET; ORAL
MORPHINE SULFATE
XX ROXANE 15MG N022207 001 Mar 17, 2008
XX + 30MG N022207 002 Mar 17, 2008
TABLET, EXTENDED RELEASE; ORAL
MORPHINE SULFATE
AB ENDO PHARMS 15MG A075295 001 Oct 28, 1998
AB 30MG A075295 002 Oct 28, 1998
AB 60MG A075295 003 Oct 28, 1998
AB 100MG A075295 004 Sep 15, 2000
AB 200MG A075295 005 Sep 15, 2000
AB KV PHARM 15MG A076733 001 May 19, 2004
AB 30MG A076720 002 Dec 23, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 278 (of 393)

MORPHINE SULFATE
TABLET, EXTENDED RELEASE; ORAL
MORPHINE SULFATE
AB KV PHARM 60MG A076720 001 May 19, 2004
AB 100MG A077855 001 Sep 27, 2007
AB 200MG A077855 002 Sep 27, 2007
AB MALLINCKRODT 15MG A076412 001 Jul 31, 2003
AB 30MG A076412 002 Jul 31, 2003
AB 60MG A076412 003 Jul 31, 2003
AB 100MG A076438 001 Jul 03, 2003
AB 200MG A076438 002 Jul 03, 2003
AB WATSON LABS 100MG A075656 001 Jan 30, 2001
MS CONTIN
AB PURDUE PHARMA LP 15MG N019516 003 Sep 12, 1989
AB 30MG N019516 001 May 29, 1987
AB + 60MG N019516 002 Apr 08, 1988
AB 100MG N019516 004 Jan 16, 1990
AB 200MG N019516 005 Nov 08, 1993
ORAMORPH SR
BC XANODYNE PHARM 15MG N019977 004 Nov 23, 1994
BC 30MG N019977 001 Aug 15, 1991
BC + 60MG N019977 002 Aug 15, 1991
BC 100MG N019977 003 Aug 15, 1991

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE


CAPSULE, EXTENDED RELEASE; ORAL
EMBEDA
XX ALPHARMA KING 20MG;0.8MG N022321 001 Aug 13, 2009
XX 30MG;1.2MG N022321 002 Aug 13, 2009
XX 50MG;2MG N022321 003 Aug 13, 2009
XX 60MG;2.4MG N022321 004 Aug 13, 2009
XX 80MG;3.2MG N022321 005 Aug 13, 2009
XX + 100MG;4MG N022321 006 Aug 13, 2009

MOXIFLOXACIN HYDROCHLORIDE
INJECTABLE; IV (INFUSION)

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER


XX + BAYER HLTHCARE 160MG/100ML N021277 001 Nov 30, 2001


SOLUTION/DROPS; OPHTHALMIC

VIGAMOX

XX + ALCON 0.5% N021598 001 Apr 15, 2003


TABLET; ORAL

AVELOX

XX + BAYER HLTHCARE EQ 400MG BASE N021085 001 Dec 10, 1999

MUPIROCIN
OINTMENT; TOPICAL
BACTROBAN
AB + GLAXOSMITHKLINE 2% N050591 001 Dec 31, 1987
MUPIROCIN
AB ALTANA 2% A065192 001 Nov 30, 2005
AB PERRIGO NEW YORK 2% A065123 001 Nov 07, 2003
AB TARO 2% A065170 001 Sep 23, 2005
AB TEVA 2% A065085 001 Nov 07, 2003
CENTANY
BX PERRIGO NEW YORK 2% N050788 001 Dec 04, 2002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 279 (of 393)

MUPIROCIN CALCIUM
CREAM, AUGMENTED; TOPICAL

BACTROBAN

XX + GLAXOSMITHKLINE EQ 2% BASE N050746 001 Dec 11, 1997


OINTMENT; NASAL

BACTROBAN

XX + GLAXOSMITHKLINE EQ 2% BASE N050703 001 Sep 18, 1995

MYCOPHENOLATE MOFETIL
CAPSULE; ORAL
CELLCEPT
AB + ROCHE PALO 250MG N050722 001 May 03, 1995
MYCOPHENOLATE MOFETIL
AB ACCORD HLTHCARE INC 250MG A090253 001 May 04, 2009
AB APOTEX CORP 250MG A090419 001 Apr 22, 2009
AB ENDO PHARMS 250MG A090111 001 Dec 22, 2009
AB MYLAN 250MG A065520 001 May 04, 2009
AB ROXANE 250MG A065410 001 Jul 29, 2008
AB SANDOZ 250MG A065379 001 Oct 15, 2008
AB TEVA PHARMS 250MG A065491 001 May 06, 2009
AB ZYDUS PHARMS USA INC 250MG A065433 001 May 04, 2009
SUSPENSION; ORAL

CELLCEPT

XX + ROCHE PALO 200MG/ML N050759 001 Oct 01, 1998


TABLET; ORAL
CELLCEPT
AB + ROCHE PALO 500MG N050723 001 Jun 19, 1997
MYCOPHENOLATE MOFETIL
AB ACCORD HLTHCARE 500MG A065416 001 May 04, 2009
AB APOTEX 500MG A090499 001 Apr 22, 2009
AB MYLAN 500MG A065521 001 May 04, 2009
AB ROXANE 500MG A065413 001 Jul 29, 2008
AB SANDOZ 500MG A065451 001 Oct 15, 2008
AB TEVA PHARMS 500MG A065457 001 May 04, 2009
AB ZYDUS PHARMS USA INC 500MG A065477 001 May 04, 2009

MYCOPHENOLATE MOFETIL HYDROCHLORIDE


INJECTABLE; INJECTION

CELLCEPT

XX + ROCHE PALO 500MG/VIAL N050758 001 Aug 12, 1998

MYCOPHENOLIC ACID
TABLET, DELAYED RELEASE; ORAL
MYFORTIC
XX NOVARTIS 180MG N050791 001 Feb 27, 2004
XX + 360MG N050791 002 Feb 27, 2004

NABILONE
CAPSULE; ORAL

CESAMET

XX + MEDA PHARMS 1MG N018677 001 Dec 26, 1985

NABUMETONE
TABLET; ORAL
NABUMETONE
AB ACTAVIS ELIZABETH 500MG A079093 001 Feb 27, 2009
AB 750MG A079093 002 Feb 27, 2009
AB DR REDDYS LABS LTD 500MG A078420 001 Sep 24, 2008
AB 750MG A078420 002 Sep 24, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 280 (of 393)

NABUMETONE
TABLET; ORAL
NABUMETONE
AB INVAGEN PHARMS 500MG A078671 001 Mar 07, 2008
AB 750MG A078671 002 Mar 07, 2008
AB PAR PHARM 500MG A076009 001 Jan 24, 2003
AB 750MG A076009 002 Jan 24, 2003
AB SANDOZ 500MG A075280 001 Feb 25, 2002
AB 750MG A075280 002 Feb 25, 2002
AB TEVA 500MG A075189 001 May 26, 2000
AB + 750MG A075189 002 Sep 24, 2001

NADOLOL
TABLET; ORAL
CORGARD
AB KING PHARMS 20MG N018063 005 Oct 28, 1986
AB 40MG N018063 001
AB + 80MG N018063 002
NADOLOL
AB IVAX SUB TEVA PHARMS 20MG A074229 001 Aug 30, 1996
AB 40MG A074229 002 Aug 30, 1996
AB 80MG A074255 001 Jan 24, 1996
AB MYLAN 20MG A074172 001 Oct 31, 1993
AB 40MG A074172 002 Oct 31, 1993
AB 80MG A074172 003 Oct 31, 1993
AB SANDOZ 20MG A074501 001 Nov 09, 1995
AB 40MG A074501 002 Nov 09, 1995
AB 80MG A074501 003 Nov 09, 1995

NAFARELIN ACETATE
SPRAY, METERED; NASAL

SYNAREL

XX + GD SEARLE LLC EQ 0.2MG BASE/SPRAY N019886 001 Feb 13, 1990

NAFCILLIN SODIUM
INJECTABLE; INJECTION
NAFCILLIN SODIUM
AP + SANDOZ EQ 1GM BASE/VIAL A062527 002 Aug 02, 1984
AP + EQ 1GM BASE/VIAL A062732 001 Dec 23, 1986
AP + EQ 2GM BASE/VIAL A062527 003 Aug 02, 1984
AP + EQ 2GM BASE/VIAL A062732 002 Dec 23, 1986
NAFCILLIN SODIUM
XX + SANDOZ EQ 10GM BASE/VIAL A062527 004 Aug 02, 1984
NALLPEN IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE EQ 20MG BASE/ML N050655 001 Oct 31, 1989
XX + EQ 2GM BASE/100ML N050655 002 Oct 31, 1989

NAFTIFINE HYDROCHLORIDE
CREAM; TOPICAL

NAFTIN

XX + MERZ PHARMS 1% N019599 001 Feb 29, 1988


GEL; TOPICAL

NAFTIN

XX + MERZ PHARMS 1% N019356 001 Jun 18, 1990

NALBUPHINE HYDROCHLORIDE
INJECTABLE; INJECTION
NALBUPHINE HYDROCHLORIDE
AP + HOSPIRA 10MG/ML A070914 001 Feb 03, 1989
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 281 (of 393)

NALBUPHINE HYDROCHLORIDE
INJECTABLE; INJECTION
NALBUPHINE HYDROCHLORIDE
AP + HOSPIRA 10MG/ML A070915 001 Feb 03, 1989
AP + 20MG/ML A070916 001 Feb 03, 1989
AP + 20MG/ML A070918 001 Feb 03, 1989

NALIDIXIC ACID
TABLET; ORAL

NEGGRAM

XX SANOFI AVENTIS US 250MG N014214 002


XX 500MG N014214 004


XX + 1GM N014214 005

NALOXONE HYDROCHLORIDE
INJECTABLE; INJECTION
NALOXONE HYDROCHLORIDE
AP + HOSPIRA 0.4MG/ML A070172 001 Sep 24, 1986
AP + 0.4MG/ML A070254 001 Jan 07, 1987
AP + 0.4MG/ML A070256 001 Jan 07, 1987
AP + 0.4MG/ML A070257 001 Jan 07, 1987
AP INTL MEDICATION 0.4MG/ML A070639 001 Sep 24, 1986
AP + 1MG/ML A072076 001 Mar 24, 1988

NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE


TABLET; ORAL
PENTAZOCINE AND NALOXONE HYDROCHLORIDE
AB ACTAVIS TOTOWA EQ 0.5MG BASE;EQ 50MG BASE A075735 001 Jul 11, 2001
PENTAZOCINE AND NALOXONE HYDROCHLORIDES
AB RANBAXY EQ 0.5MG BASE;EQ 50MG BASE A075523 001 Mar 17, 2000
AB WATSON LABS EQ 0.5MG BASE;EQ 50MG BASE A074736 001 Jan 21, 1997
TALWIN NX
AB + SANOFI AVENTIS US EQ 0.5MG BASE;EQ 50MG BASE N018733 001 Dec 16, 1982

NALTREXONE
FOR SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR

VIVITROL

XX + ALKERMES 380MG/VIAL N021897 001 Apr 13, 2006

NALTREXONE HYDROCHLORIDE
TABLET; ORAL
NALTREXONE HYDROCHLORIDE
AB ACTAVIS TOTOWA 50MG A075274 001 May 26, 1999
AB BARR 50MG A074918 001 May 08, 1998
AB MALLINCKRODT 50MG A076264 002 Mar 22, 2002
AB SANDOZ 50MG A075434 001 Mar 08, 2000
REVIA
AB + DURAMED 50MG N018932 001 Nov 20, 1984
NALTREXONE HYDROCHLORIDE
XX MALLINCKRODT 25MG A076264 001 Mar 22, 2002
XX 100MG A076264 003 Mar 22, 2002

NAPHAZOLINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
ALBALON
AT + ALLERGAN 0.1% A080248 001
NAFAZAIR
AT BAUSCH AND LOMB 0.1% A040073 001 May 25, 1994
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 282 (of 393)

NAPHAZOLINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
NAPHAZOLINE HYDROCHLORIDE
AT TAYLOR 0.1% A083590 001

NAPROXEN
SUSPENSION; ORAL
NAPROSYN
AB + ROCHE PALO 25MG/ML N018965 001 Mar 23, 1987
NAPROXEN
AB ROXANE 25MG/ML A074190 001 Mar 30, 1994
TABLET; ORAL
NAPROSYN
AB ROCHE PALO 250MG N017581 002
AB 375MG N017581 003
AB + 500MG N017581 004 Apr 15, 1982
NAPROXEN
AB AMNEAL PHARMS NY 250MG A075927 001 Dec 18, 2001
AB 375MG A075927 002 Dec 18, 2001
AB 500MG A075927 003 Dec 18, 2001
AB DAVA PHARMS INC 250MG A074410 001 Apr 28, 1995
AB 375MG A074410 002 Apr 28, 1995
AB 500MG A074410 003 Apr 28, 1995
AB GLENMARK GENERICS 250MG A078250 001 Mar 28, 2007
AB 375MG A078250 002 Mar 28, 2007
AB 500MG A078250 003 Mar 28, 2007
AB MYLAN 250MG A074121 001 Dec 21, 1993
AB 375MG A074121 002 Dec 21, 1993
AB 500MG A074121 003 Dec 21, 1993
AB PERRIGO R AND D 250MG A077339 001 Apr 27, 2005
AB 375MG A077339 002 Apr 27, 2005
AB 500MG A077339 003 Apr 27, 2005
AB SANDOZ 250MG A074140 001 Dec 21, 1993
AB 375MG A074140 002 Dec 21, 1993
AB 500MG A074140 003 Dec 21, 1993
AB TEVA 250MG A074201 001 Dec 21, 1993
AB 375MG A074201 002 Dec 21, 1993
AB 500MG A074201 003 Dec 21, 1993
AB WATSON LABS 250MG A074457 001 May 31, 1995
AB 375MG A074457 002 May 31, 1995
AB 500MG A074457 003 May 31, 1995
AB WESTWARD 250MG A076494 001 Jan 14, 2004
AB 375MG A076494 002 Jan 14, 2004
AB 500MG A076494 003 Jan 14, 2004
AB ZYDUS PHARMS USA 250MG A078620 001 Jun 07, 2007
AB 375MG A078620 002 Jun 07, 2007
AB 500MG A078620 003 Jun 07, 2007
TABLET, DELAYED RELEASE; ORAL
EC-NAPROSYN
AB + ROCHE PALO 375MG N020067 002 Oct 14, 1994
AB + 500MG N020067 003 Oct 14, 1994
NAPROXEN
AB ACTAVIS ELIZABETH 375MG A074936 001 Feb 24, 1998
AB 500MG A074936 002 Feb 24, 1998
AB ALPHAPHARM 375MG A075390 001 Apr 19, 2001
AB 500MG A075390 002 Apr 19, 2001
AB PLIVA 375MG A075337 001 May 26, 1999
AB 500MG A075337 002 May 26, 1999
AB SANDOZ 375MG A075061 001 Feb 18, 1998
AB 500MG A075061 002 Feb 18, 1998
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 283 (of 393)

NAPROXEN
TABLET, DELAYED RELEASE; ORAL
NAPROXEN
AB TEVA 375MG A075227 001 Jun 30, 1998
AB 500MG A075227 002 Jun 30, 1998

NAPROXEN SODIUM
TABLET; ORAL
ANAPROX
AB ROCHE PALO EQ 250MG BASE N018164 001
ANAPROX DS
AB + ROCHE PALO EQ 500MG BASE N018164 003 Sep 30, 1987
NAPROXEN SODIUM
AB AMNEAL PHARMS NY EQ 250MG BASE A078432 001 Apr 25, 2007
AB EQ 500MG BASE A078432 002 Apr 25, 2007
AB DR REDDYS LABS LTD EQ 250MG BASE A078486 001 Jul 26, 2007
AB EQ 500MG BASE A078486 002 Jul 26, 2007
AB GLENMARK GENERICS EQ 250MG BASE A078314 001 Apr 27, 2007
AB EQ 500MG BASE A078314 002 Apr 27, 2007
AB HIKMA EQ 250MG BASE A074480 002 Feb 18, 1998
AB EQ 500MG BASE A074480 001 May 14, 1996
AB SANDOZ EQ 250MG BASE A074162 001 Dec 21, 1993
AB EQ 250MG BASE A074495 001 Dec 05, 1994
AB EQ 500MG BASE A074162 002 Dec 21, 1993
AB EQ 500MG BASE A074495 002 Dec 05, 1994
AB TEVA EQ 250MG BASE A074198 001 Dec 21, 1993
AB EQ 500MG BASE A074198 002 Dec 21, 1993
AB WATSON LABS EQ 250MG BASE A074455 001 May 31, 1995
AB EQ 500MG BASE A074455 002 May 31, 1995
TABLET, EXTENDED RELEASE; ORAL
NAPRELAN
XX STAT TRADE EQ 375MG BASE N020353 001 Jan 05, 1996
XX EQ 500MG BASE N020353 002 Jan 05, 1996
XX + EQ 750MG BASE N020353 003 Jan 05, 1996

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE


TABLET; ORAL

TREXIMET

XX + GLAXOSMITHKLINE 500MG;EQ 85MG BASE N021926 001 Apr 15, 2008

NARATRIPTAN HYDROCHLORIDE
TABLET; ORAL
AMERGE
XX GLAXOSMITHKLINE EQ 1MG BASE N020763 002 Feb 10, 1998
XX + EQ 2.5MG BASE N020763 001 Feb 10, 1998

NATAMYCIN
SUSPENSION; OPHTHALMIC

NATACYN

XX + ALCON 5% N050514 001

NATEGLINIDE
TABLET; ORAL
NATEGLINIDE
AB DR REDDYS LABS LTD 60MG A077461 001 Sep 09, 2009
AB 120MG A077461 002 Sep 09, 2009
AB PAR PHARM 60MG A077463 001 Sep 09, 2009
AB 120MG A077463 002 Sep 09, 2009
AB TEVA PHARMS 60MG A077467 001 Sep 09, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 284 (of 393)

NATEGLINIDE
TABLET; ORAL
NATEGLINIDE
AB TEVA PHARMS 120MG A077467 002 Sep 09, 2009
STARLIX
AB NOVARTIS 60MG N021204 001 Dec 22, 2000
AB + 120MG N021204 002 Dec 22, 2000

NEBIVOLOL HYDROCHLORIDE
TABLET; ORAL
BYSTOLIC
XX FOREST LABS EQ 2.5MG BASE N021742 002 Dec 17, 2007
XX EQ 5MG BASE N021742 003 Dec 17, 2007
XX EQ 10MG BASE N021742 004 Dec 17, 2007
XX + EQ 20MG BASE N021742 005 Oct 08, 2008

NEDOCROMIL SODIUM
SOLUTION/DROPS; OPHTHALMIC

ALOCRIL

XX + ALLERGAN 2% N021009 001 Dec 08, 1999

NEFAZODONE HYDROCHLORIDE
TABLET; ORAL
NEFAZODONE HYDROCHLORIDE
AB IVAX SUB TEVA PHARMS 50MG A075763 001 Sep 16, 2003
AB 100MG A075763 002 Sep 16, 2003
AB 150MG A075763 003 Sep 16, 2003
AB 200MG A075763 004 Sep 16, 2003
AB 250MG A075763 005 Sep 16, 2003
AB RANBAXY 50MG A076409 001 Sep 16, 2003
AB 100MG A076409 002 Sep 16, 2003
AB 150MG A076409 003 Sep 16, 2003
AB 200MG A076409 004 Sep 16, 2003
AB 250MG A076409 005 Sep 16, 2003
AB SANDOZ 50MG A076302 001 Sep 16, 2003
AB 100MG A076302 002 Sep 16, 2003
AB 150MG A076302 003 Sep 16, 2003
AB 200MG A076302 004 Sep 16, 2003
AB 250MG A076302 005 Sep 16, 2003
AB TEVA 50MG A076037 001 Sep 16, 2003
AB 100MG A076037 002 Sep 16, 2003
AB 150MG A076037 003 Sep 16, 2003
AB 200MG A076037 004 Sep 16, 2003
AB + 250MG A076037 005 Sep 16, 2003
NEFAZODONE HYDROCHLORIDE
BX DR REDDYS LABS INC 50MG A076309 001 Sep 16, 2003
BX 100MG A076309 002 Sep 16, 2003
BX 150MG A076309 003 Sep 16, 2003
BX 200MG A076309 004 Sep 16, 2003
BX 250MG A076309 005 Sep 16, 2003

NELARABINE
INJECTABLE; IV (INFUSION)

ARRANON

XX + SMITHKLINE BEECHAM 250MG/50ML (5MG/ML) N021877 001 Oct 28, 2005


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 285 (of 393)

NELFINAVIR MESYLATE
POWDER; ORAL

VIRACEPT

XX + AGOURON EQ 50MG BASE/SCOOPFUL N020778 001 Mar 14, 1997


TABLET; ORAL

VIRACEPT

XX + AGOURON EQ 250MG BASE N020779 001 Mar 14, 1997


XX + EQ 625MG BASE N021503 001 Apr 30, 2003

NEOMYCIN SULFATE
POWDER; FOR RX COMPOUNDING

NEO-RX

XX X GEN PHARMS 100% A061579 001


SOLUTION; ORAL

NEO-FRADIN

XX + X GEN PHARMS EQ 87.5MG BASE/5ML A065010 001 May 23, 2002


TABLET; ORAL
NEOMYCIN SULFATE
AA + TEVA 500MG A060304 001
AA X GEN PHARMS 500MG A065220 001 Jul 28, 2006

NEOMYCIN SULFATE; POLYMYXIN B SULFATE


SOLUTION; IRRIGATION
NEOMYCIN AND POLYMYXIN B SULFATE
AT WATSON LABS EQ 40MG BASE/ML;200,000 UNITS/ML A062664 001 Apr 08, 1986
AT X GEN PHARMS EQ 40MG BASE/ML;200,000 UNITS/ML A065106 001 Jan 31, 2006
AT EQ 40MG BASE/ML;200,000 UNITS/ML A065108 001 Jan 31, 2006
NEOSPORIN G.U. IRRIGANT
AT + MONARCH PHARMS EQ 40MG BASE/ML;200,000 UNITS/ML A060707 001

NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE


SUSPENSION/DROPS; OPHTHALMIC

POLY-PRED

XX + ALLERGAN EQ 0.35% BASE;10,000 UNITS/ML;0.5% N050081 002

NEPAFENAC
SUSPENSION/DROPS; OPHTHALMIC

NEVANAC

XX + ALCON 0.1% N021862 001 Aug 19, 2005

NESIRITIDE RECOMBINANT
FOR SOLUTION; INTRAVENOUS

NATRECOR

XX + SCIOS 1.5MG/VIAL N020920 001 Aug 10, 2001

NEVIRAPINE
SUSPENSION; ORAL

VIRAMUNE

XX + BOEHRINGER INGELHEIM 50MG/5ML N020933 001 Sep 11, 1998


TABLET; ORAL

VIRAMUNE

XX + BOEHRINGER INGELHEIM 200MG N020636 001 Jun 21, 1996

NIACIN
TABLET; ORAL
NIACIN
AA WOCKHARDT 500MG A081134 001 Apr 28, 1992
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 286 (of 393)

NIACIN
TABLET; ORAL
NIACOR
AA + UPSHER SMITH 500MG A040378 001 May 03, 2000
TABLET, EXTENDED RELEASE; ORAL
NIASPAN
XX ABBOTT 500MG N020381 002 Jul 28, 1997
XX + 750MG N020381 003 Jul 28, 1997
XX + 1GM N020381 004 Jul 28, 1997

NIACIN; SIMVASTATIN
TABLET, EXTENDED RELEASE; ORAL

SIMCOR

XX + ABBOTT 500MG;20MG N022078 001 Feb 15, 2008


XX + 750MG;20MG N022078 002 Feb 15, 2008
XX + 1GM;20MG N022078 003 Feb 15, 2008

NICARDIPINE HYDROCHLORIDE
CAPSULE; ORAL
CARDENE
AB EKR THERAP 20MG N019488 001 Dec 21, 1988
AB + 30MG N019488 002 Dec 21, 1988
NICARDIPINE HYDROCHLORIDE
AB AMNEAL PHARM 20MG A074928 001 Mar 19, 1998
AB 30MG A074928 002 Mar 19, 1998
AB BARR 20MG A074439 001 Dec 10, 1996
AB 30MG A074439 002 Dec 10, 1996
AB MYLAN 20MG A074642 001 Jul 18, 1996
AB 30MG A074642 002 Jul 18, 1996
AB TEVA 20MG A074540 001 Oct 28, 1996
AB 30MG A074540 002 Oct 28, 1996
AB WATSON LABS 20MG A074670 001 Oct 28, 1996
AB 30MG A074670 002 Oct 28, 1996
CAPSULE, EXTENDED RELEASE; ORAL

CARDENE SR

XX + EKR THERAP 30MG N020005 001 Feb 21, 1992


XX + 45MG N020005 002 Feb 21, 1992
XX + 60MG N020005 003 Feb 21, 1992
INJECTABLE; INJECTION
CARDENE
AP + EKR THERAP 25MG/10ML (2.5MG/ML) N019734 001 Jan 30, 1992
NICARDIPINE HYDROCHLORIDE
AP BEDFORD 25MG/10ML (2.5MG/ML) A078714 001 Dec 28, 2009
AP GENERAMEDIX 25MG/10ML (2.5MG/ML) A090664 001 Nov 17, 2009
AP NAVINTA LLC 25MG/10ML (2.5MG/ML) A090125 001 Nov 17, 2009
AP PHARMAFORCE 25MG/10ML (2.5MG/ML) A090534 001 Nov 17, 2009
AP SUN PHARM INDS INC 25MG/10ML (2.5MG/ML) A078405 001 Nov 17, 2009
AP TEVA PARENTERAL 25MG/10ML (2.5MG/ML) N022276 001 Jul 24, 2008
AP WOCKHARDT 25MG/10ML (2.5MG/ML) A090671 001 Nov 17, 2009
INJECTABLE; INTRAVENOUS

CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER

XX + EKR THERAP 40MG/200ML (0.2MG/ML) N019734 004 Nov 07, 2008


CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
XX + EKR THERAP 20MG/200ML (0.1MG/ML) N019734 003 Jul 31, 2008
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
XX + EKR THERAP 20MG/200ML (0.1MG/ML) N019734 002 Jul 31, 2008
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
XX + EKR THERAP 40MG/200ML (0.2MG/ML) N019734 005 Nov 07, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 287 (of 393)

NICOTINE
INHALANT; ORAL

NICOTROL

XX + PHARMACIA AND UPJOHN 4MG/CARTRIDGE N020714 001 May 02, 1997


SPRAY, METERED; NASAL

NICOTROL

XX + PFIZER INC 0.5MG/SPRAY N020385 001 Mar 22, 1996

NIFEDIPINE
CAPSULE; ORAL
NIFEDIPINE
AB ACTAVIS ELIZABETH 10MG A072579 001 Jan 08, 1991
AB CATALENT 10MG A073250 001 Oct 08, 1991
AB INVERNESS MEDCL 10MG A072781 001 Jul 30, 1993
PROCARDIA
AB + PFIZER 10MG N018482 001
NIFEDIPINE
XX ACTAVIS ELIZABETH 20MG A072556 001 Sep 20, 1990
TABLET, EXTENDED RELEASE; ORAL
ADALAT CC
AB1 BAYER HLTHCARE 30MG N020198 001 Apr 21, 1993
AB1 + 60MG N020198 002 Apr 21, 1993
AB1 + 90MG N020198 003 Apr 21, 1993
AFEDITAB CR
AB1 WATSON LABS 30MG A075128 001 Mar 10, 2000
AB1 60MG A075659 001 Oct 26, 2001
NIFEDIPINE
AB1 ACTAVIS 30MG A077899 001 Dec 13, 2006
AB1 60MG A077899 002 Dec 13, 2006
AB1 BIOVAIL 30MG A075269 001 Dec 04, 2000
AB1 60MG A075269 002 Dec 04, 2000
AB1 90MG A076070 001 Aug 16, 2002
NIFEDIPINE
AB2 BIOVAIL 30MG A075289 002 Feb 06, 2001
AB2 60MG A075289 001 Sep 27, 2000
AB2 OSMOTICA PHARM 30MG A077127 001 Nov 21, 2005
AB2 60MG A077127 002 Nov 21, 2005
AB2 90MG A077410 001 Oct 03, 2007
PROCARDIA XL
AB2 PFIZER 30MG N019684 001 Sep 06, 1989
AB2 60MG N019684 002 Sep 06, 1989
AB2 + 90MG N019684 003 Sep 06, 1989

NILOTINIB HYDROCHLORIDE MONOHYDRATE


CAPSULE; ORAL

TASIGNA

XX + NOVARTIS EQ 200MG BASE N022068 001 Oct 29, 2007

NILUTAMIDE
TABLET; ORAL

NILANDRON

XX + SANOFI AVENTIS US 150MG N020169 002 Apr 30, 1999

NIMODIPINE
CAPSULE; ORAL
NIMODIPINE
AB BANNER PHARMACAPS 30MG A076740 001 Jan 17, 2008
AB + BARR 30MG A077811 001 May 02, 2007
AB SUN PHARM INDS INC 30MG A077067 001 Apr 17, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 288 (of 393)

NISOLDIPINE
TABLET, EXTENDED RELEASE; ORAL

NISOLDIPINE

XX + MYLAN 20MG A079051 001 Jul 25, 2008


XX + 30MG A079051 002 Jul 25, 2008
XX + 40MG A079051 003 Jul 25, 2008
SULAR
XX + SCIELE PHARMA INC 8.5MG N020356 008 Jan 02, 2008
XX + 17MG N020356 007 Jan 02, 2008
XX 25.5MG N020356 006 Jan 02, 2008
XX + 34MG N020356 005 Jan 02, 2008

NITAZOXANIDE
FOR SUSPENSION; ORAL

ALINIA

XX + ROMARK 100MG/5ML N021498 001 Nov 22, 2002


TABLET; ORAL

ALINIA

XX + ROMARK 500MG N021497 001 Jul 21, 2004

NITISINONE
CAPSULE; ORAL
ORFADIN
XX RARE DIS 2MG N021232 001 Jan 18, 2002
XX 5MG N021232 002 Jan 18, 2002
XX + 10MG N021232 003 Jan 18, 2002

NITRIC OXIDE
GAS; INHALATION
INOMAX
XX INO 100PPM N020845 002 Dec 23, 1999
XX + 800PPM N020845 003 Dec 23, 1999

NITROFURANTOIN
SUSPENSION; ORAL

FURADANTIN

XX + SCIELE PHARMA INC 25MG/5ML N009175 001

NITROFURANTOIN, MACROCRYSTALLINE
CAPSULE; ORAL
MACRODANTIN
AB PROCTER AND GAMBLE 25MG N016620 003
AB 50MG N016620 001
AB + 100MG N016620 002
NITROFURANTOIN
AB IVAX SUB TEVA PHARMS 50MG A073671 001 Jan 28, 1993
AB 100MG A073652 001 Jan 28, 1993
AB MYLAN 50MG A074967 001 Jul 09, 1997
AB 100MG A077025 001 Aug 18, 2004
AB WATSON LABS 25MG A073696 001 Dec 31, 1992
AB 50MG A073696 002 Dec 31, 1992
AB 100MG A073696 003 Dec 31, 1992

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE


CAPSULE; ORAL
MACROBID
AB + PROCTER AND GAMBLE 75MG;25MG N020064 001 Dec 24, 1991
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
AB MYLAN 75MG;25MG A076648 001 Mar 22, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 289 (of 393)

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE


CAPSULE; ORAL
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
AB RANBAXY 75MG;25MG A076951 001 Mar 30, 2005
AB SANDOZ 75MG;25MG A077066 001 Apr 05, 2005

NITROGLYCERIN
AEROSOL, METERED; SUBLINGUAL

NITROMIST

XX + AKRIMAX PHARMS 0.4MG/SPRAY N021780 001 Nov 02, 2006


FILM, EXTENDED RELEASE; TRANSDERMAL
MINITRAN
AB1 GRACEWAY 0.1MG/HR A089771 001 Aug 30, 1996
AB1 0.2MG/HR A089772 001 Aug 30, 1996
AB1 0.4MG/HR A089773 001 Aug 30, 1996
AB1 0.6MG/HR A089774 001 Aug 30, 1996
NITRO-DUR
AB1 + KEY PHARMS 0.1MG/HR N020145 001 Apr 04, 1995
AB1 + 0.2MG/HR N020145 002 Apr 04, 1995
AB1 + 0.4MG/HR N020145 004 Apr 04, 1995
AB1 + 0.6MG/HR N020145 005 Apr 04, 1995
NITROGLYCERIN
AB1 KREMERS URBAN 0.2MG/HR A075115 001 Aug 10, 2004
AB1 0.4MG/HR A075115 002 Aug 10, 2004
NITROGLYCERIN
AB2 HERCON LABS 0.2MG/HR A089884 001 Oct 30, 1998
AB2 0.4MG/HR A089885 001 Oct 30, 1998
AB2 0.6MG/HR A089886 001 Oct 30, 1998
AB2 + MYLAN TECHNOLOGIES 0.2MG/HR A074559 003 Aug 30, 1996
AB2 + 0.4MG/HR A074559 002 Aug 30, 1996
AB2 + 0.6MG/HR A074559 001 Aug 30, 1996
NITRO-DUR
XX + KEY PHARMS 0.3MG/HR N020145 003 Apr 04, 1995
XX + 0.8MG/HR N020145 006 Apr 04, 1995
NITROGLYCERIN
XX + MYLAN TECHNOLOGIES 0.1MG/HR A074559 004 Feb 06, 1998
INJECTABLE; INJECTION
NITROGLYCERIN
AP + HOSPIRA 5MG/ML N018531 001
AP + LUITPOLD 5MG/ML A072034 001 May 24, 1988
NITROGLYCERIN IN DEXTROSE 5%
AP + BAXTER HLTHCARE 10MG/100ML N019970 001 Dec 29, 1989
AP + 20MG/100ML N019970 002 Dec 29, 1989
AP + 40MG/100ML N019970 003 Dec 29, 1989
AP HOSPIRA 10MG/100ML A071846 001 Aug 31, 1990
AP 20MG/100ML A071847 001 Aug 31, 1990
AP 40MG/100ML A071848 001 Aug 31, 1990
OINTMENT; TRANSDERMAL

NITROGLYCERIN

XX + FOUGERA 2% A087355 001 Jul 08, 1988


SPRAY, METERED; SUBLINGUAL

NITROLINGUAL PUMPSPRAY

XX + POHL BOSKAMP 0.4MG/SPRAY N018705 002 Jan 10, 1997


TABLET; SUBLINGUAL
NITROSTAT
XX PFIZER PHARMS 0.3MG N021134 001 May 01, 2000
XX 0.4MG N021134 002 May 01, 2000
XX + 0.6MG N021134 003 May 01, 2000
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 290 (of 393)

NIZATIDINE
CAPSULE; ORAL
AXID
AB SMITHKLINE BEECHAM 150MG N019508 001 Apr 12, 1988
AB + 300MG N019508 002 Apr 12, 1988
NIZATIDINE
AB APOTEX 150MG A076383 001 Jan 23, 2003
AB 300MG A076383 002 Jan 23, 2003
AB DR REDDYS LABS LTD 150MG A077314 001 Sep 15, 2005
AB 300MG A077314 002 Sep 15, 2005
AB GENPHARM 150MG A075934 001 Jul 09, 2002
AB 300MG A075934 002 Jul 09, 2002
AB MYLAN 150MG A075806 001 Jul 05, 2002
AB 300MG A075806 002 Jul 05, 2002
AB SANDOZ 150MG A076178 001 Jul 05, 2002
AB 300MG A076178 002 Jul 05, 2002
AB TEVA 150MG A075668 001 Sep 12, 2002
AB 300MG A075668 002 Sep 12, 2002
AB WATSON LABS 150MG A075616 001 Jul 09, 2002
AB 300MG A075616 002 Jul 09, 2002
SOLUTION; ORAL
AXID
AA + BRAINTREE 15MG/ML N021494 001 May 25, 2004
NIZATIDINE
AA AMNEAL PHARMS 15MG/ML A090576 001 Nov 18, 2009

NOREPINEPHRINE BITARTRATE
INJECTABLE; INJECTION
LEVOPHED
AP + HOSPIRA EQ 1MG BASE/ML N007513 001
NOREPINEPHRINE BITARTRATE
AP BEDFORD EQ 1MG BASE/ML A040462 001 Oct 31, 2003
AP METRICS PHARM EQ 1MG BASE/ML A040522 001 Sep 30, 2004
AP TEVA PARENTERAL EQ 1MG BASE/ML A040455 001 Mar 03, 2003

NORETHINDRONE
TABLET; ORAL-28
CAMILA
AB1 BARR 0.35MG A076177 001 Oct 21, 2002
NOR-QD
AB1 + WATSON LABS (UTAH) 0.35MG N017060 001
ERRIN
AB2 BARR 0.35MG A076225 001 Oct 21, 2002
MICRONOR
AB2 + ORTHO MCNEIL JANSSEN 0.35MG N016954 001

NORETHINDRONE ACETATE
TABLET; ORAL
AYGESTIN
AB + DURAMED RES 5MG N018405 001 Apr 21, 1982
NORETHINDRONE ACETATE
AB BARR 5MG A075951 001 May 25, 2001

NORFLOXACIN
TABLET; ORAL

NOROXIN

XX + MERCK 400MG N019384 002 Oct 31, 1986


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 291 (of 393)

NORTRIPTYLINE HYDROCHLORIDE
CAPSULE; ORAL
NORTRIPTYLINE HYDROCHLORIDE
AB MYLAN EQ 10MG BASE A074234 001 Jul 26, 1993
AB EQ 25MG BASE A074234 002 Jul 26, 1993
AB EQ 50MG BASE A074234 003 Jul 26, 1993
AB EQ 75MG BASE A074234 004 Jul 26, 1993
AB TARO EQ 10MG BASE A075520 004 May 08, 2000
AB EQ 25MG BASE A075520 003 May 08, 2000
AB EQ 50MG BASE A075520 001 May 08, 2000
AB EQ 75MG BASE A075520 002 May 08, 2000
AB TEVA EQ 10MG BASE A074132 001 Mar 27, 1995
AB EQ 25MG BASE A074132 002 Mar 27, 1995
AB EQ 50MG BASE A074132 003 Mar 27, 1995
AB EQ 75MG BASE A074132 004 Mar 27, 1995
AB WATSON LABS EQ 10MG BASE A073553 001 Mar 30, 1992
AB EQ 25MG BASE A073554 001 Mar 30, 1992
AB EQ 50MG BASE A073555 001 Mar 30, 1992
AB EQ 75MG BASE A073556 001 Mar 30, 1992
PAMELOR
AB TYCO HLTHCARE EQ 10MG BASE N018013 001
AB EQ 25MG BASE N018013 002
AB EQ 50MG BASE N018013 004
AB + EQ 75MG BASE N018013 003
SOLUTION; ORAL
AVENTYL HYDROCHLORIDE
AA + RANBAXY EQ 10MG BASE/5ML N014685 001
NORTRIPTYLINE HYDROCHLORIDE
AA PHARM ASSOC EQ 10MG BASE/5ML A075606 001 Aug 28, 2000
AA TARO EQ 10MG BASE/5ML A077965 001 Jun 20, 2006
PAMELOR
AA TYCO HLTHCARE EQ 10MG BASE/5ML N018012 001

NYSTATIN
CREAM; TOPICAL
MYCOSTATIN
AT + BRISTOL MYERS SQUIBB 100,000 UNITS/GM A060575 001
NYSTATIN
AT ACTAVIS MID ATLANTIC 100,000 UNITS/GM A062949 001 Jun 13, 1988
AT ALTANA 100,000 UNITS/GM A062129 001
AT PERRIGO NEW YORK 100,000 UNITS/GM A062225 001
AT TARO 100,000 UNITS/GM A064022 001 Jan 29, 1993
AT VINTAGE 100,000 UNITS/GM A065315 001 May 31, 2006
OINTMENT; TOPICAL
NYSTATIN
AT ACTAVIS MID ATLANTIC 100,000 UNITS/GM A062840 001 Nov 13, 1987
AT + ALTANA 100,000 UNITS/GM A062124 002 Sep 23, 1982
AT PERRIGO NEW YORK 100,000 UNITS/GM A062472 001 Feb 13, 1984
POWDER; TOPICAL
MYCOSTATIN
AT + BRISTOL MYERS SQUIBB 100,000 UNITS/GM A060578 001
NYSTATIN
AT COASTAL PHARMS 100,000 UNITS/GM A065203 001 Jul 15, 2004
AT GAVIS PHARMS 100,000 UNITS/GM A065138 001 Jul 23, 2004
AT KV PHARM 100,000 UNITS/GM A065321 001 Aug 18, 2006
AT UPSHER SMITH 100,000 UNITS/GM A065183 001 May 03, 2005
AT X GEN PHARMS 100,000 UNITS/GM A065175 001 Dec 17, 2004
NYSTOP
AT PADDOCK 100,000 UNITS/GM A064118 001 Aug 16, 1996
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 292 (of 393)

NYSTATIN
SUSPENSION; ORAL
NILSTAT
AA + GLENMARK GENERICS 100,000 UNITS/ML N050299 001
NYSTATIN
AA ACTAVIS MID ATLANTIC 100,000 UNITS/ML A062349 001 Jul 14, 1982
AA BAUSCH AND LOMB 100,000 UNITS/ML A064042 001 Feb 28, 1994
AA FOUGERA 100,000 UNITS/ML A062517 001 Jun 07, 1984
AA + MORTON GROVE 100,000 UNITS/ML A062512 001 Oct 29, 1984
AA TARO 100,000 UNITS/ML A062876 001 Feb 29, 1988
AA VINTAGE PHARMS 100,000 UNITS/ML A065148 001 Jun 28, 2005
AA VISTAPHARM 100,000 UNITS/ML A064142 001 Jun 25, 1998
TABLET; ORAL
NYSTATIN
AA MUTUAL PHARM 500,000 UNITS A062838 001 Dec 22, 1988
AA + TEVA 500,000 UNITS A062506 001 Jan 16, 1984
TABLET; VAGINAL

NYSTATIN

XX + ODYSSEY PHARMS 100,000 UNITS A062615 001 Oct 17, 1985

NYSTATIN; TRIAMCINOLONE ACETONIDE


CREAM; TOPICAL
MYKACET
AT ACTAVIS MID ATLANTIC 100,000 UNITS/GM;0.1% A062367 001 May 28, 1985
NYSTATIN AND TRIAMCINOLONE ACETONIDE
AT FOUGERA 100,000 UNITS/GM;0.1% A062599 001 Oct 08, 1985
AT + TARO 100,000 UNITS/GM;0.1% A062364 001 Dec 22, 1987
OINTMENT; TOPICAL
MYKACET
AT ACTAVIS MID ATLANTIC 100,000 UNITS/GM;0.1% A062733 001 Mar 09, 1987
NYSTATIN AND TRIAMCINOLONE ACETONIDE
AT FOUGERA 100,000 UNITS/GM;0.1% A062602 001 Oct 09, 1985
AT + TARO 100,000 UNITS/GM;0.1% A063305 001 Mar 29, 1993

OCTREOTIDE ACETATE
INJECTABLE; INJECTION
OCTREOTIDE ACETATE
AP APP PHARMS EQ 0.2MG BASE/ML A077450 001 Feb 10, 2006
AP EQ 1MG BASE/ML A077450 002 Feb 10, 2006
AP + BEDFORD EQ 0.2MG BASE/ML A076330 001 Apr 08, 2005
AP + EQ 1MG BASE/ML A076330 002 Apr 08, 2005
AP SUN PHARM INDS EQ 0.05MG BASE/ML A077329 001 Mar 04, 2008
AP EQ 0.05MG BASE/ML A077372 001 Aug 14, 2007
AP EQ 0.1MG BASE/ML A077329 002 Mar 04, 2008
AP EQ 0.1MG BASE/ML A077372 002 Aug 14, 2007
AP EQ 0.2MG BASE/ML A077330 001 Mar 04, 2008
AP EQ 0.2MG BASE/ML A077373 001 Aug 14, 2007
AP EQ 0.5MG BASE/ML A077329 003 Mar 04, 2008
AP EQ 0.5MG BASE/ML A077372 003 Aug 14, 2007
AP EQ 1MG BASE/ML A077331 001 Mar 04, 2008
AP EQ 1MG BASE/ML A077373 002 Aug 14, 2007
AP TEVA PARENTERAL EQ 0.05MG BASE/ML A075957 001 Oct 03, 2005
AP EQ 0.1MG BASE/ML A075957 002 Oct 03, 2005
AP EQ 0.2MG BASE/ML A075959 001 Nov 21, 2005
AP EQ 0.5MG BASE/ML A075957 003 Oct 03, 2005
AP EQ 1MG BASE/ML A075959 002 Nov 21, 2005
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
AP APP PHARMS EQ 0.05MG BASE/ML A077457 001 Feb 10, 2006
AP EQ 0.1MG BASE/ML A077457 002 Feb 10, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 293 (of 393)

OCTREOTIDE ACETATE
INJECTABLE; INJECTION
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
AP APP PHARMS EQ 0.5MG BASE/ML A077457 003 Feb 10, 2006
AP + BEDFORD EQ 0.05MG BASE/ML A076313 001 Mar 28, 2005
AP + EQ 0.1MG BASE/ML A076313 003 Mar 28, 2005
AP + EQ 0.5MG BASE/ML A076313 002 Mar 28, 2005
SANDOSTATIN
AP + NOVARTIS EQ 0.05MG BASE/ML N019667 001 Oct 21, 1988
AP + EQ 0.1MG BASE/ML N019667 002 Oct 21, 1988
AP + EQ 0.2MG BASE/ML N019667 004 Jun 12, 1991
AP + EQ 0.5MG BASE/ML N019667 003 Oct 21, 1988
AP + EQ 1MG BASE/ML N019667 005 Jun 12, 1991
SANDOSTATIN LAR
XX NOVARTIS EQ 10MG BASE/VIAL N021008 001 Nov 25, 1998
XX EQ 20MG BASE/VIAL N021008 002 Nov 25, 1998
XX + EQ 30MG BASE/VIAL N021008 003 Nov 25, 1998

OFLOXACIN
SOLUTION/DROPS; OPHTHALMIC
OCUFLOX
AT + ALLERGAN 0.3% N019921 001 Jul 30, 1993
OFLOXACIN
AT AKORN 0.3% A076407 001 Apr 15, 2008
AT ALCON 0.3% A076231 001 May 14, 2004
AT BAUSCH AND LOMB 0.3% A076622 001 May 14, 2004
AT FDC LTD 0.3% A078559 001 Feb 25, 2009
AT HI TECH PHARMA 0.3% A076615 001 May 14, 2004
AT NOVEX 0.3% A076513 001 May 14, 2004
AT PHARMAFORCE 0.3% A076830 001 Aug 31, 2004
AT SANDOZ 0.3% A076848 001 Nov 25, 2008
SOLUTION/DROPS; OTIC
FLOXIN OTIC
AT + DAIICHI 0.3% N020799 001 Dec 16, 1997
OFLOXACIN
AT ALCON 0.3% A078222 001 Mar 17, 2008
AT APOTEX INC 0.3% A076527 001 Sep 28, 2007
AT BAUSCH AND LOMB 0.3% A076128 001 Mar 17, 2008
AT HI TECH PHARMA 0.3% A076616 001 Mar 17, 2008
AT PHARMAFORCE 0.3% A090395 001 Aug 11, 2009
TABLET; ORAL
OFLOXACIN
AB DR REDDYS LABS LTD 200MG A077098 001 Feb 10, 2006
AB 300MG A077098 002 Feb 10, 2006
AB 400MG A077098 003 Feb 10, 2006
AB RANBAXY 200MG A076220 001 Sep 02, 2003
AB 300MG A076220 002 Sep 02, 2003
AB 400MG A076220 003 Sep 02, 2003
AB TEVA 200MG A076182 001 Sep 02, 2003
AB 300MG A076182 002 Sep 02, 2003
AB + 400MG A076182 003 Sep 02, 2003

OLANZAPINE
INJECTABLE; INTRAMUSCULAR

ZYPREXA

XX + LILLY 10MG/VIAL N021253 001 Mar 29, 2004


TABLET; ORAL
ZYPREXA
XX LILLY 2.5MG N020592 001 Sep 30, 1996
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 294 (of 393)

OLANZAPINE
TABLET; ORAL

ZYPREXA

XX + LILLY 5MG N020592 002 Sep 30, 1996


XX 7.5MG N020592 003 Sep 30, 1996
XX 10MG N020592 004 Sep 30, 1996
XX 15MG N020592 005 Sep 09, 1997
XX 20MG N020592 006 Sep 09, 1997
TABLET, ORALLY DISINTEGRATING; ORAL

ZYPREXA ZYDIS

XX + LILLY 5MG N021086 001 Apr 06, 2000


XX 10MG N021086 002 Apr 06, 2000
XX 15MG N021086 003 Apr 06, 2000
XX 20MG N021086 004 Apr 06, 2000

OLANZAPINE PAMOATE
SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
ZYPREXA RELPREVV
XX ELI LILLY CO EQ 210MG BASE/VIAL N022173 001 Dec 11, 2009
XX EQ 300MG BASE/VIAL N022173 002 Dec 11, 2009
XX + EQ 405MG BASE/VIAL N022173 003 Dec 11, 2009

OLMESARTAN MEDOXOMIL
TABLET; ORAL
BENICAR
XX DAIICHI SANKYO 5MG N021286 001 Apr 25, 2002
XX 20MG N021286 003 Apr 25, 2002
XX + 40MG N021286 004 Apr 25, 2002

OLOPATADINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC

PATADAY

XX + ALCON EQ 0.2% BASE N021545 001 Dec 22, 2004


PATANOL
XX + ALCON EQ 0.1% BASE N020688 001 Dec 18, 1996
SPRAY, METERED; NASAL

PATANASE

XX + ALCON 0.665MG/SPRAY N021861 001 Apr 15, 2008

OLSALAZINE SODIUM
CAPSULE; ORAL

DIPENTUM

XX + UCB INC 250MG N019715 001 Jul 31, 1990

OMEGA-3-ACID ETHYL ESTERS


CAPSULE; ORAL

LOVAZA

XX + SMITHKLINE BEECHAM 1GM N021654 001 Nov 10, 2004

OMEPRAZOLE
CAPSULE, DELAYED REL PELLETS; ORAL
OMEPRAZOLE
AB APOTEX 10MG A076048 001 Oct 22, 2007
AB 20MG A076048 002 Oct 22, 2007
AB 40MG A076048 003 Jan 21, 2009
AB DR REDDYS LABS 40MG A078490 001 Apr 17, 2009
AB DR REDDYS LABS LTD 10MG A075576 003 Oct 22, 2007
AB 10MG A078693 001 Mar 16, 2009
AB 20MG A075576 002 Oct 22, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 295 (of 393)

OMEPRAZOLE
CAPSULE, DELAYED REL PELLETS; ORAL
OMEPRAZOLE
AB DR REDDYS LABS LTD 20MG A078693 002 Mar 16, 2009
AB 40MG A075576 001 Jan 21, 2009
AB IMPAX LABS 10MG A075785 001 Oct 22, 2007
AB 20MG A075785 002 Oct 22, 2007
AB 40MG A075785 003 Jan 21, 2009
AB KREMERS URBAN DEV 10MG A075410 001 Nov 01, 2002
AB 20MG A075410 002 Nov 01, 2002
AB 40MG A075410 003 Jan 23, 2009
AB LEK PHARMS 10MG A075757 001 Jan 28, 2003
AB 20MG A075757 002 Jan 28, 2003
AB MYLAN 10MG A075876 001 May 29, 2003
AB 20MG A075876 002 May 29, 2003
AB 40MG A075876 003 Jan 21, 2009
AB SANDOZ 40MG A076515 001 Jan 21, 2009
AB WATSON LABS FLORIDA 10MG A075347 001 May 30, 2008
AB 20MG A075347 002 May 30, 2008
AB 40MG A075347 003 May 30, 2008
PRILOSEC
AB ASTRAZENECA 10MG N019810 003 Oct 05, 1995
AB + 20MG N019810 001 Sep 14, 1989
AB + 40MG N019810 002 Jan 15, 1998

OMEPRAZOLE MAGNESIUM
FOR SUSPENSION, DELAYED RELEASE; ORAL
PRILOSEC
XX ASTRAZENECA EQ 2.5MG BASE/PACKET N022056 001 Mar 20, 2008
XX + EQ 10MG BASE/PACKET N022056 002 Mar 20, 2008

OMEPRAZOLE; SODIUM BICARBONATE


CAPSULE; ORAL
ZEGERID
XX SANTARUS 20MG;1.1GM N021849 001 Feb 27, 2006
XX + 40MG;1.1GM N021849 002 Feb 27, 2006
FOR SUSPENSION; ORAL
ZEGERID
XX SANTARUS 20MG/PACKET;1.68GM/PACKET N021636 001 Jun 15, 2004
XX + 40MG/PACKET;1.68GM/PACKET N021636 002 Dec 21, 2004

ONDANSETRON
TABLET, ORALLY DISINTEGRATING; ORAL
ONDANSETRON
AB BARR 4MG A076693 001 Jun 25, 2007
AB 8MG A076693 002 Jun 25, 2007
AB GLENMARK GENERICS 4MG A078152 001 Jun 27, 2007
AB 8MG A078152 002 Jun 27, 2007
AB KALI LABS 4MG A076506 001 Dec 26, 2006
AB 8MG A076506 002 Dec 26, 2006
AB KV PHARM 4MG A077717 001 Jun 25, 2007
AB 8MG A077717 002 Jun 25, 2007
AB MYLAN 4MG A078139 001 Jun 25, 2007
AB 8MG A078139 002 Jun 25, 2007
AB SANDOZ 4MG A078050 001 Aug 13, 2007
AB 8MG A078050 002 Aug 13, 2007
AB SUN PHARM INDS 4MG A077557 001 Aug 02, 2007
AB 8MG A077557 002 Aug 02, 2007
AB TEVA 4MG A076810 001 Jun 25, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 296 (of 393)

ONDANSETRON
TABLET, ORALLY DISINTEGRATING; ORAL
ONDANSETRON
AB TEVA 8MG A076810 002 Jun 25, 2007
ZOFRAN ODT
AB GLAXOSMITHKLINE 4MG N020781 001 Jan 27, 1999
AB + 8MG N020781 002 Jan 27, 1999
ONDANSETRON
XX KALI LABS 16MG A077406 001 Dec 26, 2006
XX 24MG A077406 002 Dec 26, 2006

ONDANSETRON HYDROCHLORIDE
INJECTABLE; INJECTION
ONDANSETRON HYDROCHLORIDE
AP AKORN STRIDES EQ 2MG BASE/ML A078257 001 Apr 23, 2008
AP APOTEX EQ 2MG BASE/ML A077368 001 Dec 26, 2006
AP APP PHARMS EQ 2MG BASE/ML A076974 001 Dec 26, 2006
AP BAXTER HLTHCARE EQ 2MG BASE/ML A077365 001 Dec 26, 2006
AP BEDFORD EQ 2MG BASE/ML A076967 001 Dec 26, 2006
AP GLAND PHARMA LTD EQ 2MG BASE/ML A079224 001 Sep 25, 2009
AP HIKMA FARMACEUTICA EQ 2MG BASE/ML A076781 001 Dec 26, 2006
AP HOSPIRA EQ 2MG BASE/ML A077473 001 Dec 26, 2006
AP EQ 2MG BASE/ML A077840 001 Jan 19, 2007
AP LUITPOLD EQ 2MG BASE/ML A079039 001 Nov 18, 2008
AP PHARMAFORCE EQ 2MG BASE/ML A077582 001 Dec 26, 2006
AP PLIVA HRVATSKA DOO EQ 2MG BASE/ML A077544 001 Dec 26, 2006
AP SANDOZ EQ 2MG BASE/ML A077430 001 Jun 27, 2007
AP SPECTRUM PHARMS EQ 2MG BASE/ML A078180 001 Mar 26, 2007
AP SUN PHARM INDS (IN) EQ 2MG BASE/ML A077172 001 Dec 26, 2006
AP WOCKHARDT EQ 2MG BASE/ML A077577 001 Dec 26, 2006
ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
AP BEDFORD LABS EQ 0.64MG BASE/ML A078291 001 Apr 13, 2009
AP CLARIS LIFESCIENCES EQ 0.64MG BASE/ML A078308 001 Mar 17, 2008
AP HOSPIRA EQ 0.64MG BASE/ML A077348 001 Feb 01, 2007
AP TEVA PARENTERAL EQ 0.64MG BASE/ML A077480 001 Nov 22, 2006
ONDANSETRON HYDROCHLORIDE AND SODIUM CHLORIDE IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE EQ 0.64MG BASE/ML N021915 002 Dec 27, 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
AP AKORN STRIDES EQ 2MG BASE/ML A078244 001 Apr 23, 2008
AP APOTEX INC EQ 2MG BASE/ML A077343 001 Dec 26, 2006
AP APP PHARMS EQ 2MG BASE/ML A076972 001 Dec 26, 2006
AP BAXTER HLTHCARE EQ 2MG BASE/ML A077541 001 Dec 26, 2006
AP BEDFORD LABS EQ 2MG BASE/ML A077011 001 Dec 26, 2006
AP HIKMA FARMACEUTICA EQ 2MG BASE/ML A076780 001 Dec 26, 2006
AP HOSPIRA EQ 2MG BASE/ML A077548 001 Dec 26, 2006
AP LUITPOLD EQ 2MG BASE/ML A079032 001 Nov 18, 2008
AP PHARMAFORCE EQ 2MG BASE/ML A077387 001 Dec 26, 2006
AP SANDOZ EQ 2MG BASE/ML A077551 001 Jun 27, 2007
AP SUN PHARM INDS LTD EQ 2MG BASE/ML A077173 001 Dec 26, 2006
AP TARO PHARMS IRELAND EQ 2MG BASE/ML A078014 001 Mar 21, 2008
AP WOCKHARDT EQ 2MG BASE/ML A077716 001 Dec 26, 2006
ZOFRAN
AP + GLAXOSMITHKLINE EQ 2MG BASE/ML N020007 001 Jan 04, 1991
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER
AP + GLAXOSMITHKLINE EQ 0.64MG BASE/ML N020403 001 Jan 31, 1995
ZOFRAN PRESERVATIVE FREE
AP + GLAXOSMITHKLINE EQ 2MG BASE/ML N020007 003 Dec 10, 1993
SOLUTION; ORAL
ONDANSETRON HYDROCHLORIDE
AA APOTEX EQ 4MG BASE/5ML A078127 001 Jun 25, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 297 (of 393)

ONDANSETRON HYDROCHLORIDE
SOLUTION; ORAL
ONDANSETRON HYDROCHLORIDE
AA AUROBINDO PHARMA EQ 4MG BASE/5ML A078776 001 Nov 28, 2007
AA ROXANE EQ 4MG BASE/5ML A076960 001 Dec 26, 2006
AA TARO EQ 4MG BASE/5ML A077009 001 Nov 30, 2007
ZOFRAN
AA + GLAXOSMITHKLINE EQ 4MG BASE/5ML N020605 001 Jan 24, 1997
TABLET; ORAL
ONDANSETRON HYDROCHLORIDE
AB APOTEX EQ 4MG BASE A077306 001 Jun 25, 2007
AB EQ 8MG BASE A077306 002 Jun 25, 2007
AB AUROBINDO PHARMA EQ 4MG BASE A078539 001 Jul 31, 2007
AB EQ 8MG BASE A078539 002 Jul 31, 2007
AB EQ 24MG BASE A078539 003 Jul 31, 2007
AB DR REDDYS LABS LTD EQ 4MG BASE A076183 003 Dec 26, 2006
AB EQ 8MG BASE A076183 002 Dec 26, 2006
AB EQ 24MG BASE A076183 001 Dec 26, 2006
AB GLENMARK GENERICS EQ 4MG BASE A077535 001 Jun 25, 2007
AB EQ 8MG BASE A077535 002 Jun 25, 2007
AB EQ 24MG BASE A077535 003 Jun 25, 2007
AB KALI LABS EQ 4MG BASE A077303 001 Jun 25, 2007
AB EQ 8MG BASE A077303 002 Jun 25, 2007
AB EQ 24MG BASE A077303 004 Jun 25, 2007
AB MYLAN EQ 4MG BASE A076930 001 Jun 25, 2007
AB EQ 8MG BASE A076930 002 Jun 25, 2007
AB EQ 24MG BASE A076930 004 Jun 25, 2007
AB NATCO PHARMA LTD EQ 4MG BASE A077851 001 Jun 25, 2007
AB EQ 8MG BASE A077851 002 Jun 25, 2007
AB PLIVA HRVATSKA DOO EQ 4MG BASE A077112 001 Jun 25, 2007
AB EQ 8MG BASE A077112 002 Jun 25, 2007
AB EQ 24MG BASE A077112 003 Jun 25, 2007
AB SANDOZ EQ 4MG BASE A077517 001 Jun 25, 2007
AB EQ 8MG BASE A077517 002 Jun 25, 2007
AB EQ 24MG BASE A077517 003 Jun 25, 2007
AB SUN PHARM INDS (IN) EQ 4MG BASE A077050 001 Jun 25, 2007
AB EQ 8MG BASE A077050 002 Jun 25, 2007
AB TEVA EQ 4MG BASE A076252 001 Jun 25, 2007
AB EQ 8MG BASE A076252 002 Jun 25, 2007
AB EQ 24MG BASE A076252 003 Jun 25, 2007
AB WEST WARD EQ 4MG BASE A077545 001 Sep 06, 2007
AB EQ 8MG BASE A077545 002 Sep 06, 2007
AB EQ 24MG BASE A077545 003 Sep 06, 2007
ZOFRAN
AB GLAXOSMITHKLINE EQ 4MG BASE N020103 001 Dec 31, 1992
AB EQ 8MG BASE N020103 002 Dec 31, 1992
AB + EQ 24MG BASE N020103 003 Aug 27, 1999
ONDANSETRON HYDROCHLORIDE
XX DR REDDYS LABS LTD EQ 16MG BASE A076559 001 Dec 26, 2006

ORLISTAT
CAPSULE; ORAL

XENICAL

XX + HOFFMANN LA ROCHE 120MG N020766 001 Apr 23, 1999

ORPHENADRINE CITRATE
INJECTABLE; INJECTION
NORFLEX
AP + GRACEWAY 30MG/ML N013055 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 298 (of 393)

ORPHENADRINE CITRATE
INJECTABLE; INJECTION
ORPHENADRINE CITRATE
AP AKORN 30MG/ML A040484 001 May 24, 2006
AP BEDFORD LABS 30MG/ML A040463 001 Mar 04, 2003
AP WATSON LABS 30MG/ML A084779 001 Mar 15, 1982
AP 30MG/ML A087062 001
TABLET, EXTENDED RELEASE; ORAL
ORPHENADRINE CITRATE
AB ACTAVIS TOTOWA 100MG A040284 001 Jun 19, 1998
AB IMPAX PHARMS 100MG A040368 001 Jun 23, 2000
AB KIEL 100MG A040249 001 Jan 29, 1999
AB + SANDOZ 100MG A040327 001 Feb 15, 2000

OSELTAMIVIR PHOSPHATE
CAPSULE; ORAL
TAMIFLU
XX ROCHE EQ 30MG BASE N021087 003 Jul 02, 2007
XX EQ 45MG BASE N021087 002 Jul 02, 2007
XX + EQ 75MG BASE N021087 001 Oct 27, 1999
FOR SUSPENSION; ORAL

TAMIFLU

XX + ROCHE EQ 12MG BASE/ML N021246 001 Dec 14, 2000

OXACILLIN SODIUM
INJECTABLE; INJECTION
OXACILLIN SODIUM
AP + SANDOZ EQ 1GM BASE/VIAL A061490 003
AP EQ 1GM BASE/VIAL A062737 001 Dec 23, 1986
AP + EQ 2GM BASE/VIAL A061490 004
AP EQ 2GM BASE/VIAL A062737 002 Dec 23, 1986
AP + EQ 10GM BASE/VIAL A061490 006 May 09, 1991
BACTOCILL IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE EQ 20MG BASE/ML N050640 001 Oct 26, 1989
XX + EQ 40MG BASE/ML N050640 002 Oct 26, 1989

OXALIPLATIN
INJECTABLE; INJECTION
OXALIPLATIN
AP HOSPIRA INC 50MG/VIAL A078815 001 Sep 30, 2009
AP 100MG/VIAL A078815 002 Sep 30, 2009
INJECTABLE; IV (INFUSION)
ELOXATIN
AP + SANOFI AVENTIS US 50MG/10ML (5MG/ML) N021759 001 Jan 31, 2005
AP + 100MG/20ML (5MG/ML) N021759 002 Jan 31, 2005
OXALIPLATIN
AP EBEWE PHARMA 50MG/10ML (5MG/ML) A078812 001 Aug 07, 2009
AP 100MG/20ML (5MG/ML) A078812 002 Aug 07, 2009
AP FRESENIUS KABI ONCOL 50MG/VIAL A078810 001 Aug 07, 2009
AP 100MG/VIAL A078810 002 Aug 07, 2009
AP HOSPIRA WORLDWIDE 50MG/10ML (5MG/ML) A078813 001 Aug 07, 2009
AP 100MG/20ML (5MG/ML) A078813 002 Aug 07, 2009
AP SUN PHARM INDS LTD 50MG/VIAL A078818 001 Aug 07, 2009
AP 100MG/VIAL A078818 002 Aug 07, 2009
AP TEVA PARENTERAL 50MG/10ML (5MG/ML) N022160 001 Aug 07, 2009
AP 100MG/20ML (5MG/ML) N022160 002 Aug 07, 2009
ELOXATIN
XX + SANOFI AVENTIS US 200MG/40ML (5MG/ML) N021759 003 Nov 17, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 299 (of 393)

OXANDROLONE
TABLET; ORAL
OXANDRIN
AB SAVIENT PHARMS 2.5MG N013718 001
AB + 10MG N013718 002 Nov 05, 2001
OXANDROLONE
AB KALI LABS 2.5MG A077827 001 Jun 22, 2007
AB 10MG A077827 002 Jun 22, 2007
AB SANDOZ 2.5MG A076897 001 Dec 01, 2006
AB 10MG A076897 002 Dec 01, 2006
AB UPSHER SMITH 2.5MG A076761 001 Dec 01, 2006
AB 10MG A078033 001 Mar 22, 2007

OXAPROZIN
TABLET; ORAL
DAYPRO
AB + GD SEARLE 600MG N018841 004 Oct 29, 1992
OXAPROZIN
AB ACTAVIS ELIZABETH 600MG A075843 001 Oct 03, 2001
AB APOTEX INC 600MG A075987 001 Sep 02, 2004
AB CARACO 600MG A075844 001 Jan 03, 2002
AB DR REDDYS LABS LTD 600MG A075855 001 Jan 31, 2001
AB GENPHARM 600MG A075847 001 Feb 28, 2001
AB IVAX SUB TEVA PHARMS 600MG A075846 001 May 13, 2002
AB SANDOZ 600MG A075845 001 Jan 31, 2001
AB TEVA 600MG A075849 001 Jul 03, 2002
AB WATSON LABS 600MG A075848 001 Feb 09, 2001

OXAZEPAM
CAPSULE; ORAL
OXAZEPAM
AB ACTAVIS ELIZABETH 10MG A072251 001 Apr 14, 1988
AB 15MG A072252 001 Apr 14, 1988
AB 30MG A072253 001 Apr 14, 1988
AB IVAX SUB TEVA PHARMS 10MG A070943 001 Aug 03, 1987
AB 15MG A070944 001 Aug 03, 1987
AB + 30MG A070945 001 Aug 03, 1987
AB SANDOZ 10MG A071813 001 Apr 19, 1988
AB 15MG A071756 001 Apr 19, 1988
AB 30MG A071814 001 Apr 19, 1988
AB WATSON LABS 10MG A072952 001 Sep 28, 1990
AB 15MG A072953 001 Sep 28, 1990
AB 30MG A072954 001 Sep 28, 1990

OXCARBAZEPINE
SUSPENSION; ORAL
OXCARBAZEPINE
AB RANBAXY 300MG/5ML A078734 001 Jun 26, 2009
TRILEPTAL
AB + NOVARTIS 300MG/5ML N021285 001 May 25, 2001
TABLET; ORAL
OXCARBAZEPINE
AB APOTEX INC 150MG A077747 001 Apr 09, 2008
AB 300MG A077747 002 Apr 09, 2008
AB 600MG A077747 003 Apr 09, 2008
AB BRECKENRIDGE PHARM 150MG A078069 001 Jan 11, 2008
AB 300MG A078069 002 Jan 11, 2008
AB 600MG A078069 003 Jan 11, 2008
AB GLENMARK GENERICS 150MG A077802 001 Oct 09, 2007
AB 300MG A077802 002 Oct 09, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 300 (of 393)

OXCARBAZEPINE
TABLET; ORAL
OXCARBAZEPINE
AB GLENMARK GENERICS 600MG A077802 003 Oct 09, 2007
AB ROXANE 150MG A077795 001 Oct 09, 2007
AB 300MG A077795 002 Oct 09, 2007
AB 600MG A077795 003 Oct 09, 2007
AB SUN PHARM INDS 150MG A077794 001 Oct 09, 2007
AB 300MG A077794 002 Oct 09, 2007
AB 600MG A077794 003 Oct 09, 2007
AB TARO 150MG A077801 001 Nov 15, 2007
AB 300MG A077801 002 Nov 15, 2007
AB 600MG A077801 003 Nov 15, 2007
AB TEVA PHARMS 150MG A078005 001 Dec 11, 2007
AB 300MG A078005 002 Dec 11, 2007
AB 600MG A078005 003 Dec 11, 2007
TRILEPTAL
AB NOVARTIS 150MG N021014 001 Jan 14, 2000
AB 300MG N021014 002 Jan 14, 2000
AB + 600MG N021014 003 Jan 14, 2000

OXICONAZOLE NITRATE
CREAM; TOPICAL

OXISTAT

XX + ALTANA EQ 1% BASE N019828 001 Dec 30, 1988


LOTION; TOPICAL

OXISTAT

XX + ALTANA EQ 1% BASE N020209 001 Sep 30, 1992

OXTRIPHYLLINE
TABLET, EXTENDED RELEASE; ORAL

CHOLEDYL SA

XX + WARNER CHILCOTT 400MG A087863 001 May 24, 1983


XX + 600MG A086742 001

OXYBUTYNIN
FILM, EXTENDED RELEASE; TRANSDERMAL

OXYTROL

XX + WATSON LABS (UTAH) 3.9MG/24HR N021351 002 Feb 26, 2003

OXYBUTYNIN CHLORIDE
GEL; TRANSDERMAL

GELNIQUE

XX + WATSON LABS 10%(100MG/PACKET) N022204 001 Jan 27, 2009


SYRUP; ORAL
OXYBUTYNIN CHLORIDE
AA MIKART 5MG/5ML A075039 001 Jan 29, 1999
AA + MORTON GROVE 5MG/5ML A074868 001 Feb 12, 1997
AA NOVEX 5MG/5ML A074997 001 Oct 15, 1997
AA PHARM ASSOC 5MG/5ML A075137 001 Dec 18, 1998
AA SILARX 5MG/5ML A074520 001 Mar 29, 1996
AA VINTAGE PHARMS 5MG/5ML A076682 001 Dec 28, 2004
TABLET; ORAL
DITROPAN
AB + ORTHO MCNEIL JANSSEN 5MG N017577 001
OXYBUTYNIN CHLORIDE
AB PLIVA 5MG A071655 001 Nov 14, 1988
AB USL PHARMA 5MG A074625 001 Jul 31, 1996
AB VINTAGE PHARMS 5MG A075079 001 Oct 31, 1997
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 301 (of 393)

OXYBUTYNIN CHLORIDE
TABLET, EXTENDED RELEASE; ORAL
DITROPAN XL
AB ORTHO MCNEIL JANSSEN 5MG N020897 001 Dec 16, 1998
AB 10MG N020897 002 Dec 16, 1998
AB + 15MG N020897 003 Jun 22, 1999
OXYBUTYNIN CHLORIDE
AB IMPAX PHARMS 5MG A076745 002 May 09, 2007
AB 10MG A076745 003 May 09, 2007
AB 15MG A076745 001 Nov 09, 2006
AB MYLAN 5MG A076702 001 Nov 09, 2006
AB 10MG A076644 001 Nov 09, 2006
AB 15MG A078293 001 May 10, 2007
AB OSMOTICA PHARM 5MG A078503 001 Feb 04, 2009
AB 10MG A078503 002 Feb 04, 2009
AB 15MG A078503 003 Feb 04, 2009

OXYCODONE HYDROCHLORIDE
TABLET; ORAL
OXYCODONE HYDROCHLORIDE
AB ACTAVIS TOTOWA 15MG A076636 001 Feb 06, 2004
AB 30MG A076636 002 Feb 06, 2004
AB AVANTHI INC 5MG A091393 001 Aug 31, 2009
AB 10MG A091393 002 Aug 31, 2009
AB 15MG A091393 003 Aug 31, 2009
AB 20MG A091393 004 Aug 31, 2009
AB 30MG A091393 005 Aug 31, 2009
AB COREPHARMA 5MG A090895 001 Aug 24, 2009
AB 15MG A090895 002 Aug 24, 2009
AB 30MG A090895 003 Aug 24, 2009
AB KV PHARM 5MG A077290 001 Dec 08, 2005
AB 10MG A077290 002 Dec 08, 2005
AB 15MG A077290 003 Dec 08, 2005
AB 20MG A077290 004 Dec 08, 2005
AB 30MG A077290 005 Dec 08, 2005
AB MALLINCKRODT 15MG A076758 001 Jun 30, 2004
AB 30MG A076758 002 Jun 30, 2004
AB SUN PHARM INDS INC 5MG A090659 001 Apr 10, 2009
AB 15MG A090659 002 Apr 10, 2009
AB 30MG A090659 003 Apr 10, 2009
AB TYCO HLTHCARE 5MG A078206 001 Mar 19, 2007
AB VINTAGE PHARMS 5MG A077712 003 Mar 02, 2009
AB 15MG A077712 001 Jan 31, 2007
AB 30MG A077712 002 Jan 31, 2007
ROXICODONE
AB XANODYNE PHARMS 5MG N021011 003 May 15, 2009
AB + 15MG N021011 001 Aug 31, 2000
AB 30MG N021011 002 Aug 31, 2000
TABLET, EXTENDED RELEASE; ORAL
OXYCODONE HYDROCHLORIDE
AB MALLINCKRODT 10MG A077822 001 Jul 24, 2008
AB 20MG A077822 002 Jul 24, 2008
AB 40MG A077822 003 Jul 24, 2008
AB 80MG A077822 004 Jul 24, 2008
OXYCONTIN
AB PURDUE PHARMA LP 10MG N020553 001 Dec 12, 1995
AB 20MG N020553 002 Dec 12, 1995
AB + 40MG N020553 003 Dec 12, 1995
AB 80MG N020553 004 Jan 06, 1997
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 302 (of 393)

OXYCODONE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL
OXYCONTIN
XX PURDUE PHARMA LP 15MG N020553 006 Sep 18, 2006
XX 30MG N020553 007 Sep 18, 2006
XX 60MG N020553 008 Sep 18, 2006

OXYMETHOLONE
TABLET; ORAL

ANADROL-50

XX + ALAVEN PHARM 50MG N016848 001

OXYMORPHONE HYDROCHLORIDE
INJECTABLE; INJECTION

OPANA

XX + ENDO PHARMS 1MG/ML N011707 002


TABLET; ORAL
OPANA
XX ENDO PHARMS 5MG N021611 001 Jun 22, 2006
XX + 10MG N021611 002 Jun 22, 2006
TABLET, EXTENDED RELEASE; ORAL
OPANA ER
XX ENDO PHARMS 5MG N021610 001 Jun 22, 2006
XX 7.5MG N021610 005 Feb 29, 2008
XX 10MG N021610 002 Jun 22, 2006
XX 15MG N021610 006 Feb 29, 2008
XX 20MG N021610 003 Jun 22, 2006
XX 30MG N021610 007 Feb 29, 2008
XX + 40MG N021610 004 Jun 22, 2006

OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE


OINTMENT; OPHTHALMIC

TERRAMYCIN W/ POLYMYXIN B SULFATE


XX + PFIZER EQ 5MG BASE/GM;10,000 UNITS/GM A061015 001

OXYTOCIN
INJECTABLE; INJECTION
OXYTOCIN
AP + APP PHARMS 10USP UNITS/ML (10USP UNITS/ML) N018248 001
AP + 100USP UNITS/10ML (10USP UNITS/ML) N018248 002
AP + BAXTER HLTHCARE CORP 10USP UNITS/ML (10USP UNITS/ML) N018243 001
AP + 100USP UNITS/10ML (10USP UNITS/ML) N018243 002 Jan 10, 2007
AP TEVA PARENTERAL 10USP UNITS/ML (10USP UNITS/ML) A077453 001 Jan 24, 2008
AP 100USP UNITS/10ML (10USP UNITS/ML) A077453 002 Jan 24, 2008
PITOCIN
AP + JHP PHARMS 10USP UNITS/ML (10USP UNITS/ML) N018261 001
AP 100USP UNITS/10ML (10USP UNITS/ML) N018261 002 Jul 27, 2007
OXYTOCIN
XX + APP PHARMS 300USP UNITS/30ML (10USP UNITS/ML) N018248 003 Jul 27, 2007

PACLITAXEL
FOR SUSPENSION; IV (INFUSION)

ABRAXANE

XX + ABRAXIS BIOSCIENCE 100MG/VIAL N021660 001 Jan 07, 2005


INJECTABLE; INJECTION
PACLITAXEL
AP ACCORD HLTHCARE INC 6MG/ML A075436 001 Nov 12, 2004
AP ACTAVIS TOTOWA 6MG/ML A090130 001 Dec 09, 2009
AP BEDFORD 6MG/ML A075190 001 Jan 28, 2002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 303 (of 393)

PACLITAXEL
INJECTABLE; INJECTION
PACLITAXEL
AP EBEWE PHARMA 6MG/ML A078167 001 Dec 26, 2007
AP FRESENIUS KABI ONCOL 6MG/ML A077574 001 Nov 27, 2006
AP HOSPIRA 6MG/ML A076131 001 May 08, 2002
AP MYLAN 6MG/ML A075278 001 Jan 25, 2002
AP PLIVA LACHEMA 6MG/ML A077413 001 Mar 12, 2008
AP TEVA PARENTERAL 6MG/ML A075184 001 Jan 25, 2002
TAXOL
AP + BRISTOL MYERS SQUIBB 6MG/ML N020262 001 Dec 29, 1992

PALIPERIDONE
TABLET, EXTENDED RELEASE; ORAL
INVEGA
XX ORTHO MCNEIL JANSSEN 1.5MG N021999 006 Aug 26, 2008
XX 3MG N021999 001 Dec 19, 2006
XX + 6MG N021999 002 Dec 19, 2006
XX 9MG N021999 003 Dec 19, 2006

PALIPERIDONE PALMITATE
SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
INVEGA SUSTENNA
XX JOHNSON AND JOHNSON 39MG/0.25ML (39MG/0.25ML) N022264 001 Jul 31, 2009
XX 78MG/0.5ML (78MG/0.5ML) N022264 002 Jul 31, 2009
XX 117MG/0.75ML (117MG/0.75ML) N022264 003 Jul 31, 2009
XX 156MG/ML (156MG/ML) N022264 004 Jul 31, 2009
XX 234MG/1.5ML (156MG/ML) N022264 005 Jul 31, 2009

PALONOSETRON HYDROCHLORIDE
CAPSULE; ORAL

ALOXI

XX + HELSINN HLTHCARE EQ 0.5MG BASE N022233 001 Aug 22, 2008


INJECTABLE; INTRAVENOUS

ALOXI

XX + HELSINN HLTHCARE EQ 0.075MG BASE/1.5ML (EQ 0.05MG N021372 002 Feb 29, 2008
BASE/ML)
XX + EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) N021372 001 Jul 25, 2003

PAMIDRONATE DISODIUM
INJECTABLE; INJECTION
AREDIA
AP + NOVARTIS 30MG/VIAL N020036 001 Oct 31, 1991
AP + 90MG/VIAL N020036 004 May 06, 1993
PAMIDRONATE DISODIUM
AP AESGEN 30MG/VIAL A075594 001 May 06, 2002
AP 90MG/VIAL A075594 002 May 06, 2002
AP AKORN STRIDES 30MG/10ML (3MG/ML) A078520 001 Oct 31, 2008
AP 90MG/10ML (9MG/ML) A078520 002 Oct 31, 2008
AP APP PHARMS 30MG/VIAL A075773 001 May 06, 2002
AP 30MG/10ML (3MG/ML) A076207 001 May 17, 2002
AP 90MG/VIAL A075773 002 May 06, 2002
AP 90MG/10ML (9MG/ML) A076207 002 May 17, 2002
AP BEDFORD 30MG/VIAL A075290 001 Apr 30, 2001
AP + 30MG/10ML (3MG/ML) N021113 001 Mar 04, 2002
AP 90MG/VIAL A075290 003 Apr 30, 2001
AP + 90MG/10ML (9MG/ML) N021113 002 Mar 04, 2002
AP CIPLA LTD 30MG/VIAL A077433 001 Nov 26, 2008
AP 60MG/VIAL A077433 002 Nov 26, 2008
AP 90MG/VIAL A077433 003 Nov 26, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 304 (of 393)

PAMIDRONATE DISODIUM
INJECTABLE; INJECTION
PAMIDRONATE DISODIUM
AP GENERAMEDIX 30MG/VIAL A078300 001 Mar 10, 2009
AP 30MG/10ML (3MG/ML) A078373 001 Dec 23, 2008
AP 90MG/VIAL A078300 002 Mar 10, 2009
AP 90MG/10ML (9MG/ML) A078373 002 Dec 23, 2008
AP + HOSPIRA 30MG/10ML (3MG/ML) A075841 001 Jun 27, 2002
AP + 60MG/10ML (6MG/ML) A075841 002 Jun 27, 2002
AP + 90MG/10ML (9MG/ML) A075841 003 Jun 27, 2002
AP PHARMAFORCE 30MG/10ML (3MG/ML) A078942 001 Jul 25, 2008
AP 90MG/10ML (9MG/ML) A078942 002 Jul 25, 2008
AP PLIVA LACHEMA 30MG/10ML (3MG/ML) A078156 001 Aug 19, 2008
AP 60MG/10ML (6MG/ML) A078156 002 Aug 19, 2008
AP 90MG/10ML (9MG/ML) A078156 003 Aug 19, 2008
AP SUN PHARM INDS 30MG/VIAL A077703 001 Dec 24, 2008
AP 90MG/VIAL A077703 002 Dec 24, 2008
AP TEVA PARENTERAL 30MG/10ML (3MG/ML) A076153 001 Mar 27, 2002
AP 90MG/10ML (9MG/ML) A076153 002 Mar 27, 2002

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
CAPSULE, DELAYED RELEASE; ORAL
CREON
XX SOLVAY 30,000USP UNITS;6,000USP N020725 001 Apr 30, 2009
UNITS;19,000USP UNITS
XX 60,000USP UNITS;12,000USP N020725 002 Apr 30, 2009
UNITS;38,000USP UNITS
XX + 120,000USP UNITS;24,000USP N020725 003 Apr 30, 2009
UNITS;76,000USP UNITS
ZENPEP
XX EURAND 27,000USP UNITS;5,000USP N022210 001 Aug 27, 2009
UNITS;17,000USP UNITS
XX 55,000USP UNITS;10,000USP N022210 002 Aug 27, 2009
UNITS;34,000USP UNITS
XX 82,000USP UNITS;15,000USP N022210 003 Aug 27, 2009
UNITS;51,000USP UNITS
XX + 109,000USP UNITS;20,000USP N022210 004 Aug 27, 2009
UNITS;68,000USP UNITS

PANCURONIUM BROMIDE
INJECTABLE; INJECTION
PANCURONIUM BROMIDE
AP ELKINS SINN 1MG/ML A072058 001 Mar 23, 1988
AP 2MG/ML A072059 001 Mar 23, 1988
AP 2MG/ML A072060 001 Mar 23, 1988
AP HOSPIRA 1MG/ML A072320 001 Jan 19, 1989
AP + TEVA PARENTERAL 1MG/ML A072759 001 Jul 31, 1990
AP + 2MG/ML A072760 001 Jul 31, 1990

PANTOPRAZOLE SODIUM
FOR SUSPENSION, DELAYED RELEASE; ORAL

PROTONIX

XX + WYETH PHARMS INC EQ 40MG BASE N022020 001 Nov 14, 2007
INJECTABLE; IV (INFUSION)

PROTONIX IV

XX + WYETH PHARMS INC EQ 40MG BASE/VIAL N020988 001 Mar 22, 2001
TABLET, DELAYED RELEASE; ORAL
PANTOPRAZOLE SODIUM
AB KUDCO IRELAND EQ 20MG BASE A078281 001 Mar 17, 2009
AB EQ 40MG BASE A078281 002 Mar 17, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 305 (of 393)

PANTOPRAZOLE SODIUM
TABLET, DELAYED RELEASE; ORAL
PANTOPRAZOLE SODIUM
AB SUN PHARM INDS EQ 20MG BASE A077058 001 Sep 10, 2007
AB EQ 40MG BASE A077058 002 Sep 10, 2007
AB TEVA EQ 20MG BASE A077056 001 Aug 02, 2007
AB EQ 40MG BASE A077056 002 Aug 02, 2007
PROTONIX
AB WYETH PHARMS INC EQ 20MG BASE N020987 002 Jun 12, 2001
AB + EQ 40MG BASE N020987 001 Feb 02, 2000

PARICALCITOL
CAPSULE; ORAL
ZEMPLAR
XX ABBOTT 1MCG N021606 001 May 26, 2005
XX 2MCG N021606 002 May 26, 2005
XX + 4MCG N021606 003 May 26, 2005
INJECTABLE; INJECTION

ZEMPLAR

XX + ABBOTT 0.002MG/ML N020819 002 Feb 01, 2000


XX + 0.005MG/ML N020819 001 Apr 17, 1998

PAROMOMYCIN SULFATE
CAPSULE; ORAL
PAROMOMYCIN SULFATE
AA + CARACO EQ 250MG BASE A064171 001 Jun 30, 1997
AA HERITAGE PHARMS INC EQ 250MG BASE A065173 001 Dec 14, 2007

PAROXETINE HYDROCHLORIDE
SUSPENSION; ORAL
PAROXETINE HYDROCHLORIDE
AB APOTEX INC EQ 10MG BASE/5ML A077395 001 Dec 05, 2006
PAXIL
AB + GLAXOSMITHKLINE EQ 10MG BASE/5ML N020710 001 Jun 25, 1997
TABLET; ORAL
PAROXETINE HYDROCHLORIDE
AB ALPHAPHARM EQ 10MG BASE A075716 001 Mar 08, 2004
AB EQ 20MG BASE A075716 002 Mar 08, 2004
AB EQ 30MG BASE A075716 003 Mar 08, 2004
AB EQ 40MG BASE A075716 004 Mar 08, 2004
AB APOTEX EQ 10MG BASE A075356 001 Jul 30, 2003
AB EQ 20MG BASE A075356 002 Jul 30, 2003
AB EQ 30MG BASE A075356 003 Jul 30, 2003
AB EQ 40MG BASE A075356 004 Jul 30, 2003
AB AUROBINDO PHARMA EQ 10MG BASE A078406 001 Jul 25, 2007
AB EQ 20MG BASE A078406 002 Jul 25, 2007
AB EQ 30MG BASE A078406 003 Jul 25, 2007
AB EQ 40MG BASE A078406 004 Jul 25, 2007
AB CARACO EQ 10MG BASE A078194 001 Jun 29, 2007
AB EQ 20MG BASE A078194 002 Jun 29, 2007
AB EQ 30MG BASE A078194 003 Jun 29, 2007
AB EQ 40MG BASE A078194 004 Jun 29, 2007
AB MYLAN EQ 10MG BASE A078902 001 Mar 13, 2008
AB EQ 20MG BASE A078902 002 Mar 13, 2008
AB EQ 30MG BASE A078902 003 Mar 13, 2008
AB EQ 40MG BASE A078902 004 Mar 13, 2008
AB TEVA EQ 10MG BASE A076618 001 Aug 15, 2005
AB EQ 20MG BASE A076618 002 Aug 15, 2005
AB EQ 30MG BASE A076618 003 Aug 15, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 306 (of 393)

PAROXETINE HYDROCHLORIDE
TABLET; ORAL
PAROXETINE HYDROCHLORIDE
AB TEVA EQ 40MG BASE A076618 004 Aug 15, 2005
AB ZYDUS PHARMS USA EQ 10MG BASE A077584 001 Mar 07, 2007
AB EQ 20MG BASE A077584 002 Mar 07, 2007
AB EQ 30MG BASE A077584 003 Mar 07, 2007
AB EQ 40MG BASE A077584 004 Mar 07, 2007
PAXIL
AB GLAXOSMITHKLINE EQ 10MG BASE N020031 001 Dec 29, 1992
AB EQ 20MG BASE N020031 002 Dec 29, 1992
AB EQ 30MG BASE N020031 003 Dec 29, 1992
AB + EQ 40MG BASE N020031 005 Dec 29, 1992
TABLET, EXTENDED RELEASE; ORAL
PAROXETINE HYDROCHLORIDE
AB MYLAN EQ 12.5MG BASE A077873 001 Jun 29, 2007
AB EQ 25MG BASE A077873 002 Jun 29, 2007
PAXIL CR
AB GLAXOSMITHKLINE EQ 12.5MG BASE N020936 001 Feb 16, 1999
AB EQ 25MG BASE N020936 002 Feb 16, 1999
PAXIL CR
XX + GLAXOSMITHKLINE EQ 37.5MG BASE N020936 003 Dec 06, 2000

PAROXETINE MESYLATE
TABLET; ORAL
PEXEVA
XX NOVEN THERAP EQ 10MG BASE N021299 001 Jul 03, 2003
XX EQ 20MG BASE N021299 002 Jul 03, 2003
XX EQ 30MG BASE N021299 003 Jul 03, 2003
XX + EQ 40MG BASE N021299 004 Jul 03, 2003

PAZOPANIB HYDROCHLORIDE
TABLET; ORAL
VOTRIENT
XX GLAXOSMITHKLINE EQ 200MG BASE N022465 001 Oct 19, 2009
XX + EQ 400MG BASE N022465 002 Oct 19, 2009

PEGADEMASE BOVINE
INJECTABLE; INJECTION

ADAGEN

XX + ENZON PHARMS 250 UNITS/ML N019818 001 Mar 21, 1990

PEGAPTANIB SODIUM
INJECTABLE; INTRAVITREAL

MACUGEN

XX + EYETECH INC EQ 0.3MG ACID/0.09ML N021756 001 Dec 17, 2004

PEGVISOMANT
INJECTABLE; SUBCUTANEOUS

SOMAVERT

XX + PHARMACIA AND UPJOHN 10MG/VIAL N021106 001 Mar 25, 2003


XX + 15MG/VIAL N021106 002 Mar 25, 2003
XX + 20MG/VIAL N021106 003 Mar 25, 2003

PEMETREXED DISODIUM
INJECTABLE; IV (INFUSION)

ALIMTA

XX + LILLY EQ 100MG BASE/VIAL N021462 002 Sep 07, 2007


XX + EQ 500MG BASE/VIAL N021462 001 Feb 04, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 307 (of 393)

PEMIROLAST POTASSIUM
SOLUTION/DROPS; OPHTHALMIC

ALAMAST

XX + SANTEN 0.1% N021079 001 Sep 24, 1999

PENBUTOLOL SULFATE
TABLET; ORAL

LEVATOL

XX + SCHWARZ PHARMA 20MG N018976 004 Jan 05, 1989

PENCICLOVIR SODIUM
CREAM; TOPICAL

DENAVIR

XX + NOVARTIS 1% N020629 001 Sep 24, 1996

PENICILLAMINE
CAPSULE; ORAL

CUPRIMINE

XX + ATON 250MG N019853 001


TABLET; ORAL

DEPEN

XX + MEDA PHARMS 250MG N019854 001

PENICILLIN G BENZATHINE
INJECTABLE; INJECTION
BICILLIN L-A
BC + KING PHARMS 600,000 UNITS/ML N050141 001
PERMAPEN
BC PFIZER 600,000 UNITS/ML A060014 001
BICILLIN L-A
XX + KING PHARMS 300,000 UNITS/ML N050141 003

PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE


INJECTABLE; INJECTION

BICILLIN C-R

XX + KING PHARMS 150,000 UNITS/ML;150,000 UNITS/ML N050138 002


XX + 300,000 UNITS/ML;300,000 UNITS/ML N050138 001

BICILLIN C-R 900/300

XX + KING PHARMS 900,000 UNITS/2ML;300,000 UNITS/2ML N050138 003

PENICILLIN G POTASSIUM
INJECTABLE; INJECTION
PENICILLIN G POTASSIUM
AP APP PHARMS 5,000,000 UNITS/VIAL A065448 001 Aug 18, 2009
AP 20,000,000 UNITS/VIAL A065448 002 Aug 18, 2009
AP HANFORD GC 5,000,000 UNITS/VIAL A065149 002 Jul 23, 2009
AP 20,000,000 UNITS/VIAL A065149 003 Jul 23, 2009
AP SANDOZ 5,000,000 UNITS/VIAL A065079 002 Aug 30, 2002
AP 20,000,000 UNITS/VIAL A065079 003 Aug 30, 2002
PFIZERPEN
AP + PFIZER 5,000,000 UNITS/VIAL A060657 002
AP + 20,000,000 UNITS/VIAL A060657 003
PENICILLIN G POTASSIUM
XX HANFORD GC 1,000,000 UNITS/VIAL A065149 001 Jul 23, 2009
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE 20,000 UNITS/ML N050638 001 Jun 25, 1990
XX + 40,000 UNITS/ML N050638 002 Jun 25, 1990
XX + 60,000 UNITS/ML N050638 003 Jun 25, 1990
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 308 (of 393)

PENICILLIN G PROCAINE
INJECTABLE; INJECTION

PENICILLIN G PROCAINE

XX + KING PHARMS 300,000 UNITS/ML A060101 002


XX + 600,000 UNITS/ML A060101 001

PENICILLIN G SODIUM
INJECTABLE; IM-IV

PENICILLIN G SODIUM

XX + SANDOZ 5,000,000 UNITS/VIAL A065068 001 Feb 26, 2001

PENICILLIN V POTASSIUM
FOR SOLUTION; ORAL
PENICILLIN V POTASSIUM
AA DAVA PHARMS INC EQ 125MG BASE/5ML A062981 001 Feb 10, 1989
AA EQ 250MG BASE/5ML A062981 002 Feb 10, 1989
PENICILLIN-VK
AA TEVA EQ 125MG BASE/5ML A060456 001
AA + EQ 250MG BASE/5ML A060456 002
TABLET; ORAL
PENICILLIN V POTASSIUM
AB AUROBINDO PHARMA EQ 250MG BASE A065435 001 Apr 29, 2008
AB EQ 500MG BASE A065435 002 Apr 29, 2008
AB DAVA PHARMS INC EQ 250MG BASE A062936 001 Nov 25, 1988
AB EQ 500MG BASE A062935 001 Nov 23, 1988
AB SANDOZ EQ 250MG BASE A064071 001 Nov 30, 1995
AB + EQ 500MG BASE A064071 002 Nov 30, 1995
PENICILLIN-VK
AB TEVA EQ 250MG BASE A060711 002
AB EQ 500MG BASE A060711 003

PENTAMIDINE ISETHIONATE
FOR SOLUTION; INHALATION

NEBUPENT

XX + APP PHARMS 300MG/VIAL N019887 001 Jun 15, 1989


INJECTABLE; INJECTION
PENTAM
AP + APP PHARMS 300MG/VIAL N019264 001 Oct 16, 1984
PENTAMIDINE ISETHIONATE
AP WATSON LABS 300MG/VIAL A074303 001 Aug 17, 1995

PENTAZOCINE LACTATE
INJECTABLE; INJECTION

TALWIN

XX + HOSPIRA EQ 30MG BASE/ML N016194 001

PENTETATE CALCIUM TRISODIUM


SOLUTION; INHALATION, INTRAVENOUS

PENTETATE CALCIUM TRISODIUM


XX + HAMELN PHARMS EQ 1GM BASE/5ML (EQ 200MG BASE/ML) N021749 001 Aug 11, 2004

PENTETATE ZINC TRISODIUM


SOLUTION; INHALATION, INTRAVENOUS

PENTETATE ZINC TRISODIUM


XX + HAMELN PHARMS EQ 1GM BASE/5ML (EQ 200MG BASE/ML) N021751 001 Aug 11, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 309 (of 393)

PENTOBARBITAL SODIUM
INJECTABLE; INJECTION

NEMBUTAL SODIUM

XX + LUNDBECK INC 50MG/ML A083246 001

PENTOSAN POLYSULFATE SODIUM


CAPSULE; ORAL

ELMIRON

XX + ORTHO MCNEIL JANSSEN 100MG N020193 001 Sep 26, 1996

PENTOSTATIN
INJECTABLE; INJECTION
NIPENT
AP + HOSPIRA INC 10MG/VIAL N020122 001 Oct 11, 1991
PENTOSTATIN
AP BEDFORD LABS 10MG/VIAL A077841 001 Aug 07, 2007

PENTOXIFYLLINE
TABLET, EXTENDED RELEASE; ORAL
PENTOXIFYLLINE
AB APOTEX 400MG A075191 001 Jun 09, 1999
AB BIOVAIL 400MG A075028 001 Jul 20, 1998
AB IMPAX LABS 400MG A075093 001 Aug 10, 1999
AB MYLAN 400MG A074425 001 Jul 08, 1997
AB PLIVA 400MG A074874 001 May 25, 1999
AB WATSON LABS 400MG A075107 001 Sep 04, 1998
PENTOXIL
AB UPSHER SMITH 400MG A074962 001 Mar 31, 1999
TRENTAL
AB + SANOFI AVENTIS US 400MG N018631 001 Aug 30, 1984

PERFLUTREN
INJECTABLE; INTRAVENOUS

DEFINITY

XX + LANTHEUS MEDCL 6.52MG/ML N021064 001 Jul 31, 2001

PERINDOPRIL ERBUMINE
TABLET; ORAL
ACEON
AB SOLVAY PHARMS 2MG N020184 001 Dec 30, 1993
AB 4MG N020184 002 Dec 30, 1993
AB + 8MG N020184 003 Dec 30, 1993
PERINDOPRIL ERBUMINE
AB AUROBINDO PHARMA 2MG A079070 001 Nov 10, 2009
AB 4MG A079070 002 Nov 10, 2009
AB 8MG A079070 003 Nov 10, 2009
AB IVAX PHARMS 2MG A078138 001 Nov 10, 2009
AB 4MG A078138 002 Nov 10, 2009
AB 8MG A078138 003 Nov 10, 2009
AB ROXANE 2MG A090072 001 Nov 10, 2009
AB 4MG A090072 002 Nov 10, 2009
AB 8MG A090072 003 Nov 10, 2009

PERMETHRIN
CREAM; TOPICAL
ELIMITE
AB + ALLERGAN 5% N019855 001 Aug 25, 1989
PERMETHRIN
AB ACTAVIS MID ATLANTIC 5% A074806 001 Jan 23, 1998
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 310 (of 393)

PERMETHRIN
CREAM; TOPICAL
PERMETHRIN
AB PERRIGO NEW YORK 5% A076369 001 Apr 21, 2003

PERPHENAZINE
CONCENTRATE; ORAL

PERPHENAZINE

XX + PHARM ASSOC 16MG/5ML A040360 001 May 25, 2001


TABLET; ORAL
PERPHENAZINE
AB SANDOZ 2MG A089683 001 Dec 08, 1988
AB 4MG A089684 001 Dec 08, 1988
AB 8MG A089685 001 Dec 08, 1988
AB + 16MG A089686 001 Dec 08, 1988
AB VINTAGE PHARMS 2MG A040226 001 Dec 31, 1998
AB 4MG A040226 002 Dec 31, 1998
AB 8MG A040226 003 Dec 31, 1998
AB 16MG A040226 004 Dec 31, 1998

PHENDIMETRAZINE TARTRATE
CAPSULE, EXTENDED RELEASE; ORAL
BONTRIL
BC MALLINCKRODT 105MG A088021 001 Sep 21, 1982
PHENDIMETRAZINE TARTRATE
BC + SANDOZ 105MG N018074 001
TABLET; ORAL
BONTRIL PDM
AA + VALEANT 35MG A085272 001
PHENDIMETRAZINE TARTRATE
AA ACTAVIS TOTOWA 35MG A040762 001 Jan 28, 2008
AA MIKART 35MG A089452 001 Oct 30, 1991
AA SANDOZ 35MG A085588 001

PHENELZINE SULFATE
TABLET; ORAL

NARDIL

XX + PARKE DAVIS EQ 15MG BASE N011909 002

PHENOXYBENZAMINE HYDROCHLORIDE
CAPSULE; ORAL

DIBENZYLINE

XX + WELLSPRING PHARM 10MG N008708 001

PHENTERMINE HYDROCHLORIDE
CAPSULE; ORAL
ADIPEX-P
AA + TEVA 37.5MG A088023 001 Aug 02, 1983
PHENTERMINE HYDROCHLORIDE
AA ACTAVIS TOTOWA 15MG A040460 001 Jan 14, 2003
AA 30MG A040227 001 Jun 18, 1997
AA 30MG A040448 001 Jan 22, 2003
AA 37.5MG A040228 001 Jun 19, 1997
AA KVK TECH 15MG A040886 002 Mar 31, 2008
AA 30MG A040875 001 Mar 21, 2008
AA 30MG A040886 001 Mar 31, 2008
AA 37.5MG A040887 001 Apr 24, 2008
AA LANNETT 30MG A087022 001 Feb 03, 1983
AA MUTUAL PHARM 30MG A040525 001 Oct 23, 2003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 311 (of 393)

PHENTERMINE HYDROCHLORIDE
CAPSULE; ORAL
PHENTERMINE HYDROCHLORIDE
AA + SANDOZ 15MG A087190 002
AA + 30MG A086945 001 Jul 20, 1983
AA + 30MG A087190 001
TABLET; ORAL
ADIPEX-P
AA + TEVA 37.5MG A085128 001
PHENTERMINE HYDROCHLORIDE
AA ACTAVIS ELIZABETH 37.5MG A040276 001 Nov 25, 1998
AA ACTAVIS TOTOWA 37.5MG A040190 001 May 30, 1997
AA BARR 37.5MG A090470 001 Aug 31, 2009
AA CARACO 37.5MG A040790 001 Aug 21, 2007
AA KVK TECH 37.5MG A040876 001 Mar 31, 2008
AA LANNETT 37.5MG A040555 001 Apr 15, 2005
AA MUTUAL PHARM 37.5MG A040526 001 Oct 23, 2003
AA VINTAGE PHARMS 37.5MG A040377 001 Jan 04, 2002
PHENTERMINE HYDROCHLORIDE
XX + SANDOZ 30MG A088605 001 Sep 28, 1987

PHENTOLAMINE MESYLATE
INJECTABLE; INJECTION
PHENTOLAMINE MESYLATE
AP BEDFORD 5MG/VIAL A040235 001 Mar 11, 1998
REGITINE
AP + NOVARTIS 5MG/VIAL N008278 003
ORAVERSE
XX + NOVALAR 0.4MG/1.7ML N022159 001 May 09, 2008

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE


SYRUP; ORAL
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
AA VINTAGE 5MG/5ML;6.25MG/5ML A040654 001 Dec 07, 2006
PROMETH VC PLAIN
AA + ACTAVIS MID ATLANTIC 5MG/5ML;6.25MG/5ML A088761 001 Nov 08, 1984
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
AA AMNEAL PHARMS 5MG/5ML;6.25MG/5ML A040902 001 Aug 25, 2009

PHENYTOIN
SUSPENSION; ORAL
DILANTIN-125
AB + PARKE DAVIS 125MG/5ML N008762 001
PHENYTOIN
AB TARO 125MG/5ML A040521 001 Mar 08, 2004
AB VISTAPHARM 125MG/5ML A040342 001 Jan 31, 2001
AB 125MG/5ML A040610 001 Aug 18, 2005
AB WOCKHARDT 125MG/5ML A040420 001 Apr 19, 2002
TABLET, CHEWABLE; ORAL
DILANTIN
XX + PFIZER PHARMS 50MG A084427 001

PHENYTOIN SODIUM
CAPSULE; ORAL
DILANTIN
AB + PARKE DAVIS 30MG EXTENDED A084349 001
AB + 100MG EXTENDED A084349 002
EXTENDED PHENYTOIN SODIUM
AB AMNEAL PHARMS NY 100MG EXTENDED A040765 001 Nov 12, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 312 (of 393)

PHENYTOIN SODIUM
CAPSULE; ORAL
EXTENDED PHENYTOIN SODIUM
AB MYLAN 100MG EXTENDED A040298 001 Dec 28, 1998
AB SUN PHARM INDS 200MG EXTENDED A040731 001 Jun 30, 2008
AB 300MG EXTENDED A040731 002 Jun 30, 2008
AB SUN PHARM INDS (IN) 100MG EXTENDED A040621 001 Dec 11, 2006
AB TARO 100MG EXTENDED A040684 001 Sep 05, 2006
AB WOCKHARDT 30MG EXTENDED A040759 001 Dec 18, 2007
AB WOCKHARDT USA 100MG EXTENDED A040732 001 Jan 30, 2008
PHENYTEK
AB MYLAN 200MG EXTENDED A040298 002 Dec 06, 2001
AB + 300MG EXTENDED A040298 003 Dec 06, 2001
INJECTABLE; INJECTION
PHENYTOIN SODIUM
AP + BAXTER HLTHCARE 50MG/ML A084307 001
AP HIKMA FARMACEUTICA 50MG/ML A040573 001 Sep 13, 2006
AP HOSPIRA 50MG/ML A089521 001 Mar 17, 1987
AP 50MG/ML A089744 001 Dec 18, 1987
AP PHARMAFORCE 50MG/ML A040781 001 Dec 04, 2007

PHYTONADIONE
INJECTABLE; INJECTION
PHYTONADIONE
BP INTL MEDICATION 1MG/0.5ML A083722 001
VITAMIN K1
BP + HOSPIRA 1MG/0.5ML A087954 001 Jul 25, 1983
VITAMIN K1
XX + HOSPIRA 10MG/ML A087955 001 Jul 25, 1983
TABLET; ORAL

MEPHYTON

XX + ATON 5MG N010104 003

PILOCARPINE HYDROCHLORIDE
GEL; OPHTHALMIC

PILOPINE HS

XX + ALCON 4% N018796 001 Oct 01, 1984


TABLET; ORAL
PILOCARPINE HYDROCHLORIDE
AB COREPHARMA 5MG A076746 001 Nov 16, 2004
AB IMPAX LABS 5MG A077248 001 Mar 31, 2006
AB 7.5MG A077248 002 Mar 31, 2006
AB LANNETT 5MG A077220 001 Oct 14, 2005
AB 7.5MG A077220 002 May 06, 2009
AB ROXANE 5MG A076963 001 Dec 22, 2004
AB 7.5MG A076963 002 Feb 27, 2007
SALAGEN
AB EISAI INC 5MG N020237 001 Mar 22, 1994
AB + 7.5MG N020237 002 Apr 18, 2003

PIMECROLIMUS
CREAM; TOPICAL

ELIDEL

XX + NOVARTIS 1% N021302 001 Dec 13, 2001

PIMOZIDE
TABLET; ORAL
ORAP
XX TEVA 1MG N017473 003 Aug 27, 1997
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 313 (of 393)

PIMOZIDE
TABLET; ORAL

ORAP

XX + TEVA 2MG N017473 001 Jul 31, 1984

PINDOLOL
TABLET; ORAL
PINDOLOL
AB MYLAN 5MG A074019 001 Sep 03, 1992
AB + 10MG A074019 002 Sep 03, 1992
AB WATSON LABS 5MG A074437 001 Feb 27, 1995
AB 10MG A074437 002 Feb 27, 1995

PIOGLITAZONE HYDROCHLORIDE
TABLET; ORAL
ACTOS
XX TAKEDA PHARMS NA EQ 15MG BASE N021073 001 Jul 15, 1999
XX EQ 30MG BASE N021073 002 Jul 15, 1999
XX + EQ 45MG BASE N021073 003 Jul 15, 1999

PIPERACILLIN SODIUM
INJECTABLE; INJECTION

PIPERACILLIN

XX + ISTITUTO BIOCHIMICO EQ 2GM BASE/VIAL A065114 001 Nov 14, 2003


XX + EQ 3GM BASE/VIAL A065114 002 Nov 14, 2003
XX + EQ 4GM BASE/VIAL A065114 003 Nov 14, 2003
XX + EQ 40GM BASE/VIAL A065157 001 Jul 12, 2004

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM


INJECTABLE; INJECTION
PIPERACILLIN AND TAZOBACTAM
AP ORCHID HLTHCARE EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A065386 001 Sep 15, 2009
AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A065386 002 Sep 15, 2009
AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A065386 003 Sep 15, 2009
AP EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL A065446 001 Sep 15, 2009
ZOSYN
AP + WYETH PHARMS INC EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL N050684 001 Oct 22, 1993
AP + EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL N050684 002 Oct 22, 1993
AP + EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL N050684 003 Oct 22, 1993
AP + EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL N050684 004 Oct 22, 1993
ZOSYN IN PLASTIC CONTAINER
XX + WYETH PHARMS INC EQ 40MG BASE/ML;EQ 5MG BASE/ML N050750 001 Feb 24, 1998
XX + EQ 60MG BASE/ML;EQ 7.5MG BASE/ML N050750 002 Feb 24, 1998
XX + EQ 4GM BASE/100ML;EQ 500MG BASE/100ML N050750 003 Feb 24, 1998

PIRBUTEROL ACETATE
AEROSOL, METERED; INHALATION

MAXAIR

XX + GRACEWAY EQ 0.2MG BASE/INH N020014 001 Nov 30, 1992

PIROXICAM
CAPSULE; ORAL
FELDENE
AB PFIZER 10MG N018147 002 Apr 06, 1982
AB + 20MG N018147 003 Apr 06, 1982
PIROXICAM
AB MUTUAL PHARM 10MG A073535 001 Mar 12, 1993
AB MYLAN 10MG A074102 001 Jul 31, 1992
AB 20MG A074102 002 Jul 31, 1992
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 314 (of 393)

PIROXICAM
CAPSULE; ORAL
PIROXICAM
AB NOSTRUM LABS 10MG A074116 001 Jun 15, 1993
AB 20MG A074118 001 Jun 15, 1993
AB TEVA 10MG A074131 001 Dec 11, 1992
AB 20MG A074131 002 Dec 11, 1992
AB WATSON LABS 10MG A074287 001 May 16, 1996
AB 10MG A074460 001 Sep 29, 1995
AB 20MG A074287 002 May 16, 1996
AB 20MG A074460 002 Sep 29, 1995

PITAVASTATIN CALCIUM
TABLET; ORAL
LIVALO
XX KOWA EQ 1MG BASE N022363 001 Aug 03, 2009
XX EQ 2MG BASE N022363 002 Aug 03, 2009
XX + EQ 4MG BASE N022363 003 Aug 03, 2009

PLERIXAFOR
SOLUTION; SUBCUTANEOUS

MOZOBIL

XX + GENZYME 24MG/1.2ML (20MG/ML) N022311 001 Dec 15, 2008

PODOFILOX
GEL; TOPICAL

CONDYLOX

XX + WATSON PHARMS 0.5% N020529 001 Mar 13, 1997


SOLUTION; TOPICAL
CONDYLOX
AT + WATSON PHARMS 0.5% N019795 001 Dec 13, 1990
PODOFILOX
AT PADDOCK 0.5% A075600 001 Jan 29, 2002

POLYETHYLENE GLYCOL 3350


FOR SOLUTION; ORAL
GLYCOLAX
AA SCHWARZ PHARMA 17GM/SCOOPFUL A076652 001 Jul 02, 2004
POLYETHYLENE GLYCOL 3350
AA BRECKENRIDGE PHARM 17GM/SCOOPFUL A077736 001 May 26, 2006
AA NEXGEN PHARMA INC 17GM/SCOOPFUL A077706 001 Sep 27, 2006
AA PADDOCK 17GM/SCOOPFUL A077893 001 May 26, 2006

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE


FOR SOLUTION; ORAL
NULYTELY
AA + BRAINTREE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ N019797 001 Apr 22, 1991
BOT
NULYTELY-FLAVORED
AA + BRAINTREE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ N019797 002 Nov 18, 1994
BOT
PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE
AA NOVEL LABS INC 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ A090019 001 May 27, 2009
BOT
TRILYTE
AA SCHWARZ PHARMA 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ A076491 001 Feb 05, 2004
BOT
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 315 (of 393)

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE;


SODIUM SULFATE ANHYDROUS
FOR SOLUTION; ORAL
COLYTE
AA + ALAVEN PHARM 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53G N018983 010 Jan 31, 1989
M/BOT;21.5GM/BOT
AA + 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ N018983 007 Jun 12, 1987
BOT;22.72GM/BOT
COLYTE WITH FLAVOR PACKS
AA + ALAVEN PHARM 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ N018983 012 Oct 08, 1998
BOT;22.72GM/BOT
COLYTE-FLAVORED
AA + ALAVEN PHARM 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53G N018983 008 Nov 14, 1991
M/BOT;21.5GM/BOT
AA + 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ N018983 009 Nov 14, 1991
BOT;22.72GM/BOT
GOLYTELY
AA + BRAINTREE 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ N019011 001 Jul 13, 1984
BOT;22.74GM/BOT
PEG 3350 AND ELECTROLYTES
AA NOVEL LABS INC 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A090231 001 Jun 01, 2009
BOT;22.74GM/BOT
AA 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ A090186 001 Jun 01, 2009
BOT;22.72GM/BOT
GOLYTELY
XX + BRAINTREE 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC N019011 002 Jun 02, 1992
KET;5.53GM/PACKET;21.5GM/PACKET

POLYMYXIN B SULFATE
INJECTABLE; INJECTION
POLYMYXIN B SULFATE
AP APP PHARMS EQ 500,000 U BASE/VIAL A065372 001 Jan 10, 2008
AP + BEDFORD EQ 500,000 U BASE/VIAL A060716 001
AP X GEN PHARMS EQ 500,000 U BASE/VIAL A063000 001 Sep 30, 1994
POWDER; FOR RX COMPOUNDING

POLY-RX

XX + X GEN PHARMS 100,000,000 UNITS/BOT A061578 001

POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE


SOLUTION/DROPS; OPHTHALMIC
POLYTRIM
AT + ALLERGAN 10,000 UNITS/ML;EQ 1MG BASE/ML N050567 001 Oct 20, 1988
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
AT BAUSCH AND LOMB 10,000 UNITS/ML;EQ 1MG BASE/ML A064120 001 Feb 14, 1997
AT FALCON PHARMS 10,000 UNITS/ML;EQ 1MG BASE/ML A064211 001 Apr 13, 1998
AT TAYLOR PHARMA 10,000 UNITS/ML;EQ 1MG BASE/ML A065006 001 Dec 17, 1998

PORACTANT ALFA
SUSPENSION; INTRATRACHEAL

CUROSURF

XX + CORNERSTONE THERAP 80MG/ML N020744 001 Nov 18, 1999

PORFIMER SODIUM
INJECTABLE; INJECTION

PHOTOFRIN

XX + AXCAN 75MG/VIAL N020451 001 Dec 27, 1995

POSACONAZOLE
SUSPENSION; ORAL

NOXAFIL

XX + SCHERING 40MG/ML N022003 001 Sep 15, 2006


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 316 (of 393)

POTASSIUM ACETATE
INJECTABLE; INJECTION

POTASSIUM ACETATE IN PLASTIC CONTAINER


XX + HOSPIRA 2MEQ/ML N018896 001 Jul 20, 1984

POTASSIUM CHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
POTASSIUM CHLORIDE
XX WATSON LABS FLORIDA 8MEQ A077419 001 Jun 02, 2008
XX + 10MEQ A077419 002 Jun 02, 2008
INJECTABLE; INJECTION
POTASSIUM CHLORIDE
AP APP PHARMS 2MEQ/ML A080225 001
AP B BRAUN 2MEQ/ML A085870 001
AP BAXTER HLTHCARE 2MEQ/ML A085499 001
AP + HOSPIRA 2MEQ/ML A080205 001
AP INTL MEDICATION 2MEQ/ML A083163 001
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 14.9MG/ML N019904 001 Dec 26, 1989
AP + 746MG/100ML N019904 005 Dec 17, 1990
AP HOSPIRA 14.9MG/ML N020161 005 Nov 30, 1992
AP 745MG/100ML N020161 001 Nov 30, 1992
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 29.8MG/ML N019904 002 Dec 26, 1989
AP + 1.49GM/100ML N019904 006 Dec 17, 1990
AP + HOSPIRA 29.8MG/ML N020161 006 Aug 11, 1998
AP 1.49GM/100ML N020161 002 Nov 30, 1992
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 2.24GM/100ML N019904 003 Dec 26, 1989
AP + HOSPIRA 2.24GM/100ML N020161 003 Aug 11, 1998
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 2.98GM/100ML N019904 004 Dec 26, 1989
AP + HOSPIRA 2.98GM/100ML N020161 004 Aug 11, 1998
POTASSIUM CHLORIDE IN PLASTIC CONTAINER
AP APP PHARMS 2MEQ/ML A088901 001 Jan 25, 1985
AP 2MEQ/ML A088908 001 Jan 25, 1985
POTASSIUM CHLORIDE
XX + APP PHARMS 3MEQ/ML A080225 003
TABLET, EXTENDED RELEASE; ORAL
KLOR-CON M10
AB UPSHER SMITH 10MEQ A074726 002 Aug 09, 2000
KLOR-CON M20
AB UPSHER SMITH 20MEQ A074726 001 Nov 20, 1998
POTASSIUM CHLORIDE
AB EURAND 20MEQ A076368 001 Aug 18, 2004
AB KV PHARM 20MEQ A076044 001 Apr 05, 2002
AB SCHERING 10MEQ N019439 002 Jun 13, 1986
AB + 20MEQ N019439 001 Jun 13, 1986
AB WATSON LABS FLORIDA 10MEQ A075604 001 Apr 10, 2002
AB 20MEQ A075604 002 Apr 10, 2002
K+10
BC FUTURE PAK 10MEQ A070999 001 Oct 22, 1987
KAON CL-10
BC SAVAGE LABS 10MEQ N017046 002
KLOR-CON
BC UPSHER SMITH 10MEQ N019123 002 Apr 17, 1986
KLOTRIX
BC APOTHECON 10MEQ N017850 001
K-TAB
BC ABBOTT 10MEQ N018279 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 317 (of 393)

POTASSIUM CHLORIDE
TABLET, EXTENDED RELEASE; ORAL
POTASSIUM CHLORIDE
BC ABBOTT 8MEQ N018279 002 Aug 01, 1988
KLOR-CON
XX + UPSHER SMITH 8MEQ N019123 001 Apr 17, 1986
KLOR-CON M15
XX UPSHER SMITH 15MEQ A074726 003 Jun 06, 2003

POTASSIUM CHLORIDE; SODIUM CHLORIDE


INJECTABLE; INJECTION
POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP HOSPIRA 149MG/100ML;450MG/100ML A078446 001 Sep 10, 2008
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 150MG/100ML;450MG/100ML N017648 005 Nov 26, 2002
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 150MG/100ML;900MG/100ML N019708 004 Sep 29, 1989
AP BAXTER HLTHCARE 150MG/100ML;900MG/100ML N017648 001
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 300MG/100ML;900MG/100ML N017648 002
POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP HOSPIRA 149MG/100ML;900MG/100ML N019686 001 Oct 17, 1988
POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP HOSPIRA 298MG/100ML;900MG/100ML N019686 002 Oct 17, 1988
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%
XX BAXTER HLTHCARE 224MG/100ML;900MG/100ML N017648 003

POTASSIUM CITRATE
TABLET, EXTENDED RELEASE; ORAL
POTASSIUM CITRATE
AB COREPHARMA 5MEQ A077440 001 Jun 09, 2006
AB 10MEQ A077440 002 Jun 09, 2006
UROCIT-K
AB MISSION PHARMA 5MEQ N019071 001 Aug 30, 1985
AB + 10MEQ N019071 002 Aug 31, 1992

POVIDONE-IODINE
SOLUTION/DROPS; OPHTHALMIC

BETADINE

XX + ALCON 5% N018634 001 Dec 17, 1986

PRALATREXATE
SOLUTION; INTRAVENOUS
FOLOTYN
XX ALLOS 20MG/ML (20MG/ML) N022468 001 Sep 24, 2009
XX + 40MG/2ML (20MG/ML) N022468 002 Sep 24, 2009

PRALIDOXIME CHLORIDE
INJECTABLE; INJECTION

PRALIDOXIME CHLORIDE

XX + MERIDIAN MEDCL TECHN 300MG/ML N018986 001 Apr 26, 1983


PROTOPAM CHLORIDE
XX + BAXTER HLTHCARE CORP 1GM/VIAL N014134 001

PRAMIPEXOLE DIHYDROCHLORIDE
TABLET; ORAL
MIRAPEX
AB BOEHRINGER INGELHEIM 0.125MG N020667 001 Jul 01, 1997
AB + 0.25MG N020667 002 Jul 01, 1997
AB 0.5MG N020667 006 Feb 12, 1998
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 318 (of 393)

PRAMIPEXOLE DIHYDROCHLORIDE
TABLET; ORAL
MIRAPEX
AB BOEHRINGER INGELHEIM 1MG N020667 003 Jul 01, 1997
AB 1.5MG N020667 005 Jul 01, 1997
PRAMIPEXOLE DIHYDROCHLORIDE
AB BARR 0.125MG A077724 001 Feb 19, 2008
AB 0.25MG A077724 002 Feb 19, 2008
AB 0.5MG A077724 003 Feb 19, 2008
AB 1MG A077724 004 Feb 19, 2008
AB 1.5MG A077724 005 Feb 19, 2008
MIRAPEX
XX BOEHRINGER INGELHEIM 0.75MG N020667 007 Jul 30, 2007

PRAMLINTIDE ACETATE
INJECTABLE; SUBCUTANEOUS
SYMLIN
XX AMYLIN EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML) N021332 002 Sep 25, 2007
XX EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML) N021332 003 Sep 25, 2007
XX + EQ 3MG BASE/5ML (EQ 600MCG BASE/ML) N021332 001 Mar 16, 2005

PRASUGREL HYDROCHLORIDE
TABLET; ORAL
EFFIENT
XX ELI LILLY AND CO EQ 5MG BASE N022307 001 Jul 10, 2009
XX + EQ 10MG BASE N022307 002 Jul 10, 2009

PRAVASTATIN SODIUM
TABLET; ORAL
PRAVACHOL
AB BRISTOL MYERS SQUIBB 10MG N019898 002 Oct 31, 1991
AB 20MG N019898 003 Oct 31, 1991
AB 40MG N019898 004 Mar 22, 1993
AB + 80MG N019898 008 Dec 18, 2001
PRAVASTATIN SODIUM
AB APOTEX 10MG A076341 001 Oct 23, 2006
AB 20MG A076341 002 Oct 23, 2006
AB 40MG A076341 003 Oct 23, 2006
AB 80MG A076341 004 Dec 28, 2007
AB COBALT LABS INC 10MG A076939 004 Oct 23, 2006
AB 20MG A076939 003 Oct 23, 2006
AB 40MG A076939 002 Oct 23, 2006
AB 80MG A076939 001 Dec 28, 2007
AB DR REDDYS LABS INC 10MG A076714 001 Oct 23, 2006
AB 20MG A076714 002 Oct 23, 2006
AB 40MG A076714 003 Oct 23, 2006
AB 80MG A076714 004 Dec 28, 2007
AB GLENMARK GENERICS 10MG A077987 001 May 11, 2007
AB 20MG A077987 002 May 11, 2007
AB 40MG A077987 003 May 11, 2007
AB 80MG A077987 004 Dec 28, 2007
AB LEK PHARMS DD 10MG A076397 003 Oct 23, 2006
AB 20MG A076397 002 Oct 23, 2006
AB 40MG A076397 001 Oct 23, 2006
AB 80MG A077491 001 Feb 11, 2008
AB LUPIN PHARMS 10MG A077917 001 Jan 08, 2008
AB 20MG A077917 002 Jan 08, 2008
AB 40MG A077917 003 Jan 08, 2008
AB 80MG A077917 004 Jan 08, 2008
AB MYLAN 10MG A077013 001 Oct 23, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 319 (of 393)

PRAVASTATIN SODIUM
TABLET; ORAL
PRAVASTATIN SODIUM
AB MYLAN 20MG A077013 002 Oct 23, 2006
AB 40MG A077013 003 Oct 23, 2006
AB 80MG A077013 004 Dec 28, 2007
AB PLIVA HRVATSKA DOO 10MG A077730 001 Nov 21, 2006
AB 20MG A077730 002 Nov 21, 2006
AB 40MG A077730 005 Nov 21, 2006
AB RANBAXY 10MG A076445 001 Apr 23, 2007
AB 20MG A076445 002 Apr 23, 2007
AB 40MG A076445 003 Apr 23, 2007
AB 80MG A076445 004 Apr 23, 2007
AB TEVA 10MG A076056 001 Apr 24, 2006
AB 20MG A076056 002 Apr 24, 2006
AB 40MG A076056 003 Apr 24, 2006
AB TEVA PHARMS 80MG A077793 001 Jan 15, 2008
AB WATSON LABS 10MG A077904 001 Oct 23, 2006
AB 20MG A077904 002 Oct 23, 2006
AB 40MG A077904 003 Oct 23, 2006
AB ZYDUS PHARMS USA 10MG A077751 001 Apr 30, 2008
AB 20MG A077751 002 Apr 30, 2008
AB 40MG A077751 003 Apr 30, 2008
AB 80MG A077751 004 Apr 30, 2008
PRAVASTATIN SODIUM
XX PLIVA HRVATSKA DOO 30MG A077730 003 Nov 21, 2006

PRAZIQUANTEL
TABLET; ORAL

BILTRICIDE

XX + BAYER HLTHCARE 600MG N018714 001 Dec 29, 1982

PRAZOSIN HYDROCHLORIDE
CAPSULE; ORAL
MINIPRESS
AB PFIZER EQ 1MG BASE N017442 002
AB + EQ 2MG BASE N017442 003
AB EQ 5MG BASE N017442 001
PRAZOSIN HYDROCHLORIDE
AB IVAX SUB TEVA PHARMS EQ 1MG BASE A071994 001 Sep 12, 1988
AB EQ 2MG BASE A071995 001 Sep 12, 1988
AB EQ 5MG BASE A071745 001 Sep 12, 1988
AB MYLAN EQ 1MG BASE A072575 003 May 16, 1989
AB EQ 2MG BASE A072575 002 May 16, 1989
AB EQ 5MG BASE A072575 001 May 16, 1989
AB WATSON LABS EQ 1MG BASE A072352 001 May 16, 1989
AB EQ 2MG BASE A072333 001 May 16, 1989

PREDNICARBATE
CREAM; TOPICAL
DERMATOP E EMOLLIENT
AB + SANOFI AVENTIS US 0.1% N020279 001 Oct 29, 1993
PREDNICARBATE
AB ALTANA 0.1% A077287 001 Sep 19, 2006
OINTMENT; TOPICAL
DERMATOP
AB + SANOFI AVENTIS US 0.1% N019568 001 Sep 23, 1991
PREDNICARBATE
AB ALTANA 0.1% A077236 001 Mar 09, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 320 (of 393)

PREDNISOLONE
SYRUP; ORAL
PREDNISOLONE
AA ALPHARMA 15MG/5ML A040323 001 May 13, 1999
AA APOTEX INC 5MG/5ML A040570 001 Aug 25, 2005
AA 15MG/5ML A040571 001 Aug 25, 2005
AA HI TECH PHARMA 15MG/5ML A040401 001 Feb 27, 2003
AA IVAX SUB TEVA PHARMS 15MG/5ML A040287 001 May 28, 1999
AA + KV PHARM 5MG/5ML A040423 001 Oct 22, 2001
AA + 15MG/5ML A040364 001 Apr 10, 2002
AA MORTON GROVE 15MG/5ML A040313 001 Sep 10, 2003
AA PHARM ASSOC 15MG/5ML A040399 001 Mar 05, 2003
AA VINTAGE 15MG/5ML A040775 001 Sep 21, 2007
PRELONE
AA TEVA 15MG/5ML A089081 001 Feb 04, 1986
TABLET; ORAL

PREDNISOLONE

XX + WATSON LABS 5MG A080354 001

PREDNISOLONE ACETATE
SUSPENSION; ORAL

FLO-PRED

XX + TARO EQ 15MG BASE/5ML N022067 002 Jan 17, 2008


SUSPENSION/DROPS; OPHTHALMIC
OMNIPRED
AB ALCON 1% N017469 001
PRED FORTE
AB + ALLERGAN 1% N017011 001
PRED MILD
XX + ALLERGAN 0.12% N017100 001

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM


OINTMENT; OPHTHALMIC

BLEPHAMIDE S.O.P.

XX + ALLERGAN 0.2%;10% A087748 001 Dec 03, 1986


SUSPENSION; OPHTHALMIC

BLEPHAMIDE

XX + ALLERGAN 0.2%;10% N012813 002

PREDNISOLONE SODIUM PHOSPHATE


SOLUTION; ORAL
ORAPRED
AA + SCIELE PHARMA INC EQ 15MG BASE/5ML A075117 001 Dec 14, 2000
PEDIAPRED
AA + UCB INC EQ 5MG BASE/5ML N019157 001 May 28, 1986
PREDNISOLONE SODIUM PHOSPHATE
AA AMNEAL PHARMS EQ 15MG BASE/5ML A078345 001 Mar 10, 2009
AA HI TECH PHARMA EQ 5MG BASE/5ML A075183 001 Mar 26, 2003
AA KV PHARM EQ 5MG BASE/5ML A076982 001 May 24, 2005
AA EQ 15MG BASE/5ML A076988 001 May 24, 2005
AA MORTON GROVE EQ 5MG BASE/5ML A075099 001 Jun 28, 2002
AA EQ 15MG BASE/5ML A076895 001 Oct 04, 2004
AA PADDOCK EQ 5MG BASE/5ML A075988 001 May 25, 2004
AA PHARM ASSOC EQ 5MG BASE/5ML A076123 001 Dec 23, 2002
AA EQ 15MG BASE/5ML A076913 001 Apr 25, 2005
AA VINTAGE EQ 5MG BASE/5ML A078416 001 Oct 31, 2007
AA EQ 15MG BASE/5ML A079010 001 May 26, 2009
AA WE PHARMS EQ 15MG BASE/5ML A075250 001 Jul 12, 2002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 321 (of 393)

PREDNISOLONE SODIUM PHOSPHATE


SOLUTION; ORAL

PREDNISOLONE SODIUM PHOSPHATE


XX + PHARM ASSOC EQ 10MG BASE/5ML A078465 001 Mar 07, 2008


XX + EQ 20MG BASE/5ML A078988 001 Jun 09, 2008
SOLUTION/DROPS; OPHTHALMIC

PREDNISOLONE SODIUM PHOSPHATE

XX + BAUSCH AND LOMB EQ 0.9% PHOSPHATE A040070 001 Jul 29, 1994
TABLET, ORALLY DISINTEGRATING; ORAL
ORAPRED ODT
XX SCIELE PHARMA INC EQ 10MG BASE N021959 001 Jun 01, 2006
XX EQ 15MG BASE N021959 002 Jun 01, 2006
XX + EQ 30MG BASE N021959 003 Jun 01, 2006

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM


SOLUTION/DROPS; OPHTHALMIC
SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE
AT ALCON EQ 0.23% PHOSPHATE;10% A073630 001 May 27, 1993
AT BAUSCH AND LOMB EQ 0.23% PHOSPHATE;10% A074449 001 Dec 29, 1995
VASOCIDIN
AT + NOVARTIS EQ 0.23% PHOSPHATE;10% N018988 001 Aug 26, 1988

PREDNISONE
SOLUTION; ORAL

PREDNISONE

XX + ROXANE 5MG/5ML A088703 001 Nov 08, 1984


PREDNISONE INTENSOL
XX + ROXANE 5MG/ML A088810 001 Feb 20, 1985
TABLET; ORAL
PREDNISONE
AB CADISTA PHARMS 1MG A040611 001 Jun 06, 2005
AB 5MG A040362 002 Aug 29, 2001
AB 10MG A040362 001 Aug 29, 2001
AB 20MG A040362 003 Jun 29, 2005
AB LEINER 5MG A080209 001
AB MUTUAL PHARM 5MG A089245 001 Dec 04, 1985
AB 10MG A089246 001 Dec 04, 1985
AB 20MG A089247 001 Dec 04, 1985
AB + ROXANE 1MG A087800 001 Apr 22, 1982
AB + 2.5MG A087801 001 Apr 22, 1982
AB + 5MG A080352 001
AB + 10MG A084122 001
AB + 20MG A087342 001
AB + 50MG A084283 001
AB VINTAGE PHARMS 1MG A040584 001 Dec 21, 2004
AB 2.5MG A040581 001 Dec 21, 2004
AB 5MG A040256 001 Jul 12, 2002
AB 10MG A040256 002 Jul 12, 2002
AB 20MG A040392 001 Feb 12, 2003
AB WATSON LABS 5MG A080356 001
AB 10MG A085162 001
AB 20MG A085161 001
AB WEST WARD 2.5MG A040538 001 Jan 08, 2004
AB 5MG A080292 001
AB 10MG A088832 001 Dec 04, 1985
AB 20MG A083677 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 322 (of 393)

PREGABALIN
CAPSULE; ORAL
LYRICA
XX CP PHARMS 25MG N021446 001 Dec 30, 2004
XX 50MG N021446 002 Dec 30, 2004
XX 75MG N021446 003 Dec 30, 2004
XX 100MG N021446 004 Dec 30, 2004
XX 150MG N021446 005 Dec 30, 2004
XX 200MG N021446 006 Dec 30, 2004
XX 225MG N021446 007 Dec 30, 2004
XX + 300MG N021446 008 Dec 30, 2004

PRILOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION

CITANEST PLAIN DENTAL


XX + DENTSPLY PHARM 4% N021382 001

PRIMAQUINE PHOSPHATE
TABLET; ORAL

PRIMAQUINE

XX + SANOFI AVENTIS US EQ 15MG BASE N008316 001

PRIMIDONE
TABLET; ORAL
MYSOLINE
AB + VALEANT 50MG N009170 003
AB 250MG N009170 002
PRIMIDONE
AB AMNEAL PHARM 50MG A040866 001 Apr 23, 2008
AB 250MG A040866 002 Apr 23, 2008
AB DR REDDYS LABS LTD 50MG A040862 001 Oct 03, 2008
AB 250MG A040862 002 Oct 03, 2008
AB IMPAX LABS 50MG A040717 001 Feb 12, 2008
AB 250MG A040717 002 Feb 12, 2008
AB LANNETT 50MG A084903 002 May 24, 2001
AB 250MG A084903 001
AB MUTUAL PHARM 50MG A040626 001 Sep 29, 2005
AB 250MG A040626 002 Sep 29, 2005
AB VINTAGE PHARMS 50MG A040586 001 Feb 24, 2005
AB 250MG A040586 002 Feb 24, 2005
AB WATSON LABS 250MG A083551 001
AB WEST WARD 50MG A040667 001 Jul 27, 2006
AB 250MG A040667 002 Jul 27, 2006

PROBENECID
TABLET; ORAL
PROBALAN
AB LANNETT 500MG A080966 001
PROBENECID
AB IVAX SUB TEVA PHARMS 500MG A083740 001 May 09, 1984
AB + MYLAN 500MG A084211 002
AB WATSON LABS 500MG A084442 004 Mar 29, 1983

PROCAINAMIDE HYDROCHLORIDE
INJECTABLE; INJECTION
PROCAINAMIDE HYDROCHLORIDE
AP + HOSPIRA 100MG/ML A089069 001 Feb 12, 1986
AP + 500MG/ML A089070 001 Feb 12, 1986
AP INTL MEDICATION 100MG/ML A088636 001 Jul 31, 1984
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 323 (of 393)

PROCAINAMIDE HYDROCHLORIDE
INJECTABLE; INJECTION
PROCAINAMIDE HYDROCHLORIDE
AP INTL MEDICATION 500MG/ML A088637 001 Jul 31, 1984

PROCAINE HYDROCHLORIDE
INJECTABLE; INJECTION

PROCAINE HYDROCHLORIDE

XX + WATSON LABS 1% A080658 001

PROCARBAZINE HYDROCHLORIDE
CAPSULE; ORAL

MATULANE

XX + SIGMA TAU EQ 50MG BASE N016785 001

PROCHLORPERAZINE
SUPPOSITORY; RECTAL
COMPRO
AB PADDOCK 25MG A040246 001 Jun 28, 2000
PROCHLORPERAZINE
AB + G AND W LABS 25MG A040058 001 Nov 24, 1993

PROCHLORPERAZINE EDISYLATE
INJECTABLE; INJECTION
PROCHLORPERAZINE EDISYLATE
AP + BAXTER HLTHCARE EQ 5MG BASE/ML A089903 001 Aug 29, 1989
AP BEDFORD EQ 5MG BASE/ML A040540 001 May 28, 2004

PROCHLORPERAZINE MALEATE
TABLET; ORAL
PROCHLORPERAZINE MALEATE
AB CADISTA PHARMS EQ 5MG BASE A040268 001 Feb 27, 1998
AB EQ 10MG BASE A040268 002 Feb 27, 1998
AB DURAMED PHARMS BARR EQ 5MG BASE A040207 001 May 01, 1997
AB EQ 10MG BASE A040207 002 May 01, 1997
AB MYLAN EQ 5MG BASE A040185 002 Oct 28, 1996
AB EQ 10MG BASE A040185 001 Oct 28, 1996
AB SANDOZ EQ 5MG BASE A040101 001 Jul 19, 1996
AB + EQ 10MG BASE A040101 002 Jul 19, 1996
AB TEVA PHARMS EQ 5MG BASE A040120 001 Jul 11, 1996
AB EQ 10MG BASE A040120 002 Jul 11, 1996

PROGESTERONE
CAPSULE; ORAL
PROMETRIUM
XX UNIMED PHARMS LLC 100MG N019781 001 May 14, 1998
XX + 200MG N019781 002 Oct 15, 1999
GEL; VAGINAL
CRINONE
XX COLUMBIA LABS 4% N020701 001 Jul 31, 1997
XX + 8% N020701 002 Jul 31, 1997
INJECTABLE; INJECTION
PROGESTERONE
AO APP PHARMS 50MG/ML A075906 001 Apr 25, 2001
AO PHARMAFORCE 50MG/ML A090845 001 Jun 22, 2009
AO + WATSON LABS (UTAH) 50MG/ML N017362 002
INSERT; VAGINAL

ENDOMETRIN

XX + FERRING 100MG N022057 001 Jun 21, 2007


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 324 (of 393)

PROMETHAZINE HYDROCHLORIDE
INJECTABLE; INJECTION
PROMETHAZINE HYDROCHLORIDE
AP BAXTER HLTHCARE 25MG/ML A083312 001
AP 50MG/ML A083312 002
AP HIKMA FARMACEUTICA 25MG/ML A040737 001 Apr 24, 2008
AP 50MG/ML A040737 002 Apr 24, 2008
AP HOSPIRA 25MG/ML A040372 001 Jun 08, 2000
AP PHARMAFORCE 25MG/ML A040515 001 Mar 19, 2003
AP + TEVA PARENTERAL 25MG/ML A040454 001 Aug 22, 2002
AP + 50MG/ML A040454 002 Aug 22, 2002
AP WOCKHARDT 25MG/ML A040785 001 Sep 26, 2008
AP 50MG/ML A040785 002 Sep 26, 2008
SUPPOSITORY; RECTAL
PROMETHAZINE HYDROCHLORIDE
AB G AND W LABS 12.5MG A040428 002 Mar 31, 2003
AB + 25MG A040428 001 Feb 05, 2002
AB PADDOCK 12.5MG A040479 001 Jun 24, 2003
AB 25MG A040479 002 Jun 24, 2003
AB PERRIGO NEW YORK 12.5MG A040500 001 Jun 30, 2003
AB 25MG A040500 002 Jun 30, 2003
AB TARO 12.5MG A040603 001 Oct 26, 2006
AB 25MG A040603 002 Oct 26, 2006
PROMETHEGAN
XX + G AND W LABS 50MG A087165 001 Aug 14, 1987
SYRUP; ORAL
PROMETHAZINE HYDROCHLORIDE
AA AMNEAL PHARMS 6.25MG/5ML A040882 001 Dec 30, 2009
AA HI TECH PHARMA 6.25MG/5ML A040026 001 Sep 25, 1998
AA SUN PHARM INDS INC 6.25MG/5ML A040891 001 Mar 13, 2009
AA TARO 6.25MG/5ML A040718 001 Apr 04, 2007
AA VINTAGE 6.25MG/5ML A040643 001 Apr 26, 2006
PROMETHAZINE PLAIN
AA + MORTON GROVE 6.25MG/5ML A087953 001 Nov 15, 1982
TABLET; ORAL
PROMETHAZINE HYDROCHLORIDE
AB ACTAVIS TOTOWA 12.5MG A040673 001 Mar 05, 2008
AB 25MG A040673 002 Mar 05, 2008
AB 50MG A040673 003 Mar 05, 2008
AB IMPAX LABS 12.5MG A040724 001 Feb 12, 2008
AB 25MG A040724 002 Feb 12, 2008
AB 50MG A040791 001 May 20, 2008
AB KVK TECH 12.5MG A040712 002 May 04, 2007
AB 25MG A040712 001 Jul 31, 2006
AB 50MG A040713 001 Jul 31, 2006
AB SANDOZ 25MG A084234 001
AB + 50MG A084176 001
AB SUN PHARM INDS INC 12.5MG A040863 001 Dec 30, 2008
AB 25MG A040863 002 Dec 30, 2008
AB 50MG A040863 003 Dec 30, 2008
AB VINTAGE PHARMS 12.5MG A040622 001 Jul 18, 2006
AB 25MG A040622 002 Jul 18, 2006
AB 50MG A040622 003 Jul 18, 2006
AB WATSON LABS 25MG A083426 001
AB 50MG A083711 001
AB ZYDUS PHARMS USA 12.5MG A040596 001 Nov 18, 2005
AB 25MG A040596 002 Nov 18, 2005
AB 50MG A040596 003 Nov 18, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 325 (of 393)

PROPAFENONE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
RYTHMOL SR
XX SMITHKLINE BEECHAM 225MG N021416 001 Sep 04, 2003
XX 325MG N021416 002 Sep 04, 2003
XX + 425MG N021416 003 Sep 04, 2003
TABLET; ORAL
PROPAFENONE HYDROCHLORIDE
AB KV PHARM 150MG A076193 001 Feb 07, 2002
AB 225MG A076193 002 Feb 07, 2002
AB 300MG A076193 003 Feb 07, 2002
AB MUTUAL PHARM 150MG A075998 001 Nov 29, 2001
AB 225MG A075998 002 Nov 29, 2001
AB 300MG A075998 003 Nov 29, 2001
AB PLIVA 150MG A076550 001 Apr 23, 2004
AB 225MG A076550 002 Apr 23, 2004
AB 300MG A076550 003 Apr 23, 2004
AB VINTAGE PHARMS 150MG A075938 001 Oct 17, 2002
AB 225MG A075938 002 Oct 17, 2002
AB 300MG A075938 003 Oct 17, 2002
AB WATSON LABS 150MG A075203 001 Oct 24, 2000
AB 225MG A075203 002 Oct 24, 2000
RYTHMOL
AB SMITHKLINE BEECHAM 150MG N019151 001 Nov 27, 1989
AB 225MG N019151 003 Nov 20, 1992
AB + 300MG N019151 002 Nov 27, 1989

PROPARACAINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
ALCAINE
AT ALCON 0.5% A080027 001
OPHTHAINE
AT + APOTHECON 0.5% N008883 001
OPHTHETIC
AT + ALLERGAN 0.5% N012583 001
PROPARACAINE HYDROCHLORIDE
AT BAUSCH AND LOMB 0.5% A040074 001 Sep 29, 1995
AT TAYLOR PHARMA 0.5% A040277 001 Mar 16, 2000

PROPOFOL
INJECTABLE; INJECTION
DIPRIVAN
AB + APP PHARMS 10MG/ML N019627 002 Jun 11, 1996
PROPOFOL
AB HOSPIRA 10MG/ML A077908 001 Mar 17, 2006
AB TEVA PARENTERAL 10MG/ML A075102 001 Jan 04, 1999
AB 10MG/ML A075392 001 Sep 19, 2000

PROPOXYPHENE HYDROCHLORIDE
CAPSULE; ORAL
DARVON
AA + XANODYNE PHARM 65MG N010997 003
DOLENE
AA HERITAGE PHARMS INC 65MG A080530 001
PROPOXYPHENE HYDROCHLORIDE
AA MYLAN 65MG A040569 001 Dec 16, 2004
AA PAR PHARM 65MG A080269 001
AA TEVA 65MG A088615 001 Oct 22, 1984
AA VINTAGE PHARMS 65MG A040908 001 Jul 17, 2009
AA WEST WARD 65MG A083501 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 326 (of 393)

PROPOXYPHENE NAPSYLATE
TABLET; ORAL

DARVON-N

XX + XANODYNE PHARM 100MG N016862 002

PROPRANOLOL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
INDERAL LA
AB AKRIMAX PHARMS 60MG N018553 004 Mar 18, 1987
AB 80MG N018553 002 Apr 19, 1983
AB 120MG N018553 003 Apr 19, 1983
AB + 160MG N018553 001 Apr 19, 1983
PROPRANOLOL HYDROCHLORIDE
AB ACTAVIS ELIZABETH 60MG A078494 001 Aug 10, 2007
AB 80MG A078494 002 Aug 10, 2007
AB 120MG A078494 003 Aug 10, 2007
AB 160MG A078494 004 Aug 10, 2007
AB MYLAN 60MG A078022 001 Feb 15, 2007
AB 80MG A078022 002 Feb 15, 2007
AB 120MG A078022 003 Feb 15, 2007
AB 160MG A078022 004 Feb 15, 2007
AB PAR PHARM 60MG A078065 001 Jan 26, 2007
AB 80MG A078065 002 Jan 26, 2007
AB 120MG A078065 003 Jan 26, 2007
AB 160MG A078065 004 Jan 26, 2007
AB UPSHER SMITH 60MG A078311 001 Mar 06, 2009
AB 80MG A078311 002 Mar 06, 2009
AB 120MG A078311 003 Mar 06, 2009
AB 160MG A078311 004 Mar 06, 2009
INNOPRAN XL
BX SMITHKLINE BEECHAM 80MG N021438 001 Mar 12, 2003
BX 120MG N021438 002 Mar 12, 2003
INJECTABLE; INJECTION
PROPRANOLOL HYDROCHLORIDE
AP APP PHARMS 1MG/ML A075826 001 Aug 31, 2001
AP + BAXTER HLTHCARE CORP 1MG/ML N016419 001
AP BEDFORD 1MG/ML A075792 001 Aug 29, 2000
AP HIKMA FARMACEUTICA 1MG/ML A077760 001 Jan 31, 2008
AP SANDOZ 1MG/ML A076400 001 Feb 26, 2003
SOLUTION; ORAL

PROPRANOLOL HYDROCHLORIDE

XX + ROXANE 20MG/5ML A070979 001 May 15, 1987


XX + 40MG/5ML A070690 001 May 15, 1987
TABLET; ORAL
INDERAL
AB AKRIMAX PHARMS 40MG N016418 002
AB 60MG N016418 009 Oct 18, 1982
AB + 80MG N016418 004
PROPRANOLOL HYDROCHLORIDE
AB IPCA LABS LTD 10MG A078955 001 Jun 02, 2008
AB 20MG A078955 002 Jun 02, 2008
AB 40MG A078955 003 Jun 02, 2008
AB 60MG A078955 004 Jun 02, 2008
AB 80MG A078955 005 Jun 02, 2008
AB MYLAN 10MG A070213 002 Nov 19, 1985
AB 20MG A070213 003 Nov 19, 1985
AB 40MG A070213 001 Nov 19, 1985
AB 80MG A070213 004 Nov 19, 1985
AB NORTHSTAR HLTHCARE 10MG A078213 001 Jan 10, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 327 (of 393)

PROPRANOLOL HYDROCHLORIDE
TABLET; ORAL
PROPRANOLOL HYDROCHLORIDE
AB NORTHSTAR HLTHCARE 20MG A078213 002 Jan 10, 2008
AB 40MG A078213 003 Jan 10, 2008
AB 60MG A078213 004 Jan 10, 2008
AB 80MG A078213 005 Jan 10, 2008
AB PLIVA 10MG A071972 001 Apr 06, 1988
AB 20MG A071973 001 Apr 06, 1988
AB 40MG A071974 001 Apr 06, 1988
AB 60MG A071975 001 Apr 06, 1988
AB + 80MG A071976 001 Apr 06, 1988
AB WATSON LABS 10MG A070175 001 May 13, 1986
AB 20MG A070176 001 May 13, 1986
AB 40MG A070177 001 May 13, 1986
AB 80MG A070178 001 May 13, 1986

PROPYLTHIOURACIL
TABLET; ORAL
PROPYLTHIOURACIL
BD ACTAVIS ELIZABETH 50MG A080172 001
BD + DAVA PHARMS INC 50MG N006188 001
BD WEST WARD 50MG A080154 001

PROTAMINE SULFATE
INJECTABLE; INJECTION

PROTAMINE SULFATE

XX + APP PHARMS 10MG/ML A089454 001 Apr 07, 1987

PROTRIPTYLINE HYDROCHLORIDE
TABLET; ORAL
PROTRIPTYLINE HYDROCHLORIDE
AB ROXANE 5MG A078913 001 Sep 16, 2008
AB 10MG A078913 002 Sep 16, 2008
VIVACTIL
AB ODYSSEY PHARMS 5MG A073644 001 Aug 24, 1995
AB + 10MG A073645 001 Aug 24, 1995

PYRAZINAMIDE
TABLET; ORAL
PYRAZINAMIDE
AB + DAVA PHARMS INC 500MG A080157 001
AB MIKART 500MG A081319 001 Jun 30, 1992

PYRIDOSTIGMINE BROMIDE
INJECTABLE; INJECTION
MESTINON
AP + VALEANT PHARM INTL 5MG/ML N009830 001
REGONOL
AP SANDOZ 5MG/ML N017398 001
SYRUP; ORAL

MESTINON

XX + VALEANT PHARM INTL 60MG/5ML N015193 001


TABLET; ORAL
MESTINON
AB + VALEANT PHARM INTL 60MG N009829 002
PYRIDOSTIGMINE BROMIDE
AB COREPHARMA 60MG A040457 001 Dec 26, 2002
AB IMPAX LABS 60MG A040502 001 Apr 24, 2003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 328 (of 393)

PYRIDOSTIGMINE BROMIDE
TABLET, EXTENDED RELEASE; ORAL

MESTINON

XX + VALEANT PHARM INTL 180MG N011665 001

PYRIDOXINE HYDROCHLORIDE
INJECTABLE; INJECTION

PYRIDOXINE HYDROCHLORIDE

XX + APP PHARMS 100MG/ML A080618 001

PYRIMETHAMINE
TABLET; ORAL

DARAPRIM

XX + GLAXOSMITHKLINE 25MG N008578 001

QUAZEPAM
TABLET; ORAL

DORAL

XX + QUESTCOR PHARMS 15MG N018708 001 Dec 27, 1985

QUETIAPINE FUMARATE
TABLET; ORAL

SEROQUEL

XX + ASTRAZENECA EQ 25MG BASE N020639 001 Sep 26, 1997


XX EQ 50MG BASE N020639 007 Oct 04, 2005
XX EQ 100MG BASE N020639 002 Sep 26, 1997
XX EQ 200MG BASE N020639 003 Sep 26, 1997
XX + EQ 300MG BASE N020639 005 Jul 26, 2000
XX EQ 400MG BASE N020639 006 Oct 04, 2005
TABLET, EXTENDED RELEASE; ORAL
SEROQUEL XR
XX ASTRAZENECA EQ 50MG BASE N022047 001 May 17, 2007
XX EQ 150MG BASE N022047 005 Aug 11, 2008
XX + EQ 200MG BASE N022047 002 May 17, 2007
XX EQ 300MG BASE N022047 003 May 17, 2007
XX EQ 400MG BASE N022047 004 May 17, 2007

QUINAPRIL HYDROCHLORIDE
TABLET; ORAL
ACCUPRIL
AB PFIZER PHARMS EQ 5MG BASE N019885 001 Nov 19, 1991
AB EQ 10MG BASE N019885 002 Nov 19, 1991
AB EQ 20MG BASE N019885 003 Nov 19, 1991
AB + EQ 40MG BASE N019885 004 Nov 19, 1991
QUINAPRIL HYDROCHLORIDE
AB ACTAVIS TOTOWA EQ 5MG BASE A076459 001 Dec 22, 2004
AB EQ 10MG BASE A076459 002 Dec 22, 2004
AB EQ 20MG BASE A076459 003 Dec 22, 2004
AB EQ 40MG BASE A076459 004 Dec 22, 2004
AB APOTEX EQ 5MG BASE A076240 001 Jan 26, 2006
AB EQ 10MG BASE A076240 002 Jan 26, 2006
AB EQ 20MG BASE A076240 003 Jan 26, 2006
AB EQ 40MG BASE A076240 004 Jan 26, 2006
AB GENPHARM EQ 5MG BASE A076036 001 Jan 28, 2005
AB EQ 10MG BASE A076036 002 Jan 28, 2005
AB EQ 20MG BASE A076036 003 Jan 28, 2005
AB EQ 40MG BASE A076036 004 Jan 28, 2005
AB INVAGEN PHARMS EQ 5MG BASE A078457 001 Aug 24, 2007
AB EQ 10MG BASE A078457 002 Aug 24, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 329 (of 393)

QUINAPRIL HYDROCHLORIDE
TABLET; ORAL
QUINAPRIL HYDROCHLORIDE
AB INVAGEN PHARMS EQ 20MG BASE A078457 003 Aug 24, 2007
AB EQ 40MG BASE A078457 004 Aug 24, 2007
AB LUPIN EQ 5MG BASE A077690 001 Jun 20, 2006
AB EQ 10MG BASE A077690 002 Jun 20, 2006
AB EQ 20MG BASE A077690 003 Jun 20, 2006
AB EQ 40MG BASE A077690 004 Jun 20, 2006
AB MYLAN EQ 5MG BASE A076694 001 Dec 23, 2004
AB EQ 10MG BASE A076694 002 Dec 23, 2004
AB EQ 20MG BASE A076694 003 Dec 23, 2004
AB EQ 40MG BASE A076694 004 Dec 23, 2004
AB RANBAXY EQ 5MG BASE A076607 001 Dec 15, 2004
AB EQ 10MG BASE A076607 002 Dec 15, 2004
AB EQ 20MG BASE A076607 003 Dec 15, 2004
AB EQ 40MG BASE A076607 004 Dec 15, 2004
AB SANDOZ EQ 5MG BASE A076803 001 Mar 02, 2005
AB EQ 10MG BASE A076803 002 Mar 02, 2005
AB EQ 20MG BASE A076803 003 Mar 02, 2005
AB EQ 40MG BASE A076803 004 Mar 02, 2005
AB SUN PHARM INDS LTD EQ 5MG BASE A090800 001 Jun 18, 2009
AB EQ 10MG BASE A090800 002 Jun 18, 2009
AB EQ 20MG BASE A090800 003 Jun 18, 2009
AB EQ 40MG BASE A090800 004 Jun 18, 2009
AB TEVA EQ 5MG BASE A075504 001 Aug 24, 2007
AB EQ 10MG BASE A075504 002 Aug 24, 2007
AB EQ 20MG BASE A075504 003 Aug 24, 2007
AB EQ 40MG BASE A075504 004 Aug 24, 2007
AB WATSON LABS FLORIDA EQ 5MG BASE A076049 001 Jan 14, 2005
AB EQ 10MG BASE A076049 002 Jan 14, 2005
AB EQ 20MG BASE A076049 003 Jan 14, 2005
AB EQ 40MG BASE A076049 004 Jan 14, 2005

QUINIDINE GLUCONATE
INJECTABLE; INJECTION

QUINIDINE GLUCONATE

XX + LILLY 80MG/ML N007529 002 Feb 10, 1989


TABLET, EXTENDED RELEASE; ORAL
QUINIDINE GLUCONATE
BX + MUTUAL PHARM 324MG A089338 001 Feb 11, 1987
BX WATSON LABS 324MG A087810 001 Sep 29, 1982

QUINIDINE SULFATE
TABLET; ORAL
QUINIDINE SULFATE
AB MUTUAL PHARM 200MG A081030 001 Apr 14, 1989
AB 300MG A081031 001 Apr 14, 1989
AB SANDOZ 200MG A088072 002
AB 300MG A088072 001 Sep 26, 1983
AB + WATSON LABS 200MG A083288 001
AB + 300MG A085583 001
TABLET, EXTENDED RELEASE; ORAL

QUINIDINE SULFATE

XX + TEVA PHARMS 300MG A040045 001 Jun 30, 1994


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 330 (of 393)

QUININE SULFATE
CAPSULE; ORAL

QUALAQUIN

XX + AR HOLDING CO INC 324MG N021799 001 Aug 12, 2005

RABEPRAZOLE SODIUM
TABLET, DELAYED RELEASE; ORAL

ACIPHEX

XX + EISAI INC 20MG N020973 002 Aug 19, 1999

RALOXIFENE HYDROCHLORIDE
TABLET; ORAL

EVISTA

XX + LILLY 60MG N020815 001 Dec 09, 1997

RALTEGRAVIR POTASSIUM
TABLET; ORAL

ISENTRESS

XX + MERCK SHARP DOHME EQ 400MG BASE N022145 001 Oct 12, 2007

RAMELTEON
TABLET; ORAL

ROZEREM

XX + TAKEDA GLOBAL 8MG N021782 001 Jul 22, 2005

RAMIPRIL
CAPSULE; ORAL
ALTACE
AB KING PHARMS 1.25MG N019901 001 Jan 28, 1991
AB 2.5MG N019901 002 Jan 28, 1991
AB 5MG N019901 003 Jan 28, 1991
AB + 10MG N019901 004 Jan 28, 1991
RAMIPRIL
AB ACTAVIS ELIZABETH 1.25MG A077513 001 Jun 18, 2008
AB 2.5MG A077513 002 Jun 18, 2008
AB 5MG A077513 003 Jun 18, 2008
AB 10MG A077513 004 Jun 18, 2008
AB APOTEX 1.25MG A079116 001 Jun 20, 2008
AB 2.5MG A079116 002 Jun 20, 2008
AB 5MG A079116 003 Jun 20, 2008
AB 10MG A079116 004 Jun 20, 2008
AB CIPLA 1.25MG A077004 001 Aug 07, 2008
AB 2.5MG A077004 002 Aug 07, 2008
AB 5MG A077004 003 Aug 07, 2008
AB 10MG A077004 004 Aug 07, 2008
AB COBALT LABS INC 1.25MG A076549 001 Oct 24, 2005
AB 2.5MG A076549 002 Oct 24, 2005
AB 5MG A076549 003 Oct 24, 2005
AB 10MG A076549 004 Oct 24, 2005
AB DR REDDYS LABS LTD 1.25MG A078191 001 Jun 18, 2008
AB 2.5MG A078191 002 Jun 18, 2008
AB 5MG A078191 003 Jun 18, 2008
AB 10MG A078191 004 Jun 18, 2008
AB INVAGEN PHARMS 1.25MG A078745 001 Jun 18, 2008
AB 2.5MG A078745 002 Jun 18, 2008
AB 5MG A078745 003 Jun 18, 2008
AB 10MG A078745 004 Jun 18, 2008
AB LUPIN 1.25MG A077626 001 Jun 09, 2008
AB 2.5MG A077626 002 Jun 09, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 331 (of 393)

RAMIPRIL
CAPSULE; ORAL
RAMIPRIL
AB LUPIN 5MG A077626 003 Jun 09, 2008
AB 10MG A077626 004 Jun 09, 2008
AB RANBAXY 5MG A078849 001 Mar 06, 2009
AB 10MG A078849 002 Mar 06, 2009
AB ROXANE 1.25MG A077900 001 Jun 18, 2008
AB 2.5MG A077900 002 Jun 18, 2008
AB 5MG A077900 003 Jun 18, 2008
AB 10MG A077900 004 Jun 18, 2008
AB SANDOZ 1.25MG A077514 001 Jun 18, 2008
AB 2.5MG A077514 002 Jun 18, 2008
AB 5MG A077514 003 Jun 18, 2008
AB 10MG A077514 004 Jun 18, 2008
AB TEVA PHARMS 1.25MG A077470 001 Jun 18, 2008
AB 2.5MG A077470 002 Jun 18, 2008
AB 5MG A077470 003 Jun 18, 2008
AB 10MG A077470 004 Jun 18, 2008
AB ZYDUS PHARMS USA 1.25MG A078832 001 Sep 02, 2008
AB 2.5MG A078832 002 Sep 02, 2008
AB 5MG A078832 003 Sep 02, 2008
AB 10MG A078832 004 Sep 02, 2008
TABLET; ORAL
ALTACE
AB KING PHARMS 1.25MG N022021 001 Feb 27, 2007
AB 2.5MG N022021 002 Feb 27, 2007
AB 5MG N022021 003 Feb 27, 2007
AB + 10MG N022021 004 Feb 27, 2007
RAMIPRIL
AB ZYDUS PHARMS USA INC 1.25MG A090697 001 Sep 24, 2009
AB 2.5MG A090697 002 Sep 24, 2009
AB 5MG A090697 003 Sep 24, 2009
AB 10MG A090697 004 Sep 24, 2009

RANITIDINE HYDROCHLORIDE
CAPSULE; ORAL
RANITIDINE HYDROCHLORIDE
AB DR REDDYS LABS LTD EQ 150MG BASE A075742 001 Nov 29, 2000
AB EQ 300MG BASE A075742 002 Nov 29, 2000
AB SANDOZ EQ 150MG BASE A074655 001 Oct 22, 1997
AB + EQ 300MG BASE A074655 002 Oct 22, 1997
INJECTABLE; INJECTION
RANITIDINE HYDROCHLORIDE
AP BEDFORD EQ 25MG BASE/ML A077458 001 Feb 16, 2006
AP BEN VENUE EQ 25MG BASE/ML A074777 001 Mar 02, 2005
ZANTAC
AP + GLAXOSMITHKLINE EQ 25MG BASE/ML N019090 001 Oct 19, 1984
ZANTAC IN PLASTIC CONTAINER
XX + GLAXOSMITHKLINE EQ 1MG BASE/ML N019593 002 Sep 27, 1991
SYRUP; ORAL
RANITIDINE HYDROCHLORIDE
AA ALPHARMA US PHARMS EQ 15MG BASE/ML A076124 001 Feb 21, 2007
AA AMNEAL PHARMS EQ 15MG BASE/ML A078312 001 Sep 02, 2008
AA APOTEX EQ 15MG BASE/ML A077602 001 Sep 17, 2007
AA CYPRESS PHARM EQ 15MG BASE/ML A078684 001 Aug 27, 2009
AA DR REDDYS LABS LTD EQ 15MG BASE/ML A090102 001 May 26, 2009
AA PHARM ASSOC EQ 15MG BASE/ML A077405 001 Sep 21, 2007
AA RANBAXY EQ 15MG BASE/ML A078448 001 Dec 13, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 332 (of 393)

RANITIDINE HYDROCHLORIDE
SYRUP; ORAL
RANITIDINE HYDROCHLORIDE
AA WOCKHARDT EQ 15MG BASE/ML A079211 001 May 26, 2009
AA EQ 15MG BASE/ML A079212 001 Feb 23, 2009
ZANTAC
AA + GLAXOSMITHKLINE EQ 15MG BASE/ML N019675 001 Dec 30, 1988
TABLET; ORAL
RANITIDINE HYDROCHLORIDE
AB AMNEAL PHARMS NY EQ 150MG BASE A077824 001 Oct 13, 2006
AB EQ 300MG BASE A077824 002 Oct 13, 2006
AB APOTEX EQ 150MG BASE A074680 001 Sep 12, 1997
AB EQ 300MG BASE A074680 002 Sep 12, 1997
AB COBALT EQ 150MG BASE A077426 001 Dec 19, 2005
AB EQ 300MG BASE A077426 002 Dec 19, 2005
AB DR REDDYS LABS INC EQ 150MG BASE A076705 001 Jul 27, 2005
AB EQ 300MG BASE A076705 002 Jul 27, 2005
AB GENPHARM EQ 150MG BASE A074023 001 Aug 22, 1997
AB EQ 300MG BASE A074023 002 Aug 22, 1997
AB GLENMARK GENERICS EQ 150MG BASE A078542 001 Nov 19, 2008
AB EQ 300MG BASE A078542 002 Nov 19, 2008
AB IVAX SUB TEVA PHARMS EQ 150MG BASE A075165 001 Sep 30, 1998
AB EQ 300MG BASE A075165 002 Sep 30, 1998
AB PAR PHARM EQ 150MG BASE A075180 001 Jan 28, 1999
AB EQ 300MG BASE A075180 002 Jan 28, 1999
AB SANDOZ EQ 150MG BASE A074467 001 Aug 29, 1997
AB EQ 300MG BASE A074467 002 Aug 29, 1997
AB TEVA EQ 150MG BASE A074488 001 Jul 31, 1997
AB EQ 300MG BASE A074488 002 Jul 31, 1997
AB WATSON LABS EQ 150MG BASE A074864 001 Oct 20, 1997
AB EQ 300MG BASE A074864 002 Oct 20, 1997
AB WOCKHARDT EQ 150MG BASE A075208 001 Dec 17, 1998
AB EQ 150MG BASE A078701 001 Nov 12, 2009
AB EQ 300MG BASE A075208 002 Dec 17, 1998
AB EQ 300MG BASE A078701 002 Dec 11, 2009
ZANTAC 150
AB GLAXOSMITHKLINE EQ 150MG BASE N018703 001 Jun 09, 1983
ZANTAC 300
AB + GLAXOSMITHKLINE EQ 300MG BASE N018703 002 Dec 09, 1985
TABLET, EFFERVESCENT; ORAL

ZANTAC 25

XX + GLAXOSMITHKLINE EQ 25MG BASE N020251 003 Apr 01, 2004

RANOLAZINE
TABLET, EXTENDED RELEASE; ORAL
RANEXA
XX GILEAD 500MG N021526 002 Jan 27, 2006
XX + 1GM N021526 001 Feb 12, 2007

RASAGILINE MESYLATE
TABLET; ORAL
AZILECT
XX TEVA EQ 0.5MG BASE N021641 001 May 16, 2006
XX + EQ 1MG BASE N021641 002 May 16, 2006

REGADENOSON
SOLUTION; INTRAVENOUS

LEXISCAN

XX + ASTELLAS 0.4MG/5ML (0.08MG/ML) N022161 001 Apr 10, 2008


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 333 (of 393)

REMIFENTANIL HYDROCHLORIDE
INJECTABLE; INJECTION
ULTIVA
XX BIONICHE TEORANTA EQ 1MG BASE/VIAL N020630 001 Jul 12, 1996
XX EQ 2MG BASE/VIAL N020630 002 Jul 12, 1996
XX + EQ 5MG BASE/VIAL N020630 003 Jul 12, 1996

REPAGLINIDE
TABLET; ORAL
PRANDIN
XX NOVO NORDISK INC 0.5MG N020741 001 Dec 22, 1997
XX 1MG N020741 002 Dec 22, 1997
XX + 2MG N020741 003 Dec 22, 1997

RESERPINE
TABLET; ORAL
RESERPINE
BP SANDOZ 0.1MG N009838 001
BP + 0.25MG N009838 002
SERPALAN
BP LANNETT 0.1MG N010124 001
BP 0.25MG N010124 002

RETAPAMULIN
OINTMENT; TOPICAL

ALTABAX

XX + GLAXO GRP LTD 1% N022055 001 Apr 12, 2007

RIBAVIRIN
CAPSULE; ORAL
REBETOL
AB + SCHERING PLOUGH RES 200MG N020903 002 Jul 25, 2001
RIBASPHERE
AB THREE RIVERS PHARMS 200MG A076203 001 Apr 06, 2004
RIBAVARIN
AB AUROBINDO PHARMA 200MG A079117 001 Sep 17, 2009
RIBAVIRIN
AB SANDOZ 200MG A076192 001 Apr 06, 2004
AB TEVA 200MG A076277 001 Oct 04, 2004
AB ZYDUS PHARMS USA 200MG A077224 001 Oct 28, 2005
REBETOL
XX + SCHERING PLOUGH RES 200MG N020903 001 Jun 03, 1998
FOR SOLUTION; INHALATION

VIRAZOLE

XX + VALEANT PHARM INTL 6GM/VIAL N018859 001 Dec 31, 1985


SOLUTION; ORAL

REBETOL

XX + SCHERING 40MG/ML N021546 001 Jul 29, 2003


TABLET; ORAL
COPEGUS
AB ROCHE 200MG N021511 001 Dec 03, 2002
RIBAVIRIN
AB AUROBINDO PHARMA 200MG A079111 001 Sep 17, 2009
AB SANDOZ 200MG A077743 001 Oct 03, 2006
AB TEVA 200MG A077053 001 Dec 05, 2005
AB THREE RIVERS PHARMS 200MG A077456 001 Dec 05, 2005
AB 400MG A077456 002 Dec 05, 2005
AB + 600MG A077456 003 Dec 05, 2005
AB ZYDUS PHARMS USA 200MG A077094 001 Dec 05, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 334 (of 393)

RIBAVIRIN
TABLET; ORAL
RIBAVIRIN
AB ZYDUS PHARMS USA 400MG A077094 002 Mar 16, 2007
AB 600MG A077094 003 Mar 16, 2007
RIBAVIRIN
XX ZYDUS PHARMS USA 500MG A077094 004 Apr 18, 2008

RIFABUTIN
CAPSULE; ORAL

MYCOBUTIN

XX + PHARMACIA AND UPJOHN 150MG N050689 001 Dec 23, 1992

RIFAMPIN
CAPSULE; ORAL
RIFADIN
AB SANOFI AVENTIS US 150MG A062303 001
AB + 300MG N050420 001
RIFAMPIN
AB LANNETT 150MG A065390 001 Mar 28, 2008
AB 300MG A065390 002 Mar 28, 2008
AB SANDOZ 150MG A064150 002 Jan 02, 1998
AB 300MG A064150 001 May 28, 1997
AB VERSAPHARM 150MG A065028 001 Mar 14, 2001
AB 300MG A065028 002 Mar 14, 2001
RIMACTANE
AB ACTAVIS TOTOWA 300MG N050429 001
INJECTABLE; INJECTION
RIFADIN
AP + SANOFI AVENTIS US 600MG/VIAL N050627 001 May 25, 1989
RIFAMPIN
AP AKORN STRIDES 600MG/VIAL A065421 001 May 22, 2008
AP BEDFORD 600MG/VIAL A064217 001 Oct 29, 1999

RIFAPENTINE
TABLET; ORAL

PRIFTIN

XX + SANOFI AVENTIS US 150MG N021024 001 Jun 22, 1998

RIFAXIMIN
TABLET; ORAL

XIFAXAN

XX + SALIX PHARMS 200MG N021361 001 May 25, 2004

RILUZOLE
TABLET; ORAL
RILUTEK
AB + SANOFI AVENTIS US 50MG N020599 001 Dec 12, 1995
RILUZOLE
AB IMPAX LABS 50MG A076173 001 Jan 29, 2003

RIMANTADINE HYDROCHLORIDE
TABLET; ORAL
FLUMADINE
AB + CARACO 100MG N019649 001 Sep 17, 1993
RIMANTADINE HYDROCHLORIDE
AB ACTAVIS TOTOWA 100MG A076375 001 Jan 14, 2003
AB COREPHARMA 100MG A075916 001 Nov 02, 2001
AB IMPAX LABS 100MG A076132 001 Aug 30, 2002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 335 (of 393)

RIMEXOLONE
SUSPENSION/DROPS; OPHTHALMIC

VEXOL

XX + ALCON 1% N020474 001 Dec 30, 1994

RISEDRONATE SODIUM
TABLET; ORAL
ACTONEL
AB PROCTER AND GAMBLE 5MG N020835 002 Apr 14, 2000
AB 30MG N020835 001 Mar 27, 1998
AB + 35MG N020835 003 May 25, 2002
RISEDRONATE SODIUM
AB TEVA PHARMS 5MG A077132 001 Oct 05, 2007
AB 30MG A077132 002 Oct 05, 2007
AB 35MG A077132 003 Oct 05, 2007
ACTONEL
XX + PROCTER AND GAMBLE 150MG N020835 005 Apr 22, 2008

RISPERIDONE
INJECTABLE; INTRAMUSCULAR
RISPERDAL CONSTA
XX ORTHO MCNEIL JANSSEN 12.5MG/VIAL N021346 004 Apr 12, 2007
XX 25MG/VIAL N021346 001 Oct 29, 2003
XX 37.5MG/VIAL N021346 002 Oct 29, 2003
XX + 50MG/VIAL N021346 003 Oct 29, 2003
SOLUTION; ORAL
RISPERDAL
AA + ORTHO MCNEIL JANSSEN 1MG/ML N020588 001 Jun 10, 1996
RISPERIDONE
AA APOTEX INC 1MG/ML A077719 001 Jul 29, 2009
AA AUROBINDO PHARMA 1MG/ML A078452 001 Sep 04, 2009
AA DR REDDYS LABS LTD 1MG/ML A078909 001 Jul 29, 2009
AA ROXANE 1MG/ML A076904 001 Jul 29, 2009
AA TEVA 1MG/ML A076440 001 Jan 30, 2009
AA WOCKHARDT 1MG/ML A078744 001 Oct 08, 2009
TABLET; ORAL
RISPERDAL
AB ORTHO MCNEIL JANSSEN 0.25MG N020272 008 May 10, 1999
AB 0.5MG N020272 007 Jan 27, 1999
AB + 1MG N020272 001 Dec 29, 1993
AB 2MG N020272 002 Dec 29, 1993
AB 3MG N020272 003 Dec 29, 1993
AB 4MG N020272 004 Dec 29, 1993
RISPERIDONE
AB ACTAVIS TOTOWA 0.25MG A078071 001 Jun 17, 2009
AB 0.5MG A078071 002 Jun 17, 2009
AB 1MG A078071 003 Jun 17, 2009
AB 2MG A078071 004 Jun 17, 2009
AB 3MG A078071 005 Jun 17, 2009
AB 4MG A078071 006 Jun 17, 2009
AB APOTEX INC 0.25MG A077953 001 Sep 15, 2008
AB 0.5MG A077953 002 Sep 15, 2008
AB 1MG A077953 003 Sep 15, 2008
AB 2MG A077953 004 Sep 15, 2008
AB 3MG A077953 005 Sep 15, 2008
AB 4MG A077953 006 Sep 15, 2008
AB AUROBINDO PHARMA 0.25MG A078269 001 Oct 08, 2008
AB 0.5MG A078269 002 Oct 08, 2008
AB 1MG A078269 003 Oct 08, 2008
AB 2MG A078269 004 Oct 08, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 336 (of 393)

RISPERIDONE
TABLET; ORAL
RISPERIDONE
AB AUROBINDO PHARMA 3MG A078269 005 Oct 08, 2008
AB 4MG A078269 006 Oct 08, 2008
AB CADISTA PHARMS 0.25MG A078828 001 Mar 23, 2009
AB 0.5MG A078828 002 Mar 23, 2009
AB 1MG A078828 003 Mar 23, 2009
AB 2MG A078828 004 Mar 23, 2009
AB 3MG A078828 005 Mar 23, 2009
AB 4MG A078828 006 Mar 23, 2009
AB COBALT LABS INC 0.25MG A077860 001 Dec 05, 2008
AB 0.5MG A077860 002 Dec 05, 2008
AB 1MG A077860 003 Dec 05, 2008
AB 2MG A077860 004 Dec 05, 2008
AB 3MG A077860 005 Dec 05, 2008
AB 4MG A077860 006 Dec 05, 2008
AB DR REDDYS LABS LTD 0.25MG A076879 001 Oct 24, 2008
AB 0.5MG A076879 002 Oct 24, 2008
AB 1MG A076879 003 Oct 24, 2008
AB 2MG A076879 004 Oct 24, 2008
AB 3MG A076879 005 Oct 24, 2008
AB 4MG A076879 006 Oct 24, 2008
AB MYLAN 0.25MG A076288 001 Sep 15, 2008
AB 0.5MG A076288 002 Sep 15, 2008
AB 1MG A076288 003 Sep 15, 2008
AB 2MG A076288 004 Sep 15, 2008
AB 3MG A076288 005 Sep 15, 2008
AB 4MG A076288 006 Sep 15, 2008
AB PLIVA HRVATSKA DOO 0.25MG A077769 001 Oct 16, 2008
AB 0.5MG A077769 002 Oct 16, 2008
AB 1MG A077769 003 Oct 16, 2008
AB 2MG A077769 004 Oct 16, 2008
AB 3MG A077769 005 Oct 16, 2008
AB 4MG A077769 006 Oct 16, 2008
AB SANDOZ 0.25MG A078528 001 Oct 16, 2009
AB 0.5MG A078528 002 Oct 16, 2009
AB 1MG A078528 003 Oct 16, 2009
AB 2MG A078528 004 Oct 16, 2009
AB 3MG A078528 005 Oct 16, 2009
AB 4MG A078528 006 Oct 16, 2009
AB SYNTHON PHARMS 0.25MG A078187 001 Oct 22, 2009
AB 0.5MG A078187 002 Oct 22, 2009
AB 1MG A078187 003 Oct 22, 2009
AB 2MG A078187 004 Oct 22, 2009
AB 3MG A078187 005 Oct 22, 2009
AB 4MG A078187 006 Oct 22, 2009
AB TEVA 0.25MG A076228 001 Jun 30, 2008
AB 0.5MG A076228 002 Jun 30, 2008
AB 1MG A076228 003 Jun 30, 2008
AB 2MG A076228 004 Jun 30, 2008
AB 3MG A076228 005 Jun 30, 2008
AB 4MG A076228 006 Jun 30, 2008
AB TORRENT PHARMS 0.25MG A079088 001 Oct 30, 2008
AB 0.5MG A079088 002 Oct 30, 2008
AB 1MG A079088 003 Oct 30, 2008
AB 2MG A079088 004 Oct 30, 2008
AB 3MG A079088 005 Oct 30, 2008
AB 4MG A079088 006 Oct 30, 2008
AB VINTAGE 0.25MG A078707 001 Dec 29, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 337 (of 393)

RISPERIDONE
TABLET; ORAL
RISPERIDONE
AB VINTAGE 0.5MG A078707 002 Dec 29, 2008
AB 1MG A078707 003 Dec 29, 2008
AB 2MG A078707 004 Dec 29, 2008
AB 3MG A078707 005 Dec 29, 2008
AB 4MG A078707 006 Dec 29, 2008
AB WEST WARD PHARMS 0.25MG A078740 001 May 29, 2009
AB 0.5MG A078740 002 May 29, 2009
AB 1MG A078740 003 May 29, 2009
AB 2MG A078740 004 May 29, 2009
AB 3MG A078740 005 May 29, 2009
AB 4MG A078740 006 May 29, 2009
AB WOCKHARDT 0.25MG A078871 001 Oct 09, 2008
AB 0.5MG A078871 002 Oct 09, 2008
AB 1MG A078871 003 Oct 09, 2008
AB 2MG A078871 004 Oct 09, 2008
AB 3MG A078871 005 Oct 09, 2008
AB 4MG A078871 006 Oct 09, 2008
AB ZYDUS PHARMS USA INC 0.25MG A078040 001 Oct 16, 2008
AB 0.5MG A078040 002 Oct 16, 2008
AB 1MG A078040 003 Oct 16, 2008
AB 2MG A078040 004 Oct 16, 2008
AB 3MG A078040 005 Oct 16, 2008
AB 4MG A078040 006 Oct 16, 2008
TABLET, ORALLY DISINTEGRATING; ORAL
RISPERDAL
AB ORTHO MCNEIL JANSSEN 0.5MG N021444 001 Apr 02, 2003
AB + 1MG N021444 002 Apr 02, 2003
AB 2MG N021444 003 Apr 02, 2003
AB 3MG N021444 004 Dec 23, 2004
AB 4MG N021444 005 Dec 23, 2004
RISPERIDONE
AB DR REDDYS LABS LTD 0.5MG A077328 001 Feb 24, 2009
AB 1MG A077328 002 Oct 05, 2009
AB 2MG A077328 003 Feb 24, 2009
AB PAR PHARM 0.5MG A077494 002 Apr 30, 2009
AB 1MG A077494 003 Oct 26, 2009
AB 2MG A077494 004 Apr 30, 2009
AB 3MG A077494 005 Apr 30, 2009
AB 4MG A077494 006 Apr 30, 2009
AB SANDOZ 0.5MG A078116 001 Dec 22, 2009
AB 1MG A078116 002 Dec 22, 2009
AB 2MG A078116 003 Dec 22, 2009
AB 3MG A078116 004 Dec 22, 2009
AB 4MG A078116 005 Dec 22, 2009
AB ZYDUS PHARMS USA 0.5MG A078516 001 May 01, 2009
AB 2MG A078516 003 May 01, 2009
RISPERIDONE
XX PAR PHARM 0.25MG A077494 001 Apr 30, 2009

RITONAVIR
CAPSULE; ORAL

NORVIR

XX + ABBOTT 100MG N020945 001 Jun 29, 1999


SOLUTION; ORAL

NORVIR

XX + ABBOTT 80MG/ML N020659 001 Mar 01, 1996


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 338 (of 393)

RIVASTIGMINE
FILM, EXTENDED RELEASE; TRANSDERMAL
EXELON
XX NOVARTIS 4.6MG/24HR N022083 001 Jul 06, 2007
XX + 9.5MG/24HR N022083 002 Jul 06, 2007

RIVASTIGMINE TARTRATE
CAPSULE; ORAL
EXELON
AB + NOVARTIS EQ 1.5MG BASE N020823 003 Apr 21, 2000
AB EQ 3MG BASE N020823 004 Apr 21, 2000
AB EQ 4.5MG BASE N020823 005 Apr 21, 2000
AB + EQ 6MG BASE N020823 006 Apr 21, 2000
RIVASTIGMINE TARTRATE
AB DR REDDYS LABS INC EQ 1.5MG BASE A077130 001 Oct 31, 2007
AB EQ 3MG BASE A077130 002 Oct 31, 2007
AB EQ 4.5MG BASE A077130 003 Oct 31, 2007
AB EQ 6MG BASE A077130 004 Oct 31, 2007
AB SUN PHARM INDS EQ 1.5MG BASE A077131 001 Oct 22, 2007
AB EQ 3MG BASE A077131 002 Oct 22, 2007
AB EQ 4.5MG BASE A077131 003 Oct 22, 2007
AB EQ 6MG BASE A077131 004 Oct 22, 2007
AB WATSON LABS EQ 1.5MG BASE A077129 001 Jan 08, 2008
AB EQ 3MG BASE A077129 002 Jan 08, 2008
AB EQ 4.5MG BASE A077129 003 Jan 08, 2008
AB EQ 6MG BASE A077129 004 Jan 08, 2008
SOLUTION; ORAL

EXELON

XX + NOVARTIS EQ 2MG BASE/ML N021025 001 Apr 21, 2000

RIZATRIPTAN BENZOATE
TABLET; ORAL
MAXALT
XX MERCK EQ 5MG BASE N020864 001 Jun 29, 1998
XX + EQ 10MG BASE N020864 002 Jun 29, 1998
TABLET, ORALLY DISINTEGRATING; ORAL
MAXALT-MLT
XX MERCK EQ 5MG BASE N020865 001 Jun 29, 1998
XX + EQ 10MG BASE N020865 002 Jun 29, 1998

ROCURONIUM BROMIDE
INJECTABLE; INJECTION
ROCURONIUM BROMIDE
AP APP PHARMS 50MG/5ML (10MG/ML) A078651 001 Dec 29, 2008
AP 100MG/10ML (10MG/ML) A078651 002 Dec 29, 2008
AP GENERAMEDIX 50MG/5ML (10MG/ML) A079199 001 Nov 26, 2008
AP 100MG/10ML (10MG/ML) A079199 002 Nov 26, 2008
AP HOSPIRA 50MG/5ML (10MG/ML) A078519 001 Nov 26, 2008
AP 100MG/10ML (10MG/ML) A078519 002 Nov 26, 2008
AP SANDOZ 50MG/5ML (10MG/ML) A079195 001 Dec 05, 2008
AP 100MG/10ML (10MG/ML) A079195 002 Dec 05, 2008
AP TEVA PARENTERAL 50MG/5ML (10MG/ML) A078717 001 Nov 26, 2008
AP 100MG/10ML (10MG/ML) A078717 002 Nov 26, 2008
ZEMURON
AP + SCHERING 50MG/5ML (10MG/ML) N020214 001 Mar 17, 1994
AP + 100MG/10ML (10MG/ML) N020214 003 Mar 17, 1994
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 339 (of 393)

ROMIDEPSIN
POWDER; IV (INFUSION)

ISTODAX

XX + GLOUCESTER PHARMS 10MG/VIAL N022393 001 Nov 05, 2009

ROPINIROLE HYDROCHLORIDE
TABLET; ORAL
REQUIP
AB + GLAXOSMITHKLINE EQ 0.25MG BASE N020658 001 Sep 19, 1997
AB EQ 0.5MG BASE N020658 002 Sep 19, 1997
AB EQ 1MG BASE N020658 003 Sep 19, 1997
AB EQ 2MG BASE N020658 004 Sep 19, 1997
AB EQ 3MG BASE N020658 006 Jan 27, 1999
AB EQ 4MG BASE N020658 007 Jan 27, 1999
AB EQ 5MG BASE N020658 005 Sep 19, 1997
ROPINIROLE HYDROCHLORIDE
AB COREPHARMA EQ 0.25MG BASE A078230 001 May 20, 2008
AB EQ 0.5MG BASE A078230 002 May 20, 2008
AB EQ 1MG BASE A078230 003 May 20, 2008
AB EQ 2MG BASE A078230 004 May 20, 2008
AB EQ 3MG BASE A078230 005 May 20, 2008
AB EQ 4MG BASE A078230 006 May 20, 2008
AB EQ 5MG BASE A078230 007 May 20, 2008
AB HUAHAI US INC EQ 0.25MG BASE A078110 001 May 05, 2008
AB EQ 0.5MG BASE A078110 002 May 05, 2008
AB EQ 1MG BASE A078110 003 May 05, 2008
AB EQ 2MG BASE A078110 004 May 05, 2008
AB EQ 3MG BASE A078110 005 May 05, 2008
AB EQ 4MG BASE A078110 006 May 05, 2008
AB MYLAN EQ 0.25MG BASE A078881 001 May 05, 2008
AB EQ 0.5MG BASE A078881 002 May 05, 2008
AB EQ 1MG BASE A078881 003 May 05, 2008
AB EQ 2MG BASE A078881 004 May 05, 2008
AB EQ 3MG BASE A078881 005 May 05, 2008
AB EQ 4MG BASE A078881 006 May 05, 2008
AB EQ 5MG BASE A078881 007 May 19, 2008
AB ROXANE EQ 0.25MG BASE A077852 001 May 05, 2008
AB EQ 0.5MG BASE A077852 002 May 05, 2008
AB EQ 1MG BASE A077852 003 May 05, 2008
AB EQ 2MG BASE A077852 004 May 05, 2008
AB EQ 3MG BASE A077852 005 May 05, 2008
AB EQ 4MG BASE A077852 006 May 05, 2008
AB EQ 5MG BASE A077852 007 May 19, 2008
AB TEVA EQ 0.25MG BASE A077460 001 May 05, 2008
AB EQ 0.5MG BASE A077460 002 May 05, 2008
AB EQ 1MG BASE A077460 003 May 05, 2008
AB EQ 2MG BASE A077460 004 May 05, 2008
AB EQ 3MG BASE A077460 005 May 05, 2008
AB EQ 4MG BASE A077460 006 May 05, 2008
AB EQ 5MG BASE A077460 007 May 19, 2008
AB WOCKHARDT EQ 0.25MG BASE A079050 001 May 29, 2008
AB EQ 0.5MG BASE A079050 002 May 29, 2008
AB EQ 1MG BASE A079050 003 May 29, 2008
AB EQ 2MG BASE A079050 004 May 29, 2008
AB EQ 3MG BASE A079050 005 May 29, 2008
AB EQ 4MG BASE A079050 006 May 29, 2008
AB EQ 5MG BASE A079050 007 May 29, 2008
AB ZYDUS PHARMS USA INC EQ 0.25MG BASE A090411 001 Jun 01, 2009
AB EQ 0.5MG BASE A090411 002 Jun 01, 2009
AB EQ 1MG BASE A090411 003 Jun 01, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 340 (of 393)

ROPINIROLE HYDROCHLORIDE
TABLET; ORAL
ROPINIROLE HYDROCHLORIDE
AB ZYDUS PHARMS USA INC EQ 2MG BASE A090411 004 Jun 01, 2009
AB EQ 3MG BASE A090411 005 Jun 01, 2009
AB EQ 4MG BASE A090411 006 Jun 01, 2009
AB EQ 5MG BASE A090411 007 Jun 01, 2009
TABLET, EXTENDED RELEASE; ORAL

REQUIP XL

XX + SMITHKLINE BEECHAM EQ 2MG BASE N022008 001 Jun 13, 2008


XX EQ 4MG BASE N022008 003 Jun 13, 2008
XX EQ 6MG BASE N022008 006 Apr 10, 2009
XX EQ 8MG BASE N022008 004 Jun 13, 2008
XX EQ 12MG BASE N022008 005 Oct 31, 2008

ROPIVACAINE HYDROCHLORIDE MONOHYDRATE


INJECTABLE; INJECTION
NAROPIN
XX APP PHARMS 2MG/ML N020533 001 Sep 24, 1996
XX 5MG/ML N020533 003 Sep 24, 1996
XX 7.5MG/ML N020533 004 Sep 24, 1996
XX + 10MG/ML N020533 005 Sep 24, 1996

ROSIGLITAZONE MALEATE
TABLET; ORAL
AVANDIA
XX SB PHARMCO EQ 2MG BASE N021071 002 May 25, 1999
XX EQ 4MG BASE N021071 003 May 25, 1999
XX + EQ 8MG BASE N021071 004 May 25, 1999

ROSUVASTATIN CALCIUM
TABLET; ORAL

CRESTOR

XX IPR 5MG
N021366 002 Aug 12, 2003
XX 10MG
N021366 003 Aug 12, 2003
XX 20MG
N021366 004 Aug 12, 2003
XX + 40MG
N021366 005 Aug 12, 2003

RUBIDIUM CHLORIDE RB-82


INJECTABLE; INJECTION

CARDIOGEN-82

XX BRACCO N/A
N019414 001 Dec 29, 1989

RUFINAMIDE
TABLET; ORAL

BANZEL

XX EISAI INC 200MG


N021911 002 Nov 14, 2008
XX + 400MG
N021911 003 Nov 14, 2008

SACROSIDASE
SOLUTION; ORAL

SUCRAID

XX + QOL MEDCL 8,500 IU/ML N020772 001 Apr 09, 1998

SAFFLOWER OIL; SOYBEAN OIL


INJECTABLE; INJECTION

LIPOSYN II 10%

XX + HOSPIRA 5%;5% (5GM/100ML) N018997 001 Aug 27, 1984


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 341 (of 393)

SAFFLOWER OIL; SOYBEAN OIL


INJECTABLE; INJECTION

LIPOSYN II 20%

XX + HOSPIRA 10%;10% (10GM/100ML) N018991 001 Aug 27, 1984

SALMETEROL XINAFOATE
POWDER; INHALATION

SEREVENT

XX + GLAXO GRP LTD EQ 0.05MG BASE/INH N020692 001 Sep 19, 1997

SAMARIUM SM 153 LEXIDRONAM PENTASODIUM


INJECTABLE; INJECTION

QUADRAMET

XX + EUSA PHARMA USA 50mCi/ML N020570 001 Mar 28, 1997

SAPROPTERIN DIHYDROCHLORIDE
TABLET; ORAL

KUVAN

XX + BIOMARIN PHARM 100MG N022181 001 Dec 13, 2007

SAQUINAVIR MESYLATE
CAPSULE; ORAL

INVIRASE

XX + HLR EQ 200MG BASE N020628 001 Dec 06, 1995


TABLET; ORAL

INVIRASE

XX + ROCHE EQ 500MG BASE N021785 001 Dec 17, 2004

SAXAGLIPTIN HYDROCHLORIDE
TABLET; ORAL
ONGLYZA
XX BRISTOL MYERS SQUIBB EQ 2.5MG BASE N022350 001 Jul 31, 2009
XX + EQ 5MG BASE N022350 002 Jul 31, 2009

SCOPOLAMINE
FILM, EXTENDED RELEASE; TRANSDERMAL

TRANSDERM SCOP

XX + NOVARTIS 1MG/72HR N017874 001

SECOBARBITAL SODIUM
CAPSULE; ORAL

SECONAL SODIUM

XX + RANBAXY 50MG A086101 001 Oct 03, 1983


XX + 100MG A086101 002 Oct 03, 1983

SECRETIN SYNTHETIC HUMAN


FOR SOLUTION; INTRAVENOUS

CHIRHOSTIM

XX + CHIRHOCLIN 16MCG/VIAL N021256 001 Apr 09, 2004


XX 40MCG/VIAL N021256 002 Jun 21, 2007

SELEGILINE
FILM, EXTENDED RELEASE; TRANSDERMAL
EMSAM
XX + SOMERSET 6MG/24HR N021336 001 Feb 27, 2006
XX 9MG/24HR N021336 002 Feb 27, 2006
XX 12MG/24HR N021336 003 Feb 27, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 342 (of 393)

SELEGILINE HYDROCHLORIDE
CAPSULE; ORAL
ELDEPRYL
AB + SOMERSET 5MG N020647 001 May 15, 1996
SELEGILINE HYDROCHLORIDE
AB APOTEX 5MG A075321 001 Dec 04, 1998
AB DAVA PHARMS INC 5MG A075352 001 Nov 30, 1998
TABLET; ORAL
SELEGILINE HYDROCHLORIDE
AB ALPHAPHARM 5MG A074866 001 Nov 26, 1997
AB + APOTEX INC 5MG A074871 001 Jun 06, 1997
AB DAVA PHARMS INC 5MG A074641 001 Aug 02, 1996
AB STASON 5MG A074912 001 Apr 30, 1998
TABLET, ORALLY DISINTEGRATING; ORAL

ZELAPAR

XX + VALEANT PHARM INTL 1.25MG N021479 001 Jun 14, 2006

SELENIUM SULFIDE
LOTION/SHAMPOO; TOPICAL
SELENIUM SULFIDE
AT ACTAVIS MID ATLANTIC 2.5% A084394 001
AT MORTON GROVE 2.5% A088228 001 Sep 01, 1983
AT PERRIGO NEW YORK 2.5% A089996 001 Jan 10, 1991
SELSUN
AT + CHATTEM 2.5% N007936 001

SERTACONAZOLE NITRATE
CREAM; TOPICAL

ERTACZO

XX + ORTHO DERMATOLOGICS 2% N021385 001 Dec 10, 2003

SERTRALINE HYDROCHLORIDE
CONCENTRATE; ORAL
SERTRALINE HYDROCHLORIDE
AA AUROBINDO PHARMA EQ 20MG BASE/ML A078861 001 Oct 31, 2008
AA RANBAXY EQ 20MG BASE/ML A078053 001 Feb 05, 2007
AA ROXANE EQ 20MG BASE/ML A076934 001 Jun 30, 2006
ZOLOFT
AA + PFIZER EQ 20MG BASE/ML N020990 001 Dec 07, 1999
TABLET; ORAL
SERTRALINE HYDROCHLORIDE
AB APOTEX INC EQ 25MG BASE A076882 001 Feb 06, 2007
AB EQ 50MG BASE A076882 002 Feb 06, 2007
AB EQ 100MG BASE A076882 003 Feb 06, 2007
AB AUROBINDO PHARMA EQ 25MG BASE A077206 001 Feb 06, 2007
AB EQ 50MG BASE A077206 002 Feb 06, 2007
AB EQ 100MG BASE A077206 003 Feb 06, 2007
AB AUSTARPHARMA LLC EQ 25MG BASE A078677 001 Mar 04, 2009
AB EQ 50MG BASE A078677 002 Mar 04, 2009
AB EQ 100MG BASE A078677 003 Mar 04, 2009
AB COBALT EQ 25MG BASE A077663 001 Feb 06, 2007
AB EQ 50MG BASE A077663 002 Feb 06, 2007
AB EQ 100MG BASE A077663 003 Feb 06, 2007
AB DR REDDYS LABS LTD EQ 25MG BASE A076442 001 Apr 30, 2007
AB EQ 50MG BASE A076442 002 Apr 30, 2007
AB EQ 100MG BASE A076442 003 Apr 30, 2007
AB GENPHARM EQ 25MG BASE A076540 001 Mar 20, 2007
AB EQ 50MG BASE A076540 002 Mar 20, 2007
AB EQ 100MG BASE A076540 003 Mar 20, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 343 (of 393)

SERTRALINE HYDROCHLORIDE
TABLET; ORAL
SERTRALINE HYDROCHLORIDE
AB HIKMA PHARMS EQ 25MG BASE A077864 001 Aug 10, 2009
AB EQ 50MG BASE A077864 002 Aug 10, 2009
AB EQ 100MG BASE A077864 003 Aug 10, 2009
AB INVAGEN PHARMS EQ 25MG BASE A077397 001 Feb 06, 2007
AB EQ 50MG BASE A077397 002 Feb 06, 2007
AB EQ 100MG BASE A077397 003 Feb 06, 2007
AB IVAX SUB TEVA PHARMS EQ 25MG BASE A075719 003 Jun 30, 2006
AB EQ 50MG BASE A075719 001 Jun 30, 2006
AB EQ 100MG BASE A075719 002 Jun 30, 2006
AB LUPIN EQ 25MG BASE A077670 001 Feb 06, 2007
AB EQ 50MG BASE A077670 002 Feb 06, 2007
AB EQ 100MG BASE A077670 003 Feb 06, 2007
AB MATRIX LABS LTD EQ 25MG BASE A078626 001 Jan 31, 2008
AB EQ 50MG BASE A078626 002 Jan 31, 2008
AB EQ 100MG BASE A078626 003 Jan 31, 2008
AB MYLAN EQ 25MG BASE A076671 001 Feb 06, 2007
AB EQ 50MG BASE A076671 002 Feb 06, 2007
AB EQ 100MG BASE A076671 003 Feb 06, 2007
AB PLIVA HRVATSKA DOO EQ 25MG BASE A077299 001 Feb 06, 2007
AB EQ 50MG BASE A077299 002 Feb 06, 2007
AB EQ 100MG BASE A077299 003 Feb 06, 2007
AB RANBAXY EQ 25MG BASE A077977 001 Feb 06, 2007
AB EQ 50MG BASE A077977 002 Feb 06, 2007
AB EQ 100MG BASE A077977 003 Feb 06, 2007
AB ROXANE EQ 25MG BASE A076881 001 Feb 06, 2007
AB EQ 50MG BASE A076881 002 Feb 06, 2007
AB EQ 100MG BASE A076881 003 Feb 06, 2007
AB SANDOZ EQ 25MG BASE A077713 001 Feb 06, 2007
AB EQ 50MG BASE A077713 002 Feb 06, 2007
AB EQ 100MG BASE A077713 003 Feb 06, 2007
AB SUN PHARM INDS (IN) EQ 25MG BASE A078108 001 Feb 06, 2007
AB EQ 50MG BASE A078108 002 Feb 06, 2007
AB EQ 100MG BASE A078108 003 Feb 06, 2007
AB TEVA EQ 25MG BASE A076465 001 Aug 11, 2006
AB EQ 50MG BASE A076465 002 Aug 11, 2006
AB EQ 100MG BASE A076465 003 Aug 11, 2006
AB TORRENT PHARMS EQ 25MG BASE A077765 001 Feb 06, 2007
AB EQ 50MG BASE A077765 002 Feb 06, 2007
AB EQ 100MG BASE A077765 003 Feb 06, 2007
AB WOCKHARDT EQ 25MG BASE A078403 001 Jan 08, 2008
AB EQ 50MG BASE A078403 002 Jan 08, 2008
AB EQ 100MG BASE A078403 003 Jan 08, 2008
AB ZYDUS PHARMS USA EQ 25MG BASE A077106 001 Feb 06, 2007
AB EQ 50MG BASE A077106 002 Feb 06, 2007
AB EQ 100MG BASE A077106 003 Feb 06, 2007
ZOLOFT
AB PFIZER EQ 25MG BASE N019839 005 Mar 06, 1996
AB EQ 50MG BASE N019839 001 Dec 30, 1991
AB + EQ 100MG BASE N019839 002 Dec 30, 1991
SERTRALINE HYDROCHLORIDE
XX RANBAXY EQ 150MG BASE A077977 004 Feb 06, 2007
XX EQ 200MG BASE A077977 005 Feb 06, 2007

SEVELAMER CARBONATE
FOR SUSPENSION; ORAL
RENVELA
XX GENZYME 800MG/PACKET N022318 001 Aug 12, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 344 (of 393)

SEVELAMER CARBONATE
FOR SUSPENSION; ORAL

RENVELA

XX + GENZYME 2.4GM/PACKET N022318 002 Feb 18, 2009


TABLET; ORAL

RENVELA

XX + GENZYME 800MG N022127 001 Oct 19, 2007

SEVELAMER HYDROCHLORIDE
TABLET; ORAL
RENAGEL
XX GENZYME 400MG N021179 001 Jul 12, 2000
XX + 800MG N021179 002 Jul 12, 2000

SEVOFLURANE
LIQUID; INHALATION
SEVOFLURANE
AN BAXTER HLTHCARE 100% A075895 001 Jul 02, 2002
AN HALOCARBON PRODS 100% A078650 001 Nov 19, 2007
SOJOURN
AN MINRAD 100% A077867 001 May 02, 2007
ULTANE
AN + ABBOTT 100% N020478 001 Jun 07, 1995

SIBUTRAMINE HYDROCHLORIDE
CAPSULE; ORAL
MERIDIA
XX ABBOTT 5MG N020632 001 Nov 22, 1997
XX 10MG N020632 002 Nov 22, 1997
XX + 15MG N020632 003 Nov 22, 1997

SILDENAFIL CITRATE
SOLUTION; INTRAVENOUS

REVATIO

XX + PFIZER EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) N022473 001 Nov 18, 2009
TABLET; ORAL

REVATIO

XX + PFIZER EQ 20MG BASE N021845 001 Jun 03, 2005


VIAGRA
XX PFIZER IRELAND EQ 25MG BASE N020895 001 Mar 27, 1998
XX EQ 50MG BASE N020895 002 Mar 27, 1998
XX + EQ 100MG BASE N020895 003 Mar 27, 1998

SILODOSIN
CAPSULE; ORAL
RAPAFLO
XX WATSON LABS 4MG N022206 001 Oct 08, 2008
XX + 8MG N022206 002 Oct 08, 2008

SILVER SULFADIAZINE
CREAM; TOPICAL
SILVADENE
AB + KING PHARMS 1% N017381 001
SSD
AB DR REDDYS LA 1% N018578 001 Feb 25, 1982
THERMAZENE
AB KENDALL LP 1% N018810 001 Dec 23, 1985
SSD AF
BX DR REDDYS LA 1% N018578 003 Jul 11, 1990
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 345 (of 393)

SIMVASTATIN
TABLET; ORAL
SIMVASTATIN
AB ACCORD HLTHCARE 10MG A078155 002 Feb 26, 2008
AB 20MG A078155 003 Feb 26, 2008
AB 40MG A078155 004 Feb 26, 2008
AB 80MG A078155 001 Feb 26, 2008
AB AUROBINDO PHARMA 5MG A077691 001 Dec 20, 2006
AB 10MG A077691 002 Dec 20, 2006
AB 20MG A077691 003 Dec 20, 2006
AB 40MG A077691 004 Dec 20, 2006
AB 80MG A077691 005 Dec 20, 2006
AB COBALT 5MG A076685 001 Dec 20, 2006
AB 10MG A076685 002 Dec 20, 2006
AB 20MG A076685 003 Dec 20, 2006
AB 40MG A076685 004 Dec 20, 2006
AB 80MG A076685 005 Dec 20, 2006
AB DR REDDYS LABS INC 10MG A077752 001 Dec 20, 2006
AB 20MG A077752 002 Dec 20, 2006
AB 40MG A077752 003 Dec 20, 2006
AB 80MG A077752 004 Dec 20, 2006
AB DR REDDYS LABS LTD 5MG A078425 001 Aug 16, 2007
AB IVAX SUB TEVA PHARMS 5MG A076052 001 Jun 23, 2006
AB 10MG A076052 002 Jun 23, 2006
AB 20MG A076052 003 Jun 23, 2006
AB 40MG A076052 004 Jun 23, 2006
AB 80MG A076052 005 Dec 20, 2006
AB LUPIN 5MG A078103 005 Apr 14, 2009
AB 10MG A078103 001 May 11, 2007
AB 20MG A078103 002 May 11, 2007
AB 40MG A078103 003 May 11, 2007
AB 80MG A078103 004 May 11, 2007
AB PERRIGO R AND D 5MG A078034 001 Dec 20, 2006
AB 10MG A078034 002 Dec 20, 2006
AB 20MG A078034 003 Dec 20, 2006
AB 40MG A078034 004 Dec 20, 2006
AB 80MG A078034 005 Dec 20, 2006
AB RANBAXY 5MG A076285 001 Dec 20, 2006
AB 10MG A076285 002 Dec 20, 2006
AB 20MG A076285 003 Dec 20, 2006
AB 40MG A076285 004 Dec 20, 2006
AB 80MG A076285 005 Jun 23, 2006
AB SANDOZ 5MG A077766 001 Dec 20, 2006
AB 10MG A077766 002 Dec 20, 2006
AB 20MG A077766 003 Dec 20, 2006
AB 40MG A077766 004 Dec 20, 2006
AB 80MG A077766 005 Dec 20, 2006
AB ZYDUS PHARMS USA 5MG A077837 001 Dec 20, 2006
AB 10MG A077837 002 Dec 20, 2006
AB 20MG A077837 003 Dec 20, 2006
AB 40MG A077837 004 Dec 20, 2006
AB 80MG A077837 005 Dec 20, 2006
ZOCOR
AB MERCK 5MG N019766 001 Dec 23, 1991
AB 10MG N019766 002 Dec 23, 1991
AB 20MG N019766 003 Dec 23, 1991
AB 40MG N019766 004 Dec 23, 1991
AB + 80MG N019766 005 Jul 10, 1998
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 346 (of 393)

SINCALIDE
INJECTABLE; INJECTION

KINEVAC

XX + BRACCO 0.005MG/VIAL N017697 001

SINECATECHINS
OINTMENT; TOPICAL

VEREGEN

XX + MEDIGENE 15% N021902 001 Oct 31, 2006

SIROLIMUS
SOLUTION; ORAL

RAPAMUNE

XX + WYETH PHARMS INC 1MG/ML N021083 001 Sep 15, 1999


TABLET; ORAL
RAPAMUNE
XX WYETH PHARMS INC 1MG N021110 001 Aug 25, 2000
XX + 2MG N021110 002 Aug 22, 2002

SITAGLIPTIN PHOSPHATE
TABLET; ORAL
JANUVIA
XX MERCK CO INC EQ 25MG BASE N021995 001 Oct 16, 2006
XX EQ 50MG BASE N021995 002 Oct 16, 2006
XX + EQ 100MG BASE N021995 003 Oct 16, 2006

SODIUM ACETATE ANHYDROUS


INJECTABLE; INJECTION

SODIUM ACETATE IN PLASTIC CONTAINER


XX + HOSPIRA 2MEQ/ML N018893 001 May 04, 1983

SODIUM BENZOATE; SODIUM PHENYLACETATE


SOLUTION; IV (INFUSION)

AMMONUL

XX + UCYCLYD 10%;10% (5GM/50ML;5GM/50ML) N020645 001 Feb 17, 2005

SODIUM BICARBONATE
INJECTABLE; INJECTION
SODIUM BICARBONATE
XX HOSPIRA 0.9MEQ/ML A077394 001 Nov 09, 2005
XX + 1MEQ/ML A077394 002 Nov 09, 2005

SODIUM CHLORIDE
INJECTABLE; INJECTION
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP APP PHARMS 9MG/ML A088911 001
Feb 07, 1985

AP + HOSPIRA 9MG/ML N018800 001


Oct 29, 1982

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER


AP B BRAUN 450MG/100ML N019635 001 Mar 09, 1988

AP BAXTER HLTHCARE 450MG/100ML N018016 001


AP HOSPIRA 450MG/100ML N018090 001
AP 450MG/100ML N019759 001 Jun 08, 1988

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER


AP + APP PHARMS 9MG/ML A088912 001 Jan 10, 1985
AP + B BRAUN 900MG/100ML N017464 001
AP + 900MG/100ML N019635 002 Mar 09, 1988
AP + BAXTER HLTHCARE 9MG/ML N016677 004 Oct 30, 1985
AP 9MG/ML N020178 002 Dec 07, 1992
AP + 900MG/100ML N016677 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 347 (of 393)

SODIUM CHLORIDE
INJECTABLE; INJECTION
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 900MG/100ML N020178 001 Dec 07, 1992
AP FRESENIUS MEDCL 900MG/100ML A078177 001 Apr 12, 2007
AP HAEMONETICS 900MG/100ML A076316 001 Oct 27, 2004
AP + HOSPIRA 9MG/ML N018803 001 Oct 29, 1982
AP + 9MG/ML N019217 001 Jul 13, 1984
AP 9MG/ML N019465 002 Jul 15, 1985
AP + 900MG/100ML N016366 001
AP + 900MG/100ML N019465 001 Jul 15, 1985
AP + 900MG/100ML N019480 001 Sep 17, 1985
AP + TARO PHARMS IRELAND 9MG/ML A077407 001 Aug 11, 2006
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
XX + MALLINCKRODT 45MG/50ML (9MG/ML) N021569 001 Jul 27, 2006
XX 112.5MG/125ML (9MG/ML) N021569 002 Jul 27, 2006
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 3GM/100ML N019022 001 Nov 01, 1983
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 5GM/100ML N019022 002 Nov 01, 1983
SODIUM CHLORIDE IN PLASTIC CONTAINER
XX HOSPIRA 2.5MEQ/ML N018897 001 Jul 20, 1984
SOLUTION FOR SLUSH; IRRIGATION
SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER
XX BAXTER HLTHCARE 900MG/100ML N019319 002 May 17, 1985
SOLUTION; IRRIGATION
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 450MG/100ML N017864 001
AT HOSPIRA 450MG/100ML N017670 001
AT 450MG/100ML N018380 001
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AT B BRAUN 900MG/100ML N016733 001
AT BAXTER HLTHCARE 900MG/100ML N017427 001
AT 900MG/100ML N017867 001
AT HOSPIRA 900MG/100ML N017514 001
AT 900MG/100ML N018314 001

SODIUM CHROMATE CR-51


INJECTABLE; INJECTION

CHROMITOPE SODIUM

XX BRACCO 200uCi/ML N013993 001


SODIUM FERRIC GLUCONATE COMPLEX


INJECTABLE; INJECTION

FERRLECIT

XX + SANOFI AVENTIS US 62.5MG/5ML N020955 001 Feb 18, 1999

SODIUM IODIDE, I-123


CAPSULE; ORAL
SODIUM IODIDE I 123
AA + GE HEALTHCARE 100uCi N017630 001
AA MALLINCKRODT 100uCi A071909 001 Feb 28, 1989
AA 200uCi A071910 001 Feb 28, 1989
AA + SYNCOR PHARMS 100uCi N018671 001 May 27, 1982
AA + 200uCi N018671 002 May 27, 1982
SOLUTION; ORAL

SODIUM IODIDE I 123


XX + GE HEALTHCARE 2mCi/ML N017630 002


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 348 (of 393)

SODIUM IODIDE, I-131


CAPSULE; ORAL
HICON
XX DRAXIMAGE 100uCi N021305 004 Nov 18, 2004
SODIUM IODIDE I 131
XX + MALLINCKRODT 0.8-100mCi N016517 001
XX + 15-100uCi N016517 002
SOLUTION; ORAL

HICON

XX + DRAXIMAGE 1-250mCi/0.25ML N021305 002 Jan 24, 2003


XX + 1-500mCi/0.5ML N021305 003 Jan 24, 2003
SODIUM IODIDE I 131
XX + MALLINCKRODT 3.5-150mCi/VIAL N016515 001

SODIUM LACTATE
INJECTABLE; INJECTION
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 1.87GM/100ML N016692 001
SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER
AP B BRAUN 1.87GM/100ML N020004 001 Apr 21, 1992
SODIUM LACTATE IN PLASTIC CONTAINER
XX + HOSPIRA 5MEQ/ML N018947 001 Sep 05, 1984

SODIUM NITROPRUSSIDE
INJECTABLE; INJECTION
NITROPRESS
AP + HOSPIRA 25MG/ML A071961 001 Aug 01, 1988
SODIUM NITROPRUSSIDE
AP TEVA PARENTERAL 25MG/ML A073465 001 Mar 30, 1992

SODIUM OXYBATE
SOLUTION; ORAL

XYREM

XX + JAZZ 500MG/ML N021196 001 Jul 17, 2002

SODIUM PHENYLBUTYRATE
POWDER; ORAL

BUPHENYL

XX + MEDICIS 3GM/TEASPOONFUL N020573 001 Apr 30, 1996


TABLET; ORAL

BUPHENYL

XX + MEDICIS 500MG N020572 001 May 13, 1996

SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE


TABLET; ORAL

OSMOPREP

XX + SALIX PHARMS 0.398GM;1.102GM N021892 001 Mar 16, 2006


VISICOL
XX + SALIX PHARMS 0.398GM;1.102GM N021097 001 Sep 21, 2000

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS


INJECTABLE; INJECTION
SODIUM PHOSPHATES IN PLASTIC CONTAINER
XX HOSPIRA 142MG/ML;276MG/ML N018892 001 May 10, 1983

SODIUM POLYSTYRENE SULFONATE


POWDER; ORAL, RECTAL
KALEXATE
AA KVK TECH 454GM/BOT A040905 001 Mar 30, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 349 (of 393)

SODIUM POLYSTYRENE SULFONATE


POWDER; ORAL, RECTAL
KAYEXALATE
AA + SANOFI AVENTIS US 453.6GM/BOT N011287 001
KIONEX
AA PADDOCK 454GM/BOT A040029 001 Feb 06, 1998
SODIUM POLYSTYRENE SULFONATE
AA CAROLINA MEDCL 454GM/BOT A089910 001 Jan 19, 1989
AA CITRUSPHRMA 454GM/BOT A040909 001 Dec 03, 2008
SUSPENSION; ORAL, RECTAL
KIONEX
AA PADDOCK 15GM/60ML A040028 001 Sep 17, 2007
SODIUM POLYSTYRENE SULFONATE
AA ROXANE 15GM/60ML A089049 001 Nov 17, 1986
SPS
AA + CAROLINA MEDCL 15GM/60ML A087859 001 Dec 08, 1982

SODIUM TETRADECYL SULFATE


INJECTABLE; INJECTION
SOTRADECOL
XX BIONICHE PHARMA 20MG/2ML (10MG/ML) A040541 001 Nov 12, 2004
XX + 60MG/2ML (30MG/ML) A040541 002 Nov 12, 2004

SOLIFENACIN SUCCINATE
TABLET; ORAL
VESICARE
XX ASTELLAS 5MG N021518 001 Nov 19, 2004
XX + 10MG N021518 002 Nov 19, 2004

SOMATROPIN RECOMBINANT
INJECTABLE; INJECTION
GENOTROPIN
BX + PHARMACIA AND UPJOHN 5.8MG/VIAL N020280 006 Aug 24, 1995
GENOTROPIN PRESERVATIVE FREE
BX PHARMACIA AND UPJOHN 1.5MG/VIAL N020280 004 Aug 24, 1995
HUMATROPE
BX + LILLY 5MG/VIAL N019640 004 Mar 08, 1987
BX 6MG/VIAL N019640 005 Feb 04, 1999
NORDITROPIN
BX NOVO NORDISK INC 5MG/1.5ML N021148 001 Jun 20, 2000
BX 10MG/1.5ML N021148 002 Jun 20, 2000
NORDITROPIN NORDIFLEX
BX NOVO NORDISK INC 5MG/1.5ML N021148 004 Oct 01, 2004
BX 10MG/1.5ML N021148 005 Oct 01, 2004
NUTROPIN
BX GENENTECH 5MG/VIAL N020168 001 Nov 17, 1993
OMNITROPE
BX SANDOZ 1.5MG/VIAL N021426 002 May 30, 2006
BX 5MG/1.5ML N021426 003 Jan 16, 2008
BX 5.8MG/VIAL N021426 001 May 30, 2006
BX 10MG/1.5ML N021426 004 Aug 25, 2008
SAIZEN
BX EMD SERONO 5MG/VIAL N019764 002 Oct 08, 1996
SEROSTIM
BX EMD SERONO 4MG/VIAL N020604 003 Jul 25, 1997
BX 5MG/VIAL N020604 002 Aug 23, 1996
BX 6MG/VIAL N020604 001 Aug 23, 1996
TEV-TROPIN
BX + FERRING 5MG/VIAL N019774 002 Jan 04, 2002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 350 (of 393)

SOMATROPIN RECOMBINANT
INJECTABLE; INJECTION
VALTROPIN
BX LG LIFE 5MG/VIAL N021905 001 Apr 19, 2007
GENOTROPIN
XX + PHARMACIA AND UPJOHN 13.8MG/VIAL N020280 007 Oct 23, 1996
GENOTROPIN PRESERVATIVE FREE
XX PHARMACIA AND UPJOHN 0.2MG/VIAL N020280 001 Jan 27, 1998
XX 0.4MG/VIAL N020280 002 Jan 27, 1998
XX 0.6MG/VIAL N020280 003 Jan 27, 1998
XX 0.8MG/VIAL N020280 005 Jan 27, 1998
XX 1MG/VIAL N020280 008 Jan 27, 1998
XX 1.2MG/VIAL N020280 009 Jan 27, 1998
XX 1.4MG/VIAL N020280 010 Jan 27, 1998
XX 1.6MG/VIAL N020280 011 Jan 27, 1998
XX 1.8MG/VIAL N020280 012 Jan 27, 1998
XX + 2MG/VIAL N020280 013 Jan 27, 1998
HUMATROPE
XX + LILLY 12MG/VIAL N019640 006 Feb 04, 1999
XX + 24MG/VIAL N019640 007 Feb 04, 1999
NORDITROPIN
XX + NOVO NORDISK INC 15MG/1.5ML N021148 003 Jun 20, 2000
NORDITROPIN NORDIFLEX
XX NOVO NORDISK INC 15MG/1.5ML N021148 006 Oct 01, 2004
XX 30MG/3ML N021148 007 Mar 10, 2009
NUTROPIN
XX + GENENTECH 10MG/VIAL N020168 002 Nov 17, 1993
NUTROPIN AQ
XX + GENENTECH 5MG/2ML (2.5MG/ML) N020522 003 Jan 03, 2008
XX + 10MG/2ML (5MG/ML) N020522 001 Dec 29, 1995
XX + 20MG/2ML (10MG/ML) N020522 004 Jan 03, 2008
NUTROPIN AQ PEN
XX + GENENTECH 10MG/2ML (5MG/ML) N020522 002 Apr 22, 2002
SAIZEN
XX + EMD SERONO 8.8MG/VIAL N019764 003 Aug 29, 2000
ZORBTIVE
XX + EMD SERONO 8.8MG/VIAL N021597 004 Dec 01, 2003

SORAFENIB TOSYLATE
TABLET; ORAL
NEXAVAR
XX + BAYER HLTHCARE EQ 200MG BASE N021923 001 Dec 20, 2005

SORBITOL
SOLUTION; IRRIGATION
SORBITOL 3% IN PLASTIC CONTAINER
XX BAXTER HLTHCARE 3GM/100ML N017863 001
SORBITOL 3.3% IN PLASTIC CONTAINER
XX B BRAUN 3.3GM/100ML N016741 001

SOTALOL HYDROCHLORIDE
SOLUTION; INTRAVENOUS
SOTALOL HYDROCHLORIDE
XX + ACADEMIC PHARMS 150MG/10ML (15MG/ML) N022306 001 Jul 02, 2009
TABLET; ORAL
BETAPACE
AB1 BAYER HLTHCARE 80MG N019865 001 Oct 30, 1992
AB1 120MG N019865 005 Apr 20, 1994
AB1 + 160MG N019865 002 Oct 30, 1992
AB1 240MG N019865 003 Oct 30, 1992
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 351 (of 393)

SOTALOL HYDROCHLORIDE
TABLET; ORAL
SORINE
AB1 UPSHER SMITH 80MG A075500 001 Apr 27, 2001
AB1 120MG A075500 004 Apr 27, 2001
AB1 160MG A075500 002 Apr 27, 2001
AB1 240MG A075500 003 Apr 27, 2001
SOTALOL HYDROCHLORIDE
AB1 APOTEX INC 80MG A076140 001 Sep 26, 2002
AB1 120MG A076140 002 Sep 26, 2002
AB1 160MG A076140 003 Sep 26, 2002
AB1 240MG A076140 004 Sep 26, 2002
AB1 IMPAX PHARMS 80MG A075663 001 Nov 07, 2000
AB1 120MG A075663 002 Nov 07, 2000
AB1 160MG A075663 003 Nov 07, 2000
AB1 240MG A075663 004 Nov 07, 2000
AB1 MYLAN 80MG A075237 001 May 01, 2000
AB1 80MG A075725 001 Dec 19, 2000
AB1 120MG A075237 002 May 01, 2000
AB1 120MG A075725 002 Dec 19, 2000
AB1 160MG A075237 003 May 01, 2000
AB1 160MG A075725 003 Dec 19, 2000
AB1 240MG A075237 004 May 01, 2000
AB1 240MG A075725 004 Dec 19, 2000
AB1 SANDOZ 80MG A075366 001 May 01, 2000
AB1 120MG A075366 002 May 01, 2000
AB1 160MG A075366 003 May 01, 2000
AB1 240MG A075366 004 May 01, 2000
AB1 TEVA 80MG A075429 001 May 01, 2000
AB1 120MG A075429 002 May 01, 2000
AB1 160MG A075429 003 May 01, 2000
AB1 240MG A075429 004 May 01, 2000
AB1 VINTAGE PHARMS 80MG A075563 001 Nov 07, 2003
AB1 120MG A075563 002 Nov 07, 2003
AB1 160MG A075563 003 Nov 07, 2003
AB1 240MG A075563 004 Nov 07, 2003
BETAPACE AF
AB2 BAYER HLTHCARE 80MG N021151 001 Feb 22, 2000
AB2 120MG N021151 002 Feb 22, 2000
AB2 + 160MG N021151 003 Feb 22, 2000
SOTALOL HYDROCHLORIDE
AB2 AMNEAL PHARM 80MG A077070 001 Nov 04, 2005
AB2 120MG A077070 002 Nov 04, 2005
AB2 160MG A077070 003 Nov 04, 2005
AB2 APOTEX 80MG A076214 001 Aug 27, 2003
AB2 120MG A076214 002 Aug 27, 2003
AB2 160MG A076214 003 Aug 27, 2003
AB2 MYLAN 80MG A077616 001 Feb 07, 2007
AB2 120MG A077616 002 Feb 07, 2007
AB2 160MG A077616 003 Feb 07, 2007
AB2 TEVA 80MG A076883 001 Jul 26, 2004
AB2 120MG A076883 002 Jul 26, 2004
AB2 160MG A076883 003 Jul 26, 2004

SOYBEAN OIL
INJECTABLE; INJECTION
INTRALIPID 10%
AP + FRESENIUS 10% N017643 001
INTRALIPID 20%
AP + FRESENIUS 20% N018449 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 352 (of 393)

SOYBEAN OIL
INJECTABLE; INJECTION
INTRALIPID 20%
AP + FRESENIUS 20% N020248 001 Aug 07, 1996
INTRALIPID 30%
AP + FRESENIUS 30% N019942 001 Dec 30, 1993
LIPOSYN III 10%
AP + HOSPIRA 10% N018969 001 Sep 24, 1984
LIPOSYN III 20%
AP + HOSPIRA 20% N018970 001 Sep 25, 1984
LIPOSYN III 30%
AP + HOSPIRA 30% N020181 001 Jan 13, 1998
NUTRILIPID 10%
AP + B BRAUN 10% N019531 001 May 28, 1993
NUTRILIPID 20%
AP + B BRAUN 20% N019531 002 May 28, 1993

SPECTINOMYCIN HYDROCHLORIDE
INJECTABLE; INJECTION

TROBICIN

XX + PHARMACIA AND UPJOHN EQ 2GM BASE/VIAL N050347 001

SPIRONOLACTONE
TABLET; ORAL
ALDACTONE
AB GD SEARLE LLC 25MG N012151 009 Dec 30, 1983
AB 50MG N012151 008 Dec 30, 1982
AB + 100MG N012151 010 Dec 30, 1983
SPIRONOLACTONE
AB ACTAVIS ELIZABETH 25MG A040353 003 Mar 15, 2006
AB 50MG A040353 001 Jul 29, 1999
AB 100MG A040353 002 Jul 29, 1999
AB MUTUAL PHARM 25MG A089424 001 Jul 23, 1986
AB 50MG A089424 002 Aug 11, 1999
AB 100MG A089424 003 Aug 11, 1999
AB MYLAN 25MG A040424 001 Aug 20, 2001
AB 50MG A040424 002 Aug 20, 2001
AB 100MG A040424 003 Aug 20, 2001
AB SANDOZ 25MG A086809 001
AB VINTAGE 25MG A040750 001 Aug 29, 2006
AB 50MG A040750 002 Aug 29, 2006
AB 100MG A040750 003 Aug 29, 2006

STAVUDINE
CAPSULE; ORAL
STAVUDINE
AB AUROBINDO PHARMA 15MG A077672 003 Dec 29, 2008
AB 20MG A077672 004 Dec 29, 2008
AB 30MG A077672 001 Dec 29, 2008
AB 40MG A077672 002 Dec 29, 2008
AB HETERO DRUGS 15MG A078957 001 Dec 29, 2008
AB 20MG A078957 002 Dec 29, 2008
AB 30MG A078957 003 Dec 29, 2008
AB 40MG A078957 004 Dec 29, 2008
AB MATRIX LABS INC 15MG A079069 001 Dec 29, 2008
AB 20MG A079069 002 Dec 29, 2008
AB 30MG A079069 003 Dec 29, 2008
AB 40MG A079069 004 Dec 29, 2008
AB MATRIX LABS LTD 30MG A078775 001 Jan 05, 2009
AB 40MG A078775 002 Jan 05, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 353 (of 393)

STAVUDINE
CAPSULE; ORAL
ZERIT
AB BRISTOL MYERS SQUIBB 15MG N020412 002 Jun 24, 1994
AB 20MG N020412 003 Jun 24, 1994
AB 30MG N020412 004 Jun 24, 1994
AB + 40MG N020412 005 Jun 24, 1994
FOR SOLUTION; ORAL
STAVUDINE
AA AUROBINDO PHARMA 1MG/ML A077774 001 Dec 29, 2008
AA CIPLA LTD 1MG/ML A078030 001 Mar 20, 2009
ZERIT
AA + BRISTOL MYERS SQUIBB 1MG/ML N020413 001 Sep 06, 1996

STREPTOMYCIN SULFATE
INJECTABLE; INJECTION

STREPTOMYCIN SULFATE

XX + PFIZER EQ 1GM BASE/2.5ML A060111 001


XX + X GEN PHARMS EQ 1GM BASE/VIAL A064210 001 Jun 30, 1998

STREPTOZOCIN
INJECTABLE; INJECTION

ZANOSAR

XX + TEVA PARENTERAL 1GM/VIAL N050577 001 May 07, 1982

STRONTIUM CHLORIDE, SR-89


INJECTABLE; INJECTION
METASTRON
AP + GE HEALTHCARE 1mCi/ML N020134 001 Jun 18, 1993
STRONTIUM CHLORIDE SR-89
AP BIO NUCLEONICS 1mCi/ML A075941 001 Jan 06, 2003

SUCCIMER
CAPSULE; ORAL

CHEMET

XX + LUNDBECK INC 100MG N019998 002 Jan 30, 1991

SUCCINYLCHOLINE CHLORIDE
INJECTABLE; INJECTION
ANECTINE
AP + SANDOZ 20MG/ML N008453 002
QUELICIN
AP + HOSPIRA 20MG/ML N008845 006
QUELICIN PRESERVATIVE FREE
AP + HOSPIRA 20MG/ML N008845 001
QUELICIN PRESERVATIVE FREE
XX + HOSPIRA 100MG/ML N008845 004

SUCRALFATE
SUSPENSION; ORAL

CARAFATE

XX + AXCAN 1GM/10ML N019183 001 Dec 16, 1993


TABLET; ORAL
CARAFATE
AB + AXCAN 1GM N018333 001
SUCRALFATE
AB RATIOPHARM 1GM A074415 001 Jun 08, 1998
AB TEVA 1GM A070848 001 Mar 29, 1996
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 354 (of 393)

SUFENTANIL CITRATE
INJECTABLE; INJECTION
SUFENTA PRESERVATIVE FREE
AP + AKORN EQ 0.05MG BASE/ML N019050 001 May 04, 1984
SUFENTANIL CITRATE
AP BAXTER HLTHCARE EQ 0.05MG BASE/ML A074413 001 Dec 15, 1995
AP HOSPIRA EQ 0.05MG BASE/ML A074534 001 Dec 11, 1996

SULCONAZOLE NITRATE
CREAM; TOPICAL

EXELDERM

XX + RANBAXY 1% N018737 001 Feb 28, 1989


SOLUTION; TOPICAL

EXELDERM

XX + RANBAXY 1% N018738 001 Aug 30, 1985

SULFACETAMIDE SODIUM
LOTION; TOPICAL

KLARON

AB + SANOFI AVENTIS US 10% N019931 001 Dec 23, 1996


SULFACETAMIDE SODIUM
AB ALTANA 10% A077015 001 Nov 17, 2006
AB PERRIGO CO TENNESSEE 10% A078649 001 Mar 23, 2009
AB TARO 10% A078668 001 May 20, 2009
OINTMENT; OPHTHALMIC
CETAMIDE
AT + ALCON 10% A080021 001
SULFACETAMIDE SODIUM
AT ALTANA 10% A080029 001
SOLUTION/DROPS; OPHTHALMIC
BLEPH-10
AT + ALLERGAN 10% A080028 001
SULFACETAMIDE SODIUM
AT ALCON UNIVERSAL 10% A089560 001 Oct 18, 1988
AT BAUSCH AND LOMB 10% A040066 001 Dec 28, 1994

SULFADIAZINE
TABLET; ORAL

SULFADIAZINE

XX + SANDOZ 500MG A040091 001 Jul 29, 1994

SULFAMETHOXAZOLE; TRIMETHOPRIM
INJECTABLE; INJECTION

SULFAMETHOXAZOLE AND TRIMETHOPRIM


XX + TEVA PARENTERAL 80MG/ML;16MG/ML A073303 001 Oct 31, 1991


SUSPENSION; ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIM
AB HI TECH PHARMA 200MG/5ML;40MG/5ML A074650 001 Dec 29, 1997
AB + TEVA PHARMS 200MG/5ML;40MG/5ML A077612 001 Nov 13, 2006
AB VINTAGE 200MG/5ML;40MG/5ML A077785 001 Jan 24, 2007
SULFATRIM PEDIATRIC
AB ACTAVIS MID ATLANTIC 200MG/5ML;40MG/5ML N018615 001 Jan 07, 1983
TABLET; ORAL
BACTRIM
AB MUTUAL PHARM 400MG;80MG N017377 001
BACTRIM DS
AB + MUTUAL PHARM 800MG;160MG N017377 002
SEPTRA
AB MONARCH PHARMS 400MG;80MG N017376 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 355 (of 393)

SULFAMETHOXAZOLE; TRIMETHOPRIM
TABLET; ORAL
SEPTRA DS
AB MONARCH PHARMS 800MG;160MG N017376 002
SULFAMETHOPRIM
AB PAR PHARM 400MG;80MG A070022 001 Feb 15, 1985
SULFAMETHOPRIM-DS
AB PAR PHARM 800MG;160MG A070032 001 Feb 15, 1985
SULFAMETHOXAZOLE AND TRIMETHOPRIM
AB AMNEAL PHARMS NY 400MG;80MG A076899 001 Jan 27, 2005
AB 800MG;160MG A076899 002 Jan 27, 2005
AB MUTUAL PHARM 800MG;160MG A071017 001 Aug 25, 1986
AB VINTAGE 400MG;80MG A078060 002 Jan 25, 2007
AB 800MG;160MG A078060 001 Jan 25, 2007
AB VISTA PHARMS 400MG;80MG A076817 001 Oct 07, 2005
AB 800MG;160MG A076817 002 Oct 07, 2005
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
AB SANDOZ 800MG;160MG N018598 004 May 19, 1982
AB TEVA 800MG;160MG A070037 001 Jun 02, 1987
SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH
AB PLANTEX 400MG;80MG A070030 001 Jun 02, 1987

SULFANILAMIDE
CREAM; VAGINAL

AVC

XX + AZUR PHARMA 15% N006530 003 Jan 27, 1987

SULFASALAZINE
SUSPENSION; ORAL

AZULFIDINE

XX + PHARMACIA AND UPJOHN 250MG/5ML A086983 001


TABLET; ORAL
AZULFIDINE
AB + PHARMACIA AND UPJOHN 500MG N007073 001
SULFASALAZINE
AB VINTAGE PHARMS 500MG A040349 001 Jan 11, 2002
AB WATSON LABS 500MG A085828 001
AB 500MG A087197 001
TABLET, DELAYED RELEASE; ORAL
AZULFIDINE EN-TABS
AB + PHARMACIA AND UPJOHN 500MG N007073 002 Apr 06, 1983
SULFASALAZINE
AB VINTAGE PHARMS 500MG A075339 001 Jan 11, 2002

SULFISOXAZOLE
TABLET; ORAL

SULFISOXAZOLE

XX + IVAX SUB TEVA PHARMS 500MG A080142 001

SULINDAC
TABLET; ORAL
CLINORIL
AB + MERCK 200MG N017911 002
SULINDAC
AB EPIC PHARMA 150MG A072710 001 Mar 25, 1991
AB 200MG A072711 001 Mar 25, 1991
AB MUTUAL PHARM 150MG A072050 001 Apr 17, 1991
AB 200MG A072051 001 Apr 17, 1991
AB MYLAN 150MG A073039 002 Jun 22, 1993
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 356 (of 393)

SULINDAC
TABLET; ORAL
SULINDAC
AB MYLAN 200MG A073039 001 Jun 22, 1993
AB WATSON LABS 150MG A071891 001 Apr 03, 1990
AB 200MG A071795 001 Apr 03, 1990

SUMATRIPTAN
SPRAY; NASAL

IMITREX

XX + GLAXOSMITHKLINE 5MG/SPRAY N020626 001 Aug 26, 1997


XX + 10MG/SPRAY N020626 002 Aug 26, 1997
XX + 20MG/SPRAY N020626 003 Aug 26, 1997

SUMATRIPTAN SUCCINATE
INJECTABLE; SUBCUTANEOUS
IMITREX
AP + GLAXOSMITHKLINE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) N020080 001 Dec 28, 1992
SUMATRIPTAN SUCCINATE
AP APP PHARMS EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A079242 001 Mar 02, 2009
AP EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A079240 002 Sep 18, 2009
AP EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) A079240 001 Sep 18, 2009
AP BEDFORD EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A079123 001 Feb 06, 2009
AP JHP PHARMS EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A077871 001 Jul 09, 2009
AP PAR PHARM EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A077332 001 Oct 09, 2009
AP SANDOZ EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) A078067 002 Feb 06, 2009
AP EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A078067 001 Feb 06, 2009
AP TEVA PARENTERAL EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) A078318 001 Feb 06, 2009
AP EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A078318 002 Feb 06, 2009
AP EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A077907 001 Feb 06, 2009
AP WOCKHARDT EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A078593 001 Feb 06, 2009
IMITREX STATDOSE
XX + GLAXOSMITHKLINE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) N020080 002 Feb 01, 2006
XX + EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) N020080 003 Dec 23, 1996
SUMAVEL DOSEPRO
XX + ZOGENIX INC EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML) N022239 001 Jul 15, 2009
TABLET; ORAL
IMITREX
AB GLAXOSMITHKLINE EQ 25MG BASE N020132 002 Jun 01, 1995
AB EQ 50MG BASE N020132 003 Jun 01, 1995
AB + EQ 100MG BASE N020132 001 Jun 01, 1995
SUMATRIPTAN SUCCINATE
AB AUROBINDO PHARMA EQ 25MG BASE A078327 001 Aug 10, 2009
AB EQ 50MG BASE A078327 002 Aug 10, 2009
AB EQ 100MG BASE A078327 003 Aug 10, 2009
AB COBALT LABS INC EQ 25MG BASE A076933 001 Aug 10, 2009
AB EQ 50MG BASE A076933 002 Aug 10, 2009
AB EQ 100MG BASE A076933 003 Aug 10, 2009
AB DR REDDYS LABS INC EQ 25MG BASE A076847 001 Aug 10, 2009
AB EQ 50MG BASE A076847 002 Aug 10, 2009
AB EQ 100MG BASE A076847 003 Aug 10, 2009
AB MYLAN EQ 25MG BASE A077163 001 Nov 02, 2009
AB EQ 25MG BASE A077744 001 Aug 10, 2009
AB EQ 50MG BASE A077163 002 Nov 02, 2009
AB EQ 50MG BASE A077744 002 Aug 10, 2009
AB EQ 100MG BASE A077163 003 Nov 02, 2009
AB EQ 100MG BASE A077744 003 Aug 10, 2009
AB ORCHID HLTHCARE EQ 25MG BASE A078284 001 Aug 10, 2009
AB EQ 50MG BASE A078284 002 Aug 10, 2009
AB EQ 100MG BASE A078284 003 Aug 10, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 357 (of 393)

SUMATRIPTAN SUCCINATE
TABLET; ORAL
SUMATRIPTAN SUCCINATE
AB RANBAXY EQ 25MG BASE A076554 001 Aug 10, 2009
AB EQ 50MG BASE A076554 002 Aug 10, 2009
AB EQ 100MG BASE A076572 001 Feb 09, 2009
AB ROXANE EQ 25MG BASE A078241 001 Aug 10, 2009
AB EQ 50MG BASE A078241 002 Aug 10, 2009
AB EQ 100MG BASE A078241 003 Aug 10, 2009
AB SANDOZ EQ 25MG BASE A076976 001 Aug 10, 2009
AB EQ 50MG BASE A076976 002 Aug 10, 2009
AB EQ 100MG BASE A076976 003 Aug 10, 2009
AB SUN PHARM INDS EQ 25MG BASE A078295 001 Aug 10, 2009
AB EQ 50MG BASE A078295 002 Aug 10, 2009
AB EQ 100MG BASE A078295 003 Aug 10, 2009
AB TEVA EQ 25MG BASE A076840 001 Feb 09, 2009
AB EQ 50MG BASE A076840 002 Feb 09, 2009
AB EQ 100MG BASE A076840 003 Feb 09, 2009

SUNITINIB MALATE
CAPSULE; ORAL
SUTENT
XX CPPI CV EQ 12.5MG BASE N021938 001 Jan 26, 2006
XX EQ 25MG BASE N021938 002 Jan 26, 2006
XX EQ 37.5MG BASE N021938 004 Mar 31, 2009
XX + EQ 50MG BASE N021938 003 Jan 26, 2006

TACRINE HYDROCHLORIDE
CAPSULE; ORAL
COGNEX
XX SCIELE PHARMA INC EQ 10MG BASE N020070 001 Sep 09, 1993
XX EQ 20MG BASE N020070 002 Sep 09, 1993
XX EQ 30MG BASE N020070 003 Sep 09, 1993
XX + EQ 40MG BASE N020070 004 Sep 09, 1993

TACROLIMUS
CAPSULE; ORAL
PROGRAF
AB ASTELLAS EQ 0.5MG BASE N050708 003 Aug 24, 1998
AB EQ 1MG BASE N050708 001 Apr 08, 1994
AB + EQ 5MG BASE N050708 002 Apr 08, 1994
TACROLIMUS
AB SANDOZ EQ 0.5MG BASE A065461 001 Aug 10, 2009
AB EQ 1MG BASE A065461 002 Aug 10, 2009
AB EQ 5MG BASE A065461 003 Aug 10, 2009
INJECTABLE; INJECTION

PROGRAF

XX + ASTELLAS EQ 5MG BASE/ML N050709 001 Apr 08, 1994


OINTMENT; TOPICAL
PROTOPIC
XX ASTELLAS 0.03% N050777 001 Dec 08, 2000
XX + 0.1% N050777 002 Dec 08, 2000

TADALAFIL
TABLET; ORAL

ADCIRCA

XX + ELI LILLY CO 20MG N022332 001 May 22, 2009


CIALIS
XX LILLY 2.5MG N021368 004 Jan 07, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 358 (of 393)

TADALAFIL
TABLET; ORAL
CIALIS
XX LILLY 5MG N021368 001 Nov 21, 2003
XX 10MG N021368 002 Nov 21, 2003
XX + 20MG N021368 003 Nov 21, 2003

TALC
AEROSOL, METERED; INTRAPLEURAL

SCLEROSOL

XX + BRYAN 400MG/SPRAY N020587 001 Dec 24, 1997


POWDER; INTRAPLEURAL

TALC

XX + BRYAN 5GM/BOT N021388 001 Dec 15, 2003

TAMOXIFEN CITRATE
TABLET; ORAL
TAMOXIFEN CITRATE
AB AEGIS PHARMS EQ 10MG BASE A076398 001 Mar 31, 2003
AB EQ 20MG BASE A076398 002 Mar 31, 2003
AB MYLAN EQ 10MG BASE A074732 002 Feb 20, 2003
AB EQ 20MG BASE A074732 001 Feb 20, 2003
AB TEVA EQ 10MG BASE A075797 001 Feb 20, 2003
AB + TEVA PHARMS EQ 20MG BASE A074858 001 Feb 20, 2003
AB WATSON LABS EQ 10MG BASE A070929 001 Feb 20, 2003
AB EQ 20MG BASE A070929 002 Feb 20, 2003
AB WATSON LABS FLORIDA EQ 10MG BASE A076179 001 Feb 20, 2003
AB EQ 20MG BASE A076179 002 Feb 20, 2003

TAMSULOSIN HYDROCHLORIDE
CAPSULE; ORAL

FLOMAX

XX + BOEHRINGER INGELHEIM 0.4MG N020579 001 Apr 15, 1997

TAPENTADOL HYDROCHLORIDE
TABLET; ORAL
NUCYNTA
XX ORTHO MCNEIL JANSSEN EQ 50MG BASE N022304 001 Nov 20, 2008
XX EQ 75MG BASE N022304 002 Nov 20, 2008
XX + EQ 100MG BASE N022304 003 Nov 20, 2008

TAZAROTENE
CREAM; TOPICAL

AVAGE

XX + ALLERGAN 0.1% N021184 003 Sep 30, 2002


TAZORAC
XX + ALLERGAN 0.05% N021184 001 Sep 29, 2000
XX + 0.1% N021184 002 Sep 29, 2000
GEL; TOPICAL

TAZORAC

XX + ALLERGAN 0.05% N020600 001 Jun 13, 1997


XX + 0.1% N020600 002 Jun 13, 1997

TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT


INJECTABLE; INJECTION
PULMOLITE
BS PHARMALUCENCE N/A N017776 001
TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT
BS DRAXIMAGE N/A N017881 001 Dec 30, 1987
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 359 (of 393)

TECHNETIUM TC-99M BICISATE KIT


INJECTABLE; INJECTION
NEUROLITE
XX LANTHEUS MEDCL N/A N020256 001 Nov 23, 1994

TECHNETIUM TC-99M DISOFENIN KIT


INJECTABLE; INJECTION
HEPATOLITE
XX PHARMALUCENCE N/A N018467 001 Mar 16, 1982

TECHNETIUM TC-99M EXAMETAZIME KIT


INJECTABLE; INJECTION

CERETEC

XX + GE HEALTHCARE N/A N019829 001 Dec 30, 1988

TECHNETIUM TC-99M MEBROFENIN KIT


INJECTABLE; INJECTION
CHOLETEC
AP + BRACCO N/A N018963 001 Jan 21, 1987
TECHNETIUM TC-99M MEBROFENIN
AP PHARMALUCENCE N/A A078242 001 Jan 29, 2008

TECHNETIUM TC-99M MEDRONATE KIT


INJECTABLE; INJECTION
CIS-MDP
AP PHARMALUCENCE N/A N018124 001
MDP-BRACCO
AP BRACCO N/A N018107 001
DRAXIMAGE MDP-10
XX + DRAXIMAGE N/A N018035 001

TECHNETIUM TC-99M MERTIATIDE KIT


INJECTABLE; INJECTION
TECHNESCAN MAG3
XX MALLINCKRODT N/A N019882 001 Jun 15, 1990

TECHNETIUM TC-99M OXIDRONATE KIT


INJECTABLE; INJECTION

TECHNESCAN

XX + MALLINCKRODT N/A N018321 001

TECHNETIUM TC-99M PENTETATE KIT


INJECTABLE; INJECTION
AN-DTPA
AP PHARMALUCENCE N/A N017714 001
DTPA
AP DRAXIMAGE N/A N018511 001 Dec 29, 1989
TECHNETIUM TC-99M PENTETATE KIT
AP GE HEALTHCARE N/A N017264 002

TECHNETIUM TC-99M PYROPHOSPHATE KIT


INJECTABLE; INJECTION
CIS-PYRO
AP PHARMALUCENCE N/A N019039 001 Jun 30, 1987
TECHNESCAN PYP KIT
AP MALLINCKRODT N/A N017538 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 360 (of 393)

TECHNETIUM TC-99M RED BLOOD CELL KIT


INJECTABLE; INJECTION

ULTRATAG

XX MALLINCKRODT N/A
N019981 001 Jun 10, 1991

TECHNETIUM TC-99M SESTAMIBI KIT


INJECTABLE; INJECTION
CARDIOLITE
AP + LANTHEUS MEDCL N/A N019785 001 Dec 21, 1990
TECHNETIUM TC 99M SESTAMIBI
AP CARDINAL HEALTH 414 N/A A078809 001 Apr 28, 2009
AP DRAXIMAGE N/A A078806 001 Apr 29, 2009
AP PHARMALUCENCE 10-30mCi A079157 001 Jul 10, 2009
TECHNETIUM TC-99 SESTAMIBI
AP MALLINCKRODT N/A A078098 001 Sep 22, 2008

TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR


SOLUTION; INJECTION, ORAL

TECHNELITE

XX LANTHEUS MEDCL 0.0083-2.7 CI/GENERATOR N017771 001

ULTRA-TECHNEKOW FM

XX MALLINCKRODT 0.25-3 CI/GENERATOR N017243 002

TECHNETIUM TC-99M SUCCIMER KIT


INJECTABLE; INJECTION
MPI DMSA KIDNEY REAGENT
XX GE HEALTHCARE N/A N017944 001 May 18, 1982

TECHNETIUM TC-99M SULFUR COLLOID KIT


SOLUTION; INJECTION, ORAL

AN-SULFUR COLLOID

XX + PHARMALUCENCE N/A N017858 001

TECHNETIUM TC-99M TETROFOSMIN KIT


INJECTABLE; INJECTION

MYOVIEW

XX + GE HEALTHCARE N/A N020372 001 Feb 09, 1996


MYOVIEW 30ML
XX + GE HEALTHCARE N/A N020372 002 Jul 07, 2005

TELAVANCIN HYDROCHLORIDE
POWDER; IV (INFUSION)
VIBATIV
XX THERAVANCE INC EQ 250MG BASE/VIAL N022110 001 Sep 11, 2009
XX + EQ 750MG BASE/VIAL N022110 002 Sep 11, 2009

TELBIVUDINE
SOLUTION; ORAL

TYZEKA

XX + NOVARTIS 100MG/5ML N022154 001 Apr 28, 2009


TABLET; ORAL

TYZEKA

XX + NOVARTIS 600MG N022011 001 Oct 25, 2006

TELITHROMYCIN
TABLET; ORAL
KETEK
XX SANOFI AVENTIS US 300MG N021144 002 Feb 09, 2005

XX + 400MG N021144 001 Apr 01, 2004

30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 361 (of 393)

TELMISARTAN
TABLET; ORAL
MICARDIS
XX BOEHRINGER INGELHEIM 20MG N020850 003 Apr 04, 2000
XX 40MG N020850 001 Nov 10, 1998
XX + 80MG N020850 002 Nov 10, 1998

TEMAZEPAM
CAPSULE; ORAL
RESTORIL
AB TYCO HLTHCARE 7.5MG N018163 003 Oct 25, 1991
AB 15MG N018163 001
AB 22.5MG N018163 004 Nov 02, 2004
AB + 30MG N018163 002
TEMAZEPAM
AB ACTAVIS ELIZABETH 15MG A071638 001 Aug 07, 1987
AB 30MG A071620 001 Aug 07, 1987
AB MUTUAL PHARM 7.5MG A078581 001 Sep 08, 2009
AB 22.5MG A071175 002 Sep 14, 2009
AB MYLAN 15MG A070920 004 Jul 07, 1986
AB 22.5MG A070920 003 Jun 12, 2009
AB 30MG A070920 001 Jul 10, 1986
AB NOVEL LABS INC 15MG A071456 001 Apr 21, 1987
AB 30MG A071457 001 Apr 21, 1987
AB SANDOZ 15MG A071427 001 Jan 12, 1988
AB 30MG A071428 001 Jan 12, 1988
AB WATSON LABS 15MG A071446 001 May 21, 1993
AB 30MG A071447 001 May 21, 1993

TEMOZOLOMIDE
CAPSULE; ORAL
TEMODAR
XX SCHERING 5MG N021029 001 Aug 11, 1999
XX 20MG N021029 002 Aug 11, 1999
XX 100MG N021029 003 Aug 11, 1999
XX 140MG N021029 005 Oct 19, 2006
XX 180MG N021029 006 Oct 19, 2006
XX + 250MG N021029 004 Aug 11, 1999
POWDER; INTRAVENOUS

TEMODAR

XX + SCHERING 100MG/VIAL N022277 001 Feb 27, 2009

TEMSIROLIMUS
SOLUTION; INTRAVENOUS

TORISEL

XX + WYETH PHARMS INC 25MG/ML (25MG/ML) N022088 001 May 30, 2007

TENIPOSIDE
INJECTABLE; INJECTION

VUMON

XX + BRISTOL MYERS SQUIBB 10MG/ML N020119 001 Jul 14, 1992

TENOFOVIR DISOPROXIL FUMARATE


TABLET; ORAL

VIREAD

XX + GILEAD 300MG N021356 001 Oct 26, 2001


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 362 (of 393)

TERAZOSIN HYDROCHLORIDE
CAPSULE; ORAL
HYTRIN
AB ABBOTT EQ 1MG BASE N020347 001 Dec 14, 1994
AB + EQ 2MG BASE N020347 002 Dec 14, 1994
AB EQ 5MG BASE N020347 003 Dec 14, 1994
AB EQ 10MG BASE N020347 004 Dec 14, 1994
TERAZOSIN HYDROCHLORIDE
AB APOTEX EQ 1MG BASE A075498 001 Apr 12, 2001
AB EQ 2MG BASE A075498 002 Apr 12, 2001
AB EQ 5MG BASE A075498 003 Apr 12, 2001
AB EQ 10MG BASE A075498 004 Apr 12, 2001
AB CADISTA PHARMS EQ 1MG BASE A075317 001 Dec 20, 2004
AB EQ 2MG BASE A075317 002 Dec 20, 2004
AB EQ 5MG BASE A075317 003 Dec 20, 2004
AB EQ 10MG BASE A075317 004 Dec 20, 2004
AB IVAX SUB TEVA PHARMS EQ 1MG BASE A075614 002 Jan 30, 2001
AB EQ 2MG BASE A075614 001 Jan 30, 2001
AB EQ 5MG BASE A075614 003 Jan 30, 2001
AB EQ 10MG BASE A075614 004 Jan 30, 2001
AB MYLAN EQ 1MG BASE A075140 002 Feb 11, 2000
AB EQ 2MG BASE A075140 003 Feb 11, 2000
AB EQ 5MG BASE A075140 001 Feb 11, 2000
AB EQ 10MG BASE A075140 004 Feb 11, 2000
AB RANBAXY EQ 1MG BASE A076021 001 Aug 22, 2002
AB EQ 2MG BASE A076021 002 Aug 22, 2002
AB EQ 5MG BASE A076021 003 Aug 22, 2002
AB EQ 10MG BASE A076021 004 Aug 22, 2002
AB SANDOZ EQ 1MG BASE A074823 001 Mar 30, 1998
AB EQ 2MG BASE A074823 002 Mar 30, 1998
AB EQ 5MG BASE A074823 003 Mar 30, 1998
AB EQ 10MG BASE A074823 004 Mar 30, 1998
TABLET; ORAL
HYTRIN
XX ABBOTT EQ 1MG BASE N019057 001 Aug 07, 1987
XX + EQ 2MG BASE N019057 002 Aug 07, 1987
XX EQ 5MG BASE N019057 003 Aug 07, 1987
XX EQ 10MG BASE N019057 004 Aug 07, 1987

TERBINAFINE
GEL; TOPICAL
LAMISIL
XX NOVARTIS 1% N020846 001 Apr 29, 1998

TERBINAFINE HYDROCHLORIDE
GRANULE; ORAL
LAMISIL
XX NOVARTIS EQ 125MG BASE/PACKET N022071 001 Sep 28, 2007
XX + EQ 187.5MG BASE/PACKET N022071 002 Sep 28, 2007
SOLUTION; TOPICAL

LAMISIL

XX + NOVARTIS 1% N020749 001 Oct 17, 1997


TABLET; ORAL
LAMISIL
AB + NOVARTIS EQ 250MG BASE N020539 001 May 10, 1996
TERBINAFINE HYDROCHLORIDE
AB APOTEX EQ 250MG BASE A078199 001 Jul 02, 2007
AB AUROBINDO PHARMA EQ 250MG BASE A078297 001 Jul 02, 2007
AB DR REDDYS LABS INC EQ 250MG BASE A076390 001 Jul 02, 2007
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 363 (of 393)

TERBINAFINE HYDROCHLORIDE
TABLET; ORAL
TERBINAFINE HYDROCHLORIDE
AB GEDEON RICHTER USA EQ 250MG BASE A077065 001 Jul 02, 2007
AB GENPHARM EQ 250MG BASE A077136 001 Jul 02, 2007
AB GLENMARK GENERICS EQ 250MG BASE A078157 001 Jul 02, 2007
AB HARRIS PHARM EQ 250MG BASE A077919 001 Jul 02, 2007
AB INVAGEN PHARMS EQ 250MG BASE A077533 001 Jul 02, 2007
AB MYLAN EQ 250MG BASE A077195 001 Jul 02, 2007
AB ORCHID HLTHCARE EQ 250MG BASE A078163 001 Jul 02, 2007
AB ROXANE EQ 250MG BASE A077223 001 Jul 02, 2007
AB TEVA EQ 250MG BASE A076377 001 Jul 02, 2007
AB WATSON LABS EQ 250MG BASE A077137 001 Jul 02, 2007
AB WOCKHARDT EQ 250MG BASE A078229 001 Jul 02, 2007

TERBUTALINE SULFATE
INJECTABLE; INJECTION
TERBUTALINE SULFATE
AP AKORN 1MG/ML A078151 001 Jan 07, 2008
AP APP PHARMS 1MG/ML A076887 001 May 26, 2004
AP + BEDFORD 1MG/ML A076770 001 Apr 23, 2004
AP HIKMA FARMACEUTICA 1MG/ML A078630 001 May 20, 2009
AP TEVA PARENTERAL 1MG/ML A076853 001 Jul 20, 2004
TABLET; ORAL
TERBUTALINE SULFATE
AB IMPAX LABS 2.5MG A075877 001 Jun 26, 2001
AB 5MG A075877 002 Jun 26, 2001
AB LANNETT 2.5MG A077152 001 Mar 25, 2005
AB 5MG A077152 002 Mar 25, 2005

TERCONAZOLE
CREAM; VAGINAL
TERAZOL 3
AB + ORTHO MCNEIL JANSSEN 0.8% N019964 001 Feb 21, 1991
TERAZOL 7
AB + ORTHO MCNEIL JANSSEN 0.4% N019579 001 Dec 31, 1987
TERCONAZOLE
AB ALTANA 0.4% A076712 001 Feb 18, 2005
AB TARO 0.4% A076043 001 Jan 19, 2005
AB 0.8% A075953 001 Apr 06, 2004
TERCONAZOLE
BX + ALTANA 0.8% N021735 001 Oct 01, 2004
SUPPOSITORY; VAGINAL
TERAZOL 3
AB + ORTHO MCNEIL JANSSEN 80MG N019641 001 May 24, 1988
TERCONAZOLE
AB ALTANA 80MG A076850 001 Jul 12, 2006
AB PERRIGO NEW YORK 80MG A077149 001 Mar 17, 2006
AB TARO 80MG A077553 001 Mar 09, 2007

TERIPARATIDE RECOMBINANT HUMAN


INJECTABLE; SUBCUTANEOUS
FORTEO
XX LILLY 0.6MG/2.4ML (0.25MG/ML) N021318 002 Jun 25, 2008
XX + 0.75MG/3ML (0.25MG/ML) N021318 001 Nov 26, 2002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 364 (of 393)

TESTOSTERONE
FILM, EXTENDED RELEASE; TRANSDERMAL

ANDRODERM

XX + WATSON LABS 2.5MG/24HR N020489 001 Sep 29, 1995


XX + 5MG/24HR N020489 002 May 02, 1997
GEL; TRANSDERMAL
ANDROGEL
BX + UNIMED PHARMS 1% (5GM/PACKET) N021015 002 Feb 28, 2000
TESTIM
BX + AUXILIUM PHARMS 1% (5GM/PACKET) N021454 001 Oct 31, 2002
ANDROGEL
XX UNIMED PHARMS 1% (2.5GM/PACKET) N021015 001 Feb 28, 2000
GEL, METERED; TRANSDERMAL

ANDROGEL

XX + UNIMED PHARMS 1% (1.25GM/ACTIVATION) N021015 003 Sep 26, 2003


PELLET; IMPLANTATION

TESTOPEL

XX + SLATE PHARMS 75MG A080911 001


TABLET, EXTENDED RELEASE; BUCCAL

STRIANT

XX + COLUMBIA LABS 30MG N021543 001 Jun 19, 2003

TESTOSTERONE CYPIONATE
INJECTABLE; INJECTION
DEPO-TESTOSTERONE
AO + PHARMACIA AND UPJOHN 100MG/ML A085635 002
AO + 200MG/ML A085635 003
TESTOSTERONE CYPIONATE
AO PADDOCK 200MG/ML A040530 001 Jan 31, 2005
AO SANDOZ 100MG/ML A040615 001 Aug 10, 2006
AO 200MG/ML A040615 002 Aug 10, 2006
AO SYNERX PHARMA 200MG/ML A040652 001 Dec 11, 2006
AO WATSON LABS 200MG/ML A086030 001

TESTOSTERONE ENANTHATE
INJECTABLE; INJECTION
DELATESTRYL
AO + ENDO PHARM 200MG/ML N009165 003
TESTOSTERONE ENANTHATE
AO PADDOCK 200MG/ML A040575 001 Jun 14, 2006
AO SYNERX PHARMA 200MG/ML A040647 001 Oct 05, 2009
AO WATSON LABS 200MG/ML A085598 001

TETRABENAZINE
TABLET; ORAL
XENAZINE
XX BIOVAIL AMERICAS 12.5MG N021894 001 Aug 15, 2008
XX + 25MG N021894 002 Aug 15, 2008

TETRACYCLINE HYDROCHLORIDE
CAPSULE; ORAL
TETRACYCLINE HYDROCHLORIDE
AB IMPAX LABS 250MG A060469 001
AB 500MG A060469 003
AB IVAX SUB TEVA PHARMS 250MG A060704 001
AB + 500MG A060704 002
AB WATSON LABS 250MG A061837 001
AB 500MG A061837 002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 365 (of 393)

TETRACYCLINE HYDROCHLORIDE
CAPSULE; ORAL

TETRACYCLINE HYDROCHLORIDE

XX IMPAX LABS 100MG A060469 002


SUSPENSION; ORAL

SUMYCIN

XX + PAR PHARM 125MG/5ML A060400 001


TABLET; ORAL

SUMYCIN

XX PAR PHARM 250MG A061147 001


XX + 500MG A061147 004

TETRAHYDROZOLINE HYDROCHLORIDE
SOLUTION; NASAL

TYZINE

XX + NYCOMED US 0.05% A086576 002


XX 0.1% A086576 001


SPRAY; NASAL

TYZINE

XX + NYCOMED US 0.1% A086576 003

THALIDOMIDE
CAPSULE; ORAL
THALOMID
XX CELGENE 50MG N020785 001 Jul 16, 1998
XX 100MG N020785 002 Jan 17, 2003
XX 150MG N020785 004 Jan 10, 2007
XX + 200MG N020785 003 Jan 17, 2003

THALLOUS CHLORIDE, TL-201


INJECTABLE; INJECTION
THALLOUS CHLORIDE TL 201
AP + GE HEALTHCARE 1mCi/ML N018110 002 Feb 27, 1996
AP + LANTHEUS MEDCL 1mCi/ML N017806 001
AP + MALLINCKRODT 1mCi/ML N018150 001
INJECTABLE; INTRAVENOUS
THALLOUS CHLORIDE TL 201
AP + LANTHEUS MEDCL 2mCi/ML N017806 002 Oct 09, 1998
AP MALLINCKRODT 2mCi/ML A077698 001 Nov 09, 2006

THEOPHYLLINE
CAPSULE, EXTENDED RELEASE; ORAL
THEO-24
BC UCB INC 100MG A087942 001 Aug 22, 1983
BC 200MG A087943 001 Aug 22, 1983
BC 300MG A087944 001 Aug 22, 1983
THEOPHYLLINE
BC INWOOD LABS 100MG A040052 001 Feb 14, 1994
BC 200MG A040052 003 Feb 14, 1994
BC + 300MG A040052 004 Feb 14, 1994
THEO-24
XX UCB INC 400MG A081034 001 Feb 28, 1992
THEOPHYLLINE
XX INWOOD LABS 125MG A040052 002 Feb 14, 1994
ELIXIR; ORAL

ELIXOPHYLLIN

XX + FOREST LABS 80MG/15ML A085186 001


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 366 (of 393)

THEOPHYLLINE
INJECTABLE; INJECTION
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 40MG/100ML N019826 001 Aug 14, 1992
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 80MG/100ML N019826 002 Aug 14, 1992
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 160MG/100ML N019826 003 Aug 14, 1992
THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 320MG/100ML N019826 006 Aug 14, 1992
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 4MG/ML N018649 007 Jul 26, 1982
AP + 40MG/100ML N018649 001 Jul 26, 1982
AP + 80MG/100ML N018649 002 Jul 26, 1982
AP + 160MG/100ML N018649 003 Jul 26, 1982
AP + 200MG/100ML N018649 004 Jul 26, 1982
AP + 320MG/100ML N018649 006 Nov 13, 1985
AP + 400MG/100ML N018649 005 Jul 26, 1982
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + HOSPIRA 4MG/ML N019211 007 Dec 14, 1984
AP + 40MG/100ML N019211 001 Dec 14, 1984
AP + 80MG/100ML N019211 002 Dec 14, 1984
AP + 160MG/100ML N019211 003 Dec 14, 1984
AP + 200MG/100ML N019211 004 Dec 14, 1984
AP + 320MG/100ML N019211 006 Jan 20, 1988
AP + 400MG/100ML N019211 005 Dec 14, 1984
TABLET; ORAL

THEOLAIR

XX + GRACEWAY 125MG A086399 001


XX + 250MG A086399 002
TABLET, EXTENDED RELEASE; ORAL
THEOCHRON
AB INWOOD LABS 100MG A088320 001 Feb 21, 1985
AB 200MG A088321 001 Feb 21, 1985
AB 300MG A087400 002 Jan 11, 1983
THEOPHYLLINE
AB INWOOD LABS 450MG A040034 001 Apr 28, 1995
AB NOSTRUM 400MG A040595 001 Apr 21, 2006
AB 600MG A040560 002 Apr 21, 2006
AB + PLIVA 100MG A089807 001 Apr 30, 1990
AB + 200MG A089808 001 Apr 30, 1990
AB 300MG A089763 001 Apr 30, 1990
AB + 450MG A081236 001 Nov 09, 1992
UNIPHYL
AB PURDUE PHARM PRODS 400MG A087571 001 Sep 01, 1982
AB + 600MG A040086 001 Apr 15, 1996

THIAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
THIAMINE HYDROCHLORIDE
AP + APP PHARMS 100MG/ML A080556 001
AP HOSPIRA 100MG/ML A040079 001 May 03, 1996
AP WATSON LABS 100MG/ML A080571 001
THIAMINE HYDROCHLORIDE
XX + WATSON LABS 200MG/ML A080571 002

THIOGUANINE
TABLET; ORAL

THIOGUANINE

XX + GLAXOSMITHKLINE 40MG N012429 001


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 367 (of 393)

THIORIDAZINE HYDROCHLORIDE
TABLET; ORAL
THIORIDAZINE HYDROCHLORIDE
AB MUTUAL PHARM 10MG A089431 001 Aug 01, 1986
AB 25MG A089432 001 Aug 01, 1986
AB 50MG A089433 001 Aug 01, 1986
AB 100MG A089953 001 Oct 07, 1988
AB MYLAN 10MG A088004 002 Mar 15, 1983
AB 25MG A088004 003 Mar 15, 1983
AB 50MG A088004 004 Mar 15, 1983
AB + 100MG A088004 001 Nov 18, 1983

THIOTEPA
INJECTABLE; INJECTION
THIOTEPA
AP APP PHARMS 15MG/VIAL A075698 001 Sep 20, 2001
AP BEDFORD 15MG/VIAL A075547 001 Apr 02, 2001
AP + TEVA PARENTERAL 15MG/VIAL A075730 001 Apr 20, 2001
THIOTEPA
XX + TEVA PARENTERAL 30MG/VIAL A075730 002 Apr 20, 2001

THIOTHIXENE
CAPSULE; ORAL
NAVANE
AB PFIZER 1MG N016584 001
AB 2MG N016584 002
AB + 5MG N016584 003
AB 10MG N016584 004
THIOTHIXENE
AB MYLAN 1MG A071093 002 Jun 23, 1987
AB 2MG A071093 003 Jun 23, 1987
AB 5MG A071093 004 Jun 23, 1987
AB 10MG A071093 001 Jun 23, 1987
AB SANDOZ 1MG A071610 001 Jun 24, 1987
AB 2MG A071570 001 Jun 24, 1987
AB 5MG A071529 001 Jun 24, 1987
AB 10MG A071530 001 Jun 24, 1987
AB WATSON LABS 2MG A070601 001 Jun 05, 1987
AB 5MG A070602 001 Jun 05, 1987

THYROTROPIN ALFA
INJECTABLE; INJECTION

THYROGEN

XX + GENZYME 1.1MG/VIAL N020898 001 Nov 30, 1998

TIAGABINE HYDROCHLORIDE
TABLET; ORAL
GABITRIL
XX CEPHALON 2MG N020646 005 Apr 16, 1999
XX + 4MG N020646 001 Sep 30, 1997
XX 6MG N020646 006 Nov 29, 2005
XX 8MG N020646 007 Nov 29, 2005
XX 10MG N020646 008 Nov 29, 2005
XX 12MG N020646 002 Sep 30, 1997
XX 16MG N020646 003 Sep 30, 1997
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 368 (of 393)

TICLOPIDINE HYDROCHLORIDE
TABLET; ORAL
TICLOPIDINE HYDROCHLORIDE
AB ACTAVIS ELIZABETH 250MG A075253 001 Aug 20, 1999
AB APOTEX 250MG A075089 001 Jul 01, 1999
AB CARACO 250MG A075526 001 Sep 26, 2002
AB GENPHARM 250MG A075161 001 Sep 13, 1999
AB SANDOZ 250MG A075326 001 Aug 20, 1999
AB + TEVA 250MG A075149 001 Aug 20, 1999

TIGECYCLINE
INJECTABLE; IV (INFUSION)

TYGACIL

XX + WYETH PHARMS INC 50MG/VIAL N021821 001 Jun 15, 2005

TILUDRONATE DISODIUM
TABLET; ORAL

SKELID

XX + SANOFI AVENTIS US EQ 200MG BASE N020707 001 Mar 07, 1997

TIMOLOL
SOLUTION/DROPS; OPHTHALMIC

BETIMOL

XX + SANTEN OY EQ 0.25% BASE N020439 001 Mar 31, 1995


XX + EQ 0.5% BASE N020439 002 Mar 31, 1995

TIMOLOL MALEATE
SOLUTION, GEL FORMING/DROPS; OPHTHALMIC
TIMOLOL MALEATE
AB FALCON PHARMS EQ 0.25% BASE N020963 001 Oct 21, 1998
AB EQ 0.5% BASE N020963 002 Oct 21, 1998
TIMOPTIC-XE
AB + ATON EQ 0.25% BASE N020330 001 Nov 04, 1993
AB + EQ 0.5% BASE N020330 002 Nov 04, 1993
SOLUTION/DROPS; OPHTHALMIC
TIMOLOL MALEATE
AT AKORN EQ 0.25% BASE A074515 001 Mar 25, 1997
AT EQ 0.5% BASE A074466 001 Mar 25, 1997
AT EQ 0.5% BASE A074516 001 Mar 25, 1997
AT BAUSCH AND LOMB EQ 0.25% BASE A074778 001 Mar 25, 1997
AT EQ 0.5% BASE A074776 001 Mar 25, 1997
AT FALCON PHARMS EQ 0.25% BASE A074261 001 Apr 28, 1995
AT EQ 0.5% BASE A074262 001 Apr 28, 1995
AT FDC LTD EQ 0.25% BASE A077259 001 Apr 30, 2008
AT EQ 0.5% BASE A077259 002 Apr 30, 2008
AT HI TECH PHARMA EQ 0.5% BASE A075163 001 Sep 10, 2002
AT NOVEX EQ 0.25% BASE A075411 001 Sep 08, 2000
AT EQ 0.5% BASE A075412 001 Sep 08, 2000
AT PACIFIC PHARMA EQ 0.25% BASE A074746 001 Mar 25, 1997
AT EQ 0.5% BASE A074747 001 Mar 25, 1997
AT WOCKHARDT EQ 0.25% BASE A078771 001 Sep 28, 2009
AT EQ 0.5% BASE A078771 002 Sep 28, 2009
TIMOPTIC
AT + ATON EQ 0.25% BASE N018086 001
AT + EQ 0.5% BASE N018086 002
ISTALOL
BT + ISTA PHARMS EQ 0.5% BASE N021516 001 Jun 04, 2004
TIMOPTIC IN OCUDOSE
XX + ATON EQ 0.25% BASE N019463 001 Nov 05, 1986
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 369 (of 393)

TIMOLOL MALEATE
SOLUTION/DROPS; OPHTHALMIC

TIMOPTIC IN OCUDOSE

XX + ATON EQ 0.5% BASE N019463 002 Nov 05, 1986


TABLET; ORAL
TIMOLOL MALEATE
XX MYLAN 5MG A072668 002 Jun 08, 1990
XX 10MG A072668 003 Jun 08, 1990
XX + 20MG A072668 001 Jun 08, 1990

TINIDAZOLE
TABLET; ORAL
TINDAMAX
XX MISSION PHARMA 250MG N021618 001 May 17, 2004
XX + 500MG N021618 002 May 17, 2004

TINZAPARIN SODIUM
INJECTABLE; INJECTION

INNOHEP

XX + CELGENE 20,000 IU/ML N020484 001 Jul 14, 2000

TIOPRONIN
TABLET; ORAL

TIOPRONIN

XX + MISSION PHARMA 100MG N019569 001 Aug 11, 1988

TIOTROPIUM BROMIDE MONOHYDRATE


POWDER; INHALATION

SPIRIVA

XX + BOEHRINGER INGELHEIM EQ 0.018MG BASE/INH N021395 001 Jan 30, 2004

TIPRANAVIR
CAPSULE; ORAL

APTIVUS

XX + BOEHRINGER INGELHEIM 250MG N021814 001 Jun 22, 2005


SOLUTION; ORAL

APTIVUS

XX + BOEHRINGER INGELHEIM 100MG/ML N022292 001 Jun 23, 2008

TIROFIBAN HYDROCHLORIDE
INJECTABLE; INJECTION
AGGRASTAT
XX MEDICURE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) N020913 002 May 17, 2002
XX + EQ 12.5MG BASE/250ML (EQ 0.05MG N020913 003 Apr 20, 2000
BASE/ML)

TIZANIDINE HYDROCHLORIDE
CAPSULE; ORAL
ZANAFLEX
XX ACORDA EQ 2MG BASE N021447 001 Aug 29, 2002
XX EQ 4MG BASE N021447 002 Aug 29, 2002
XX + EQ 6MG BASE N021447 003 Aug 29, 2002
TABLET; ORAL
TIZANIDINE HYDROCHLORIDE
AB ACTAVIS ELIZABETH EQ 2MG BASE A076283 001 Jul 12, 2002
AB EQ 4MG BASE A076283 002 Jul 12, 2002
AB ACTAVIS TOTOWA EQ 2MG BASE A076281 001 Oct 20, 2003
AB EQ 4MG BASE A076281 002 Oct 20, 2003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 370 (of 393)

TIZANIDINE HYDROCHLORIDE
TABLET; ORAL
TIZANIDINE HYDROCHLORIDE
AB ALPHAPHARM EQ 2MG BASE A076282 001 Dec 16, 2003
AB EQ 4MG BASE A076282 002 Dec 16, 2003
AB APOTEX EQ 2MG BASE A076533 001 Jan 16, 2004
AB EQ 4MG BASE A076533 002 Jan 16, 2004
AB CARACO EQ 2MG BASE A076416 001 Sep 29, 2003
AB EQ 4MG BASE A076416 002 Sep 29, 2003
AB COREPHARMA EQ 2MG BASE A076347 001 Oct 11, 2002
AB EQ 4MG BASE A076347 002 Oct 11, 2002
AB DR REDDYS LABS INC EQ 2MG BASE A076286 001 Jul 03, 2002
AB EQ 4MG BASE A076286 002 Jul 03, 2002
AB MYLAN EQ 2MG BASE A076354 001 Mar 28, 2003
AB EQ 4MG BASE A076354 002 Mar 28, 2003
AB SANDOZ EQ 2MG BASE A076399 001 Nov 26, 2002
AB EQ 4MG BASE A076280 002 Jun 27, 2002
AB TEVA EQ 2MG BASE A076284 001 Jul 03, 2002
AB EQ 4MG BASE A076284 002 Jul 03, 2002
ZANAFLEX
AB + ACORDA EQ 4MG BASE N020397 001 Nov 27, 1996

TOBRAMYCIN
OINTMENT; OPHTHALMIC

TOBREX

XX + ALCON 0.3% N050555 001


SOLUTION; INHALATION

TOBI

XX + NOVARTIS PHARMS 300MG/5ML N050753 001 Dec 22, 1997


SOLUTION/DROPS; OPHTHALMIC
AKTOB
AT AKORN 0.3% A064096 001 Jan 31, 1996
TOBRAMYCIN
AT ALTANA 0.3% A065026 001 Sep 11, 2001
AT BAUSCH AND LOMB 0.3% A064052 001 Nov 29, 1993
AT NOVEX 0.3% A065087 001 Feb 25, 2002
TOBREX
AT ALCON 0.3% A062535 001 Dec 13, 1984
AT + FALCON PHARMS 0.3% N050541 001

TOBRAMYCIN SULFATE
INJECTABLE; INJECTION
TOBRAMYCIN SULFATE
AP AKORN STRIDES EQ 40MG BASE/ML A065407 001 Mar 11, 2008
AP APOTHECON EQ 10MG BASE/ML A064021 001 May 31, 1994
AP APP PHARMS EQ 10MG BASE/ML A065122 001 Nov 29, 2002
AP + EQ 40MG BASE/ML A065122 002 Nov 29, 2002
AP EQ 1.2GM BASE/VIAL N050789 001 Jul 13, 2004
AP BAXTER HLTHCARE EQ 40MG BASE/ML A063117 001 Apr 26, 1991
AP + HOSPIRA EQ 10MG BASE/ML A063080 001 Apr 30, 1991
AP EQ 10MG BASE/ML A063112 001 Apr 30, 1991
AP EQ 40MG BASE/ML A063111 001 Apr 30, 1991
AP + EQ 40MG BASE/ML A063116 001 May 18, 1992
AP MARSAM PHARMS LLC EQ 10MG BASE/ML A062945 001 Aug 09, 1989
AP TEVA PARENTERAL EQ 40MG BASE/ML A063100 001 Jan 30, 1992
AP + X GEN PHARMS EQ 1.2GM BASE/VIAL A065013 001 Aug 17, 2001
TOBRAMYCIN SULFATE (PHARMACY BULK)
AP APP PHARMS EQ 40MG BASE/ML A065120 001 Nov 29, 2002
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
XX + HOSPIRA EQ 1.2MG BASE/ML A063081 003 Jul 31, 1990
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 371 (of 393)

TOBRAMYCIN SULFATE
INJECTABLE; INJECTION

TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER


XX + HOSPIRA EQ 1.6MG BASE/ML A063081 006 Jun 02, 1993


XX + EQ 80MG BASE/100ML A063081 001 Jul 31, 1990

TOLAZAMIDE
TABLET; ORAL
TOLAZAMIDE
AB MYLAN 250MG A070259 001 Jan 02, 1986
AB + 500MG A070259 003 Mar 17, 1986
AB WATSON LABS 250MG A070514 001 Jan 09, 1986
AB 500MG A070515 001 Jan 09, 1986

TOLBUTAMIDE
TABLET; ORAL
TOLBUTAMIDE
AB MYLAN 500MG A086445 001
AB + WATSON LABS 500MG A086109 001
AB 500MG A087318 001

TOLCAPONE
TABLET; ORAL
TASMAR
XX VALEANT PHARM INTL 100MG N020697 001 Jan 29, 1998
XX + 200MG N020697 002 Jan 29, 1998

TOLMETIN SODIUM
CAPSULE; ORAL
TOLECTIN DS
AB + ORTHO MCNEIL JANSSEN EQ 400MG BASE N018084 001
TOLMETIN SODIUM
AB ACTAVIS ELIZABETH EQ 400MG BASE A073308 001 Jan 24, 1992
AB MYLAN EQ 400MG BASE A073393 001 May 27, 1993
AB TEVA EQ 400MG BASE A073290 001 Nov 27, 1991
TABLET; ORAL
TOLECTIN
AB ORTHO MCNEIL JANSSEN EQ 200MG BASE N017628 001
TOLECTIN 600
AB + ORTHO MCNEIL JANSSEN EQ 600MG BASE N017628 002 Mar 08, 1989
TOLMETIN SODIUM
AB IVAX SUB TEVA PHARMS EQ 600MG BASE A074399 001 Mar 28, 1996
AB MUTUAL PHARM EQ 200MG BASE A073310 001 Nov 27, 1991
AB MYLAN EQ 600MG BASE A074473 001 Aug 30, 1994

TOLTERODINE TARTRATE
CAPSULE, EXTENDED RELEASE; ORAL
DETROL LA
XX PHARMACIA AND UPJOHN 2MG N021228 001 Dec 22, 2000
XX + 4MG N021228 002 Dec 22, 2000
TABLET; ORAL
DETROL
XX PHARMACIA AND UPJOHN 1MG N020771 001 Mar 25, 1998
XX + 2MG N020771 002 Mar 25, 1998

TOLVAPTAN
TABLET; ORAL
SAMSCA
XX OTSUKA AMERICA PHARM 15MG N022275 001 May 19, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 372 (of 393)

TOLVAPTAN
TABLET; ORAL

SAMSCA

XX + OTSUKA AMERICA PHARM 30MG N022275 002 May 19, 2009

TOPIRAMATE
CAPSULE; ORAL
TOPAMAX
AB ORTHO MCNEIL JANSSEN 15MG N020844 001 Oct 26, 1998
AB + 25MG N020844 002 Oct 26, 1998
TOPIRAMATE
AB COBALT LABS INC 15MG A077868 001 Apr 15, 2009
AB 25MG A077868 002 Apr 15, 2009
AB MYLAN 15MG A078418 001 Oct 14, 2009
AB 25MG A078418 002 Oct 14, 2009
AB SANDOZ 15MG A079206 001 Oct 14, 2009
AB 25MG A079206 002 Oct 14, 2009
AB TEVA 15MG A076575 001 Apr 17, 2009
AB 25MG A076575 002 Apr 17, 2009
AB ZYDUS PHARMS USA INC 15MG A078877 001 Oct 14, 2009
AB 25MG A078877 002 Oct 14, 2009
TABLET; ORAL
TOPAMAX
AB + ORTHO MCNEIL JANSSEN 25MG N020505 004 Dec 24, 1996
AB 50MG N020505 005 Dec 24, 1996
AB 100MG N020505 001 Dec 24, 1996
AB 200MG N020505 002 Dec 24, 1996
TOPIRAMATE
AB ACCORD HLTHCARE 25MG A076311 001 Mar 27, 2009
AB 50MG A076311 002 Mar 27, 2009
AB 100MG A076311 003 Mar 27, 2009
AB 200MG A076311 004 Mar 27, 2009
AB APOTEX INC 25MG A077733 001 Mar 27, 2009
AB 50MG A077733 002 Mar 27, 2009
AB 100MG A077733 003 Mar 27, 2009
AB 200MG A077733 004 Mar 27, 2009
AB AUROBINDO PHARMA 25MG A078462 001 Mar 27, 2009
AB 50MG A078462 002 Mar 27, 2009
AB 100MG A078462 003 Mar 27, 2009
AB 200MG A078462 004 Mar 27, 2009
AB CIPLA LTD 25MG A076343 001 Mar 27, 2009
AB 50MG A076343 002 Mar 27, 2009
AB 100MG A076343 003 Mar 27, 2009
AB 200MG A076343 004 Mar 27, 2009
AB COBALT LABS INC 25MG A077643 001 Mar 27, 2009
AB 50MG A077643 002 Mar 27, 2009
AB 100MG A077643 003 Mar 27, 2009
AB 200MG A077643 004 Mar 27, 2009
AB GLENMARK GENERICS 25MG A077627 001 Mar 27, 2009
AB 50MG A077627 002 Mar 27, 2009
AB 100MG A077627 003 Mar 27, 2009
AB 200MG A077627 004 Mar 27, 2009
AB INVAGEN PHARMS 25MG A079162 001 Mar 27, 2009
AB 50MG A079162 002 Mar 27, 2009
AB 100MG A079162 003 Mar 27, 2009
AB 200MG A079162 004 Mar 27, 2009
AB MYLAN 25MG A076314 001 Mar 27, 2009
AB 50MG A076314 002 Mar 27, 2009
AB 100MG A076314 003 Mar 27, 2009
AB 200MG A076314 004 Mar 27, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 373 (of 393)

TOPIRAMATE
TABLET; ORAL
TOPIRAMATE
AB PLIVA HRVATSKA DOO 25MG A077905 001 Mar 30, 2009
AB 50MG A077905 002 Mar 30, 2009
AB 100MG A077905 003 Mar 30, 2009
AB 200MG A077905 004 Mar 30, 2009
AB RANBAXY 25MG A076327 001 Mar 27, 2009
AB 100MG A076327 002 Mar 27, 2009
AB 200MG A076327 003 Mar 27, 2009
AB ROXANE 25MG A076306 001 Mar 27, 2009
AB 50MG A076306 002 Mar 27, 2009
AB 100MG A076306 003 Mar 27, 2009
AB 200MG A076306 004 Mar 27, 2009
AB SUN PHARM INDS LTD 25MG A090278 001 Mar 27, 2009
AB 50MG A090278 002 Mar 27, 2009
AB 100MG A090278 003 Mar 27, 2009
AB 200MG A090278 004 Mar 27, 2009
AB TEVA 25MG A076317 001 Mar 27, 2009
AB 50MG A076317 002 Mar 27, 2009
AB 100MG A076317 003 Mar 27, 2009
AB 200MG A076317 004 Mar 27, 2009
AB TORRENT PHARMS 25MG A079153 001 Mar 27, 2009
AB 50MG A079153 002 Mar 27, 2009
AB 100MG A079153 003 Mar 27, 2009
AB 200MG A079153 004 Mar 27, 2009
AB UNICHEM 25MG A090162 001 Mar 27, 2009
AB 50MG A090162 002 Mar 27, 2009
AB 100MG A090162 003 Mar 27, 2009
AB UPSHER SMITH 25MG A078499 001 Jan 07, 2010
AB 50MG A078499 002 Jan 07, 2010
AB 100MG A078499 003 Jan 07, 2010
AB 200MG A078499 004 Jan 07, 2010
AB ZYDUS PHARMS USA INC 25MG A078235 001 Mar 27, 2009
AB 50MG A078235 002 Mar 27, 2009
AB 100MG A078235 003 Mar 27, 2009
AB 200MG A078235 004 Mar 27, 2009

TOPOTECAN HYDROCHLORIDE
CAPSULE; ORAL
HYCAMTIN
XX SMITHKLINE BEECHAM EQ 0.25MG BASE N020981 001 Oct 11, 2007
XX + EQ 1MG BASE N020981 002 Oct 11, 2007
INJECTABLE; INJECTION

HYCAMTIN

XX + GLAXOSMITHKLINE EQ 4MG BASE/VIAL N020671 001 May 28, 1996

TOREMIFENE CITRATE
TABLET; ORAL

FARESTON

XX + GTX INC EQ 60MG BASE N020497 001 May 29, 1997

TORSEMIDE
INJECTABLE; INJECTION

TORSEMIDE

XX + BEDFORD LABS 20MG/2ML (10MG/ML) A078007 001 Jun 11, 2008


XX + 50MG/5ML (10MG/ML) A078007 002 Jun 11, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 374 (of 393)

TORSEMIDE
TABLET; ORAL
DEMADEX
AB MEDA PHARMS 5MG N020136 001 Aug 23, 1993
AB 10MG N020136 002 Aug 23, 1993
AB + 20MG N020136 003 Aug 23, 1993
AB 100MG N020136 004 Aug 23, 1993
TORSEMIDE
AB APOTEX INC 5MG A076894 001 May 31, 2005
AB 10MG A076894 002 May 31, 2005
AB 20MG A076894 003 May 31, 2005
AB 100MG A076894 004 May 31, 2005
AB AUROBINDO PHARMA 5MG A078249 001 Oct 17, 2007
AB 10MG A078249 002 Oct 17, 2007
AB 20MG A078249 003 Oct 17, 2007
AB 100MG A078249 004 Oct 17, 2007
AB HETERO DRUGS 5MG A079234 001 Jan 27, 2009
AB 10MG A079234 002 Jan 27, 2009
AB 20MG A079234 003 Jan 27, 2009
AB 100MG A079234 004 Jan 27, 2009
AB PAR PHARM 5MG A076226 001 May 27, 2003
AB 10MG A076226 002 May 27, 2003
AB 20MG A076226 003 May 27, 2003
AB 100MG A076226 004 May 27, 2003
AB PLIVA PHARM IND 5MG A076346 001 May 30, 2003
AB 10MG A076346 002 May 30, 2003
AB 20MG A076346 003 May 30, 2003
AB 100MG A076346 004 Oct 19, 2004
AB ROXANE 5MG A076943 001 Mar 01, 2005
AB 10MG A076943 002 Mar 01, 2005
AB 20MG A076943 003 Mar 01, 2005
AB SUN PHARM INDS 5MG A078478 001 Feb 26, 2008
AB 10MG A078478 002 Feb 26, 2008
AB 20MG A078478 003 Feb 26, 2008
AB 100MG A078478 004 Feb 26, 2008
AB TEVA 5MG A076110 001 May 14, 2002
AB 10MG A076110 002 May 14, 2002
AB 20MG A076110 003 May 14, 2002
AB 100MG A076110 004 May 14, 2002

TRAMADOL HYDROCHLORIDE
TABLET; ORAL
TRAMADOL HYDROCHLORIDE
AB ACTAVIS ELIZABETH 50MG A075960 001 Jun 19, 2002
AB ALPHAPHARM 50MG A075980 001 Nov 21, 2002
AB AMNEAL PHARMS 50MG A076003 001 Jun 20, 2002
AB APOTEX 50MG A075981 001 Jul 10, 2002
AB CARACO 50MG A075964 001 Jun 19, 2002
AB MALLINCKRODT 50MG A075983 001 Jun 25, 2002
AB MUTUAL PHARM 50MG A076100 001 Jun 20, 2002
AB MYLAN 50MG A075986 001 Jun 21, 2002
AB PLIVA 50MG A075982 001 Jul 01, 2002
AB SANDOZ 50MG A075968 001 Jun 25, 2002
AB TEVA 50MG A075977 001 Jun 19, 2002
AB WATSON LABS 50MG A075962 001 Jun 24, 2002
ULTRAM
AB + ORTHO MCNEIL JANSSEN 50MG N020281 002 Mar 03, 1995
TABLET, EXTENDED RELEASE; ORAL
TRAMADOL HYDROCHLORIDE
AB PAR PHARM 100MG A078783 001 Nov 13, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 375 (of 393)

TRAMADOL HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL
TRAMADOL HYDROCHLORIDE
AB PAR PHARM 200MG A078783 002 Nov 13, 2009
ULTRAM ER
AB + BIOVAIL LABS INTL 100MG N021692 001 Sep 08, 2005
AB 200MG N021692 002 Sep 08, 2005
RYZOLT
BC + PURDUE PHARMA 100MG N021745 001 Dec 30, 2008
BC 200MG N021745 002 Dec 30, 2008
BC 300MG N021745 003 Dec 30, 2008
ULTRAM ER
BC BIOVAIL LABS INTL 300MG N021692 003 Sep 08, 2005

TRANDOLAPRIL
TABLET; ORAL
MAVIK
AB ABBOTT 1MG N020528 001 Apr 26, 1996
AB 2MG N020528 002 Apr 26, 1996
AB + 4MG N020528 003 Apr 26, 1996
TRANDOLAPRIL
AB AUROBINDO PHARMA 1MG A078438 001 Jun 12, 2007
AB 2MG A078438 002 Jun 12, 2007
AB 4MG A078438 003 Jun 12, 2007
AB CIPLA 1MG A077307 002 Jun 12, 2007
AB 2MG A077307 001 Jun 12, 2007
AB 4MG A077307 003 Jun 12, 2007
AB COBALT 1MG A077805 001 Jun 12, 2007
AB 2MG A077805 002 Jun 12, 2007
AB 4MG A077805 003 Jun 12, 2007
AB COREPHARMA 1MG A077256 001 Jun 12, 2007
AB 2MG A077256 002 Jun 12, 2007
AB 4MG A077256 003 Jun 12, 2007
AB DR REDDYS LABS LTD 1MG A078493 001 Aug 25, 2008
AB 2MG A078493 002 Aug 25, 2008
AB 4MG A078493 003 Aug 25, 2008
AB GLENMARK GENERICS 1MG A078508 003 Jun 18, 2008
AB 2MG A078508 001 Jun 18, 2008
AB 4MG A078508 002 Jun 18, 2008
AB INVAGEN PHARMS 1MG A078320 001 Jun 12, 2007
AB 2MG A078320 002 Jun 12, 2007
AB 4MG A078320 003 Jun 12, 2007
AB LUPIN 1MG A077522 001 Jun 12, 2007
AB 2MG A077522 002 Jun 12, 2007
AB 4MG A077522 003 Jun 12, 2007
AB MYLAN 1MG A078346 001 Apr 28, 2008
AB 2MG A078346 002 Apr 28, 2008
AB 4MG A078346 003 Apr 28, 2008
AB TEVA PHARMS 1MG A077489 001 Dec 12, 2006
AB 2MG A077489 002 Dec 12, 2006
AB 4MG A077489 003 Dec 12, 2006

TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE


TABLET, EXTENDED RELEASE; ORAL
TARKA
XX ABBOTT 1MG;240MG N020591 003 Oct 22, 1996
XX 2MG;180MG N020591 001 Oct 22, 1996
XX 2MG;240MG N020591 004 Oct 22, 1996
XX + 4MG;240MG N020591 002 Oct 22, 1996
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 376 (of 393)

TRANEXAMIC ACID
INJECTABLE; INJECTION

CYKLOKAPRON

XX + PHARMACIA AND UPJOHN 100MG/ML N019281 001 Dec 30, 1986


TABLET; ORAL

LYSTEDA

XX + XANODYNE PHARM 650MG N022430 001 Nov 13, 2009

TRANYLCYPROMINE SULFATE
TABLET; ORAL
PARNATE
AB + GLAXOSMITHKLINE EQ 10MG BASE N012342 003 Aug 16, 1985
TRANYLCYPROMINE SULFATE
AB KALI LABS EQ 10MG BASE A040640 001 Jun 29, 2006

TRAVOPROST
SOLUTION/DROPS; OPHTHALMIC

TRAVATAN

XX + ALCON 0.004% N021257 001 Mar 16, 2001


TRAVATAN Z
XX + ALCON 0.004% N021994 001 Sep 21, 2006

TRAZODONE HYDROCHLORIDE
TABLET; ORAL
TRAZODONE HYDROCHLORIDE
AB ALVOGEN 50MG A071636 001 Apr 18, 1988
AB 100MG A071514 001 Apr 18, 1988
AB APOTEX 50MG A071258 001 Mar 25, 1987
AB + APOTEX INC 100MG A071196 001 Mar 25, 1987
AB 150MG A071196 002 Apr 26, 1999
AB 300MG A071196 003 Apr 26, 1999
AB MATRIX LABS LTD 50MG A090514 001 Jun 02, 2009
AB 100MG A090514 002 Jun 02, 2009
AB 150MG A090514 003 Jun 02, 2009
AB 300MG A090514 004 Jun 02, 2009
AB MUTUAL PHARM 50MG A073137 002 Mar 24, 1993
AB 100MG A073137 001 Mar 24, 1993
AB 150MG A073137 003 Dec 22, 1995
AB PLIVA 50MG A071523 001 Dec 11, 1987
AB 100MG A071524 001 Dec 11, 1987
AB 150MG A071525 001 Mar 09, 1988
AB TEVA 50MG A072192 001 Feb 02, 1989
AB 100MG A072193 001 Feb 02, 1989
AB WATSON LABS 50MG A070857 001 Oct 10, 1986
AB 100MG A070858 001 Oct 10, 1986

TREPROSTINIL SODIUM
INJECTABLE; IV (INFUSION)-SC
REMODULIN
XX UNITED THERAP 1MG/ML N021272 001 May 21, 2002
XX 2.5MG/ML N021272 002 May 21, 2002
XX 5MG/ML N021272 003 May 21, 2002
XX + 10MG/ML N021272 004 May 21, 2002
SOLUTION; INHALATION

TYVASO

XX + UNITED THERAP EQ 0.6MG BASE/ML N022387 001 Jul 30, 2009


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 377 (of 393)

TRETINOIN
CAPSULE; ORAL
TRETINOIN
AB BARR 10MG A077684 001 Jun 22, 2007
VESANOID
AB + ROCHE 10MG N020438 001 Nov 22, 1995
CREAM; TOPICAL
AVITA
AB MYLAN BERTEK 0.025% N020404 003 Jan 14, 1997
RETIN-A
AB + JOHNSON AND JOHNSON 0.025% N019049 001 Sep 16, 1988
AB + 0.1% N017340 001
TRETINOIN
AB TRIAX PHARMS LLC 0.025% A075264 001 Dec 24, 1998
AB 0.1% A075213 001 Dec 24, 1998
RETIN-A
AB1 + JOHNSON AND JOHNSON 0.05% N017522 001
TRETINOIN
AB1 TRIAX PHARMS LLC 0.05% A075265 001 Dec 24, 1998
RENOVA
AB2 + ORTHO DERMATOLOGICS 0.05% N019963 001 Dec 29, 1995
TRETINOIN
AB2 SPEAR PHARMS 0.05% A076498 001 Sep 15, 2005
RENOVA
XX + ORTHO DERMATOLOGICS 0.02% N021108 001 Aug 31, 2000
GEL; TOPICAL
RETIN-A
AB + JOHNSON AND JOHNSON 0.01% N017955 001
AB + 0.025% N017579 002
TRETINOIN
AB TRIAX PHARMS LLC 0.01% A075589 001 Jun 11, 2002
AB 0.025% A075529 001 Feb 22, 2000
AVITA
BT MYLAN BERTEK 0.025% N020400 001 Jan 29, 1998
ATRALIN
XX + DOW PHARM SCIENCES 0.05% N022070 001 Jul 26, 2007
RETIN-A MICRO
XX + ORTHO DERMATOLOGICS 0.04% N020475 002 May 10, 2002
XX + 0.1% N020475 001 Feb 07, 1997
SOLUTION; TOPICAL
RETIN-A
AT + JOHNSON AND JOHNSON 0.05% N016921 001
TRETINOIN
AT MORTON GROVE 0.05% A075260 001 Jan 25, 1999

TRIAMCINOLONE ACETONIDE
AEROSOL, METERED; INHALATION

AZMACORT

XX + ABBOTT 0.1MG/INH N018117 001 Apr 23, 1982


CREAM; TOPICAL
KENALOG
AT + APOTHECON 0.025% N011601 003
AT + 0.1% N011601 006
TRIACET
AT TEVA 0.025% A084908 001
AT 0.5% A084908 003
TRIAMCINOLONE ACETONIDE
AT ACTAVIS MID ATLANTIC 0.1% A087798 001 Jun 04, 1982
AT ALTANA 0.025% A085692 001
AT 0.1% A085692 003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 378 (of 393)

TRIAMCINOLONE ACETONIDE
CREAM; TOPICAL
TRIAMCINOLONE ACETONIDE
AT + ALTANA 0.5% A085692 002
AT G AND W LABS 0.025% A089797 001 May 31, 1991
AT PERRIGO NEW YORK 0.025% A086415 001
AT 0.1% A086414 001
AT 0.5% A086413 001
AT TARO 0.025% A086277 001
AT 0.1% A040039 001 Nov 26, 1997
AT 0.1% A086276 001
AT 0.5% A086275 001
AT VINTAGE 0.025% A040671 001 Jun 09, 2006
AT 0.1% A040671 002 Jun 09, 2006
TRIDERM
AT DEL RAY LABS 0.1% A088042 001 Mar 19, 1984
INJECTABLE; INJECTION
KENALOG-10
AB APOTHECON 10MG/ML N012041 001
KENALOG-40
AB + APOTHECON 40MG/ML N014901 001
TRIAMCINOLONE ACETONIDE
AB SANDOZ 10MG/ML A090166 001 May 27, 2009
AB 40MG/ML A090164 001 May 27, 2009
INJECTABLE; INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL

TRIVARIS

XX + ALLERGAN 8MG/0.1ML (8MG/0.1ML) N022220 001 Jun 16, 2008


INJECTABLE; INTRAVITREAL

TRIESENCE

XX + ALCON 40MG/ML (40MG/ML) N022048 001 Nov 29, 2007


LOTION; TOPICAL
TRIAMCINOLONE ACETONIDE
AT ALTANA 0.025% A040467 001 Apr 21, 2003
AT 0.1% A040467 002 Apr 21, 2003
AT MORTON GROVE 0.025% A088450 001 Apr 01, 1985
AT + 0.1% A088451 001 Apr 03, 1985
AT TARO 0.1% A089129 001 Aug 14, 1986
AT VINTAGE 0.1% A040672 002 Dec 13, 2006
OINTMENT; TOPICAL
KENALOG
AT APOTHECON 0.025% N011600 003
AT 0.1% N011600 001
TRIAMCINOLONE ACETONIDE
AT ACTAVIS MID ATLANTIC 0.1% A087799 001 Jun 07, 1982
AT ALTANA 0.025% A085691 001
AT 0.1% A085691 003
AT 0.5% A085691 002
AT + PERRIGO NEW YORK 0.025% A087356 001
AT + 0.1% A087357 001
AT + 0.5% A087385 001
AT TARO 0.025% A040040 001 Sep 30, 1994
AT 0.025% A040374 001 Jun 05, 2001
AT 0.1% A040037 001 Sep 30, 1994
AT 0.1% A087902 001 Dec 27, 1982
AT 0.5% A040386 001 Jun 05, 2001
TRIAMCINOLONE ACETONIDE IN ABSORBASE
XX + CAROLINA MEDCL 0.05% A089595 001 Mar 23, 1995
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 379 (of 393)

TRIAMCINOLONE ACETONIDE
PASTE; DENTAL

ORACORT

XX + TARO 0.1% A070730 001 Oct 01, 1986


SPRAY; TOPICAL

KENALOG

XX + RANBAXY 0.147MG/GM N012104 001


SPRAY, METERED; NASAL
NASACORT AQ
AB + SANOFI AVENTIS US 0.055MG/SPRAY N020468 001 May 20, 1996
TRIAMCINOLONE ACETONIDE
AB BARR 0.055MG/SPRAY A078104 001 Jul 30, 2009

TRIAMCINOLONE HEXACETONIDE
INJECTABLE; INJECTION

ARISTOSPAN

XX + SANDOZ 5MG/ML N016466 001


XX + 20MG/ML N016466 002

TRIAMTERENE
CAPSULE; ORAL

DYRENIUM

XX WELLSPRING PHARM 50MG N013174 001


XX + 100MG N013174 002

TRIAZOLAM
TABLET; ORAL
HALCION
AB PHARMACIA AND UPJOHN 0.125MG N017892 003 Apr 26, 1985
AB + 0.25MG N017892 001 Nov 15, 1982
TRIAZOLAM
AB ALPHAPHARM 0.125MG A074031 001 Mar 25, 1994
AB 0.25MG A074031 002 Mar 25, 1994
AB ROXANE 0.125MG A074224 001 Jun 01, 1994
AB 0.25MG A074224 002 Jun 01, 1994
AB WATSON LABS 0.125MG A074445 001 Oct 20, 1995
AB 0.25MG A074445 002 Oct 20, 1995

TRIENTINE HYDROCHLORIDE
CAPSULE; ORAL

SYPRINE

XX + ATON 250MG N019194 001 Nov 08, 1985

TRIFLUOPERAZINE HYDROCHLORIDE
TABLET; ORAL
TRIFLUOPERAZINE HYDROCHLORIDE
AB MYLAN EQ 1MG BASE A040209 001 Jul 07, 1997
AB EQ 2MG BASE A040209 002 Jul 07, 1997
AB EQ 5MG BASE A040209 003 Jul 07, 1997
AB + EQ 10MG BASE A040209 004 Jul 07, 1997
AB SANDOZ EQ 1MG BASE A085785 001
AB EQ 2MG BASE A085786 001
AB EQ 5MG BASE A085789 001
AB EQ 10MG BASE A085788 001

TRIFLURIDINE
SOLUTION/DROPS; OPHTHALMIC
TRIFLURIDINE
AT ALCON 1% A074311 001 Oct 06, 1995
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 380 (of 393)

TRIFLURIDINE
SOLUTION/DROPS; OPHTHALMIC
VIROPTIC
AT + MONARCH PHARMS 1% N018299 001

TRIHEXYPHENIDYL HYDROCHLORIDE
ELIXIR; ORAL
TRIHEXYPHENIDYL HYDROCHLORIDE
AA MIKART 2MG/5ML A040251 001 Sep 27, 1999
AA + PHARM ASSOC 2MG/5ML A040177 001 Apr 17, 1997
TABLET; ORAL
TRIHEXYPHENIDYL HYDROCHLORIDE
AA VINTAGE PHARMS 2MG A040254 001 Dec 24, 1998
AA 5MG A040254 002 Dec 24, 1998
AA WATSON LABS 2MG A040184 001 Feb 06, 1998
AA + 2MG A084363 001
AA 5MG A040184 002 Feb 06, 1998
AA + 5MG A084364 001
AA WEST WARD 2MG A040337 002 Feb 16, 2000
AA 5MG A040337 001 Feb 16, 2000

TRIMETHADIONE
TABLET; ORAL

TRIDIONE

XX + ABBOTT 150MG N005856 009

TRIMETHOBENZAMIDE HYDROCHLORIDE
CAPSULE; ORAL
TIGAN
AB + KING PHARMS 300MG N017531 006 Dec 13, 2001
TRIMETHOBENZAMIDE HYDROCHLORIDE
AB ACTAVIS TOTOWA 300MG A076546 001 Aug 20, 2003
AB MUTUAL PHARMA 300MG A076570 001 Aug 28, 2003
INJECTABLE; INJECTION
TIGAN
AP + JHP PHARMS 100MG/ML N017530 001
TRIMETHOBENZAMIDE HYDROCHLORIDE
AP HOSPIRA 100MG/ML A088804 001 Apr 03, 1987

TRIMETHOPRIM
TABLET; ORAL
TRIMETHOPRIM
AB TEVA 100MG N018679 001 Jul 30, 1982
AB WATSON LABS 100MG A070049 001 Jun 06, 1985
TRIMETHOPRIM
XX + TEVA 200MG A071259 001 Jun 18, 1987

TRIMETHOPRIM HYDROCHLORIDE
SOLUTION; ORAL

PRIMSOL

XX + FSC EQ 50MG BASE/5ML A074973 001 Jan 24, 2000

TRIMIPRAMINE MALEATE
CAPSULE; ORAL
SURMONTIL
AB ODYSSEY PHARMS EQ 25MG BASE N016792 001
AB EQ 50MG BASE N016792 002
AB + EQ 100MG BASE N016792 003 Sep 15, 1982
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 381 (of 393)

TRIMIPRAMINE MALEATE
CAPSULE; ORAL
TRIMIPRAMINE MALEATE
AB ACTAVIS TOTOWA EQ 25MG BASE A077361 001 Aug 02, 2006
AB EQ 50MG BASE A077361 002 Aug 02, 2006
AB EQ 100MG BASE A077361 003 Aug 02, 2006

TRIPTORELIN PAMOATE
INJECTABLE; INTRAMUSCULAR

TRELSTAR DEPOT

XX + WATSON LABS EQ 3.75MG BASE/VIAL N020715 001 Jun 15, 2000


TRELSTAR LA
XX + WATSON LABS EQ 11.25MG BASE/VIAL N021288 001 Jun 29, 2001

TROMETHAMINE
INJECTABLE; INJECTION

THAM

XX + HOSPIRA 3.6GM/100ML N013025 002

TROPICAMIDE
SOLUTION/DROPS; OPHTHALMIC
MYDRIACYL
AT + ALCON 0.5% A084305 001
AT + 1% A084306 001
TROPICACYL
AT AKORN 0.5% A040314 001 Sep 29, 2000
AT 1% A040315 001 Sep 29, 2000
TROPICAMIDE
AT BAUSCH AND LOMB 0.5% A040067 001 Jul 27, 1994
AT 1% A040064 001 Jul 27, 1994

TROSPIUM CHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL

SANCTURA XR

XX + ALLERGAN 60MG N022103 001 Aug 03, 2007


TABLET; ORAL

SANCTURA

XX + ALLERGAN 20MG N021595 001 May 28, 2004

TRYPAN BLUE
SOLUTION; OPHTHALMIC

MEMBRANEBLUE

XX + DORC 0.15%
N022278 001 Feb 20, 2009
VISIONBLUE

XX + DORC 0.06% N021670 001 Dec 16, 2004

UNOPROSTONE ISOPROPYL
SOLUTION/DROPS; OPHTHALMIC

RESCULA

XX + R TECH UENO LTD 0.15% N021214 001 Aug 03, 2000

UREA, C-13
FOR SOLUTION; ORAL

BREATHTEK UBT FOR H-PYLORI


XX + OTSUKA AMERICA EQ 75MG /POUCH N020586 002 May 10, 2001


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 382 (of 393)

UREA, C-14
CAPSULE; ORAL

PYTEST

XX + BALLARD MEDCL 1uCi N020617 001 May 09, 1997


PYTEST KIT
XX + BALLARD MEDCL 1uCi N020617 002 May 09, 1997

UROFOLLITROPIN
INJECTABLE; INTRAMUSCULAR, SUBCUTANEOUS

BRAVELLE

XX + FERRING 75 IU/VIAL N021289 001 May 06, 2002

URSODIOL
CAPSULE; ORAL
ACTIGALL
AB + WATSON PHARMS 300MG N019594 002 Dec 31, 1987
URSODIOL
AB ACTAVIS TOTOWA 300MG A075517 001 Mar 14, 2000
AB COREPHARMA 300MG A077895 001 Jul 27, 2006
AB LANNETT 300MG A079082 001 Dec 15, 2008
AB TEVA PHARMS 300MG A075592 001 May 25, 2000
TABLET; ORAL
URSO 250
AB AXCAN 250MG N020675 001 Dec 10, 1997
URSO FORTE
AB + AXCAN 500MG N020675 002 Jul 21, 2004
URSODIOL
AB TEVA PHARMS 250MG A079184 001 May 13, 2009
AB 500MG A079184 002 May 13, 2009

VALACYCLOVIR HYDROCHLORIDE
TABLET; ORAL
VALACYCLOVIR HYDROCHLORIDE
AB RANBAXY EQ 500MG BASE A076588 001 Jan 31, 2007
AB EQ 1GM BASE A076588 002 Jan 31, 2007
VALTREX
AB GLAXOSMITHKLINE EQ 500MG BASE N020487 001 Jun 23, 1995
AB + EQ 1GM BASE N020487 002 Jun 23, 1995

VALGANCICLOVIR HYDROCHLORIDE
FOR SOLUTION; ORAL

VALCYTE

XX + ROCHE PALO 50MG/ML N022257 001 Aug 28, 2009


TABLET; ORAL

VALCYTE

XX + ROCHE PALO EQ 450MG BASE N021304 001 Mar 29, 2001

VALPROATE SODIUM
INJECTABLE; INJECTION
DEPACON
AP + ABBOTT EQ 100MG BASE/ML N020593 001 Dec 30, 1996
VALPROATE SODIUM
AP APP PHARMS EQ 100MG BASE/ML A076539 001 Jun 26, 2003
AP BEDFORD EQ 100MG BASE/ML A076295 001 Nov 14, 2002

VALPROIC ACID
CAPSULE; ORAL
DEPAKENE
AB + ABBOTT 250MG N018081 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 383 (of 393)

VALPROIC ACID
CAPSULE; ORAL
VALPROIC ACID
AB BANNER PHARMACAPS 250MG A073484 001 Jun 29, 1993
AB CATALENT 250MG A073229 001 Oct 29, 1991
CAPSULE, DELAYED RELEASE; ORAL
STAVZOR
XX BANNER PHARMACAPS 125MG N022152 001 Jul 29, 2008
XX 250MG N022152 002 Jul 29, 2008
XX + 500MG N022152 003 Jul 29, 2008
SYRUP; ORAL
DEPAKENE
AA + ABBOTT 250MG/5ML N018082 001
VALPROIC ACID
AA ALPHARMA 250MG/5ML A075782 001 Dec 22, 2000
AA APOTEX INC 250MG/5ML A077105 001 Jul 29, 2005
AA HIGH TECH PHARMA 250MG/5ML A074060 001 Jan 13, 1995
AA MORTON GROVE 250MG/5ML A070868 001 Jul 01, 1986
AA PHARM ASSOC 250MG/5ML A075379 001 Dec 15, 2000
AA TEVA PHARMS 250MG/5ML A073178 001 Aug 25, 1992
AA VINTAGE 250MG/5ML A077960 001 Oct 13, 2006

VALRUBICIN
SOLUTION; INTRAVESICAL

VALSTAR PRESERVATIVE FREE


XX + ENDO PHARM 40MG/ML N020892 001 Sep 25, 1998

VALSARTAN
TABLET; ORAL
DIOVAN
XX NOVARTIS 40MG N021283 004 Aug 14, 2002
XX 80MG N021283 001 Jul 18, 2001
XX 160MG N021283 002 Jul 18, 2001
XX + 320MG N021283 003 Jul 18, 2001

VANCOMYCIN HYDROCHLORIDE
CAPSULE; ORAL
VANCOCIN HYDROCHLORIDE
XX VIROPHARMA EQ 125MG BASE N050606 001 Apr 15, 1986
XX + EQ 250MG BASE N050606 002 Apr 15, 1986
INJECTABLE; INJECTION
VANCOMYCIN HYDROCHLORIDE
AP AKORN STRIDES EQ 500MG BASE/VIAL A065397 001 Dec 30, 2008
AP EQ 1GM BASE/VIAL A065397 002 Dec 30, 2008
AP EQ 5GM BASE/VIAL A065432 001 Dec 30, 2008
AP + APP PHARMS EQ 500MG BASE/VIAL A062663 001 Mar 17, 1987
AP + EQ 1GM BASE/VIAL A062663 002 Jul 31, 1987
AP + EQ 5GM BASE/VIAL A062663 003 Jun 03, 1988
AP + EQ 10GM BASE/VIAL A062663 004 Nov 28, 1997
AP GENERAMEDIX EQ 500MG BASE/VIAL A065401 001 Jun 30, 2008
AP EQ 1GM BASE/VIAL A065401 002 Jun 30, 2008
AP + HOSPIRA EQ 500MG BASE/VIAL A062911 001 Aug 04, 1988
AP + EQ 500MG BASE/VIAL A062931 001 Oct 29, 1992
AP EQ 750MG BASE/VIAL A062912 002 Jan 07, 2009
AP EQ 750MG BASE/VIAL A062933 002 May 27, 2009
AP + EQ 1GM BASE/VIAL A062912 001 Aug 04, 1988
AP + EQ 1GM BASE/VIAL A062933 001 Oct 29, 1992
AP + EQ 5GM BASE/VIAL A063076 001 Dec 21, 1990
AP HOSPIRA INC EQ 10GM BASE/VIAL A065455 001 Apr 29, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 384 (of 393)

VANCOMYCIN HYDROCHLORIDE
INJECTABLE; INJECTION

VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER


XX + BAXTER HLTHCARE EQ 500MG BASE/100ML N050671 001 Apr 29, 1993

VARDENAFIL HYDROCHLORIDE
TABLET; ORAL
LEVITRA
XX BAYER HLTHCARE 2.5MG N021400 003 Aug 19, 2003
XX 5MG N021400 001 Aug 19, 2003
XX 10MG N021400 002 Aug 19, 2003
XX + 20MG N021400 004 Aug 19, 2003

VARENICLINE TARTRATE
TABLET; ORAL
CHANTIX
XX PFIZER INC EQ 0.5MG BASE N021928 001 May 10, 2006
XX + EQ 1MG BASE N021928 002 May 10, 2006

VECURONIUM BROMIDE
INJECTABLE; INJECTION
VECURONIUM BROMIDE
AP + BEDFORD 10MG/VIAL A075549 001 Jun 13, 2000
AP + 20MG/VIAL A075549 002 Jun 13, 2000
AP GENERAMEDIX 10MG/VIAL A078274 001 Dec 29, 2008
AP 20MG/VIAL A078274 002 Dec 29, 2008
AP HOSPIRA 10MG/VIAL A075164 001 Oct 21, 1999
AP 20MG/VIAL A075164 002 Oct 21, 1999
AP SUN PHARMA GLOBAL 10MG/VIAL A079001 001 Jun 17, 2009
AP 20MG/VIAL A079001 002 Jun 17, 2009
AP TEVA PARENTERAL 10MG/VIAL A074688 001 Aug 25, 1999
AP 20MG/VIAL A074688 002 Aug 25, 1999
AP WATSON LABS 10MG/VIAL A074334 001 Aug 31, 1995
AP 20MG/VIAL A074334 002 Aug 31, 1995

VENLAFAXINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
EFFEXOR XR
XX WYETH PHARMS INC EQ 37.5MG BASE N020699 001 Oct 20, 1997
XX EQ 75MG BASE N020699 002 Oct 20, 1997
XX + EQ 150MG BASE N020699 004 Oct 20, 1997
TABLET; ORAL
EFFEXOR
AB WYETH PHARMS INC EQ 25MG BASE N020151 002 Dec 28, 1993
AB EQ 37.5MG BASE N020151 006 Dec 28, 1993
AB + EQ 50MG BASE N020151 003 Dec 28, 1993
AB EQ 75MG BASE N020151 004 Dec 28, 1993
AB EQ 100MG BASE N020151 005 Dec 28, 1993
VENLAFAXINE HYDROCHLORIDE
AB ACTAVIS TOTOWA EQ 25MG BASE A078554 001 Jan 09, 2009
AB EQ 37.5MG BASE A078554 002 Jan 09, 2009
AB EQ 50MG BASE A078554 003 Jan 09, 2009
AB EQ 75MG BASE A078554 004 Jan 09, 2009
AB EQ 100MG BASE A078554 005 Jan 09, 2009
AB CARACO EQ 25MG BASE A078627 001 Jun 13, 2008
AB EQ 37.5MG BASE A078627 002 Jun 13, 2008
AB EQ 50MG BASE A078627 003 Jun 13, 2008
AB EQ 75MG BASE A078627 004 Jun 13, 2008
AB EQ 100MG BASE A078627 005 Jun 13, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 385 (of 393)

VENLAFAXINE HYDROCHLORIDE
TABLET; ORAL
VENLAFAXINE HYDROCHLORIDE
AB DR REDDYS LABS LTD EQ 25MG BASE A078301 001 Jun 13, 2008
AB EQ 37.5MG BASE A078301 002 Jun 13, 2008
AB EQ 50MG BASE A078301 003 Jun 13, 2008
AB EQ 75MG BASE A078301 004 Jun 13, 2008
AB EQ 100MG BASE A078301 005 Jun 13, 2008
AB MYLAN EQ 25MG BASE A077166 001 Jun 13, 2008
AB EQ 37.5MG BASE A077166 002 Jun 13, 2008
AB EQ 50MG BASE A077166 003 Jun 13, 2008
AB EQ 75MG BASE A077166 004 Jun 13, 2008
AB EQ 100MG BASE A077166 005 Jun 13, 2008
AB PLIVA HRVATSKA DOO EQ 25MG BASE A078517 001 Jun 13, 2008
AB EQ 37.5MG BASE A078517 002 Jun 13, 2008
AB EQ 50MG BASE A078517 003 Jun 13, 2008
AB EQ 75MG BASE A078517 004 Jun 13, 2008
AB EQ 100MG BASE A078517 005 Jun 13, 2008
AB TEVA EQ 25MG BASE A076690 001 Aug 03, 2006
AB EQ 37.5MG BASE A076690 002 Aug 03, 2006
AB EQ 50MG BASE A076690 003 Aug 03, 2006
AB EQ 75MG BASE A076690 004 Aug 03, 2006
AB EQ 100MG BASE A076690 005 Aug 03, 2006
AB ZYDUS PHARMS USA EQ 25MG BASE A077653 001 Jun 13, 2008
AB EQ 37.5MG BASE A077653 002 Jun 13, 2008
AB EQ 50MG BASE A077653 003 Jun 13, 2008
AB EQ 75MG BASE A077653 004 Jun 13, 2008
AB EQ 100MG BASE A077653 005 Jun 13, 2008
TABLET, EXTENDED RELEASE; ORAL
VENLAFAXINE HYDROCHLORIDE
XX OSMOTICA PHARM EQ 37.5MG BASE N022104 001 May 20, 2008
XX EQ 75MG BASE N022104 002 May 20, 2008
XX + EQ 150MG BASE N022104 003 May 20, 2008
XX EQ 225MG BASE N022104 004 May 20, 2008

VERAPAMIL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
VERAPAMIL HYDROCHLORIDE
AB MYLAN 100MG A078306 001 Aug 09, 2007
AB 120MG A075138 001 Apr 20, 1999
AB 180MG A075138 002 Apr 20, 1999
AB 200MG A078306 002 Aug 09, 2007
AB 240MG A075138 003 Apr 20, 1999
AB 300MG A078306 003 Aug 09, 2007
VERELAN
AB ELAN DRUG 120MG N019614 001 May 29, 1990
AB 180MG N019614 003 Jan 09, 1992
AB 240MG N019614 002 May 29, 1990
VERELAN PM
AB ELAN DRUG 100MG N020943 001 Nov 25, 1998
AB 200MG N020943 002 Nov 25, 1998
AB + 300MG N020943 003 Nov 25, 1998
VERELAN
XX + ELAN DRUG 360MG N019614 004 May 10, 1996
INJECTABLE; INJECTION
VERAPAMIL HYDROCHLORIDE
AP HOSPIRA 2.5MG/ML A070577 001 Feb 02, 1987
AP 2.5MG/ML A070737 001 May 06, 1987
AP 2.5MG/ML A070738 001 May 06, 1987
AP 2.5MG/ML A075136 001 Oct 20, 1998
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 386 (of 393)

VERAPAMIL HYDROCHLORIDE
INJECTABLE; INJECTION
VERAPAMIL HYDROCHLORIDE
AP INTL MEDICATION 2.5MG/ML A070451 001 Dec 16, 1985
AP + LUITPOLD 2.5MG/ML A070617 001 Nov 12, 1985
TABLET; ORAL
CALAN
AB GD SEARLE LLC 40MG N018817 003 Feb 23, 1988
AB 80MG N018817 001 Sep 10, 1984
AB + 120MG N018817 002 Sep 10, 1984
VERAPAMIL HYDROCHLORIDE
AB ACTAVIS ELIZABETH 80MG A071019 001 Sep 24, 1986
AB 120MG A070468 001 Sep 24, 1986
AB MYLAN 80MG A071482 001 Feb 15, 1989
AB 120MG A071483 001 Feb 15, 1989
AB WATSON LABS 40MG A072923 001 Jun 29, 1993
AB 40MG A072924 001 Jun 29, 1993
AB 80MG A070855 001 Sep 24, 1986
AB 80MG A070995 001 Oct 01, 1986
AB 80MG A071366 001 Oct 01, 1986
AB 120MG A070856 001 Sep 24, 1986
AB 120MG A070994 001 Oct 01, 1986
AB 120MG A071367 001 Oct 01, 1986
TABLET, EXTENDED RELEASE; ORAL
ISOPTIN SR
AB + RANBAXY 120MG N019152 003 Mar 06, 1991
AB + 180MG N019152 002 Dec 15, 1989
AB + 240MG N019152 001 Dec 16, 1986
VERAPAMIL HYDROCHLORIDE
AB GLENMARK GENERICS 240MG A078906 001 Sep 17, 2009
AB IVAX SUB TEVA PHARMS 120MG A073568 002 Oct 10, 1997
AB 180MG A074330 001 Jan 31, 1994
AB 240MG A073568 001 Jul 31, 1992
AB KALI LABS 120MG A075072 001 May 25, 1999
AB 240MG A075072 003 May 25, 1999
AB MYLAN 120MG A074587 002 Feb 21, 1997
AB 180MG A074587 003 Sep 09, 1997
AB 240MG A074587 001 Mar 23, 1996
COVERA-HS
BC + GD SEARLE LLC 180MG N020552 001 Feb 26, 1996
BC + 240MG N020552 002 Feb 26, 1996

VERTEPORFIN
INJECTABLE; INJECTION

VISUDYNE

XX + QLT 15MG/VIAL N021119 001 Apr 12, 2000

VIGABATRIN
FOR SOLUTION; ORAL

SABRIL

XX + LUNDBECK INC 500MG/PACKET N022006 001 Aug 21, 2009


TABLET; ORAL

SABRIL

XX + LUNDBECK INC 500MG N020427 001 Aug 21, 2009

VINBLASTINE SULFATE
INJECTABLE; INJECTION

VINBLASTINE SULFATE

XX + APP PHARMS 1MG/ML A089515 001 Apr 29, 1987


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 387 (of 393)

VINBLASTINE SULFATE
INJECTABLE; INJECTION

VINBLASTINE SULFATE

XX + BEDFORD 10MG/VIAL A089395 001 Apr 09, 1987

VINCRISTINE SULFATE
INJECTABLE; INJECTION
VINCRISTINE SULFATE
AP APP PHARMS 1MG/ML A076401 001 Oct 28, 2003
VINCRISTINE SULFATE PFS
AP HOSPIRA 1MG/ML A071484 001 Apr 19, 1988
AP TEVA PARENTERAL 1MG/ML A075493 001 Sep 01, 1999

VINORELBINE TARTRATE
INJECTABLE; INJECTION
NAVELBINE
AP + PIERRE FABRE EQ 10MG BASE/ML N020388 001 Dec 23, 1994
VINORELBINE TARTRATE
AP ACTAVIS TOTOWA EQ 10MG BASE/ML A078011 001 Jul 22, 2009
AP APP PHARMS EQ 10MG BASE/ML A076849 001 Apr 18, 2005
AP BAXTER HLTHCARE EQ 10MG BASE/ML A075992 001 Jun 10, 2003
AP BEDFORD EQ 10MG BASE/ML A076461 001 Dec 11, 2003
AP EBEWE PHARMA EQ 10MG BASE/ML A078408 001 Feb 13, 2008
AP HOSPIRA EQ 10MG BASE/ML A076827 001 Jun 02, 2005
AP TEVA PARENTERAL EQ 10MG BASE/ML A076028 001 Feb 03, 2003

VITAMIN A PALMITATE
INJECTABLE; INJECTION

AQUASOL A

XX + HOSPIRA EQ 50,000 UNITS BASE/ML N006823 001

VORICONAZOLE
FOR SUSPENSION; ORAL

VFEND

XX + PFIZER 200MG/5ML N021630 001 Dec 19, 2003


INJECTABLE; IV (INFUSION)

VFEND

XX + PFIZER 200MG/VIAL N021267 001 May 24, 2002


TABLET; ORAL
VFEND
XX PFIZER 50MG N021266 001 May 24, 2002
XX + 200MG N021266 002 May 24, 2002

VORINOSTAT
CAPSULE; ORAL

ZOLINZA

XX + MERCK 100MG N021991 001 Oct 06, 2006

WARFARIN SODIUM
INJECTABLE; INJECTION

COUMADIN

XX + BRISTOL MYERS SQUIBB 5MG/VIAL N009218 024 Feb 07, 1995


TABLET; ORAL
COUMADIN
AB BRISTOL MYERS SQUIBB 1MG N009218 022 Mar 01, 1990
AB 2MG N009218 013
AB 2.5MG N009218 018
AB 3MG N009218 025 Nov 18, 1996
AB 4MG N009218 023 Aug 24, 1993
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 388 (of 393)

WARFARIN SODIUM
TABLET; ORAL
COUMADIN
AB BRISTOL MYERS SQUIBB 5MG N009218 007
AB 6MG N009218 026 Nov 18, 1996
AB 7.5MG N009218 016
AB + 10MG N009218 005
JANTOVEN
AB USL PHARMA 1MG A040416 001 Oct 02, 2003
AB 2MG A040416 002 Oct 02, 2003
AB 2.5MG A040416 003 Oct 02, 2003
AB 3MG A040416 004 Oct 02, 2003
AB 4MG A040416 005 Oct 02, 2003
AB 5MG A040416 006 Oct 02, 2003
AB 6MG A040416 007 Oct 02, 2003
AB 7.5MG A040416 008 Oct 02, 2003
AB 10MG A040416 009 Oct 02, 2003
WARFARIN SODIUM
AB BARR 1MG A040145 001 Mar 26, 1997
AB 2MG A040145 002 Mar 26, 1997
AB 2.5MG A040145 003 Mar 26, 1997
AB 3MG A040145 008 Nov 05, 1998
AB 4MG A040145 004 Mar 26, 1997
AB 5MG A040145 005 Mar 26, 1997
AB 6MG A040145 009 Nov 05, 1998
AB 7.5MG A040145 006 Mar 26, 1997
AB 10MG A040145 007 Mar 26, 1997
AB MYLAN 1MG A040415 001 Sep 27, 2004
AB 2MG A040415 002 Sep 27, 2004
AB 2.5MG A040415 003 Sep 29, 2004
AB 3MG A040415 004 Sep 27, 2004
AB 4MG A040415 005 Sep 27, 2004
AB 5MG A040415 006 Sep 27, 2004
AB 6MG A040415 007 Sep 27, 2004
AB 7.5MG A040415 008 Sep 27, 2004
AB 10MG A040415 009 Sep 27, 2004
AB PLIVA 1MG A040616 009 Jul 05, 2006
AB 2MG A040616 001 Jul 05, 2006
AB 2.5MG A040616 002 Jul 05, 2006
AB 3MG A040616 003 Jul 05, 2006
AB 4MG A040616 004 Jul 05, 2006
AB 5MG A040616 005 Jul 05, 2006
AB 6MG A040616 006 Jul 05, 2006
AB 7.5MG A040616 007 Jul 05, 2006
AB 10MG A040616 008 Jul 05, 2006
AB SANDOZ 1MG A040196 001 Sep 30, 1997
AB 2MG A040196 002 Sep 30, 1997
AB 2.5MG A040196 003 Sep 30, 1997
AB 3MG A040196 008 Jul 26, 2000
AB 4MG A040196 004 Sep 30, 1997
AB 5MG A040196 005 Sep 30, 1997
AB 6MG A040196 009 Jul 26, 2000
AB 7.5MG A040196 006 Sep 30, 1997
AB 10MG A040196 007 Sep 30, 1997
AB TARO 1MG A040301 002 Jul 15, 1999
AB 2MG A040301 003 Jul 15, 1999
AB 2.5MG A040301 004 Jul 15, 1999
AB 3MG A040301 005 Jul 15, 1999
AB 4MG A040301 006 Jul 15, 1999
AB 5MG A040301 007 Jul 15, 1999
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 389 (of 393)

WARFARIN SODIUM
TABLET; ORAL
WARFARIN SODIUM
AB TARO 6MG A040301 008 Jul 15, 1999
AB 7.5MG A040301 009 Jul 15, 1999
AB 10MG A040301 001 Jul 15, 1999
AB ZYDUS PHARMS USA 1MG A040663 001 May 30, 2006
AB 2MG A040663 002 May 30, 2006
AB 2.5MG A040663 003 May 30, 2006
AB 3MG A040663 004 May 30, 2006
AB 4MG A040663 005 May 30, 2006
AB 5MG A040663 006 May 30, 2006
AB 6MG A040663 007 May 30, 2006
AB 7.5MG A040663 008 May 30, 2006
AB 10MG A040663 009 May 30, 2006

WATER FOR INJECTION, STERILE


LIQUID; N/A
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
AP + HOSPIRA 100% N018802 001 Oct 27, 1982
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
AP APP PHARMS 100% A088400 001 Jan 16, 1984
AP + B BRAUN 100% N019633 001 Feb 29, 1988
AP + BAXTER HLTHCARE 100% N018632 001 Jun 30, 1982
AP + 100% N018632 002 Apr 19, 1988
AP + HOSPIRA 100% N018233 001
AP + 100% N018801 001 Oct 27, 1982
AP + 100% N019869 001 Dec 26, 1989
AP TARO PHARMS IRELAND 100% A077393 001 Aug 11, 2006

WATER FOR IRRIGATION, STERILE


LIQUID; IRRIGATION
STERILE WATER
AT BAXTER HLTHCARE 100% N017428 001
STERILE WATER IN PLASTIC CONTAINER
AT B BRAUN 100% N016734 001
AT BAXTER HLTHCARE 100% N017866 001
AT HOSPIRA 100% N017513 001
AT 100% N018313 001

XENON XE 133
GAS; INHALATION
XENON XE 133
AA LANTHEUS MEDCL 10mCi/VIAL N017284 001
AA 20mCi/VIAL N017284 002
AA MALLINCKRODT 10mCi/VIAL N018327 001 Mar 09, 1982
AA 20mCi/VIAL N018327 002 Mar 09, 1982

ZAFIRLUKAST
TABLET; ORAL
ACCOLATE
XX ASTRAZENECA 10MG N020547 003 Sep 17, 1999
XX + 20MG N020547 001 Sep 26, 1996

ZALEPLON
CAPSULE; ORAL
SONATA
AB KING PHARMS 5MG N020859 001 Aug 13, 1999
AB + 10MG N020859 002 Aug 13, 1999
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 390 (of 393)

ZALEPLON
CAPSULE; ORAL
ZALEPLON
AB AUROBINDO PHARMA 5MG A078829 001 Jun 06, 2008
AB 10MG A078829 002 Jun 06, 2008
AB CIPLA LTD 5MG A077505 001 Jun 20, 2008
AB 10MG A077505 002 Jun 20, 2008
AB MYLAN 5MG A077238 001 Jun 06, 2008
AB 10MG A077238 002 Jun 06, 2008
AB ORCHID HLTHCARE 5MG A090374 001 Sep 17, 2009
AB 10MG A090374 002 Sep 17, 2009
AB ROXANE 5MG A077237 001 Jun 06, 2008
AB 10MG A077237 002 Jun 06, 2008
AB TEVA PHARMS 5MG A077239 001 Jun 06, 2008
AB 10MG A077239 002 Jun 06, 2008
AB UNICHEM 5MG A078989 001 Jun 06, 2008
AB 10MG A078989 002 Jun 06, 2008
AB UPSHER SMITH 5MG A078706 001 Jun 06, 2008
AB 10MG A078706 002 Jun 06, 2008
AB WEST WARD 5MG A078147 001 Nov 25, 2008
AB 10MG A078147 002 Nov 25, 2008

ZANAMIVIR
POWDER; INHALATION

RELENZA

XX + GLAXOSMITHKLINE 5MG N021036 001 Jul 26, 1999

ZICONOTIDE
INJECTABLE; INTRATHECAL

PRIALT

XX + ELAN PHARMS 100MCG/1ML (100MCG/ML) N021060 002 Dec 28, 2004


XX + 500MCG/5ML (100MCG/ML) N021060 004 Dec 28, 2004
XX + 500MCG/20ML (25MCG/ML) N021060 001 Dec 28, 2004

ZIDOVUDINE
CAPSULE; ORAL
RETROVIR
AB + VIIV HLTHCARE 100MG N019655 001 Mar 19, 1987
ZIDOVUDINE
AB AUROBINDO PHARMA LTD 100MG A078128 001 Mar 27, 2006
AB CIPLA LTD 100MG A078349 001 May 23, 2007
INJECTABLE; INJECTION

RETROVIR

XX + VIIV HLTHCARE 10MG/ML N019951 001 Feb 02, 1990


SYRUP; ORAL
RETROVIR
AA + VIIV HLTHCARE 50MG/5ML N019910 001 Sep 28, 1989
ZIDOVUDINE
AA AUROBINDO 50MG/5ML A077268 001 Sep 19, 2005
AA CIPLA LTD 50MG/5ML A077981 001 Jun 26, 2008
TABLET; ORAL
RETROVIR
AB + VIIV HLTHCARE 300MG N020518 002 Oct 04, 1996
ZIDOVUDINE
AB AUROBINDO 300MG A077267 001 Sep 19, 2005
AB HETERO DRUGS LTD 300MG A090092 001 Apr 25, 2008
AB MATRIX LABS LTD 300MG A078922 001 Feb 14, 2008
AB RANBAXY 300MG A077327 001 Sep 19, 2005
AB ROXANE 300MG A076844 001 Sep 19, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 391 (of 393)

ZILEUTON
TABLET; ORAL

ZYFLO

XX + CRITICAL 600MG N020471 003 Dec 09, 1996


TABLET, EXTENDED RELEASE; ORAL

ZYFLO CR

XX + CRITICAL 600MG N022052 001 May 30, 2007

ZINC ACETATE
CAPSULE; ORAL
GALZIN
XX TEVA EQ 25MG ZINC N020458 001 Jan 28, 1997
XX + EQ 50MG ZINC N020458 002 Jan 28, 1997

ZINC CHLORIDE
INJECTABLE; INJECTION

ZINC CHLORIDE IN PLASTIC CONTAINER


XX + HOSPIRA EQ 1MG ZINC/ML N018959 001 Jun 26, 1986

ZIPRASIDONE HYDROCHLORIDE
CAPSULE; ORAL

GEODON

XX + PFIZER EQ 20MG BASE N020825 001 Feb 05, 2001


XX EQ 40MG BASE N020825 002 Feb 05, 2001
XX EQ 60MG BASE N020825 003 Feb 05, 2001
XX EQ 80MG BASE N020825 004 Feb 05, 2001
SUSPENSION; ORAL

GEODON

XX + PFIZER INC EQ 10MG BASE/ML N021483 001 Mar 29, 2006

ZIPRASIDONE MESYLATE
INJECTABLE; INTRAMUSCULAR

GEODON

XX + PFIZER EQ 20MG BASE/ML N020919 001 Jun 21, 2002

ZOLEDRONIC ACID
INJECTABLE; IV (INFUSION)

RECLAST

XX + NOVARTIS EQ 5MG BASE/100ML N021817 001 Apr 16, 2007


ZOMETA
XX + NOVARTIS EQ 4MG BASE/5ML N021223 002 Mar 07, 2003

ZOLMITRIPTAN
SPRAY; NASAL

ZOMIG

XX + ASTRAZENECA 5MG/SPRAY N021450 004 Sep 30, 2003


TABLET; ORAL
ZOMIG
XX IPR 2.5MG N020768 001 Nov 25, 1997
XX + 5MG N020768 002 Nov 25, 1997
TABLET, ORALLY DISINTEGRATING; ORAL
ZOMIG-ZMT
XX ASTRAZENECA 2.5MG N021231 001 Feb 13, 2001
XX + 5MG N021231 002 Sep 17, 2001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 392 (of 393)

ZOLPIDEM TARTRATE
SPRAY, METERED; ORAL

ZOLPIMIST

XX + NOVADEL 5MG/SPRAY N022196 001 Dec 19, 2008


TABLET; ORAL
AMBIEN
AB SANOFI AVENTIS US 5MG N019908 001 Dec 16, 1992
AB + 10MG N019908 002 Dec 16, 1992
ZOLPIDEM TARTRATE
AB APOTEX INC 5MG A077884 001 Apr 23, 2007
AB 10MG A077884 002 Apr 23, 2007
AB AUROBINDO PHARMA 5MG A078413 001 May 04, 2007
AB 10MG A078413 002 May 04, 2007
AB CARACO 5MG A077359 001 Apr 23, 2007
AB 10MG A077359 002 Apr 23, 2007
AB CARLSBAD 5MG A077990 001 Apr 23, 2007
AB 10MG A077990 002 Apr 23, 2007
AB DR REDDYS LABS LTD 5MG A077985 001 Apr 23, 2007
AB 10MG A077985 002 Apr 23, 2007
AB GENPHARM 5MG A078016 001 Apr 23, 2007
AB 10MG A078016 002 Apr 23, 2007
AB HIKMA 5MG A078129 001 Apr 30, 2008
AB 10MG A078129 002 Apr 30, 2008
AB INVAGEN PHARMS 5MG A078184 001 Sep 07, 2007
AB 10MG A078184 002 Sep 07, 2007
AB LEK PHARMS DD 5MG A077322 001 Apr 23, 2007
AB 10MG A077322 002 Apr 23, 2007
AB MYLAN 5MG A076578 001 Apr 23, 2007
AB 10MG A076578 002 Apr 23, 2007
AB RANBAXY 5MG A078055 001 Apr 23, 2007
AB 10MG A078055 002 Apr 23, 2007
AB ROXANE 5MG A077214 001 Apr 23, 2007
AB 10MG A077214 002 Apr 23, 2007
AB TEVA 5MG A076410 001 Apr 23, 2007
AB 10MG A076410 002 Apr 23, 2007
AB TORRENT PHARMS 5MG A077903 001 Aug 17, 2007
AB 10MG A077903 002 Aug 17, 2007
AB VINTAGE 5MG A078616 001 Nov 21, 2008
AB 10MG A078616 002 Nov 21, 2008
AB WATSON LABS 5MG A077773 001 Apr 23, 2007
AB 10MG A077773 002 Apr 23, 2007
AB WOCKHARDT 5MG A078426 001 May 15, 2007
AB 10MG A078426 002 May 15, 2007
TABLET; SUBLINGUAL
EDLUAR
XX MEDA PHARMS 5MG N021997 001 Mar 13, 2009
XX + 10MG N021997 002 Mar 13, 2009
TABLET, EXTENDED RELEASE; ORAL
AMBIEN CR
XX SANOFI AVENTIS US 6.25MG N021774 002 Sep 02, 2005
XX + 12.5MG N021774 001 Sep 02, 2005

ZONISAMIDE
CAPSULE; ORAL
ZONEGRAN
AB EISAI INC 25MG N020789 003 Aug 22, 2003
AB 50MG N020789 002 Aug 22, 2003
AB + 100MG N020789 001 Mar 27, 2000
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST 3 - 393 (of 393)

ZONISAMIDE
CAPSULE; ORAL
ZONISAMIDE
AB ALPHAPHARM 25MG A077647 001 Dec 22, 2005
AB 50MG A077647 002 Dec 22, 2005
AB 100MG A077647 003 Dec 22, 2005
AB APOTEX INC 25MG A077642 001 Dec 22, 2005
AB 50MG A077642 002 Dec 22, 2005
AB 100MG A077642 003 Dec 22, 2005
AB BANNER PHARMACAPS 25MG A077813 001 Aug 16, 2006
AB 50MG A077813 002 Aug 16, 2006
AB 100MG A077813 003 Aug 16, 2006
AB BARR 25MG A077639 001 Dec 22, 2005
AB 50MG A077639 002 Dec 22, 2005
AB 100MG A077639 003 Dec 22, 2005
AB COREPHARMA 25MG A077876 001 Feb 21, 2007
AB 50MG A077876 002 Feb 21, 2007
AB 100MG A077876 003 Feb 21, 2007
AB DR REDDYS LABS LTD 25MG A077645 002 Sep 29, 2006
AB 50MG A077645 003 Sep 29, 2006
AB 100MG A077645 001 Dec 22, 2005
AB GLENMARK GENERICS 25MG A077651 001 Jan 30, 2006
AB 50MG A077651 002 Jan 30, 2006
AB 100MG A077651 003 Jan 30, 2006
AB INVAGEN PHARMS 25MG A077869 001 May 31, 2006
AB 50MG A077869 002 May 31, 2006
AB 100MG A077869 003 May 31, 2006
AB MYLAN 25MG A077637 001 Dec 22, 2005
AB 50MG A077637 002 Dec 22, 2005
AB 100MG A077637 003 Dec 22, 2005
AB SANDOZ 25MG A077644 001 Dec 22, 2005
AB 50MG A077644 002 Dec 22, 2005
AB 100MG A077644 003 Dec 22, 2005
AB SUN PHARM INDS (IN) 25MG A077634 001 Mar 17, 2006
AB 50MG A077634 002 Mar 17, 2006
AB 100MG A077634 003 Mar 17, 2006
AB WOCKHARDT 25MG A077636 003 Jul 27, 2006
AB 50MG A077636 002 Jul 27, 2006
AB 100MG A077636 001 Dec 22, 2005
AB ZYDUS PHARMS USA 25MG A077625 001 Oct 16, 2006
AB 50MG A077625 002 Oct 16, 2006
AB 100MG A077625 003 Oct 16, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST 4 - 1 (of 17)

ACETAMINOPHEN
SUPPOSITORY; RECTAL
ACEPHEN
G AND W LABS 120MG N018060 001
325MG A072344 001 Mar 27, 1992
325MG N018060 003 Dec 18, 1986
650MG A072237 001 Mar 27, 1992
650MG N018060 002
ACETAMINOPHEN
ACTAVIS MID ATLANTIC 120MG N018337 003 Sep 12, 1983
325MG N018337 002
+ 650MG N018337 001
SUPPOSITORIA 120MG A070607 001 Apr 06, 1987
650MG A070608 001 Dec 01, 1986
INFANTS' FEVERALL
ACTAVIS MID ATLANTIC 80MG N018337 004 Aug 26, 1992
NEOPAP
POLYMEDICA 120MG N016401 001
TABLET, EXTENDED RELEASE; ORAL
ACETAMINOPHEN
OHM LABS 650MG A076200 001 Mar 19, 2002
PERRIGO 650MG A075077 001 Feb 25, 2000
RANBAXY 650MG A090205 001 Nov 18, 2009
TYLENOL (CAPLET)
+ MCNEIL CONS 650MG N019872 001 Jun 08, 1994
TYLENOL (GELTAB)
+ MCNEIL CONS 650MG N019872 002 Jan 11, 2001

ACETAMINOPHEN; ASPIRIN; CAFFEINE


TABLET; ORAL
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
PERRIGO 250MG;250MG;65MG A075794 001 Nov 26, 2001
EXCEDRIN (MIGRAINE)
+ NOVARTIS 250MG;250MG;65MG N020802 001 Jan 14, 1998

ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE


TABLET; ORAL

TAVIST ALLERGY/SINUS/HEADACHE

+ NOVARTIS 500MG;EQ 0.25MG BASE;30MG N021082 001 Mar 01, 2001

ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE


TABLET, EXTENDED RELEASE; ORAL

DRIXORAL PLUS

+ SCHERING PLOUGH 500MG;3MG;60MG N019453 001 May 22, 1987

ALCOHOL; CHLORHEXIDINE GLUCONATE


SOLUTION; TOPICAL

AVAGARD

+ 3M 61%;1% N021074 001 Jun 07, 2001

ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE


TABLET, CHEWABLE; ORAL
FOAMCOAT
GUARDIAN DRUG 80MG;20MG A071793 001 Sep 04, 1987
GAVISCON
SANOFI AVENTIS US 80MG;20MG N018685 001 Dec 09, 1983
+ 160MG;40MG N018685 002 Dec 09, 1983

ANTAZOLINE PHOSPHATE; NAPHAZOLINE HYDROCHLORIDE


SOLUTION/DROPS; OPHTHALMIC

VASOCON-A

+ NOVARTIS 0.5%;0.05% N018746 002 Jul 11, 1994


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST 4 - 2 (of 17)

AVOBENZONE; ECAMSULE; OCTOCRYLENE


CREAM; TOPICAL

ANTHELIOS SX

+ LOREAL USA 2%;2%;10% N021502 001 Jul 21, 2006


CAPITAL SOLEIL 15
+ LOREAL USA 2%;3%;10% N021501 001 Oct 02, 2006

AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE


CREAM; TOPICAL

ANTHELIOS 20

+ LOREAL USA 2%;2%;10%;2% N021471 001 Oct 05, 2006


ANTHELIOS 40
+ LOREAL USA 2%;3%;10%;5% N022009 001 Mar 31, 2008
+ 2%;3%;10%;5% N022009 002 Oct 29, 2009

AVOBENZONE; OCTINOXATE; OXYBENZONE


LOTION; TOPICAL

SHADE UVAGUARD

+ SCHERING PLOUGH 3%;7.5%;3% N020045 001 Dec 07, 1992

BENTOQUATAM
LOTION; TOPICAL

IVY BLOCK

+ STAND HOMEOPATH 5% N020532 001 Aug 26, 1996

BUTENAFINE HYDROCHLORIDE
CREAM; TOPICAL

LOTRIMIN ULTRA

+ SCHERING PLOUGH 1% N021307 001 Dec 07, 2001

BUTOCONAZOLE NITRATE
CREAM; VAGINAL

FEMSTAT 3

+ BAYER 2% N020421 001 Dec 21, 1995

CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE


TABLET, CHEWABLE; ORAL
CALCIUM CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE
PERRIGO R AND D 800MG;10MG;165MG A077355 001 Feb 06, 2008
PEPCID COMPLETE
+ MERCK 800MG;10MG;165MG N020958 001 Oct 16, 2000

CETIRIZINE HYDROCHLORIDE
CAPSULE; ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
BANNER PHARMACAPS 5MG N022429 001 Jul 23, 2009
10MG N022429 004 Jul 23, 2009
CETIRIZINE HYDROCHLORIDE HIVES
BANNER PHARMACAPS 5MG N022429 003 Jul 23, 2009
+ 10MG N022429 002 Jul 23, 2009
SYRUP; ORAL
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
ACTAVIS MID ATLANTIC 5MG/5ML A090378 002 May 09, 2008
AMNEAL PHARMS 5MG/5ML A090765 002 Oct 07, 2009
APOTEX 5MG/5ML A090188 002 Apr 22, 2008
CYPRESS PHARM 5MG/5ML A090300 001 Oct 10, 2008
DR REDDYS LABS LTD 5MG/5ML A090474 002 Mar 30, 2009
PERRIGO R AND D 5MG/5ML A090254 002 Apr 09, 2008
RANBAXY 5MG/5ML A090183 002 Apr 24, 2008
TARO 5MG/5ML A090182 002 Apr 22, 2008
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
ACTAVIS MID ATLANTIC 5MG/5ML A090378 001 May 09, 2008
AMNEAL PHARMS 5MG/5ML A090765 001 Oct 07, 2009
APOTEX 5MG/5ML A090188 001 Apr 22, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST 4 - 3 (of 17)

CETIRIZINE HYDROCHLORIDE
SYRUP; ORAL
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
CYPRESS PHARM 5MG/5ML A090300 002 Oct 10, 2008
DR REDDYS LABS LTD 5MG/5ML A090474 001 Mar 30, 2009
PERRIGO R AND D 5MG/5ML A090254 001 Apr 09, 2008
RANBAXY 5MG/5ML A090183 001 Apr 24, 2008
TARO 5MG/5ML A090182 001 Apr 22, 2008
CHILDREN'S ZYRTEC ALLERGY
+ MCNEIL CONSUMER 5MG/5ML N022155 002 Nov 16, 2007
CHILDREN'S ZYRTEC HIVES RELIEF
+ MCNEIL CONSUMER 5MG/5ML N022155 001 Nov 16, 2007
TABLET, CHEWABLE; ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
CARACO 5MG A077631 004 Jan 11, 2008
10MG A077631 003 Jan 11, 2008
SANDOZ 5MG A078692 001 Feb 14, 2008
10MG A078692 002 Feb 14, 2008
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
CARACO 5MG A077631 001 Jan 11, 2008
10MG A077631 002 Jan 11, 2008
CHILDREN'S ZYRTEC ALLERGY
PFIZER 5MG N021621 003 Nov 16, 2007
+ 10MG N021621 004 Nov 16, 2007
CHILDREN'S ZYRTEC HIVES RELIEF
PFIZER 5MG N021621 005 Nov 16, 2007
+ 10MG N021621 006 Nov 16, 2007
TABLET; ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
ACTAVIS ELIZABETH 5MG A078615 003 Dec 28, 2007
10MG A078615 004 Dec 28, 2007
APOTEX INC 5MG A078317 001 Dec 27, 2007
10MG A078317 002 Dec 27, 2007
CARACO 5MG A077499 001 Dec 27, 2007
10MG A077499 002 Dec 27, 2007
CONTRACT PHARMA 5MG A076047 001 Dec 27, 2007
10MG A076047 002 Dec 27, 2007
DR REDDYS LABS LTD 5MG A078343 004 Jan 15, 2008
10MG A078343 003 Jan 15, 2008
MYLAN 5MG A076677 001 Dec 27, 2007
10MG A076677 002 Dec 27, 2007
ORCHID HLTHCARE 5MG A078862 001 Feb 19, 2009
10MG A078862 002 Feb 19, 2009
PERRIGO R AND D 5MG A078336 001 Dec 27, 2007
10MG A078336 002 Dec 27, 2007
RANBAXY 5MG A077498 001 Dec 27, 2007
10MG A077498 002 Dec 27, 2007
SANDOZ 5MG A077946 001 Dec 27, 2007
10MG A077946 002 Dec 27, 2007
TARO 5MG A078072 001 Jul 22, 2009
5MG A078072 003 Jul 22, 2009
UNICHEM 5MG A078680 003 Jun 26, 2009
10MG A078680 004 Jun 26, 2009
UNIQUE PHARM LABS 5MG A077829 001 Aug 26, 2009
10MG A077829 004 Aug 26, 2009
WOCKHARDT 5MG A078427 003 Dec 28, 2007
10MG A078427 004 Dec 28, 2007
CETIRIZINE HYDROCHLORIDE HIVES
CARACO 5MG A077499 003 Dec 27, 2007
10MG A077499 004 Dec 27, 2007
DR REDDYS LABS LTD 5MG A078343 001 Jan 15, 2008
10MG A078343 002 Jan 15, 2008
MYLAN 5MG A076677 004 Dec 27, 2007
10MG A076677 003 Dec 27, 2007
ORCHID HLTHCARE 5MG A078862 003 Feb 19, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST 4 - 4 (of 17)

CETIRIZINE HYDROCHLORIDE
TABLET; ORAL
CETIRIZINE HYDROCHLORIDE HIVES
ORCHID HLTHCARE 10MG A078862 004 Feb 19, 2009
PERRIGO R AND D 5MG A078336 003 Dec 27, 2007
10MG A078336 004 Dec 27, 2007
RANBAXY 5MG A077498 003 Dec 27, 2007
10MG A077498 004 Dec 27, 2007
UNICHEM 5MG A078680 001 Jun 26, 2009
10MG A078680 002 Jun 26, 2009
UNIQUE PHARM LABS 5MG A077829 003 Aug 26, 2009
10MG A077829 002 Aug 26, 2009
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
TARO 10MG A078072 002 Jul 22, 2009
10MG A078072 004 Jul 22, 2009
ZYRTEC ALLERGY
MCNEIL CONSUMER 5MG N019835 003 Nov 16, 2007
+ 10MG N019835 004 Nov 16, 2007
ZYRTEC HIVES RELIEF
MCNEIL CONSUMER 5MG N019835 005 Nov 16, 2007
+ 10MG N019835 006 Nov 16, 2007

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE


TABLET, EXTENDED RELEASE; ORAL
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
SANDOZ 5MG;120MG A077991 001 Mar 05, 2008
TEVA PHARMS 5MG;120MG A077170 001 Feb 25, 2008
ZYRTEC-D 12 HOUR
+ MCNEIL 5MG;120MG N021150 002 Nov 09, 2007

CHLORHEXIDINE GLUCONATE
AEROSOL, METERED; TOPICAL

EXIDINE

+ XTTRIUM 4% N019127 001 Dec 24, 1984


CLOTH; TOPICAL

CHLORHEXIDINE GLUCONATE

+ SAGE PRODS 2% N021669 001 Apr 25, 2005


SOLUTION; TOPICAL
BRIAN CARE
SOAPCO 4% A071419 001 Dec 17, 1987
CHG SCRUB
ECOLAB 4% N019258 002 Jul 22, 1986
CIDA-STAT
ECOLAB 2% N019258 001 Jul 22, 1986
DYNA-HEX
XTTRIUM 0.75% N020111 001 Sep 11, 1997
EXIDINE
+ XTTRIUM 2% N019422 001 Dec 17, 1985
4% N019125 001 Dec 24, 1984
HIBICLENS
+ REGENT 4% N017768 001

HIBISTAT

+ REGENT 0.5% N018300 001


SPONGE; TOPICAL
BIOSCRUB
GRIFFEN 4% N019822 001 Mar 31, 1989
CHLORHEXIDINE GLUCONATE
BECTON DICKINSON 4% A072525 001 Oct 24, 1989
PHARMASEAL SCRUB CARE
+ PHARMASEAL 4% N019793 001 Dec 02, 1988
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST 4 - 5 (of 17)

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL


SPONGE; TOPICAL

CHLORAPREP ONE-STEP

+ ENTURIA INC 2%;70% (3ML) N020832 001 Jul 14, 2000


+ 2%;70% (10.5ML) N020832 004 Aug 20, 2003
+ 2%;70% (26ML) N020832 006 Nov 21, 2006
CHLORAPREP ONE-STEP FREPP
+ ENTURIA INC 2%;70% (1.5ML) N020832 003 Apr 26, 2002
CHLORAPREP WITH TINT
+ ENTURIA INC 2%;70% (26ML) N020832 002 May 03, 2005
+ 2%;70% (10.5ML) N020832 005 Apr 03, 2006
+ 2%;70% (3ML) N020832 007 Oct 10, 2006
SWAB; TOPICAL

CHLORAPREP ONE-STEP SEPP

+ ENTURIA INC 2%;70% (0.67ML) N021555 001 Oct 07, 2002


CHLORAPREP SINGLE SWABSTICK
+ ENTURIA INC 2%;70% (1.75ML) N021555 002 May 10, 2005
CHLORASCRUB MAXI SWABSTICK
+ SOLUMED 3.15%;70% (5.1ML) N021524 003 Jun 03, 2005
CHLORASCRUB SWAB
+ SOLUMED 3.15%;70% (1ML) N021524 001 Jun 03, 2005
CHLORASCRUB SWABSTICK
+ SOLUMED 3.15%;70% (1.6ML) N021524 002 Jun 03, 2005

CHLORPHENIRAMINE MALEATE
TABLET, EXTENDED RELEASE; ORAL
CHLORPHENIRAMINE MALEATE
AVANTHI INC 12MG A040829 001 May 13, 2009
CHLOR-TRIMETON
+ SCHERING PLOUGH 12MG N007638 002

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE


SUSPENSION; ORAL

CHILDREN'S ADVIL ALLERGY SINUS


+ WYETH CONS 1MG/5ML;100MG/5ML;15MG/5ML N021587 001 Feb 24, 2004


TABLET; ORAL

ADVIL ALLERGY SINUS


+ WYETH CONS 2MG;200MG;30MG N021441 001 Dec 19, 2002

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE


TABLET, EXTENDED RELEASE; ORAL

CHLOR-TRIMETON

+ SCHERING PLOUGH 8MG;120MG N018397 001

CIMETIDINE
TABLET; ORAL
CIMETIDINE
IVAX SUB TEVA PHARMS 200MG A075345 001 Jun 16, 1999
LEINER 200MG A074961 001 Jun 19, 1998
200MG A074963 001 Jun 19, 1998
PERRIGO 200MG A075285 001 Oct 29, 1998
WATSON LABS 200MG A075425 001 Jul 29, 1999
TAGAMET HB
+ GLAXOSMITHKLINE 200MG N020238 002 Aug 21, 1996

CLEMASTINE FUMARATE
TABLET; ORAL
CLEMASTINE FUMARATE
PERRIGO 1.34MG A074512 001 Nov 22, 1995
SANDOZ 1.34MG A073458 001 Oct 31, 1993
TAVIST-1
+ NOVARTIS 1.34MG N020925 001 Aug 21, 1992
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST 4 - 6 (of 17)

CLOTRIMAZOLE
CREAM, TABLET; TOPICAL, VAGINAL

GYNE-LOTRIMIN 3 COMBINATION PACK

+ SCHERING PLOUGH 1%,200MG N020526 002 Jul 29, 1996


GYNE-LOTRIMIN COMBINATION PACK
+ SCHERING PLOUGH 1%,100MG N020289 002 Apr 26, 1993
MYCELEX-7 COMBINATION PACK
BAYER PHARMS 1%,100MG N020389 002 Jun 23, 1994
CREAM; VAGINAL
CLOTRIMAZOLE
ACTAVIS MID ATLANTIC 1% A074165 001 Jul 16, 1993
TARO 1% A072641 001 Dec 04, 1995
GYNE-LOTRIMIN
+ SCHERING PLOUGH 1% N018052 002 Nov 30, 1990
GYNE-LOTRIMIN 3
+ SCHERING PLOUGH 2% N020574 001 Nov 24, 1998
MYCELEX-7
BAYER PHARMS 1% N018230 002 Dec 26, 1991
TRIVAGIZOLE 3
TARO 2% N021143 001 Apr 12, 2000
TABLET; VAGINAL

GYNE-LOTRIMIN

+ SCHERING PLOUGH 100MG N017717 002 Nov 30, 1990


GYNE-LOTRIMIN 3
+ SCHERING PLOUGH 200MG N020525 001 Jul 29, 1996
MYCELEX-7
BAYER PHARMS 100MG N018182 002 Dec 26, 1991

CROMOLYN SODIUM
SPRAY, METERED; NASAL
CROMOLYN SODIUM
ACTAVIS MID ATLANTIC 5.2MG/SPRAY A074800 001 Jul 26, 2001
+ BAUSCH AND LOMB 5.2MG/SPRAY A075702 001 Jul 03, 2001
PERRIGO 5.2MG/SPRAY A075427 001 Dec 12, 2001
QPHARMA 5.2MG/SPRAY A077976 001 Sep 07, 2007

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE


TABLET, EXTENDED RELEASE; ORAL
DISOPHROL
SCHERING PLOUGH 6MG;120MG N013483 004 Sep 13, 1982
DRIXORAL
+ SCHERING PLOUGH 6MG;120MG N013483 003 Sep 13, 1982

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN


TABLET, EXTENDED RELEASE; ORAL
MUCINEX DM
RECKITT BENCKISER 30MG;600MG N021620 002 Apr 29, 2004
+ 60MG;1.2GM N021620 001 Apr 29, 2004

DEXTROMETHORPHAN POLISTIREX
SUSPENSION, EXTENDED RELEASE; ORAL

DELSYM

+ RECKITT BENCKISER EQ 30MG HBR/5ML N018658 001 Oct 08, 1982

DIPHENHYDRAMINE CITRATE; IBUPROFEN


TABLET; ORAL

ADVIL PM

+ WYETH CONS 38MG;200MG N021394 001 Dec 21, 2005


IBUPROFEN AND DIPHENHYDRAMINE CITRATE
DR REDDYS LABS LTD 38MG;200MG A090619 001 Jul 08, 2009
PERRIGO R AND D 38MG;200MG A079113 001 Dec 22, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST 4 - 7 (of 17)

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN


CAPSULE; ORAL

ADVIL PM

+ WYETH CONS 25MG;EQ 200MG FREE ACID AND POTASSIUM N021393 001 Dec 21, 2005
SALT

DOCOSANOL
CREAM; TOPICAL

ABREVA

+ GLAXOSMITHKLINE 10% N020941 001 Jul 25, 2000

DOXYLAMINE SUCCINATE
TABLET; ORAL
DOXYLAMINE SUCCINATE
LNK 25MG A040564 001 Aug 27, 2004
PERRIGO 25MG A040167 001 Sep 18, 1996
UNISOM
+ CHATTEM 25MG N018066 001

EPINEPHRINE
AEROSOL, METERED; INHALATION
EPINEPHRINE
ARMSTRONG PHARMS 0.2MG/INH A087907 001 May 23, 1984

FAMOTIDINE
TABLET, CHEWABLE; ORAL

FAMOTIDINE

+ PERRIGO 10MG A075715 001 Aug 22, 2003


PEPCID AC
MERCK 20MG N020801 002 Dec 17, 2007
TABLET; ORAL
FAMOTIDINE
DR REDDYS LABS LTD 10MG A075758 001 Aug 17, 2001
20MG A077367 001 Sep 25, 2006
GENPHARM 10MG A075674 001 Dec 21, 2001
IVAX SUB TEVA PHARMS 10MG A075512 001 Jul 26, 2001
PERRIGO 10MG A075400 001 Mar 18, 2005
20MG A077351 001 Sep 25, 2006
RANBAXY 10MG A090283 001 Nov 17, 2009
20MG A090283 002 Nov 17, 2009
SANDOZ 10MG A076101 001 Oct 21, 2002
TEVA 10MG A075312 001 May 31, 2001
WATSON LABS 10MG A075404 001 Nov 28, 2001
WOCKHARDT 10MG A077146 001 Mar 07, 2005
PEPCID AC
MERCK 10MG N020325 001 Apr 28, 1995
+ 20MG N020325 002 Sep 23, 2003
PEPCID AC (GELTAB)
MERCK 10MG N020902 001 Aug 05, 1999

GUAIFENESIN
TABLET, EXTENDED RELEASE; ORAL
MUCINEX
RECKITT BENCKISER 600MG N021282 001 Jul 12, 2002
+ 1.2GM N021282 002 Dec 18, 2002

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE


TABLET, EXTENDED RELEASE; ORAL
MUCINEX D
RECKITT BENCKISER 600MG;60MG N021585 001 Jun 22, 2004
+ 1.2GM;120MG N021585 002 Jun 22, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST 4 - 8 (of 17)

IBUPROFEN
CAPSULE; ORAL

ADVIL LIQUI-GELS

+ WYETH CONS EQ 200MG FREE ACID AND POTASSIUM SALT N020402 001 Apr 20, 1995
ADVIL MIGRAINE LIQUI-GELS
+ WYETH CONS EQ 200MG FREE ACID AND POTASSIUM SALT N020402 002 Mar 16, 2000
IBUPROFEN
BANNER PHARMACAPS EQ 200MG FREE ACID AND POTASSIUM SALT A078682 001 Mar 24, 2009
DR REDDYS LABS LTD EQ 200MG FREE ACID AND POTASSIUM SALT A077338 001 Jul 10, 2009
+ LEINER 200MG A074782 001 Jul 06, 1998
MARKSANS PHARMA EQ 200MG FREE ACID AND POTASSIUM SALT A079205 001 Jun 26, 2009
MIDOL LIQUID GELS
+ BANNER PHARMACAPS 200MG N021472 001 Oct 18, 2002
SUSPENSION/DROPS; ORAL

CHILDREN'S MOTRIN

+ MCNEIL CONS 40MG/ML N020603 001 Jun 10, 1996


IBUPROFEN
PERRIGO 40MG/ML A075217 001 Dec 16, 1998
TRIS PHARMA INC 40MG/ML A079058 001 Aug 31, 2009
PEDIATRIC ADVIL
+ WYETH CONS 100MG/2.5ML N020812 001 Jan 30, 1998
SUSPENSION; ORAL
CHILDREN'S ADVIL
WYETH CONS 100MG/5ML N020589 001 Jun 27, 1996
CHILDREN'S ADVIL-FLAVORED
WYETH CONS 100MG/5ML N020589 002 Nov 07, 1997
CHILDREN'S ELIXSURE
ALTERNA TCHP LLC 100MG/5ML N021604 001 Jan 07, 2004
CHILDREN'S IBUPROFEN
PERRIGO 100MG/5ML A074937 001 Dec 22, 1998
CHILDREN'S MOTRIN
+ MCNEIL 100MG/5ML N020516 001 Jun 16, 1995
IBUPROFEN
ACTAVIS MID ATLANTIC 100MG/5ML A074916 001 Apr 30, 1999
TABLET, CHEWABLE; ORAL
CHILDREN'S ADVIL
WYETH CONS 50MG N020944 001 Dec 18, 1998
CHILDREN'S MOTRIN
MCNEIL CONS 50MG N020601 001 Nov 15, 1996
IBUPROFEN
PERRIGO 50MG A076359 001 Jan 16, 2004
100MG A076359 002 Jan 16, 2004
JUNIOR STRENGTH ADVIL
WYETH CONS 100MG N020944 002 Dec 18, 1998
JUNIOR STRENGTH MOTRIN
+ MCNEIL CONS 100MG N020601 003 Nov 15, 1996
TABLET; ORAL
ADVIL
WYETH CONS 200MG N018989 001 May 18, 1984
IBUPROFEN
ADVENT PHARMS 200MG A076460 001 Nov 26, 2003
AMNEAL PHARMS NY 200MG A071333 001 Feb 17, 1987
200MG A072199 001 May 23, 1988
DR REDDYS LA 200MG A075661 001 Dec 12, 2001
DR REDDYS LABS INC 100MG A076117 001 Nov 20, 2001
LEINER 200MG A071732 001 Sep 10, 1987
200MG A071735 001 Sep 10, 1987
200MG A072299 001 Jul 01, 1988
200MG A073691 001 Feb 25, 1994
200MG A074931 001 Jul 20, 1998
LNK 100MG A076741 001 Jun 17, 2004
200MG A075010 001 Mar 01, 1999
200MG A075139 001 Mar 01, 1999
MCNEIL 200MG A073019 001 Mar 30, 1994
OHM 200MG A071163 001 Jul 15, 1986
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST 4 - 9 (of 17)

IBUPROFEN
TABLET; ORAL

IBUPROFEN

PAR PHARM 200MG A070481 001 Sep 24, 1986


200MG A070985 001 Oct 02, 1987
PERRIGO 200MG A072096 001 Dec 08, 1987
200MG A075995 001 Mar 14, 2002
PERRIGO R AND D 200MG A077349 001 Jun 21, 2005
SANDOZ 200MG A071807 001 Feb 25, 1988
200MG A074525 001 Dec 15, 1995
200MG A074533 001 Dec 15, 1995
VINTAGE PHARMS 200MG A071229 001 Apr 01, 1987
200MG A071639 001 Feb 02, 1988
WATSON LABS 200MG A070435 001 Mar 05, 1986
IBUPROHM
OHM LABS 200MG A071214 001 Dec 01, 1986
IBU-TAB 200
ALRA 200MG A071057 001 Aug 11, 1988
JUNIOR STRENGTH ADVIL
WYETH CONS 100MG N020267 002 Dec 13, 1996
JUNIOR STRENGTH IBUPROFEN
PERRIGO 100MG A075367 001 Apr 22, 1999
JUNIOR STRENGTH MOTRIN
MCNEIL CONS 100MG N020602 001 Jun 10, 1996
MOTRIN IB
+ MCNEIL 200MG N019012 003 Dec 17, 1990
MOTRIN MIGRAINE PAIN
+ MCNEIL 200MG N019012 004 Feb 25, 2000
PROFEN
LEINER 200MG A071265 001 Oct 15, 1986
TAB-PROFEN
PERRIGO 200MG A072095 001 Dec 08, 1987

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE


CAPSULE; ORAL

ADVIL COLD AND SINUS

+ WYETH CONS EQ 200MG FREE ACID AND POTASSIUM N021374 001 May 30, 2002
SALT;30MG
SUSPENSION; ORAL
CHILDREN'S ADVIL COLD
WYETH CONS 100MG/5ML;15MG/5ML N021373 001 Apr 18, 2002
CHILDREN'S MOTRIN COLD
+ MCNEIL CONS 100MG/5ML;15MG/5ML N021128 001 Aug 01, 2000
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
PERRIGO 100MG/5ML;15MG/5ML A076478 001 Nov 05, 2003
TABLET; ORAL

ADVIL COLD AND SINUS

+ WYETH CONS 200MG;30MG N019771 001 Sep 19, 1989


IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
DR REDDYS LABS LTD 200MG;30MG A077628 001 Aug 14, 2006
LEINER 200MG;30MG A075588 001 Apr 08, 2002
IBUPROHM COLD AND SINUS
OHM LABS 200MG;30MG A074567 001 Apr 17, 2001
SINE-AID IB
MCNEIL CONS 200MG;30MG N019899 001 Dec 31, 1992

INSULIN RECOMBINANT HUMAN


INJECTABLE; INJECTION

HUMULIN R

+ LILLY 100 UNITS/ML N018780 001 Oct 28, 1982


HUMULIN R PEN
+ LILLY 100 UNITS/ML N018780 005 Aug 06, 1998
NOVOLIN R
+ NOVO NORDISK INC 100 UNITS/ML N019938 001 Jun 25, 1991
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST 4 - 10 (of 17)

INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN


INJECTABLE; INJECTION

HUMULIN 70/30

+ LILLY 30 UNITS/ML;70 UNITS/ML N019717 001 Apr 25, 1989


HUMULIN 70/30 PEN
+ LILLY 30 UNITS/ML;70 UNITS/ML N019717 002 Aug 06, 1998
NOVOLIN 70/30
+ NOVO NORDISK INC 30 UNITS/ML;70 UNITS/ML N019991 001 Jun 25, 1991

INSULIN SUSP ISOPHANE RECOMBINANT HUMAN


INJECTABLE; INJECTION

HUMULIN N

+ LILLY 100 UNITS/ML N018781 001 Oct 28, 1982


NOVOLIN N
NOVO NORDISK INC 100 UNITS/ML N019959 001 Jul 01, 1991

IODINE POVACRYLEX; ISOPROPYL ALCOHOL


SPONGE; TOPICAL

DURAPREP

+ 3M EQ 0.7% IODINE;74% (6ML) N021586 001 Sep 29, 2006


+ EQ 0.7% IODINE;74% (26ML) N021586 002 Sep 29, 2006

KETOCONAZOLE
SHAMPOO; TOPICAL

NIZORAL A-D

+ MCNEIL CONS 1% N020310 001 Oct 10, 1997

KETOPROFEN
FILM; ORAL

NEXCEDE

+ NOVARTIS 12.5MG N022470 001 Nov 25, 2009

KETOTIFEN FUMARATE
SOLUTION/DROPS; OPHTHALMIC

ALAWAY

+ BAUSCH AND LOMB EQ 0.025% BASE N021996 001 Dec 01, 2006
KETOTIFEN FUMARATE
AKORN EQ 0.025% BASE A077958 001 Jul 26, 2007
ALCON EQ 0.025% BASE A077200 001 Sep 02, 2008
APOTEX INC EQ 0.025% BASE A077354 001 May 09, 2006
ZADITOR
+ NOVARTIS EQ 0.025% BASE N021066 002 Oct 19, 2006

LANSOPRAZOLE
CAPSULE, DELAYED REL PELLETS; ORAL

PREVACID 24 HR

+ NOVARTIS 15MG N022327 001 May 18, 2009

LEVONORGESTREL
TABLET; ORAL
LEVONORGESTREL
WATSON LABS 0.75MG A078665 001 Aug 28, 2009
PLAN B
+ DURAMED 0.75MG N021045 002 Aug 24, 2006
PLAN B ONE-STEP
+ DURAMED 1.5MG N021998 001 Jul 10, 2009

LOPERAMIDE HYDROCHLORIDE
CAPSULE; ORAL
LOPERAMIDE HYDROCHLORIDE
BANNER PHARMACAPS 1MG N021855 001 Aug 04, 2005
+ 2MG N021855 002 Aug 04, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST 4 - 11 (of 17)

LOPERAMIDE HYDROCHLORIDE
SOLUTION; ORAL

IMODIUM A-D

+ MCNEIL CONS 1MG/5ML N019487 001 Mar 01, 1988


LOPERAMIDE HYDROCHLORIDE
HI TECH PHARMA 1MG/5ML A074352 001 Nov 17, 1995
MORTON GROVE 1MG/5ML A074730 001 Aug 28, 1997
PERRIGO 1MG/5ML A073243 001 Jan 21, 1992
ROXANE 1MG/5ML A073079 001 Apr 30, 1992
SUSPENSION; ORAL

IMODIUM A-D

+ MCNEIL CONS 1MG/7.5ML N019487 002 Jul 08, 2004


TABLET, CHEWABLE; ORAL

IMODIUM A-D EZ CHEWS


+ MCNEIL 2MG N020448 001 Jul 24, 1997


TABLET; ORAL

IMODIUM A-D

+ MCNEIL CONS 2MG N019860 001 Nov 22, 1989


LOPERAMIDE HYDROCHLORIDE
LEINER 2MG A073254 001 Jul 30, 1993
LNK 2MG A076497 001 Jun 10, 2003
OHM LABS 2MG A074091 001 Dec 10, 1992
PERRIGO 2MG A075232 001 Jan 06, 2000

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE


TABLET, CHEWABLE; ORAL

IMODIUM MULTI-SYMPTOM RELIEF

+ MCNEIL 2MG;125MG N020606 001 Jun 26, 1996


LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
PERRIGO 2MG;125MG A076029 001 Aug 30, 2002
TABLET; ORAL

IMODIUM MULTI-SYMPTOM RELIEF

+ MCNEIL CONS 2MG;125MG N021140 001 Nov 30, 2000


LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
RANBAXY 2MG;125MG A077500 001 Sep 06, 2006

LORATADINE
CAPSULE; ORAL

CLARITIN

+ SCHERING PLOUGH 10MG N021952 001 Jun 16, 2008


SUSPENSION; ORAL

LORATADINE

+ TARO 1MG/ML N021734 001 Oct 04, 2005


SYRUP; ORAL

CLARITIN

+ SCHERING PLOUGH 1MG/ML N020641 002 Nov 27, 2002


LORATADINE
APOTEX INC 1MG/ML A075565 001 Oct 05, 2004
MORTON GROVE 1MG/ML A075815 001 Aug 20, 2004
PERRIGO 1MG/ML A075728 001 Aug 20, 2004
RANBAXY 1MG/ML A076529 001 Aug 20, 2004
SILARX 1MG/ML A077421 001 Jun 29, 2006
TARO 1MG/ML A076805 001 Aug 20, 2004
TEVA 1MG/ML A075505 001 Nov 07, 2003
TABLET, CHEWABLE; ORAL

CHILDREN'S CLARITIN

+ SCHERING PLOUGH 5MG N021891 001 Aug 23, 2006


TABLET, ORALLY DISINTEGRATING; ORAL
ALAVERT
WYETH CONS 10MG N021375 001 Dec 19, 2002
CLARITIN HIVES RELIEF REDITAB
+ SCHERING PLOUGH 10MG N020704 003 Nov 19, 2003
CLARITIN REDITABS
+ SCHERING PLOUGH 5MG N021993 001 Dec 12, 2006
+ 10MG N020704 002 Nov 27, 2002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST 4 - 12 (of 17)

LORATADINE
TABLET, ORALLY DISINTEGRATING; ORAL
LORATADINE
IMPAX LABS 10MG A076011 001 Sep 29, 2003
WATSON LABS FLORIDA 10MG A075990 001 Nov 03, 2003
WYETH CONS 10MG A075822 001 Feb 10, 2003
LORATADINE REDIDOSE
RANBAXY 10MG A077153 001 Apr 11, 2007
TABLET; ORAL
CLARITIN
+ SCHERING PLOUGH 10MG N019658 002 Nov 27, 2002
CLARITIN HIVES RELIEF
+ SCHERING PLOUGH 10MG N019658 003 Nov 19, 2003
LORATADINE
APOTEX INC 10MG A076471 001 Feb 14, 2006
MYLAN 10MG A075790 001 Nov 07, 2008
10MG A076154 001 Aug 20, 2003
PERRIGO 10MG A076301 001 Jun 25, 2004
RANBAXY 10MG A076134 001 Aug 18, 2003
SANDOZ 10MG A075209 001 Jan 21, 2003

LORATADINE; PSEUDOEPHEDRINE SULFATE


TABLET, EXTENDED RELEASE; ORAL

CLARITIN-D 24 HOUR

+ SCHERING PLOUGH 10MG;240MG N020470 002 Nov 27, 2002


LORATADINE AND PSEUDOEPHEDRINE SULFATE
+ IMPAX LABS 5MG;120MG A076050 001 Jan 30, 2003
10MG;240MG A075989 001 Mar 04, 2004
RANBAXY 10MG;240MG A076557 001 Sep 22, 2004
WATSON LABS FLORIDA 5MG;120MG A076208 001 Jan 28, 2004
10MG;240MG A075706 001 Feb 21, 2003

MENTHOL; METHYL SALICYLATE


PATCH; TOPICAL

SALONPAS

+ HISAMITSU 3%;10% N022029 001 Feb 20, 2008

MICONAZOLE NITRATE
CREAM, SUPPOSITORY; TOPICAL, VAGINAL
MICONAZOLE 7 COMBINATION PACK
G AND W LABS 2%,100MG A076585 001 Mar 26, 2004
MICONAZOLE NITRATE COMBINATION PACK
PERRIGO 2%,200MG A075329 001 Apr 20, 1999
MONISTAT 1 COMBINATION PACK
+ JOHNSON AND JOHNSON 1.2GM,2% N021308 001 Jun 29, 2001
MONISTAT 7 COMBINATION PACK
+ JOHNSON AND JOHNSON 2%,100MG N020288 002 Apr 26, 1993
MONISTAT-3 COMBINATION PACK
+ JOHNSON AND JOHNSON 2%,200MG N020670 002 Apr 16, 1996
M-ZOLE 3 COMBINATION PACK
ACTAVIS MID ATLANTIC 2%,200MG A074926 001 Apr 16, 1999
M-ZOLE 7 DUAL PACK
ACTAVIS MID ATLANTIC 2%,100MG A074586 001 Jul 17, 1997
CREAM; TOPICAL, VAGINAL
MICONAZOLE 3 COMBINATION PACK
PERRIGO 2%,4% A076357 001 Mar 30, 2004
MONISTAT 3 COMBINATION PACK
JOHNSON AND JOHNSON 2%,4% N021261 003 Jun 17, 2003
MONISTAT 3 COMBINATION PACK (PREFILLED)
+ JOHNSON AND JOHNSON 2%,4% N021261 001 Feb 02, 2001
CREAM; VAGINAL
MICONAZOLE 3
TARO 4% A076773 001 Mar 02, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST 4 - 13 (of 17)

MICONAZOLE NITRATE
CREAM; VAGINAL
MICONAZOLE 7
ACTAVIS MID ATLANTIC 2% A074164 001 Mar 29, 1996
MICONAZOLE NITRATE
G AND W LABS 2% A074366 001 Feb 22, 1996
PERRIGO 2% A074760 001 May 15, 1997
TARO 2% A074444 001 Jan 13, 1997
MONISTAT 3
+ JOHNSON AND JOHNSON 4% N020827 001 Mar 30, 1998
MONISTAT 7
+ JOHNSON AND JOHNSON 2% N017450 002 Feb 15, 1991
SUPPOSITORY; VAGINAL
MICONAZOLE NITRATE
ACTAVIS MID ATLANTIC 100MG A073507 001 Nov 19, 1993
G AND W LABS 100MG A074414 001 Apr 30, 1997
+ PERRIGO 100MG A074395 001 Mar 20, 1997
MONISTAT 7
+ JOHNSON AND JOHNSON 100MG N018520 002 Feb 15, 1991

MINOXIDIL
AEROSOL, FOAM; TOPICAL

MEN'S ROGAINE

+ JOHNSON AND JOHNSON 5% N021812 001 Jan 20, 2006


SOLUTION; TOPICAL
MINOXIDIL (FOR MEN)
ACTAVIS MID ATLANTIC 2% A074588 001 Apr 05, 1996
BAUSCH AND LOMB 2% A074643 001 Apr 09, 1996
HI TECH PHARMA 2% A074731 001 Dec 24, 1996
MORTON GROVE 2% A074767 001 Feb 28, 1997
NOVEX 2% A074924 001 Apr 29, 1998
PERRIGO 2% A075357 001 Jul 30, 1999
SIGHT PHARMS 2% A074743 002 Oct 18, 1996
MINOXIDIL (FOR WOMEN)
HI TECH PHARMA 2% A074731 002 May 11, 2005
NOVEX 2% A074924 002 Apr 29, 1998
PERRIGO 2% A075357 002 Jul 30, 1999
SIGHT PHARMS 2% A074743 001 Oct 18, 1996
MINOXIDIL EXTRA STRENGTH (FOR MEN)
ACTAVIS MID ATLANTIC 5% A075518 001 Nov 17, 2000
MORTON GROVE 5% A075438 001 Feb 27, 2003
NOVEX 5% A075839 001 Oct 01, 2001
PERRIGO 5% A075598 001 Jun 13, 2001
PERRIGO NEW YORK 5% A075737 001 Mar 15, 2002
ROGAINE (FOR MEN)
+ JOHNSON AND JOHNSON 2% N019501 002 Feb 09, 1996
ROGAINE (FOR WOMEN)
+ JOHNSON AND JOHNSON 2% N019501 003 Feb 09, 1996
ROGAINE EXTRA STRENGTH (FOR MEN)
+ JOHNSON AND JOHNSON 5% N020834 001 Nov 14, 1997
THEROXIDIL
HARMONY LABS 2% A078176 001 Nov 09, 2007
5% A076239 001 Aug 24, 2004

NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE


SOLUTION/DROPS; OPHTHALMIC

NAPHCON-A

+ ALCON 0.025%;0.3% N020226 001 Jun 08, 1994


OPCON-A
+ BAUSCH AND LOMB 0.02675%;0.315% N020065 001 Jun 08, 1994
VISINE-A
JOHNSON AND JOHNSON 0.025%;0.3% N020485 001 Jan 31, 1996
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST 4 - 14 (of 17)

NAPROXEN SODIUM
CAPSULE; ORAL

NAPROXEN SODIUM

+ BANNER PHARMACAPS EQ 200MG BASE N021920 001 Feb 17, 2006


TABLET; ORAL

ALEVE

+ BAYER EQ 200MG BASE N020204 002 Jan 11, 1994


NAPROXEN SODIUM
AMNEAL PHARMS NY EQ 200MG BASE A079096 001 Dec 16, 2008
CONTRACT PHARMACAL EQ 200MG BASE A074635 001 Jan 13, 1997
EQ 200MG BASE A074789 001 Feb 27, 1997
DR REDDYS LABS INC EQ 200MG BASE A075168 001 Jul 28, 1998
PERRIGO EQ 200MG BASE A074661 001 Jan 13, 1997
SANDOZ EQ 200MG BASE A074646 001 Jan 13, 1997

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE


TABLET, EXTENDED RELEASE; ORAL

ALEVE-D SINUS & COLD


+ BAYER 200MG;120MG N021076 001 Nov 29, 1999


NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
DR REDDYS LABS INC EQ 220MG BASE;120MG A077381 001 Sep 27, 2006
PERRIGO EQ 200MG BASE;120MG A076518 001 Mar 17, 2004

NICOTINE
FILM, EXTENDED RELEASE; TRANSDERMAL

HABITROL

+ NOVARTIS 7MG/24HR N020076 004 Nov 12, 1999


+ 14MG/24HR N020076 005 Nov 12, 1999
+ 21MG/24HR N020076 006 Nov 12, 1999
NICODERM CQ
+ SANOFI AVENTIS US 7MG/24HR N020165 006 Aug 02, 1996
+ 14MG/24HR N020165 005 Aug 02, 1996
+ 21MG/24HR N020165 004 Aug 02, 1996
NICOTINE
AVEVA 7MG/24HR A074645 001 Oct 20, 1997
14MG/24HR A074611 001 Oct 20, 1997
21MG/24HR A074612 001 Oct 20, 1997

NICOTINE POLACRILEX
GUM, CHEWING; BUCCAL

NICORETTE

+ GLAXOSMITHKLINE EQ 2MG BASE N018612 002 Feb 09, 1996


EQ 2MG BASE N018612 004 Sep 25, 2000
+ EQ 4MG BASE N020066 002 Feb 09, 1996
EQ 4MG BASE N020066 004 Sep 25, 2000
NICORETTE (MINT)
GLAXOSMITHKLINE EQ 2MG BASE N018612 003 Dec 23, 1998
EQ 4MG BASE N020066 003 Dec 23, 1998
NICOTINE POLACRILEX
IVAX SUB TEVA PHARMS EQ 2MG BASE A076880 001 Feb 18, 2009
EQ 4MG BASE A077850 001 Feb 18, 2009
PERRIGO EQ 2MG BASE A076775 001 Sep 16, 2004
EQ 2MG BASE A076776 001 Sep 16, 2004
EQ 2MG BASE A076777 001 Sep 16, 2004
EQ 4MG BASE A076778 001 Sep 16, 2004
EQ 4MG BASE A076779 001 Sep 16, 2004
EQ 4MG BASE A076789 001 Sep 16, 2004
PERRIGO R AND D EQ 2MG BASE A078325 001 Oct 30, 2006
EQ 2MG BASE A078547 001 May 24, 2007
EQ 2MG BASE A078967 001 Apr 23, 2008
EQ 4MG BASE A078326 001 Oct 30, 2006
EQ 4MG BASE A078546 001 May 24, 2007
EQ 4MG BASE A078968 001 Apr 23, 2008
WATSON LABS EQ 2MG BASE A074507 001 Mar 15, 1999
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST 4 - 15 (of 17)

NICOTINE POLACRILEX
GUM, CHEWING; BUCCAL
NICOTINE POLACRILEX
WATSON LABS EQ 2MG BASE A076569 001 Jul 29, 2004
EQ 2MG BASE A078699 001 Dec 29, 2008
EQ 2MG BASE A079044 001 Jul 08, 2009
EQ 2MG BASE A079216 001 Jul 08, 2009
EQ 4MG BASE A074707 001 Mar 19, 1999
EQ 4MG BASE A076568 002 Jul 29, 2004
EQ 4MG BASE A078697 001 Dec 29, 2008
EQ 4MG BASE A079038 001 Jul 08, 2009
EQ 4MG BASE A079219 001 Jul 08, 2009
THRIVE
NOVARTIS EQ 2MG BASE A077658 001 Jun 19, 2007
EQ 4MG BASE A077656 001 Jun 19, 2007
TROCHE/LOZENGE; ORAL
COMMIT
GLAXOSMITHKLINE CONS EQ 2MG BASE N021330 001 Oct 31, 2002
+ EQ 4MG BASE N021330 002 Oct 31, 2002
NICORETTE
GLAXOSMITHKLINE CONS EQ 2MG BASE N022360 001 May 18, 2009
+ EQ 4MG BASE N022360 002 May 18, 2009
NICOTINE POLACRILEX
PERRIGO R AND D EQ 2MG BASE A077007 001 Jan 31, 2006
EQ 2MG BASE A090711 001 Jul 10, 2009
EQ 2MG BASE A090821 001 Jul 10, 2009
EQ 4MG BASE A077007 002 Jan 31, 2006
EQ 4MG BASE A090711 002 Jul 10, 2009
EQ 4MG BASE A090821 002 Jul 10, 2009

NIZATIDINE
TABLET; ORAL

AXID AR

+ WYETH CONS 75MG N020555 001 May 09, 1996

NONOXYNOL-9
SPONGE; VAGINAL

TODAY

+ PAV NOVA 1GM N018683 001 Apr 01, 1983

OMEPRAZOLE
TABLET, DELAYED RELEASE; ORAL

OMEPRAZOLE

+ DEXCEL PHARMA 20MG N022032 001 Dec 04, 2007

OMEPRAZOLE MAGNESIUM
CAPSULE, DELAYED RELEASE; ORAL

OMEPRAZOLE MAGNESIUM

+ DR REDDYS LABS LTD EQ 20MG BASE A078878 001 Jun 05, 2009
TABLET, DELAYED RELEASE; ORAL

PRILOSEC OTC

+ ASTRAZENECA EQ 20MG BASE N021229 001 Jun 20, 2003

OMEPRAZOLE; SODIUM BICARBONATE


CAPSULE; ORAL

ZEGERID OTC

+ SCHERING PLOUGH 20MG;1.1GM N022281 001 Dec 01, 2009

ORLISTAT
CAPSULE; ORAL

ALLI

+ GLAXOSMITHKLINE CONS 60MG N021887 001 Feb 07, 2007


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST 4 - 16 (of 17)

OXYMETAZOLINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
OCUCLEAR
SCHERING PLOUGH 0.025% N018471 001 May 30, 1986
VISINE L.R.
+ JOHNSON AND JOHNSON 0.025% N019407 001 Mar 31, 1989

PERMETHRIN
LOTION; TOPICAL

NIX

+ INSIGHT PHARMS 1% N019918 001 May 02, 1990


PERMETHRIN
ACTAVIS MID ATLANTIC 1% A075014 001 Mar 28, 2000
PERRIGO NEW YORK 1% A076090 001 Dec 20, 2001

PIPERONYL BUTOXIDE; PYRETHRINS


AEROSOL; TOPICAL

RID MOUSSE

+ PFIZER 4%;EQ 0.33% BASE N021043 001 Mar 07, 2000

POLYETHYLENE GLYCOL 3350


FOR SOLUTION; ORAL
GLYCOLAX
KREMERS URBAN DEV 17GM/PACKET A090600 001 Oct 06, 2009
17GM/SCOOPFUL A090600 002 Oct 06, 2009
MIRALAX
+ SCHERING PLOUGH 17GM/SCOOPFUL N022015 001 Oct 06, 2006
POLYETHYLENE GLYCOL 3350
MYLAN 17GM/PACKET A078915 001 Oct 06, 2009
17GM/SCOOPFUL A078915 002 Oct 06, 2009
NEXGEN PHARMA 17GM/SCOOPFUL A090812 001 Oct 07, 2009
NOVEL LABS INC 17GM/SCOOPFUL A091077 001 Oct 06, 2009
PADDOCK 17GM/SCOOPFUL A090567 001 Oct 15, 2009
PERRIGO R AND D 17GM/PACKET A090685 001 Oct 06, 2009
17GM/SCOOPFUL A090685 002 Oct 06, 2009

POTASSIUM IODIDE
SOLUTION; ORAL

THYROSHIELD

+ FLEMING 65MG/ML A077218 001 Jan 12, 2005


TABLET; ORAL

IOSAT

+ ANBEX 130MG N018664 001 Oct 14, 1982


THYROSAFE
+ RECIP 65MG A076350 001 Sep 10, 2002

POVIDONE-IODINE
SOLUTION; TOPICAL

POVIDONE IODINE

+ ALLEGIANCE HLTHCARE 1% N019522 001 Mar 31, 1989


SPONGE; TOPICAL

E-Z SCRUB 201

+ BECTON DICKINSON 20% N019240 001 Nov 29, 1985


E-Z SCRUB 241
+ BECTON DICKINSON 10% N019476 001 Jan 07, 1987

PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL
PSEUDOEPHEDRINE HYDROCHLORIDE
PERRIGO 120MG A075153 001 Feb 26, 1999
RANBAXY 120MG A077442 001 Sep 28, 2005
SUDAFED 12 HOUR
+ MCNEIL CONS 120MG A073585 001 Oct 31, 1991
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST 4 - 17 (of 17)

PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL

SUDAFED 24 HOUR

+ ALZA 240MG N020021 002 Dec 15, 1992

PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE; ORAL

AFRINOL

+ SCHERING PLOUGH 120MG N018191 001

RANITIDINE HYDROCHLORIDE
TABLET; ORAL
RANITIDINE HYDROCHLORIDE
DR REDDYS LABS LTD EQ 75MG BASE A075294 001 Mar 28, 2000
EQ 150MG BASE A078192 001 Aug 31, 2007
GENPHARM EQ 75MG BASE A075497 001 Jan 14, 2000
IVAX SUB TEVA PHARMS EQ 75MG BASE A075296 001 Jan 14, 2000
LEINER EQ 75MG BASE A075094 001 Jun 21, 1999
PERRIGO EQ 75MG BASE A076195 001 Aug 30, 2002
TORPHARM EQ 75MG BASE A075167 001 May 04, 2000
WATSON LABS EQ 75MG BASE A075212 001 Jan 14, 2000
WOCKHARDT EQ 75MG BASE A076760 001 Feb 24, 2006
EQ 75MG BASE A078884 001 Jul 31, 2008
EQ 150MG BASE A078653 001 Nov 26, 2007
ZANTAC 150
+ BOEHRINGER INGELHEIM EQ 150MG BASE N021698 001 Aug 31, 2004
EQ 150MG BASE N021698 002 Mar 13, 2007
ZANTAC 75
BOEHRINGER INGELHEIM EQ 75MG BASE N020520 001 Dec 19, 1995

SODIUM CHLORIDE
AEROSOL, METERED; INHALATION

BRONCHO SALINE

+ BLAIREX 0.9% N019912 001 Sep 03, 1992

SODIUM FLUORIDE; TRICLOSAN


PASTE; DENTAL

COLGATE TOTAL

+ COLGATE PALMOLIVE 0.24%;0.3% N020231 001 Jul 11, 1997

TERBINAFINE
GEL; TOPICAL

LAMISIL AT

+ NOVARTIS 1% N021958 001 Jul 24, 2006

TERBINAFINE HYDROCHLORIDE
CREAM; TOPICAL

LAMISIL

+ NOVARTIS 1% N020980 001 Mar 09, 1999


TERBINAFINE HYDROCHLORIDE
TARO 1% A077511 001 Jul 02, 2007
SOLUTION; TOPICAL

LAMISIL AT

+ NOVARTIS 1% N021124 001 Mar 17, 2000


SPRAY; TOPICAL

LAMISIL AT

+ NOVARTIS 1% N021124 002 Mar 17, 2000

TIOCONAZOLE
OINTMENT; VAGINAL
TIOCONAZOLE
PERRIGO 6.5% A075915 001 Nov 21, 2001
VAGISTAT-1
+ NOVARTIS 6.5% N020676 001 Feb 11, 1997
30TH EDITION - 2010 - APPROVED DRUG PRODUCT LIST 5 - 1 of 5

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

ANTICOAGULANT 4% SODIUM CITRATE SOLUTION USP


INJECTABLE; INJECTION
NONE
MEDSEP CORPORATION N760305 Jun 30, 1978

ANTICOAGULANT CITRATE DEXTROSE SOLUTION (ACD)


INJECTABLE; INJECTION
CYTOSOL N020037 Aug 26, 2003
LABORATORIES INC
ACD-A SOLUTION
GAMBRO BCT INC A010228 ANDA Feb 25, 2002
ADSOL WITH ACD-A
FENWAL INC N000922 Aug 29, 2002
ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A
HAEMONETICS CORP A980728 ANDA Feb 06, 2002
AS3 SOLUTION/ACD-A
GAMBRO BCT INC N001214 May 29, 2002

ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP


INJECTABLE; INJECTION
NONE
FENWAL INC N100855 Jun 03, 1959
N160918 Mar 17, 1978
FRESENIUS USA INC N110912 Sep 02, 1959
MEDSEP CORPORATION A710497 ANDA
MILES INC N100102 Dec 14, 1961

ANTICOAGULANT CITRATE PHOSPHATE 2X DEXTROSE SOLUTION (CP2D)


INJECTABLE; INJECTION
CITRATE PHOSPHATE DOUBLE DEXTROSE/ADDITIVE SOLUTION 3
HAEMONETICS CORP N000127 Jan 18, 2002

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION


INJECTABLE; INJECTION
NONE
FRESENIUS USA INC N780519 Apr 23, 1980
TERUMO MEDICAL CORP N820528 Nov 03, 1982

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION (CPDA)


INJECTABLE; INJECTION
CPDA-1 BLOOD-PACK UNIT (PL 146 PLASTIC) 250, 450, 500 ML BLOOD PACK UNITS
FENWAL INC N770420 May 12, 1978

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION USP


INJECTABLE; INJECTION
BLOOD PACK UNIT CPDA-1 IN PLASTIC CONTAINER
FENWAL INC N940404 Jul 28, 1994

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE-1 SOLUTION


INJECTABLE; INJECTION
NONE
MEDSEP CORPORATION N800077 Nov 06, 1980
30TH EDITION - 2010 - APPROVED DRUG PRODUCT LIST 5 - 2 of 5

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST


ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION


INJECTABLE; INJECTION
ADSOL IN PLASTIC CONTAINER
FENWAL INC N900223 Dec 27, 1991
CPD BLOOD BAG UNIT IN PLASTIC CONTAINER
FENWAL INC N900224 Dec 27, 1991

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION (CPD)


INJECTABLE; INJECTION
MACOPRODUCTIONS SAS CPD/AS-1: MACOPHARMA LEUCOFLEX MTL1 LEUKOREDUCTION SYSTEM FOR BLOOD
COMPONENTS KNOWN AS MTL1-WB
MACOPRODUCTIONS SAS N040083 Nov 21, 2005

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP


INJECTABLE; INJECTION
NONE
FENWAL INC N170401 Dec 06, 1977
N811012 Jun 28, 1983
FRESENIUS USA INC N160907 May 16, 1973
MEDSEP CORPORATION N800222 Aug 23, 1982
MILES INC N160527 Jun 22, 1970
TERUMO MEDICAL CORP N781211 Jun 10, 1981

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP WITH: AS-1:


DEXTROSE USP; SODIUM CHLORIDE USP; MANNITOL USP; ADENINE
INJECTABLE; INJECTION
ADSOL RED BLOOD CELL PRESERVATIVE SOLUTION
FENWAL INC N811104 May 16, 1983

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP WITH: AS-5:


DEXTROSE USP; SODIUM CHLORIDE USP; MANNITOL USP; ADENINE
INJECTABLE; INJECTION
OPTISOL RED BLOOD CELL PRESERVATIVE SOLUTION
TERUMO MEDICAL CORP N880217 Oct 07, 1988

ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION WITH:

AS-3: CITRIC ACID USP; MONOBASIC SODIUM PHOSPHATE USP; SODIUM CHLORIDE USP; ADENINE;

DEXTROSE USP; SODIUM CITRATE USP


INJECTABLE; INJECTION
AS-3 NUTRICEL ADDITIVE SYSTEM
MEDSEP CORP 0.042GM/100ML;0.276GM/100ML; N820915 Oct 19, 1984
0.410GM/100ML;0.30GM/100ML;
1.10GM/100ML;0.588GM/100ML

ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION WITH:


AS-2: CITRIC ACID USP; DIBASIC SODIUM PHOSPHATE USP; SODIUM CHLORIDE USP; ADENINE;

DEXTROSE USP; SODIUM CITRATE USP


INJECTABLE; INJECTION
AS-2 NUTRICEL ADDITIVE SYSTEM
MEDSEP CORP 0.042GM/100ML;0.285GM/100ML; N820915 Sep 22, 1983
0.718GM/100ML;0.017GM/100ML;
0.396GM/100ML;0.588GM/100ML

ANTICOAGULANT ETHYLENEDIAMINE TETRAACETIC ACID (EDTA)


INJECTABLE; INJECTION
NONE
FENWAL INC N090480 Mar 07, 1955
30TH EDITION - 2010 - APPROVED DRUG PRODUCT LIST 5 - 3 of 5

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

ANTICOAGULANT HEPARIN SOLUTION USP


INJECTABLE; INJECTION
NONE
FRESENIUS USA INC N770822 May 17, 1978

ANTICOAGULANT SODIUM CITRATE 4% SOLUTION


INJECTABLE; INJECTION
NONE
HAEMONETICS N980123 Mar 03, 2000
CORPORATION

ANTICOAGULANT SODIUM CITRATE SOLUTION


INJECTABLE; INJECTION
TRICITRASOL
CYTOSOL N010409 Jul 10, 2003
LABORATORIES INC

ANTICOAGULANT SODIUM CITRATE SOLUTION USP


INJECTABLE; INJECTION
NONE
FENWAL INC N770923 Jan 20, 1978
FRESENIUS USA INC N160702 Dec 28, 1970
TERUMO MEDICAL CORP N781214 Feb 08, 1980

DEXTRAN 1 IN SODIUM CHLORIDE 0.6%


INJECTABLE; INJECTION
PROMIT
MEDA AB N830715 Oct 30, 1984

DEXTRAN 40, 10% IN DEXTROSE 5%


INJECTABLE; INJECTION
GENTRAN 40
BAXTER HLTHCARE CORP 10GM/100ML;5GM/100ML N840619 Feb 22, 1985
LMD IN PLASTIC CONTAINER
HOSPIRA INC 10GM/100ML;5GM/100ML A720563 ANDA Oct 30, 1992
NONE
B BRAUN MEDICAL INC 10GM/100ML;5GM/100ML N160767 Apr 06, 1970
HOSPIRA INC 10GM/100ML;5GM/100ML N160375 Jul 25, 1967
MILES INC 10GM/100ML;5GM/100ML N160653 Sep 23, 1969
PHARMACHEM 10GM/100ML;5GM/100ML N160836 Nov 14, 1972
RHEOMACRODEX
MEDA AB 10GM/100ML;5GM/100ML N140716 Jan 18, 1967

DEXTRAN 40, 10% IN SODIUM CHLORIDE 0.9%


INJECTABLE; INJECTION
GENTRAN 40
BAXTER HLTHCARE CORP 10GM/100ML;0.9GM/100ML N840620 Feb 22, 1985
LMD IN PLASTIC CONTAINER
HOSPIRA INC 10GM/100ML;0.9GM/100ML A720562 ANDA Oct 30, 1992
NONE
HOSPIRA INC 10GM/100ML;0.9GM/100ML N160375 Jul 25, 1967
MCGAW INC 10GM/100ML;0.9GM/100ML N160767 Apr 06, 1970
MILES INC 10GM/100ML;0.9GM/100ML N160653 Sep 23, 1969
PHARMACHEM 10GM/100ML;0.9GM/100ML N160836 Nov 14, 1972
RHEOMACRODEX
PHARMALINK 10GM/100ML;0.9GM/100ML N140716 Jan 18, 1967
BASLAKEMEDEL AB
30TH EDITION - 2010 - APPROVED DRUG PRODUCT LIST 5 - 4 of 5

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

DEXTRAN 40, 10% W/V DEXTRAN 40 IN 0.8% NACL 500 ML PVC BAGS
INJECTABLE; INJECTION
RHEOMACRODEX
MEDA AB N830527 Mar 27, 1985

DEXTRAN 40, 10% W/V DEXTRAN 40 IN 5% DEXTROSE 500 ML PVC BAGS


INJECTABLE; INJECTION
RHEOMACRODEX
MEDA AB N830627 Mar 27, 1985

DEXTRAN 70, 6% IN DEXTROSE 5%


INJECTABLE; INJECTION
MACRODEX
MEDA AB 6GM/100ML;5GM/100ML N060826 Jun 08, 1954
NONE
HOSPIRA INC 6GM/100ML;5GM/100ML N080819 Mar 31, 1953

DEXTRAN 70, 6% IN SODIUM CHLORIDE 0.9%


INJECTABLE; INJECTION
GENTRAIN 70
BAXTER HLTHCARE CORP N160607 Jan 26, 1970
MACRODEX
PHARMALINK 6GM/100ML;5GM/100ML N060826 Jun 08, 1954
BASLAKEMEDEL AB
NONE
B BRAUN MEDICAL INC 6GM/100ML;0.9 GM/100ML N090024 Aug 18, 1969
MILES INC 6GM/100ML;0.9 GM/100ML N080716 Mar 13, 1953

DEXTRAN 70, 6% W/V DEXTRAN 70 IN 0.9% NACL IN 500 ML PVC BAGS


INJECTABLE; INJECTION
MACRODEX
MEDA AB N830613 Mar 27, 1985

DEXTRAN 70, 6% W/V DEXTRAN 70 IN 5% DEXTROSE


INJECTABLE; INJECTION
MACRODEX
MEDA AB N830629 Mar 27, 1985

DEXTRAN 75, 6% IN SODIUM CHLORIDE 0.9%


INJECTABLE; INJECTION
NONE
PHARMACHEM 6GM/100ML;0.9GM/100ML N080564 Sep 19, 1952
6GM/100ML;0.9GM/100ML N160759 Aug 19, 1970

HETASTARCH 6% IN LACTATED ELECTROLYTE INJECTION


INJECTABLE; INJECTION
HEXTEND
BIOTIME INC 6GM/100ML N200952 Mar 31, 1999
30TH EDITION - 2010 - APPROVED DRUG PRODUCT LIST 5 - 5 of 5

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST


HETASTARCH 6% IN SODIUM CHLORIDE 0.9%


INJECTABLE; INJECTION
6% HETASTARCH IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ABBOTT 6GM/100ML;0.9GM/100ML A740193 ANDA Jan 30, 1995
HESPAN
B BRAUN MEDICAL INC 6GM/100ML;0.9GM/100ML N160889 Jul 17, 1972
HESPAN IN PLASTIC CONTAINER
B BRAUN MEDICAL INC 6GM/100ML;0.9GM/100ML N890105 Apr 04, 1991
NONE
B BRAUN MEDICAL INC 6GM/100ML;0.9GM/100ML A740283 ANDA Oct 21, 1998
TEVA PARENTERAL 6GM/100ML;0.9GM/100ML A740592 ANDA Nov 12, 1998
MEDICINES INC

HETASTARCH 6% IN SODIUM CHLORIDE 0.9% NACL 500 ML GLASS BOTTLES


INJECTABLE; INJECTION
NONE
HOSPIRA INC 6GM/100ML;0.9 GM/100ML A720746 ANDA Feb 07, 1996

HYDROXYETHYL STARCH 130/0.4 IN 6% SODIUM CHLORIDE 0.9%


INJECTABLE; INJECTION
VOLUVEN
FRESNIUS KABI 6GM/100ML;0.9GM/100ML A070012 NDA Dec 27, 2007
CAROLINA RESEARCH
GROUP

PENTASTARCH 10% IN SODIUM CHLORIDE 0.9%


INJECTABLE; INJECTION
PENTASPAN
B BRAUN MEDICAL INC 10GM/100ML;0.9GM/100ML N841207 May 19, 1987
PENTASPAN IN PLASTIC CONTAINER
B BRAUN MEDICAL INC 10GM/100ML;0.9GM/100ML N890104 Apr 04, 1991

PERFLUORODECALIN; PERFLUOROTRI-N-PROPYLAMINE
INJECTABLE; INJECTION
FLUOSOL
ALPHA THERPTC CORP 17.5GM/100ML;7.5GM/100ML N860909 Dec 26, 1989

RED BLOOD CELL PROCESSING SOLUTION


INJECTABLE; INJECTION
REJUVESOL
CYTOSOL LABS INC N950522 Feb 26, 1997

SODIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE,


DIABASIC ANHYDROUS; SODIUM PHOSPHATE MONOBASIC, MONOHYDRATE
INJECTABLE; INJECTION
INTERSOL
FENWAL INC. 2.26G/500ML; 2.21G/500ML; 1.59G/500ML; N080041 NDA Dec 09, 2009
1.53G/500ML; 0.465G/500ML
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 1 (of 324)

ABARELIX
INJECTABLE; INTRAMUSCULAR
PLENAXIS
SPECIALITY EUROPEAN 100MG/VIAL N021320 001 Nov 25, 2003

ACETAMINOPHEN
INJECTABLE; INJECTION
INJECTAPAP
ORTHO MCNEIL PHARM 100MG/ML N017785 001 Mar 07, 1986
SUPPOSITORY; RECTAL
ACEPHEN
G AND W LABS 120MG A072218 001 Mar 27, 1992
ACETAMINOPHEN
ABLE 120MG A073106 001 Feb 27, 1995
325MG A073107 001 Feb 27, 1995
650MG A073108 001 Feb 27, 1995
ROXANE 120MG A071010 001 May 12, 1987
650MG A071011 001 May 12, 1987
TYLENOL
MCNEIL CONS 120MG N017756 002
650MG N017756 001

ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE


CAPSULE; ORAL
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
MIKART 150MG;180MG;15MG A081095 001 Oct 26, 1990
150MG;180MG;60MG A081097 001 Oct 26, 1990
CODEINE, ASPIRIN, APAP FORMULA NO. 2
SCHERER LABS 150MG;180MG;15MG A085640 001
CODEINE, ASPIRIN, APAP FORMULA NO. 3
SCHERER LABS 150MG;180MG;30MG A085639 001
CODEINE, ASPIRIN, APAP FORMULA NO. 4
SCHERER LABS 150MG;180MG;60MG A085638 001

ACETAMINOPHEN; BUTALBITAL
CAPSULE; ORAL
BANCAP
FOREST PHARMS 325MG;50MG A088889 001 Jan 16, 1986
BUCET
MALLINCKRODT 650MG;50MG A088991 001 Jun 28, 1985
TENCON
MALLINCKRODT 650MG;50MG A089405 001 May 15, 1990
TRIAPRIN
DUNHALL 325MG;50MG A089268 001 Jul 02, 1987
TABLET; ORAL
BUTALBITAL AND ACETAMINOPHEN
HALSEY 325MG;50MG A089568 001 Oct 05, 1988
WATSON LABS 325MG;50MG A087550 001 Oct 19, 1984
SEDAPAP
MAYRAND 650MG;50MG A088944 001 Oct 17, 1985

ACETAMINOPHEN; BUTALBITAL; CAFFEINE


CAPSULE; ORAL
ANOQUAN
SHIRE 325MG;50MG;40MG A087628 001 Oct 01, 1986
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
GRAHAM DM 325MG;50MG;40MG A088743 001 Jul 18, 1985
325MG;50MG;40MG A088765 001 Mar 27, 1985
325MG;50MG;40MG A089067 001 Apr 19, 1985
MALLINCKRODT 325MG;50MG;40MG A088758 001 Mar 27, 1985
BUTALIBITAL, ACETAMINOPHEN AND CAFFEINE
GILBERT LABS 325MG;50MG;40MG A088825 001 Dec 05, 1984
FEMCET
MALLINCKRODT 325MG;50MG;40MG A089102 001 Jun 19, 1985
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 2 (of 324)

ACETAMINOPHEN; BUTALBITAL; CAFFEINE


CAPSULE; ORAL
MEDIGESIC PLUS
US CHEM 325MG;50MG;40MG A089115 001 Jan 14, 1986
TRIAD
MALLINCKRODT 325MG;50MG;40MG A089023 001 Jun 19, 1985
TABLET; ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ABLE 325MG;50MG;40MG A040390 001 Jul 23, 2001
500MG;50MG;40MG A040394 001 Jul 23, 2001
GILBERT LABS 325MG;50MG;40MG A087629 001 Nov 13, 1984
MUTUAL PHARM 325MG;50MG;40MG A040601 001 Jul 29, 2005
WATSON LABS 325MG;50MG;40MG A089536 001 Feb 16, 1988
ESGIC
FOREST PHARMS 325MG;50MG;40MG A089660 001 Dec 23, 1988

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE


CAPSULE; ORAL
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ABLE 325MG;50MG;40MG;30MG A076528 001 Aug 21, 2003

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE


CAPSULE; ORAL
DHC PLUS
PHARM RES ASSOC 356.4MG;30MG;16MG A088584 001 Mar 04, 1986
SYNALGOS-DC-A
LEITNER PHARMS 356.4MG;30MG;16MG A089166 001 May 14, 1986

ACETAMINOPHEN; CODEINE PHOSPHATE


CAPSULE; ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
TEVA 300MG;15MG A088537 001 Jun 04, 1984
300MG;30MG A088324 001 Dec 29, 1983
300MG;60MG A088599 001 Jun 01, 1984
PHENAPHEN W/ CODEINE NO. 2
ROBINS AH 325MG;15MG A084444 001
PHENAPHEN W/ CODEINE NO. 3
ROBINS AH 325MG;30MG A084445 001
PHENAPHEN W/ CODEINE NO. 4
ROBINS AH 325MG;60MG A084446 001
PROVAL #3
SOLVAY 325MG;30MG A085685 001
TYLENOL W/ CODEINE NO. 3
ORTHO MCNEIL PHARM 300MG;30MG A087422 001
TYLENOL W/ CODEINE NO. 4
ORTHO MCNEIL PHARM 300MG;60MG A087421 001
SOLUTION; ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
CLONMEL 120MG/5ML;12MG/5ML A040098 001 Sep 20, 1996
ROXANE 120MG/5ML;12MG/5ML A086366 001
TYLENOL W/ CODEINE
ORTHO MCNEIL PHARM 120MG/5ML;12MG/5ML A085057 001
TABLET; ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
ABLE 300MG;30MG A040452 001 Aug 01, 2002
300MG;60MG A040459 001 Aug 01, 2002
AM THERAP 300MG;15MG A089478 001 Mar 03, 1987
300MG;15MG A089481 001 Mar 03, 1987
300MG;30MG A089479 001 Mar 03, 1987
300MG;30MG A089482 001 Mar 03, 1987
300MG;60MG A089480 001 Mar 03, 1987
300MG;60MG A089483 001 Mar 03, 1987
DURAMED PHARMS BARR 300MG;15MG A088353 001 Feb 06, 1984
300MG;30MG A088354 001 Feb 06, 1984
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 3 (of 324)

ACETAMINOPHEN; CODEINE PHOSPHATE


TABLET; ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
DURAMED PHARMS BARR 300MG;60MG A088355 001 Feb 06, 1984
EVERYLIFE 325MG;30MG A085217 001
HALSEY 300MG;15MG A083871 001
300MG;30MG A083872 001
300MG;60MG A086549 001
KV PHARM 300MG;30MG A085288 001
300MG;60MG A085365 001
325MG;15MG A085364 001
325MG;45MG A085363 001
LEDERLE 300MG;30MG A087141 001
MIKART 300MG;60MG A089244 001 Feb 25, 1986
MUTUAL PHARM 300MG;15MG A085795 001
300MG;15MG A089671 001 Feb 10, 1988
300MG;30MG A085794 001
300MG;30MG A089672 001 Feb 10, 1988
300MG;60MG A087653 001 Apr 13, 1982
300MG;60MG A089673 001 Feb 10, 1988
PHARMERAL 300MG;30MG A087762 001 Dec 10, 1982
PUREPAC PHARM 300MG;30MG A086681 001
300MG;30MG A089080 001 Jul 17, 1986
300MG;60MG A086683 001
ROXANE 300MG;15MG A084659 001
300MG;30MG A084656 001
300MG;60MG A084667 001
500MG;15MG A089511 001 Apr 25, 1989
500MG;30MG A089512 001 Apr 25, 1989
500MG;60MG A089513 001 Apr 25, 1989
SANDOZ 300MG;15MG A087433 001
300MG;30MG A081250 001 Jul 16, 1992
300MG;30MG A085291 002
300MG;30MG A085917 001
300MG;60MG A081249 001 Jul 16, 1992
300MG;60MG A085964 001
300MG;60MG A087423 001
SUPERPHARM 300MG;15MG A089183 001 Oct 18, 1985
300MG;30MG A089184 001 Oct 18, 1985
300MG;30MG A089253 001 May 19, 1986
300MG;60MG A089185 001 Oct 18, 1985
300MG;60MG A089254 001 May 19, 1986
USL PHARMA 300MG;30MG A087919 001 Jun 22, 1982
300MG;60MG A087920 001 Jun 22, 1982
VALEANT PHARM INTL 300MG;30MG A085896 001
VITARINE 300MG;30MG A085676 001
WARNER CHILCOTT 300MG;15MG A085992 001
300MG;30MG A085218 002
300MG;60MG A087306 001
WATSON LABS 300MG;15MG A087277 001 May 26, 1982
300MG;30MG A087276 001 May 26, 1982
300MG;60MG A087275 001 May 26, 1982
WHITEWORTH TOWN PLSN 300MG;30MG A084360 001
300MG;60MG A085607 001
CAPITAL AND CODEINE
CARNRICK 325MG;30MG A083643 001
CODRIX
WATSON LABS FLORIDA 500MG;15MG A040447 001 Feb 26, 2003
500MG;30MG A040441 001 Mar 27, 2003
500MG;60MG A040488 001 Mar 28, 2003
EMPRACET W/ CODEINE PHOSPHATE #3
GLAXOSMITHKLINE 300MG;30MG A083951 001
EMPRACET W/ CODEINE PHOSPHATE #4
GLAXOSMITHKLINE 300MG;60MG A083951 002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 4 (of 324)

ACETAMINOPHEN; CODEINE PHOSPHATE


TABLET; ORAL
PAPA-DEINE #3
VANGARD 300MG;30MG A088037 001 Mar 20, 1984
PAPA-DEINE #4
VANGARD 300MG;60MG A088715 001 Mar 20, 1984
PHENAPHEN-650 W/ CODEINE
ROBINS AH 650MG;30MG A085856 001
TYLENOL W/ CODEINE
ORTHO MCNEIL PHARM 325MG;7.5MG A085056 001
325MG;15MG A085056 002
325MG;30MG A085056 003
325MG;60MG A085056 004
TYLENOL W/ CODEINE NO. 1
ORTHO MCNEIL JANSSEN 300MG;7.5MG A085055 001
TYLENOL W/ CODEINE NO. 2
ORTHO MCNEIL JANSSEN 300MG;15MG A085055 002

ACETAMINOPHEN; HYDROCODONE BITARTRATE


CAPSULE; ORAL
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
CENT PHARMS 500MG;5MG A088898 001 Mar 27, 1985
ALLAY
IVAX PHARMS 500MG;5MG A089907 001 Jan 13, 1989
BANCAP HC
FOREST PHARMS 500MG;5MG A087961 001 Mar 17, 1983
CO-GESIC
CENT PHARMS 500MG;5MG A089360 001 Mar 02, 1988
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
MALLINCKRODT 500MG;5MG A088956 001 Jul 19, 1985
500MG;5MG A089006 001 Aug 09, 1985
MIKART 500MG;5MG A081068 001 Nov 30, 1989
500MG;5MG A081069 001 Nov 30, 1989
500MG;5MG A081070 001 Nov 30, 1989
LORCET-HD
MALLINCKRODT 500MG;5MG A087336 001 Jul 08, 1982
SOLUTION; ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
MIKART 500MG/15ML;5MG/15ML A081226 001 Oct 27, 1992
500MG/15ML;5MG/15ML A089557 001 Apr 29, 1992
TABLET; ORAL
DURADYNE DHC
FOREST PHARMS 500MG;5MG A087809 001 Mar 17, 1983
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ABLE 325MG;5MG A040478 001 Nov 08, 2002
325MG;7.5MG A040464 001 Oct 23, 2002
325MG;10MG A040464 002 Oct 23, 2002
500MG;5MG A040477 001 Nov 06, 2002
500MG;7.5MG A040490 001 May 21, 2003
500MG;10MG A040473 001 Nov 06, 2002
650MG;7.5MG A040474 001 Jan 02, 2003
650MG;10MG A040476 001 Oct 23, 2002
750MG;7.5MG A040469 001 Oct 25, 2002
BARR 500MG;2.5MG A040307 001 Jul 26, 2000
500MG;5MG A040308 001 Jul 26, 2000
500MG;5MG A088577 001 Dec 21, 1984
500MG;7.5MG A040307 002 Jul 26, 2000
500MG;10MG A040309 001 Jul 26, 2000
650MG;7.5MG A040307 003 Jul 26, 2000
650MG;10MG A040307 004 Jul 26, 2000
750MG;7.5MG A040308 002 Jul 26, 2000
ENDO PHARMS 500MG;5MG A040281 001 Sep 30, 1998
500MG;7.5MG A040280 001 Sep 30, 1998
650MG;7.5MG A040280 002 Sep 30, 1998
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 5 (of 324)

ACETAMINOPHEN; HYDROCODONE BITARTRATE


TABLET; ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ENDO PHARMS 650MG;10MG A040280 003 Sep 30, 1998
750MG;7.5MG A040281 002 Sep 30, 1998
HALSEY 500MG;5MG A089554 001 Jun 12, 1987
IVAX PHARMS 500MG;5MG A089696 001 Apr 21, 1988
MIKART 500MG;5MG A089271 001 Jul 16, 1986
500MG;5MG A089697 001 Jan 28, 1992
MUTUAL PHARM 500MG;5MG A040236 001 Sep 25, 1997
650MG;7.5MG A040240 002 Nov 26, 1997
650MG;10MG A040240 001 Nov 26, 1997
750MG;7.5MG A040236 002 Sep 25, 1997
UCB INC 500MG;10MG A040210 001 Aug 13, 1997
650MG;7.5MG A040134 001 Nov 21, 1996
USL PHARMA 500MG;5MG A089290 001 May 29, 1987
500MG;5MG A089291 001 May 29, 1987
VINTAGE PHARMS 500MG;5MG A089831 001 Sep 07, 1988
WATSON LABS 325MG;7.5MG A040248 001 Apr 28, 2000
500MG;5MG A040122 001 Mar 04, 1996
750MG;7.5MG A040122 002 Mar 04, 1996
HY-PHEN
ASCHER 500MG;5MG A087677 001 May 03, 1982
NORCET
ABANA 500MG;5MG A088871 001 May 15, 1986
TYCOLET
ORTHO MCNEIL PHARM 500MG;5MG A089385 001 Aug 27, 1986
VICODIN
ABBOTT 500MG;5MG A085667 001

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE


CAPSULE; ORAL
OXYCODONE AND ACETAMINOPHEN
BARR 500MG;5MG A040304 001 Oct 02, 2000
HALSEY 500MG;5MG A089994 001 May 04, 1989
MUTUAL PHARM 500MG;5MG A040219 001 Jan 22, 1998
TYLOX-325
ORTHO MCNEIL PHARM 325MG;5MG A088246 001 Nov 08, 1984
TABLET; ORAL
OXYCODONE 2.5/APAP 500
BRISTOL MYERS SQUIBB 500MG;2.5MG A085910 001
OXYCODONE 5/APAP 500
BRISTOL MYERS SQUIBB 500MG;5MG A085911 001
OXYCODONE AND ACETAMINOPHEN
BARR 325MG;5MG A087406 001
DURAMED PHARMS BARR 325MG;5MG A040272 001 Jun 30, 1998
PERCOCET
ENDO PHARMS 325MG;5MG A085106 002

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE


CAPSULE; ORAL
TYLOX
ORTHO MCNEIL PHARM 500MG;4.5MG;0.38MG A085375 001

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE


TABLET; ORAL
DARVOCET
AAIPHARMA LLC 325MG;32.5MG N016844 001
DOLENE AP-65
LEDERLE 650MG;65MG A085100 001
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
MYLAN 325MG;32MG A083689 001
SANDOZ 650MG;65MG A089959 001 Jul 18, 1989
WATSON LABS 650MG;65MG A040139 001 Dec 16, 1996
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 6 (of 324)

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE


TABLET; ORAL
WYGESIC
LEITNER PHARMS 650MG;65MG A084999 001

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE


TABLET; ORAL
PROPACET 100
TEVA 650MG;100MG A070107 001 Jun 12, 1985
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
ABLE 650MG;100MG A075838 001 Jul 11, 2001
ACTAVIS ELIZABETH 650MG;100MG A070910 001 Jan 02, 1987
HALSEY 325MG;50MG A072105 001 May 13, 1988
650MG;100MG A072106 001 May 13, 1988
IVAX SUB TEVA PHARMS 650MG;100MG A070146 001 Aug 02, 1985
MALLINCKRODT 650MG;100MG A075738 001 Feb 02, 2001
MUTUAL PHARM 325MG;50MG A070115 001 Jun 12, 1985
650MG;100MG A070116 001 Jun 12, 1985
650MG;100MG A070615 001 Mar 21, 1986
650MG;100MG A070771 001 Mar 21, 1986
650MG;100MG A070775 001 Mar 21, 1986
MYLAN 650MG;100MG A072195 001 Feb 16, 1988
SANDOZ 650MG;100MG A070443 001 Jan 23, 1986
SUPERPHARM 650MG;100MG A071319 001 Jan 06, 1987
TEVA 650MG;100MG A070732 001 Jan 03, 1986
WATSON LABS 325MG;50MG A070398 001 Dec 18, 1986
650MG;100MG A070399 001 Dec 18, 1986
WATSON LABS FLORIDA 500MG;100MG A077196 001 Jun 28, 2005
650MG;100MG A076609 001 Nov 16, 2004

ACETAZOLAMIDE
TABLET; ORAL
ACETAZOLAMIDE
ALRA 250MG A083320 001
ASCOT 250MG A087686 001 Oct 20, 1982
MUTUAL PHARM 250MG A089753 001 Jun 22, 1988
VANGARD 250MG A087654 001 Feb 05, 1982
WATSON LABS 250MG A084498 002
DIAMOX
DURAMED PHARMS BARR 125MG N008943 001
250MG N008943 002

ACETAZOLAMIDE SODIUM
INJECTABLE; INJECTION
ACETAZOLAMIDE SODIUM
HOSPIRA EQ 500MG BASE/VIAL A040108 001 Oct 30, 1995

ACETIC ACID, GLACIAL


SOLUTION/DROPS; OTIC
ACETIC ACID
KV PHARM 2% A085493 001
ORLEX
PROCTER AND GAMBLE 2% A086845 001

ACETIC ACID, GLACIAL; ALUMINUM ACETATE


SOLUTION/DROPS; OTIC
BOROFAIR
PHARMAFAIR 2%;0.79% A088606 001 Aug 21, 1985
DOMEBORO
BAYER PHARMS 2%;0.79% A084476 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 7 (of 324)

ACETIC ACID, GLACIAL; DESONIDE


SOLUTION/DROPS; OTIC
TRIDESILON
BAYER PHARMS 2%;0.05% N017914 001

ACETIC ACID, GLACIAL; HYDROCORTISONE


SOLUTION/DROPS; OTIC
ACETIC ACID W/ HYDROCORTISONE
KV PHARM 2%;1% A085492 001
HYDROCORTISONE AND ACETIC ACID
BAUSCH AND LOMB 2%;1% A040097 001 Oct 31, 1994
MORTON GROVE 2%;1% A040168 001 Aug 30, 1996
ORLEX HC
PROCTER AND GAMBLE 2%;1% A086844 001

ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE


SUSPENSION/DROPS; OTIC
NEO-CORT-DOME
BAYER PHARMS 2%;1%;EQ 0.35% BASE N050238 001

ACETOHEXAMIDE
TABLET; ORAL
ACETOHEXAMIDE
BARR 250MG A070869 001 Feb 09, 1987
500MG A070870 001 Feb 09, 1987
USL PHARMA 250MG A070753 001 Nov 03, 1986
500MG A070754 001 Nov 03, 1986
DYMELOR
LILLY 250MG N013378 002
500MG N013378 001

ACETOPHENAZINE MALEATE
TABLET; ORAL
TINDAL
SCHERING 20MG N012254 002

ACETRIZOATE SODIUM
SOLUTION; INTRAUTERINE
SALPIX
ORTHO MCNEIL PHARM 53% N009008 001

ACETYLCHOLINE CHLORIDE
FOR SOLUTION; OPHTHALMIC
MIOCHOL
NOVARTIS 20MG/VIAL N016211 001

ACETYLCYSTEINE
SOLUTION; INHALATION, ORAL
ACETYLCYSTEINE
HOSPIRA 10% A071364 001 May 01, 1989
20% A071365 001 May 01, 1989
ROXANE 10% A072621 001 Sep 30, 1992
20% A072622 001 Sep 30, 1992
MUCOMYST
APOTHECON 10% N013601 002
20% N013601 001
MUCOSIL-10
DEY 10% A070575 001 Oct 14, 1986
MUCOSIL-20
DEY 20% A070576 001 Oct 14, 1986
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 8 (of 324)

ACETYLCYSTEINE; ISOPROTERENOL HYDROCHLORIDE


SOLUTION; INHALATION
MUCOMYST W/ ISOPROTERENOL
MEAD JOHNSON 10%;0.05% N017366 001

ACETYLDIGITOXIN
TABLET; ORAL
ACYLANID
NOVARTIS 0.1MG N009436 001

ACRISORCIN
CREAM; TOPICAL
AKRINOL
SCHERING 2MG/GM N012470 001

ACYCLOVIR
CAPSULE; ORAL
ACYCLOVIR
BELCHER PHARMS 200MG A074889 001 Oct 31, 1997
DAVA PHARMS INC 200MG A074872 001 Apr 22, 1997
LEK PHARM 200MG A074750 001 Apr 22, 1997
MYLAN 200MG A074727 001 Apr 22, 1997
ROXANE 200MG A074570 002 Apr 22, 1997
TEVA 200MG A074828 001 Apr 22, 1997
TEVA PHARMS 200MG A074914 001 Nov 26, 1997
TABLET; ORAL
ACYCLOVIR
BELCHER PHARMS 400MG A074891 001 Oct 31, 1997
800MG A074891 002 Oct 31, 1997
DAVA PHARMS INC 400MG A074834 001 Apr 24, 1997
800MG A074834 002 Apr 24, 1997
LEK PHARM 400MG A074658 001 Apr 22, 1997
800MG A074658 002 Apr 22, 1997
MYLAN 400MG A075211 001 Sep 28, 1998
800MG A075211 002 Sep 28, 1998
TEVA 200MG A074556 001 Apr 22, 1997
TEVA PHARMS 400MG A075021 001 Mar 18, 1998
800MG A075021 002 Mar 18, 1998

ACYCLOVIR SODIUM
INJECTABLE; INJECTION
ACYCLOVIR
ABBOTT EQ 50MG BASE/ML A075114 001 Jul 26, 1999
ACYCLOVIR SODIUM
APOTHECON EQ 500MG BASE/VIAL A074897 001 Feb 27, 1998
EQ 1GM BASE/VIAL A074897 002 Feb 27, 1998
HOSPIRA EQ 500MG BASE/VIAL A074663 001 Apr 22, 1997
EQ 500MG BASE/VIAL A074758 001 Apr 22, 1997
EQ 1GM BASE/VIAL A074663 002 Apr 22, 1997
EQ 1GM BASE/VIAL A074758 002 Apr 22, 1997
ZOVIRAX
GLAXOSMITHKLINE EQ 250MG BASE/VIAL N018603 003 Aug 30, 1983

ADAPALENE
SOLUTION; TOPICAL
DIFFERIN
GALDERMA LABS LP 0.1% N020338 001 May 31, 1996

ALATROFLOXACIN MESYLATE
INJECTABLE; INJECTION
TROVAN PRESERVATIVE FREE
PFIZER EQ 200MG BASE/VIAL N020760 001 Dec 18, 1997
EQ 300MG BASE/VIAL N020760 002 Dec 18, 1997
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 9 (of 324)

ALBUMIN CHROMATED CR-51 SERUM


INJECTABLE; INJECTION
CHROMALBIN
ISO TEX 100uCi/VIAL N017835 001
250uCi/VIAL N017835 002
500uCi/VIAL N017835 003

ALBUMIN IODINATED I-125 SERUM


INJECTABLE; INJECTION
RADIO-IODINATED (I 125) SERUM ALBUMIN (HUMAN)
BAYER PHARMS 2.5uCi/AMP N017846 001
RADIOIODINATED SERUM ALBUMIN (HUMAN) IHSA I 125
MALLINCKRODT 6.67uCi/ML N017844 003
10uCi/ML N017844 001
100uCi/ML N017844 002

ALBUMIN IODINATED I-131 SERUM


INJECTABLE; INJECTION
MEGATOPE
ISO TEX 2mCi/VIAL N017837 003
5uCi/AMP N017837 004
20uCi/AMP N017837 005

ALBUTEROL
AEROSOL, METERED; INHALATION
ALBUTEROL
ARMSTRONG PHARMS 0.09MG/INH A072273 001 Aug 14, 1996
GENPHARM 0.09MG/INH A073045 001 Aug 19, 1997
IVAX SUB TEVA PHARMS 0.09MG/INH A073272 001 Dec 28, 1995
PLIVA 0.09MG/INH A074072 001 Aug 01, 1996
PROVENTIL
SCHERING 0.09MG/INH N017559 001
VENTOLIN
GLAXOSMITHKLINE 0.09MG/INH N018473 001

ALBUTEROL SULFATE
CAPSULE; INHALATION
VENTOLIN ROTACAPS
GLAXOSMITHKLINE EQ 0.2MG BASE N019489 001 May 04, 1988
SOLUTION; INHALATION
ALBUTEROL SULFATE
BAUSCH AND LOMB EQ 0.083% BASE A075358 001 Mar 29, 2000
COPLEY PHARM EQ 0.083% BASE A073495 001 May 28, 1993
EQ 0.5% BASE A073307 001 Nov 27, 1991
ROXANE EQ 0.083% BASE A075129 001 Feb 13, 2001
PROVENTIL
SCHERING EQ 0.083% BASE N019243 002 Jan 14, 1987
EQ 0.5% BASE N019243 001 Jan 14, 1987
VENTOLIN
GLAXOSMITHKLINE EQ 0.083% BASE N019773 001 Apr 23, 1992
EQ 0.5% BASE N019269 002 Jan 16, 1987
SYRUP; ORAL
ALBUTEROL SULFATE
ACTAVIS MID ATLANTIC EQ 2MG BASE/5ML A075262 001 Mar 30, 1999
MOVA EQ 2MG BASE/5ML A074302 001 Sep 30, 1994
WATSON LABS EQ 2MG BASE/5ML A073165 001 Apr 29, 1993
PROVENTIL
SCHERING EQ 2MG BASE/5ML N018062 001 Jan 19, 1983
VENTOLIN
GLAXOSMITHKLINE EQ 2MG BASE/5ML N019621 001 Jun 10, 1987
TABLET; ORAL
ALBUTEROL SULFATE
AM THERAP EQ 2MG BASE A072449 001 Dec 05, 1989
EQ 4MG BASE A072450 001 Dec 05, 1989
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 10 (of 324)

ALBUTEROL SULFATE
TABLET; ORAL
ALBUTEROL SULFATE
COPLEY PHARM EQ 2MG BASE A072966 001 Nov 22, 1991
EQ 4MG BASE A072967 001 Nov 22, 1991
DAVA PHARMS INC EQ 2MG BASE A072859 001 Dec 20, 1989
EQ 4MG BASE A072860 001 Dec 20, 1989
PLIVA EQ 2MG BASE A072316 001 Dec 05, 1989
EQ 4MG BASE A072317 001 Dec 05, 1989
SANDOZ EQ 2MG BASE A072151 001 Dec 05, 1989
EQ 4MG BASE A072152 001 Dec 05, 1989
TEVA EQ 2MG BASE A072619 001 Dec 05, 1989
EQ 2MG BASE A072779 001 Jun 25, 1993
EQ 2MG BASE A072938 001 Mar 30, 1990
EQ 4MG BASE A072620 001 Dec 05, 1989
EQ 4MG BASE A072780 001 Jun 25, 1993
EQ 4MG BASE A072939 001 Mar 30, 1990
UCB INC EQ 2MG BASE A073120 001 Sep 29, 1992
EQ 4MG BASE A073121 001 Sep 29, 1992
WARNER CHILCOTT EQ 2MG BASE A072817 001 Jan 09, 1990
EQ 4MG BASE A072818 001 Jan 09, 1990
WATSON LABS EQ 2MG BASE A072629 001 Jan 31, 1991
EQ 4MG BASE A072630 001 Jan 31, 1991
EQ 4MG BASE A072765 001 Aug 28, 1991
PROVENTIL
SCHERING EQ 2MG BASE N017853 001 May 07, 1982
EQ 4MG BASE N017853 002 May 07, 1982
VENTOLIN
GLAXOSMITHKLINE EQ 2MG BASE N019112 001 Jul 10, 1986
EQ 4MG BASE N019112 002 Jul 10, 1986
TABLET, EXTENDED RELEASE; ORAL
PROVENTIL
SCHERING EQ 4MG BASE N019383 001 Jul 13, 1987
VOLMAX
MURO EQ 4MG BASE N019604 002 Dec 23, 1992
EQ 8MG BASE N019604 001 Dec 23, 1992

ALCOHOL
INJECTABLE; INJECTION
ALCOHOL 5% IN DEXTROSE 5%
MILES 5ML/100ML A083483 001

ALCOHOL; DEXTROSE
INJECTABLE; INJECTION
ALCOHOL 5% IN DEXTROSE 5% IN WATER
BAXTER HLTHCARE 5ML/100ML;5GM/100ML A083256 001

ALGLUCERASE
INJECTABLE; INJECTION
CEREDASE
GENZYME 10 UNITS/ML N020057 004 May 08, 1992

ALKAVERVIR
TABLET; ORAL
VERILOID
3M 2MG N007336 002
3MG N007336 003

ALLOPURINOL
TABLET; ORAL
ALLOPURINOL
MUTUAL PHARM 100MG A070466 001 Dec 24, 1985
300MG A070467 001 Dec 24, 1985
PAR PHARM 100MG A070150 001 Dec 10, 1985
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 11 (of 324)

ALLOPURINOL
TABLET; ORAL
ALLOPURINOL
PAR PHARM 300MG A070147 001 Dec 10, 1985
PUREPAC PHARM 100MG A070579 001 Apr 14, 1986
300MG A070580 001 Apr 14, 1986
SANDOZ 100MG A070268 001 Dec 31, 1985
300MG A070269 001 Dec 31, 1985
SUPERPHARM 100MG A070950 001 Nov 30, 1988
300MG A070951 001 Nov 30, 1988
WATSON LABS 100MG N018241 001 Nov 16, 1984
100MG N018785 001 Sep 28, 1984
300MG N018241 002 Nov 16, 1984
300MG N018785 002 Sep 28, 1984
LOPURIN
ABBOTT 100MG N018297 001
300MG N018297 002

ALPHA-TOCOPHEROL; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC


ACID; NIACINAMIDE; PANTOTHENIC ACID; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A
INJECTABLE; INJECTION
CERNEVIT-12
BAXTER HLTHCARE 11.2 IU/VIAL;125MG/VIAL;60MCG/VIAL;200 N020924 001 Apr 06, 1999
IU/VIAL;5.5MG/VIAL;414MCG/VIAL;46MG/VIA
L;17.25MG/VIAL;4.53MG/VIAL;4.14MG/VIAL;
3.51MG/VIAL;3,500 IU/VIAL

ALPRAZOLAM
SOLUTION; ORAL
ALPRAZOLAM
ROXANE 0.5MG/5ML A074314 001 Oct 31, 1993
TABLET; ORAL
ALPRAZOLAM
IVAX SUB TEVA PHARMS 0.25MG A074294 001 Jul 29, 1994
0.5MG A074294 002 Jul 29, 1994
1MG A074294 003 Jul 29, 1994
2MG A074294 004 Jul 29, 1994
ROXANE 0.25MG A074199 001 Oct 19, 1993
0.5MG A074199 002 Oct 19, 1993
1MG A074199 003 Oct 19, 1993
TEVA 0.25MG A074085 001 Feb 16, 1994
0.5MG A074085 002 Feb 16, 1994
1MG A074085 003 Feb 16, 1994
2MG A074085 004 Feb 26, 1996
WATSON LABS 0.25MG A074456 001 Aug 31, 1995
0.25MG A074479 001 Jan 21, 1997
0.5MG A074456 002 Aug 31, 1995
0.5MG A074479 002 Jan 21, 1997
1MG A074456 003 Aug 31, 1995
1MG A074479 003 Jan 21, 1997

ALPROSTADIL
INJECTABLE; INJECTION
CAVERJECT
PFIZER 0.005MG/ML N020755 001 Oct 31, 1997
0.01MG/ML N020755 002 Oct 01, 1997
0.02MG/ML N020755 003 Oct 01, 1997
EDEX
SCHWARZ PHARMA 0.005MG/VIAL N020649 001 Jun 12, 1997

ALSEROXYLON
TABLET; ORAL

RAUTENSIN

NOVARTIS 2MG N009215 001


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 12 (of 324)

ALSEROXYLON
TABLET; ORAL
RAUWILOID
3M 2MG N008867 001

ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE


TABLET, CHEWABLE; ORAL
ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE
PENNEX 80MG;20MG A089449 001 Nov 27, 1987
FOAMICON
NOVARTIS 80MG;20MG A072687 001 Jun 28, 1989

AMANTADINE HYDROCHLORIDE
CAPSULE; ORAL
AMANTADINE HYDROCHLORIDE
WATSON LABS 100MG A071382 001 Jan 21, 1987
SYMADINE
SOLVAY 100MG A071000 001 Sep 04, 1986
SYMMETREL
ENDO PHARMS 100MG N016020 001
SYRUP; ORAL
AMANTADINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC 50MG/5ML A072655 001 Oct 30, 1990
TEVA PHARMS 50MG/5ML A073115 001 Aug 23, 1991
SYMMETREL
ENDO PHARMS 50MG/5ML N016023 002

AMCINONIDE
CREAM; TOPICAL
CYCLOCORT
ASTELLAS 0.025% N018116 001
0.1% N018116 002
LOTION; TOPICAL
CYCLOCORT
ASTELLAS 0.1% N019729 001 Jun 13, 1988
OINTMENT; TOPICAL
CYCLOCORT
ASTELLAS 0.1% N018498 001

AMDINOCILLIN
INJECTABLE; INJECTION
COACTIN
ROCHE 250MG/VIAL N050565 001 Dec 21, 1984
500MG/VIAL N050565 002 Dec 21, 1984
1GM/VIAL N050565 003 Dec 21, 1984

AMIFOSTINE
INJECTABLE; INJECTION
ETHYOL
MEDIMMUNE 375MG/VIAL N020221 002 Sep 10, 1999

AMIKACIN SULFATE
INJECTABLE; INJECTION
AMIKACIN SULFATE
ABBOTT EQ 250MG BASE/ML A063265 001 Nov 30, 1994
EQ 250MG BASE/ML A063266 001 Oct 31, 1994
ASTRAZENECA EQ 50MG BASE/ML A063167 001 Dec 14, 1995
EQ 250MG BASE/ML A063169 001 Dec 14, 1995
BAXTER HLTHCARE EQ 50MG BASE/ML A063274 001 May 18, 1992
EQ 250MG BASE/ML A063275 001 May 18, 1992
HOSPIRA EQ 50MG BASE/ML A063350 001 Jul 30, 1993
EQ 62.5MG BASE/ML A063283 001 Oct 31, 1994
EQ 250MG BASE/ML A063350 002 Jul 30, 1993
EQ 250MG BASE/ML A064098 001 Jun 26, 1995
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 13 (of 324)

AMIKACIN SULFATE
INJECTABLE; INJECTION
AMIKACIN SULFATE
HOSPIRA EQ 250MG BASE/ML A064099 001 Jun 20, 1995
TEVA PARENTERAL EQ 50MG BASE/ML A064045 001 Sep 28, 1993
AMIKIN
APOTHECON EQ 50MG BASE/ML A062311 001
EQ 50MG BASE/ML A062562 001 Sep 20, 1984
EQ 50MG BASE/ML N050495 001
EQ 250MG BASE/ML A062311 002
EQ 250MG BASE/ML A062562 002 Sep 20, 1984
EQ 250MG BASE/ML N050495 002
AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
APOTHECON EQ 5MG BASE/ML N050618 002 Nov 30, 1987
EQ 10MG BASE/ML N050618 001 Nov 30, 1987

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE


TABLET; ORAL
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
SANDOZ EQ 5MG ANHYDROUS;50MG A073357 001 Nov 27, 1991
TEVA EQ 5MG ANHYDROUS;50MG A070795 001 Apr 17, 1988
WATSON LABS EQ 5MG ANHYDROUS;50MG A073334 001 Jul 19, 1991
HYDRO-RIDE
PAR PHARM EQ 5MG ANHYDROUS;50MG A070347 001 Dec 25, 1990
MODURETIC 5-50
MERCK EQ 5MG ANHYDROUS;50MG N018201 001

AMINO ACIDS
INJECTABLE; INJECTION
AMINESS 5.2% ESSENTIAL AMINO ACIDS W/ HISTADINE
HOSPIRA 5.2% (5.2GM/100ML) N018901 001 Apr 06, 1984
AMINOSYN 3.5% IN PLASTIC CONTAINER
ABBOTT 3.5% (3.5GM/100ML) N018804 001 May 15, 1984
3.5% (3.5GM/100ML) N018875 001 Aug 08, 1984
AMINOSYN II 3.5%
HOSPIRA 3.5% (3.5GM/100ML) N019438 001 Apr 03, 1986
AMINOSYN II 3.5% IN PLASTIC CONTAINER
ABBOTT 3.5% (3.5GM/100ML) N019491 001 Oct 10, 1986
AMINOSYN II 5%
HOSPIRA 5% (5GM/100ML) N019438 002 Apr 03, 1986
AMINOSYN-HBC 7% IN PLASTIC CONTAINER
ABBOTT 7% (7GM/100ML) N019400 001 Jul 23, 1986
BRANCHAMIN 4%
BAXTER HLTHCARE 4% (4GM/100ML) N018678 001 Sep 28, 1984
FREAMINE 8.5%
B BRAUN 8.5% (8.5GM/100ML) N016822 001
FREAMINE II 8.5%
B BRAUN 8.5% (8.5GM/100ML) N016822 002
NEOPHAM 6.4%
HOSPIRA 6.4% (6.4GM/100ML) N018792 001 Jan 17, 1984
NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER
BAXTER HLTHCARE 15% (15GM/100ML) N020107 001 Feb 05, 1993
NOVAMINE 8.5%
HOSPIRA 8.5% (8.5GM/100ML) N017957 002 Aug 09, 1982

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE;


POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE; INJECTION
AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
ABBOTT 3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML N019714 001 Sep 12, 1988
;22.4MG/100ML;261MG/100ML;205MG/100ML
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
ABBOTT 4.25%;36.8MG/100ML;20GM/100ML;51MG/100M N019714 002 Sep 12, 1988
L;22.4MG/100ML;261MG/100ML;205MG/100ML
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 14 (of 324)

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE;


POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE; INJECTION
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
ABBOTT 4.25%;36.8MG/100ML;25GM/100ML;51MG/100M N019714 004 Sep 12, 1988
L;22.4MG/100ML;261MG/100ML;205MG/100ML
AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
ABBOTT 5%;36.8MG/100ML;25GM/100ML;51MG/100ML;2 N019714 003 Sep 12, 1988
2.4MG/100ML;261MG/100ML;205MG/100ML
HOSPIRA 5%;36.8MG/100ML;25GM/100ML;51MG/100ML;2 N019683 004 Nov 07, 1988
2.4MG/100ML;261MG/100ML;205MG/100ML

AMINO ACIDS; DEXTROSE


INJECTABLE; INJECTION
AMINOSYN 3.5% W/ DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 3.5%;25GM/100ML N019118 001 Oct 11, 1984
AMINOSYN 3.5% W/ DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTT 3.5%;5GM/100ML N019120 001 Oct 11, 1984
AMINOSYN 4.25% W/ DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 4.25%;25GM/100ML N019119 001 Oct 11, 1984
AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 3.5%;25GM/100ML N019505 002 Nov 07, 1986
3.5%;25GM/100ML N019713 006 Sep 09, 1988
AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTT 3.5%;5GM/100ML N019506 001 Nov 07, 1986
3.5%;5GM/100ML N019713 002 Sep 09, 1988
AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER
ABBOTT 4.25%;10GM/100ML N019713 001 Sep 09, 1988
AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
ABBOTT 4.25%;20GM/100ML N019713 004 Sep 09, 1988
AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 4.25%;25GM/100ML N019504 002 Nov 07, 1986
4.25%;25GM/100ML N019713 005 Sep 09, 1988
AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 5%;25GM/100ML N019565 001 Dec 17, 1986
5%;25GM/100ML N019713 003 Sep 09, 1988
TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;10GM/100ML N019520 002 Sep 23, 1988
TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;15GM/100ML N019520 003 Sep 23, 1988
TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;20GM/100ML N019520 004 Sep 23, 1988
TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;25GM/100ML N019520 005 Sep 23, 1988
TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;5GM/100ML N019520 001 Sep 23, 1988
TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;10GM/100ML N019520 007 Sep 23, 1988
TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;15GM/100ML N019520 008 Sep 23, 1988
TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;20GM/100ML N019520 009 Sep 23, 1988
TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;25GM/100ML N019520 010 Sep 23, 1988
TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;5GM/100ML N019520 006 Sep 23, 1988

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE;


POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE; INJECTION
AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER
ABBOTT 4.25%;10GM/100ML;51MG/100ML;176.5MG/100 N019712 002 Sep 08, 1988
ML;22.4MG/100ML;104.5MG/100ML;205MG/100
ML
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 15 (of 324)

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE;


POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE; INJECTION
AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER
HOSPIRA 4.25%;10GM/100ML;51MG/100ML;176.5MG/100 N019682 003 Nov 01, 1988
ML;22.4MG/100ML;104.5MG/100ML;205MG/100
ML

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE,


DIBASIC; SODIUM CHLORIDE
INJECTABLE; INJECTION
AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML N019564 002 Dec 16, 1986
;261MG/100ML;205MG/100ML
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 4.25%;25GM/100ML;51MG/100ML;22.4MG/100M N019564 004 Dec 16, 1986
L;261MG/100ML;205MG/100ML

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE;


SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE; INJECTION
AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTT 3.5%;5GM/100ML;30MG/100ML;97MG/100ML;12 N019564 001 Dec 16, 1986
0MG/100ML;49.3MG/100ML
3.5%;5GM/100ML;30MG/100ML;97MG/100ML;12 N019712 001 Sep 08, 1988
0MG/100ML;49.3MG/100ML
AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER
ABBOTT 4.25%;10GM/100ML;30MG/100ML;97MG/100ML; N019564 003 Dec 16, 1986
120MG/100ML;49.3MG/100ML

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM


ACETATE; SODIUM CHLORIDE
INJECTABLE; INJECTION
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;10GM/100ML;51MG/100ML;261MG/100ML N020147 002 Oct 23, 1995
;216MG/100ML;112MG/100ML
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;15GM/100ML;51MG/100ML;261MG/100ML N020147 003 Oct 23, 1995
;216MG/100ML;112MG/100ML
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;20GM/100ML;51MG/100ML;261MG/100ML N020147 004 Oct 23, 1995
;216MG/100ML;112MG/100ML
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;25GM/100ML;51MG/100ML;261MG/100ML N020147 005 Oct 23, 1995
;216MG/100ML;112MG/100ML
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;5GM/100ML;51MG/100ML;261MG/100ML; N020147 001 Oct 23, 1995
216MG/100ML;112MG/100ML
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;10GM/100ML;51MG/100ML;261MG/100ML N020147 007 Oct 23, 1995
;297MG/100ML;77MG/100ML
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;15GM/100ML;51MG/100ML;261MG/100ML N020147 008 Oct 23, 1995
;297MG/100ML;77MG/100ML
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;20GM/100ML;51MG/100ML;261MG/100ML N020147 009 Oct 23, 1995
;297MG/100ML;77MG/100ML
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;25GM/100ML;51MG/100ML;261MG/100ML N020147 010 Oct 23, 1995
;297MG/100ML;77MG/100ML
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;5GM/100ML;51MG/100ML;261MG/100ML; N020147 006 Oct 23, 1995
297MG/100ML;77MG/100ML
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 16 (of 324)

AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE
INJECTABLE; INJECTION
AMINOSYN 3.5% M IN PLASTIC CONTAINER
ABBOTT 3.5%;21MG/100ML;40MG/100ML;128MG/100ML; N018804 002 May 15, 1984
234MG/100ML
3.5%;21MG/100ML;40MG/100ML;128MG/100ML; N018875 002 Aug 08, 1984
234MG/100ML

AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE


INJECTABLE; INJECTION

AMINOSYN 3.5% M

HOSPIRA 3.5%;21MG/100ML;128MG/100ML;234MG/100ML N017789 005


AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE; SODIUM


PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE; INJECTION
AMINOSYN II 3.5% M IN PLASTIC CONTAINER
ABBOTT 3.5%;32MG/100ML;128MG/100ML;222MG/100ML N019493 001 Oct 16, 1986
;49MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM


ACETATE
INJECTABLE; INJECTION
VEINAMINE 8%
HOSPIRA 8%;61MG/100ML;211MG/100ML;56MG/100ML;38 N017957 001
8MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC;


SODIUM CHLORIDE
INJECTABLE; INJECTION
AMINOSYN II 7% W/ ELECTROLYTES
HOSPIRA 7%;102MG/100ML;45MG/100ML;522MG/100ML;4 N019437 006 Apr 03, 1986
10MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM


PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE; INJECTION
AMINOSYN II 3.5% M
HOSPIRA 3.5%;30MG/100ML;97MG/100ML;120MG/100ML; N019437 007 Apr 03, 1986
49MG/100ML

AMINOCAPROIC ACID
INJECTABLE; INJECTION
AMICAR
XANODYNE PHARM 250MG/ML N015229 002
AMINOCAPROIC ACID
ABRAXIS PHARM 250MG/ML A070522 001 Jun 17, 1986
BAXTER HLTHCARE 250MG/ML N018590 001 Oct 29, 1982
HOSPIRA 250MG/ML A070888 001 Jun 16, 1988

AMINOGLUTETHIMIDE
TABLET; ORAL

CYTADREN

NOVARTIS 250MG N018202 001


AMINOPHYLLINE
ENEMA; RECTAL
SOMOPHYLLIN
FISONS 300MG/5ML N018232 001 Apr 02, 1982
INJECTABLE; INJECTION
AMINOPHYLLIN
GD SEARLE LLC 25MG/ML A087243 001 May 24, 1982
25MG/ML A087621 001 May 24, 1982
AMINOPHYLLINE
ABRAXIS PHARM 25MG/ML A084568 001
25MG/ML A087200 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 17 (of 324)

AMINOPHYLLINE
INJECTABLE; INJECTION
AMINOPHYLLINE
ABRAXIS PHARM 25MG/ML A087250 001 Jan 06, 1982
25MG/ML A087431 001
25MG/ML A087886 001 Aug 30, 1983
25MG/ML A088407 001 Jan 25, 1984
ELKINS SINN 25MG/ML A087239 001
HOSPIRA 25MG/ML A087601 001 Jul 23, 1982
INTL MEDICATION 25MG/ML A087867 001 Nov 10, 1983
25MG/ML A087868 001 Nov 10, 1983
KING PHARMS 25MG/ML A086606 001
PHARMA SERVE NY 25MG/ML A087387 001 Jun 03, 1983
SMITH AND NEPHEW 25MG/ML A088429 001 May 30, 1985
25MG/ML A088749 001 May 30, 1985
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%
HOSPIRA 100MG/100ML A088147 002 May 03, 1983
200MG/100ML A088147 003 May 03, 1983
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
HOSPIRA 100MG/100ML N018924 001 Dec 12, 1984
200MG/100ML N018924 002 Dec 12, 1984
400MG/100ML N018924 003 Dec 12, 1984
500MG/100ML N018924 004 Dec 12, 1984
SOLUTION; ORAL
AMINOPHYLLINE
MORTON GROVE 105MG/5ML A088156 001 Dec 05, 1983
ROXANE 105MG/5ML A088126 001 Aug 19, 1983
AMINOPHYLLINE DYE FREE
ACTAVIS MID ATLANTIC 105MG/5ML A087727 001 Apr 16, 1982
SOMOPHYLLIN
FISONS 105MG/5ML A086466 001
SOMOPHYLLIN-DF
FISONS 105MG/5ML A087045 001
SUPPOSITORY; RECTAL
TRUPHYLLINE
G AND W LABS 250MG A085498 001 Mar 23, 1983
500MG A085498 002 Jan 03, 1983
TABLET; ORAL
AMINOPHYLLIN
GD SEARLE LLC 100MG N002386 002
200MG N002386 003
AMINOPHYLLINE
ASCOT 100MG A087522 001 Feb 12, 1982
200MG A087523 001 Feb 12, 1982
BARR 100MG A088297 001 Aug 19, 1983
200MG A088298 001 Aug 19, 1983
DURAMED PHARMS BARR 100MG A088182 001 Mar 31, 1983
200MG A088183 001 Mar 31, 1983
HALSEY 100MG A084674 001
IMPAX LABS 100MG A084574 001
200MG A084576 001
KV PHARM 100MG A085284 001
200MG A085289 001
LANNETT 100MG A084588 001
200MG A084588 002
PAL PAK 100MG A084533 001
PANRAY 100MG A084552 001
200MG A084552 002
PUREPAC PHARM 100MG A084699 001
200MG A085333 001
ROXANE 100MG A087500 001 Feb 09, 1982
200MG A087501 001 Feb 09, 1982
SANDOZ 100MG A085261 003
100MG A085262 002
200MG A085261 002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 18 (of 324)

AMINOPHYLLINE
TABLET; ORAL
AMINOPHYLLINE
VALEANT PHARM INTL 200MG A084563 001
VANGARD 100MG A088314 001 Oct 03, 1983
200MG A088319 001 Oct 03, 1983
VINTAGE PHARMS 100MG A085409 001
200MG A085410 001
WATSON LABS 100MG A085567 001
200MG A085564 001
TABLET, DELAYED RELEASE; ORAL
AMINOPHYLLINE
IMPAX LABS 100MG A084577 001
200MG A084575 001
TABLICAPS 100MG A084632 002
VALE 100MG A084531 001
200MG A084530 001
TABLET, EXTENDED RELEASE; ORAL
PHYLLOCONTIN
PHARM RES ASSOC 225MG A086760 001

AMINOSALICYLATE SODIUM
POWDER; ORAL
P.A.S. SODIUM

CENTURY PHARMS 4GM/PACKET A080947 001


SODIUM AMINOSALICYLATE

HEXCEL 100% A080097 001


TABLET; ORAL

PARASAL SODIUM

PANRAY 500MG N006811 006


1GM N006811 011


SODIUM P.A.S.

LANNETT 500MG A080138 002


TEEBACIN

CONSOLIDATED MIDLAND 500MG N007320 002


AMINOSALICYLATE SODIUM; AMINOSALICYLIC ACID


TABLET; ORAL
NEOPASALATE
MEDPOINTE PHARM HLC 846MG;112MG A080059 002

AMINOSALICYLIC ACID
TABLET; ORAL
PARASAL
PANRAY 500MG N006811 001
1GM N006811 002

AMINOSALICYLIC ACID RESIN COMPLEX


POWDER; ORAL
REZIPAS
BRISTOL MYERS SQUIBB EQ 500MG BASE/GM N009052 001

AMIODARONE HYDROCHLORIDE
INJECTABLE; INJECTION
AMIODARONE HYDROCHLORIDE
BEN VENUE 50MG/ML A076088 001 Oct 15, 2002
HOSPIRA 50MG/ML A076108 001 Oct 15, 2002
INTL MEDICATION SYS 50MG/ML N021594 001 Feb 04, 2004
CORDARONE
WYETH PHARMS INC 50MG/ML N020377 001 Aug 03, 1995
TABLET; ORAL
AMIODARONE HYDROCHLORIDE
TEVA 200MG A074895 001 Apr 16, 1999
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 19 (of 324)

AMITRIPTYLINE HYDROCHLORIDE
CONCENTRATE; ORAL
ENDEP
ROCHE 40MG/ML A085749 001
INJECTABLE; INJECTION
AMITRIPTYLINE HYDROCHLORIDE
WATSON LABS 10MG/ML A085594 001
ELAVIL
ASTRAZENECA 10MG/ML N012704 001
TABLET; ORAL
AMITID
BRISTOL MYERS SQUIBB 10MG A086454 001
25MG A086454 002
50MG A086454 003
75MG A086454 004
100MG A086454 005
AMITRIL
WARNER CHILCOTT 10MG A083939 001
25MG A083937 001
50MG A083938 002
75MG A084957 001
100MG A085093 001
150MG A086295 001
AMITRIPTYLINE HYDROCHLORIDE
AM THERAP 25MG A088672 001 Nov 20, 1984
50MG A088673 001 Nov 20, 1984
75MG A088674 001 Nov 20, 1984
100MG A088675 001 Nov 20, 1984
COPLEY PHARM 10MG A088421 001 Apr 30, 1984
25MG A088422 001 Apr 30, 1984
50MG A088423 001 Apr 30, 1984
75MG A088424 001 Apr 30, 1984
100MG A088425 001 Apr 30, 1984
150MG A088426 001 Apr 30, 1984
HALSEY 10MG A085923 001
25MG A085922 001
50MG A085925 001
50MG A087557 001 Mar 05, 1982
75MG A085926 001 May 20, 1983
100MG A085927 001 May 20, 1983
LEDERLE 10MG A086744 001
10MG A087366 001 Jan 04, 1982
25MG A086746 001
25MG A087367 001 May 03, 1982
50MG A086743 001
50MG A087181 001 Jan 04, 1982
75MG A086745 001
75MG A087369 001 Jan 04, 1982
100MG A086747 001
100MG A087368 001 May 03, 1982
150MG A087370 001 Jan 04, 1982
MUTUAL PHARM 10MG A085744 001
25MG A085627 001
50MG A085745 001
75MG A085743 001
100MG A085742 002 May 11, 1982
150MG A089423 001 Feb 17, 1987
PAR PHARM 10MG A088697 001 Sep 25, 1984
25MG A088698 001 Sep 25, 1984
50MG A088699 001 Sep 25, 1984
75MG A088700 001 Sep 25, 1984
100MG A088701 001 Sep 25, 1984
150MG A088702 001 Sep 25, 1984
PLIVA 10MG A088883 001 Sep 26, 1984
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 20 (of 324)

AMITRIPTYLINE HYDROCHLORIDE
TABLET; ORAL
AMITRIPTYLINE HYDROCHLORIDE
PLIVA 25MG A088884 001 Sep 26, 1984
50MG A088885 001 Sep 26, 1984
75MG A088886 001 Sep 26, 1984
100MG A088887 001 Sep 26, 1984
150MG A088888 001 Sep 26, 1984
PUREPAC PHARM 10MG A088075 001 Sep 16, 1983
10MG A088084 001 Jul 18, 1983
25MG A088076 001 May 20, 1983
25MG A088085 001 Jul 18, 1983
50MG A088077 001 Sep 16, 1983
50MG A088105 001 Jul 18, 1983
75MG A088078 001 Sep 16, 1983
75MG A088106 001 Jul 18, 1983
100MG A088079 001 Sep 16, 1983
100MG A088107 001 Jul 18, 1983
ROXANE 10MG A086002 001
10MG A086144 001
25MG A085944 001
25MG A086145 001
50MG A085945 001
50MG A086143 001
75MG A086004 001
75MG A086147 001
100MG A086003 001
100MG A086146 001
150MG A086090 001
150MG A086148 001
SUPERPHARM 10MG A088853 001 Nov 13, 1984
25MG A088854 001 Nov 13, 1984
50MG A088855 001 Nov 13, 1984
75MG A088856 001 Nov 13, 1984
100MG A088857 001 Nov 13, 1984
TEVA 10MG A084910 003
10MG A086610 001
25MG A085031 001
25MG A086859 001
50MG A085032 001
50MG A086857 001
75MG A085030 001
75MG A086860 001
100MG A085836 001
100MG A086854 001
150MG A086853 001
UCB INC 10MG A085864 001
25MG A085935 001
50MG A085936 001
75MG A086337 001
100MG A086336 001
150MG A086335 001
USL PHARMA 25MG A087775 001 Feb 10, 1982
VANGARD 10MG A087632 001 Feb 01, 1982
50MG A087616 001 Feb 08, 1982
75MG A087617 001 Feb 05, 1982
100MG A087639 001 Feb 08, 1982
WATSON LABS 10MG A085816 001
10MG A088620 001 Mar 02, 1984
25MG A085817 001
25MG A088621 001 Mar 02, 1984
50MG A085815 001
50MG A088622 001 Mar 02, 1984
75MG A085819 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 21 (of 324)

AMITRIPTYLINE HYDROCHLORIDE
TABLET; ORAL
AMITRIPTYLINE HYDROCHLORIDE
WATSON LABS 75MG A088633 001 Mar 02, 1984
100MG A085820 001
100MG A088634 001 Mar 02, 1984
150MG A085821 001
150MG A088635 001 Mar 02, 1984
WEST WARD 10MG A087647 001 Mar 05, 1982
25MG A087278 001
ELAVIL
ASTRAZENECA 10MG N012703 001
25MG N012703 003
50MG N012703 004
75MG N012703 005
100MG N012703 006
150MG N012703 007
ENDEP
ROCHE 10MG A083639 001
25MG A083639 002
50MG A083639 003
75MG A083639 004
100MG A083639 005
150MG A085303 001

AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE


TABLET; ORAL
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
MUTUAL PHARM EQ 12.5MG BASE;5MG A070765 001 Dec 10, 1986
EQ 25MG BASE;10MG A070766 001 Dec 10, 1986
PAR PHARM EQ 12.5MG BASE;5MG A072277 001 May 09, 1988
EQ 25MG BASE;10MG A072278 001 May 09, 1988
USL PHARMA EQ 12.5MG BASE;5MG A070477 001 Jan 12, 1988
EQ 25MG BASE;10MG A070478 001 Jan 12, 1988
WATSON LABS EQ 12.5MG BASE;5MG A072052 001 Dec 16, 1988
EQ 25MG BASE;10MG A072053 001 Dec 16, 1988

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE


TABLET; ORAL
ETRAFON 2-10
SCHERING 10MG;2MG N014713 007
ETRAFON 2-25
SCHERING 25MG;2MG N014713 004
ETRAFON-A
SCHERING 10MG;4MG N014713 002
ETRAFON-FORTE
SCHERING 25MG;4MG N014713 006
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
IVAX SUB TEVA PHARMS 10MG;2MG A070935 001 Sep 11, 1986
10MG;4MG A070937 001 Sep 11, 1986
25MG;2MG A070936 001 Sep 11, 1986
25MG;4MG A070938 001 Sep 11, 1986
50MG;4MG A070939 001 Sep 12, 1986
MUTUAL PHARM 10MG;2MG A071077 001 Nov 12, 1986
10MG;4MG A071078 001 Nov 12, 1986
25MG;2MG A070297 001 Nov 12, 1986
25MG;4MG A071079 001 Nov 12, 1986
PAR PHARM 10MG;2MG A070565 001 Sep 11, 1986
10MG;4MG A070620 001 Sep 11, 1986
25MG;2MG A070621 001 Sep 11, 1986
25MG;4MG A070595 001 Sep 11, 1986
50MG;4MG A070574 001 Sep 11, 1986
SANDOZ 10MG;2MG A071062 001 Nov 27, 1987
10MG;4MG A071862 001 Dec 21, 1987
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 22 (of 324)

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE


TABLET; ORAL
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
SANDOZ 25MG;2MG A071063 001 Nov 27, 1987
25MG;4MG A071064 001 Nov 27, 1987
50MG;4MG A071863 001 Dec 21, 1987
WATSON LABS 10MG;2MG A070373 001 Aug 25, 1986
10MG;2MG A072539 001 Feb 15, 1989
10MG;2MG A073007 001 Oct 17, 1991
10MG;4MG A070375 001 Aug 25, 1986
10MG;4MG A072540 001 Feb 15, 1989
10MG;4MG A073009 001 Oct 17, 1991
25MG;2MG A070374 001 Aug 25, 1986
25MG;2MG A072541 001 Feb 15, 1989
25MG;2MG A073008 001 Oct 17, 1991
25MG;4MG A070376 001 Aug 25, 1986
25MG;4MG A072134 001 Feb 15, 1989
25MG;4MG A073010 001 Oct 17, 1991
50MG;4MG A070377 001 Nov 04, 1986
50MG;4MG A071558 001 Mar 02, 1987
50MG;4MG A072135 001 Feb 15, 1989
TRIAVIL 2-10
NEW RIVER 10MG;2MG N014715 004
TRIAVIL 2-25
NEW RIVER 25MG;2MG N014715 002
TRIAVIL 4-10
NEW RIVER 10MG;4MG N014715 003
TRIAVIL 4-25
NEW RIVER 25MG;4MG N014715 005
TRIAVIL 4-50
NEW RIVER 50MG;4MG N014715 006

AMLEXANOX
PATCH; TOPICAL
AMLEXANOX
ULURU 2MG N021727 001 Sep 29, 2004

AMLODIPINE BESYLATE
TABLET; ORAL
AMLODIPINE BESYLATE
GENPHARM EQ 2.5MG BASE A077362 001 Jul 09, 2007
EQ 5MG BASE A077362 002 Jul 09, 2007
EQ 10MG BASE A077362 003 Jul 09, 2007
MUTUAL PHARMA EQ 2.5MG BASE A078081 001 Jan 31, 2008
EQ 5MG BASE A078081 002 Jan 31, 2008
EQ 10MG BASE A078081 003 Jan 31, 2008
TABLET, ORALLY DISINTEGRATING; ORAL
AMLODIPINE BESYLATE
SYNTHON PHARMS EQ 2.5MG BASE N022026 001 Sep 27, 2007
EQ 5MG BASE N022026 002 Sep 27, 2007
EQ 10MG BASE N022026 003 Sep 27, 2007

AMLODIPINE MALEATE
TABLET; ORAL
AMVAZ
DR REDDYS LABS INC 2.5MG N021435 001 Oct 31, 2003
5MG N021435 002 Oct 31, 2003
10MG N021435 003 Oct 31, 2003

AMMONIUM CHLORIDE
INJECTABLE; INJECTION
AMMONIUM CHLORIDE
ABBOTT 5MEQ/ML A083130 001
GD SEARLE LLC 3MEQ/ML A086205 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 23 (of 324)

AMMONIUM CHLORIDE
INJECTABLE; INJECTION
AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
MCGAW 900MG/100ML N006580 001
AMMONIUM CHLORIDE 2.14%
B BRAUN 40MEQ/100ML A085734 001

AMODIAQUINE HYDROCHLORIDE
TABLET; ORAL
CAMOQUIN HYDROCHLORIDE
PARKE DAVIS EQ 200MG BASE N006441 001

AMOXAPINE
TABLET; ORAL
AMOXAPINE
SANDOZ 25MG A072943 001 Jun 28, 1991
50MG A072944 001 Jun 28, 1991
100MG A072878 001 Jun 28, 1991
150MG A072879 001 Jun 28, 1991
WATSON LABS 25MG A072418 001 May 11, 1989
50MG A072419 001 May 11, 1989
100MG A072420 001 May 11, 1989
150MG A072421 001 May 11, 1989
ASENDIN
LEDERLE 25MG N018021 001
50MG N018021 002
100MG N018021 003
150MG N018021 004

AMOXICILLIN
CAPSULE; ORAL
AMOXICILLIN
AM ANTIBIOTICS 250MG A062058 001
500MG A062058 002
LABS ATRAL 250MG A062528 001 Aug 07, 1985
500MG A062528 002 Aug 07, 1985
MYLAN 250MG A062067 001
500MG A062067 002
TEVA 250MG A062853 001 Dec 22, 1987
250MG A063030 001 Feb 28, 1989
500MG A062854 001 Dec 22, 1987
500MG A063031 001 Feb 28, 1989
AMOXIL
GLAXOSMITHKLINE 250MG A062216 001
250MG A062216 003
250MG N050459 001
500MG A062216 004
500MG N050459 002
TRIMOX
APOTHECON 250MG A061885 001
250MG A062098 001
250MG A062152 001
250MG A063099 001 Mar 20, 1992
500MG A061885 002
500MG A062098 002
500MG A062152 002
500MG A063099 002 Mar 20, 1992
UTIMOX
PARKE DAVIS 250MG A062107 001
500MG A062107 002
WYMOX
WYETH AYERST 250MG A062120 001
500MG A062120 002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 24 (of 324)

AMOXICILLIN
FOR SUSPENSION; ORAL
AMOXICILLIN
AM ANTIBIOTICS 125MG/5ML A062059 001
250MG/5ML A062059 002
MYLAN 125MG/5ML A062090 001
250MG/5ML A062090 002
TEVA 125MG/5ML A062946 001 Nov 01, 1988
250MG/5ML A063001 001 Jan 06, 1989
AMOXIL
GLAXOSMITHKLINE 50MG/ML A062226 005
50MG/ML N050460 005
125MG/5ML A062226 001
125MG/5ML N050460 001
200MG/5ML N050760 001 Apr 15, 1999
250MG/5ML A062226 002
250MG/5ML N050460 002
400MG/5ML N050760 002 Apr 15, 1999
LAROTID
GLAXOSMITHKLINE 50MG/ML N050460 006
POLYMOX
APOTHECON 125MG/5ML A061851 001
125MG/5ML A062323 001
250MG/5ML A061851 002
250MG/5ML A062323 002
TRIMOX
APOTHECON 125MG/5ML A062099 001
125MG/5ML A062154 001
250MG/5ML A062099 002
250MG/5ML A062154 002
UTIMOX
PARKE DAVIS 125MG/5ML A062127 001
250MG/5ML A062127 002
WYMOX
WYETH AYERST 125MG/5ML A062131 001
250MG/5ML A062131 002
TABLET; ORAL
AMOXIL
GLAXOSMITHKLINE 500MG N050754 002 Jul 10, 1998
875MG N050754 001 Jul 10, 1998
TABLET, CHEWABLE; ORAL
AMOXICILLIN
APOTHECON 125MG A064131 001 May 06, 1996
250MG A064131 002 May 06, 1996
TEVA 125MG A064031 001 Dec 19, 1996
250MG A064031 002 Dec 19, 1996
AMOXIL
GLAXOSMITHKLINE 125MG N050542 002
200MG N050761 001 Apr 15, 1999
250MG N050542 001
400MG N050761 002 Apr 15, 1999

AMOXICILLIN; CLAVULANATE POTASSIUM


FOR SUSPENSION; ORAL
AUGMENTIN '125'
GLAXOSMITHKLINE 125MG/5ML;EQ 31.25MG BASE/5ML N050575 001 Aug 06, 1984
AUGMENTIN '200'
GLAXOSMITHKLINE 200MG/5ML;EQ 28.5MG BASE/5ML N050725 001 May 31, 1996
AUGMENTIN '250'
GLAXOSMITHKLINE 250MG/5ML;EQ 62.5MG BASE/5ML N050575 002 Aug 06, 1984
AUGMENTIN '400'
GLAXOSMITHKLINE 400MG/5ML;EQ 57MG BASE/5ML N050725 002 May 31, 1996
AUGMENTIN ES-600
SMITHKLINE BEECHAM 600MG/5ML;EQ 42.9MG BASE/5ML N050755 001 Jun 22, 2001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 25 (of 324)

AMOXICILLIN; CLAVULANATE POTASSIUM


TABLET; ORAL
AUGMENTIN '250'
GLAXOSMITHKLINE 250MG;EQ 125MG BASE N050564 001 Aug 06, 1984
AUGMENTIN '500'
GLAXOSMITHKLINE 500MG;EQ 125MG BASE N050564 002 Aug 06, 1984
AUGMENTIN '875'
GLAXOSMITHKLINE 875MG;EQ 125MG BASE N050720 001 Feb 13, 1996
TABLET, CHEWABLE; ORAL
AUGMENTIN '125'
GLAXOSMITHKLINE 125MG;EQ 31.25MG BASE N050597 001 Jul 22, 1985
AUGMENTIN '200'
GLAXOSMITHKLINE 200MG;EQ 28.5MG BASE N050726 001 May 31, 1996
AUGMENTIN '250'
GLAXOSMITHKLINE 250MG;EQ 62.5MG BASE N050597 002 Jul 22, 1985
AUGMENTIN '400'
GLAXOSMITHKLINE 400MG;EQ 57MG BASE N050726 002 May 31, 1996
TABLET, EXTENDED RELEASE; ORAL
AUGMENTIN XR
GLAXOSMITHKLINE 1GM;EQ 62.5MG BASE N050785 001 Sep 25, 2002

AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE;


DEXTROAMPHETAMINE SULFATE
CAPSULE; ORAL
DELCOBESE
TEVA 1.25MG;1.25MG;1.25MG;1.25MG A083564 001

2.5MG;2.5MG;2.5MG;2.5MG A083564 002


3.75MG;3.75MG;3.75MG;3.75MG A083564 003


5MG;5MG;5MG;5MG A083564 004


TABLET; ORAL

DELCOBESE

TEVA 1.25MG;1.25MG;1.25MG;1.25MG A083563 004


2.5MG;2.5MG;2.5MG;2.5MG A083563 003


3.75MG;3.75MG;3.75MG;3.75MG A083563 002


5MG;5MG;5MG;5MG A083563 001


AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE;


DEXTROAMPHETAMINE SULFATE
TABLET; ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
MUTUAL PHARM 1.25MG;1.25MG;1.25MG;1.25MG A040480 001 Sep 09, 2003
1.875MG;1.875MG;1.875MG;1.875MG A040480 002 Sep 09, 2003
2.5MG;2.5MG;2.5MG;2.5MG A040480 003 Sep 09, 2003
3.125MG;3.125MG;3.125MG;3.125MG A040480 004 Sep 09, 2003
3.75MG;3.75MG;3.75MG;3.75MG A040480 005 Sep 09, 2003
5MG;5MG;5MG;5MG A040480 006 Sep 09, 2003
7.5MG;7.5MG;7.5MG;7.5MG A040480 007 Sep 09, 2003
WATSON LABS 1.25MG;1.25MG;1.25MG;1.25MG A040456 001 May 06, 2003
2.5MG;2.5MG;2.5MG;2.5MG A040456 002 May 06, 2003
5MG;5MG;5MG;5MG A040456 003 May 06, 2003
7.5MG;7.5MG;7.5MG;7.5MG A040456 004 May 06, 2003

AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX


CAPSULE, EXTENDED RELEASE; ORAL

BIPHETAMINE 12.5

UCB INC EQ 6.25MG BASE;EQ 6.25MG BASE N010093 007


BIPHETAMINE 20

UCB INC EQ 10MG BASE;EQ 10MG BASE N010093 003


BIPHETAMINE 7.5

UCB INC EQ 3.75MG BASE;EQ 3.75MG BASE N010093 009


AMPHETAMINE SULFATE
TABLET; ORAL
AMPHETAMINE SULFATE
LANNETT 5MG A083901 001 Aug 31, 1984
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 26 (of 324)

AMPHETAMINE SULFATE
TABLET; ORAL
AMPHETAMINE SULFATE
LANNETT 10MG A083901 002 Aug 31, 1984

AMPHOTERICIN B
CREAM; TOPICAL

FUNGIZONE

APOTHECON 3% N050314 001

INJECTABLE; INJECTION

AMPHOTERICIN B
ABBOTT 50MG/VIAL A064141 001 Dec 23, 1996
ABRAXIS PHARM 50MG/VIAL A062728 001 Apr 13, 1987
LOTION; TOPICAL

FUNGIZONE

APOTHECON 3% A060570 001

OINTMENT; TOPICAL

FUNGIZONE

APOTHECON 3% N050313 001

SUSPENSION; ORAL

FUNGIZONE

BRISTOL MYERS SQUIBB 100MG/ML N050341 003

AMPICILLIN SODIUM
INJECTABLE; INJECTION
AMPICILLIN SODIUM
APOTHECON EQ 125MG BASE/VIAL A062860 001 Feb 05, 1988
EQ 250MG BASE/VIAL A062860 002 Feb 05, 1988
EQ 500MG BASE/VIAL A062860 003 Feb 05, 1988
EQ 1GM BASE/VIAL A062860 004 Feb 05, 1988
EQ 2GM BASE/VIAL A062860 005 Feb 05, 1988
BAXTER HLTHCARE EQ 125MG BASE/VIAL A062692 001 Jun 24, 1986
EQ 250MG BASE/VIAL A062692 002 Jun 24, 1986
EQ 500MG BASE/VIAL A062692 003 Jun 24, 1986
EQ 1GM BASE/VIAL A062692 004 Jun 24, 1986
EQ 2GM BASE/VIAL A062692 005 Jun 24, 1986
EQ 10GM BASE/VIAL A062692 006 Jun 24, 1986
CONSOLIDATED PHARM EQ 125MG BASE/VIAL A061936 005
EQ 250MG BASE/VIAL A061936 001
EQ 500MG BASE/VIAL A061936 002
EQ 1GM BASE/VIAL A061936 003
EQ 2GM BASE/VIAL A061936 004
HANFORD GC EQ 125MG BASE/VIAL A063143 001 Apr 15, 1993
EQ 250MG BASE/VIAL A063145 001 Apr 15, 1993
EQ 500MG BASE/VIAL A063147 001 Apr 15, 1993
EQ 1GM BASE/VIAL A063139 001 Apr 15, 1993
EQ 2GM BASE/VIAL A063141 001 Apr 15, 1993
INTL MEDICATION EQ 1GM BASE/VIAL A062634 002 Jan 09, 1987
EQ 2GM BASE/VIAL A062634 003 Jan 09, 1987
LILLY EQ 500MG BASE/VIAL A062565 001 Apr 04, 1985
EQ 1GM BASE/VIAL A062565 002 Apr 04, 1985
EQ 2GM BASE/VIAL A062565 003 Jun 24, 1986
MARSAM PHARMS LLC EQ 125MG BASE/VIAL A062816 001 Oct 24, 1988
EQ 250MG BASE/VIAL A062816 002 Oct 24, 1988
EQ 500MG BASE/VIAL A062816 003 Oct 24, 1988
EQ 1GM BASE/VIAL A062816 004 Oct 24, 1988
EQ 2GM BASE/VIAL A062816 005 Oct 24, 1988
EQ 10GM BASE/VIAL A062994 001 Sep 15, 1988
OMNIPEN-N
WYETH AYERST EQ 125MG BASE/VIAL A060626 001
EQ 125MG BASE/VIAL A062718 001 Dec 16, 1986
EQ 250MG BASE/VIAL A060626 002
EQ 250MG BASE/VIAL A062718 002 Dec 16, 1986
EQ 500MG BASE/VIAL A060626 003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 27 (of 324)

AMPICILLIN SODIUM
INJECTABLE; INJECTION
OMNIPEN-N
WYETH AYERST EQ 500MG BASE/VIAL A062718 003 Dec 16, 1986
EQ 1GM BASE/VIAL A060626 004
EQ 1GM BASE/VIAL A062718 004 Dec 16, 1986
EQ 2GM BASE/VIAL A060626 005
EQ 2GM BASE/VIAL A062718 005 Dec 16, 1986
PENBRITIN-S
WYETH AYERST EQ 125MG BASE/VIAL N050072 001
EQ 250MG BASE/VIAL N050072 002
EQ 500MG BASE/VIAL N050072 003
EQ 1GM BASE/VIAL N050072 004
EQ 2GM BASE/VIAL N050072 005
EQ 4GM BASE/VIAL N050072 006
POLYCILLIN-N
BRISTOL EQ 125MG BASE/VIAL N050309 001
EQ 250MG BASE/VIAL N050309 002
EQ 500MG BASE/VIAL N050309 003
EQ 1GM BASE/VIAL N050309 004
EQ 2GM BASE/VIAL N050309 005
TOTACILLIN-N
GLAXOSMITHKLINE EQ 125MG BASE/VIAL A060677 001
EQ 250MG BASE/VIAL A060677 002
EQ 500MG BASE/VIAL A060677 003
EQ 1GM BASE/VIAL A060677 004
EQ 1GM BASE/VIAL A062727 001 Dec 19, 1986
EQ 2GM BASE/VIAL A060677 005
EQ 2GM BASE/VIAL A062727 002 Dec 19, 1986
EQ 10GM BASE/VIAL A060677 006

AMPICILLIN SODIUM; SULBACTAM SODIUM


INJECTABLE; INJECTION
UNASYN
PFIZER EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL N050608 003 Dec 31, 1986

AMPICILLIN/AMPICILLIN TRIHYDRATE
CAPSULE; ORAL
AMCILL
PARKE DAVIS EQ 250MG BASE A062041 001
EQ 500MG BASE A062041 002
AMPICILLIN TRIHYDRATE
AM ANTIBIOTICS EQ 250MG BASE A061602 001
EQ 500MG BASE A061602 002
IVAX SUB TEVA PHARMS EQ 250MG BASE A060765 001
EQ 500MG BASE A060765 002
LEDERLE EQ 250MG BASE A062208 001
EQ 500MG BASE A062208 002
MYLAN EQ 250MG BASE A061755 001
EQ 500MG BASE A061755 002
PUREPAC PHARM EQ 250MG BASE A061853 001
EQ 500MG BASE A061853 002
TEVA EQ 250MG BASE A061502 001
EQ 500MG BASE A061502 002
VITARINE EQ 250MG BASE A061387 001
EQ 500MG BASE A061387 003
OMNIPEN (AMPICILLIN)
WYETH AYERST 250MG A060624 001
500MG A060624 002
PENBRITIN
WYETH AYERST EQ 250MG BASE A060908 001
EQ 500MG BASE A060908 002
PFIZERPEN-A
PFIZER EQ 250MG BASE A062050 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 28 (of 324)

AMPICILLIN/AMPICILLIN TRIHYDRATE
CAPSULE; ORAL
PFIZERPEN-A
PFIZER EQ 500MG BASE A062050 002
POLYCILLIN
BRISTOL EQ 250MG BASE N050310 001
EQ 500MG BASE N050310 002
PRINCIPEN
APOTHECON EQ 250MG BASE A062888 001 Mar 04, 1988
EQ 500MG BASE A062888 002 Mar 04, 1988
BRISTOL MYERS SQUIBB EQ 250MG BASE A061392 001
EQ 500MG BASE A061392 002
PRINCIPEN '250'
APOTHECON EQ 250MG BASE A062157 002
EQ 250MG BASE N050056 001
PRINCIPEN '500'
APOTHECON EQ 500MG BASE A062157 001
EQ 500MG BASE N050056 002
TOTACILLIN
GLAXOSMITHKLINE EQ 250MG BASE A060060 001
EQ 250MG BASE A062212 001
EQ 500MG BASE A060060 002
EQ 500MG BASE A062212 002
FOR SUSPENSION; ORAL
AMCILL
PARKE DAVIS EQ 125MG BASE/5ML A062030 001
EQ 250MG BASE/5ML A062030 002
AMPICILLIN TRIHYDRATE
AM ANTIBIOTICS EQ 125MG BASE/5ML A061601 001
EQ 250MG BASE/5ML A061601 002
MYLAN EQ 125MG BASE/5ML A061829 002
EQ 250MG BASE/5ML A061829 001
PUREPAC PHARM EQ 125MG BASE/5ML A061980 001
EQ 250MG BASE/5ML A061980 002
TEVA EQ 125MG BASE/5ML A061370 001
EQ 250MG BASE/5ML A061370 002
OMNIPEN (AMPICILLIN)
WYETH AYERST 100MG/ML A060625 001
125MG/5ML A060625 002
250MG/5ML A060625 003
500MG/5ML A060625 004
PENBRITIN
WYETH AYERST EQ 100MG BASE/ML N050019 001
EQ 125MG BASE/5ML N050019 002
EQ 250MG BASE/5ML N050019 003
PFIZERPEN-A
PFIZER EQ 125MG BASE/5ML A062049 001
EQ 250MG BASE/5ML A062049 002
POLYCILLIN
APOTHECON EQ 125MG BASE/5ML A062297 001
EQ 250MG BASE/5ML A062297 002
BRISTOL EQ 100MG BASE/ML N050308 004
EQ 125MG BASE/5ML N050308 001
EQ 250MG BASE/5ML N050308 002
EQ 500MG BASE/5ML N050308 003
PRINCIPEN
APOTHECON EQ 100MG BASE/ML A061394 001
EQ 250MG BASE/5ML A061394 003
PRINCIPEN '125'
APOTHECON EQ 125MG BASE/5ML A060127 002
EQ 125MG BASE/5ML A062151 001
PRINCIPEN '250'
APOTHECON EQ 250MG BASE/5ML A060127 001
EQ 250MG BASE/5ML A062151 002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 29 (of 324)

AMPICILLIN/AMPICILLIN TRIHYDRATE
FOR SUSPENSION; ORAL
TOTACILLIN
GLAXOSMITHKLINE EQ 125MG BASE/5ML A060666 001
EQ 125MG BASE/5ML A062223 001
EQ 250MG BASE/5ML A060666 002
EQ 250MG BASE/5ML A062223 002
TABLET, CHEWABLE; ORAL
POLYCILLIN
BRISTOL EQ 125MG BASE N050093 001

AMPICILLIN/AMPICILLIN TRIHYDRATE; PROBENECID


CAPSULE; ORAL
PRINCIPEN W/ PROBENECID
APOTHECON EQ 389MG BASE;111MG A062150 001
EQ 389MG BASE;111MG N050488 001
FOR SUSPENSION; ORAL
POLYCILLIN-PRB
APOTHECON EQ 3.5GM BASE/BOT;1GM/BOT A061898 001
BRISTOL EQ 3.5GM BASE/BOT;1GM/BOT N050457 001
PROBAMPACIN
TEVA EQ 3.5GM BASE/BOT;1GM/BOT A061741 001

AMPRENAVIR
CAPSULE; ORAL
AGENERASE
GLAXOSMITHKLINE 150MG N021007 002 Apr 15, 1999

ANAGRELIDE HYDROCHLORIDE
CAPSULE; ORAL
AGRYLIN
SHIRE EQ 1MG BASE N020333 002 Mar 14, 1997
ANAGRELIDE HYDROCHLORIDE
ROXANE EQ 0.5MG BASE A076489 001 Apr 18, 2005
EQ 1MG BASE A076489 002 Apr 18, 2005

ANILERIDINE HYDROCHLORIDE
TABLET; ORAL
LERITINE
MERCK EQ 25MG BASE N010585 002

ANILERIDINE PHOSPHATE
INJECTABLE; INJECTION
LERITINE
MERCK 25MG/ML N010520 003

ANISINDIONE
TABLET; ORAL
MIRADON
SCHERING 50MG N010909 003

ANISOTROPINE METHYLBROMIDE
TABLET; ORAL
ANISOTROPINE METHYLBROMIDE
WATSON LABS 50MG A086046 001
VALPIN 50
ENDO PHARMS 50MG N013428 001

APOMORPHINE HYDROCHLORIDE
INJECTABLE; SUBCUTANEOUS
APOKYN
IPSEN LTD 20MG/2ML (10MG/ML) N021264 001 Apr 20, 2004
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DISCONTINUED DRUG PRODUCT LIST 6 - 30 (of 324)

ARBUTAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
GENESA
GENSIA AUTOMEDICS 0.05MG/ML N020420 001 Sep 12, 1997

ARDEPARIN SODIUM
INJECTABLE; INJECTION
NORMIFLO
PHARMACIA AND UPJOHN 5,000 UNITS/0.5ML N020227 002 May 23, 1997
10,000 UNITS/0.5ML N020227 001 May 23, 1997

ARIPIPRAZOLE
TABLET, ORALLY DISINTEGRATING; ORAL
ABILIFY
OTSUKA 20MG N021729 004 Jun 07, 2006
30MG N021729 005 Jun 07, 2006

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID;


NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE
HYDROCHLORIDE; VITAMIN A; VITAMIN E
INJECTABLE; INJECTION
M.V.C. 9+3
ABRAXIS PHARM 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N018440 002 Aug 08, 1985
0
IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/
ML;0.3MG/ML;330 UNITS/ML;1 IU/ML
M.V.I.-12
HOSPIRA 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N008809 004 Aug 08, 1985
0
IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/
ML;0.3MG/ML;330 UNITS/ML;1 IU/ML
MVC PLUS
WATSON LABS 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N018439 002 Aug 08, 1985
0
IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/
ML;0.3MG/ML;330 UNITS/ML;1 IU/ML

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID;


NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE
HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN E
INJECTABLE; INJECTION

BEROCCA PN

ROCHE 50MG/ML;0.03MG/ML;0.0025MG/ML;7.5MG/ML; N006071 003 Oct 10, 1985


100
IU/ML;0.2MG/ML;20MG/ML;2MG/ML;1.8MG/ML;
1.5MG/ML;1,650 IU/ML;5 IU/ML

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID;


NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN
A; VITAMIN E
INJECTABLE; INJECTION

M.V.I.-12

HOSPIRA 20MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N008809 005 Apr 22, 2004


0
IU/ML;0.6MG/ML;4MG/ML;0.4MG/ML;0.36MG/M
L;0.6MG/ML;330 UNITS/ML;1 IU/ML

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID;


NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE; VITAMIN A;
VITAMIN E
INJECTABLE; INJECTION

M.V.I.-12 LYOPHILIZED

ASTRAZENECA 100MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15M N018933 002 Aug 08, 1985


G/VIAL;5MCG/VIAL;0.4MG/VIAL;40MG/VIAL;4
MG/VIAL;3.6MG/VIAL;3MG/VIAL;1MG/VIAL;10
MG/VIAL
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 31 (of 324)

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;


PANTOTHENIC ACID; PHYTONADIONE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A
PALMITATE; VITAMIN E
INJECTABLE; INJECTION

VITAPED

HOSPIRA N/A,80MG/VIAL;N/A,0.02MG/VIAL;N/A,0.001 N020176 001 Dec 29, 1993


MG/VIAL;400
IU/10ML,N/A;N/A,0.14MG/VIAL;N/A,17MG/VI
AL;N/A,5MG/VIAL;0.2MG/10ML,N/A;N/A,1MG/
VIAL;N/A,1.4MG/VIAL;N/A,1.2MG/VIAL;EQ
2,300 UNITS BASE/10ML,N/A;7 IU/10ML,N/A

ASPIRIN
TABLET; ORAL
BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN
BAYER 500MG N021317 001 Oct 18, 2001
TABLET, EXTENDED RELEASE; ORAL
8-HOUR BAYER
BAYER 650MG N016030 001
MEASURIN
BAYER 650MG N016030 002

ASPIRIN; BUTALBITAL
TABLET; ORAL
AXOTAL
SAVAGE LABS 650MG;50MG A088305 001 Oct 13, 1983

ASPIRIN; BUTALBITAL; CAFFEINE


CAPSULE; ORAL
BUTALBITAL, ASPIRIN AND CAFFEINE
MUTUAL PHARM 325MG;50MG;40MG A078149 001 Jun 13, 2007
WATSON LABS 325MG;50MG;40MG A086231 002 Feb 12, 1985
TABLET; ORAL
BUTALBITAL, ASPIRIN AND CAFFEINE
HALSEY 325MG;50MG;40MG A089448 001 Dec 01, 1986
IVAX PHARMS 325MG;50MG;40MG A085441 002 Oct 31, 1984
PHARMERAL 325MG;50MG;40MG A087048 002 Dec 09, 1983
QUANTUM PHARMICS 325MG;50MG;40MG A088972 001 Jun 18, 1985
SANDOZ 325MG;50MG;40MG A086398 002 Apr 06, 1984
WATSON LABS 325MG;50MG;40MG A086237 002 Mar 23, 1984
FIORINAL
WATSON PHARMS 325MG;50MG;40MG N017534 003 Apr 16, 1986
LANORINAL
LANNETT 325MG;50MG;40MG A086986 002 Oct 18, 1985

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE


CAPSULE; ORAL
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
ENDO PHARMS 325MG;50MG;40MG;30MG A075351 001 Mar 05, 1999

ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE


TABLET; ORAL
ORPHENGESIC
SOLCO HLTHCARE 385MG;30MG;25MG A075141 001 May 29, 1998
ORPHENGESIC FORTE
SOLCO HLTHCARE 770MG;60MG;50MG A075141 002 May 29, 1998

ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE


CAPSULE; ORAL
COMPOUND 65
ALRA 389MG;32.4MG;65MG A084553 002 Aug 17, 1983
DARVON COMPOUND
XANODYNE PHARM 389MG;32.4MG;32MG N010996 006 Mar 08, 1983
DARVON COMPOUND-65
XANODYNE PHARM 389MG;32.4MG;65MG N010996 007 Mar 08, 1983
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 32 (of 324)

ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE


CAPSULE; ORAL
PROPOXYPHENE COMPOUND 65
IVAX SUB TEVA PHARMS 389MG;32.4MG;65MG A083077 002 Dec 07, 1984
SANDOZ 389MG;32.4MG;65MG A080044 002 Sep 16, 1983
TEVA 389MG;32.4MG;65MG A089025 001 Mar 29, 1985
PROPOXYPHENE COMPOUND-65
SANDOZ 389MG;32.4MG;65MG A083101 002 Jun 24, 1985
PROPOXYPHENE HYDROCHLORIDE W/ ASPIRIN AND CAFFEINE
WATSON LABS 389MG;32.4MG;65MG A085732 002 Sep 03, 1984

ASPIRIN; CARISOPRODOL
TABLET; ORAL
CARISOPRODOL COMPOUND
WATSON LABS 325MG;200MG A088809 001 Oct 03, 1985

ASPIRIN; HYDROCODONE BITARTRATE


TABLET; ORAL
AZDONE
SCHWARZ PHARMA 500MG;5MG A089420 001 Jan 25, 1988
VICOPRIN
ABBOTT 500MG;5MG A086333 001 Sep 14, 1983

ASPIRIN; MEPROBAMATE
TABLET; ORAL
EQUAGESIC
CARACO 325MG;200MG N011702 003 Dec 29, 1983
MEPRO-ASPIRIN
SANDOZ 325MG;200MG A089127 001 Mar 02, 1987
MEPROBAMATE AND ASPIRIN
PAR PHARM 325MG;200MG A089126 001 Aug 19, 1986
MICRAININ
MEDPOINTE PHARM HLC 325MG;200MG A084978 001
Q-GESIC
QUANTUM PHARMICS 325MG;200MG A088740 001 Jun 01, 1984

ASPIRIN; METHOCARBAMOL
TABLET; ORAL
METHOCARBAMOL AND ASPIRIN
MCNEIL 325MG;400MG A089193 001 Feb 12, 1986
PAR PHARM 325MG;400MG A089657 001 Nov 04, 1988
ROBAXISAL
ROBINS AH 325MG;400MG N012281 001

ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE


TABLET; ORAL
CODOXY
HALSEY 325MG;4.5MG;0.38MG A087464 001 Jul 01, 1982
OXYCODONE AND ASPIRIN
MUTUAL PHARM 325MG;4.5MG;0.38MG A040260 001 Jul 17, 1998
325MG;4.5MG;0.38MG A087794 001 May 26, 1982
OXYCODONE AND ASPIRIN (HALF-STRENGTH)
ROXANE 325MG;2.25MG;0.19MG A087742 001 Jun 04, 1982
PERCODAN-DEMI
ENDO PHARMS 325MG;2.25MG;0.19MG N007337 005
ROXIPRIN
ROXANE 325MG;4.5MG;0.38MG A087743 001 Jun 04, 1982

ASPIRIN; PENTAZOCINE HYDROCHLORIDE


TABLET; ORAL
TALWIN COMPOUND
SANOFI AVENTIS US 325MG;EQ 12.5MG BASE N016891 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 33 (of 324)

ASPIRIN; PRAVASTATIN SODIUM


TABLET, TABLET; ORAL
PRAVIGARD PAC (COPACKAGED)
BRISTOL MYERS SQUIBB 325MG,N/A;N/A,80MG N021387 006 Jun 24, 2003
TABLET; TABLET, TABLET; ORAL
PRAVIGARD PAC (COPACKAGED)
BRISTOL MYERS SQUIBB 81MG,N/A;N/A,20MG N021387 001 Jun 24, 2003
81MG,N/A;N/A,40MG N021387 002 Jun 24, 2003
81MG,N/A;N/A,80MG N021387 003 Jun 24, 2003
325MG,N/A;N/A,20MG N021387 004 Jun 24, 2003
325MG,N/A;N/A,40MG N021387 005 Jun 24, 2003

ASPIRIN; PROPOXYPHENE HYDROCHLORIDE


CAPSULE; ORAL
DARVON W/ ASA
XANODYNE PHARM 325MG;65MG N010996 005

ASPIRIN; PROPOXYPHENE NAPSYLATE


CAPSULE; ORAL

DARVON-N W/ ASA

AAIPHARMA LLC 325MG;100MG N016829 001

TABLET; ORAL

DARVON-N W/ ASA

AAIPHARMA LLC 325MG;100MG N016863 001

ATENOLOL
INJECTABLE; INJECTION
TENORMIN
ASTRAZENECA 0.5MG/ML N019058 001 Sep 13, 1989
TABLET; ORAL
ATENOLOL
ABLE 25MG A076907 001 Jul 30, 2004
50MG A076907 002 Jul 30, 2004
100MG A076907 003 Jul 30, 2004
APOTHECON 50MG A073317 001 Mar 20, 1992
100MG A073318 001 Mar 20, 1992
NOSTRUM LABS 50MG A074127 001 Feb 21, 1995
100MG A074127 002 Feb 21, 1995
PLIVA 25MG A074101 001 Jul 17, 1997
50MG A074101 002 Jul 17, 1997
100MG A074101 003 Jul 17, 1997
SANDOZ 25MG A074265 001 Feb 28, 1994
50MG A074265 002 Feb 28, 1994
100MG A074265 003 Feb 28, 1994
SCS 50MG A073676 001 Oct 30, 1992
100MG A073676 002 Oct 30, 1992
TEVA 50MG A073315 001 May 28, 1993
100MG A073316 001 May 28, 1993
TEVA PHARMS 50MG A074120 001 Feb 24, 1995
100MG A074120 002 Feb 24, 1995

ATENOLOL; CHLORTHALIDONE
TABLET; ORAL
ATENOLOL AND CHLORTHALIDONE
NOSTRUM LABS 50MG;25MG A074404 001 May 14, 1998
100MG;25MG A074404 002 May 14, 1998
PLIVA 50MG;25MG A074107 001 Sep 24, 1997
100MG;25MG A074107 002 Sep 24, 1997

ATOMOXETINE HYDROCHLORIDE
CAPSULE; ORAL
STRATTERA
LILLY 5MG N021411 001 Nov 26, 2002
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DISCONTINUED DRUG PRODUCT LIST 6 - 34 (of 324)

ATOVAQUONE
TABLET; ORAL
MEPRON
GLAXOSMITHKLINE 250MG N020259 001 Nov 25, 1992

ATRACURIUM BESYLATE
INJECTABLE; INJECTION
ATRACURIUM BESYLATE
BAXTER HLTHCARE 10MG/ML A074824 001 Sep 30, 1997
BAXTER HLTHCARE CORP 10MG/ML A074753 001 Jan 23, 1997
HOSPIRA 10MG/ML A074632 001 Dec 23, 1996
10MG/ML A074740 001 Mar 28, 1997
MARSAM PHARMS LLC 10MG/ML A074945 001 Jul 28, 1998
TEVA PARENTERAL 10MG/ML A074784 001 Jun 11, 1997
ATRACURIUM BESYLATE PRESERVATIVE FREE
BAXTER HLTHCARE 10MG/ML A074825 001 Sep 30, 1997
BAXTER HLTHCARE CORP 10MG/ML A074768 001 Jan 23, 1997
HOSPIRA 10MG/ML A074633 001 Dec 23, 1996
10MG/ML A074639 001 Mar 25, 1997
10MG/ML A074741 001 Mar 28, 1997
MARSAM PHARMS LLC 10MG/ML A074944 001 Jul 28, 1998
TRACRIUM
HOSPIRA 10MG/ML N018831 002 Jun 20, 1985
TRACRIUM PRESERVATIVE FREE
HOSPIRA 10MG/ML N018831 001 Nov 23, 1983

ATROPINE
INJECTABLE; INJECTION
ATROPINE
SOLVAY EQ 2MG SULFATE/0.7ML A071295 001 Jan 30, 1987

ATROPINE SULFATE
AEROSOL, METERED; INHALATION
ATROPINE SULFATE
US ARMY EQ 0.36MG BASE/INH N020056 001 Sep 19, 1990

ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE


TABLET; ORAL
MOTOFEN HALF-STRENGTH
VALEANT 0.025MG;0.5MG N017744 001

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE


CAPSULE; ORAL
DIPHENOXYLATE HYDROCHLORIDE W/ ATROPINE SULFATE
SCHERER RP 0.025MG;2.5MG A086440 001
SOLUTION; ORAL
COLONAID
MEDPOINTE PHARM HLC 0.025MG/5ML;2.5MG/5ML A085735 001
LOMANATE
ALPHARMA US PHARMS 0.025MG/5ML;2.5MG/5ML A085746 001
TABLET; ORAL
COLONAID
MEDPOINTE PHARM HLC 0.025MG;2.5MG A085737 001
DI-ATRO
MD PHARM 0.025MG;2.5MG A085266 001
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ABLE 0.025MG;2.5MG A040395 001 Nov 27, 2000
ASCOT 0.025MG;2.5MG A087934 001 Jul 19, 1983
HEATHER 0.025MG;2.5MG A086798 001
INWOOD LABS 0.025MG;2.5MG A085509 001
IVAX PHARMS 0.025MG;2.5MG A086727 001
KV PHARM 0.025MG;2.5MG A085659 001
LEDERLE 0.025MG;2.5MG A086950 001
MUTUAL PHARM 0.025MG;2.5MG A085506 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 35 (of 324)

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE


TABLET; ORAL
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
PARKE DAVIS 0.025MG;2.5MG A087131 001
PVT FORM 0.025MG;2.5MG A085766 001
R AND S PHARMA 0.025MG;2.5MG A085035 001
ROXANE 0.025MG;2.5MG A086057 001
SANDOZ 0.025MG;2.5MG A086173 001
USL PHARMA 0.025MG;2.5MG A087842 001 Mar 29, 1982
VALEANT PHARM INTL 0.025MG;2.5MG A087195 001 Feb 16, 1982
WATSON LABS 0.025MG;2.5MG A085876 001
WEST WARD 0.025MG;2.5MG A087765 001 Mar 15, 1982
LOGEN
SUPERPHARM 0.025MG;2.5MG A088962 001 May 10, 1985
LO-TROL
VANGARD 0.025MG;2.5MG A088009 001 Mar 25, 1983
LOW-QUEL
HALSEY 0.025MG;2.5MG A085211 001

ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE


INJECTABLE; INJECTION
ATROPINE AND DEMEROL
ABBOTT 0.4MG/ML;50MG/ML A087853 001 Nov 26, 1982
0.4MG/ML;75MG/ML A087847 001 Nov 26, 1982
0.4MG/ML;100MG/ML A087848 001 Nov 26, 1982
MEPERIDINE AND ATROPINE SULFATE
WYETH AYERST 0.4MG/ML;50MG/ML A085121 001
0.4MG/ML;75MG/ML A085121 002
0.4MG/ML;100MG/ML A085121 003

ATROPINE; PRALIDOXIME CHLORIDE


INJECTABLE; INTRAMUSCULAR
ATNAA
US ARMY 2.1MG/0.7ML;600MG/0.7ML N021175 001 Jan 17, 2002

AZATADINE MALEATE
TABLET; ORAL
OPTIMINE
SCHERING 1MG N017601 001

AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE


TABLET, EXTENDED RELEASE; ORAL
TRINALIN
SCHERING 1MG;120MG N018506 001 Mar 23, 1982

AZATHIOPRINE
TABLET; ORAL
IMURAN
PROMETHEUS LABS 25MG N016324 002

AZATHIOPRINE SODIUM
INJECTABLE; INJECTION
IMURAN
PROMETHEUS LABS EQ 100MG BASE/VIAL N017391 001

AZELASTINE HYDROCHLORIDE
SPRAY, METERED; NASAL
AZELASTINE HYDROCHLORIDE
APOTEX INC EQ 0.125MG BASE/SPRAY A077954 001 Apr 30, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 36 (of 324)

AZITHROMYCIN
CAPSULE; ORAL
ZITHROMAX
PFIZER EQ 250MG BASE N050670 001 Nov 01, 1991

AZITHROMYCIN DIHYDRATE; TROVAFLOXACIN MESYLATE


FOR SUSPENSION, TABLET; ORAL
TROVAN/ZITHROMAX COMPLIANCE PAK
PFIZER EQ 1GM BASE,N/A;N/A,EQ 100MG BASE N050762 001 Dec 18, 1998

AZLOCILLIN SODIUM
INJECTABLE; INJECTION
AZLIN
BAYER PHARMS EQ 2GM BASE/VIAL A062388 001 Sep 08, 1982
EQ 2GM BASE/VIAL A062417 001 Oct 12, 1982
EQ 2GM BASE/VIAL N050562 001 Sep 03, 1982
EQ 3GM BASE/VIAL A062388 002 Sep 08, 1982
EQ 3GM BASE/VIAL A062417 002 Oct 12, 1982
EQ 3GM BASE/VIAL N050562 002 Sep 03, 1982
EQ 4GM BASE/VIAL A062388 003 Sep 08, 1982
EQ 4GM BASE/VIAL A062417 003 Oct 12, 1982
EQ 4GM BASE/VIAL N050562 003 Sep 03, 1982

AZTREONAM
INJECTABLE; INJECTION
AZACTAM
BRISTOL MYERS SQUIBB 500MG/VIAL N050580 001 Dec 31, 1986
AZACTAM IN PLASTIC CONTAINER
BRISTOL MYERS SQUIBB 10MG/ML N050632 003 May 24, 1989

BACAMPICILLIN HYDROCHLORIDE
FOR SUSPENSION; ORAL
SPECTROBID
PFIZER 125MG/5ML N050556 001 Mar 23, 1982
TABLET; ORAL
SPECTROBID
PFIZER 400MG N050520 001
800MG N050520 002 Sep 12, 1983

BACITRACIN
INJECTABLE; INJECTION
BACITRACIN
PFIZER 50,000 UNITS/VIAL A060282 001
OINTMENT; OPHTHALMIC
BACIGUENT
PHARMACIA AND UPJOHN 500 UNITS/GM A060734 001
BACITRACIN
LILLY 500 UNITS/GM A060687 001
PHARMADERM 500 UNITS/GM A062158 001
PHARMAFAIR 500 UNITS/GM A062453 001 Mar 28, 1984
OINTMENT; TOPICAL
BACITRACIN
COMBE 500 UNITS/GM A062799 001 May 14, 1987
NASKA 500 UNITS/GM A062857 001 Nov 13, 1987
POWDER; FOR RX COMPOUNDING
BACITRACIN
APOTHEKERNES 5,000,000 UNITS/BOT A061699 001
PADDOCK 5,000,000 UNITS/BOT A062456 001 Jul 27, 1983

BACITRACIN ZINC
POWDER; FOR RX COMPOUNDING
ZIBA-RX
X GEN PHARMS 500,000 UNITS/BOT A061737 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 37 (of 324)

BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


OINTMENT; OPHTHALMIC
CORTISPORIN
MONARCH PHARMS 400 UNITS/GM;1%;EQ 3.5MG N050416 002
BASE/GM;10,000 UNITS/GM
ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & HYDROCORTISONE
PHARMAFAIR 400 UNITS/GM;1%;EQ 3.5MG A062389 001 Jul 02, 1982
BASE/GM;10,000 UNITS/GM
OINTMENT; TOPICAL
NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE
PHARMAFAIR 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 A062381 001 Sep 06, 1985
UNITS/GM

BACITRACIN ZINC; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


OINTMENT; TOPICAL
LANABIOTIC
COMBE 400 UNITS/GM;40MG/GM;EQ 5MG A062499 001 Jun 03, 1985
BASE/GM;5,000 UNITS/GM

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


OINTMENT; OPHTHALMIC
BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE
PHARMAFAIR 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 A062386 001 Sep 09, 1982
UNITS/GM
BACITRACIN-NEOMYCIN-POLYMYXIN
PHARMADERM 400 UNITS/GM;EQ 3.5MG BASE/GM;5,000 A062167 001
UNITS/GM
NEO-POLYCIN
DOW PHARM 500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 A060647 001
UNITS/GM
NEOSPORIN
MONARCH PHARMS 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 N050417 001
UNITS/GM
OINTMENT; TOPICAL
BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE
NASKA 400 UNITS/GM;EQ 3.5MG BASE/GM;5,000 A062833 001 Nov 09, 1987
UNITS/GM

BACITRACIN ZINC; POLYMYXIN B SULFATE


AEROSOL; TOPICAL
POLYSPORIN
GLAXOSMITHKLINE 10,000 UNITS/GM;2,000,000 UNITS/GM N050167 002 Mar 01, 1985

OINTMENT; OPHTHALMIC
OCUMYCIN
PHARMAFAIR 500 UNITS/GM;10,000 UNITS/GM A062430 001 Apr 08, 1983

POLYSPORIN
MONARCH PHARMS 500 UNITS/GM;10,000 UNITS/GM A061229 001
OINTMENT; TOPICAL
BACITRACIN ZINC-POLYMYXIN B SULFATE
NASKA 500 UNITS/GM;10,000 UNITS/GM A062849 001 Nov 13, 1987

BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


OINTMENT; OPHTHALMIC

BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE

ALTANA 400 UNITS/GM;1%;EQ 3.5MG A060731 002

BASE/GM;10,000 UNITS/GM

BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


OINTMENT; OPHTHALMIC

MYCITRACIN

PHARMACIA AND UPJOHN 500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 A061048 001

UNITS/GM

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BACITRACIN; POLYMYXIN B SULFATE


DISC; TOPICAL
LANABIOTIC
COMBE 500 UNITS/GM;5,000 UNITS/GM N050598 001 Sep 22, 1986

BACLOFEN
TABLET; ORAL
BACLOFEN
TEVA 10MG A073043 001 Feb 27, 1992
20MG A073044 001 Feb 27, 1992
USL PHARMA 10MG A071260 001 May 06, 1988
20MG A071261 001 May 06, 1988
WATSON LABS 10MG A073092 001 Jan 28, 1994
10MG A074698 001 Aug 20, 1996
20MG A073093 001 Jan 28, 1994
20MG A074698 002 Aug 20, 1996
LIORESAL
NOVARTIS 10MG N017851 001
20MG N017851 003 Jan 20, 1982

BECLOMETHASONE DIPROPIONATE
AEROSOL, METERED; INHALATION
BECLOVENT
GLAXOSMITHKLINE 0.042MG/INH N018153 001
VANCERIL
SCHERING 0.042MG/INH N017573 001
VANCERIL DOUBLE STRENGTH
SCHERING 0.084MG/INH N020486 001 Dec 24, 1996
AEROSOL, METERED; NASAL
BECONASE
GLAXOSMITHKLINE 0.042MG/INH N018584 001
VANCENASE
SCHERING 0.042MG/INH N018521 001

BECLOMETHASONE DIPROPIONATE MONOHYDRATE


SPRAY, METERED; NASAL
VANCENASE AQ
SCHERING EQ 0.042MG DIPROP/SPRAY N019589 001 Dec 23, 1987
EQ 0.084MG DIPROP/SPRAY N020469 001 Jun 26, 1996

BENAZEPRIL HYDROCHLORIDE
TABLET; ORAL
BENAZEPRIL HYDROCHLORIDE
GENPHARM 5MG A076476 001 Feb 11, 2004
10MG A076476 002 Feb 11, 2004
20MG A076476 003 Feb 11, 2004
40MG A076476 004 Feb 11, 2004

BENDROFLUMETHIAZIDE
TABLET; ORAL
NATURETIN-10
APOTHECON 10MG N012164 003
NATURETIN-2.5
APOTHECON 2.5MG N012164 001
NATURETIN-5
APOTHECON 5MG N012164 002

BENOXINATE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
BENOXINATE HYDROCHLORIDE
SOLA BARNES HIND 0.4% A084149 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 39 (of 324)

BENTIROMIDE
SOLUTION; ORAL
CHYMEX
SAVAGE LABS 500MG/7.5ML N018366 001 Dec 29, 1983

BENZPHETAMINE HYDROCHLORIDE
TABLET; ORAL
DIDREX
PHARMACIA AND UPJOHN 25MG N012427 003

BENZQUINAMIDE HYDROCHLORIDE
INJECTABLE; INJECTION

EMETE-CON

PFIZER EQ 50MG BASE/VIAL N016820 001

SUPPOSITORY; RECTAL

EMETE-CON

ROERIG EQ 100MG BASE N016818 006

BENZTHIAZIDE
TABLET; ORAL
AQUATAG
SOLVAY 25MG N016001 001
50MG N016001 002
BENZTHIAZIDE
PVT FORM 50MG A083206 001
EXNA
AH ROBINS INC 50MG N012489 001
FOVANE
PFIZER 50MG N012128 002
URESE
PFIZER 25MG N012128 003

BENZTROPINE MESYLATE
TABLET; ORAL
BENZTROPINE MESYLATE
MUTUAL PHARM 1MG A081264 001 Jan 23, 1992
2MG A081265 001 Jan 23, 1992
QUANTUM PHARMICS 0.5MG A088514 001 Jan 31, 1984
1MG A088510 001 Jan 31, 1984
2MG A088511 001 Jan 31, 1984
USL PHARMA 0.5MG A089211 001 Jun 14, 1988
1MG A089212 001 Jun 14, 1988
2MG A089213 001 Jun 14, 1988
COGENTIN
MERCK 0.5MG N009193 004
1MG N009193 003
2MG N009193 002

BENZYL BENZOATE
EMULSION; TOPICAL
BENZYL BENZOATE
LANNETT 50% A084535 001

BENZYL PENICILLOYL-POLYLYSINE
INJECTABLE; INJECTION
PRE-PEN
ALLERQUEST 60UMOLAR N050114 001

BEPRIDIL HYDROCHLORIDE
TABLET; ORAL
BEPADIN
MEDPOINTE PHARM HLC 200MG N019001 001 Dec 28, 1990
300MG N019001 002 Dec 28, 1990
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DISCONTINUED DRUG PRODUCT LIST 6 - 40 (of 324)

BEPRIDIL HYDROCHLORIDE
TABLET; ORAL
BEPADIN
MEDPOINTE PHARM HLC 400MG N019001 003 Dec 28, 1990
VASCOR
JOHNSON AND JOHNSON 200MG N019002 001 Dec 28, 1990
300MG N019002 002 Dec 28, 1990
400MG N019002 003 Dec 28, 1990

BETA CAROTENE
CAPSULE; ORAL
SOLATENE
ROCHE 30MG N017589 001

BETAMETHASONE
CREAM; TOPICAL
CELESTONE
SCHERING 0.2% N014762 001
TABLET; ORAL
CELESTONE
SCHERING 0.6MG N012657 003

BETAMETHASONE BENZOATE
CREAM; TOPICAL

UTICORT

PARKE DAVIS 0.025% N016998 002


GEL; TOPICAL

UTICORT

PARKE DAVIS 0.025% N017244 001


LOTION; TOPICAL

UTICORT

PARKE DAVIS 0.025% N017528 001


OINTMENT; TOPICAL

UTICORT

PARKE DAVIS 0.025% N018089 001


BETAMETHASONE DIPROPIONATE
CREAM; TOPICAL
ALPHATREX
SAVAGE LABS EQ 0.05% BASE N019138 001 Jun 26, 1984
BETAMETHASONE DIPROPIONATE
PERRIGO NEW YORK EQ 0.05% BASE A072536 001 Jan 31, 1990
EQ 0.05% BASE A074579 001 Nov 26, 1997
PHARMADERM EQ 0.05% BASE N019136 001 Jun 26, 1984
TARO EQ 0.05% BASE A071143 001 Jun 17, 1987
TEVA EQ 0.05% BASE A071476 001 Aug 10, 1987
DIPROSONE
SCHERING EQ 0.05% BASE N017536 001
CREAM, AUGMENTED; TOPICAL
DIPROLENE
SCHERING EQ 0.05% BASE N019408 001 Jan 31, 1986
DISC; TOPICAL
DIPROSONE
SCHERING EQ 0.1% BASE N017829 001
GEL, AUGMENTED; TOPICAL
DIPROLENE
SCHERING EQ 0.05% BASE N019408 002 Nov 22, 1991
LOTION; TOPICAL
ALPHATREX
SAVAGE LABS EQ 0.05% BASE A070273 001 Aug 12, 1985
BETAMETHASONE DIPROPIONATE
ALPHARMA US PHARMS EQ 0.05% BASE A071085 001 Feb 03, 1987
PHARMADERM EQ 0.05% BASE A070274 001 Aug 12, 1985
TARO EQ 0.05% BASE A072276 001 Aug 24, 1988
EQ 0.05% BASE A074272 001 Sep 30, 1994
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DISCONTINUED DRUG PRODUCT LIST 6 - 41 (of 324)

BETAMETHASONE DIPROPIONATE
LOTION; TOPICAL
BETAMETHASONE DIPROPIONATE
TEVA PHARMS EQ 0.05% BASE A071882 001 Jun 06, 1988
DIPROSONE
SCHERING EQ 0.05% BASE N017781 001
OINTMENT; TOPICAL
ALPHATREX
SAVAGE LABS EQ 0.05% BASE N019143 001 Sep 04, 1984
BETAMETHASONE DIPROPIONATE
PERRIGO NEW YORK EQ 0.05% BASE A072526 001 Jan 31, 1990
PHARMADERM EQ 0.05% BASE N019140 001 Sep 04, 1984
TEVA EQ 0.05% BASE A071477 001 Aug 10, 1987
DIPROSONE
SCHERING EQ 0.05% BASE N017691 001

BETAMETHASONE SODIUM PHOSPHATE


INJECTABLE; INJECTION
BETAMETHASONE SODIUM PHOSPHATE
WATSON LABS EQ 3MG BASE/ML A085738 001
CELESTONE
SCHERING EQ 3MG BASE/ML N017561 001

BETAMETHASONE VALERATE
CREAM; TOPICAL
BETADERM
ROACO EQ 0.1% BASE N018839 001 Jun 30, 1983
BETAMETHASONE VALERATE
PERRIGO NEW YORK EQ 0.1% BASE A070053 001 Jun 10, 1986
PHARMADERM EQ 0.1% BASE N018860 002 Aug 31, 1983
PHARMAFAIR EQ 0.1% BASE A070485 001 May 29, 1987
TARO EQ 0.1% BASE A070062 001 May 14, 1985
BETATREX
SAVAGE LABS EQ 0.1% BASE N018862 001 Aug 31, 1983
VALISONE
SCHERING EQ 0.01% BASE N016322 002
EQ 0.1% BASE N016322 001
LOTION; TOPICAL
BETAMETHASONE VALERATE
PHARMADERM EQ 0.1% BASE N018870 001 Aug 31, 1983
PHARMAFAIR EQ 0.1% BASE A070484 001 May 29, 1987
TEVA PHARMS EQ 0.1% BASE A071883 001 Apr 22, 1988
BETATREX
SAVAGE LABS EQ 0.1% BASE N018867 001 Aug 31, 1983
VALISONE
SCHERING EQ 0.1% BASE N016932 001
OINTMENT; TOPICAL
BETAMETHASONE VALERATE
PERRIGO NEW YORK EQ 0.1% BASE A071478 001 Dec 23, 1987
PHARMADERM EQ 0.1% BASE N018864 001 Aug 31, 1983
PHARMAFAIR EQ 0.1% BASE A070486 001 May 29, 1987
BETATREX
SAVAGE LABS EQ 0.1% BASE N018863 001 Aug 31, 1983
BETA-VAL
TEVA EQ 0.1% BASE A070069 001 Dec 19, 1985
VALISONE
SCHERING EQ 0.1% BASE N016740 001

BETAXOLOL HYDROCHLORIDE
TABLET; ORAL
KERLONE
SANOFI AVENTIS US 10MG N019507 001 Oct 27, 1989
20MG N019507 002 Oct 27, 1989
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DISCONTINUED DRUG PRODUCT LIST 6 - 42 (of 324)

BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE


TABLET; ORAL
KERLEDEX
SANOFI AVENTIS US 5MG;12.5MG N019807 001 Oct 30, 1992
10MG;12.5MG N019807 002 Oct 30, 1992

BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE


SUSPENSION/DROPS; OPHTHALMIC
BETOPTIC PILO
ALCON EQ 0.25% BASE;1.75% N020619 001 Apr 17, 1997

BETAZOLE HYDROCHLORIDE
INJECTABLE; INJECTION
HISTALOG
LILLY 50MG/ML N009344 001

BETHANECHOL CHLORIDE
INJECTABLE; INJECTION
URECHOLINE
ODYSSEY PHARMS 5MG/ML N006536 001
TABLET; ORAL
BETHANECHOL CHLORIDE
ABLE 5MG A040492 001 Jul 27, 2004
10MG A040483 001 Jul 27, 2004
25MG A040485 001 Jul 27, 2004
50MG A040509 001 Jul 27, 2004
ACTAVIS TOTOWA 50MG A040551 001 Oct 28, 2004
ASCOT 10MG A088288 001 Jun 08, 1983
25MG A088289 001 Jun 08, 1983
IVAX SUB TEVA PHARMS 25MG A084689 001
LANNETT 5MG A084702 001
10MG A084712 001
25MG A084074 001
SANDOZ 5MG A084353 001
10MG A084378 001
10MG A084379 001
25MG A084383 001
25MG A084384 001
WATSON LABS 5MG A084402 001
5MG A085230 002
5MG A085841 001
10MG A084408 001
10MG A085228 001
10MG A085842 001
25MG A084441 001
25MG A085229 001
25MG A085839 001
50MG A087397 001
50MG A087444 001
MYOTONACHOL
GLENWOOD 5MG A084188 001
10MG A084188 003
25MG A084188 004
URECHOLINE
ODYSSEY PHARMS 5MG N006536 003
10MG N006536 002
25MG N006536 004
50MG N006536 005

BETHANIDINE SULFATE
TABLET; ORAL
TENATHAN
ROBINS AH 10MG N017675 001
25MG N017675 002
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DISCONTINUED DRUG PRODUCT LIST 6 - 43 (of 324)

BIPERIDEN LACTATE
INJECTABLE; INJECTION

AKINETON

ABBOTT 5MG/ML N012418 002


BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM


CHLORIDE
FOR SOLUTION; ORAL
HALFLYTELY
BRAINTREE 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM N021551 001 May 10, 2004
;N/A,5.6GM

BISOPROLOL FUMARATE
TABLET; ORAL
BISOPROLOL FUMARATE
MUTUAL PHARM 5MG A075474 001 Oct 25, 2002
10MG A075474 002 Oct 25, 2002

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE


TABLET; ORAL

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE


APOTHECON 2.5MG;6.25MG A075642 002 Dec 27, 2000


5MG;6.25MG A075642 001 Dec 27, 2000
10MG;6.25MG A075642 003 Dec 27, 2000
IVAX SUB TEVA PHARMS 2.5MG;6.25MG A075632 001 Sep 27, 2000
5MG;6.25MG A075632 002 Sep 27, 2000
10MG;6.25MG A075632 003 Sep 27, 2000
SANDOZ 2.5MG;6.25MG A075527 001 Sep 25, 2000
5MG;6.25MG A075527 003 Sep 25, 2000
10MG;6.25MG A075527 002 Sep 25, 2000
TEVA 2.5MG;6.25MG A075686 001 Jan 19, 2001
5MG;6.25MG A075686 002 Jan 19, 2001
10MG;6.25MG A075686 003 Jan 19, 2001

BITOLTEROL MESYLATE
AEROSOL, METERED; INHALATION
TORNALATE
SANOFI AVENTIS US 0.37MG/INH N018770 001 Dec 28, 1984
SOLUTION; INHALATION
TORNALATE
SANOFI AVENTIS US 0.2% N019548 001 Feb 19, 1992

BLEOMYCIN SULFATE
INJECTABLE; INJECTION
BLEOMYCIN SULFATE
TEVA PARENTERAL EQ 15 UNITS BASE/VIAL A064084 001 Jun 01, 1996
EQ 30 UNITS BASE/VIAL A064084 002 Jun 01, 1996

BRETYLIUM TOSYLATE
INJECTABLE; INJECTION
BRETYLIUM TOSYLATE
ABRAXIS PHARM 50MG/ML A070134 001 Apr 29, 1986
100MG/ML A071298 001 Feb 13, 1987
ASTRAZENECA 50MG/ML A071151 001 Aug 10, 1987
50MG/ML A071152 001 Aug 10, 1987
50MG/ML A071153 001 Aug 10, 1987
BAXTER HLTHCARE 50MG/ML A070545 001 May 14, 1986
50MG/ML A070546 001 May 14, 1986
HOSPIRA 50MG/ML N019033 001 Apr 29, 1986
INTL MEDICATION 50MG/ML A070119 001 Apr 29, 1986
BRETYLIUM TOSYLATE IN DEXTROSE 5%
ABBOTT 200MG/100ML N019005 002 Apr 29, 1986
400MG/100ML N019005 003 Apr 29, 1986
800MG/100ML N019005 001 Apr 29, 1986
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DISCONTINUED DRUG PRODUCT LIST 6 - 44 (of 324)

BRETYLIUM TOSYLATE
INJECTABLE; INJECTION
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 200MG/100ML N019837 002 Apr 12, 1989
400MG/100ML N019837 001 Apr 12, 1989
HOSPIRA 800MG/100ML N019008 001 Apr 29, 1986
BRETYLOL
HOSPIRA 50MG/ML N017954 001

BRIMONIDINE TARTRATE
SOLUTION/DROPS; OPHTHALMIC
ALPHAGAN
ALLERGAN 0.2% N020613 001 Sep 06, 1996
0.5% N020490 001 Mar 13, 1997

BROMOCRIPTINE MESYLATE
CAPSULE; ORAL
BROMOCRIPTINE MESYLATE
LEK PHARM EQ 5MG BASE A075100 001 Dec 10, 1998

BROMODIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE; ORAL
AMBODRYL
PARKE DAVIS 25MG N007984 001

BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE


SYRUP; ORAL
AMBENYL
FOREST LABS 12.5MG/5ML;10MG/5ML N009319 006 Jan 10, 1984
BROMANYL
ALPHARMA US PHARMS 12.5MG/5ML;10MG/5ML A088343 001 Aug 15, 1984
BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE
MORTON GROVE 12.5MG/5ML;10MG/5ML A088626 001 Oct 12, 1984

BROMPHENIRAMINE MALEATE
ELIXIR; ORAL
BROMPHENIRAMINE MALEATE
ALPHARMA US PHARMS 2MG/5ML A086936 001
KV PHARM 2MG/5ML A085466 001
PHARM ASSOC 2MG/5ML A087517 001
USL PHARMA 2MG/5ML A087964 001 Jan 25, 1983
INJECTABLE; INJECTION
BROMPHENIRAMINE MALEATE
WATSON LABS 10MG/ML A083821 001
100MG/ML A083820 001
DIMETANE-TEN
WYETH AYERST 10MG/ML N011418 002
TABLET; ORAL
BROMPHENIRAMINE MALEATE
BARR 4MG A084468 001
IVAX SUB TEVA PHARMS 4MG A084351 001
NEWTRON PHARMS 4MG A086987 001
NEXGEN PHARMA INC 4MG A086187 001
PAR PHARM 4MG A087009 001
PIONEER PHARMS 4MG A088604 001 Jul 13, 1984
SANDOZ 4MG A083215 001
VITARINE 4MG A085850 001
WATSON LABS 4MG A083123 001
4MG A085769 001
DIMETANE
WYETH CONS 4MG N010799 003
TABLET, EXTENDED RELEASE; ORAL
DIMETANE
WYETH CONS 8MG N010799 010 Jun 10, 1983
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DISCONTINUED DRUG PRODUCT LIST 6 - 45 (of 324)

BROMPHENIRAMINE MALEATE
TABLET, EXTENDED RELEASE; ORAL
DIMETANE
WYETH CONS 12MG N010799 011 Jun 10, 1983

BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PHENYLPROPANOLAMINE HYDROCHLORIDE


SYRUP; ORAL
BROMANATE DC
ALPHARMA US PHARMS 2MG/5ML;10MG/5ML;12.5MG/5ML A088723 001 Feb 25, 1985
DIMETANE-DC
ROBINS AH 2MG/5ML;10MG/5ML;12.5MG/5ML N011694 006 Mar 29, 1984
MYPHETANE DC
MORTON GROVE 2MG/5ML;10MG/5ML;12.5MG/5ML A088904 001 Feb 21, 1985

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE


SYRUP; ORAL
BROMANATE DM
ALPHARMA US PHARMS 2MG/5ML;10MG/5ML;30MG/5ML A088722 001 Mar 07, 1985
BROMFED-DM
WOCKHARDT 2MG/5ML;10MG/5ML;30MG/5ML A089681 001 Dec 22, 1988
DIMETANE-DX
ROBINS AH 2MG/5ML;10MG/5ML;30MG/5ML N019279 001 Aug 24, 1984

BROMPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE


ELIXIR; ORAL
BIPHETAP
MORTON GROVE 4MG/5ML;25MG/5ML A088687 001 Sep 26, 1984
BROMANATE
ALPHARMA US PHARMS 4MG/5ML;25MG/5ML A088688 001 Feb 06, 1985
DIMETAPP
WYETH CONS 2MG/5ML;12.5MG/5ML N013087 003 Mar 29, 1984
TABLET, EXTENDED RELEASE; ORAL
BROMATAPP
COPLEY PHARM 12MG;75MG A071099 001 Jul 02, 1987
DIMETAPP
WYETH CONS 12MG;75MG N012436 003 May 14, 1985

BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE


TABLET, EXTENDED RELEASE; ORAL
EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE
ALZA 16MG;240MG N019672 001 Mar 29, 1996

BUCLIZINE HYDROCHLORIDE
TABLET; ORAL
BUCLADIN-S
STUART PHARMS 50MG N010911 006

BUDESONIDE
AEROSOL, METERED; NASAL
RHINOCORT
ASTRAZENECA 0.032MG/INH N020233 001 Feb 14, 1994
POWDER, METERED; INHALATION
PULMICORT
ASTRAZENECA 0.32MG/INH N020441 003 Jun 24, 1997
SPRAY, METERED; NASAL
RHINOCORT
ASTRAZENECA 0.064MG/INH N020746 002 Oct 01, 1999

BUMETANIDE
INJECTABLE; INJECTION
BUMETANIDE
HOSPIRA 0.25MG/ML A074160 001 Oct 30, 1997
BUMEX
VALIDUS PHARMS INC 0.25MG/ML N018226 001 Feb 28, 1983
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DISCONTINUED DRUG PRODUCT LIST 6 - 46 (of 324)

BUMETANIDE
TABLET; ORAL

BUMEX

VALIDUS PHARMS INC 0.5MG N018225 002 Feb 28, 1983


1MG N018225 001 Feb 28, 1983
2MG N018225 003 Jun 14, 1985

BUPIVACAINE HYDROCHLORIDE
INJECTABLE; INJECTION

BUPIVACAINE HYDROCHLORIDE KIT


HOSPIRA 0.075% N019978 001 Sep 03, 1992


0.114% N019978 002 Sep 03, 1992
0.23% N019978 003 Sep 03, 1992

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE


INJECTABLE; INJECTION

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE


HOSPIRA 0.25%;0.005MG/ML A071166 001 Jun 16, 1988


0.5%;0.005MG/ML A071169 001 Jun 16, 1988
0.5%;0.005MG/ML A071170 001 Jun 16, 1988
0.75%;0.005MG/ML A071171 001 Jun 16, 1988

BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE


INJECTABLE; INJECTION
DUOCAINE
AMPHASTAR EQ 0.375% (37.5MG/10ML);EQ 1% N021496 001 May 23, 2003
(100MG/10ML)

BUPROPION HYDROCHLORIDE
TABLET; ORAL
BUPROPION HYDROCHLORIDE
SANDOZ 75MG A075613 002 Oct 10, 2000
100MG A075613 001 Oct 10, 2000
WELLBUTRIN
GLAXOSMITHKLINE 50MG N018644 001 Dec 30, 1985
TABLET, EXTENDED RELEASE; ORAL
BUPROPION HYDROCHLORIDE
SANDOZ 100MG A076845 001 Jul 14, 2005
150MG A076834 001 Jul 14, 2005
150MG A076845 002 Jul 14, 2005
ZYBAN
GLAXOSMITHKLINE 100MG N020711 002 May 14, 1997

BUSPIRONE HYDROCHLORIDE
CAPSULE; ORAL

BUSPAR

BRISTOL MYERS SQUIBB 5MG N021190 001 Dec 20, 2000


7.5MG N021190 002 Dec 20, 2000
10MG N021190 003 Dec 20, 2000
15MG N021190 004 Dec 20, 2000
TABLET; ORAL
BUSPAR
BRISTOL MYERS SQUIBB 30MG N018731 004 Apr 22, 1996
BUSPIRONE HYDROCHLORIDE
SANDOZ 5MG A075413 001 Mar 19, 2002
10MG A075413 002 Mar 19, 2002
15MG A075413 003 Mar 19, 2002

BUTABARBITAL SODIUM
CAPSULE; ORAL

BUTICAPS

MEDPOINTE PHARM HLC 15MG A085381 001


30MG A085381 002


50MG A085381 003


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DISCONTINUED DRUG PRODUCT LIST 6 - 47 (of 324)

BUTABARBITAL SODIUM
CAPSULE; ORAL
BUTICAPS
MEDPOINTE PHARM HLC 100MG A085381 004
ELIXIR; ORAL
BUTABARB
ALPHARMA US PHARMS 30MG/5ML A085873 001
BUTABARBITAL SODIUM
MORTON GROVE 30MG/5ML A085383 001
BUTALAN
LANNETT 33.3MG/5ML A085880 001
SARISOL
HALSEY 30MG/5ML A084723 001
TABLET; ORAL
BUTABARBITAL
BUNDY 30MG A085550 001
BUTABARBITAL SODIUM
SANDOZ 15MG A084292 003 Feb 09, 1982
15MG A085938 001
30MG A084272 002
30MG A085934 001
SOLVAY 16.2MG A083606 001
32.4MG A083898 001
48.6MG A083897 001
97.2MG A083896 001
TEVA 15MG A088632 001 May 18, 1985
30MG A088631 001 May 01, 1985
WATSON LABS 15MG A085764 001
30MG A085772 001
WHITEWORTH TOWN PLSN 15MG A083325 002
30MG A083337 001
BUTISOL SODIUM
MEDA PHARMS 15MG N000793 002
100MG N000793 005
SARISOL NO. 1
HALSEY 15MG A084719 001
SARISOL NO. 2
HALSEY 30MG A084719 002
SODIUM BUTABARBITAL
IVAX SUB TEVA PHARMS 15MG A083484 001
30MG A084040 001
LANNETT 15MG A085849 001
30MG A085866 001
100MG A085881 001
MARSHALL PHARMA 16.2MG A083524 001
32.4MG A083858 001
WEST WARD 15MG A085418 001
30MG A085432 001

BUTOCONAZOLE NITRATE
CREAM; VAGINAL
FEMSTAT
ROCHE PALO 2% N019215 001 Nov 25, 1985
SUPPOSITORY; VAGINAL
FEMSTAT
ROCHE PALO 100MG N019359 001 Nov 25, 1985

BUTORPHANOL TARTRATE
INJECTABLE; INJECTION
BUTORPHANOL TARTRATE
HOSPIRA 1MG/ML A075342 001 Nov 04, 1999
1MG/ML A075559 001 Mar 20, 2000
2MG/ML A075342 002 Nov 04, 1999
2MG/ML A075559 002 Mar 20, 2000
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DISCONTINUED DRUG PRODUCT LIST 6 - 48 (of 324)

BUTORPHANOL TARTRATE
INJECTABLE; INJECTION
BUTORPHANOL TARTRATE PRESERVATIVE FREE
HOSPIRA 1MG/ML A074620 001 Jan 22, 1997
1MG/ML A075170 001 Sep 28, 1998
2MG/ML A074620 002 Jan 22, 1997
2MG/ML A075170 002 Sep 28, 1998
SPRAY, METERED; NASAL
STADOL
BRISTOL MYERS SQUIBB 1MG/SPRAY N019890 001 Dec 12, 1991

CABERGOLINE
TABLET; ORAL
DOSTINEX
PHARMACIA AND UPJOHN 0.5MG N020664 001 Dec 23, 1996

CAFFEINE; ERGOTAMINE TARTRATE


SUPPOSITORY; RECTAL
CAFERGOT
NOVARTIS 100MG;2MG N009000 002
TABLET; ORAL
CAFERGOT
NOVARTIS 100MG;1MG N006620 001
WIGRAINE
ORGANON USA INC 100MG;1MG A086562 001

CALCIFEDIOL
CAPSULE; ORAL
CALDEROL
ORGANON USA INC 0.02MG N018312 001
0.05MG N018312 002

CALCIPOTRIENE
OINTMENT; TOPICAL
DOVONEX
LEO PHARM 0.005% N020273 001 Dec 29, 1993

CALCITONIN HUMAN
INJECTABLE; INJECTION
CIBACALCIN
NOVARTIS 0.5MG/VIAL N018470 001 Oct 31, 1986

CALCITONIN, SALMON
INJECTABLE; INJECTION
CALCIMAR
SANOFI AVENTIS US 200 IU/ML N017769 001
400 IU/VIAL N017497 001
CALCITONIN-SALMON
ASTRAZENECA 200 IU/ML A073690 001 Apr 14, 1995
MIACALCIN
NOVARTIS 100 IU/ML N017808 001 Jul 03, 1986

CALCITRIOL
INJECTABLE; INJECTION
CALCITRIOL
HOSPIRA 0.001MG/ML A075816 001 Jan 16, 2004
0.002MG/ML A075816 002 Jan 16, 2004

CALCIUM ACETATE
CAPSULE; ORAL
PHOSLO
FRESENIUS MEDCL EQ 84.5MG CALCIUM N021160 001 Apr 02, 2001
EQ 169MG CALCIUM N021160 002 Apr 02, 2001
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DISCONTINUED DRUG PRODUCT LIST 6 - 49 (of 324)

CALCIUM ACETATE
TABLET; ORAL
CALCIUM ACETATE
ROXANE EQ 169MG CALCIUM A077693 001 Jan 30, 2008
PHOSLO
FRESENIUS MEDCL EQ 169MG CALCIUM N019976 001 Dec 10, 1990

CALCIUM CARBONATE; RISEDRONATE SODIUM


TABLET, TABLET; ORAL
ACTONEL WITH CALCIUM (COPACKAGED)
PROCTER AND GAMBLE EQ 500MG BASE,N/A;N/A,35MG N021823 001 Aug 12, 2005

CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE;


SODIUM BICARBONATE; SODIUM CHLORIDE
INJECTABLE; INJECTION
PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER
GAMBRO RENAL PRODS 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML; N021703 012 Oct 10, 2008
3.05GM/1000ML;0.157GM/1000ML;2.21GM/100
0ML;7.07GM/1000ML
PRISMASOL BGK 4/0 IN PLASTIC CONTAINER
GAMBRO RENAL PRODS N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0 N021703 005 Oct 25, 2006
5GM/1000ML;0.314GM/1000ML;3.09GM/1000ML
;6.46GM/1000ML
PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER
GAMBRO RENAL PRODS 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML; N021703 008 Oct 25, 2006
2.03GM/1000ML;0.314GM/1000ML;3.09GM/100
0ML;6.46GM/1000ML
PRISMASOL BK 0/0 IN PLASTIC CONTAINER
GAMBRO RENAL PRODS N/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05 N021703 007 Oct 25, 2006
GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46
GM/1000ML
PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER
GAMBRO RENAL PRODS 3.68GM/1000ML;N/A/1000ML;5.4GM/1000ML;3 N021703 009 Oct 25, 2006
.05GM/1000ML;0.314GM/1000ML;3.09GM/1000
ML;6.46GM/1000ML

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE;


SODIUM CHLORIDE
INJECTABLE; INJECTION
ISOLYTE R W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 37MG/100ML;5GM/100ML;31MG/100ML;120MG/1 N018271 001
00ML;330MG/100ML;88MG/100ML

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE;


SODIUM CHLORIDE; SODIUM CITRATE
INJECTABLE; INJECTION
ISOLYTE E W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 35MG/100ML;5GM/100ML;30MG/100ML;74MG/10 N018269 002 Jan 17, 1983
0ML;640MG/100ML;500MG/100ML;74MG/100ML

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE


SOLUTION; INTRAPERITONEAL
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER
B BRAUN 29MG/100ML;2.5GM/100ML;15MG/100ML;610MG N018460 006 Jan 29, 1986
/100ML;560MG/100ML
DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
B BRAUN 29MG/100ML;1.5GM/100ML;15MG/100ML;610MG N018460 001
/100ML;560MG/100ML
DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
B BRAUN 29MG/100ML;4.25GM/100ML;15MG/100ML;610M N018460 003
G/100ML;560MG/100ML

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE


SOLUTION; INTRAPERITONEAL

DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER

B BRAUN 26MG/100ML;1.5GM/100ML;15MG/100ML;560MG N018460 002


/100ML;390MG/100ML

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DISCONTINUED DRUG PRODUCT LIST 6 - 50 (of 324)

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE


SOLUTION; INTRAPERITONEAL
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER
B BRAUN 26MG/100ML;5GM/100ML;5MG/100ML;530MG/10 N018460 008 Jan 29, 1986
0ML;450MG/100ML
DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER
B BRAUN 26MG/100ML;4.25GM/100ML;15MG/100ML;560M N018460 004
G/100ML;390MG/100ML

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE


INJECTABLE; INJECTION

DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER


B BRAUN 33MG/100ML;5GM/100ML;30MG/100ML;860MG/1 N018256 001


00ML

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE


INJECTABLE; INJECTION
DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER
B BRAUN 4MG/100ML;4GM/100ML;6MG/100ML;120MG/100 N019634 002 Feb 24, 1988
ML;62MG/100ML
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER
B BRAUN 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N017510 001
00ML;310MG/100ML
MILES 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N018499 001
00ML;310MG/100ML
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
HOSPIRA 20MG/100ML;5GM/100ML;104MG/100ML;600MG/ N019685 005 Oct 17, 1988
100ML;310MG/100ML
20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019685 006 Oct 17, 1988
100ML;310MG/100ML
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
HOSPIRA 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019685 007 Oct 17, 1988
100ML;310MG/100ML
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
HOSPIRA 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019685 003 Oct 17, 1988
100ML;310MG/100ML
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
HOSPIRA 20MG/100ML;5GM/100ML;104MG/100ML;600MG/ N019685 001 Oct 17, 1988
100ML;310MG/100ML

CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE


SOLUTION; INTRAPERITONEAL
INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;538MG/100ML;44 N019395 001 Mar 26, 1986
8MG/100ML
INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;538MG/100ML;44 N019395 002 Mar 26, 1986
8MG/100ML
INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;538MG/100ML;4 N019395 003 Mar 26, 1986
48MG/100ML

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM


CHLORIDE
INJECTABLE; INJECTION
TPN ELECTROLYTES IN PLASTIC CONTAINER
ABBOTT 16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML; N019399 001 Jun 16, 1986
16.1MG/ML

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM


CHLORIDE; SODIUM CITRATE
INJECTABLE; INJECTION
ISOLYTE E IN PLASTIC CONTAINER
B BRAUN 35MG/100ML;30MG/100ML;74MG/100ML;640MG/ N018899 001 Oct 31, 1983
100ML;500MG/100ML;74MG/100ML
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DISCONTINUED DRUG PRODUCT LIST 6 - 51 (of 324)

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE


INJECTABLE; INJECTION
ACETATED RINGER'S IN PLASTIC CONTAINER
B BRAUN 20MG/100ML;30MG/100ML;380MG/100ML;600MG N018725 001 Nov 29, 1982
/100ML

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE


INJECTABLE; INJECTION
RINGER'S IN PLASTIC CONTAINER
B BRAUN 33MG/100ML;30MG/100ML;860MG/100ML N018721 001 Nov 09, 1982
SOLUTION; IRRIGATION
RINGER'S IN PLASTIC CONTAINER
ABBOTT 33MG/100ML;30MG/100ML;860MG/100ML N018462 001

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE


INJECTABLE; INJECTION
LACTATED RINGER'S IN PLASTIC CONTAINER
ABBOTT 20MG/100ML;30MG/100ML;600MG/100ML;310MG N019485 001 Oct 24, 1985
/100ML
B BRAUN 20MG/100ML;30MG/100ML;600MG/100ML;310MG N018023 001
/100ML
MILES 20MG/100ML;30MG/100ML;600MG/100ML;310MG N018417 001
/100ML

CALCIUM GLUCEPTATE
INJECTABLE; INJECTION

CALCIUM GLUCEPTATE

ABBOTT EQ 90MG CALCIUM/5ML A080001 001

EQ 90MG CALCIUM/5ML A083159 001


ABRAXIS PHARM EQ 90MG CALCIUM/5ML A089373 001 Apr 30, 1987
LILLY EQ 90MG CALCIUM/5ML N006470 001

CALCIUM METRIZOATE; MEGLUMINE METRIZOATE; METRIZOATE MAGNESIUM; METRIZOATE SODIUM


INJECTABLE; INJECTION

ISOPAQUE 440

GE HEALTHCARE 0.78MG/ML;75.9MG/ML;0.15MG/ML;16.6MG/ML N016847 001

CALCIUM; MEGLUMINE; METRIZOIC ACID


INJECTABLE; INJECTION

ISOPAQUE 280

GE HEALTHCARE 0.35MG/ML;140.1MG/ML;461.8MG/ML N017506 001

CANDICIDIN
OINTMENT; VAGINAL

VANOBID

SANOFI AVENTIS US 0.6MG/GM A061596 001


TABLET; VAGINAL

VANOBID

SANOFI AVENTIS US 3MG A061613 001


CAPTOPRIL
TABLET; ORAL

CAPOTEN

PAR PHARM 37.5MG N018343 006 Sep 17, 1986


75MG N018343 007 Jun 13, 1995
150MG N018343 004 Jun 13, 1995
CAPTOPRIL
APOTHECON 12.5MG A074472 001 Mar 31, 1995
25MG A074472 002 Mar 31, 1995
50MG A074472 003 Mar 31, 1995
100MG A074472 004 Mar 31, 1995
CLONMEL HLTHCARE 12.5MG A074423 001 Feb 13, 1996
25MG A074423 002 Feb 13, 1996
50MG A074423 003 Feb 13, 1996
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DISCONTINUED DRUG PRODUCT LIST 6 - 52 (of 324)

CAPTOPRIL
TABLET; ORAL
CAPTOPRIL
CLONMEL HLTHCARE 100MG A074423 004 Feb 13, 1996
EGIS PHARMS 12.5MG A074748 004 May 29, 1997
25MG A074748 002 May 29, 1997
50MG A074748 001 May 29, 1997
100MG A074748 003 May 29, 1997
ENDO LABS 12.5MG A074418 001 Feb 13, 1996
25MG A074418 002 Feb 13, 1996
50MG A074418 003 Feb 13, 1996
100MG A074418 004 Feb 13, 1996
IVAX SUB TEVA PHARMS 12.5MG A074590 004 Aug 30, 1996
25MG A074590 002 Aug 30, 1996
50MG A074590 001 Aug 30, 1996
100MG A074590 003 Aug 30, 1996
PAR PHARM 12.5MG A074493 001 Feb 13, 1996
25MG A074493 002 Feb 13, 1996
50MG A074493 003 Feb 13, 1996
100MG A074493 004 Feb 13, 1996
PUREPAC PHARM 12.5MG A074640 001 Mar 31, 1997
25MG A074640 002 Mar 31, 1997
50MG A074640 003 Mar 31, 1997
100MG A074640 004 Mar 31, 1997
SANDOZ 12.5MG A074481 001 Feb 13, 1996
12.5MG A074519 001 Feb 13, 1996
25MG A074481 002 Feb 13, 1996
25MG A074519 002 Feb 13, 1996
50MG A074481 003 Feb 13, 1996
50MG A074519 003 Feb 13, 1996
100MG A074481 004 Feb 13, 1996
100MG A074519 004 Feb 13, 1996
TEVA 12.5MG A074433 001 Feb 13, 1996
25MG A074433 002 Feb 13, 1996
50MG A074433 003 Feb 13, 1996
100MG A074433 004 Feb 13, 1996
TEVA PHARMS 12.5MG A074462 001 Feb 13, 1996
25MG A074462 002 Feb 13, 1996
50MG A074462 003 Feb 13, 1996
100MG A074462 004 Feb 13, 1996
WATSON LABS 12.5MG A074576 001 Apr 23, 1996
25MG A074576 002 Apr 23, 1996
50MG A074576 003 Apr 23, 1996
100MG A074576 004 Apr 23, 1996

CAPTOPRIL; HYDROCHLOROTHIAZIDE
TABLET; ORAL
CAPTOPRIL AND HYDROCHLOROTHIAZIDE
ENDO LABS 25MG;15MG A074788 001 Dec 29, 1997
25MG;25MG A074788 002 Dec 29, 1997
50MG;15MG A074788 004 Dec 29, 1997
50MG;25MG A074788 003 Dec 29, 1997
WATSON LABS 50MG;25MG A074832 001 Dec 29, 1997

CARBACHOL
SOLUTION; INTRAOCULAR
CARBACHOL
PHARMAFAIR 0.01% A070292 001 May 21, 1986
CARBASTAT
NOVARTIS 0.01% A073677 001 Apr 28, 1995
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 53 (of 324)

CARBAMAZEPINE
SUSPENSION; ORAL
CARBAMAZEPINE
TARO 100MG/5ML A075875 001 Dec 21, 2000
TABLET; ORAL
CARBAMAZEPINE
ACTAVIS ELIZABETH 200MG A071696 001 Nov 09, 1987
PLIVA 200MG A071479 001 Jul 24, 1987
USL PHARMA 200MG A070300 001 May 15, 1986
WARNER CHILCOTT 200MG A070429 001 Jan 02, 1987
TERIL
TARO 200MG A076525 001 Sep 26, 2003
TABLET, CHEWABLE; ORAL
CARBAMAZEPINE
CADISTA PHARMS 100MG A071940 001 Feb 01, 1988

CARBENICILLIN DISODIUM
INJECTABLE; INJECTION
GEOPEN
ROERIG EQ 1GM BASE/VIAL N050306 001
EQ 2GM BASE/VIAL N050306 004
EQ 5GM BASE/VIAL N050306 002
EQ 10GM BASE/VIAL N050306 006
EQ 30GM BASE/VIAL N050306 007
PYOPEN
GLAXOSMITHKLINE EQ 1GM BASE/VIAL N050298 001
EQ 2GM BASE/VIAL N050298 002
EQ 5GM BASE/VIAL N050298 003
EQ 10GM BASE/VIAL N050298 006
EQ 20GM BASE/VIAL N050298 007

CARBENICILLIN INDANYL SODIUM


TABLET; ORAL
GEOCILLIN
PFIZER EQ 382MG BASE N050435 001

CARBIDOPA; LEVODOPA
TABLET; ORAL
CARBIDOPA AND LEVODOPA
SANDOZ 10MG;100MG A073586 001 Jun 29, 1995
25MG;100MG A073587 001 Jun 29, 1995
25MG;250MG A073620 001 Jun 29, 1995
SCS 10MG;100MG A074080 001 Mar 25, 1994
25MG;100MG A074080 002 Mar 25, 1994
25MG;250MG A074080 003 Mar 25, 1994
WATSON LABS 10MG;100MG A073381 001 Sep 28, 1993
25MG;100MG A073382 001 Sep 28, 1993
25MG;250MG A073383 001 Sep 28, 1993
TABLET, EXTENDED RELEASE; ORAL
CARBIDOPA AND LEVODOPA
KV PHARM 50MG;200MG A076663 001 Jun 24, 2004
TABLET, FOR SUSPENSION; ORAL
CARBILEV
RANBAXY 10MG;100MG A076643 001 Jun 10, 2005
25MG;100MG A076643 002 Jun 10, 2005
25MG;250MG A076643 003 Jun 10, 2005

CARBINOXAMINE MALEATE
ELIXIR; ORAL
CLISTIN
MCNEIL 4MG/5ML N008955 001
TABLET; ORAL
CLISTIN
ORTHO MCNEIL PHARM 4MG N008915 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 54 (of 324)

CARBOPLATIN
INJECTABLE; INJECTION
CARBOPLATIN
HOSPIRA 50MG/VIAL A076473 001 Oct 27, 2004
150MG/VIAL A076473 002 Oct 27, 2004
450MG/VIAL A076473 003 Oct 27, 2004
PARAPLATIN
BRISTOL MYERS SQUIBB 50MG/VIAL N019880 001 Mar 03, 1989
150MG/VIAL N019880 002 Mar 03, 1989
450MG/VIAL N019880 003 Mar 03, 1989
INJECTABLE; IV (INFUSION)
CARBOPLATIN
APP PHARMS 50MG/5ML (10MG/ML) A077247 001 Oct 21, 2004
150MG/15ML (10MG/ML) A077247 002 Oct 21, 2004
SPECTRUM PHARMS 50MG/5ML (10MG/ML) A077096 001 Jun 14, 2005
150MG/15ML (10MG/ML) A077096 002 Jun 14, 2005
450MG/45ML (10MG/ML) A077096 003 Jun 14, 2005

CARISOPRODOL
CAPSULE; ORAL
SOMA
MEDA PHARMS 250MG N011792 003
TABLET; ORAL
CARISOPRODOL
ABLE 350MG A040421 001 Jun 21, 2001
PIONEER PHARMS 350MG A089390 001 Oct 13, 1988
SANDOZ 350MG A081025 001 Apr 13, 1989
350MG A089566 001 Aug 30, 1988
WATSON LABS 350MG A040152 001 Dec 03, 1996
350MG A085433 001
350MG A086179 001
RELA
SCHERING 350MG N012155 001

CARPHENAZINE MALEATE
CONCENTRATE; ORAL
PROKETAZINE
WYETH AYERST 50MG/ML N014173 001
TABLET; ORAL
PROKETAZINE
WYETH AYERST 12.5MG N012768 001
25MG N012768 002
50MG N012768 004

CARPROFEN
TABLET; ORAL
RIMADYL
ROCHE 100MG N018550 002 Dec 31, 1987
150MG N018550 003 Dec 31, 1987

CARTEOLOL HYDROCHLORIDE
TABLET; ORAL
CARTROL
ABBOTT 2.5MG N019204 001 Dec 28, 1988
5MG N019204 002 Dec 28, 1988
10MG N019204 003 Dec 28, 1988

CEFACLOR
CAPSULE; ORAL
CECLOR
LILLY EQ 250MG BASE N050521 001
EQ 500MG BASE N050521 002
CEFACLOR
CEPH INTL EQ 250MG BASE A062205 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 55 (of 324)

CEFACLOR
CAPSULE; ORAL
CEFACLOR
CEPH INTL EQ 500MG BASE A062205 002
CLONMEL HLTHCARE EQ 250MG BASE A064107 001 Apr 27, 1995
EQ 500MG BASE A064107 002 Apr 27, 1995
IVAX SUB TEVA PHARMS EQ 250MG BASE A064061 001 Apr 27, 1995
EQ 500MG BASE A064061 002 Apr 27, 1995
MARSAM PHARMS LLC EQ 250MG BASE A064148 001 May 23, 1996
EQ 500MG BASE A064148 002 May 23, 1996
TEVA EQ 250MG BASE A064081 001 Sep 16, 1996
EQ 250MG BASE A064145 001 Jun 24, 1996
EQ 500MG BASE A064081 002 Sep 16, 1996
EQ 500MG BASE A064145 002 Jun 24, 1996
FOR SUSPENSION; ORAL
CECLOR
LILLY EQ 125MG BASE/5ML N050522 001
EQ 250MG BASE/5ML N050522 002
CEFACLOR
CEPH INTL EQ 125MG BASE/5ML A062206 001
EQ 187MG BASE/5ML A062206 003 Apr 20, 1988
EQ 250MG BASE/5ML A062206 002
EQ 375MG BASE/5ML A062206 004 Apr 20, 1988
CLONMEL HLTHCARE EQ 125MG BASE/5ML A064114 001 Apr 28, 1995
EQ 187MG BASE/5ML A064115 001 Apr 28, 1995
EQ 250MG BASE/5ML A064116 001 Apr 28, 1995
EQ 375MG BASE/5ML A064110 001 Apr 28, 1995
IVAX SUB TEVA PHARMS EQ 125MG BASE/5ML A064087 001 Apr 28, 1995
EQ 187MG BASE/5ML A064086 001 Apr 28, 1995
EQ 250MG BASE/5ML A064085 001 Apr 28, 1995
EQ 375MG BASE/5ML A064070 001 Apr 28, 1995
MARSAM PHARMS LLC EQ 125MG BASE/5ML A064204 001 Feb 18, 1998
EQ 187MG BASE/5ML A064205 001 Feb 18, 1998
EQ 250MG BASE/5ML A064206 001 Feb 18, 1998
EQ 375MG BASE/5ML A064207 001 Feb 18, 1998
TABLET, EXTENDED RELEASE; ORAL
CECLOR CD
LILLY EQ 375MG BASE N050673 001 Jun 28, 1996
EQ 500MG BASE N050673 002 Jun 28, 1996

CEFADROXIL/CEFADROXIL HEMIHYDRATE
CAPSULE; ORAL
CEFADROXIL
IVAX SUB TEVA PHARMS EQ 500MG BASE A062766 001 Mar 03, 1987
PUREPAC PHARM EQ 500MG BASE A063017 001 Jan 05, 1989
TEVA EQ 500MG BASE A062695 001 Feb 10, 1989
DURICEF
WARNER CHILCOTT EQ 250MG BASE N050512 002
EQ 500MG BASE N050512 001
ULTRACEF
BRISTOL EQ 500MG BASE A062378 001 Mar 16, 1982
FOR SUSPENSION; ORAL
CEFADROXIL
APOTHECON EQ 125MG BASE/5ML A062334 001
EQ 250MG BASE/5ML A062334 002
EQ 500MG BASE/5ML A062334 003
TEVA EQ 125MG BASE/5ML A062698 001 Mar 01, 1989
EQ 250MG BASE/5ML A062698 002 Mar 01, 1989
EQ 500MG BASE/5ML A062698 003 Mar 01, 1989
DURICEF
WARNER CHILCOTT EQ 125MG BASE/5ML N050527 002
ULTRACEF
BRISTOL EQ 125MG BASE/5ML A062376 001 Mar 16, 1982
EQ 250MG BASE/5ML A062376 002 Mar 16, 1982
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 56 (of 324)

CEFADROXIL/CEFADROXIL HEMIHYDRATE
FOR SUSPENSION; ORAL
ULTRACEF
BRISTOL EQ 500MG BASE/5ML A062376 003 Mar 16, 1982
TABLET; ORAL
DURICEF
WARNER CHILCOTT EQ 1GM BASE N050528 001
ULTRACEF
APOTHECON EQ 1GM BASE A062390 001 Jun 10, 1982
BRISTOL EQ 1GM BASE A062408 001 Aug 31, 1982

CEFAMANDOLE NAFATE
INJECTABLE; INJECTION
MANDOL
LILLY EQ 500MG BASE/VIAL N050504 001
EQ 1GM BASE/VIAL A062560 001 Sep 10, 1985
EQ 1GM BASE/VIAL N050504 002
EQ 2GM BASE/VIAL A062560 002 Sep 10, 1985
EQ 2GM BASE/VIAL N050504 003
EQ 10GM BASE/VIAL N050504 004

CEFAZOLIN SODIUM
INJECTABLE; INJECTION
ANCEF
GLAXOSMITHKLINE EQ 250MG BASE/VIAL N050461 001
EQ 500MG BASE/VIAL N050461 002
EQ 1GM BASE/VIAL N050461 003
EQ 5GM BASE/VIAL N050461 004
EQ 10GM BASE/VIAL N050461 005
ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE EQ 10MG BASE/ML N050566 003 Jun 08, 1983
EQ 20MG BASE/ML N050566 004 Jun 08, 1983
ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE EQ 10MG BASE/ML N050566 001 Jun 08, 1983
EQ 20MG BASE/ML N050566 002 Jun 08, 1983
CEFAZOLIN AND DEXTROSE
B BRAUN EQ 500MG BASE/VIAL N050779 001 Jul 27, 2000
CEFAZOLIN SODIUM
ABRAXIS PHARM EQ 500MG BASE/VIAL A062688 002 Nov 17, 1986
EQ 1GM BASE/VIAL A062688 003 Nov 17, 1986
EQ 10GM BASE/VIAL A062688 004 Nov 17, 1986
EQ 20GM BASE/VIAL A062688 005 Aug 03, 1987
BEDFORD EQ 250MG BASE/VIAL A062894 001 Jul 21, 1988
EQ 500MG BASE/VIAL A062894 002 Jul 21, 1988
EQ 1GM BASE/VIAL A062894 003 Jul 21, 1988
EQ 5GM BASE/VIAL A062894 004 Jul 21, 1988
EQ 10GM BASE/VIAL A062894 005 Jul 21, 1988
ELKINS SINN EQ 250MG BASE/VIAL A062807 001 Jan 12, 1988
EQ 500MG BASE/VIAL A062807 002 Jan 12, 1988
EQ 1GM BASE/VIAL A062807 003 Jan 12, 1988
EQ 5GM BASE/VIAL A062807 004 Jan 12, 1988
EQ 10GM BASE/VIAL A062807 005 Jan 12, 1988
EQ 20GM BASE/VIAL A062807 006 Jan 12, 1988
GLAXOSMITHKLINE EQ 1GM BASE/VIAL A064033 001 Oct 31, 1993
HANFORD GC EQ 500MG BASE/VIAL A063214 001 Dec 27, 1991
EQ 500MG BASE/VIAL A063216 001 Dec 27, 1991
MARSAM PHARMS LLC EQ 250MG BASE/VIAL A062988 001 Dec 29, 1989
EQ 500MG BASE/VIAL A062988 002 Dec 29, 1989
EQ 1GM BASE/VIAL A062988 003 Dec 29, 1989
EQ 5GM BASE/VIAL A062989 001 Dec 29, 1989
EQ 10GM BASE/VIAL A062989 002 Dec 29, 1989
EQ 20GM BASE/VIAL A062989 003 Dec 29, 1989
TEVA EQ 250MG BASE/VIAL A063016 001 Mar 14, 1989
EQ 500MG BASE/VIAL A063016 002 Mar 14, 1989
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 57 (of 324)

CEFAZOLIN SODIUM
INJECTABLE; INJECTION
CEFAZOLIN SODIUM
TEVA EQ 1GM BASE/VIAL A063016 003 Mar 14, 1989
EQ 5GM BASE/VIAL A063018 001 Mar 05, 1990
EQ 10GM BASE/VIAL A063018 002 Mar 05, 1990
KEFZOL
ACS DOBFAR EQ 250MG BASE/VIAL A061773 001
EQ 20GM BASE/VIAL A061773 005 Sep 08, 1987
LILLY EQ 500MG BASE/VIAL A062557 001 Sep 10, 1985
EQ 1GM BASE/VIAL A062557 002 Sep 10, 1985

CEFIXIME
FOR SUSPENSION; ORAL
SUPRAX
LEDERLE 100MG/5ML N050622 001 Apr 28, 1989
TABLET; ORAL
SUPRAX
LEDERLE 200MG N050621 001 Apr 28, 1989
400MG N050621 002 Apr 28, 1989

CEFMENOXIME HYDROCHLORIDE
INJECTABLE; INJECTION
CEFMAX
TAP PHARM EQ 500MG BASE/VIAL N050571 001 Dec 30, 1987
EQ 1GM BASE/VIAL N050571 002 Dec 30, 1987
EQ 2GM BASE/VIAL N050571 003 Dec 30, 1987

CEFMETAZOLE SODIUM
INJECTABLE; INJECTION
ZEFAZONE
PHARMACIA AND UPJOHN EQ 1GM BASE/VIAL N050637 001 Dec 11, 1989
EQ 2GM BASE/VIAL N050637 002 Dec 11, 1989
ZEFAZONE IN PLASTIC CONTAINER
PHARMACIA AND UPJOHN EQ 20MG BASE/ML N050683 001 Dec 29, 1992
EQ 40MG BASE/ML N050683 002 Dec 29, 1992

CEFONICID SODIUM
INJECTABLE; INJECTION
MONOCID
GLAXOSMITHKLINE EQ 500MG BASE/VIAL N050579 001 May 23, 1984
EQ 1GM BASE/VIAL A063295 001 Jul 26, 1993
EQ 1GM BASE/VIAL N050579 002 May 23, 1984
EQ 2GM BASE/VIAL N050579 003 May 23, 1984
EQ 10GM BASE/VIAL N050579 004 May 23, 1984

CEFOPERAZONE SODIUM
INJECTABLE; INJECTION
CEFOBID
PFIZER EQ 1GM BASE/VIAL A063333 001 Mar 31, 1995
EQ 1GM BASE/VIAL N050551 001 Nov 18, 1982
EQ 2GM BASE/VIAL A063333 002 Mar 31, 1995
EQ 2GM BASE/VIAL N050551 002 Nov 18, 1982
EQ 10GM BASE/VIAL N050551 003 Mar 05, 1990
CEFOBID IN PLASTIC CONTAINER
PFIZER EQ 20MG BASE/ML N050613 002 Jul 31, 1987
EQ 40MG BASE/ML N050613 001 Jul 23, 1986

CEFORANIDE
INJECTABLE; INJECTION
PRECEF
APOTHECON 500MG/VIAL A062579 001 Nov 26, 1984
1GM/VIAL A062579 002 Nov 26, 1984
2GM/VIAL A062579 003 Nov 26, 1984
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 58 (of 324)

CEFORANIDE
INJECTABLE; INJECTION
PRECEF
APOTHECON 10GM/VIAL A062579 004 Nov 26, 1984
20GM/VIAL A062579 005 Nov 26, 1984
BRISTOL 500MG/VIAL N050554 001 May 24, 1984
1GM/VIAL N050554 002 May 24, 1984
2GM/VIAL N050554 003 May 24, 1984
10GM/VIAL N050554 004 May 24, 1984
20GM/VIAL N050554 005 May 24, 1984

CEFOTAXIME SODIUM
INJECTABLE; INJECTION
CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
B BRAUN EQ 2GM BASE N050792 001 Jul 29, 2004
CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
B BRAUN EQ 1GM BASE N050792 002 Jul 29, 2004
CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
SANOFI AVENTIS US EQ 20MG BASE/ML N050596 001 May 20, 1985
EQ 40MG BASE/ML N050596 003 May 20, 1985

CEFOTETAN DISODIUM
INJECTABLE; INJECTION
CEFOTAN
ASTRAZENECA EQ 1GM BASE/VIAL A063293 001 Apr 29, 1993
EQ 1GM BASE/VIAL N050588 001 Dec 27, 1985
EQ 2GM BASE/VIAL A063293 002 Apr 29, 1993
EQ 2GM BASE/VIAL N050588 002 Dec 27, 1985
EQ 10GM BASE/VIAL N050588 003 Apr 25, 1988
CEFOTAN IN PLASTIC CONTAINER
ASTRAZENECA EQ 20MG BASE/ML N050694 002 Jul 30, 1993
EQ 40MG BASE/ML N050694 001 Jul 30, 1993

CEFOTIAM HYDROCHLORIDE
INJECTABLE; INJECTION
CERADON
TAKEDA EQ 1GM BASE/VIAL N050601 001 Dec 30, 1988

CEFOXITIN SODIUM
INJECTABLE; INJECTION
MEFOXIN
BIONICHE PHARMA EQ 1GM BASE/VIAL A062757 001 Jan 08, 1987
EQ 2GM BASE/VIAL A062757 002 Jan 08, 1987
MERCK EQ 1GM BASE/VIAL N050517 001
EQ 2GM BASE/VIAL N050517 002
EQ 10GM BASE/VIAL N050517 003
MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
MERCK EQ 20MG BASE/ML N050581 003 Sep 20, 1984
EQ 40MG BASE/ML N050581 004 Sep 20, 1984
MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
MERCK EQ 20MG BASE/ML N050581 002 Sep 20, 1984
EQ 40MG BASE/ML N050581 001 Sep 20, 1984

CEFPIRAMIDE SODIUM
INJECTABLE; INJECTION
CEFPIRAMIDE SODIUM
WYETH AYERST EQ 1GM BASE/VIAL N050633 002 Jan 31, 1989
EQ 2GM BASE/VIAL N050633 003 Jan 31, 1989
EQ 10GM BASE/VIAL N050633 005 Jan 31, 1989
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 59 (of 324)

CEFPODOXIME PROXETIL
FOR SUSPENSION; ORAL
BANAN
SANKYO EQ 50MG BASE/5ML N050688 002 Aug 07, 1992
EQ 100MG BASE/5ML N050688 001 Aug 07, 1992
VANTIN
PHARMACIA AND UPJOHN EQ 50MG BASE/5ML N050675 001 Aug 07, 1992
EQ 100MG BASE/5ML N050675 002 Aug 07, 1992
TABLET; ORAL
BANAN
SANKYO EQ 100MG BASE N050687 001 Aug 07, 1992
EQ 200MG BASE N050687 002 Aug 07, 1992

CEFTAZIDIME
INJECTABLE; INJECTION
CEPTAZ
GLAXOSMITHKLINE 500MG/VIAL N050646 001 Sep 27, 1990
1GM/VIAL N050646 002 Sep 27, 1990
2GM/VIAL N050646 003 Sep 27, 1990
10GM/VIAL N050646 004 Sep 27, 1990
PENTACEF
GLAXOSMITHKLINE 1GM/VIAL A063322 001 Nov 07, 1995
1GM/VIAL A064006 001 Mar 31, 1992
2GM/VIAL A063322 002 Nov 07, 1995
2GM/VIAL A064006 002 Mar 31, 1992
6GM/VIAL A064008 001 Mar 31, 1992
10GM/VIAL A064008 002 Mar 31, 1992
TAZIDIME
LILLY 1GM/VIAL A062655 001 Nov 20, 1985
2GM/VIAL A062655 002 Nov 20, 1985
TAZIDIME IN PLASTIC CONTAINER
LILLY 1GM/VIAL A062739 001 Jul 10, 1986
2GM/VIAL A062739 002 Jul 10, 1986

CEFTAZIDIME SODIUM
INJECTABLE; INJECTION
CEFTAZIDIME SODIUM IN PLASTIC CONTAINER
BAXTER HLTHCARE EQ 10MG BASE/ML A063221 001 Apr 29, 1993
EQ 20MG BASE/ML A063221 002 Apr 29, 1993
EQ 40MG BASE/ML A063221 003 Apr 29, 1993
FORTAZ IN PLASTIC CONTAINER
GLAXOSMITHKLINE EQ 10MG BASE/ML N050634 001 Apr 28, 1989

CEFTIBUTEN DIHYDRATE
FOR SUSPENSION; ORAL
CEDAX
SCIELE PHARMA INC EQ 180MG BASE/5ML N050686 002 Dec 20, 1995

CEFTIZOXIME SODIUM
INJECTABLE; INJECTION
CEFIZOX
ASTELLAS EQ 500MG BASE/VIAL N050560 001 Sep 15, 1983
EQ 1GM BASE/VIAL A063294 002 Mar 31, 1994
EQ 1GM BASE/VIAL N050560 002 Sep 15, 1983
EQ 2GM BASE/VIAL A063294 003 Mar 31, 1994
EQ 2GM BASE/VIAL N050560 003 Sep 15, 1983
EQ 10GM BASE/VIAL N050560 005 Mar 19, 1993
CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER
ASTELLAS EQ 20MG BASE/ML N050589 001 Oct 03, 1984
EQ 40MG BASE/ML N050589 002 Oct 03, 1984
CEFIZOX IN PLASTIC CONTAINER
ASTELLAS EQ 20MG BASE/ML N050589 003 Apr 13, 1995
EQ 40MG BASE/ML N050589 004 Apr 13, 1995
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 60 (of 324)

CEFTRIAXONE SODIUM
INJECTABLE; IM-IV
ROCEPHIN
HOFFMANN LA ROCHE EQ 250MG BASE/VIAL N050585 001 Dec 21, 1984
EQ 500MG BASE/VIAL N050585 002 Dec 21, 1984
EQ 1GM BASE/VIAL N050585 003 Dec 21, 1984
EQ 2GM BASE/VIAL N050585 004 Dec 21, 1984
INJECTABLE; INJECTION
ROCEPHIN
HLR EQ 250MG BASE/VIAL A063239 001 Aug 13, 1993
EQ 500MG BASE/VIAL A062654 001 Apr 30, 1987
EQ 1GM BASE/VIAL A062654 002 Apr 30, 1987
EQ 2GM BASE/VIAL A062654 003 Apr 30, 1987
HOFFMANN LA ROCHE EQ 10GM BASE/VIAL N050585 005 Dec 21, 1984
ROCHE EQ 250MG BASE/VIAL A062510 001 Mar 12, 1985
EQ 500MG BASE/VIAL A062510 002 Mar 12, 1985
EQ 1GM BASE/VIAL A062510 003 Mar 12, 1985
ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER
HOFFMANN LA ROCHE EQ 10MG BASE/ML N050624 001 Feb 11, 1987
EQ 20MG BASE/ML N050624 002 Feb 11, 1987
EQ 40MG BASE/ML N050624 003 Feb 11, 1987

CEFTRIAXONE SODIUM; LIDOCAINE


INJECTABLE; INJECTION
ROCEPHIN KIT
HOFFMANN LA ROCHE EQ 500MG BASE/VIAL,N/A;N/A,1% N050585 007 May 08, 1996
EQ 1GM BASE/VIAL,N/A;N/A,1% N050585 006 May 08, 1996

CEFUROXIME SODIUM
INJECTABLE; IM-IV
CEFUROXIME SODIUM
MARSAM PHARMS LLC EQ 750MG BASE/VIAL A064035 001 Feb 26, 1993
KEFUROX
ACS DOBFAR EQ 750MG BASE/VIAL A062591 001 Jan 10, 1986
INJECTABLE; INJECTION
CEFUROXIME SODIUM
MARSAM PHARMS LLC EQ 1.5GM BASE/VIAL A064035 002 Feb 26, 1993
EQ 7.5GM BASE/VIAL A064036 001 Feb 26, 1993
KEFUROX
ACS DOBFAR EQ 1.5GM BASE/VIAL A062591 002 Jan 10, 1986
EQ 7.5GM BASE/VIAL A062591 003 Dec 17, 1987
LILLY EQ 1.5GM BASE/VIAL A062592 002 Jan 10, 1986
KEFUROX IN PLASTIC CONTAINER
LILLY EQ 1.5GM BASE/VIAL A062590 002 Jan 10, 1986
INJECTABLE; INTRAVENOUS
KEFUROX
LILLY EQ 750MG BASE/VIAL A062592 001 Jan 10, 1986
KEFUROX IN PLASTIC CONTAINER
LILLY EQ 750MG BASE/VIAL A062590 001 Jan 10, 1986

CELLULOSE SODIUM PHOSPHATE


POWDER; ORAL
CALCIBIND
MISSION PHARMA 2.5GM/PACKET N018757 002 Dec 28, 1982
300GM/BOT N018757 003 Oct 16, 1984

CEPHALEXIN
CAPSULE; ORAL
CEPHALEXIN
APOTHECON EQ 250MG BASE A062973 001 Nov 08, 1988
EQ 250MG BASE A063063 001 Sep 29, 1989
EQ 250MG BASE A063186 001 Dec 30, 1994
EQ 500MG BASE A062974 001 Nov 23, 1988
EQ 500MG BASE A063063 002 Sep 29, 1989
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 61 (of 324)

CEPHALEXIN
CAPSULE; ORAL
CEPHALEXIN
APOTHECON EQ 500MG BASE A063186 002 Dec 30, 1994
BARR EQ 250MG BASE A062773 001 Jun 26, 1987
EQ 500MG BASE A062775 001 Apr 22, 1987
PUREPAC PHARM EQ 250MG BASE A062809 001 Apr 22, 1987
EQ 500MG BASE A062809 002 Apr 22, 1987
STEVENS J EQ 500MG BASE A062869 001 Mar 17, 1988
TEVA EQ 250MG BASE A062760 001 Apr 24, 1987
EQ 250MG BASE A062821 001 Feb 05, 1988
EQ 500MG BASE A062761 001 Apr 24, 1987
EQ 500MG BASE A062823 001 Feb 05, 1988
YOSHITOMI EQ 250MG BASE A062872 001 Jun 20, 1988
EQ 500MG BASE A062871 001 Jul 05, 1988
KEFLEX
MIDDLEBROOK PHARMS EQ 333MG BASE N050405 004 May 12, 2006
FOR SUSPENSION; ORAL
CEPHALEXIN
APOTHECON EQ 125MG BASE/5ML A062986 001 Apr 18, 1991
EQ 250MG BASE/5ML A062987 001 Jul 25, 1989
BARR EQ 125MG BASE/5ML A062778 001 Aug 06, 1987
EQ 250MG BASE/5ML A062777 001 Aug 06, 1987
CEPH INTL EQ 100MG BASE/ML A062117 001
TEVA EQ 125MG BASE/5ML A062767 001 Jun 16, 1987
EQ 125MG BASE/5ML A062873 001 May 23, 1988
EQ 250MG BASE/5ML A062768 001 Jun 16, 1987
EQ 250MG BASE/5ML A062867 001 Apr 15, 1988
VITARINE EQ 125MG BASE/5ML A062779 001 Dec 22, 1987
EQ 250MG BASE/5ML A062781 001 Dec 22, 1987
KEFLEX
LEX PHARMS EQ 100MG BASE/ML N050406 003
EQ 125MG BASE/5ML N050406 001
EQ 250MG BASE/5ML N050406 002
TABLET; ORAL
CEPHALEXIN
BARR EQ 250MG BASE A062826 001 Aug 17, 1987
EQ 500MG BASE A062827 001 Aug 17, 1987
VITARINE EQ 250MG BASE A062863 001 Aug 11, 1988
EQ 500MG BASE A062863 002 Aug 11, 1988
EQ 1GM BASE A062863 003 Aug 11, 1988
KEFLET
LILLY EQ 250MG BASE A062745 001 Dec 01, 1986
EQ 250MG BASE N050440 003 Feb 26, 1987
EQ 500MG BASE A062745 002 Dec 01, 1986
EQ 500MG BASE N050440 001
EQ 1GM BASE N050440 002

CEPHALEXIN HYDROCHLORIDE
TABLET; ORAL
KEFTAB
LILLY EQ 250MG BASE N050614 001 Oct 29, 1987
EQ 333MG BASE N050614 003 May 16, 1988
EQ 500MG BASE N050614 002 Oct 29, 1987

CEPHALOGLYCIN
CAPSULE; ORAL
KAFOCIN
LILLY 250MG N050219 001

CEPHALOTHIN SODIUM
INJECTABLE; INJECTION
CEPHALOTHIN
INTL MEDICATION EQ 500MG BASE/VIAL A062426 001 May 03, 1985
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 62 (of 324)

CEPHALOTHIN SODIUM
INJECTABLE; INJECTION
CEPHALOTHIN
INTL MEDICATION EQ 1GM BASE/VIAL A062426 002 May 03, 1985
EQ 2GM BASE/VIAL A062426 003 May 03, 1985
EQ 4GM BASE/VIAL A062426 004 May 03, 1985
CEPHALOTHIN SODIUM
ABBOTT EQ 1GM BASE/VIAL A062547 001 Sep 11, 1985
EQ 1GM BASE/VIAL A062548 001 Sep 11, 1985
EQ 2GM BASE/VIAL A062547 002 Sep 11, 1985
EQ 2GM BASE/VIAL A062548 002 Sep 11, 1985
ABRAXIS PHARM EQ 1GM BASE/VIAL A062666 002 Jun 10, 1987
EQ 2GM BASE/VIAL A062666 001 Jun 10, 1987
BRISTOL EQ 1GM BASE/VIAL A062464 001 May 07, 1984
EQ 2GM BASE/VIAL A062464 002 May 07, 1984
EQ 4GM BASE/VIAL A062464 003 May 07, 1984
CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER
BAXTER HLTHCARE EQ 20MG BASE/ML A062422 003 Jan 31, 1984
EQ 20MG BASE/ML A062422 005 Jul 16, 1991
EQ 20MG BASE/ML A062730 001 Mar 05, 1987
EQ 40MG BASE/ML A062422 004 Jan 31, 1984
EQ 40MG BASE/ML A062422 006 Jul 16, 1991
EQ 40MG BASE/ML A062730 002 Mar 05, 1987
CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER
BAXTER HLTHCARE EQ 20MG BASE/ML A062422 001 Jan 31, 1984
EQ 40MG BASE/ML A062422 002 Jan 31, 1984
KEFLIN
LILLY EQ 1GM BASE/VIAL N050482 001
EQ 2GM BASE/VIAL N050482 002
EQ 4GM BASE/VIAL N050482 003
EQ 20GM BASE/VIAL N050482 007
KEFLIN IN PLASTIC CONTAINER
LILLY EQ 1GM BASE/VIAL A062549 001 Sep 10, 1985
EQ 2GM BASE/VIAL A062549 002 Sep 10, 1985
SEFFIN
GLAXOSMITHKLINE EQ 1GM BASE/VIAL A062435 001 Nov 15, 1983
EQ 2GM BASE/VIAL A062435 002 Nov 15, 1983
EQ 10GM BASE/VIAL A062435 003 Nov 15, 1983

CEPHAPIRIN SODIUM
INJECTABLE; INJECTION
CEFADYL
APOTHECON EQ 500MG BASE/VIAL A062961 001 Sep 20, 1988
EQ 500MG BASE/VIAL N050446 005
EQ 1GM BASE/VIAL A061769 001
EQ 1GM BASE/VIAL A062724 001 Dec 23, 1986
EQ 1GM BASE/VIAL A062961 002 Sep 20, 1988
EQ 1GM BASE/VIAL N050446 001
EQ 2GM BASE/VIAL A061769 002
EQ 2GM BASE/VIAL A062724 002 Dec 23, 1986
EQ 2GM BASE/VIAL A062961 003 Sep 20, 1988
EQ 2GM BASE/VIAL N050446 002
EQ 4GM BASE/VIAL A061769 003
EQ 4GM BASE/VIAL A062961 004 Sep 20, 1988
EQ 4GM BASE/VIAL N050446 003
EQ 20GM BASE/VIAL N050446 004
CEPHAPIRIN SODIUM
ABRAXIS PHARM EQ 500MG BASE/VIAL A062723 001 Nov 17, 1986
EQ 1GM BASE/VIAL A062723 002 Nov 17, 1986
EQ 2GM BASE/VIAL A062723 003 Nov 17, 1986
EQ 4GM BASE/VIAL A062723 004 Nov 17, 1986
EQ 20GM BASE/VIAL A062723 005 Nov 17, 1986
BAXTER HLTHCARE EQ 500MG BASE/VIAL A062720 001 Jul 02, 1987
EQ 1GM BASE/VIAL A062720 002 Jul 02, 1987
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 63 (of 324)

CEPHAPIRIN SODIUM
INJECTABLE; INJECTION
CEPHAPIRIN SODIUM
BAXTER HLTHCARE EQ 2GM BASE/VIAL A062720 003 Jul 02, 1987
EQ 20GM BASE/VIAL A062720 004 Jul 02, 1987

CEPHRADINE
CAPSULE; ORAL
ANSPOR
GLAXOSMITHKLINE 250MG A061859 001
500MG A061859 002
CEPHRADINE
BARR 250MG A062850 001 Apr 22, 1988
500MG A062851 001 Apr 22, 1988
IVAX SUB TEVA PHARMS 250MG A062762 001 Mar 06, 1987
500MG A062762 002 Mar 06, 1987
TEVA 250MG A062683 001 Jan 09, 1987
500MG A062683 002 Jan 09, 1987
VITARINE 250MG A062813 001 Feb 25, 1988
500MG A062813 002 Feb 25, 1988
VELOSEF
APOTHECON 250MG A061764 001
500MG A061764 002
VELOSEF '250'
ERSANA 250MG N050548 001
VELOSEF '500'
ERSANA 500MG N050548 002
FOR SUSPENSION; ORAL
ANSPOR
GLAXOSMITHKLINE 125MG/5ML A061866 001
250MG/5ML A061866 002
CEPHRADINE
BARR 125MG/5ML A062858 001 May 19, 1988
250MG/5ML A062859 001 May 19, 1988
TEVA 125MG/5ML A062693 001 Jan 09, 1987
250MG/5ML A062693 002 Jan 09, 1987
VELOSEF '125'
APOTHECON 125MG/5ML A061763 001
VELOSEF '250'
APOTHECON 250MG/5ML A061763 002
INJECTABLE; INJECTION
VELOSEF
APOTHECON 250MG/VIAL A061976 001
500MG/VIAL A061976 002
1GM/VIAL A061976 004
2GM/VIAL A061976 003
4GM/VIAL A061976 005
TABLET; ORAL
VELOSEF
BRISTOL MYERS SQUIBB 1GM N050530 001

CERIVASTATIN SODIUM
TABLET; ORAL
BAYCOL
BAYER PHARMS 0.05MG N020740 001 Jun 26, 1997
0.1MG N020740 002 Jun 26, 1997
0.2MG N020740 003 Jun 26, 1997
0.3MG N020740 004 Jun 26, 1997
0.4MG N020740 005 May 24, 1999
0.8MG N020740 006 Jul 24, 2000
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 64 (of 324)

CERULETIDE DIETHYLAMINE
INJECTABLE; INJECTION
TYMTRAN
PHARMACIA AND UPJOHN 0.02MG/ML N018296 001

CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL


FOR SUSPENSION; INTRATRACHEAL
EXOSURF NEONATAL
GLAXOSMITHKLINE 12MG/VIAL;108MG/VIAL;8MG/VIAL N020044 001 Aug 02, 1990

CHENODIOL
TABLET; ORAL
CHENIX
SIGMA TAU 250MG N018513 002 Jul 28, 1983

CHLOPHEDIANOL HYDROCHLORIDE
SYRUP; ORAL
ULO
3M 25MG/5ML N012126 001

CHLORAMPHENICOL
CAPSULE; ORAL
AMPHICOL
FERRANTE 100MG A060058 001
250MG A060058 002
CHLORAMPHENICOL
IVAX SUB TEVA PHARMS 250MG A062247 001
CHLOROMYCETIN
PARKEDALE 50MG A060591 001
100MG A060591 003
250MG A060591 002
MYCHEL
ARMENPHARM 250MG A060851 001
CREAM; TOPICAL
CHLOROMYCETIN
PARKE DAVIS 1% N050183 001
FOR SOLUTION; OPHTHALMIC
CHLOROMYCETIN
PARKEDALE 25MG/VIAL N050143 001
INJECTABLE; INJECTION
CHLOROMYCETIN
PARKE DAVIS 250MG/ML N050153 001
OINTMENT; OPHTHALMIC
CHLORAMPHENICOL
ALTANA 1% A060133 001
CHLOROFAIR
PHARMAFAIR 1% A062439 001 Apr 21, 1983
CHLOROMYCETIN
PARKEDALE 1% N050156 001
CHLOROPTIC S.O.P.
ALLERGAN 1% A061187 001
ECONOCHLOR
ALCON 1% A061648 001
SOLUTION/DROPS; OPHTHALMIC
CHLORAMPHENICOL
AKORN 0.5% A062042 001
ALCON 0.5% A062628 001 Sep 25, 1985
CHLOROFAIR
PHARMAFAIR 0.5% A062437 001 Apr 14, 1983
CHLOROPTIC
ALLERGAN 0.5% N050091 001
ECONOCHLOR
ALCON 0.5% A061645 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 65 (of 324)

CHLORAMPHENICOL
SOLUTION/DROPS; OPHTHALMIC
OPHTHOCHLOR
PARKEDALE 0.5% A061220 001
OPTOMYCIN
OPTOPICS 0.5% A062171 001 Mar 31, 1982
SOLUTION/DROPS; OTIC
CHLOROMYCETIN
PARKEDALE 0.5% N050205 001

CHLORAMPHENICOL PALMITATE
SUSPENSION; ORAL
CHLOROMYCETIN PALMITATE
PARKE DAVIS EQ 150MG BASE/5ML A062301 001
EQ 150MG BASE/5ML N050152 001

CHLORAMPHENICOL SODIUM SUCCINATE


INJECTABLE; INJECTION
CHLORAMPHENICOL
ELKINS SINN EQ 1GM BASE/VIAL A062406 001 Nov 09, 1982
CHLORAMPHENICOL SODIUM SUCCINATE
GRUPPO LEPETIT EQ 1GM BASE/VIAL A062278 001
CHLOROMYCETIN
PARKEDALE EQ 1GM BASE/VIAL N050155 001
MYCHEL-S
ANGUS EQ 1GM BASE/VIAL A060132 001

CHLORAMPHENICOL; DESOXYRIBONUCLEASE; FIBRINOLYSIN


OINTMENT; TOPICAL
ELASE-CHLOROMYCETIN
PARKE DAVIS 10MG/GM;666 UNITS/GM;1 UNITS/GM N050294 001

CHLORAMPHENICOL; HYDROCORTISONE ACETATE


FOR SUSPENSION; OPHTHALMIC
CHLOROMYCETIN HYDROCORTISONE
PARKEDALE 12.5MG/VIAL;25MG/VIAL N050202 001

CHLORAMPHENICOL; HYDROCORTISONE ACETATE; POLYMYXIN B SULFATE


OINTMENT; OPHTHALMIC
OPHTHOCORT
PARKEDALE 10MG/GM;5MG/GM;10,000 UNITS/GM N050201 002

CHLORAMPHENICOL; POLYMYXIN B SULFATE


OINTMENT; OPHTHALMIC
CHLOROMYXIN
PARKE DAVIS 1%;10,000 UNITS/GM N050203 002

CHLORAMPHENICOL; PREDNISOLONE
OINTMENT; OPHTHALMIC
CHLOROPTIC-P S.O.P.
ALLERGAN 1%;0.5% A061188 001

CHLORDIAZEPOXIDE
CAPSULE, EXTENDED RELEASE; ORAL
LIBRELEASE
VALEANT PHARM INTL 30MG N017813 001 Sep 12, 1983
TABLET; ORAL
LIBRITABS
VALEANT PHARM INTL 5MG A085482 001
10MG A085481 001
25MG A085488 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 66 (of 324)

CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE; ORAL
A-POXIDE
ABBOTT 5MG A085447 001
5MG A085517 001
10MG A085447 002
10MG A085518 001
25MG A085447 003
25MG A085513 001
CHLORDIAZACHEL
RACHELLE 5MG A085086 001
10MG A084639 001
25MG A085087 001
CHLORDIAZEPOXIDE HYDROCHLORIDE
ASCOT 5MG A087525 001 Jan 07, 1982
10MG A087524 001 Jan 07, 1982
25MG A087512 001 Jan 07, 1982
FERRANTE 5MG A085118 001
10MG A085119 001
25MG A085120 001
HALSEY 5MG A085340 001
10MG A085339 001
25MG A084685 001
IMPAX LABS 5MG A086213 001
10MG A085113 001
25MG A086212 001
IVAX SUB TEVA PHARMS 5MG A083741 001
10MG A083742 001
25MG A083570 001
LEDERLE 5MG A086892 001
5MG A087234 001
10MG A086876 001
10MG A087037 001
25MG A086893 001
25MG A087231 001
MAST MM 10MG A086217 001
MYLAN 5MG A084886 001
10MG A084601 001
25MG A084887 001
PARKE DAVIS 5MG A085163 001
10MG A084598 001
25MG A085164 001
PIONEER PHARMS 10MG A089533 001 Jul 15, 1988
25MG A089558 001 Jul 15, 1988
PUREPAC PHARM 5MG A085155 001
10MG A084939 002
25MG A085144 001
ROXANE 5MG A084706 001
10MG A084700 001
25MG A084705 001
SANDOZ 5MG A084678 001
5MG A084919 001
10MG A084041 001
10MG A084920 001
25MG A084679 002
25MG A084823 001
SUPERPHARM 5MG A088987 001 Apr 25, 1985
10MG A088986 001 Apr 25, 1985
25MG A088988 001 Apr 25, 1985
TEVA 5MG A088705 001 Jan 18, 1985
10MG A088706 001 Jan 18, 1985
25MG A086494 001
25MG A088707 001 Jan 18, 1985
USL PHARMA 5MG A084644 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 67 (of 324)

CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE; ORAL
CHLORDIAZEPOXIDE HYDROCHLORIDE
USL PHARMA 25MG A084645 001
VANGARD 5MG A088129 001 Mar 28, 1983
10MG A088010 001 Mar 28, 1983
25MG A088130 001 Mar 28, 1983
WEST WARD 5MG A085014 001
10MG A085000 001
25MG A085294 001
LIBRIUM
VALEANT PHARM INTL 5MG N012249 002
10MG N012249 001
25MG N012249 003
LYGEN
ALRA 5MG A085107 001
10MG A085009 001
25MG A085108 001
INJECTABLE; INJECTION
LIBRIUM
VALEANT PHARM INTL 100MG/AMP N012301 001

CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED


TABLET; ORAL
MENRIUM 10-4
ROCHE 10MG;0.4MG N014740 006
MENRIUM 5-2
ROCHE 5MG;0.2MG N014740 002
MENRIUM 5-4
ROCHE 5MG;0.4MG N014740 004

CHLORHEXIDINE GLUCONATE
SOLUTION; TOPICAL
EXIDINE
XTTRIUM 2.5% N019421 001 Dec 17, 1985
MICRODERM
J AND J 4% A072255 001 Apr 15, 1991
PREVACARE R
J AND J 0.5% A072292 001 Jan 28, 1992
STERI-STAT
MATRIX MEDCL 4% A070104 001 Jul 24, 1986
SPONGE; TOPICAL
CHLORHEXIDINE GLUCONATE
KENDALL IL 4% N019490 001 Mar 27, 1987
E-Z SCRUB
BECTON DICKINSON 4% A073416 001 Mar 14, 2000
HIBICLENS
MOLNLYCKE HLTH 4% N018423 001
MICRODERM
J AND J 4% A072295 001 Feb 28, 1991

CHLORMERODRIN, HG-197
INJECTABLE; INJECTION
CHLORMERODRIN HG 197
BRACCO 0.6-1.4mCi/ML N017269 001

CHLORMEZANONE
TABLET; ORAL
TRANCOPAL
SANOFI AVENTIS US 100MG N011467 003
200MG N011467 005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 68 (of 324)

CHLOROPROCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
NESACAINE-MPF
APP PHARMS 2% N009435 003
3% N009435 004

CHLOROQUINE HYDROCHLORIDE
INJECTABLE; INJECTION
ARALEN HYDROCHLORIDE
SANOFI AVENTIS US EQ 40MG BASE/ML N006002 002

CHLOROQUINE PHOSPHATE
TABLET; ORAL
CHLOROQUINE PHOSPHATE
MD PHARM EQ 150MG BASE A087228 001
PUREPAC PHARM EQ 150MG BASE A080886 001
TEVA EQ 150MG BASE A087504 001 Jan 13, 1982
WATSON LABS EQ 150MG BASE A087979 001 Dec 21, 1982
EQ 300MG BASE A088030 001 Dec 21, 1982

CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE


TABLET; ORAL
ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE
SANOFI AVENTIS US EQ 300MG BASE;EQ 45MG BASE N014860 002

CHLOROTHIAZIDE
TABLET; ORAL
CHLOROTHIAZIDE
ABC HOLDING 250MG A085569 001
LEDERLE 250MG A086940 001
500MG A086938 001
SANDOZ 250MG A085485 001
WATSON LABS 250MG A085165 001
250MG A085173 001
250MG A086795 001 Aug 15, 1983
500MG A084026 001 Sep 01, 1982
500MG A086796 001 Aug 15, 1983
DIURIL
LUNDBECK INC 250MG N011145 004
500MG N011145 002

CHLOROTHIAZIDE; METHYLDOPA
TABLET; ORAL
ALDOCLOR-150
MERCK 150MG;250MG N016016 001
ALDOCLOR-250
MERCK 250MG;250MG N016016 002
METHYLDOPA AND CHLOROTHIAZIDE
PAR PHARM 150MG;250MG A070783 001 Nov 06, 1987
250MG;250MG A070654 001 Nov 06, 1987

CHLOROTHIAZIDE; RESERPINE
TABLET; ORAL
CHLOROTHIAZIDE AND RESERPINE
WEST WARD 250MG;0.125MG A088557 001 Dec 22, 1983
500MG;0.125MG A088365 001 Dec 22, 1983
CHLOROTHIAZIDE W/ RESERPINE
WATSON LABS 250MG;0.125MG A084853 001
500MG;0.125MG A088151 001 Jun 09, 1983
CHLOROTHIAZIDE-RESERPINE
MYLAN 250MG;0.125MG A087744 001 May 06, 1982
500MG;0.125MG A087745 001 May 06, 1982
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 69 (of 324)

CHLOROTHIAZIDE; RESERPINE
TABLET; ORAL
DIUPRES-250
MERCK 250MG;0.125MG N011635 003 Aug 26, 1987
DIUPRES-500
MERCK 500MG;0.125MG N011635 006 Aug 26, 1987

CHLOROTRIANISENE
CAPSULE; ORAL
CHLOROTRIANISENE
BANNER PHARMACAPS 12MG A084652 001
TACE
SANOFI AVENTIS US 12MG N008102 004
25MG N011444 001
72MG N016235 001

CHLOROXINE
SHAMPOO; TOPICAL
CAPITROL
WESTWOOD SQUIBB 2% N017594 001

CHLORPHENESIN CARBAMATE
TABLET; ORAL
MAOLATE
PHARMACIA AND UPJOHN 400MG N014217 002

CHLORPHENIRAMINE MALEATE
CAPSULE, EXTENDED RELEASE; ORAL
CHLORPHENIRAMINE MALEATE
SANDOZ 12MG A070797 001 Aug 12, 1988
TELDRIN
GLAXOSMITHKLINE 8MG N017369 001
12MG N017369 002
INJECTABLE; INJECTION
CHLORPHENIRAMINE MALEATE
BEL MAR 10MG/ML A080821 001
ELKINS SINN 10MG/ML A080797 001
WATSON LABS 10MG/ML A083593 001
10MG/ML A086096 001
100MG/ML A086095 001
CHLOR-TRIMETON
SCHERING PLOUGH 10MG/ML N008826 001
100MG/ML N008794 001
PYRIDAMAL 100
BEL MAR 100MG/ML A083733 001
SYRUP; ORAL
CHLORPHENIRAMINE MALEATE
PHARM ASSOC 2MG/5ML A087520 001 Feb 10, 1982
CHLOR-TRIMETON
SCHERING 2MG/5ML N006921 006
TABLET; ORAL
ANTAGONATE
BAYER PHARMS 4MG A083381 001
CHLORPHENIRAMINE MALEATE
ANABOLIC 4MG A083078 001
BELL PHARMA 4MG A083062 001
ELKINS SINN 4MG A080938 001
IMPAX LABS 4MG A080809 001
IVAX SUB TEVA PHARMS 4MG A080779 001
KV PHARM 4MG A087164 001
LEDERLE 4MG A086941 001
MUTUAL PHARM 4MG A080700 001
NEWTRON PHARMS 4MG A086519 001
PANRAY 4MG A083243 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 70 (of 324)

CHLORPHENIRAMINE MALEATE
TABLET; ORAL
CHLORPHENIRAMINE MALEATE
PHARMAVITE 4MG A085104 001
PHARMERAL 4MG A083753 001
PIONEER PHARMS 4MG A088556 001 Jul 13, 1984
PUREPAC PHARM 4MG A086306 001
PVT FORM 4MG A080786 001
ROXANE 4MG A080626 001
SANDOZ 4MG A080961 001
VITARINE 4MG A085837 001
WATSON LABS 4MG A080696 001
4MG A080791 001
4MG A085139 001
WEST WARD 4MG A083787 001
CHLOR-TRIMETON
SCHERING 4MG N006921 002
KLOROMIN
HALSEY 4MG A083629 001
PHENETRON
LANNETT 4MG A080846 001
TABLET, EXTENDED RELEASE; ORAL
CHLOR-TRIMETON
SCHERING PLOUGH 8MG N007638 001
EFIDAC 24 CHLORPHENIRAMINE MALEATE
ALZA 16MG N019746 002 Nov 18, 1994

CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE


CAPSULE, EXTENDED RELEASE; ORAL
CHLOROHENIRAMINE MALEATE AND PHENYLPROPANOLAMINE HYDROCHLORIDE
WATSON LABS 12MG;75MG A088681 001 Sep 29, 1987
CHLORPHENIRAMINE MALEATE AND PHENYLPROPANOLAMINE HYDROCHLORIDE
SANDOZ 12MG;75MG A088940 001 Jan 26, 1989
COLD CAPSULE IV
GRAHAM DM 12MG;75MG N018793 001 Apr 25, 1985
COLD CAPSULE V
GRAHAM DM 8MG;75MG N018794 001 Apr 23, 1985
CONTAC 12 HOUR
GLAXOSMITHKLINE 8MG;75MG N018099 001
DRIZE
ASCHER 12MG;75MG A088359 001 Feb 13, 1986
ORNADE
GLAXOSMITHKLINE 12MG;75MG N012152 004
PHENYLPROPANOLAMINE HYDROCHLORIDE W/ CHLORPHENIRAMINE MALEATE
CENT PHARMS 8MG;75MG N018809 001 May 07, 1984
TABLET, EXTENDED RELEASE; ORAL
CONTAC
NOVARTIS 12MG;75MG N019613 001 Jun 13, 1986
DEMAZIN
SCHERING PLOUGH 4MG;25MG N018556 001 May 14, 1984
TRIAMINIC-12
NOVARTIS 12MG;75MG N018115 001

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE


CAPSULE, EXTENDED RELEASE; ORAL
CODIMAL-L.A. 12
SCHWARZ PHARMA 12MG;120MG N018935 001 Apr 15, 1985
ISOCLOR
FISONS 8MG;120MG N018747 001 Mar 06, 1986
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
CENT PHARMS 8MG;120MG N019428 001 Aug 02, 1988
GRAHAM DM 8MG;120MG N018844 001 Mar 20, 1985
12MG;120MG N018843 001 Mar 18, 1985
KV PHARM 12MG;120MG A071455 001 Mar 01, 1989
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 71 (of 324)

CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX


SUSPENSION, EXTENDED RELEASE; ORAL
CODEPREX
UCB INC EQ 4MG MALEATE/5ML;EQ 20MG BASE/5ML N021369 001 Jun 21, 2004
PENNTUSS
FISONS EQ 4MG MALEATE/5ML;EQ 10MG BASE/5ML N018928 001 Aug 14, 1985

CHLORPHENIRAMINE POLISTIREX; PHENYLPROPANOLAMINE POLISTIREX


SUSPENSION, EXTENDED RELEASE; ORAL
CORSYM
UCB INC EQ 4MG MALEATE/5ML;EQ 37.5MG HCL/5ML N018050 001 Jan 04, 1984

CHLORPHENTERMINE HYDROCHLORIDE
TABLET; ORAL
PRE-SATE
PARKE DAVIS EQ 65MG BASE N014696 001

CHLORPROMAZINE
SUPPOSITORY; RECTAL
THORAZINE
GLAXOSMITHKLINE 25MG N009149 024
100MG N009149 033

CHLORPROMAZINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
THORAZINE
GLAXOSMITHKLINE 30MG N011120 016
75MG N011120 017
150MG N011120 018
200MG N011120 019
300MG N011120 020
CONCENTRATE; ORAL
CHLORPROMAZINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC 100MG/ML A086863 001
MORTON GROVE 30MG/ML A087032 001 Jul 08, 1982
100MG/ML A087053 001
PHARM ASSOC 30MG/ML A040231 001 Dec 30, 1999
100MG/ML A040224 001 Jan 26, 1999
CHLORPROMAZINE HYDROCHLORIDE INTENSOL
ROXANE 30MG/ML A088157 001 Apr 27, 1983
100MG/ML A088158 001 Apr 27, 1983
SONAZINE
SANDOZ 30MG/ML A080983 004
100MG/ML A080983 005
THORAZINE
GLAXOSMITHKLINE 30MG/ML N009149 032
100MG/ML N009149 043
INJECTABLE; INJECTION
CHLORPROMAZINE HYDROCHLORIDE
ABRAXIS PHARM 25MG/ML A084911 001
MARSAM PHARMS LLC 25MG/ML A089563 001 Apr 15, 1988
WATSON LABS 25MG/ML A080365 001
25MG/ML A085591 001
WYETH AYERST 25MG/ML A080370 001
THORAZINE
GLAXOSMITHKLINE 25MG/ML N009149 011
SYRUP; ORAL
CHLORPROMAZINE HYDROCHLORIDE
ALPHARMA US PHARMS 10MG/5ML A086712 001
SONAZINE
SANDOZ 10MG/5ML A083040 001
THORAZINE
GLAXOSMITHKLINE 10MG/5ML N009149 022
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 72 (of 324)

CHLORPROMAZINE HYDROCHLORIDE
TABLET; ORAL
CHLORPROMAZINE HYDROCHLORIDE
ABBOTT 10MG A084414 001
25MG A084415 001
50MG A084411 001
100MG A084412 001
200MG A084413 001
IVAX SUB TEVA PHARMS 10MG A083549 001
25MG A083549 002
50MG A083549 003
100MG A083574 001
200MG A083575 001
KV PHARM 10MG A085750 002 Jan 04, 1982
25MG A085751 001
50MG A085484 001
100MG A085752 001
200MG A085748 002 Jan 04, 1982
LEDERLE 10MG A084803 001
25MG A084801 001
50MG A084800 001
100MG A084789 001
200MG A084802 001
PUREPAC PHARM 10MG A080403 004
25MG A080403 001
50MG A080403 002
100MG A080403 003
200MG A080403 005
PVT FORM 25MG A080340 001
50MG A080340 002
200MG A080340 003
ROXANE 10MG A085331 001
25MG A085331 002
50MG A085331 003
100MG A085331 004
200MG A085331 005
VANGARD 10MG A088038 001 Aug 16, 1982
25MG A087645 001
50MG A087646 001
WATSON LABS 10MG A085959 001
25MG A085956 001
50MG A085960 001
100MG A085957 001
200MG A085958 001
WEST WARD 10MG A087783 001 Sep 16, 1982
25MG A087865 001 Sep 16, 1982
50MG A087878 001 Sep 15, 1982
100MG A087884 001 Sep 15, 1982
200MG A087880 001 Sep 16, 1982
PROMAPAR
PARKE DAVIS 10MG A086886 001
25MG A084423 001
50MG A086887 001
100MG A086888 001
200MG A086885 001
THORAZINE
GLAXOSMITHKLINE 10MG N009149 002
25MG N009149 007
50MG N009149 013
100MG N009149 018
200MG N009149 020
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 73 (of 324)

CHLORPROPAMIDE
TABLET; ORAL
CHLORPROPAMIDE
BARR 100MG A088812 001 Oct 19, 1984
100MG A089446 001 Nov 17, 1986
250MG A088813 001 Oct 19, 1984
250MG A089447 001 Nov 17, 1986
CLONMEL HLTHCARE 100MG A089561 001 Sep 04, 1987
250MG A089562 001 Sep 04, 1987
DURAMED PHARMS BARR 100MG A088918 001 Oct 16, 1984
250MG A088919 001 Oct 16, 1984
HALSEY 100MG A089321 001 Jan 16, 1986
250MG A088662 001 Jan 09, 1986
IVAX PHARMS 100MG A088840 001 Oct 25, 1984
250MG A087353 001
PAR PHARM 100MG A088175 001 Feb 27, 1984
250MG A088176 001 Feb 27, 1984
SANDOZ 100MG A088725 001 Aug 31, 1984
250MG A084669 001
250MG A088726 001 Aug 31, 1984
SUPERPHARM 100MG A088694 001 Sep 17, 1984
250MG A088695 001 Sep 17, 1984
TEVA 100MG A088768 001 Oct 11, 1984
USL PHARMA 100MG A088708 001 Aug 30, 1984
250MG A088709 001 Aug 30, 1984
WATSON LABS 100MG A086865 001 Sep 24, 1984
100MG A088608 001 Apr 12, 1984
250MG A086866 001
250MG A088568 001 Apr 12, 1984
GLUCAMIDE
TEVA 250MG A088641 001 Oct 11, 1984

CHLORPROTHIXENE
CONCENTRATE; ORAL
TARACTAN
ROCHE 100MG/5ML N016149 002
INJECTABLE; INJECTION
TARACTAN
ROCHE 12.5MG/ML N012487 001
TABLET; ORAL
TARACTAN
ROCHE 10MG N012486 005
25MG N012486 004
50MG N012486 003
100MG N012486 001

CHLORTETRACYCLINE HYDROCHLORIDE
OINTMENT; OPHTHALMIC
AUREOMYCIN
LEDERLE 1% N050404 001

CHLORTHALIDONE
TABLET; ORAL
CHLORTHALIDONE
ABBOTT 25MG A087364 001
50MG A087384 001
ASCOT 25MG A087698 001 Oct 20, 1982
50MG A087699 001 Oct 20, 1982
CLONMEL HLTHCARE 25MG A087451 001
50MG A087450 001
IVAX PHARMS 25MG A087555 001
25MG A088164 001 Jan 09, 1984
50MG A087176 001
50MG A087947 001 Feb 27, 1984
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 74 (of 324)

CHLORTHALIDONE
TABLET; ORAL
CHLORTHALIDONE
KV PHARM 25MG A087311 001
50MG A087312 001
MUTUAL PHARM 25MG A087292 001
25MG A089285 001 Jul 21, 1986
25MG A089738 001 Sep 19, 1988
50MG A087293 001
50MG A089286 001 Jul 21, 1986
50MG A089739 001 Sep 19, 1988
PIONEER PHARMS 50MG A089591 001 Jul 21, 1988
PUREPAC PHARM 25MG A088139 001 Jul 16, 1986
50MG A088140 001 Aug 11, 1983
SANDOZ 25MG A087380 001
50MG A087118 001
50MG A087381 001
SUPERPHARM 25MG A087473 001 Feb 09, 1983
50MG A087247 001 Feb 09, 1983
TEVA 50MG A088651 001 May 30, 1985
USL PHARMA 25MG A089051 001 Jun 01, 1987
50MG A089052 001 Jun 01, 1987
VANGARD 25MG A088012 001 Jul 14, 1982
50MG A088073 001 Mar 25, 1983
WARNER CHILCOTT 25MG A087515 001 Jan 24, 1983
50MG A087516 001 Feb 09, 1983
WATSON LABS 25MG A087050 001
25MG A087100 001
25MG A087296 001
25MG A087706 001
50MG A087029 001
50MG A087082 001
50MG A087521 001
50MG A087689 001
HYGROTON
SANOFI AVENTIS US 25MG N012283 004
50MG N012283 003
THALITONE
MONARCH PHARMS 25MG A088051 001 Nov 12, 1982
25MG N019574 002 Feb 12, 1992

CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE


TABLET; ORAL
CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
PAR PHARM 15MG;0.1MG A071179 001 Dec 16, 1987
15MG;0.2MG A071178 001 Dec 16, 1987
15MG;0.3MG A071142 001 Dec 16, 1987
COMBIPRES
BOEHRINGER INGELHEIM 15MG;0.1MG N017503 001
15MG;0.2MG N017503 002
15MG;0.3MG N017503 003 Apr 10, 1984

CHLORTHALIDONE; METOPROLOL TARTRATE


CAPSULE; ORAL
LOPRESSIDONE
NOVARTIS 25MG;100MG N019451 001 Dec 31, 1987
25MG;200MG N019451 002 Dec 31, 1987

CHLORTHALIDONE; RESERPINE
TABLET; ORAL
DEMI-REGROTON
SANOFI AVENTIS US 25MG;0.125MG N015103 002
REGROTON
SANOFI AVENTIS US 50MG;0.25MG N015103 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 75 (of 324)

CHLORZOXAZONE
TABLET; ORAL
CHLORZOXAZONE
MUTUAL PHARM 500MG A089970 001 Sep 27, 1990
PAR PHARM 250MG A087981 001 Sep 20, 1983
PIONEER PHARMS 250MG A089592 001 Jan 06, 1989
500MG A089948 001 Jan 06, 1989
SANDOZ 250MG A089852 001 May 04, 1988
500MG A089853 001 May 04, 1988
WATSON LABS 250MG A086901 001
250MG A086948 001 Aug 09, 1982
500MG A081019 001 Jul 29, 1991
PARAFLEX
ORTHO MCNEIL PHARM 250MG N011300 003
STRIFON FORTE DSC
FERNDALE LABS 500MG A081008 001 Dec 23, 1988

CHOLESTYRAMINE
BAR, CHEWABLE; ORAL
CHOLYBAR
PARKE DAVIS EQ 4GM RESIN/BAR A071621 001 May 26, 1988
EQ 4GM RESIN/BAR A071739 001 May 26, 1988
POWDER; ORAL
CHOLESTYRAMINE
IVAX SUB TEVA PHARMS EQ 4GM RESIN/PACKET A074771 001 Jul 09, 1997
EQ 4GM RESIN/SCOOPFUL A074771 002 Jul 09, 1997
TEVA EQ 4GM RESIN/PACKET A074347 001 May 28, 1998
EQ 4GM RESIN/SCOOPFUL A074347 002 May 28, 1998
TEVA PHARMS EQ 4GM RESIN/PACKET A074554 001 Oct 02, 1996
EQ 4GM RESIN/SCOOPFUL A074554 002 Oct 02, 1996
CHOLESTYRAMINE LIGHT
TEVA EQ 4GM RESIN/PACKET A074348 001 May 28, 1998
EQ 4GM RESIN/SCOOPFUL A074348 002 May 28, 1998
TEVA PHARMS EQ 4GM RESIN/PACKET A074555 001 Sep 30, 1998
EQ 4GM RESIN/SCOOPFUL A074555 002 Sep 30, 1998
TABLET; ORAL
QUESTRAN
APOTHECON EQ 800MG RESIN A073403 002 Dec 27, 1999
EQ 1GM RESIN A073403 001 Apr 28, 1994

CHORIOGONADOTROPIN ALFA
INJECTABLE; INJECTION
OVIDREL
EMD SERONO 0.25MG/VIAL N021149 001 Sep 20, 2000

CHROMIC CHLORIDE
INJECTABLE; INJECTION
CHROMIC CHLORIDE
ABRAXIS PHARM EQ 0.004MG CHROMIUM/ML N019271 001 May 05, 1987

CHROMIC PHOSPHATE P-32


INJECTABLE; INJECTION
PHOSPHOCOL P32
MALLINCKRODT 5mCi/ML N017084 001

CHYMOPAPAIN
INJECTABLE; INJECTION
CHYMODIACTIN
CHART MEDCL 4,000 UNITS/VIAL N018663 002 Aug 21, 1984
10,000 UNITS/VIAL N018663 001 Nov 10, 1982
DISCASE
ABBOTT 12,500 UNITS/VIAL N018625 001 Jan 18, 1984
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 76 (of 324)

CHYMOTRYPSIN
FOR SOLUTION; OPHTHALMIC
ALPHA CHYMAR
SOLA BARNES HIND 750 UNITS/VIAL N011837 001
CATARASE
CIBA 300 UNITS/VIAL N016938 001
NOVARTIS 150 UNITS/VIAL N018121 001
ZOLYSE
ALCON 750 UNITS/VIAL N011903 001

CILASTATIN SODIUM; IMIPENEM


INJECTABLE; INJECTION
PRIMAXIN
MERCK EQ 750MG BASE/VIAL;750MG/VIAL N050630 002 Dec 14, 1990

CILOSTAZOL
TABLET; ORAL
CILOSTAZOL
MUTUAL PHARM 50MG A077208 002 Mar 29, 2006
100MG A077208 001 Mar 29, 2006

CIMETIDINE
SUSPENSION; ORAL
TAGAMET HB 200
GLAXOSMITHKLINE 200MG/20ML N020951 001 Jul 09, 1999
TABLET; ORAL
CIMETIDINE
APOTEX 100MG A074948 001 Jun 19, 1998
200MG A074948 002 Jul 26, 2002
ENDO PHARMS 200MG A074281 001 May 17, 1994
300MG A074281 002 May 17, 1994
400MG A074281 003 May 17, 1994
800MG A074329 001 May 17, 1994
IVAX SUB TEVA PHARMS 200MG A074401 001 May 30, 1995
300MG A074401 002 May 30, 1995
400MG A074401 003 May 30, 1995
800MG A074402 001 May 30, 1995
LEK PHARMS 100MG A075122 001 Jun 19, 1998
200MG A074250 001 Jun 29, 1995
200MG A075122 002 Jun 19, 1998
300MG A074250 002 Jun 29, 1995
400MG A074250 003 Jun 29, 1995
800MG A074250 004 Jun 29, 1995
PERRIGO 100MG A074972 001 Jun 19, 1998
ROXANE 300MG A074361 001 Dec 23, 1994
400MG A074361 002 Dec 23, 1994
800MG A074371 001 Dec 23, 1994
SANDOZ 200MG A074100 001 Jan 31, 1995
300MG A074100 002 Jan 31, 1995
400MG A074100 003 Jan 31, 1995
800MG A074100 004 Jan 31, 1995
TEVA 200MG A074365 001 Feb 28, 1995
300MG A074365 002 Feb 28, 1995
400MG A074365 003 Feb 28, 1995
800MG A074365 004 Feb 28, 1995
TAGAMET HB
GLAXOSMITHKLINE 100MG N020238 001 Jun 19, 1995

CIMETIDINE HYDROCHLORIDE
INJECTABLE; INJECTION
CIMETIDINE HYDROCHLORIDE
ENDO PHARMS EQ 300MG BASE/2ML A074005 001 Aug 31, 1994
HOSPIRA EQ 300MG BASE/2ML A074296 001 Mar 28, 1997
EQ 300MG BASE/2ML A074412 001 Mar 28, 1997
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 77 (of 324)

CIMETIDINE HYDROCHLORIDE
INJECTABLE; INJECTION
CIMETIDINE HYDROCHLORIDE
HOSPIRA EQ 300MG BASE/2ML A074422 001 Jan 31, 1995
LUITPOLD EQ 300MG BASE/2ML A074353 001 Dec 20, 1994
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA EQ 90MG BASE/100ML A074468 005 Dec 29, 1994
EQ 120MG BASE/100ML A074468 006 Dec 29, 1994
EQ 180MG BASE/100ML A074468 003 Dec 29, 1994
EQ 240MG BASE/100ML A074468 004 Dec 29, 1994
EQ 360MG BASE/100ML A074468 001 Dec 29, 1994
EQ 480MG BASE/100ML A074468 002 Dec 29, 1994
TAGAMET
GLAXOSMITHKLINE EQ 300MG BASE/2ML N017939 002
TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
GLAXOSMITHKLINE EQ 6MG BASE/ML N019434 001 Oct 31, 1985
SOLUTION; ORAL
CIMETIDINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC EQ 300MG BASE/5ML A074176 001 Jun 01, 1994
DURAMED PHARMS BARR EQ 300MG BASE/5ML A075110 001 Jun 18, 1998
ENDO PHARMS EQ 300MG BASE/5ML A074251 001 Dec 22, 1994
ROXANE EQ 300MG BASE/5ML A074541 001 Aug 05, 1997
TEVA PHARMS EQ 300MG BASE/5ML A074859 001 Jul 09, 1998
TAGAMET
GLAXOSMITHKLINE EQ 300MG BASE/5ML N017924 001

CINOXACIN
CAPSULE; ORAL
CINOBAC
LILLY 250MG N018067 001
500MG N018067 002
CINOXACIN
TEVA 250MG A073005 001 Feb 28, 1992
500MG A073006 001 Feb 28, 1992

CIPROFLOXACIN
INJECTABLE; INJECTION
CIPRO
BAYER HLTHCARE 1200MG/120ML (10MG/ML) N019847 003 Dec 26, 1990
CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAYER PHARMS 200MG/100ML N019858 001 Dec 26, 1990
CIPROFLOXACIN
APP PHARMS 200MG/20ML (10MG/ML) A076484 001 Aug 28, 2006
400MG/40ML (10MG/ML) A076484 002 Aug 28, 2006
BEDFORD LABS 200MG/20ML (10MG/ML) A076992 001 Aug 28, 2006
400MG/40ML (10MG/ML) A076992 002 Aug 28, 2006
1200MG/120ML (10MG/ML) A076993 001 Aug 28, 2006
CIPROFLOXACIN IN DEXTROSE 5%
HIKMA FARMACEUTICA 200MG/100ML A076757 001 Apr 21, 2008
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
BEDFORD 200MG/100ML A078114 001 Mar 18, 2008
400MG/200ML A078114 002 Mar 18, 2008

CIPROFLOXACIN HYDROCHLORIDE
TABLET; ORAL
CIPROFLOXACIN HYDROCHLORIDE
BARR EQ 250MG BASE A074124 001 Jun 09, 2004
EQ 500MG BASE A074124 002 Jun 09, 2004
EQ 750MG BASE A074124 003 Jun 09, 2004
NOSTRUM LABS EQ 250MG BASE A076138 001 Jun 09, 2004
EQ 500MG BASE A076138 002 Jun 09, 2004
EQ 750MG BASE A076138 003 Jun 09, 2004
SANDOZ EQ 100MG BASE A075939 001 Mar 03, 2005
EQ 250MG BASE A075939 002 Jun 09, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 78 (of 324)

CIPROFLOXACIN HYDROCHLORIDE
TABLET; ORAL
CIPROFLOXACIN HYDROCHLORIDE
SANDOZ EQ 250MG BASE A076593 002 Jun 09, 2004
EQ 500MG BASE A075939 003 Jun 09, 2004
EQ 500MG BASE A076593 003 Jun 09, 2004
EQ 750MG BASE A075939 004 Jun 09, 2004
EQ 750MG BASE A076593 004 Jun 09, 2004
TEVA EQ 250MG BASE A076136 001 Jun 09, 2004
EQ 500MG BASE A076136 002 Jun 09, 2004
EQ 750MG BASE A076136 003 Jun 09, 2004

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE


TABLET, EXTENDED RELEASE; ORAL
CIPROFLOXACIN EXTENDED RELEASE
ANCHEN PHARMS 212.6MG;EQ 287.5MG BASE A078166 002 Nov 27, 2007
425.2MG;EQ 574.9MG BASE A078166 001 Nov 27, 2007
SANDOZ 212.6MG;EQ 287.5MG BASE A078712 001 Dec 11, 2007

CISAPRIDE MONOHYDRATE
SUSPENSION; ORAL
PROPULSID
ORTHO MCNEIL JANSSEN EQ 1MG BASE/ML N020398 001 Sep 15, 1995
TABLET; ORAL
PROPULSID
ORTHO MCNEIL JANSSEN EQ 10MG BASE N020210 001 Jul 29, 1993
EQ 20MG BASE N020210 002 Dec 23, 1993
TABLET, ORALLY DISINTEGRATING; ORAL
PROPULSID QUICKSOLV
JANSSEN PHARMA EQ 20MG BASE N020767 001 Nov 07, 1997

CISPLATIN
INJECTABLE; INJECTION
CISPLATIN
BEDFORD 10MG/VIAL A074713 001 Nov 14, 2000
50MG/VIAL A074713 002 Nov 14, 2000
PLATINOL-AQ
BRISTOL MYERS 0.5MG/ML N018057 003 Jul 18, 1984

CITALOPRAM HYDROBROMIDE
SOLUTION; ORAL
CITALOPRAM HYDROBROMIDE
APOTEX INC EQ 10MG BASE/5ML A077601 001 Nov 15, 2005
TABLET; ORAL
CELEXA
FOREST LABS EQ 60MG BASE N020822 004 Jul 17, 1998
CITALOPRAM HYDROBROMIDE
ACTAVIS ELIZABETH EQ 10MG BASE A077033 001 Oct 28, 2004
EQ 20MG BASE A077033 002 Oct 28, 2004
EQ 40MG BASE A077033 003 Oct 28, 2004
AMNEAL PHARMS EQ 10MG BASE A077045 003 Apr 29, 2005
EQ 20MG BASE A077045 002 Apr 29, 2005
EQ 40MG BASE A077045 001 Apr 29, 2005
MUTUAL PHARM EQ 10MG BASE A077052 001 Jul 03, 2006
EQ 20MG BASE A077052 002 Jul 03, 2006
EQ 40MG BASE A077052 003 Jul 03, 2006
ROXANE EQ 10MG BASE A077041 001 Nov 23, 2004
EQ 20MG BASE A077041 002 Nov 23, 2004
EQ 40MG BASE A077041 003 Nov 23, 2004
SANDOZ EQ 10MG BASE A077040 001 Aug 17, 2005
EQ 20MG BASE A077040 002 Aug 17, 2005
EQ 40MG BASE A077040 003 Aug 17, 2005
TARO EQ 10MG BASE A077278 001 Mar 22, 2006
EQ 20MG BASE A077278 002 Mar 22, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 79 (of 324)

CITALOPRAM HYDROBROMIDE
TABLET; ORAL
CITALOPRAM HYDROBROMIDE
TARO EQ 40MG BASE A077278 003 Mar 22, 2006
TEVA PHARMS EQ 10MG BASE A077213 001 Mar 31, 2006
EQ 20MG BASE A077213 002 Mar 31, 2006
EQ 40MG BASE A077213 003 Mar 31, 2006
TABLET, ORALLY DISINTEGRATING; ORAL
CITALOPRAM HYDROBROMIDE
BIOVAIL LABS INTL EQ 10MG BASE N021763 001 Dec 20, 2005
EQ 20MG BASE N021763 002 Dec 20, 2005
EQ 40MG BASE N021763 003 Dec 20, 2005

CITRIC ACID; MAGNESIUM OXIDE; SODIUM CARBONATE


SOLUTION; IRRIGATION
IRRIGATING SOLUTION G IN PLASTIC CONTAINER
BAXTER HLTHCARE 3.24GM/100ML;380MG/100ML;430MG/100ML N018519 001 Jun 22, 1982
UROLOGIC G IN PLASTIC CONTAINER
HOSPIRA 3.24GM/100ML;380MG/100ML;430MG/100ML N018904 001 May 27, 1983

CLARITHROMYCIN
FOR SUSPENSION; ORAL
BIAXIN
ABBOTT 187MG/5ML N050698 003 Sep 30, 1998
TABLET, EXTENDED RELEASE; ORAL
CLARITHROMYCIN
RANBAXY 1GM A065210 001 Jan 26, 2005

CLEMASTINE FUMARATE
SYRUP; ORAL
CLEMASTINE FUMARATE
TEVA PHARMS EQ 0.5MG BASE/5ML A073095 001 Apr 21, 1992
TAVIST
NOVARTIS EQ 0.5MG BASE/5ML N018675 001 Jun 28, 1985
TABLET; ORAL
CLEMASTINE FUMARATE
TEVA 1.34MG A073282 001 Jan 31, 1992
1.34MG A073282 002 Dec 03, 1992
TAVIST
NOVARTIS 2.68MG N017661 001
TAVIST-1
NOVARTIS 1.34MG N017661 002
1.34MG N017661 003 Aug 21, 1992

CLEMASTINE FUMARATE; PHENYLPROPANOLAMINE HYDROCHLORIDE


TABLET, EXTENDED RELEASE; ORAL
TAVIST-D
NOVARTIS EQ 1MG BASE;75MG N018298 001 Dec 15, 1982
1.34MG;75MG N018298 002 Aug 21, 1992
1.34MG;75MG N020640 001 Aug 09, 1996

CLIDINIUM BROMIDE
CAPSULE; ORAL
QUARZAN
ROCHE 2.5MG N010355 001
5MG N010355 002

CLINDAMYCIN HYDROCHLORIDE
CAPSULE; ORAL
CLEOCIN
PHARMACIA AND UPJOHN EQ 75MG BASE A061809 001
EQ 150MG BASE A061809 002
CLINDAMYCIN HYDROCHLORIDE
TEVA EQ 75MG BASE A063027 001 Sep 20, 1989
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 80 (of 324)

CLINDAMYCIN HYDROCHLORIDE
CAPSULE; ORAL
CLINDAMYCIN HYDROCHLORIDE
WATSON LABS EQ 75MG BASE A063082 001 Jul 31, 1991

CLINDAMYCIN PALMITATE HYDROCHLORIDE


FOR SOLUTION; ORAL
CLEOCIN
PHARMACIA AND UPJOHN EQ 75MG BASE/5ML A061827 001

CLINDAMYCIN PHOSPHATE
CREAM; VAGINAL
CLEOCIN
PHARMACIA AND UPJOHN EQ 2% BASE N050680 001 Aug 11, 1992
INJECTABLE; INJECTION
CLEOCIN PHOSPHATE
PHARMACIA AND UPJOHN EQ 150MG BASE/ML A061839 001
CLINDAMYCIN PHOSPHATE
ABRAXIS PHARM EQ 150MG BASE/ML A062747 001 Jun 03, 1988
ASTRAZENECA EQ 150MG BASE/ML A062928 001 Feb 13, 1989
BAXTER HLTHCARE EQ 150MG BASE/ML A062806 001 Oct 15, 1987
EQ 150MG BASE/ML A062953 001 Apr 21, 1988
EQ 150MG BASE/ML A063068 001 Aug 28, 1989
BEDFORD EQ 150MG BASE/ML A063163 001 Jun 30, 1994
BRISTOL MYERS SQUIBB EQ 150MG BASE/ML A062908 001 Feb 01, 1989
LOCH EQ 150MG BASE/ML A062905 001 May 09, 1988
MARSAM PHARMS LLC EQ 150MG BASE/ML A062913 001 Oct 20, 1988
SOLOPAK EQ 150MG BASE/ML A062819 001 Mar 15, 1988
EQ 150MG BASE/ML A062852 001 Mar 17, 1988
TEVA PARENTERAL EQ 150MG BASE/ML A063041 001 Dec 29, 1989
EQ 150MG BASE/ML A063282 001 May 29, 1992
WATSON LABS EQ 150MG BASE/ML A062900 001 Jun 08, 1988
EQ 150MG BASE/ML A063079 001 Mar 05, 1990
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
ABRAXIS PHARM EQ 12MG BASE/ML N050636 001 Dec 22, 1989
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTT EQ 6MG BASE/ML A065027 001 Jun 29, 2001
EQ 12MG BASE/ML A065027 002 Jun 29, 2001
EQ 18MG BASE/ML A065027 003 Jun 29, 2001
BAXTER HLTHCARE EQ 6MG BASE/ML N050648 001 Dec 29, 1989
EQ 12MG BASE/ML N050648 002 Dec 29, 1989
EQ 900MG BASE/100ML N050648 003 Dec 29, 1989
SOLUTION; TOPICAL
CLEOCIN T
PHARMACIA AND UPJOHN EQ 1% BASE A062363 001 Feb 08, 1982
CLINDAMYCIN PHOSPHATE
BOCA PHARMA EQ 1% BASE A062930 001 Jun 28, 1989
COPLEY PHARM EQ 1% BASE A062944 001 Jan 11, 1989
STIEFEL GSK EQ 1% BASE A064108 001 Sep 27, 1996

CLIOQUINOL; NYSTATIN
OINTMENT; TOPICAL
NYSTAFORM
BAYER PHARMS 10MG/GM;100,000 UNITS/GM N050235 001

CLOBETASOL PROPIONATE
CREAM; TOPICAL
CLOBETASOL PROPIONATE
STIEFEL 0.05% A075338 001 Feb 09, 2001
CLOBETASOL PROPIONATE (EMOLLIENT)
STIEFEL GSK 0.05% A075733 001 Aug 22, 2001
OINTMENT; TOPICAL
CLOBETASOL PROPIONATE
STIEFEL GSK 0.05% A075057 001 Aug 12, 1998
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 81 (of 324)

CLOFAZIMINE
CAPSULE; ORAL
LAMPRENE
NOVARTIS 100MG N019500 001 Dec 15, 1986

CLOFIBRATE
CAPSULE; ORAL
ATROMID-S
WYETH AYERST 500MG N016099 002
CLOFIBRATE
BANNER PHARMACAPS 500MG A073396 001 Mar 20, 1992
SANDOZ 500MG A072191 001 May 02, 1988
TEVA 500MG A072600 001 Jul 25, 1991
USL PHARMA 500MG A070531 001 Jun 16, 1986
WATSON LABS 500MG A071603 001 Sep 18, 1987

CLOMIPHENE CITRATE
TABLET; ORAL
MILOPHENE
MILEX 50MG A072196 001 Dec 20, 1988

CLOMIPRAMINE HYDROCHLORIDE
CAPSULE; ORAL
CLOMIPRAMINE HYDROCHLORIDE
SANDOZ 25MG A074953 001 Jun 25, 1997
50MG A074953 002 Jun 25, 1997
75MG A074953 003 Jun 25, 1997
TEVA 25MG A074849 001 Apr 04, 1997
50MG A074849 002 Apr 04, 1997
75MG A074849 003 Apr 04, 1997
WATSON LABS 25MG A074600 001 Nov 27, 1996
25MG A074751 001 Sep 30, 1998
50MG A074600 002 Nov 27, 1996
50MG A074751 002 Sep 30, 1998
75MG A074600 003 Nov 27, 1996
75MG A074751 003 Sep 30, 1998

CLONAZEPAM
TABLET; ORAL
CLONAZEPAM
KALI LABS 0.5MG A077147 001 May 02, 2005
1MG A077147 002 May 02, 2005
2MG A077147 003 May 02, 2005
SANDOZ 0.5MG A074925 001 Sep 30, 1997
1MG A074925 002 Sep 30, 1997
2MG A074925 003 Sep 30, 1997
TEVA 0.5MG A074920 001 Aug 04, 1998
1MG A074920 002 Aug 04, 1998
2MG A074920 003 Aug 04, 1998
KLONOPIN
ROCHE 0.125MG N017533 005 Apr 09, 1997
0.25MG N017533 006 Apr 09, 1997
TABLET, ORALLY DISINTEGRATING; ORAL
KLONOPIN RAPIDLY DISINTEGRATING
ROCHE 0.125MG N020813 001 Dec 23, 1997
0.25MG N020813 002 Dec 23, 1997
0.5MG N020813 003 Dec 23, 1997
1MG N020813 004 Dec 23, 1997
2MG N020813 005 Dec 23, 1997

CLONIDINE HYDROCHLORIDE
TABLET; ORAL
CLONIDINE HYDROCHLORIDE
AM THERAP 0.1MG A070881 001 Jul 08, 1986
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 82 (of 324)

CLONIDINE HYDROCHLORIDE
TABLET; ORAL
CLONIDINE HYDROCHLORIDE
AM THERAP 0.2MG A070882 001 Jul 08, 1986
0.3MG A070883 001 Jul 08, 1986
AMNEAL PHARMS NY 0.1MG A071252 001 Oct 01, 1986
0.2MG A071253 001 Oct 01, 1986
0.3MG A071254 001 Oct 01, 1986
DURAMED PHARMS BARR 0.1MG A071103 001 Aug 14, 1986
0.2MG A071102 001 Aug 14, 1986
0.3MG A071101 001 Aug 14, 1986
PAR PHARM 0.1MG A070461 001 Jul 08, 1986
0.2MG A070460 001 Jul 08, 1986
0.3MG A070459 001 Jul 08, 1986
SANDOZ 0.1MG A070887 001 Aug 31, 1988
0.2MG A070886 001 Aug 31, 1988
0.3MG A071294 001 Aug 31, 1988
TEVA 0.1MG A070747 001 Jul 08, 1986
0.2MG A070702 001 Jul 08, 1986
0.3MG A070659 001 Jul 08, 1986
WARNER CHILCOTT 0.1MG A072138 001 Jun 13, 1988
0.2MG A072139 001 Jun 13, 1988
0.3MG A072140 001 Jun 13, 1988
WATSON LABS 0.1MG A070395 001 Mar 23, 1987
0.1MG A070965 001 Jul 08, 1986
0.2MG A070396 001 Mar 23, 1987
0.2MG A070964 001 Jul 08, 1986
0.3MG A070397 001 Mar 23, 1987

CLOPIDOGREL BISULFATE
TABLET; ORAL
CLOPIDOGREL BISULFATE
DR REDDYS LABS INC EQ 75MG BASE A076273 001 Jan 14, 2008

CLORAZEPATE DIPOTASSIUM
CAPSULE; ORAL
CLORAZEPATE DIPOTASSIUM
ABLE 3.75MG A071777 001 Jul 14, 1987
7.5MG A071778 001 Jul 14, 1987
15MG A071779 001 Jul 14, 1987
AM THERAP 3.75MG A071429 001 Jun 23, 1987
7.5MG A071430 001 Jun 23, 1987
15MG A071431 001 Jun 23, 1987
CLONMEL HLTHCARE 3.75MG A071742 001 Dec 14, 1987
7.5MG A071743 001 Dec 14, 1987
15MG A071744 001 Dec 14, 1987
GD SEARLE LLC 3.75MG A071727 001 Dec 18, 1987
7.5MG A071728 001 Dec 18, 1987
15MG A071729 001 Dec 18, 1987
MYLAN 3.75MG A071509 001 Oct 19, 1987
7.5MG A071510 001 Oct 19, 1987
15MG A071511 001 Oct 19, 1987
PUREPAC PHARM 3.75MG A071924 001 Apr 25, 1988
7.5MG A071925 001 Apr 25, 1988
15MG A071926 001 Apr 25, 1988
QUANTUM PHARMICS 3.75MG A071549 001 Sep 12, 1988
7.5MG A071550 001 Sep 12, 1988
15MG A071522 001 Sep 12, 1988
SANDOZ 3.75MG A072219 001 Aug 26, 1988
7.5MG A072220 001 Aug 26, 1988
15MG A072112 001 Aug 26, 1988
USL PHARMA 3.75MG A071242 001 Jun 23, 1987
7.5MG A071243 001 Jun 23, 1987
15MG A071244 001 Jun 23, 1987
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 83 (of 324)

CLORAZEPATE DIPOTASSIUM
CAPSULE; ORAL
CLORAZEPATE DIPOTASSIUM
WARNER CHILCOTT 3.75MG A071774 001 Mar 01, 1988
7.5MG A071775 001 Mar 01, 1988
15MG A071776 001 Mar 01, 1988
WATSON LABS 3.75MG A071878 001 Mar 15, 1988
7.5MG A071879 001 Mar 15, 1988
15MG A071860 001 Mar 15, 1988
TRANXENE
LUNDBECK INC 3.75MG N017105 001
7.5MG N017105 002
15MG N017105 003
TABLET; ORAL
CLORAZEPATE DIPOTASSIUM
ABLE 3.75MG A071780 001 Jun 26, 1987
7.5MG A071781 001 Jun 26, 1987
15MG A071782 001 Jun 26, 1987
AM THERAP 3.75MG A071747 001 Jun 23, 1987
7.5MG A071748 001 Jun 23, 1987
15MG A071749 001 Jun 23, 1987
LEDERLE 3.75MG A072013 001 Dec 15, 1987
7.5MG A072014 001 Dec 15, 1987
15MG A072015 001 Dec 15, 1987
PUREPAC PHARM 3.75MG A072330 001 Aug 08, 1988
7.5MG A072331 001 Aug 08, 1988
15MG A072332 001 Aug 08, 1988
QUANTUM PHARMICS 3.75MG A071730 001 Oct 26, 1987
7.5MG A071731 001 Oct 26, 1987
15MG A071702 001 Oct 26, 1987
SANDOZ 3.75MG A072512 001 May 11, 1990
7.5MG A072513 001 May 11, 1990
15MG A072514 001 May 11, 1990
WARNER CHILCOTT 3.75MG A071828 001 Mar 03, 1988
7.5MG A071829 001 Mar 03, 1988
15MG A071830 001 Mar 03, 1988
TRANXENE SD
LUNDBECK INC 11.25MG N017105 005
22.5MG N017105 004

CLOTRIMAZOLE
CREAM; TOPICAL
LOTRIMIN
SCHERING PLOUGH 1% N017619 001
MYCELEX
BAYER PHARMS 1% N018183 001
LOTION; TOPICAL
LOTRIMIN
SCHERING 1% N018813 001 Feb 17, 1984
SOLUTION; TOPICAL
LOTRIMIN
SCHERING PLOUGH 1% N017613 001
TABLET; VAGINAL
GYNIX
TEVA PHARMS 100MG A073249 001 Feb 13, 1998
MYCELEX-G
BAYER PHARMS 500MG N019069 001 Apr 19, 1985

CLOXACILLIN SODIUM
CAPSULE; ORAL
CLOXACILLIN SODIUM
APOTHECON EQ 250MG BASE A061452 001
EQ 500MG BASE A061452 002
TEVA EQ 250MG BASE A062240 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 84 (of 324)

CLOXACILLIN SODIUM
CAPSULE; ORAL
CLOXACILLIN SODIUM
TEVA EQ 500MG BASE A062240 002
CLOXAPEN
GLAXOSMITHKLINE EQ 250MG BASE A061806 001
EQ 250MG BASE A062233 001
EQ 500MG BASE A061806 002
EQ 500MG BASE A062233 002
FOR SOLUTION; ORAL
CLOXACILLIN SODIUM
TEVA EQ 125MG BASE/5ML A062268 001
EQ 125MG BASE/5ML A062978 001 Apr 06, 1989
TEGOPEN
APOTHECON EQ 125MG BASE/5ML A061453 001
EQ 125MG BASE/5ML N050192 001

CLOZAPINE
TABLET; ORAL
CLOZAPINE
PAR PHARM 25MG A075162 001 Apr 26, 2005
100MG A075162 002 Apr 26, 2005
SANDOZ 25MG A074546 001 Aug 30, 1996
100MG A074546 002 Aug 30, 1996
TABLET, ORALLY DISINTEGRATING; ORAL
FAZACLO ODT
AZUR PHARMA INTL 50MG N021590 003 Jun 03, 2005

COBALT CHLORIDE, CO-57; CYANOCOBALAMIN; CYANOCOBALAMIN, CO-57; INTRINSIC FACTOR


N/A; N/A
RUBRATOPE-57 KIT
BRACCO N/A;N/A;N/A;N/A N016089 001

COBALT CHLORIDE, CO-60; CYANOCOBALAMIN; CYANOCOBALAMIN, CO-60; INTRINSIC FACTOR


N/A; N/A
RUBRATOPE-60 KIT
BRACCO N/A;N/A;N/A;N/A N016090 001

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE


SYRUP; ORAL
PHENERGAN VC W/ CODEINE
ANI PHARMS 10MG/5ML;5MG/5ML;6.25MG/5ML N008306 005 Apr 02, 1984
PHERAZINE VC W/ CODEINE
HALSEY 10MG/5ML;5MG/5ML;6.25MG/5ML A088870 001 Mar 02, 1987
PROMETHAZINE VC W/ CODEINE
CENCI 10MG/5ML;5MG/5ML;6.25MG/5ML A088816 001 Nov 22, 1985
MORTON GROVE 10MG/5ML;5MG/5ML;6.25MG/5ML A088896 001 Jan 04, 1985

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE


SYRUP; ORAL
PHENERGAN W/ CODEINE
ANI PHARMS 10MG/5ML;6.25MG/5ML N008306 004 Apr 02, 1984
PHERAZINE W/ CODEINE
HALSEY 10MG/5ML;6.25MG/5ML A088739 001 Dec 23, 1988
PROMETHAZINE W/ CODEINE
CENCI 10MG/5ML;6.25MG/5ML A088814 001 Nov 22, 1985

CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE


SYRUP; ORAL
ACTIFED W/ CODEINE
GLAXOSMITHKLINE 10MG/5ML;30MG/5ML;1.25MG/5ML N012575 003 Apr 04, 1984
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE
CENCI 10MG/5ML;30MG/5ML;1.25MG/5ML A089018 001 Jul 23, 1986
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 85 (of 324)

CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE


SYRUP; ORAL
TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL AND CODEINE PHOSPHATE
MORTON GROVE 10MG/5ML;30MG/5ML;1.25MG/5ML A088833 001 Nov 16, 1984

COLCHICINE; PROBENECID
TABLET; ORAL
COLBENEMID
MERCK 0.5MG;500MG N012383 001
PROBEN-C
WATSON LABS 0.5MG;500MG A085552 001
PROBENECID AND COLCHICINE
BEECHAM 0.5MG;500MG A084321 001
IMPAX LABS 0.5MG;500MG A083720 002
SANDOZ 0.5MG;500MG A086130 001
PROBENECID W/ COLCHICINE
LEDERLE 0.5MG;500MG A086954 001
WATSON LABS 0.5MG;500MG A083221 001

COLESEVELAM HYDROCHLORIDE
CAPSULE; ORAL
WELCHOL
DAIICHI SANKYO 375MG N021141 001 May 26, 2000

COLISTIN SULFATE
SUSPENSION; ORAL
COLY-MYCIN S
PARKE DAVIS EQ 25MG BASE/5ML N050355 001

CONIVAPTAN HYDROCHLORIDE
INJECTABLE; IV (INFUSION)
VAPRISOL
ASTELLAS 20MG/4ML (5MG/ML) N021697 001 Dec 29, 2005

COPPER
INTRAUTERINE DEVICE; INTRAUTERINE
CU-7
GD SEARLE LLC 89MG N017408 001
TATUM-T
GD SEARLE LLC 120MG N018205 001

CORTICOTROPIN
INJECTABLE; INJECTION
ACTH
PARKEDALE 25 UNITS/VIAL N008317 002
40 UNITS/VIAL N008317 004
ACTHAR
SANOFI AVENTIS US 25 UNITS/VIAL N007504 002
40 UNITS/VIAL N007504 003
CORTICOTROPIN
ORGANICS LAGRANGE 40 UNITS/ML N010831 001
80 UNITS/ML N010831 002
WATSON LABS 40 UNITS/VIAL A088772 001 Nov 21, 1984
H.P. ACTHAR GEL

QUESTCOR PHARMS 40 UNITS/ML N008372 006


PURIFIED CORTROPHIN GEL


ORGANON USA INC 40 UNITS/ML N008975 001


80 UNITS/ML N008975 002


CORTICOTROPIN-ZINC HYDROXIDE
INJECTABLE; INJECTION
CORTROPHIN-ZINC
ORGANON USA INC 40 UNITS/ML N009854 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 86 (of 324)

CORTISONE ACETATE
INJECTABLE; INJECTION
CORTISONE ACETATE
PHARMACIA AND UPJOHN 25MG/ML N008126 002
WATSON LABS 25MG/ML A083147 003
25MG/ML A085677 001
50MG/ML A083147 004
50MG/ML A085677 002
CORTONE
MERCK 25MG/ML N007110 002
50MG/ML N007110 003
TABLET; ORAL
CORTISONE ACETATE
BARR 25MG A083471 001
ELKINS SINN 25MG A080836 001
EVERYLIFE 25MG A084246 001
HEATHER 25MG A085736 001
IMPAX LABS 25MG N009458 001
INWOOD LABS 25MG A080731 001
IVAX SUB TEVA PHARMS 25MG A080630 001
25MG A083536 001
LANNETT 25MG A080694 001
PANRAY 5MG N008284 002
25MG N008284 001
PHARMACIA AND UPJOHN 5MG N008126 003
10MG N008126 004
25MG N008126 001
PUREPAC PHARM 25MG A080493 001
VITARINE 25MG A080333 001
WATSON LABS 25MG A085884 001
WHITEWORTH TOWN PLSN 25MG A080341 001
CORTONE
MERCK 25MG N007750 003

CROMOLYN SODIUM
CAPSULE; INHALATION
INTAL
SANOFI AVENTIS US 20MG N016990 001
CAPSULE; ORAL
GASTROCROM
UCB INC 100MG N019188 001 Dec 22, 1989
SOLUTION; INHALATION
CROMOLYN SODIUM
PHARMASCIENCE INC 10MG/ML A075437 001 Apr 21, 2000
ROXANE 10MG/ML A075175 001 Sep 30, 1999
INTAL
KING PHARMS 10MG/ML N018596 001 May 28, 1982
SOLUTION/DROPS; OPHTHALMIC
CROMOPTIC
KING PHARMS 4% A075088 001 Apr 27, 1999
SPRAY, METERED; NASAL
NASALCROM
MCNEIL CONS 5.2MG/SPRAY N020463 001 Jan 03, 1997

CRYPTENAMINE ACETATES
INJECTABLE; INJECTION
UNITENSEN
MEDPOINTE PHARM HLC 260CSR UNIT/ML N008814 001

CRYPTENAMINE TANNATES
TABLET; ORAL
UNITENSEN
MEDPOINTE PHARM HLC 260CSR UNIT N009217 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 87 (of 324)

CUPRIC SULFATE
INJECTABLE; INJECTION
CUPRIC SULFATE
ABRAXIS PHARM EQ 0.4MG COPPER/ML N019350 001 May 05, 1987

CYANOCOBALAMIN
GEL, METERED; NASAL
NASCOBAL
PAR PHARM 0.5MG/INH N019722 001 Nov 05, 1996
INJECTABLE; INJECTION
BERUBIGEN
PHARMACIA AND UPJOHN 1MG/ML N006798 001
BETALIN 12
LILLY 0.1MG/ML A080855 001
1MG/ML A080855 002
COBAVITE
WATSON LABS 0.1MG/ML A083013 001
1MG/ML A083064 001
CYANOCOBALAMIN
ABRAXIS PHARM 0.03MG/ML A080510 003
0.1MG/ML A080510 001
1MG/ML A080510 002
1MG/ML A083075 001
AKORN 1MG/ML A087969 001 Nov 10, 1983
APP PHARMS 0.1MG/ML A080557 002
BAXTER HLTHCARE 1MG/ML A080515 002
BIONICHE PHARMA 1MG/ML A040451 001 Sep 23, 2003
DELL LABS 0.03MG/ML A080689 001
0.1MG/ML A080689 002
1MG/ML A080689 003
LUITPOLD 0.03MG/ML A080668 001
SANOFI AVENTIS US 1MG/ML A080564 001
SOLOPAK 1MG/ML A087551 001 Feb 29, 1984
WARNER CHILCOTT 1MG/ML N007085 002
WATSON LABS 0.1MG/ML A080573 002
0.1MG/ML A083120 001
1MG/ML A080573 001
1MG/ML A083120 002
WYETH AYERST 0.1MG/ML A080554 001
1MG/ML A080554 002
REDISOL
MERCK 1MG/ML N006668 010
RUBIVITE
BEL MAR 0.03MG/ML N010791 004
0.05MG/ML N010791 001
0.1MG/ML N010791 002
0.12MG/ML N010791 005
1MG/ML N010791 003
RUBRAMIN PC
BRISTOL MYERS SQUIBB 0.1MG/ML N006799 002
1MG/ML N006799 004
1MG/ML N006799 010 Apr 28, 1988
RUVITE
SAVAGE LABS 1MG/ML A080570 002
VI-TWEL
BAYER HLTHCARE 1MG/ML N007012 002
TABLET; ORAL
CYANOCOBALAMIN
WEST WARD 1MG A084264 001

CYANOCOBALAMIN, CO-57
CAPSULE; ORAL
RUBRATOPE-57
BRACCO 0.5-1uCi N016089 002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 88 (of 324)

CYANOCOBALAMIN, CO-60
CAPSULE; ORAL
RUBRATOPE-60
BRACCO 0.5-1uCi N016090 002

CYANOCOBALAMIN; CYANOCOBALAMIN, CO-57; CYANOCOBALAMIN, CO-58


N/A; N/A
DICOPAC KIT
GE HEALTHCARE N/A;N/A;N/A N017406 001

CYANOCOBALAMIN; CYANOCOBALAMIN, CO-57; INTRINSIC FACTOR


N/A; N/A
CYANOCOBALAMIN CO 57 SCHILLING TEST KIT
MALLINCKRODT 0.1MG;0.5uCi;60MG N016635 001

CYANOCOBALAMIN; TANNIC ACID; ZINC ACETATE


INJECTABLE; INJECTION
DEPINAR
ARMOUR PHARM 0.5MG/ML;2.3MG/ML;1MG/ML N011208 001

CYCLACILLIN
FOR SUSPENSION; ORAL
CYCLAPEN-W
WYETH AYERST 125MG/5ML N050508 001
250MG/5ML N050508 002
500MG/5ML N050508 003
TABLET; ORAL
CYCLACILLIN
TEVA 250MG A062895 001 Aug 04, 1988
500MG A062895 002 Aug 04, 1988
CYCLAPEN-W
WYETH AYERST 250MG N050509 001
500MG N050509 002

CYCLIZINE LACTATE
INJECTABLE; INJECTION
MAREZINE
GLAXOSMITHKLINE 50MG/ML N009495 001

CYCLOBENZAPRINE HYDROCHLORIDE
TABLET; ORAL
CYCLOBENZAPRINE HYDROCHLORIDE
SANDOZ 10MG A073683 001 Feb 26, 1993
WATSON LABS 10MG A073143 001 Nov 27, 1991
10MG A074436 001 Nov 30, 1994

CYCLOPENTOLATE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
AK-PENTOLATE
AKORN 1% A085555 001
CYCLOPENTOLATE HYDROCHLORIDE
ALCON UNIVERSAL 1% A089162 001 Jan 24, 1991
SOLA BARNES HIND 1% A084150 001
1% A084863 001
PENTOLAIR
PHARMAFAIR 0.5% A088643 001 Feb 09, 1987
1% A088150 001 Feb 25, 1983

CYCLOPHOSPHAMIDE
INJECTABLE; INJECTION
CYCLOPHOSPHAMIDE
BAXTER HLTHCARE 100MG/VIAL A088371 001 Jul 03, 1986
200MG/VIAL A088372 001 Jul 03, 1986
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 89 (of 324)

CYCLOPHOSPHAMIDE
INJECTABLE; INJECTION
CYCLOPHOSPHAMIDE
BAXTER HLTHCARE 500MG/VIAL A088373 001 Jul 03, 1986
1GM/VIAL A088374 001 Sep 24, 1986
CYTOXAN
BAXTER HLTHCARE 100MG/VIAL N012142 001
200MG/VIAL N012142 002
500MG/VIAL N012142 003
1GM/VIAL N012142 004 Aug 30, 1982
2GM/VIAL N012142 005 Aug 30, 1982
NEOSAR
TEVA PARENTERAL 100MG/VIAL A040015 001 Apr 29, 1993
100MG/VIAL A087442 001 Feb 16, 1982
200MG/VIAL A040015 002 Apr 29, 1993
200MG/VIAL A087442 002 Feb 16, 1982
500MG/VIAL A040015 003 Apr 29, 1993
500MG/VIAL A087442 003 Feb 16, 1982
1GM/VIAL A040015 004 Apr 29, 1993
1GM/VIAL A087442 004 Jul 08, 1983
2GM/VIAL A040015 005 Apr 29, 1993
2GM/VIAL A087442 005 Mar 30, 1989
TABLET; ORAL
CYTOXAN
BAXTER HLTHCARE 25MG N012141 002
50MG N012141 001

CYCLOSPORINE
CAPSULE; ORAL
NEORAL
NOVARTIS 50MG N050715 003 Jul 14, 1995

CYCLOTHIAZIDE
TABLET; ORAL
ANHYDRON
LILLY 2MG N013157 002
FLUIDIL
PHARMACIA AND UPJOHN 2MG N018173 001

CYCRIMINE HYDROCHLORIDE
TABLET; ORAL
PAGITANE
LILLY 1.25MG N008951 001
2.5MG N008951 002

CYPROHEPTADINE HYDROCHLORIDE
SYRUP; ORAL
CYPROHEPTADINE HYDROCHLORIDE
HALSEY 2MG/5ML A089199 001 Jul 03, 1986
MORTON GROVE 2MG/5ML A087001 001 Nov 04, 1982
NASKA 2MG/5ML A089021 001 Dec 21, 1987
PERIACTIN
MERCK 2MG/5ML N013220 002
TABLET; ORAL
CYPROHEPTADINE HYDROCHLORIDE
AM THERAP 4MG A088798 001 Feb 15, 1985
ASCOT 4MG A087685 001 Oct 25, 1982
DURAMED PHARMS BARR 4MG A088232 001 Oct 25, 1983
HALSEY 4MG A089057 001 Jul 03, 1986
KV PHARM 4MG A086737 001
MD PHARM 4MG A087566 001 Nov 10, 1982
MYLAN 4MG A086678 001
PIONEER PHARMS 4MG A087839 001 Feb 08, 1984
SANDOZ 4MG A086808 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 90 (of 324)

CYPROHEPTADINE HYDROCHLORIDE
TABLET; ORAL
CYPROHEPTADINE HYDROCHLORIDE
SUPERPHARM 4MG A087405 001
TG UNITED LABS 4MG A088212 001 May 26, 1983
VITARINE 4MG A087284 001
WATSON LABS 4MG A085245 001
4MG A086165 001
4MG A086580 001
PERIACTIN
MERCK 4MG N012649 001

CYSTEINE HYDROCHLORIDE
INJECTABLE; INJECTION
CYSTEINE HYDROCHLORIDE
HOSPIRA 7.25% N019523 001 Oct 22, 1986

CYTARABINE
INJECTABLE; INJECTION
CYTARABINE
TEVA PARENTERAL 100MG/VIAL N016793 001
500MG/VIAL N016793 002
1GM/VIAL N016793 003 Dec 21, 1987
2GM/VIAL N016793 004 Dec 21, 1987

DACARBAZINE
INJECTABLE; INJECTION
DACARBAZINE
ABRAXIS PHARM 100MG/VIAL A070962 001 Aug 28, 1986
200MG/VIAL A070990 001 Aug 28, 1986

DALFOPRISTIN; QUINUPRISTIN
INJECTABLE; IV (INFUSION)
SYNERCID
KING PHARMS 420MG/VIAL;180MG/VIAL N050748 002 Aug 24, 2000

DALTEPARIN SODIUM
INJECTABLE; INJECTION
FRAGMIN
EISAI INC 7,500 IU/0.75ML N020287 008 Apr 04, 2002

DANAPAROID SODIUM
INJECTABLE; INJECTION
ORGARAN
ORGANON USA INC 750 UNITS/0.6ML N020430 001 Dec 24, 1996

DANAZOL
CAPSULE; ORAL
DANAZOL
AM THERAP 200MG A071569 001 Dec 30, 1987
DANOCRINE
SANOFI AVENTIS US 50MG N017557 003
100MG N017557 004
200MG N017557 002

DAPIPRAZOLE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
REV-EYES
ANGELINI 0.5% N019849 001 Dec 31, 1990
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 91 (of 324)

DAPTOMYCIN
INJECTABLE; IV (INFUSION)
CUBICIN
CUBIST 250MG/VIAL N021572 001 Sep 12, 2003

DAUNORUBICIN CITRATE
INJECTABLE, LIPOSOMAL; INJECTION
DAUNOXOME
GILEAD EQ 2MG BASE/ML N050704 002 Apr 08, 1996

DAUNORUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION
CERUBIDINE
SANOFI AVENTIS US EQ 20MG BASE/VIAL A061876 001
WYETH AYERST EQ 20MG BASE/VIAL N050484 001
DAUNORUBICIN HYDROCHLORIDE
TEVA PARENTERAL EQ 20MG BASE/VIAL A064212 001 Jun 23, 1998
EQ 50MG BASE/VIAL A064212 002 May 03, 1999

DECAMETHONIUM BROMIDE
INJECTABLE; INJECTION
SYNCURINE
GLAXOSMITHKLINE 1MG/ML N006931 002

DEMECARIUM BROMIDE
SOLUTION/DROPS; OPHTHALMIC
HUMORSOL
MERCK 0.125% N011860 002
0.25% N011860 001

DEMECLOCYCLINE HYDROCHLORIDE
CAPSULE; ORAL
DECLOMYCIN
LEDERLE 150MG N050262 001
SYRUP; ORAL
DECLOMYCIN
LEDERLE 75MG/5ML N050257 001
TABLET; ORAL
DECLOMYCIN
STIEFEL 75MG N050261 001

DESERPIDINE
TABLET; ORAL
HARMONYL
ABBOTT 0.1MG N010796 001
0.25MG N010796 002

DESERPIDINE; HYDROCHLOROTHIAZIDE
TABLET; ORAL
ORETICYL 25
ABBOTT 0.125MG;25MG N012148 001
ORETICYL 50
ABBOTT 0.125MG;50MG N012148 003
ORETICYL FORTE
ABBOTT 0.25MG;25MG N012148 002

DESERPIDINE; METHYCLOTHIAZIDE
TABLET; ORAL
ENDURONYL
ABBOTT 0.25MG;5MG N012775 001
ENDURONYL FORTE
ABBOTT 0.5MG;5MG N012775 002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 92 (of 324)

DESERPIDINE; METHYCLOTHIAZIDE
TABLET; ORAL
METHYCLOTHIAZIDE AND DESERPIDINE
WATSON LABS 0.25MG;5MG A088486 001 Aug 10, 1984
0.5MG;5MG A088452 001 Aug 10, 1984

DESIPRAMINE HYDROCHLORIDE
CAPSULE; ORAL
PERTOFRANE
SANOFI AVENTIS US 25MG N013621 001
50MG N013621 002
TABLET; ORAL
DESIPRAMINE HYDROCHLORIDE
PLIVA 25MG A071800 001 Dec 08, 1987
50MG A071801 001 Dec 08, 1987
75MG A071802 001 Dec 08, 1987
100MG A071803 001 May 29, 1997
150MG A071804 001 May 29, 1997
USL PHARMA 25MG A071864 001 Sep 09, 1987
50MG A071865 001 Sep 09, 1987
75MG A071866 001 Sep 09, 1987
100MG A071867 001 Sep 09, 1987

DESLANOSIDE
INJECTABLE; INJECTION
CEDILANID-D
NOVARTIS 0.2MG/ML N009282 002

DESMOPRESSIN ACETATE
INJECTABLE; INJECTION
DDAVP
SANOFI AVENTIS US 0.015MG/ML N018938 002 Apr 25, 1995
DESMOPRESSIN ACETATE
BEDFORD 0.004MG/ML A074575 001 Feb 18, 2000
DESMOPRESSIN ACETATE PRESERVATIVE FREE
BEDFORD 0.004MG/ML A074574 001 Feb 18, 2000
SOLUTION; NASAL
CONCENTRAID
FERRING 0.01% N019776 001 Dec 26, 1990
SPRAY, METERED; NASAL
DDAVP
SANOFI AVENTIS US 0.01MG/SPRAY N017922 002 Feb 06, 1989

DESOGESTREL; ETHINYL ESTRADIOL


TABLET; ORAL-21
DESOGEN
ORGANON USA INC 0.15MG;0.03MG N020071 001 Dec 10, 1992
DESOGESTREL AND ETHINYL ESTRADIOL
DURAMED PHARMS BARR 0.15MG;0.03MG A075256 001 Aug 12, 1999
ORTHO-CEPT
ORTHO MCNEIL JANSSEN 0.15MG;0.03MG N020301 001 Dec 14, 1992

DESONIDE
CREAM; TOPICAL
DESONIDE
TEVA PHARMS 0.05% A074027 001 Sep 28, 1992

DESOXIMETASONE
OINTMENT; TOPICAL
DESOXIMETASONE
ALTANA 0.25% A073440 001 Apr 01, 1998
TOPICORT
TARO PHARMS NORTH 0.05% N018594 001 Jan 17, 1985
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 93 (of 324)

DESOXYCORTICOSTERONE ACETATE
INJECTABLE; INJECTION

DOCA

ORGANON USA INC 5MG/ML N001104 001


PELLET; IMPLANTATION

PERCORTEN

NOVARTIS 125MG N005151 001


DESOXYCORTICOSTERONE PIVALATE
INJECTABLE; INJECTION
PERCORTEN
NOVARTIS 25MG/ML N008822 001

DEXAMETHASONE
AEROSOL; TOPICAL
AEROSEB-DEX
ALLERGAN HERBERT 0.01% A083296 002
DECASPRAY
MERCK 0.04% N012731 002
ELIXIR; ORAL
DECADRON
MERCK 0.5MG/5ML N012376 002
DEXAMETHASONE
ALPHARMA US PHARMS 0.5MG/5ML A088997 001 Oct 10, 1986
HEXADROL
ORGANON USA INC 0.5MG/5ML N012674 001
GEL; TOPICAL
DECADERM
MERCK 0.1% N013538 001
SUSPENSION/DROPS; OPHTHALMIC
DEXAMETHASONE
WATSON LABS 0.1% A089170 001 May 09, 1989
TABLET; ORAL
DECADRON
MERCK 0.25MG N011664 004
0.5MG N011664 001
0.75MG N011664 002
1.5MG N011664 003
4MG N011664 005
6MG N011664 006 Jul 30, 1982
DEXAMETHASONE
IMPAX LABS 0.75MG A085376 001
MUTUAL PHARM 0.25MG A084013 001
0.25MG A084764 001
0.5MG A084084 001
0.5MG A084766 001
0.75MG A084081 001
0.75MG A084765 001
1.5MG A084086 001
1.5MG A084763 001
PAR PHARM 0.25MG A088149 001 Apr 28, 1983
0.5MG A088148 001 Apr 28, 1983
0.75MG A088160 001 Apr 28, 1983
1.5MG A088237 001 Apr 28, 1983
4MG A088238 001 Apr 28, 1983
6MG A088481 001 Nov 28, 1983
PHOENIX LABS NY 0.75MG A083806 001
PVT FORM 0.75MG A083420 001
ROXANE 0.25MG A084614 001
SANDOZ 0.75MG A080399 001
UPSHER SMITH 0.75MG A087534 001
1.5MG A087533 001
WATSON LABS 0.25MG A085455 001
0.5MG A085458 001
0.75MG A080968 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 94 (of 324)

DEXAMETHASONE
TABLET; ORAL
DEXAMETHASONE
WATSON LABS 0.75MG A084457 001
0.75MG A085818 001
1.5MG A085456 001
1.5MG A085840 001
WHITEWORTH TOWN PLSN 0.75MG A084327 001
DEXONE 0.5
SOLVAY 0.5MG A084991 001
DEXONE 0.75
SOLVAY 0.75MG A084993 001
DEXONE 1.5
SOLVAY 1.5MG A084990 001
DEXONE 4
SOLVAY 4MG A084992 001
HEXADROL
ORGANON USA INC 0.5MG N012675 004
0.75MG N012675 007
1.5MG N012675 009
4MG N012675 010

DEXAMETHASONE ACETATE
INJECTABLE; INJECTION
DECADRON-LA
MERCK EQ 8MG BASE/ML N016675 001
DEXAMETHASONE ACETATE
WATSON LABS EQ 8MG BASE/ML A084315 001
EQ 16MG BASE/ML A087711 001 May 24, 1982

DEXAMETHASONE SODIUM PHOSPHATE


AEROSOL; NASAL
DEXACORT
UCB INC EQ 0.1MG PHOSPHATE/INH N014242 001
AEROSOL, METERED; INHALATION
DEXACORT
UCB INC EQ 0.1MG PHOSPHATE/INH N013413 001
CREAM; TOPICAL
DECADRON
MERCK EQ 0.1% PHOSPHATE N011983 002
INJECTABLE; INJECTION
DECADRON
MERCK EQ 4MG PHOSPHATE/ML N012071 002
EQ 24MG PHOSPHATE/ML N012071 004
DEXACEN-4
CENT PHARMS EQ 4MG PHOSPHATE/ML A084342 001
DEXAMETHASONE
ABRAXIS PHARM EQ 4MG PHOSPHATE/ML A088448 001 Jan 25, 1984
APP PHARMS EQ 10MG PHOSPHATE/ML A088469 001 Jan 25, 1984
DEXAMETHASONE SODIUM PHOSPHATE
ABRAXIS PHARM EQ 4MG PHOSPHATE/ML A087065 001
AKORN EQ 4MG PHOSPHATE/ML A084493 001
BAXTER HLTHCARE EQ 4MG PHOSPHATE/ML A084282 001
BEL MAR EQ 4MG PHOSPHATE/ML A084752 001
DELL LABS EQ 4MG PHOSPHATE/ML A083161 001
INTL MEDICATION EQ 20MG PHOSPHATE/ML A088522 001 Feb 17, 1984
TEVA PARENTERAL EQ 4MG PHOSPHATE/ML A081125 001 Aug 31, 1990
WATSON LABS EQ 4MG PHOSPHATE/ML A083702 001
EQ 4MG PHOSPHATE/ML A084355 001
EQ 4MG PHOSPHATE/ML A089169 001 Apr 09, 1986
EQ 10MG PHOSPHATE/ML A087668 001 Jul 01, 1982
EQ 24MG PHOSPHATE/ML A085606 001
WYETH AYERST EQ 4MG PHOSPHATE/ML A085641 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 95 (of 324)

DEXAMETHASONE SODIUM PHOSPHATE


INJECTABLE; INJECTION
HEXADROL
ORGANON USA INC EQ 4MG PHOSPHATE/ML N014694 002
EQ 10MG PHOSPHATE/ML N014694 003
EQ 20MG PHOSPHATE/ML N014694 004
OINTMENT; OPHTHALMIC
DECADRON
MERCK EQ 0.05% PHOSPHATE N011977 001
DEXAIR
PHARMAFAIR EQ 0.05% PHOSPHATE A088071 001 Dec 28, 1982
MAXIDEX
ALCON EQ 0.05% PHOSPHATE A083342 001
SOLUTION/DROPS; OPHTHALMIC
DEXAIR
PHARMAFAIR EQ 0.1% PHOSPHATE A088433 001 Dec 15, 1983
DEXAMETHASONE SODIUM PHOSPHATE
SOLA BARNES HIND EQ 0.1% PHOSPHATE A084170 001
EQ 0.1% PHOSPHATE A084173 001
SOLUTION/DROPS; OPHTHALMIC, OTIC
DECADRON
MERCK EQ 0.1% PHOSPHATE N011984 001
SOLUTION/DROPS; OTIC
DEXAMETHASONE SODIUM PHOSPHATE
AKORN EQ 0.1% PHOSPHATE A084855 001

DEXAMETHASONE SODIUM PHOSPHATE; LIDOCAINE HYDROCHLORIDE


INJECTABLE; INJECTION
DECADRON W/ XYLOCAINE
MERCK EQ 4MG PHOSPHATE/ML;10MG/ML N013334 002

DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE


OINTMENT; OPHTHALMIC
NEODECADRON
MERCK EQ 0.05% PHOSPHATE;EQ 3.5MG BASE/GM N050324 001
SOLUTION/DROPS; OPHTHALMIC
NEODECADRON
MERCK EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML N050322 001
NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE
BAUSCH AND LOMB EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML A064055 001 Oct 30, 1995
NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE
ALCON UNIVERSAL EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML A062714 001 Jul 21, 1986
PHARMAFAIR EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML A062539 001 Jan 10, 1985

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


OINTMENT; OPHTHALMIC
DEXACIDIN
NOVARTIS 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM A062566 001 Feb 22, 1985
DEXASPORIN
PHARMAFAIR 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM A062411 001 May 16, 1983
SUSPENSION/DROPS; OPHTHALMIC
DEXACIDIN
NOVARTIS 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062544 001 Oct 29, 1984
DEXASPORIN
PHARMAFAIR 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062428 001 May 18, 1983

DEXBROMPHENIRAMINE MALEATE
SYRUP; ORAL
DISOMER
SCHERING 2MG/5ML N011814 002
TABLET; ORAL
DISOMER
SCHERING 2MG N011814 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 96 (of 324)

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE


TABLET; ORAL
DISOPHROL
SCHERING 2MG;60MG N012394 002
TABLET, EXTENDED RELEASE; ORAL
BROMPHERIL
COPLEY PHARM 6MG;120MG A089116 001 Jan 22, 1987
DISOBROM
SANDOZ 6MG;120MG A070770 001 Sep 30, 1991
RESPORAL
PIONEER PHARMS 6MG;120MG A089139 001 Jun 16, 1988

DEXCHLORPHENIRAMINE MALEATE
SYRUP; ORAL
POLARAMINE
SCHERING 2MG/5ML A086837 001 Jul 19, 1982
TABLET; ORAL
DEXCHLORPHENIRAMINE MALEATE
PLIVA 2MG A088682 001 Jan 17, 1986
POLARAMINE
SCHERING 2MG A086835 001

DEXTROAMPHETAMINE SULFATE
CAPSULE; ORAL
DEXAMPEX
TEVA 15MG A085355 001
CAPSULE, EXTENDED RELEASE; ORAL
DEXTROAMPHETAMINE SULFATE
ABLE 5MG A076814 001 Aug 25, 2004
10MG A076814 002 Aug 25, 2004
15MG A076814 003 Aug 25, 2004
ELIXIR; ORAL
DEXEDRINE
GLAXOSMITHKLINE 5MG/5ML A083902 001
TABLET; ORAL
DEXAMPEX
TEVA 5MG A083735 001
10MG A083735 002
DEXEDRINE
GLAXOSMITHKLINE 5MG A084935 001
DEXTROAMPHETAMINE SULFATE
ENDO PHARMS 5MG A040299 001 May 13, 1999
HALSEY 10MG A083930 001
LANNETT 5MG A083903 001
10MG A083903 003
15MG A085652 001
MAST MM 5MG A086521 001
PUREPAC PHARM 5MG A084125 001
SANDOZ 5MG A085370 001
10MG A085371 001
VITARINE 5MG A084986 001
10MG A085892 001
DEXTROSTAT
SHIRE 5MG A084051 001
10MG A084051 002
FERNDEX
FERNDALE LABS 5MG A084001 001

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE


SYRUP; ORAL
PHERAZINE DM
HALSEY 15MG/5ML;6.25MG/5ML A088913 001 Mar 02, 1987
PROMETHAZINE HYDROCHLORIDE AND DESTROMETHORPHAN HYDROBROMIDE
ANI PHARMS 15MG/5ML;6.25MG/5ML N011265 002 Apr 02, 1984
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 97 (of 324)

DEXTROSE
INJECTABLE; INJECTION
DEXTROSE 10% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML N018046 001
MILES 10GM/100ML N018504 001
DEXTROSE 2.5% IN PLASTIC CONTAINER
B BRAUN 2.5GM/100ML N018358 001
2.5GM/100ML N019626 001 Feb 02, 1988
DEXTROSE 38.5% IN PLASTIC CONTAINER
ABBOTT 38.5GM/100ML N018923 001 Sep 19, 1984
DEXTROSE 5% IN PLASTIC CONTAINER
DHL 5GM/100ML N019971 001 Sep 28, 1995
DEXTROSE 60%
B BRAUN 60GM/100ML N017995 002 Sep 22, 1982
DEXTROSE 60% IN PLASTIC CONTAINER
B BRAUN 60GM/100ML N017995 001
BAXTER HLTHCARE 60GM/100ML N020047 002 Jul 02, 1991
HOSPIRA 60GM/100ML N019346 001 Jan 25, 1985
DEXTROSE 7.7% IN PLASTIC CONTAINER
B BRAUN 7.7GM/100ML N019626 003 Feb 02, 1988

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC;


SODIUM ACETATE
INJECTABLE; INJECTION
ISOLYTE P W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;31MG/100ML;130MG/100ML;26MG/1 N019025 001 Dec 27, 1984
00ML;320MG/100ML

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE


INJECTABLE; INJECTION

ISOLYTE H W/ DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;30MG/100ML;97MG/100ML;220MG/1 N018273 001


00ML;140MG/100ML

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE;


SODIUM GLUCONATE
INJECTABLE; INJECTION
ISOLYTE S W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;30MG/100ML;37MG/100ML;370MG/1 N018274 001
00ML;530MG/100ML;500MG/100ML

DEXTROSE; POTASSIUM CHLORIDE


INJECTABLE; INJECTION
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;37MG/100ML N019699 001 Sep 29, 1989
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;75MG/100ML N019699 002 Sep 29, 1989
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;110MG/100ML N019699 003 Sep 29, 1989
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML N019699 005 Sep 29, 1989

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM


CHLORIDE
INJECTABLE; INJECTION
ISOLYTE M W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;150MG/100ML;130MG/100ML;280MG N018270 001
/100ML;91MG/100ML

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE


INJECTABLE; INJECTION

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%


B BRAUN 5GM/100ML;75MG/100ML;200MG/100ML N018268 009


DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;150MG/100ML;200MG/100ML N018268 004


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 98 (of 324)

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE


INJECTABLE; INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;200MG/100ML N018268 005
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;300MG/100ML;200MG/100ML N018268 006
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;75MG/100ML;330MG/100ML N018268 011 Jan 18, 1986
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;150MG/100ML;330MG/100ML N018268 012 Jan 18, 1986
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;330MG/100ML N018268 013 Jan 18, 1986
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;300MG/100ML;330MG/100ML N018268 014 Jan 18, 1986
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%
B BRAUN 5GM/100ML;75MG/100ML;450MG/100ML N018268 010
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;150MG/100ML;450MG/100ML N018268 001
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;450MG/100ML N018268 002
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;300MG/100ML;450MG/100ML N018268 003
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;224MG/100ML;450MG/100ML N018008 003
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;300MG/100ML;450MG/100ML N018008 001
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;75MG/100ML;450MG/100ML N018008 002

DEXTROSE; SODIUM CHLORIDE


INJECTABLE; INJECTION
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;200MG/100ML N018386 001
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;450MG/100ML N018229 001
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;900MG/100ML N018047 001
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 2.5GM/100ML;450MG/100ML N018030 001
HOSPIRA 2.5GM/100ML;450MG/100ML N018096 001
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 2.5GM/100ML;900MG/100ML N018376 001
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
ABBOTT 3.3GM/100ML;300MG/100ML N018055 001
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;110MG/100ML N018030 005
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;200MG/100ML N018030 004
MILES 5GM/100ML;200MG/100ML N018399 001
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
ABBOTT 5GM/100ML;225MG/100ML N019482 001 Oct 04, 1985
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
ABBOTT 5GM/100ML;300MG/100ML N019486 001 Oct 04, 1985
MILES 5GM/100ML;300MG/100ML N018501 001
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;330MG/100ML N018030 003
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
ABBOTT 5GM/100ML;450MG/100ML N019484 001 Oct 04, 1985
B BRAUN 5GM/100ML;450MG/100ML N018030 002
MILES 5GM/100ML;450MG/100ML N018400 001
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ABBOTT 5GM/100ML;900MG/100ML N019483 001 Oct 04, 1985
B BRAUN 5GM/100ML;900MG/100ML N018026 001
MILES 5GM/100ML;900MG/100ML N018500 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 99 (of 324)

DEXTROTHYROXINE SODIUM
TABLET; ORAL
CHOLOXIN
ABBOTT 1MG N012302 005
2MG N012302 002
4MG N012302 004
6MG N012302 006

DEZOCINE
INJECTABLE; INJECTION
DALGAN
ASTRAZENECA 5MG/ML N019082 001 Dec 29, 1989
10MG/ML N019082 002 Dec 29, 1989
15MG/ML N019082 003 Dec 29, 1989

DIATRIZOATE MEGLUMINE
INJECTABLE; INJECTION
ANGIOVIST 282
BAYER HLTHCARE 60% A087726 001 Sep 23, 1982
CARDIOGRAFIN
BRACCO 85% N011620 002
DIATRIZOATE MEGLUMINE
BRACCO 76% N010040 017
HYPAQUE
GE HEALTHCARE 30% N016403 002
60% N016403 001
RENO-60
BRACCO 60% N010040 016
RENO-DIP
BRACCO 30% N010040 012
UROVIST MEGLUMINE DIU/CT
BAYER HLTHCARE 30% A087739 001 Sep 23, 1982
SOLUTION; URETERAL
RENO-30
BRACCO 30% N010040 021
UROVIST CYSTO
BAYER HLTHCARE 30% A087729 001 Sep 23, 1982
UROVIST CYSTO PEDIATRIC
BAYER HLTHCARE 30% A087731 001 Sep 23, 1982
SOLUTION; URETHRAL
HYPAQUE-CYSTO
GE HEALTHCARE 30% N016403 003

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM


INJECTABLE; INJECTION
ANGIOVIST 292
BAYER HLTHCARE 52%;8% A087724 001 Sep 23, 1982
ANGIOVIST 370
BAYER HLTHCARE 66%;10% A087723 001 Sep 23, 1982
DIATRIZOATE-60
INTL MEDICATION 52%;8% A088166 001 Jun 17, 1983
HYPAQUE-76
GE HEALTHCARE 66%;10% A086505 001
HYPAQUE-M,75%
GE HEALTHCARE 50%;25% N010220 003
HYPAQUE-M,90%
GE HEALTHCARE 60%;30% N010220 002
MD-60
MALLINCKRODT 52%;8% A087074 001
MD-76
MALLINCKRODT 66%;10% A087073 001
RENOCAL-76
BRACCO 66%;10% A089347 001 Jun 01, 1988
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DISCONTINUED DRUG PRODUCT LIST 6 - 100 (of 324)

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM


INJECTABLE; INJECTION
RENOGRAFIN-60
BRACCO 52%;8% N010040 006
RENOVIST
BRACCO 34.3%;35% N010040 020
RENOVIST II
BRACCO 28.5%;29.1% N010040 019
SOLUTION; ORAL, RECTAL
GASTROVIST
BAYER HLTHCARE 66%;10% A087728 001 Sep 23, 1982

DIATRIZOATE SODIUM
INJECTABLE; INJECTION
HYPAQUE
GE HEALTHCARE 25% N009561 003
50% N009561 001
MD-50
MALLINCKRODT 50% A087075 001
UROVIST SODIUM 300
BAYER HLTHCARE 50% A087725 001 Sep 23, 1982
SOLUTION; ORAL, RECTAL
HYPAQUE
GE HEALTHCARE 40% N011386 003
SOLUTION; URETERAL
HYPAQUE SODIUM 20%
GE HEALTHCARE 20% N009561 002

DIAZEPAM
CAPSULE, EXTENDED RELEASE; ORAL
VALRELEASE
ROCHE 15MG N018179 001
GEL; RECTAL
DIASTAT
VALEANT 5MG/ML (5MG/ML) N020648 002 Jul 29, 1997
10MG/2ML (5MG/ML) N020648 003 Jul 29, 1997
15MG/3ML (5MG/ML) N020648 004 Jul 29, 1997
20MG/4ML (5MG/ML) N020648 005 Jul 29, 1997
INJECTABLE; INJECTION
DIAZEPAM
ABRAXIS PHARM 5MG/ML A070662 001 Jun 25, 1986
BAXTER HLTHCARE 5MG/ML A070311 001 Dec 16, 1985
5MG/ML A070312 001 Dec 16, 1985
5MG/ML A070313 001 Dec 16, 1985
5MG/ML A071308 001 Jul 17, 1987
5MG/ML A071309 001 Jul 17, 1987
5MG/ML A071310 001 Jul 17, 1987
MARSAM PHARMS LLC 5MG/ML A072370 001 Jan 29, 1993
5MG/ML A072371 001 Jan 29, 1993
5MG/ML A072397 001 Jan 29, 1993
PARENTA PHARMS 5MG/ML A076815 001 Apr 15, 2004
US ARMY 5MG/ML N020124 001 Dec 05, 1990
WARNER CHILCOTT 5MG/ML A071613 001 Oct 22, 1987
5MG/ML A071614 001 Oct 22, 1987
WATSON LABS 5MG/ML A070911 001 Aug 28, 1986
5MG/ML A070912 001 Aug 28, 1986
5MG/ML A070930 001 Dec 01, 1986
DIZAC
PHARMACIA AND UPJOHN 5MG/ML N019287 001 Jun 18, 1993
VALIUM
ROCHE 5MG/ML N016087 001
TABLET; ORAL
DIAZEPAM
DAVA PHARMS INC 5MG A070227 001 Sep 26, 1985
10MG A070228 001 Sep 26, 1985
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DISCONTINUED DRUG PRODUCT LIST 6 - 101 (of 324)

DIAZEPAM
TABLET; ORAL
DIAZEPAM
DURAMED PHARMS BARR 2MG A070894 001 Aug 27, 1986
5MG A070895 001 Aug 27, 1986
10MG A070896 001 Aug 27, 1986
FERNDALE LABS 2MG A070903 001 Apr 01, 1987
5MG A070904 001 Apr 01, 1987
10MG A070905 001 Apr 01, 1987
HALSEY 2MG A070987 001 Aug 15, 1986
5MG A070996 001 Aug 15, 1986
10MG A070956 001 Aug 15, 1986
IVAX SUB TEVA PHARMS 2MG A070360 001 Sep 04, 1985
5MG A070361 001 Sep 04, 1985
10MG A070362 001 Sep 04, 1985
MARTEC USA LLC 10MG A072402 001 Apr 25, 1989
PAR PHARM 2MG A070462 001 Feb 25, 1986
5MG A070463 001 Feb 25, 1986
10MG A070464 001 Feb 25, 1986
PIONEER PHARMS 2MG A070787 001 Aug 02, 1988
5MG A070788 001 Aug 02, 1988
10MG A070776 001 Aug 02, 1988
ROXANE 2MG A070356 001 Jun 17, 1986
5MG A070357 001 Jun 17, 1986
10MG A070358 001 Jun 17, 1986
SANDOZ 2MG A070302 001 Dec 20, 1985
5MG A070303 001 Dec 20, 1985
10MG A070304 001 Dec 20, 1985
WARNER CHILCOTT 2MG A070209 001 Sep 04, 1985
5MG A070210 001 Sep 04, 1985
10MG A070222 001 Sep 04, 1985
WATSON LABS 2MG A070456 001 Nov 01, 1985
5MG A070457 001 Nov 01, 1985
10MG A070458 001 Nov 01, 1985
Q-PAM
QUANTUM PHARMICS 2MG A070423 001 Dec 12, 1985
2MG A072431 001 Apr 29, 1988
5MG A070424 001 Dec 12, 1985
5MG A072432 001 Apr 29, 1988
10MG A070425 001 Dec 12, 1985
10MG A072433 001 Apr 29, 1988

DIAZOXIDE
CAPSULE; ORAL
PROGLYCEM
TEVA GLOBAL 50MG N017425 001
100MG N017425 002
INJECTABLE; INJECTION
DIAZOXIDE
ABRAXIS PHARM 15MG/ML A071519 001 Aug 26, 1987
HYPERSTAT
SCHERING 15MG/ML N016996 001

DIBUCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
HEAVY SOLUTION NUPERCAINE
NOVARTIS 2.5MG/ML N006203 001

DICHLORPHENAMIDE
TABLET; ORAL
DARANIDE
TARO 50MG N011366 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 102 (of 324)

DICLOFENAC POTASSIUM
TABLET; ORAL
CATAFLAM
NOVARTIS 25MG N020142 001 Nov 24, 1993
DICLOFENAC POTASSIUM
MUTUAL PHARM 50MG A075470 001 Feb 21, 2002

DICLOFENAC SODIUM
SOLUTION/DROPS; OPHTHALMIC
DICLOFENAC SODIUM
FALCON PHARMS 0.1% N020809 001 May 04, 1998
TABLET, DELAYED RELEASE; ORAL
DICLOFENAC SODIUM
PLIVA 50MG A074432 002 Jul 29, 1999
75MG A074432 003 Jul 29, 1999
ROXANE 25MG A074391 001 Jun 29, 1995
50MG A074391 002 Jun 29, 1995
75MG A074391 003 Jun 29, 1995
TEVA 50MG A074723 001 Mar 30, 1999
75MG A074390 001 Aug 15, 1996
TEVA PHARMS 25MG A074459 001 Jun 25, 1997
50MG A074459 002 Jun 25, 1997
75MG A074459 003 Jun 25, 1997
VOLTAREN
NOVARTIS 25MG N019201 001 Jul 28, 1988
50MG N019201 002 Jul 28, 1988

DICLOXACILLIN SODIUM
CAPSULE; ORAL
DYCILL
GLAXOSMITHKLINE EQ 250MG BASE A060254 002
EQ 250MG BASE A062238 001
EQ 500MG BASE A060254 003
EQ 500MG BASE A062238 002
PATHOCIL
WYETH AYERST EQ 250MG BASE N050011 002
EQ 500MG BASE N050011 003 Mar 28, 1983
FOR SUSPENSION; ORAL
DICLOXACILLIN SODIUM
APOTHECON EQ 62.5MG BASE/5ML A061455 001
DYNAPEN
APOTHECON EQ 62.5MG BASE/5ML N050337 002
PATHOCIL
WYETH AYERST EQ 62.5MG BASE/5ML N050092 001

DICUMAROL
CAPSULE; ORAL
DICUMAROL
LILLY 25MG N005509 003
50MG N005509 001
TABLET; ORAL
DICUMAROL
ABBOTT 25MG N005545 003
50MG N005545 004
100MG N005545 005

DICYCLOMINE HYDROCHLORIDE
CAPSULE; ORAL
DICYCLOMINE HYDROCHLORIDE
MUTUAL PHARM 10MG A084505 001 Oct 21, 1986
PIONEER PHARMS 10MG A089361 001 Jan 10, 1989
WATSON LABS 10MG A083179 001 Feb 12, 1986
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DISCONTINUED DRUG PRODUCT LIST 6 - 103 (of 324)

DICYCLOMINE HYDROCHLORIDE
INJECTABLE; INJECTION
DICYCLOMINE HYDROCHLORIDE
WATSON LABS 10MG/ML A080614 001 Feb 11, 1986
SYRUP; ORAL
DICYCLOMINE HYDROCHLORIDE
ALPHARMA US PHARMS 10MG/5ML A084479 001
TABLET; ORAL
DICYCLOMINE HYDROCHLORIDE
MUTUAL PHARM 20MG A084600 001 Jul 29, 1985
PIONEER PHARMS 20MG A088585 001 Aug 20, 1986
WATSON LABS 20MG A084361 001 Feb 06, 1986

DIDANOSINE
FOR SOLUTION; ORAL
VIDEX
BRISTOL MYERS SQUIBB 100MG/PACKET N020155 003 Oct 09, 1991
167MG/PACKET N020155 004 Oct 09, 1991
250MG/PACKET N020155 005 Oct 09, 1991
375MG/PACKET N020155 006 Oct 09, 1991
TABLET, CHEWABLE; ORAL
VIDEX
BRISTOL MYERS SQUIBB 25MG N020154 002 Oct 09, 1991
50MG N020154 003 Oct 09, 1991
100MG N020154 004 Oct 09, 1991
150MG N020154 005 Oct 09, 1991
200MG N020154 006 Oct 28, 1999

DIENESTROL
CREAM; VAGINAL
DIENESTROL
ORTHO MCNEIL PHARM 0.01% N006110 005
DV
SANOFI AVENTIS US 0.01% A083518 001
ESTRAGUARD
SOLVAY 0.01% A084436 001
SUPPOSITORY; VAGINAL
DV
SANOFI AVENTIS US 0.7MG A083517 001

DIETHYLCARBAMAZINE CITRATE
TABLET; ORAL
HETRAZAN
LEDERLE 50MG N006459 001

DIETHYLPROPION HYDROCHLORIDE
TABLET; ORAL
DIETHYLPROPION HYDROCHLORIDE
SANDOZ 25MG A085916 001
TEVA 25MG A088642 001 Sep 20, 1984
TG UNITED LABS 25MG A088267 001 Aug 25, 1983
25MG A088268 001 Aug 25, 1983
UCB INC 25MG A085544 001
WATSON LABS 25MG A085741 001
TENUATE
SANOFI AVENTIS US 25MG N017668 001
TEPANIL
3M 25MG N011673 001
TABLET, EXTENDED RELEASE; ORAL
TENUATE
SANOFI AVENTIS US 75MG N017669 001
TEPANIL TEN-TAB
3M 75MG N017956 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 104 (of 324)

DIETHYLSTILBESTROL
INJECTABLE; INJECTION
STILBESTROL
BRISTOL MYERS SQUIBB 0.2MG/ML N004056 003
0.5MG/ML N004056 004
1MG/ML N004056 005
5MG/ML N004056 006
SUPPOSITORY; VAGINAL
DIETHYLSTILBESTROL
LILLY 0.1MG N004040 001
0.5MG N004040 002
STILBESTROL
BRISTOL MYERS SQUIBB 0.1MG N004056 001
0.5MG N004056 002
TABLET; ORAL
DIETHYLSTILBESTROL
LILLY 0.1MG N004041 002
0.5MG N004041 003
1MG N004041 004
5MG N004041 005
STILBESTROL
TABLICAPS 0.5MG A083004 001
1MG A083002 001
5MG A083006 001
STILBETIN
BRISTOL MYERS SQUIBB 0.1MG N004056 007
0.25MG N004056 017
0.5MG N004056 008
1MG N004056 009
5MG N004056 010
TABLET, DELAYED RELEASE; ORAL
DIETHYLSTILBESTROL
LILLY 0.1MG N004039 002
0.25MG N004039 005
0.5MG N004039 003
1MG N004039 004
5MG N004039 006
STILBESTROL
TABLICAPS 0.5MG A083003 001
1MG A083005 001
5MG A083007 001
STILBETIN
BRISTOL MYERS SQUIBB 0.1MG N004056 011
0.5MG N004056 012
1MG N004056 013
5MG N004056 014

DIETHYLSTILBESTROL DIPHOSPHATE
INJECTABLE; INJECTION
STILPHOSTROL
BAYER PHARMS 250MG/5ML N010010 001
TABLET; ORAL
STILPHOSTROL
BAYER PHARMS 50MG N010010 002

DIFLORASONE DIACETATE
CREAM; TOPICAL
FLORONE
PHARMACIA AND UPJOHN 0.05% N017741 001
FLORONE E
PHARMACIA AND UPJOHN 0.05% N019259 001 Aug 28, 1985
OINTMENT; TOPICAL
PSORCON
PHARMACIA AND UPJOHN 0.05% N019260 001 Aug 28, 1985
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DISCONTINUED DRUG PRODUCT LIST 6 - 105 (of 324)

DIFLORASONE DIACETATE
OINTMENT; TOPICAL

PSORCON E

PHARMACIA AND UPJOHN 0.05% N017994 001


DIFLUNISAL
TABLET; ORAL

DIFLUNISAL

PUREPAC PHARM 250MG A074285 001 May 07, 1996


500MG A074285 002 May 07, 1996
ROXANE 250MG A073562 001 Nov 27, 1992
500MG A073563 001 Nov 27, 1992
SANDOZ 500MG A074604 001 Jun 10, 1996
TEVA 250MG A073679 001 Jul 31, 1992
WATSON LABS 250MG A074400 001 Jul 17, 1997
500MG A074400 002 Jul 17, 1997
DOLOBID
MERCK 250MG N018445 001 Apr 19, 1982
500MG N018445 002 Apr 19, 1982

DIGITOXIN
INJECTABLE; INJECTION

CRYSTODIGIN

LILLY 0.2MG/ML A084100 005


DIGOXIN
CAPSULE; ORAL
LANOXICAPS
SMITHKLINE BEECHAM 0.15MG N018118 004 Sep 24, 1984
INJECTABLE; INJECTION
DIGOXIN
ABRAXIS PHARM 0.25MG/ML A083217 001
HOSPIRA 0.25MG/ML A040206 001 Aug 28, 1998
WYETH AYERST 0.25MG/ML A084386 001
DIGOXIN PEDIATRIC
HOSPIRA 0.1MG/ML A040092 001 Apr 25, 1996
TABLET; ORAL
LANOXIN
SMITHKLINE BEECHAM 0.0625MG N020405 001 Sep 30, 1997
0.1875MG N020405 003 Sep 30, 1997
0.375MG N020405 005 Sep 30, 1997
0.5MG N020405 006 Sep 30, 1997

DIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDE


INJECTABLE; INJECTION

EMBOLEX

NOVARTIS 0.5MG/0.5ML;2,500 N018885 001 Nov 30, 1984


UNITS/0.5ML;5.33MG/0.5ML
0.5MG/0.7ML;5,000 N018885 002 Nov 30, 1984
UNITS/0.7ML;7.46MG/0.7ML

DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL

CARDIZEM SR

BIOVAIL 60MG N019471 001 Jan 23, 1989


90MG N019471 002 Jan 23, 1989
120MG N019471 003 Jan 23, 1989
180MG N019471 004 Jan 23, 1989
DILTIAZEM HYDROCHLORIDE
BIOVAIL 60MG A074845 001 Sep 15, 1999
90MG A074845 002 Sep 15, 1999
120MG A074845 003 Sep 15, 1999
120MG N020939 001 Jan 28, 2000
180MG N020939 002 Jan 28, 2000
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DISCONTINUED DRUG PRODUCT LIST 6 - 106 (of 324)

DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
DILTIAZEM HYDROCHLORIDE
BIOVAIL 240MG N020939 003 Jan 28, 2000
300MG N020939 004 Jan 28, 2000
360MG N020939 005 Sep 14, 2001
420MG N020939 006 Sep 14, 2001
TEVA 60MG A074079 001 Nov 30, 1993
90MG A074079 002 Nov 30, 1993
120MG A074079 003 Nov 30, 1993
INJECTABLE; INJECTION
CARDIZEM
BIOVAIL 100MG/VIAL N020792 001 Sep 05, 1997
BIOVAIL LABS INTL 5MG/ML N020027 001 Oct 24, 1991
25MG/VIAL N020027 003 Aug 18, 1995
DILTIAZEM HYDROCHLORIDE
HOSPIRA 5MG/ML A075004 001 Feb 16, 2000
5MG/ML A075106 001 Apr 29, 1999
TABLET; ORAL
DILTIAZEM HYDROCHLORIDE
APOTHECON 30MG A074051 001 Mar 31, 1993
60MG A074051 002 Mar 31, 1993
90MG A074051 003 Mar 31, 1993
120MG A074051 004 Mar 31, 1993
IVAX SUB TEVA PHARMS 30MG A074168 001 Mar 03, 1995
60MG A074168 002 Mar 03, 1995
90MG A074168 003 Mar 03, 1995
120MG A074168 004 Mar 03, 1995
TEVA 30MG A074084 001 Feb 25, 1994
60MG A074084 002 Feb 25, 1994
TEVA PHARMS 30MG A074067 001 Nov 05, 1992
60MG A074067 002 Nov 05, 1992
90MG A074067 003 Nov 05, 1992
120MG A074067 004 Nov 05, 1992

DILTIAZEM MALATE
TABLET, EXTENDED RELEASE; ORAL
TIAMATE
MERCK EQ 120MG HCL N020506 001 Oct 04, 1996
EQ 180MG HCL N020506 002 Oct 04, 1996
EQ 240MG HCL N020506 003 Oct 04, 1996

DILTIAZEM MALATE; ENALAPRIL MALEATE


TABLET, EXTENDED RELEASE; ORAL
TECZEM
BIOVAIL EQ 180MG HCL;5MG N020507 001 Oct 04, 1996

DIMENHYDRINATE
INJECTABLE; INJECTION
DIMENHYDRINATE
BAXTER HLTHCARE 50MG/ML A084767 001
WATSON LABS 50MG/ML A083531 001
WYETH AYERST 50MG/ML A084316 001
LIQUID; ORAL
DIMENHYDRINATE
ALRA 12.5MG/4ML A080715 001
TABLET; ORAL
DIMENHYDRINATE
HEATHER 50MG A080841 001
NEXGEN PHARMA INC 50MG A085985 001
WATSON LABS 50MG A085166 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 107 (of 324)

DIMYRISTOYL LECITHIN; PERFLEXANE


INJECTABLE; INTRAVENOUS
IMAGENT
IMCOR PHARMS CO 0.92MG/VIAL;0.092MG/VIAL N021191 001 May 31, 2002

DINOPROST TROMETHAMINE
INJECTABLE; INJECTION
PROSTIN F2 ALPHA
PHARMACIA AND UPJOHN EQ 5MG BASE/ML N017434 001

DIPHEMANIL METHYLSULFATE
TABLET; ORAL
PRANTAL
SCHERING 100MG N008114 004

DIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE; ORAL
BENADRYL
MCNEIL CONS 25MG N005845 007
50MG N005845 001
DIPHENHYDRAMINE HYDROCHLORIDE
ALRA 25MG A080519 004
50MG A080519 003
ANABOLIC 50MG A083275 001
ELKINS SINN 25MG A085701 001
50MG A085701 002
HALSEY 50MG A087914 001 Jun 04, 1984
HEATHER 25MG A084524 001
50MG A083953 001
IMPAX LABS 25MG A080807 001
50MG A080807 002
IVAX SUB TEVA PHARMS 25MG A080762 001
50MG A080762 002
LANNETT 25MG A080868 001
50MG A080868 002
LEDERLE 25MG A086874 001
50MG A086875 001
LNK 25MG A087977 001 Jan 27, 1983
50MG A087978 001 Jan 27, 1983
MK LABS 25MG A083087 001
50MG A083087 002
MUTUAL PHARM 25MG A084506 001
25MG A089488 001 Jan 02, 1987
50MG A089489 001 Jan 02, 1987
NEWTRON PHARMS 25MG A086543 001
50MG A086544 001
NEXGEN PHARMA INC 25MG A083634 001
PERRIGO 25MG A083061 001
50MG A083061 002
PIONEER PHARMS 25MG A089101 001 Dec 20, 1985
50MG A088880 001 Dec 20, 1985
PUREPAC PHARM 25MG A085156 001
50MG A085150 001
PVT FORM 25MG A083027 001
50MG A083027 002
ROXANE 50MG A080635 001
SANDOZ 25MG A080832 001
25MG A080845 002
50MG A080832 002
50MG A080845 001
SUPERPHARM 25MG A089040 001 May 15, 1985
50MG A089041 001 May 15, 1985
TEVA 25MG A085874 001
50MG A085874 002
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DISCONTINUED DRUG PRODUCT LIST 6 - 108 (of 324)

DIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE; ORAL
DIPHENHYDRAMINE HYDROCHLORIDE
VALEANT PHARM INTL 25MG A080596 001
50MG A080592 001
VANGARD 25MG A088034 001 Oct 27, 1982
50MG A087630 001
WATSON LABS 25MG A080728 001
25MG A083797 001
25MG A085138 001
50MG A080727 001
50MG A083797 002
50MG A085083 001
WEST WARD 50MG A083567 001
WHITEWORTH TOWN PLSN 25MG A083441 001
50MG A080800 001
ELIXIR; ORAL
BELIX
HALSEY 12.5MG/5ML A086586 001 Oct 03, 1983
BENADRYL
MCNEIL CONS 12.5MG/5ML N005845 004
DIBENIL
CENCI 12.5MG/5ML A088304 001 Dec 16, 1983
DIPHEN
USL PHARMA 12.5MG/5ML A084640 001
DIPHENHYDRAMINE HYDROCHLORIDE
BUNDY 12.5MG/5ML A083674 001
CENCI 12.5MG/5ML A087941 001 Dec 17, 1982
KV PHARM 12.5MG/5ML A085621 001
LANNETT 12.5MG/5ML A080939 002
LEDERLE 12.5MG/5ML A086937 001
MK LABS 12.5MG/5ML A083088 002
NASKA 12.5MG/5ML A088680 001 May 31, 1985
PERRIGO 12.5MG/5ML A083063 001
PUREPAC PHARM 12.5MG/5ML A083237 001 Jan 25, 1982
PVT FORM 12.5MG/5ML A085287 001
ROXANE 12.5MG/5ML A080643 001
HYDRAMINE
ALPHARMA US PHARMS 12.5MG/5ML A080763 002
INJECTABLE; INJECTION
BENADRYL
MCNEIL CONS 10MG/ML N006146 001
DIPHENHYDRAMINE HYDROCHLORIDE
ABRAXIS PHARM 10MG/ML A087066 001
BAXTER HLTHCARE 50MG/ML A083183 001
BEL MAR 10MG/ML A080822 001
WATSON LABS 10MG/ML A083533 001
WYETH AYERST 50MG/ML A080577 001
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
ABRAXIS PHARM 50MG/ML A080586 002
SYRUP; ORAL
ANTITUSSIVE
PERRIGO 12.5MG/5ML A071292 001 Apr 10, 1987
BELDIN
HALSEY 12.5MG/5ML A089179 001 Jun 05, 1986
BENYLIN
PARKE DAVIS 12.5MG/5ML N006514 004
DIPHEN
MORTON GROVE 12.5MG/5ML A070118 001 Oct 01, 1985
DIPHENHYDRAMINE HYDROCHLORIDE
ALPHARMA US PHARMS 12.5MG/5ML A070497 001 Apr 25, 1989
CUMBERLAND SWAN 12.5MG/5ML A073611 001 Aug 20, 1992
HI TECH PHARMA 12.5MG/5ML A072416 001 Sep 28, 1990
HYDRAMINE
ALPHARMA US PHARMS 12.5MG/5ML A070205 001 Jan 28, 1986
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 109 (of 324)

DIPHENHYDRAMINE HYDROCHLORIDE
SYRUP; ORAL
SILPHEN
SILARX 12.5MG/5ML A072646 001 Feb 27, 1992
VICKS FORMULA 44
PROCTER AND GAMBLE 12.5MG/5ML A070524 001 Jan 14, 1987

DIPHENHYDRAMINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE


SOLUTION; ORAL
BENYLIN
PARKE DAVIS 12.5MG/5ML;30MG/5ML N019014 001 Jun 11, 1985

DIPHENIDOL HYDROCHLORIDE
TABLET; ORAL
VONTROL
GLAXOSMITHKLINE EQ 25MG BASE N016033 001

DIPHENYLPYRALINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
HISPRIL
GLAXOSMITHKLINE 5MG N011945 001

DIPYRIDAMOLE
INJECTABLE; INJECTION
IV PERSANTINE
BOEHRINGER INGELHEIM 5MG/ML N019817 001 Dec 13, 1990
TABLET; ORAL
DIPYRIDAMOLE
PUREPAC PHARM 50MG A089426 001 Jul 12, 1990
75MG A089427 001 Jul 12, 1990
SANDOZ 25MG A086944 002 Apr 16, 1991
50MG A087562 001 Feb 25, 1992
75MG A087561 001 Feb 25, 1992

DIRITHROMYCIN
TABLET, DELAYED RELEASE; ORAL
DYNABAC
LILLY RES LABS 250MG N050678 001 Jun 19, 1995

DISOPYRAMIDE PHOSPHATE
CAPSULE; ORAL
DISOPYRAMIDE PHOSPHATE
AMNEAL PHARMS NY EQ 100MG BASE A071190 001 Jan 15, 1987
EQ 150MG BASE A071191 001 Jan 15, 1987
IVAX SUB TEVA PHARMS EQ 100MG BASE A070186 001 Nov 18, 1985
EQ 150MG BASE A070187 001 Nov 18, 1985
MUTUAL PHARM EQ 100MG BASE A070351 001 Dec 17, 1985
EQ 150MG BASE A070352 001 Dec 17, 1985
MYLAN EQ 100MG BASE A070138 001 Jun 14, 1985
EQ 150MG BASE A070139 001 Jun 14, 1985
SANDOZ EQ 100MG BASE A070470 001 Dec 10, 1985
EQ 150MG BASE A070471 001 Dec 10, 1985
SUPERPHARM EQ 100MG BASE A070940 001 Feb 09, 1987
EQ 150MG BASE A070941 001 Feb 09, 1987
WATSON LABS EQ 100MG BASE A070240 001 Feb 02, 1986
EQ 150MG BASE A070241 001 Feb 02, 1986

DISULFIRAM
TABLET; ORAL
ANTABUSE
ODYSSEY PHARMS 250MG N007883 003
500MG N007883 002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 110 (of 324)

DISULFIRAM
TABLET; ORAL
DISULFIRAM
PAR PHARM 250MG A088792 001 Aug 14, 1984
500MG A088793 001 Aug 14, 1984
WATSON LABS 250MG A086889 001
250MG A087973 001 Aug 05, 1983
500MG A086890 001
500MG A087974 001 Aug 05, 1983

DIVALPROEX SODIUM
TABLET, DELAYED RELEASE; ORAL
DEPAKOTE CP
ABBOTT EQ 250MG BASE N019794 001 Jul 11, 1990
EQ 500MG BASE N019794 002 Jul 11, 1990

DOBUTAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
DOBUTAMINE HYDROCHLORIDE
ASTRAZENECA EQ 12.5MG BASE/ML A074098 001 Feb 21, 1995
BAXTER HLTHCARE EQ 12.5MG BASE/ML A074381 001 Sep 26, 1996
HOSPIRA EQ 1.25GM BASE/100ML A074634 001 Sep 27, 1996
LUITPOLD EQ 12.5MG BASE/ML A074545 001 Jun 25, 1998
MARSAM PHARMS LLC EQ 12.5MG BASE/ML A074279 001 Feb 18, 1998
EQ 12.5MG BASE/ML A074995 001 Mar 31, 1998
DOBUTREX
LILLY EQ 12.5MG BASE/ML N017820 002

DONEPEZIL HYDROCHLORIDE
SOLUTION; ORAL
ARICEPT
EISAI INC 5MG/5ML N021719 001 Oct 18, 2004

DOPAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
DOPAMINE HYDROCHLORIDE
ABBOTT 40MG/ML A070656 001 Jan 24, 1989
80MG/ML A070657 001 Jan 24, 1989
ABRAXIS PHARM 40MG/ML A070012 001 Jun 12, 1985
40MG/ML A070058 001 Mar 20, 1985
40MG/ML N018549 001 Mar 11, 1983
80MG/ML A070013 001 Jun 12, 1985
80MG/ML A070059 001 Mar 20, 1985
160MG/ML A070364 001 Dec 04, 1985
ASTRAZENECA 40MG/ML A070087 001 Oct 23, 1985
40MG/ML N018656 001 Jun 28, 1983
80MG/ML A070089 001 Oct 23, 1985
80MG/ML A070090 001 Oct 23, 1985
80MG/ML A070091 001 Oct 23, 1985
160MG/ML A070092 001 Oct 23, 1985
160MG/ML A070093 001 Oct 23, 1985
160MG/ML A070094 001 Oct 23, 1985
BAXTER HLTHCARE 40MG/ML N018398 001
80MG/ML N018398 002 Mar 22, 1982
HOSPIRA 40MG/ML A074403 001 May 23, 1996
INTL MEDICATION 40MG/ML N018014 001
SMITH AND NEPHEW 40MG/ML A070011 001 Aug 29, 1985
40MG/ML A070046 001 Aug 29, 1985
80MG/ML A070047 001 Aug 29, 1985
TEVA PARENTERAL 40MG/ML A072999 001 Oct 23, 1991
80MG/ML A073000 001 Oct 23, 1991
WARNER CHILCOTT 40MG/ML A070558 001 Sep 20, 1985
40MG/ML N018138 001
80MG/ML A070559 001 Sep 20, 1985
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 111 (of 324)

DOPAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5%
HOSPIRA 1.6MG/ML N020542 001 Aug 30, 1995
INTROPIN
HOSPIRA 40MG/ML N017395 001
80MG/ML N017395 002
160MG/ML N017395 003

DOXACURIUM CHLORIDE
INJECTABLE; INJECTION
NUROMAX
ABBOTT EQ 1MG BASE/ML N019946 001 Mar 07, 1991

DOXAZOSIN MESYLATE
TABLET; ORAL
DOXAZOSIN MESYLATE
GENPHARM EQ 1MG BASE A075466 001 Oct 18, 2000
EQ 2MG BASE A075466 002 Oct 18, 2000
EQ 4MG BASE A075466 003 Oct 18, 2000
EQ 8MG BASE A075466 004 Oct 18, 2000
SANDOZ EQ 1MG BASE A075646 001 Oct 18, 2000
EQ 2MG BASE A075646 002 Oct 18, 2000
EQ 4MG BASE A075646 003 Oct 18, 2000
EQ 8MG BASE A075646 004 Oct 18, 2000
TEVA EQ 1MG BASE A075353 001 Jan 12, 2001
EQ 2MG BASE A075353 002 Jan 12, 2001
EQ 4MG BASE A075353 003 Jan 12, 2001
EQ 8MG BASE A075353 004 Jan 12, 2001

DOXEPIN HYDROCHLORIDE
CAPSULE; ORAL
DOXEPIN HYDROCHLORIDE
CLONMEL HLTHCARE EQ 10MG BASE A071685 001 Jan 05, 1988
EQ 25MG BASE A071686 001 Jan 05, 1988
EQ 50MG BASE A071673 001 Jan 05, 1988
EQ 75MG BASE A071674 001 Jan 05, 1988
EQ 100MG BASE A071675 001 Jan 05, 1988
EQ 150MG BASE A071676 001 Jan 05, 1988
MUTUAL PHARM EQ 25MG BASE A071502 001 Feb 18, 1988
EQ 50MG BASE A071653 001 Feb 18, 1988
EQ 75MG BASE A071654 001 Feb 18, 1988
EQ 100MG BASE A071521 001 Feb 18, 1988
NEW RIVER EQ 10MG BASE N016987 001
EQ 25MG BASE N016987 002
EQ 50MG BASE N016987 003
EQ 75MG BASE N016987 006
EQ 100MG BASE N016987 004
EQ 150MG BASE N016987 007 Apr 13, 1987
PUREPAC PHARM EQ 10MG BASE A073054 001 Dec 28, 1990
EQ 25MG BASE A072109 001 Dec 28, 1990
EQ 50MG BASE A073055 001 Dec 28, 1990
EQ 75MG BASE A072386 001 Sep 08, 1988
EQ 100MG BASE A072110 001 Sep 08, 1988
EQ 150MG BASE A072387 001 Sep 08, 1988
QUANTUM PHARMICS EQ 10MG BASE A070972 001 Sep 29, 1987
EQ 25MG BASE A070973 001 Sep 29, 1987
EQ 50MG BASE A070931 001 Sep 29, 1987
EQ 75MG BASE A070932 001 Sep 29, 1987
EQ 100MG BASE A072375 001 Mar 15, 1989
EQ 150MG BASE A072376 001 Mar 15, 1989
SANDOZ EQ 10MG BASE A071487 001 Mar 02, 1987
EQ 25MG BASE A070827 001 May 15, 1986
EQ 50MG BASE A070828 001 May 15, 1986
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 112 (of 324)

DOXEPIN HYDROCHLORIDE
CAPSULE; ORAL
DOXEPIN HYDROCHLORIDE
SANDOZ EQ 75MG BASE A070825 001 May 15, 1986
EQ 100MG BASE A071562 001 Mar 02, 1987
WATSON LABS EQ 10MG BASE A070952 001 Mar 04, 1987
EQ 10MG BASE A072985 001 Mar 29, 1991
EQ 25MG BASE A070953 001 May 15, 1986
EQ 25MG BASE A072986 001 Mar 29, 1991
EQ 50MG BASE A070954 001 May 15, 1986
EQ 50MG BASE A072987 001 Mar 29, 1991
EQ 75MG BASE A071763 001 Feb 09, 1988
EQ 100MG BASE A070955 001 May 15, 1986
EQ 150MG BASE A071764 001 Feb 09, 1988
SINEQUAN
PFIZER EQ 10MG BASE N016798 003
EQ 25MG BASE N016798 001
EQ 50MG BASE N016798 002
EQ 75MG BASE N016798 006
EQ 100MG BASE N016798 005
EQ 150MG BASE N016798 007
CONCENTRATE; ORAL
SINEQUAN
PFIZER EQ 10MG BASE/ML N017516 001

DOXORUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION
ADRIAMYCIN PFS
PHARMACIA AND UPJOHN 2MG/ML A063165 001 Jan 30, 1991
2MG/ML N050629 001 Dec 23, 1987
200MG/100ML A063165 002 Jan 30, 1991
200MG/100ML N050629 002 May 03, 1988
ADRIAMYCIN RDF
PHARMACIA AND UPJOHN 10MG/VIAL N050467 001
20MG/VIAL N050467 003 May 20, 1985
50MG/VIAL N050467 002
150MG/VIAL N050467 004 Jul 22, 1987
RUBEX
BRISTOL MYERS SQUIBB 10MG/VIAL A062926 001 Apr 13, 1989
50MG/VIAL A062926 002 Apr 13, 1989
100MG/VIAL A062926 003 Apr 13, 1989

DOXYCYCLINE
CAPSULE; ORAL
DOXYCYCLINE
PAR PHARM EQ 75MG BASE A065055 004 Apr 18, 2005
FOR SUSPENSION; ORAL
DOXYCHEL
RACHELLE EQ 25MG BASE/5ML A061720 001

DOXYCYCLINE HYCLATE
CAPSULE; ORAL
DOXYCYCLINE HYCLATE
AMNEAL PHARMS NY EQ 50MG BASE A062763 001 Sep 02, 1988
EQ 100MG BASE A062763 002 Sep 02, 1988
HALSEY EQ 50MG BASE A062119 002 May 24, 1985
EQ 100MG BASE A062119 001 May 24, 1985
HEATHER EQ 50MG BASE A062463 001 Dec 07, 1983
EQ 100MG BASE A062463 002 Dec 07, 1983
MUTUAL PHARM EQ 50MG BASE A062418 001 Jan 28, 1983
EQ 100MG BASE A062418 002 Jan 28, 1983
MYLAN EQ 50MG BASE A062337 001 Mar 29, 1982
EQ 100MG BASE A062337 002 Mar 29, 1982
PAR PHARM EQ 50MG BASE A062434 001 Oct 19, 1984
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 113 (of 324)

DOXYCYCLINE HYCLATE
CAPSULE; ORAL
DOXYCYCLINE HYCLATE
PAR PHARM EQ 100MG BASE A062442 001 Dec 22, 1983
PVT FORM EQ 50MG BASE A062631 001 Jul 24, 1986
EQ 100MG BASE A062631 002 Jul 24, 1986
RANBAXY EQ 50MG BASE A062479 001 Dec 23, 1983
EQ 100MG BASE A062479 002 Dec 23, 1983
SUPERPHARM EQ 50MG BASE A062469 001 Oct 31, 1984
EQ 100MG BASE A062469 002 Oct 31, 1984
WARNER CHILCOTT EQ 50MG BASE A062594 001 Dec 05, 1985
EQ 100MG BASE A062594 002 Dec 05, 1985
WATSON LABS EQ 50MG BASE A061717 001
EQ 50MG BASE A062142 001
EQ 100MG BASE A061717 002
EQ 100MG BASE A062142 002
DOXY-LEMMON
TEVA EQ 50MG BASE A062497 001 Aug 23, 1984
EQ 100MG BASE A062497 002 Jun 15, 1984
PERIOSTAT
COLLAGENEX EQ 20MG BASE N050744 001 Sep 30, 1998
CAPSULE, COATED PELLETS; ORAL
DOXYCYCLINE HYCLATE
PLIVA EQ 100MG BASE A063187 001 Jun 30, 1992
CAPSULE, DELAYED RELEASE; ORAL
DORYX
MAYNE PHARMA INTL EQ 75MG BASE N050582 002 Aug 13, 2001
EQ 100MG BASE N050582 001 Jul 22, 1985
WARNER CHILCOTT EQ 100MG BASE A062653 001 Oct 30, 1985
INJECTABLE; INJECTION
DOXYCHEL HYCLATE
RACHELLE EQ 100MG BASE/VIAL A061953 001
DOXYCYCLINE
BAXTER HLTHCARE EQ 100MG BASE/VIAL A062450 001 Oct 27, 1983
EQ 200MG BASE/VIAL A062450 002 Oct 27, 1983
BEDFORD EQ 200MG BASE/VIAL A062569 002 Mar 09, 1988
DOXYCYCLINE HYCLATE
BAXTER HLTHCARE EQ 100MG BASE/VIAL A062992 001 Feb 16, 1989
EQ 200MG BASE/VIAL A062992 002 Feb 16, 1989
VIBRAMYCIN
PFIZER EQ 100MG BASE/VIAL N050442 002
EQ 200MG BASE/VIAL N050442 001
TABLET; ORAL
DOXYCYCLINE HYCLATE
AMNEAL PHARMS NY EQ 100MG BASE A062764 001 Sep 02, 1988
HEATHER EQ 100MG BASE A062462 001 May 11, 1983
MUTUAL PHARM EQ 100MG BASE A062391 001 Sep 30, 1982
MYLAN EQ 100MG BASE A062432 001 Feb 15, 1983
PAR PHARM EQ 20MG BASE A065287 001 Feb 28, 2006
SUPERPHARM EQ 100MG BASE A062494 001 Feb 20, 1985
TRUXTON INC EQ 50MG BASE A062269 003
EQ 100MG BASE A062269 002 Nov 08, 1982
WARNER CHILCOTT EQ 100MG BASE A062593 001 Aug 28, 1985
WATSON LABS EQ 50MG BASE A062392 001 Mar 31, 1983
EQ 100MG BASE A062392 002 Mar 31, 1983
DOXY-LEMMON
TEVA EQ 100MG BASE A062581 001 Mar 15, 1985

DOXYLAMINE SUCCINATE
CAPSULE; ORAL
UNISOM
PFIZER 25MG N019440 001 Feb 05, 1986
TABLET; ORAL
DECAPRYN
SANOFI AVENTIS US 12.5MG N006412 015
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 114 (of 324)

DOXYLAMINE SUCCINATE
TABLET; ORAL
DECAPRYN
SANOFI AVENTIS US 25MG N006412 014
DOXYLAMINE SUCCINATE
COPLEY PHARM 25MG A088900 002 Feb 12, 1988
QUANTUM PHARMICS 25MG A088603 001 Aug 07, 1984
DOXY-SLEEP-AID
PAR PHARM 25MG A070156 001 Jul 02, 1987

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE


TABLET, EXTENDED RELEASE; ORAL
BENDECTIN
SANOFI AVENTIS US 10MG;10MG N010598 002

DROMOSTANOLONE PROPIONATE
INJECTABLE; INJECTION
DROLBAN
LILLY 50MG/ML N012936 001

DROPERIDOL
INJECTABLE; INJECTION
DROPERIDOL
ABRAXIS PHARM 2.5MG/ML A070992 001 Nov 17, 1986
2.5MG/ML A070993 001 Nov 17, 1986
ASTRAZENECA 2.5MG/ML A072018 001 Oct 20, 1988
2.5MG/ML A072019 001 Oct 19, 1988
2.5MG/ML A072020 001 Oct 19, 1988
2.5MG/ML A072021 001 Oct 19, 1988
HOSPIRA 2.5MG/ML A071645 001 Apr 07, 1988
2.5MG/ML A072272 001 Aug 31, 1995
SMITH AND NEPHEW 2.5MG/ML A071750 001 Sep 06, 1988
SOLOPAK 2.5MG/ML A071754 001 Sep 06, 1988
2.5MG/ML A071755 001 Sep 06, 1988
WATSON LABS 2.5MG/ML A073520 001 Nov 27, 1991
2.5MG/ML A073521 001 Nov 27, 1991
2.5MG/ML A073523 001 Nov 27, 1991

DROPERIDOL; FENTANYL CITRATE


INJECTABLE; INJECTION
FENTANYL CITRATE AND DROPERIDOL
ASTRAZENECA 2.5MG/ML;EQ 0.05MG BASE/ML A072026 001 Apr 13, 1989
2.5MG/ML;EQ 0.05MG BASE/ML A072027 001 Apr 13, 1989
2.5MG/ML;EQ 0.05MG BASE/ML A072028 001 Apr 13, 1989
HOSPIRA 2.5MG/ML;EQ 0.05MG BASE/ML A071982 001 May 04, 1988
INNOVAR
AKORN MFG 2.5MG/ML;EQ 0.05MG BASE/ML N016049 001

DYCLONINE HYDROCHLORIDE
SOLUTION; TOPICAL
DYCLONE
ASTRAZENECA 0.5% N009925 002
1% N009925 001

DYDROGESTERONE
TABLET; ORAL
GYNOREST
SOLVAY 5MG N017388 001
10MG N017388 002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 115 (of 324)

DYPHYLLINE
ELIXIR; ORAL
NEOTHYLLINE
TEVA 160MG/15ML N007794 003
INJECTABLE; INJECTION
NEOTHYLLINE
TEVA 250MG/ML N009088 001
TABLET; ORAL
DILOR
SAVAGE LABS 200MG A084514 001
DILOR-400
SAVAGE LABS 400MG A084751 001
NEOTHYLLINE
TEVA 200MG N007794 001
400MG N007794 002

ECHOTHIOPHATE IODIDE
FOR SOLUTION; OPHTHALMIC
PHOSPHOLINE IODIDE
WYETH PHARMS INC 0.03% N011963 002
0.06% N011963 004
0.25% N011963 003

ECONAZOLE NITRATE
CREAM; TOPICAL
SPECTAZOLE
ORTHONEUTROGENA 1% N018751 001 Dec 23, 1982

EDETATE CALCIUM DISODIUM


TABLET; ORAL
CALCIUM DISODIUM VERSENATE
GRACEWAY 500MG N008922 002

EDETATE DISODIUM
INJECTABLE; INJECTION
DISODIUM EDETATE
WATSON LABS 150MG/ML A084356 001
EDETATE DISODIUM
WATSON LABS 150MG/ML A080391 001
SODIUM VERSENATE
3M 200MG/ML N010573 001

EDROPHONIUM CHLORIDE
INJECTABLE; INJECTION
EDROPHONIUM CHLORIDE
WATSON LABS 10MG/ML A040044 001 Mar 20, 1996
EDROPHONIUM CHLORIDE PRESERVATIVE FREE
WATSON LABS 10MG/ML A040043 001 Mar 20, 1996
REVERSOL
ORGANON USA INC 10MG/ML A089624 001 May 13, 1988

EFAVIRENZ
CAPSULE; ORAL
SUSTIVA
BRISTOL MYERS SQUIBB 100MG N020972 002 Sep 17, 1998
TABLET; ORAL
SUSTIVA
BRISTOL MYERS SQUIBB 300MG N021360 001 Feb 01, 2002

EFLORNITHINE HYDROCHLORIDE
INJECTABLE; INJECTION
ORNIDYL
SANOFI AVENTIS US 200MG/ML N019879 002 Nov 28, 1990
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 116 (of 324)

ENALAPRIL MALEATE
TABLET; ORAL
ENALAPRIL MALEATE
APOTHECON 2.5MG A075583 001 Aug 22, 2000
5MG A075583 002 Aug 22, 2000
10MG A075583 003 Aug 22, 2000
20MG A075583 004 Aug 22, 2000
IVAX SUB TEVA PHARMS 2.5MG A075482 001 Aug 22, 2000
5MG A075482 002 Aug 22, 2000
10MG A075482 003 Aug 22, 2000
20MG A075482 004 Aug 22, 2000
SANDOZ 2.5MG A075048 001 Aug 22, 2000
5MG A075048 002 Aug 22, 2000
10MG A075048 003 Aug 22, 2000
20MG A075048 004 Aug 22, 2000

ENALAPRIL MALEATE; FELODIPINE


TABLET, EXTENDED RELEASE; ORAL
LEXXEL
ASTRAZENECA 5MG;2.5MG N020668 002 Oct 28, 1998

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE


TABLET; ORAL
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
IVAX SUB TEVA PHARMS 5MG;12.5MG A075736 001 Mar 25, 2003
10MG;25MG A075736 002 Mar 25, 2003

ENALAPRILAT
INJECTABLE; INJECTION
ENALAPRILAT
HOSPIRA 1.25MG/ML A075456 001 Aug 22, 2000
1.25MG/ML A075571 001 Aug 22, 2000
VASOTEC
BIOVAIL LABS INTL 1.25MG/ML N019309 001 Feb 09, 1988

ENFLURANE
LIQUID; INHALATION
ENFLURANE
ABBOTT 99.9% A070803 001 Sep 08, 1987

ENOXACIN
TABLET; ORAL
PENETREX
SANOFI AVENTIS US 200MG N019616 004 Dec 31, 1991
400MG N019616 005 Dec 31, 1991

ENOXAPARIN SODIUM
INJECTABLE; SUBCUTANEOUS
LOVENOX (PRESERVATIVE FREE)
SANOFI AVENTIS US 90MG/0.6ML (150MG/ML) N020164 006 Jun 02, 2000

EPINEPHRINE
AEROSOL, METERED; INHALATION
BRONKAID MIST
STERLING 0.25MG/INH N016803 001
PRIMATENE MIST
WYETH CONS 0.2MG/INH N016126 001
INJECTABLE; INJECTION
SUS-PHRINE SULFITE-FREE
FOREST LABS 1.5MG/AMP N007942 003 Feb 05, 1999
5MG/ML N007942 001
INJECTABLE; INTRAMUSCULAR
EPI E Z PEN JR
MERIDIAN MEDCL TECHN 0.15MG/DELIVERY N019430 004 Aug 03, 1995
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 117 (of 324)

EPINEPHRINE
INJECTABLE; INTRAMUSCULAR
EPIPEN E Z PEN
MERIDIAN MEDCL TECHN 0.3MG/DELIVERY N019430 003 Aug 03, 1995

EPINEPHRINE BITARTRATE
AEROSOL, METERED; INHALATION
BRONITIN MIST
WYETH CONS 0.3MG/INH N016126 002
MEDIHALER-EPI
3M 0.3MG/INH N010374 003

EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE


INJECTABLE; INJECTION
DURANEST
ASTRAZENECA 0.005MG/ML;1% N017751 006
0.005MG/ML;1.5% N017751 007
DENTSPLY PHARM 0.005MG/ML;1.5% N021384 001

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE


INJECTABLE; INJECTION
CITANEST FORTE
ASTRAZENECA 0.005MG/ML;4% N014763 008

EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE


INJECTABLE; INJECTION
DURANEST
ASTRAZENECA 0.005MG/ML;0.5% N017751 004

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE


INJECTABLE; INJECTION
ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE
CARLISLE 0.01MG/ML;2% A084720 001
0.02MG/ML;2% A084732 001
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ELKINS SINN 0.01MG/ML;1% A080406 001
0.01MG/ML;2% A080406 002
GRAHAM CHEM 0.01MG/ML;2% A080504 004 Oct 19, 1983
0.02MG/ML;2% A080504 005 Oct 19, 1983
HOSPIRA 0.005MG/ML;1.5% A089650 001 Jun 21, 1988
LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
ABBOTT 0.01MG/ML;1% A083154 001
BEL MAR 0.01MG/ML;1% A080820 001
0.01MG/ML;2% A080757 001
DELL LABS 0.01MG/ML;1% A083389 001
0.01MG/ML;2% A083390 001
INTL MEDICATION 0.01MG/ML;1% A086402 001
WATSON LABS 0.01MG/ML;1% A080377 003
0.01MG/ML;1% A085463 001
0.01MG/ML;2% A080377 004
LIDOCATON
PHARMATON 0.01MG/ML;2% A084729 001 Aug 17, 1983
0.02MG/ML;2% A084728 001 Aug 17, 1983
XYLOCAINE W/ EPINEPHRINE
APP PHARMS 0.01MG/ML;2% N006488 003
ASTRAZENECA 0.005MG/ML;1% N010418 006
0.005MG/ML;1.5% N010418 010
0.005MG/ML;2% N010418 008
PATCH; IONTOPHORESIS, TOPICAL
LIDOSITE TOPICAL SYSTEM KIT
VYTERIS 1.05MG/PATCH;100MG/PATCH N021504 001 May 06, 2004
SOLUTION; IONTOPHORESIS
IONTOCAINE
IOMED 0.01MG/ML;2% N020530 001 Dec 21, 1995
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 118 (of 324)

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE


SOLUTION; IONTOPHORESIS, TOPICAL
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
EMPI 0.01MG/ML;2% N021486 001 Oct 26, 2004

EPINEPHRINE; PROCAINE HYDROCHLORIDE


INJECTABLE; INJECTION
PROCAINE HYDROCHLORIDE W/ EPINEPHRINE
BEL MAR 0.02MG/ML;1% A080758 001
0.02MG/ML;2% A080759 001

EPIRUBICIN HYDROCHLORIDE
INJECTABLE; IV (INFUSION)
EPIRUBICIN HYDROCHLORIDE
HOSPIRA 200MG/VIAL N050807 002 Sep 15, 2006

EPLERENONE
TABLET; ORAL
INSPRA
GD SEARLE LLC 100MG N021437 003 Sep 27, 2002

EPROSARTAN MESYLATE
TABLET; ORAL
TEVETEN
ABBOTT EQ 300MG BASE N020738 004 Dec 22, 1997

ERGOCALCIFEROL
CAPSULE; ORAL
DELTALIN
LILLY 50,000 IU A080884 001
VITAMIN D
CHASE CHEM 50,000 IU A080747 001
EVERYLIFE 50,000 IU A080956 001
IMPAX LABS 50,000 IU A080951 001
LANNETT 50,000 IU A080825 001
VITARINE 50,000 IU A084053 001
WEST WARD 50,000 IU A083102 001

ERGOLOID MESYLATES
CAPSULE; ORAL
HYDERGINE LC
NOVARTIS 1MG N018706 001 Jan 18, 1983
SOLUTION; ORAL
HYDERGINE
NOVARTIS 1MG/ML N018418 001
TABLET; ORAL
ERGOLOID MESYLATES
MUTUAL PHARM 1MG A088891 001 Nov 01, 1985
WATSON LABS 1MG A086433 001 May 27, 1982
1MG A087244 001 Aug 16, 1982
GERIMAL
WATSON LABS 1MG A088207 001 Mar 22, 1984
HYDERGINE
NOVARTIS 0.5MG N017993 003
TABLET; SUBLINGUAL
ALKERGOT
SANDOZ 0.5MG A085153 001
1MG A087417 001
CIRCANOL
3M 0.5MG A084868 001
1MG A085809 001
DEAPRIL-ST
BRISTOL MYERS SQUIBB 1MG A085020 002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 119 (of 324)

ERGOLOID MESYLATES
TABLET; SUBLINGUAL
ERGOLOID MESYLATES
KV PHARM 0.5MG A085899 001
0.5MG A086265 001
1MG A085900 001
1MG A086264 001
LEDERLE 0.5MG A086984 001
1MG A086985 001
MUTUAL PHARM 0.5MG A087407 001
1MG A087552 001
SUPERPHARM 0.5MG A089233 001 Sep 23, 1986
1MG A089234 001 Sep 23, 1986
VANGARD 0.5MG A088013 001 Sep 20, 1982
1MG A088014 001 Sep 20, 1982
WATSON LABS 0.5MG A084930 001
1MG A085177 001
1MG A087183 001
GERIMAL
WATSON LABS 0.5MG A086189 001
1MG A086188 001
HYDERGINE
NOVARTIS 0.5MG N009087 002
1MG N009087 001
HYDROGENATED ERGOT ALKALOIDS
IVAX PHARMS 0.5MG A087186 001
1MG A087185 001

ERGOTAMINE TARTRATE
AEROSOL, METERED; INHALATION
MEDIHALER ERGOTAMINE
3M 0.36MG/INH N012102 001
TABLET; SUBLINGUAL
ERGOSTAT
PARKE DAVIS 2MG A088337 001 Jun 08, 1984
WIGRETTES
ORGANON USA INC 2MG A086750 001 Jul 29, 1982

ERYTHROMYCIN
CAPSULE, DELAYED REL PELLETS; ORAL
ERYC
PARKE DAVIS 250MG A062546 001 Jul 25, 1985
250MG A062618 001 Sep 25, 1985
ERYC 125
PARKE DAVIS 125MG A062648 001 Oct 24, 1985
ERYC SPRINKLES
HOSPIRA 125MG N050593 001 Jul 22, 1985
ERYTHROMYCIN
BARR 250MG A063098 001 May 04, 1989
GEL; TOPICAL
EMGEL
ALTANA 2% A063107 001 Aug 23, 1991
LOTION; TOPICAL
E-SOLVE 2
SYOSSET 2% A062467 001 Jul 03, 1985
OINTMENT; OPHTHALMIC
ERYTHROMYCIN
AKORN 0.5% A064030 001 Jul 18, 1996
PHARMADERM 5MG/GM A062446 001 Sep 26, 1983
PHARMAFAIR 5MG/GM A062481 001 Apr 05, 1984
ILOTYCIN
DISTA 0.5% N050368 001
POWDER; FOR RX COMPOUNDING
ERYTHROMYCIN
PADDOCK 100% N050610 001 Nov 07, 1986
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 120 (of 324)

ERYTHROMYCIN
SOLUTION; TOPICAL
A/T/S
TARO PHARMS NORTH 2% A062405 001 Nov 18, 1982
C-SOLVE-2
BIOGLAN PHARMA 2% A062468 001 Jul 03, 1985
ERYDERM
ABBOTT 2% A062290 001
ERYMAX
MERZ PHARMS 2% A062508 002 Jul 11, 1985
ERYTHROMYCIN
ALPHARMA US PHARMS 1.5% A062328 001 Apr 19, 1982
2% A062326 001 Apr 19, 1982
2% A062327 001 Apr 19, 1982
2% A062342 001 Feb 25, 1982
2% A062957 001 Jul 21, 1988
BAUSCH AND LOMB 2% A064039 001 Jan 27, 1994
LILLY 2% N050532 001
PHARMAFAIR 1.5% A062485 001 Jul 11, 1984
2% A062616 001 Jul 25, 1985
STIEFEL 2% A064127 001 Feb 14, 1997
SANSAC
DOW PHARM SCIENCES 2% A062522 001 Jan 24, 1985
STATICIN
WESTWOOD SQUIBB 1.5% N050526 001
T-STAT
WESTWOOD SQUIBB 2% A062436 001 Mar 09, 1983
SWAB; TOPICAL
C-SOLVE-2
IVAX SUB TEVA PHARMS 2% A062751 001 Jul 30, 1993
ERYCETTE
ORTHONEUTROGENA 2% N050594 001 Feb 15, 1985
ERYTHROMYCIN
STIEFEL 2% A064128 001 Jul 03, 1996
T-STAT
WESTWOOD SQUIBB 2% A062748 001 Jul 23, 1987
TABLET, DELAYED RELEASE; ORAL
E-BASE
BARR 333MG A063028 001 May 15, 1990
333MG A063086 001 May 15, 1990
500MG A062999 001 Nov 25, 1988
E-MYCIN
ABBOTT 250MG A060272 001
333MG A060272 002
ILOTYCIN
DISTA 250MG A061910 001
ROBIMYCIN
ROBINS AH 250MG A061633 001
R-P MYCIN
SOLVAY 250MG A061659 001

ERYTHROMYCIN ESTOLATE
CAPSULE; ORAL
ERYTHROMYCIN ESTOLATE
BARR EQ 125MG BASE A062162 001
EQ 250MG BASE A062162 002
IVAX SUB TEVA PHARMS EQ 250MG BASE A062237 001
WATSON LABS EQ 250MG BASE A062087 001
ILOSONE
LILLY EQ 125MG BASE A061897 001
EQ 250MG BASE A061897 002
FOR SUSPENSION; ORAL
ILOSONE
DISTA EQ 125MG BASE/5ML A061893 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 121 (of 324)

ERYTHROMYCIN ESTOLATE
SUSPENSION; ORAL
ERYTHROMYCIN ESTOLATE
ALPHARMA US PHARMS EQ 125MG BASE/5ML A062353 001 Nov 18, 1982
EQ 250MG BASE/5ML A062409 001 Dec 16, 1982
BARR EQ 125MG BASE/5ML A062169 001 Oct 17, 1990
EQ 250MG BASE/5ML A062169 002 Oct 17, 1990
LIFE LABS EQ 250MG BASE/5ML A062362 001 Dec 17, 1982
ILOSONE
LILLY EQ 125MG BASE/5ML A061894 001
EQ 125MG BASE/5ML N050010 001
EQ 250MG BASE/5ML A061894 002
EQ 250MG BASE/5ML N050010 002
SUSPENSION/DROPS; ORAL
ILOSONE
LILLY EQ 100MG BASE/ML A061894 003
TABLET; ORAL
ILOSONE
LILLY EQ 500MG BASE A061896 001
TABLET, CHEWABLE; ORAL
ILOSONE
DISTA EQ 125MG BASE A061895 001
EQ 250MG BASE A061895 002

ERYTHROMYCIN ESTOLATE; SULFISOXAZOLE ACETYL


SUSPENSION; ORAL
ILOSONE SULFA
LILLY EQ 125MG BASE/5ML;EQ 600MG BASE/5ML N050599 001 Sep 29, 1989

ERYTHROMYCIN ETHYLSUCCINATE
GRANULE; ORAL
ERYTHROMYCIN ETHYLSUCCINATE
BARR EQ 200MG BASE/5ML A062055 001
PEDIAMYCIN
ROSS LABS EQ 200MG BASE/5ML A062305 001
SUSPENSION; ORAL
E-MYCIN E
PHARMACIA AND UPJOHN EQ 200MG BASE/5ML A062198 001
EQ 400MG BASE/5ML A062198 002
ERYTHROMYCIN ETHYLSUCCINATE
ALPHARMA US PHARMS EQ 200MG BASE/5ML A062200 001
EQ 400MG BASE/5ML A062200 002
DISTA EQ 200MG BASE/5ML A062177 001
EQ 400MG BASE/5ML A062177 002
NASKA EQ 400MG BASE/5ML A062674 001 Mar 10, 1987
PARKE DAVIS EQ 200MG BASE/5ML A062231 001
EQ 400MG BASE/5ML A062231 002
PHARMAFAIR EQ 200MG BASE/5ML A062559 001 Mar 15, 1985
EQ 400MG BASE/5ML A062558 001 Mar 15, 1985
WYAMYCIN E
WYETH AYERST EQ 200MG BASE/5ML A062123 002
EQ 400MG BASE/5ML A062123 001
SUSPENSION/DROPS; ORAL
PEDIAMYCIN
ROSS LABS EQ 100MG BASE/2.5ML A062305 002
TABLET; ORAL
E.E.S. 400

ABBOTT EQ 400MG BASE A061905 001


ERYTHROMYCIN ETHYLSUCCINATE
BARR EQ 400MG BASE A062256 001
MYLAN EQ 400MG BASE A062847 001 Sep 14, 1988
TABLET, CHEWABLE; ORAL

E.E.S.

ABBOTT EQ 200MG BASE N050297 002


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 122 (of 324)

ERYTHROMYCIN ETHYLSUCCINATE
TABLET, CHEWABLE; ORAL
ERYPED
ABBOTT EQ 200MG BASE N050297 003 Jul 05, 1988
PEDIAMYCIN
ROSS LABS EQ 200MG BASE A062306 001

ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL


GRANULE; ORAL
ERYZOLE
ALRA EQ 200MG BASE/5ML;EQ 600MG BASE/5ML A062758 001 Jun 15, 1988
PEDIAZOLE
ROSS LABS EQ 200MG BASE/5ML;EQ 600MG BASE/5ML N050529 001

ERYTHROMYCIN GLUCEPTATE
INJECTABLE; INJECTION
ILOTYCIN GLUCEPTATE
DISTA EQ 250MG BASE/VIAL N050370 001
EQ 500MG BASE/VIAL N050370 002
EQ 1GM BASE/VIAL N050370 003

ERYTHROMYCIN LACTOBIONATE
INJECTABLE; INJECTION
ERYTHROCIN
ABBOTT EQ 500MG BASE/VIAL A062586 001 Jan 04, 1988
EQ 1GM BASE/VIAL A062586 002 Jan 04, 1988
HOSPIRA EQ 500MG BASE/VIAL N050182 002
EQ 1GM BASE/VIAL N050182 003
EQ 1GM BASE/VIAL N050609 002 Sep 24, 1986
ERYTHROMYCIN
ELKINS SINN EQ 500MG BASE/VIAL A062563 001 Mar 28, 1985
EQ 1GM BASE/VIAL A062563 002 Mar 28, 1985
ERYTHROMYCIN LACTOBIONATE
ABRAXIS PHARM EQ 500MG BASE/VIAL A062604 001 Nov 24, 1986
EQ 1GM BASE/VIAL A062604 002 Nov 24, 1986
BAXTER HLTHCARE EQ 500MG BASE/VIAL A062993 001 May 09, 1989
EQ 1GM BASE/VIAL A062993 002 May 09, 1989

ERYTHROMYCIN STEARATE
TABLET; ORAL
BRISTAMYCIN
BRISTOL EQ 250MG BASE A061304 001
EQ 250MG BASE A061887 001
ERYPAR
PARKE DAVIS EQ 250MG BASE A062032 001
EQ 500MG BASE A062032 002
WARNER CHILCOTT EQ 250MG BASE A062322 001
ERYTHROCIN STEARATE
ABBOTT EQ 125MG BASE A060359 002
ERYTHROMYCIN STEARATE
BARR EQ 250MG BASE A061591 001
EQ 500MG BASE A063179 001 May 15, 1990
IVAX SUB TEVA PHARMS EQ 250MG BASE A061461 001
EQ 500MG BASE A061461 002
LEDERLE EQ 250MG BASE A062089 001
EQ 500MG BASE A062089 002
MYLAN EQ 250MG BASE A061505 001
EQ 500MG BASE A061505 002
PUREPAC PHARM EQ 250MG BASE A061743 001
WATSON LABS EQ 250MG BASE A062121 002
EQ 500MG BASE A062121 001
ETHRIL 250
BRISTOL MYERS SQUIBB EQ 250MG BASE A061605 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 123 (of 324)

ERYTHROMYCIN STEARATE
TABLET; ORAL
ETHRIL 500
BRISTOL MYERS SQUIBB EQ 500MG BASE A061605 002
PFIZER-E
PFIZER EQ 250MG BASE A061791 001
EQ 500MG BASE A061791 002
WYAMYCIN S
WYETH AYERST EQ 250MG BASE A061675 001
EQ 500MG BASE A061675 002

ESMOLOL HYDROCHLORIDE
INJECTABLE; INJECTION
BREVIBLOC
BAXTER HLTHCARE CORP 10MG/ML N019386 003 Aug 15, 1988
250MG/ML N019386 002 Dec 31, 1986

ESTAZOLAM
TABLET; ORAL
PROSOM
ABBOTT 1MG N019080 001 Dec 26, 1990
2MG N019080 002 Dec 26, 1990

ESTRADIOL
FILM, EXTENDED RELEASE; TRANSDERMAL
ESCLIM
WOMEN FIRST HLTHCARE 0.025MG/24HR N020847 001 Aug 04, 1998
0.0375MG/24HR N020847 002 Aug 04, 1998
0.05MG/24HR N020847 003 Aug 04, 1998
0.075MG/24HR N020847 004 Aug 04, 1998
0.1MG/24HR N020847 005 Aug 04, 1998
ESTRADIOL
ORTHO MCNEIL PHARM 0.05MG/24HR N021048 001 Sep 20, 1999
0.075MG/24HR N021048 002 Sep 20, 1999
0.1MG/24HR N021048 003 Sep 20, 1999
FEMPATCH
PARKE DAVIS 0.025MG/24HR N020417 001 Dec 03, 1996
VIVELLE
NOVARTIS 0.025MG/24HR N020323 005 Aug 16, 2000
0.0375MG/24HR N020323 001 Oct 28, 1994
0.075MG/24HR N020323 003 Oct 28, 1994
GEL; TOPICAL
ESTROGEL
ASCEND 0.06% N021166 001 Feb 09, 2004
TABLET; ORAL
ESTRADIOL
AAI PHARMA INC 0.5MG A040138 001 Jan 30, 1998
1MG A040138 002 Jan 30, 1998
2MG A040138 003 Jan 30, 1998
HERITAGE PHARMS INC 0.5MG A040275 001 Dec 29, 1998
1MG A040275 002 Dec 29, 1998
2MG A040275 003 Dec 29, 1998
GYNODIOL
DURAMED PHARMS BARR 0.5MG A040212 001 Dec 29, 1997
1MG A040212 002 Dec 29, 1997
1.5MG A040212 003 Dec 29, 1997
2MG A040212 004 Dec 29, 1997
INNOFEM
NOVO NORDISK INC 0.5MG A040312 001 Nov 19, 1999
1MG A040312 002 Nov 19, 1999
2MG A040312 003 Nov 19, 1999
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 124 (of 324)

ESTRADIOL CYPIONATE
INJECTABLE; INJECTION
DEPO-ESTRADIOL
PHARMACIA AND UPJOHN 1MG/ML A085470 001
3MG/ML A085470 002

ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE


INJECTABLE; INTRAMUSCULAR
LUNELLE
PHARMACIA AND UPJOHN 5MG/0.5ML;25MG/0.5ML N020874 001 Oct 05, 2000

ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE


INJECTABLE; INJECTION
DEPO-TESTADIOL
PHARMACIA AND UPJOHN 2MG/ML;50MG/ML N017968 001
TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE
WATSON LABS 2MG/ML;50MG/ML A085603 001 Mar 13, 1986

ESTRADIOL VALERATE
INJECTABLE; INJECTION
ESTRADIOL VALERATE
WATSON LABS 10MG/ML A083546 001

ESTRADIOL VALERATE; TESTOSTERONE ENANTHATE


INJECTABLE; INJECTION
DITATE-DS
SAVAGE LABS 8MG/ML;180MG/ML A086423 001
TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE
WATSON LABS 4MG/ML;90MG/ML A085865 001
8MG/ML;180MG/ML A085860 001

ESTROGENS, CONJUGATED
TABLET; ORAL
PREMARIN
WYETH PHARMS INC 2.5MG N004782 002

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE


TABLET; ORAL-28
PREMPHASE (PREMARIN;CYCRIN 14/14)
WYETH PHARMS INC 0.625MG,0.625MG;N/A,5MG N020303 002 Dec 30, 1994
PREMPRO (PREMARIN;CYCRIN)
WYETH PHARMS INC 0.625MG,0.625MG;2.5MG,2.5MG N020303 001 Dec 30, 1994

ESTROGENS, CONJUGATED; MEPROBAMATE


TABLET; ORAL
MILPREM-200
MEDPOINTE PHARM HLC 0.45MG;200MG N011045 002
MILPREM-400
MEDPOINTE PHARM HLC 0.45MG;400MG N011045 001
PMB 200
WYETH AYERST 0.45MG;200MG N010971 005
PMB 400
WYETH AYERST 0.45MG;400MG N010971 003

ESTROGENS, ESTERIFIED
TABLET; ORAL
AMNESTROGEN
BRISTOL MYERS SQUIBB 0.3MG A083266 001
0.625MG A083266 002
1.25MG A083266 003
2.5MG A083266 004
ESTERIFIED ESTROGENS
PVT FORM 0.625MG A083414 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 125 (of 324)

ESTROGENS, ESTERIFIED
TABLET; ORAL
ESTERIFIED ESTROGENS
PVT FORM 1.25MG A083765 001
2.5MG A085907 001
SANDOZ 1.25MG A085302 001
ESTRATAB
SOLVAY 0.3MG A086715 001
0.625MG A083209 001
1.25MG A083856 001
2.5MG A083857 001
EVEX
ROCHE PALO 0.625MG A084215 001
1.25MG A083376 002
FEMOGEN
PVT FORM 0.625MG A085076 001
1.25MG A085008 001
2.5MG A085007 001

ESTRONE
INJECTABLE; INJECTION
ESTROGENIC SUBSTANCE
WYETH AYERST 2MG/ML A083488 001
ESTRONE
WATSON LABS 2MG/ML A083397 001
NATURAL ESTROGENIC SUBSTANCE-ESTRONE
WATSON LABS 2MG/ML A085237 001 Nov 23, 1982
THEELIN
PARKEDALE 1MG/ML N003977 001
2MG/ML N003977 002
5MG/ML N003977 003

ESTROPIPATE
TABLET; ORAL
ESTROPIPATE
DURAMED PHARMS BARR 0.75MG A040296 001 Nov 01, 1999
1.5MG A040296 002 Nov 01, 1999
3MG A040296 003 Nov 01, 1999
MYLAN 3MG A040359 003 Aug 26, 1999

ETHACRYNIC ACID
TABLET; ORAL
EDECRIN
ATON 50MG N016092 002

ETHAMBUTOL HYDROCHLORIDE
TABLET; ORAL
MYAMBUTOL
STI PHARMA LLC 200MG N016320 002
500MG N016320 004

ETHCHLORVYNOL
CAPSULE; ORAL
ETHCHLORVYNOL
BANNER PHARMACAPS 100MG A084463 001
200MG A084463 002
500MG A084463 003
750MG A084463 004
PLACIDYL
ABBOTT 100MG N010021 004
200MG N010021 007
500MG N010021 002
750MG N010021 010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 126 (of 324)

ETHINAMATE
CAPSULE; ORAL

VALMID

DISTA 500MG N009750 001


ETHINYL ESTRADIOL
TABLET; ORAL
ESTINYL
SCHERING 0.02MG N005292 001
0.05MG N005292 002
0.5MG N005292 003
FEMINONE
PHARMACIA AND UPJOHN 0.05MG N016649 001
LYNORAL
ORGANON USA INC 0.01MG N005490 003
0.05MG N005490 002

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE


TABLET; ORAL-21
DEMULEN 1/35-21
GD SEARLE LLC 0.035MG;1MG N018168 001
DEMULEN 1/50-21
GD SEARLE LLC 0.05MG;1MG N016927 001
ZOVIA 1/35E-21
WATSON LABS 0.035MG;1MG A072720 001 Dec 30, 1991
ZOVIA 1/50E-21
WATSON LABS 0.05MG;1MG A072722 001 Dec 30, 1991
TABLET; ORAL-28
DEMULEN 1/35-28
GD SEARLE LLC 0.035MG;1MG N018160 001
DEMULEN 1/50-28
GD SEARLE LLC 0.05MG;1MG N016936 001

ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE


TABLET; ORAL-28
NORQUEST FE
GD SEARLE LLC 0.035MG;75MG;1MG N018926 001 Jul 18, 1986

ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE ACETATE


TABLET; ORAL-28

NORLESTRIN FE 1/50

PARKE DAVIS 0.05MG;75MG;1MG N016766 001


NORLESTRIN FE 2.5/50

PARKE DAVIS 0.05MG;75MG;2.5MG N016854 001


ETHINYL ESTRADIOL; LEVONORGESTREL


TABLET; ORAL
PREVEN EMERGENCY CONTRACEPTIVE KIT
DURAMED 0.05MG;0.25MG N020946 001 Sep 01, 1998
TABLET; ORAL-21
ALESSE
WYETH PHARMS INC 0.02MG;0.1MG N020683 001 Mar 27, 1997
AVIANE-21
DURAMED PHARMS BARR 0.02MG;0.1MG A075796 002 Apr 30, 2001
ENPRESSE-21
DURAMED PHARMS BARR 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 A075809 001 Jul 16, 2001
25MG
LESSINA-21
BARR 0.02MG;0.1MG A075803 001 Mar 20, 2002
LEVLITE
BAYER HLTHCARE 0.02MG;0.1MG N020860 001 Jul 13, 1998
LEVONORGESTREL AND ETHINYL ESTRADIOL
BARR 0.02MG;0.1MG A075862 001 Apr 29, 2003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 127 (of 324)

ETHINYL ESTRADIOL; LEVONORGESTREL


TABLET; ORAL-21
LEVORA 0.15/30-21
WATSON LABS 0.03MG;0.15MG A073592 001 Dec 13, 1993
NORDETTE-21
DURAMED RES 0.03MG;0.15MG N018668 001 May 10, 1982
PORTIA-21
BARR 0.03MG;0.15MG A075866 001 May 23, 2002
TRIPHASIL-21
AKRIMAX PHARMS 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 N019192 001 Nov 01, 1984
25MG
TRIVORA-21
WATSON LABS 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 A074538 001 Dec 18, 1997
25MG
TABLET; ORAL-28
ALESSE
WYETH PHARMS INC 0.02MG;0.1MG N020683 002 Mar 27, 1997
LEVLITE
BAYER HLTHCARE 0.02MG;0.1MG N020860 002 Jul 13, 1998
LEVONORGESTREL AND ETHINYL ESTRADIOL
BARR 0.02MG;0.1MG A075862 002 Apr 29, 2003
TRIPHASIL-28
WYETH PHARMS INC 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 N019190 001 Nov 01, 1984
25MG

ETHINYL ESTRADIOL; NORETHINDRONE


TABLET; ORAL-21
BALZIVA-21
BARR 0.035MG;0.4MG A076198 001 Apr 22, 2004
BREVICON 21-DAY
WATSON LABS 0.035MG;0.5MG N017566 001
GENCEPT 10/11-21
BARR 0.035MG,0.035MG;0.5MG,1MG A072694 001 Feb 28, 1992
MODICON 21
ORTHO MCNEIL PHARM 0.035MG;0.5MG N017488 001
N.E.E. 1/35 21
LPI 0.035MG;1MG A071541 001 Dec 14, 1987
NORCEPT-E 1/35 21
ORTHO MCNEIL PHARM 0.035MG;1MG A071545 001 Feb 09, 1989
NORETHINDRONE AND ETHINYL ESTRADIOL
WATSON LABS 0.035MG;0.5MG A070684 001 Jan 29, 1987
NORTREL 0.5/35-21
BARR 0.035MG;0.5MG A072692 001 Feb 28, 1992
ORTHO-NOVUM 1/35-21
ORTHO MCNEIL PHARM 0.035MG;1MG N017489 002
ORTHO-NOVUM 10/11-21
ORTHO MCNEIL JANSSEN 0.035MG,0.035MG;0.5MG,1MG N018354 001 Jan 11, 1982
ORTHO-NOVUM 7/14-21
ORTHO MCNEIL PHARM 0.035MG,0.035MG;0.5MG,1MG N019004 001 Apr 04, 1984
ORTHO-NOVUM 7/7/7-21
ORTHO MCNEIL JANSSEN 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M N018985 001 Apr 04, 1984
G
OVCON-35
WARNER CHILCOTT 0.035MG;0.4MG N018127 001
OVCON-50
WARNER CHILCOTT 0.05MG;1MG N018128 001
TRI-NORINYL 21-DAY
WATSON LABS 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG N018977 001 Apr 13, 1984
TABLET; ORAL-28
GENCEPT 10/11-28
BARR 0.035MG,0.035MG;0.5MG,1MG A072697 001 Feb 28, 1992
N.E.E. 1/35 28
LPI 0.035MG;1MG A071542 001 Dec 14, 1987
NORCEPT-E 1/35 28
ORTHO MCNEIL PHARM 0.035MG;1MG A071546 001 Feb 09, 1989
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DISCONTINUED DRUG PRODUCT LIST 6 - 128 (of 324)

ETHINYL ESTRADIOL; NORETHINDRONE


TABLET; ORAL-28
ORTHO-NOVUM 10/11-28
ORTHO MCNEIL JANSSEN 0.035MG,0.035MG;0.5MG,1MG N018354 002 Jan 11, 1982
ORTHO-NOVUM 7/14-28
ORTHO MCNEIL PHARM 0.035MG,0.035MG;0.5MG,1MG N019004 002 Apr 04, 1984

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE


TABLET; ORAL-21
ESTROSTEP 21
WARNER CHILCOTT 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG N020130 001 Oct 09, 1996
NORLESTRIN 21 1/50
PARKE DAVIS 0.05MG;1MG N016749 001
NORLESTRIN 21 2.5/50
PARKE DAVIS 0.05MG;2.5MG N016852 001
TABLET; ORAL-28
NORLESTRIN 28 1/50
PARKE DAVIS 0.05MG;1MG N016723 001

ETHINYL ESTRADIOL; NORGESTIMATE


TABLET; ORAL-21
ORTHO CYCLEN-21
ORTHO MCNEIL JANSSEN 0.035MG;0.25MG N019653 001 Dec 29, 1989
ORTHO TRI-CYCLEN
ORTHO MCNEIL JANSSEN 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, N019697 002 Jul 03, 1992
0.25MG

ETHINYL ESTRADIOL; NORGESTREL


TABLET; ORAL-21
LO/OVRAL
WYETH PHARMS INC 0.03MG;0.3MG N017612 001
OGESTREL 0.5/50-21
WATSON LABS 0.05MG;0.5MG A075406 001 Dec 15, 1999
OVRAL
AKRIMAX PHARMS 0.05MG;0.5MG N016672 001
TABLET; ORAL-28
OVRAL-28
WYETH PHARMS INC 0.05MG;0.5MG N016806 001

ETHOPROPAZINE HYDROCHLORIDE
TABLET; ORAL

PARSIDOL

PARKE DAVIS 10MG N009078 003


50MG N009078 006


100MG N009078 008


ETHOTOIN
TABLET; ORAL

PEGANONE

LUNDBECK INC 500MG N010841 003


ETHOXZOLAMIDE
TABLET; ORAL

CARDRASE

PHARMACIA AND UPJOHN 62.5MG N011047 002


125MG N011047 001


ETHAMIDE

ALLERGAN 125MG N016144 001


ETHYLESTRENOL
ELIXIR; ORAL

MAXIBOLIN

ORGANON USA INC 2MG/5ML N014006 002


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DISCONTINUED DRUG PRODUCT LIST 6 - 129 (of 324)

ETHYLESTRENOL
TABLET; ORAL
MAXIBOLIN
ORGANON USA INC 2MG N014005 002

ETHYNODIOL DIACETATE; MESTRANOL


TABLET; ORAL-20

OVULEN

GD SEARLE LLC 1MG;0.1MG N016029 002


TABLET; ORAL-21

OVULEN-21

GD SEARLE LLC 1MG;0.1MG N016029 003


TABLET; ORAL-28

OVULEN-28

GD SEARLE LLC 1MG;0.1MG N016705 001


ETIDOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
DURANEST
ASTRAZENECA 0.5% N017751 003
1% N017751 005

ETIDRONATE DISODIUM
INJECTABLE; INJECTION
DIDRONEL
MGI PHARMA INC 50MG/ML N019545 001 Apr 20, 1987

ETODOLAC
CAPSULE; ORAL
ETODOLAC
AAIPHARMA LLC 300MG A074929 001 Jan 30, 1998
ENDO PHARMS 200MG A074842 001 Jul 17, 1997
300MG A074842 002 Jul 17, 1997
GENPHARM 200MG A075071 001 Sep 30, 1998
300MG A075071 002 Sep 30, 1998
IVAX SUB TEVA PHARMS 200MG A074899 001 Jul 08, 1997
300MG A074899 002 Jul 08, 1997
MYLAN 200MG A074932 001 May 16, 1997
300MG A074932 002 May 16, 1997
SANDOZ 200MG A074840 001 Aug 29, 1997
200MG A074942 001 Sep 30, 1997
300MG A074840 002 Aug 29, 1997
300MG A074942 002 Sep 30, 1997
TEVA 200MG A075126 001 Sep 16, 1999
WATSON LABS 200MG A074844 001 Dec 23, 1997
300MG A074844 002 Dec 23, 1997
LODINE
WYETH PHARMS INC 200MG N018922 002 Jan 31, 1991
300MG N018922 003 Jan 31, 1991
TABLET; ORAL
ETODOLAC
AAIPHARMA LLC 400MG A074927 001 Oct 30, 1997
ENDO PHARMS 400MG A074841 001 Jun 27, 1997
GENPHARM 400MG A075012 001 Sep 30, 1998
500MG A075012 002 Sep 30, 1998
IVAX SUB TEVA PHARMS 400MG A074883 001 Feb 28, 1997
500MG A074883 002 Nov 20, 1998
RANBAXY 400MG A075226 001 Nov 24, 1998
500MG A075226 002 Nov 24, 1998
SANDOZ 400MG A074839 001 Jul 11, 1997
400MG A074846 001 Feb 28, 1997
TEVA 400MG A074847 001 Apr 23, 1999
500MG A074847 002 Apr 23, 1999
WATSON LABS 400MG A074892 001 Apr 16, 1997
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 130 (of 324)

ETODOLAC
TABLET; ORAL
ETODOLAC
WATSON LABS 400MG A075069 001 Apr 16, 1998
500MG A074892 002 Oct 29, 1998
LODINE
WYETH PHARMS INC 400MG N018922 004 Jul 29, 1993
500MG N018922 005 Jun 28, 1996
TABLET, EXTENDED RELEASE; ORAL
ETODOLAC
POINT HOLDINGS 400MG A075696 001 Jul 31, 2000
SANDOZ 400MG A075943 001 Jul 26, 2002
500MG A075943 002 Jul 26, 2002
600MG A075943 003 Jul 26, 2002
WATSON LABS FLORIDA 400MG A075829 001 Nov 30, 2001
500MG A075829 002 Nov 30, 2001
LODINE XL
WYETH PHARMS INC 400MG N020584 001 Oct 25, 1996
500MG N020584 003 Jan 20, 1998
600MG N020584 002 Oct 25, 1996

ETOPOSIDE
CAPSULE; ORAL
VEPESID
BRISTOL MYERS SQUIBB 50MG N019557 001 Dec 30, 1986
100MG N019557 002 Dec 30, 1986
INJECTABLE; INJECTION
ETOPOSIDE
HOSPIRA 20MG/ML A074320 001 Aug 30, 1995
20MG/ML A074351 001 Aug 30, 1995
MARSAM PHARMS LLC 20MG/ML A074968 001 Jan 09, 1998
PIERRE FABRE 20MG/ML A074813 001 Jul 09, 1997
TEVA PARENTERAL 20MG/ML A074510 001 Jun 29, 1995
WATSON LABS 20MG/ML A074228 001 Oct 15, 1996
TOPOSAR
TEVA PARENTERAL 20MG/ML A074166 001 Feb 27, 1995

ETOPOSIDE PHOSPHATE
INJECTABLE; INJECTION
ETOPOPHOS PRESERVATIVE FREE
BRISTOL MYERS SQUIBB EQ 500MG BASE/VIAL N020906 001 Feb 27, 1998
EQ 1GM BASE/VIAL N020906 002 Feb 27, 1998

ETRETINATE
CAPSULE; ORAL
TEGISON
ROCHE 10MG N019369 001 Sep 30, 1986
25MG N019369 002 Sep 30, 1986

EVANS BLUE
INJECTABLE; INJECTION
EVANS BLUE
PARKE DAVIS 0.5% N008041 001

FAMOTIDINE
INJECTABLE; INJECTION
FAMOTIDINE
APOTEX INC 10MG/ML A075942 001 Aug 02, 2002
APOTHECON 10MG/ML A075707 001 Apr 16, 2001
HOSPIRA 10MG/ML A075705 001 Apr 16, 2001
10MG/ML A075905 001 Nov 23, 2001
FAMOTIDINE PRESERVATIVE FREE
APOTHECON 10MG/ML A075708 001 Apr 16, 2001
HOSPIRA 10MG/ML A075669 001 Apr 16, 2001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 131 (of 324)

FAMOTIDINE
INJECTABLE; INJECTION
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER
ABBOTT 0.4MG/ML A075729 001 Dec 17, 2001
TABLET; ORAL
FAMOTIDINE
APOTEX 10MG A075610 001 Mar 12, 2002
MUTUAL PHARM 20MG A075639 002 Dec 12, 2001
40MG A075639 001 Dec 12, 2001
SANDOZ 20MG A075302 001 Apr 16, 2001
20MG A075793 001 Apr 16, 2001
40MG A075302 002 Apr 16, 2001
40MG A075793 002 Apr 16, 2001
TABLET, CHEWABLE; ORAL
PEPCID AC
MERCK 10MG N020801 001 Sep 24, 1998
TABLET, ORALLY DISINTEGRATING; ORAL
PEPCID RPD
MERCK 20MG N020752 001 May 28, 1998
40MG N020752 002 May 28, 1998

FELODIPINE
TABLET, EXTENDED RELEASE; ORAL
PLENDIL
ASTRAZENECA 2.5MG N019834 004 Sep 22, 1994
5MG N019834 001 Jul 25, 1991
10MG N019834 002 Jul 25, 1991

FENOFIBRATE
CAPSULE; ORAL
ANTARA (MICRONIZED)
OSCIENT 87MG N021695 002 Nov 30, 2004
LIPIDIL
ABBOTT 100MG N019304 001 Dec 31, 1993
TRICOR (MICRONIZED)
ABBOTT 67MG N019304 002 Feb 09, 1998
134MG N019304 003 Jun 30, 1999
200MG N019304 004 Jun 30, 1999
TABLET; ORAL
FENOFIBRATE
MYLAN 107MG A076520 002 Dec 29, 2005
TRICOR
ABBOTT 54MG N021203 001 Sep 04, 2001
160MG N021203 003 Sep 04, 2001

FENOPROFEN CALCIUM
CAPSULE; ORAL
FENOPROFEN CALCIUM
AM THERAP EQ 200MG BASE A072307 001 Aug 22, 1988
EQ 300MG BASE A072308 001 Aug 22, 1988
HALSEY EQ 200MG BASE A072355 001 Aug 17, 1988
EQ 300MG BASE A072356 001 Aug 17, 1988
PAR PHARM EQ 200MG BASE A072437 001 Aug 22, 1988
EQ 300MG BASE A072438 001 Aug 22, 1988
QUANTUM PHARMICS EQ 200MG BASE A072214 001 Aug 17, 1988
EQ 300MG BASE A071738 001 Aug 17, 1988
SANDOZ EQ 200MG BASE A072394 001 Oct 17, 1988
EQ 300MG BASE A072395 001 Oct 17, 1988
WARNER CHILCOTT EQ 200MG BASE A072946 001 Apr 30, 1991
EQ 300MG BASE A072472 001 Apr 30, 1991
WATSON LABS EQ 200MG BASE A072294 001 Aug 17, 1988
EQ 200MG BASE A072981 001 Aug 19, 1991
EQ 300MG BASE A072293 001 Aug 17, 1988
EQ 300MG BASE A072982 001 Aug 19, 1991
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 132 (of 324)

FENOPROFEN CALCIUM
CAPSULE; ORAL
NALFON
PEDINOL EQ 300MG BASE N017604 002
TABLET; ORAL
FENOPROFEN CALCIUM
ACTAVIS ELIZABETH EQ 600MG BASE A072274 001 May 02, 1988
AM THERAP EQ 600MG BASE A072309 001 Aug 17, 1988
CLONMEL HLTHCARE EQ 600MG BASE A072326 001 Aug 17, 1988
HALSEY EQ 600MG BASE A072357 001 Aug 17, 1988
MUTUAL PHARM EQ 600MG BASE A072902 001 Dec 21, 1990
PAR PHARM EQ 600MG BASE A072429 001 Aug 17, 1988
QUANTUM PHARMICS EQ 600MG BASE A072194 001 Aug 17, 1988
SANDOZ EQ 600MG BASE A072396 001 Oct 17, 1988
USL PHARMA EQ 600MG BASE A072362 001 Aug 17, 1988
WATSON LABS EQ 600MG BASE A072165 001 Aug 17, 1988
EQ 600MG BASE A072407 001 Aug 17, 1988
EQ 600MG BASE A072602 001 Oct 11, 1988
NALFON
DISTA EQ 600MG BASE N017710 001

FENTANYL CITRATE
INJECTABLE; INJECTION
FENTANYL CITRATE
ABBOTT EQ 0.05MG BASE/ML A070636 001 Apr 30, 1990
EQ 0.05MG BASE/ML A070637 001 Apr 30, 1990
WATSON LABS EQ 0.05MG BASE/ML A073488 001 Jun 30, 1992
FENTANYL CITRATE PRESERVATIVE FREE
MARSAM PHARMS LLC EQ 0.05MG BASE/ML A074917 001 Feb 03, 1998
TROCHE/LOZENGE; ORAL
FENTANYL
CEPHALON EQ 0.1MG BASE N020195 007 Oct 30, 1995
EQ 0.2MG BASE N020195 001 Oct 04, 1993
EQ 0.3MG BASE N020195 002 Oct 04, 1993
EQ 0.4MG BASE N020195 003 Oct 04, 1993

FENTANYL HYDROCHLORIDE
SYSTEM; IONTOPHORESIS, TRANSDERMAL
IONSYS
ALZA 10.8MCG N021338 001 May 22, 2006

FERRIC AMMONIUM CITRATE


FOR SOLUTION; ORAL
FERRISELTZ
OTSUKA 600MG/PACKET N020292 001 Oct 14, 1997

FERROUS CITRATE, FE-59


INJECTABLE; INJECTION
FERROUS CITRATE FE 59
MALLINCKRODT 25uCi/ML N016729 001

FERROUS SULFATE; FOLIC ACID


CAPSULE; ORAL
FOLVRON
LEDERLE 182MG;0.33MG N006012 003

FEXOFENADINE HYDROCHLORIDE
CAPSULE; ORAL
ALLEGRA
SANOFI AVENTIS US 60MG N020625 001 Jul 25, 1996
FEXOFENADINE HYDROCHLORIDE
BARR 60MG A076169 001 Jul 13, 2005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 133 (of 324)

FIBRINOGEN, I-125
INJECTABLE; INJECTION
IBRIN
GE HEALTHCARE 154uCi/VIAL N017879 001
RADIONUCLIDE-LABELED (125 I) FIBRINOGEN (HUMAN) SENSOR
ABBOTT 140uCi/ML N017787 001

FINASTERIDE
TABLET; ORAL
FINASTERIDE
IVAX SUB TEVA PHARMS 5MG A076340 001 Jun 19, 2006

FLECAINIDE ACETATE
TABLET; ORAL
FLECAINIDE ACETATE
SANDOZ 50MG A076030 001 Oct 28, 2002
100MG A076030 002 Oct 28, 2002
150MG A076030 003 Oct 28, 2002
TAMBOCOR
GRACEWAY 200MG N018830 002 Oct 31, 1985

FLOXURIDINE
INJECTABLE; INJECTION
FUDR
HOSPIRA 500MG/VIAL N016929 001

FLUCONAZOLE
INJECTABLE; INJECTION
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
APOTEX INC 200MG/100ML (2MG/ML) A076889 001 Mar 25, 2005
400MG/200ML (2MG/ML) A076889 002 Mar 25, 2005
TABLET; ORAL
FLUCONAZOLE
GEDEON RICHTER USA 50MG A076432 001 Jul 29, 2004
100MG A076432 002 Jul 29, 2004
150MG A076432 003 Jul 29, 2004
200MG A076432 004 Jul 29, 2004
ROXANE 50MG A076213 001 Jul 29, 2004
100MG A076213 002 Jul 29, 2004
150MG A076213 003 Jul 29, 2004
200MG A076213 004 Jul 29, 2004
SANDOZ 50MG A076086 001 Jul 29, 2004
100MG A076086 002 Jul 29, 2004
150MG A076086 003 Jul 29, 2004
200MG A076086 004 Jul 29, 2004

FLUDEOXYGLUCOSE F-18
INJECTABLE; INJECTION
FLUDEOXYGLUCOSE F 18
DOWNSTATE CLINCL 4-40mCi/ML N020306 001 Aug 19, 1994
4-90mCi/ML N020306 002 Sep 25, 2001

FLUDROCORTISONE ACETATE
TABLET; ORAL
FLORINEF
KING PHARMS 0.1MG N010060 001

FLUMETHASONE PIVALATE
CREAM; TOPICAL
LOCORTEN
NOVARTIS 0.03% N016379 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 134 (of 324)

FLUNISOLIDE
SPRAY, METERED; NASAL
NASALIDE
IVAX RES 0.025MG/SPRAY N018148 001

FLUOCINOLONE ACETONIDE
CREAM; TOPICAL
FLUOCET
ALPHARMA US PHARMS 0.025% A088360 001 Jan 16, 1984
FLUOCINOLONE ACETONIDE
ALPHARMA US PHARMS 0.01% A088361 001 Jan 16, 1984
G AND W LABS 0.01% A089526 001 Jul 26, 1988
0.025% A089525 001 Jul 26, 1988
PERRIGO NEW YORK 0.01% A086810 001 Mar 04, 1982
0.025% A086811 001 Mar 04, 1982
PHARMADERM 0.01% A088047 001 Dec 16, 1982
0.025% A088045 001 Dec 16, 1982
PHARMAFAIR 0.01% A088499 001 Aug 02, 1984
0.025% A088506 001 Aug 02, 1984
TARO 0.01% A040035 001 Oct 31, 1994
0.01% A087102 001 Apr 27, 1982
0.025% A040042 001 Oct 31, 1994
USL PHARMA 0.01% A088757 001 Feb 11, 1985
0.025% A088756 001 Mar 28, 1985
FLUONID
ALLERGAN HERBERT 0.025% A087156 002 Sep 06, 1984
FLUOTREX
SAVAGE LABS 0.01% A088174 001 May 06, 1983
0.025% A088173 001 Mar 09, 1983
SYNALAR-HP
MEDICIS 0.2% N016161 002
GEL; TOPICAL
FLUONID
ALLERGAN HERBERT 0.025% A087300 001 May 27, 1982
OINTMENT; TOPICAL
FLUOCINOLONE ACETONIDE
G AND W LABS 0.025% A089524 001 Jul 26, 1988
PHARMADERM 0.025% A088046 001 Dec 16, 1982
PHARMAFAIR 0.025% A088507 001 Feb 27, 1984
USL PHARMA 0.025% A088742 001 Feb 08, 1985
FLUONID
ALLERGAN HERBERT 0.025% A087157 001 Sep 06, 1984
FLUOTREX
SAVAGE LABS 0.025% A088172 001 Mar 09, 1983
SOLUTION; TOPICAL
FLUOCINOLONE ACETONIDE
ALPHARMA US PHARMS 0.01% A087159 001 Jun 16, 1982
BAUSCH AND LOMB 0.01% A040059 001 Dec 20, 1993
MORTON GROVE 0.01% A088312 001 Jan 27, 1984
PHARMADERM 0.01% A088048 001 Dec 16, 1982
PHARMAFAIR 0.01% A088449 001 Feb 08, 1984
FLUONID
ALLERGAN HERBERT 0.01% A087158 001 Mar 17, 1983
FLUOTREX
SAVAGE LABS 0.01% A088171 001 Mar 09, 1983

FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE


CREAM; TOPICAL
NEO-SYNALAR
MEDICIS 0.025%;EQ 3.5MG BASE/GM A060700 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 135 (of 324)

FLUOCINONIDE
CREAM; TOPICAL
FLUOCINONIDE
PERRIGO NEW YORK 0.05% A071790 001 Jul 13, 1988
TARO 0.05% A071500 001 Jun 10, 1987
FLUOCINONIDE EMULSIFIED BASE
ACTAVIS MID ATLANTIC 0.05% A074204 001 Jun 13, 1995
SOLUTION; TOPICAL
FLUOCINONIDE
TARO 0.05% A072857 001 Aug 02, 1989
TEVA PHARMS 0.05% A072522 001 Sep 28, 1990

FLUORESCEIN SODIUM
INJECTABLE; INJECTION
FUNDUSCEIN-25
NOVARTIS 25% N017869 001

FLUOROMETHOLONE
CREAM; TOPICAL
OXYLONE
PHARMACIA AND UPJOHN 0.025% N011748 001
SUSPENSION/DROPS; OPHTHALMIC
FLUOR-OP
NOVARTIS 0.1% A070185 001 Feb 27, 1986

FLUOROMETHOLONE ACETATE; TOBRAMYCIN


SUSPENSION/DROPS; OPHTHALMIC
TOBRASONE
ALCON 0.1%;0.3% N050628 001 Jul 21, 1989

FLUOROMETHOLONE; SULFACETAMIDE SODIUM


SUSPENSION/DROPS; OPHTHALMIC
FML-S
ALLERGAN 0.1%;10% N019525 001 Sep 29, 1989

FLUOROURACIL
INJECTABLE; INJECTION
ADRUCIL
PHARMACIA AND UPJOHN 50MG/ML A081222 001 Jun 28, 1991
50MG/ML N017959 001
TEVA PARENTERAL 50MG/ML A040023 001 Oct 18, 1991
50MG/ML A081225 001 Aug 28, 1991
FLUOROURACIL
ABIC 50MG/ML A088929 001 Mar 04, 1986
ABRAXIS PHARM 50MG/ML A089152 001 Mar 21, 1986
50MG/ML A089428 001 Jan 12, 1987
50MG/ML A089519 001 Mar 12, 1987
APP PHARMS 50MG/ML A040291 001 Mar 24, 1999
50MG/ML A040379 001 Nov 15, 2000
BEDFORD 50MG/ML A089508 001 Jan 26, 1988
MARCHAR 50MG/ML A087791 001 Jan 18, 1983
SMITH AND NEPHEW 50MG/ML A088766 001 Dec 28, 1984
50MG/ML A088767 001 Dec 28, 1984
50MG/ML A089434 001 Mar 26, 1987
WATSON LABS 50MG/ML A087792 001 Oct 13, 1982
SOLUTION; TOPICAL
FLUOROPLEX
ELORAC 1% N016765 001

FLUOXETINE HYDROCHLORIDE
CAPSULE; ORAL
FLUOXETINE
MUTUAL PHARMA EQ 10MG BASE A075787 001 Jan 29, 2002
EQ 20MG BASE A075787 002 Jan 29, 2002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 136 (of 324)

FLUOXETINE HYDROCHLORIDE
CAPSULE; ORAL
FLUOXETINE
WATSON LABS EQ 10MG BASE A075662 001 Jan 29, 2002
EQ 20MG BASE A075662 002 Jan 29, 2002
FLUOXETINE HYDROCHLORIDE
BARR EQ 40MG BASE A076251 001 May 18, 2005
CARLSBAD EQ 10MG BASE A076022 001 Jan 30, 2002
EQ 20MG BASE A076022 002 Jan 30, 2002
PAR PHARM EQ 10MG BASE A076922 001 Dec 16, 2004
EQ 20MG BASE A076922 002 Dec 16, 2004
EQ 40MG BASE A076922 003 Dec 16, 2004
SANDOZ EQ 10MG BASE A075807 001 Jan 29, 2002
EQ 20MG BASE A075807 002 Jan 29, 2002
PROZAC
LILLY EQ 60MG BASE N018936 004 Jun 15, 1999
SOLUTION; ORAL
FLUOXETINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC EQ 20MG BASE/5ML A075690 001 Jan 31, 2002
HI TECH PHARMA EQ 20MG BASE/5ML A075525 001 Jun 27, 2002
PROZAC
LILLY EQ 20MG BASE/5ML N020101 001 Apr 24, 1991
TABLET; ORAL
FLUOXETINE HYDROCHLORIDE
BARR EQ 10MG BASE A075810 001 Feb 01, 2002
IVAX SUB TEVA PHARMS EQ 10MG BASE A075865 001 Feb 28, 2002
EQ 40MG BASE A075865 003 Aug 30, 2004
SANDOZ EQ 10MG BASE A076024 001 Jan 29, 2002
PROZAC
LILLY EQ 10MG BASE N020974 001 Mar 09, 1999
EQ 20MG BASE N020974 002 Mar 09, 1999

FLUOXYMESTERONE
TABLET; ORAL
ANDROID-F
VALEANT PHARM INTL 10MG A087196 001
FLUOXYMESTERONE
VALEANT PHARM INTL 10MG A088221 001 May 05, 1983
WATSON LABS 2MG A088260 001 Dec 06, 1983
5MG A088265 001 Dec 06, 1983
10MG A088309 001 Dec 06, 1983
HALOTESTIN
PHARMACIA AND UPJOHN 2MG N010611 002
5MG N010611 006
10MG N010611 010
ORA-TESTRYL
BRISTOL MYERS SQUIBB 2MG N011359 001
5MG N011359 002

FLUPHENAZINE DECANOATE
INJECTABLE; INJECTION
FLUPHENAZINE DECANOATE
HOSPIRA 25MG/ML A074966 001 Apr 16, 1998
PROLIXIN DECANOATE
BRISTOL MYERS SQUIBB 25MG/ML N016727 001

FLUPHENAZINE ENANTHATE
INJECTABLE; INJECTION
PROLIXIN ENANTHATE
APOTHECON 25MG/ML N016110 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 137 (of 324)

FLUPHENAZINE HYDROCHLORIDE
CONCENTRATE; ORAL
FLUPHENAZINE HYDROCHLORIDE
TEVA PHARMS 5MG/ML A073058 001 Aug 30, 1991
PERMITIL
SCHERING 5MG/ML N016008 001
PROLIXIN
APOTHECON 5MG/ML A070533 001 Nov 07, 1985
ELIXIR; ORAL
FLUPHENAZINE HYDROCHLORIDE
TEVA PHARMS 2.5MG/5ML A081310 001 Apr 29, 1993
PROLIXIN
APOTHECON 2.5MG/5ML N012145 003
INJECTABLE; INJECTION
PROLIXIN
APOTHECON 2.5MG/ML N011751 005
TABLET; ORAL
FLUPHENAZINE HYDROCHLORIDE
WATSON LABS 1MG A088555 001 Dec 18, 1987
2.5MG A088544 001 Dec 18, 1987
5MG A088527 001 Dec 18, 1987
10MG A088550 001 Dec 18, 1987
PERMITIL
SCHERING 0.25MG N012034 001
2.5MG N012034 004
5MG N012034 005
10MG N012034 006
PROLIXIN
APOTHECON 1MG N011751 004
2.5MG N011751 001
5MG N011751 003
10MG N011751 002
TABLET, EXTENDED RELEASE; ORAL
PERMITIL
SCHERING 1MG N012419 004

FLUPREDNISOLONE
TABLET; ORAL
ALPHADROL
PHARMACIA AND UPJOHN 1.5MG N012259 002

FLURANDRENOLIDE
LOTION; TOPICAL
FLURANDRENOLIDE
ALPHARMA US PHARMS 0.05% A087203 001 Apr 29, 1982

FLURANDRENOLIDE; NEOMYCIN SULFATE


CREAM; TOPICAL

CORDRAN-N

LILLY 0.05%;EQ 3.5MG BASE/GM N050346 001


OINTMENT; TOPICAL

CORDRAN-N

LILLY 0.05%;EQ 3.5MG BASE/GM N050345 001


FLURAZEPAM HYDROCHLORIDE
CAPSULE; ORAL
FLURAZEPAM HYDROCHLORIDE
HALSEY 15MG A071808 001 Jan 07, 1988
30MG A071809 001 Jan 07, 1988
MUTUAL PHARM 15MG A070454 001 Aug 04, 1986
30MG A070455 001 Aug 04, 1986
PAR PHARM 15MG A070444 001 Mar 20, 1986
30MG A070445 001 Mar 20, 1986
PUREPAC PHARM 15MG A071927 001 Sep 09, 1987
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DISCONTINUED DRUG PRODUCT LIST 6 - 138 (of 324)

FLURAZEPAM HYDROCHLORIDE
CAPSULE; ORAL
FLURAZEPAM HYDROCHLORIDE
PUREPAC PHARM 30MG A071551 001 Sep 09, 1987
SANDOZ 15MG A071716 001 Jul 31, 1991
30MG A071717 001 Jul 31, 1991
SUPERPHARM 15MG A071659 001 Aug 04, 1988
30MG A071660 001 Aug 04, 1988
USL PHARMA 15MG A070562 001 Jul 09, 1987
30MG A070563 001 Jul 09, 1987
WARNER CHILCOTT 15MG A071767 001 Dec 04, 1987
30MG A071768 001 Dec 04, 1987
WATSON LABS 15MG A072368 001 Mar 30, 1989

FLURBIPROFEN
TABLET; ORAL
FLURBIPROFEN
IVAX SUB TEVA PHARMS 50MG A074411 001 May 31, 1995
100MG A074411 002 May 31, 1995
PLIVA 50MG A074647 001 Apr 01, 1997
100MG A074647 002 Apr 01, 1997
SANDOZ 50MG A074448 001 Jul 28, 1995
100MG A074448 002 Jul 28, 1995
TEVA 50MG A074405 002 May 24, 1995
100MG A074405 001 May 24, 1995
THERAGEN 100MG A074560 002 May 16, 1997

FLUTAMIDE
CAPSULE; ORAL
EULEXIN
SCHERING 125MG N018554 001 Jan 27, 1989

FLUTICASONE PROPIONATE
AEROSOL, METERED; INHALATION
FLOVENT
GLAXOSMITHKLINE 0.044MG/INH N020548 001 Mar 27, 1996
0.11MG/INH N020548 002 Mar 27, 1996
0.22MG/INH N020548 003 Mar 27, 1996
OINTMENT; TOPICAL
FLUTICASONE PROPIONATE
TARO PHARM INDS 0.005% A077145 001 Jun 14, 2005
POWDER; INHALATION
FLOVENT
GLAXOSMITHKLINE 0.044MG/INH N020549 001 Nov 07, 1997
0.088MG/INH N020549 002 Nov 07, 1997
0.22MG/INH N020549 003 Nov 07, 1997

FLUVOXAMINE MALEATE
TABLET; ORAL
FLUVOXAMINE MALEATE
ACTAVIS ELIZABETH 25MG A075901 001 Dec 28, 2000
50MG A075901 002 Dec 28, 2000
100MG A075901 003 Dec 28, 2000
GENPHARM 50MG A075950 001 Oct 15, 2001
100MG A075950 002 Oct 15, 2001
IVAX SUB TEVA PHARMS 25MG A075898 001 Mar 12, 2001
50MG A075898 002 Mar 12, 2001
100MG A075898 003 Mar 12, 2001
MUTUAL PHARM 25MG A076125 001 Apr 29, 2002
50MG A076125 002 Apr 29, 2002
100MG A076125 003 Apr 29, 2002
SANDOZ 25MG A075887 001 Jan 05, 2001
50MG A075887 002 Jan 05, 2001
100MG A075887 003 Jan 05, 2001
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DISCONTINUED DRUG PRODUCT LIST 6 - 139 (of 324)

FLUVOXAMINE MALEATE
TABLET; ORAL
FLUVOXAMINE MALEATE
SYNTHON PHARMS 25MG A075899 001 Jan 17, 2001
50MG A075899 002 Jan 17, 2001
100MG A075899 003 Jan 17, 2001
WATSON LABS 25MG A075894 001 Apr 18, 2001
50MG A075894 002 Apr 18, 2001
100MG A075894 003 Apr 18, 2001
LUVOX
SOLVAY 25MG N020243 001 Dec 05, 1994
50MG N020243 002 Dec 05, 1994
100MG N020243 003 Dec 05, 1994
150MG N020243 004 Dec 05, 1994

FOLIC ACID
INJECTABLE; INJECTION
FOLIC ACID
BEN VENUE 5MG/ML A081066 001 Dec 29, 1993
FOLVITE
WYETH PHARMS INC 5MG/ML N005897 008
TABLET; ORAL
FOLIC ACID
BARR 1MG A089177 001 Jan 08, 1986
EVERYLIFE 1MG A080755 001
HALSEY 1MG A083598 001
IMPAX LABS 1MG A080686 001
IVAX SUB TEVA PHARMS 1MG A083000 001
LANNETT 1MG A080816 001
LILLY 1MG N006135 003
MK LABS 1MG A083526 001
NEXGEN PHARMA INC 1MG A084915 001
PHARMERAL 1MG A084158 001
PIONEER PHARMS 1MG A088949 001 Sep 13, 1985
PUREPAC PHARM 1MG A080784 001
SANDOZ 1MG A084472 001
TABLICAPS 1MG A083133 002
UDL 1MG A088199 001 Mar 29, 1983
USL PHARMA 1MG A087828 001 May 13, 1982
VALEANT PHARM INTL 1MG A080903 001
VANGARD 1MG A088730 001 Mar 23, 1984
VINTAGE PHARMS 1MG A086296 001
WATSON LABS 1MG A080680 001
1MG A083141 001
1MG A085141 002
WHITEWORTH TOWN PLSN 1MG A080691 002
FOLICET
MISSION PHARMA 1MG A087438 001
FOLVITE
WYETH PHARMS INC 1MG N005897 004

FOLLITROPIN ALFA/BETA
INJECTABLE; IM-SC
FOLLISTIM
ORGANON USA INC 75 IU/VIAL N020582 001 Sep 29, 1997
150 IU/VIAL N020582 002 Sep 29, 1997
INJECTABLE; SUBCUTANEOUS
FOLLISTIM AQ
ORGANON USA INC 150 IU/0.18ML N021211 003 Feb 11, 2004
GONAL-F
EMD SERONO 37.5 IU/VIAL N020378 003 May 25, 2000
37.5 IU/VIAL N021765 001 Mar 25, 2004
75 IU/VIAL N020378 001 Sep 29, 1997
150 IU/VIAL N020378 002 Sep 29, 1997
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DISCONTINUED DRUG PRODUCT LIST 6 - 140 (of 324)

FOLLITROPIN ALFA/BETA
INJECTABLE; SUBCUTANEOUS
GONAL-F
EMD SERONO 150 IU/VIAL N021765 003 Mar 25, 2004

FOMIVIRSEN SODIUM
INJECTABLE; INJECTION
VITRAVENE PRESERVATIVE FREE
NOVARTIS 6.6MG/ML N020961 001 Aug 26, 1998

FOSINOPRIL SODIUM
TABLET; ORAL
FOSINOPRIL SODIUM
SANDOZ 10MG A076188 001 Oct 08, 2004
20MG A076188 002 Oct 08, 2004
40MG A076188 003 Oct 08, 2004

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE


TABLET; ORAL
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
TEVA 10MG;12.5MG A076945 001 Jul 05, 2006
20MG;12.5MG A076945 002 Jul 05, 2006
WATSON LABS 10MG;12.5MG A077144 001 Aug 16, 2005
20MG;12.5MG A077144 002 Aug 16, 2005
MONOPRIL-HCT
BRISTOL MYERS SQUIBB 10MG;12.5MG N020286 002 Nov 30, 1994
20MG;12.5MG N020286 001 Nov 30, 1994

FURAZOLIDONE
SUSPENSION; ORAL

FUROXONE

SHIRE 50MG/15ML N011323 002


TABLET; ORAL

FUROXONE

SHIRE 100MG N011270 002


FUROSEMIDE
INJECTABLE; INJECTION
FUROSEMIDE
ABRAXIS PHARM 10MG/ML N018507 001 Jul 30, 1982
10MG/ML N019036 001 Aug 13, 1984
ASTRAZENECA 10MG/ML A070014 001 Sep 09, 1985
10MG/ML A070095 001 Sep 09, 1985
10MG/ML A070096 001 Sep 09, 1985
BAXTER HLTHCARE 10MG/ML A071439 001 Sep 14, 1990
10MG/ML N018267 001
HOSPIRA 10MG/ML A072080 001 Aug 13, 1991
10MG/ML A074337 001 Oct 31, 1994
MARSAM PHARMS LLC 10MG/ML A074017 001 Jun 30, 1994
ORGANON USA INC 10MG/ML A070017 001 Dec 15, 1986
SMITH AND NEPHEW 10MG/ML A070023 001 Feb 05, 1986
10MG/ML A070078 001 Feb 05, 1986
WARNER CHILCOTT 10MG/ML N018420 001 Feb 26, 1982
WATSON LABS 10MG/ML A070019 001 Sep 22, 1986
10MG/ML A070604 001 Jan 02, 1987
WYETH AYERST 10MG/ML N018670 001 Jul 20, 1982
LASIX
SANOFI AVENTIS US 10MG/ML N016363 001
SOLUTION; ORAL
LASIX
SANOFI AVENTIS US 10MG/ML N017688 001
TABLET; ORAL
FUROSEMIDE
INTL MEDICATION 20MG N018753 001 Feb 28, 1984
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DISCONTINUED DRUG PRODUCT LIST 6 - 141 (of 324)

FUROSEMIDE
TABLET; ORAL
FUROSEMIDE
INTL MEDICATION 40MG N018753 002 Feb 28, 1984
KALAPHARM 20MG N018868 001 Jun 28, 1983
40MG N018868 002 Jun 28, 1983
MUTUAL PHARM 20MG A070043 001 Sep 26, 1985
40MG N018790 001 Nov 29, 1983
80MG A070100 001 Jan 26, 1988
SANDOZ 40MG N018750 002 Jul 30, 1984
SUPERPHARM 20MG N018370 002 Jun 26, 1984
40MG N018370 001 Feb 10, 1983
WARNER CHILCOTT 20MG N018419 001 Jan 31, 1983
40MG N018419 002 Jan 31, 1983
80MG N018419 003 Nov 13, 1984
WATSON LABS 20MG N018369 001 May 14, 1982
40MG A070413 001 Feb 26, 1986
40MG N018369 002 May 14, 1982

GABAPENTIN
CAPSULE; ORAL
GABAPENTIN
IVAX SUB TEVA PHARMS 100MG A075477 001 Mar 23, 2005
300MG A075477 002 Mar 23, 2005
400MG A075477 003 Mar 23, 2005
MUTUAL PHARM 100MG A076537 001 Jun 30, 2005
300MG A076537 002 Jun 30, 2005
400MG A076537 003 Jun 30, 2005
SANDOZ 100MG A075428 001 Jan 24, 2006
300MG A075428 002 Jan 24, 2006
400MG A075428 003 Jan 24, 2006
TABLET; ORAL
GABAPENTIN
RANBAXY 600MG A076605 001 Sep 14, 2005
800MG A076605 002 Sep 14, 2005
SANDOZ 600MG A076120 001 Jan 27, 2006
800MG A076120 002 Jan 27, 2006

GADODIAMIDE
INJECTABLE; INJECTION
OMNISCAN
GE HEALTHCARE 14.35GM/50ML (287MG/ML) N022066 001 Sep 05, 2007

GALLAMINE TRIETHIODIDE
INJECTABLE; INJECTION
FLAXEDIL
DAVIS AND GECK 20MG/ML N007842 001
100MG/ML N007842 002

GALLIUM CITRATE, GA-67


INJECTABLE; INJECTION
GALLIUM CITRATE GA 67
GE HEALTHCARE 1mCi/ML N017700 001
NEOSCAN
GE HEALTHCARE 2mCi/ML N017655 001

GANCICLOVIR
CAPSULE; ORAL
CYTOVENE
ROCHE PALO 250MG N020460 001 Dec 22, 1994
500MG N020460 002 Dec 12, 1997
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DISCONTINUED DRUG PRODUCT LIST 6 - 142 (of 324)

GANCICLOVIR SODIUM
INJECTABLE; INJECTION
CYTOVENE
ROCHE PALO EQ 500MG BASE/VIAL N019661 001 Jun 23, 1989

GEMFIBROZIL
CAPSULE; ORAL
GEMFIBROZIL
MYLAN 300MG A073466 001 Jan 25, 1993
PUREPAC PHARM 300MG A072929 001 Jan 29, 1993
LOPID
PFIZER PHARMS 200MG N018422 001
300MG N018422 002
TABLET; ORAL
GEMFIBROZIL
DAVA PHARMS INC 600MG A074270 001 Sep 27, 1993
MYLAN 600MG A074452 001 Feb 16, 1995
PUREPAC PHARM 600MG A074360 001 Aug 31, 1994
SANDOZ 600MG A074615 001 Sep 29, 1995
WATSON LABS 600MG A074156 001 Oct 24, 1994

GENTAMICIN SULFATE
CREAM; TOPICAL
GARAMYCIN
SCHERING EQ 0.1% BASE A060462 001
GENTAFAIR
PHARMAFAIR EQ 0.1% BASE A062458 001 Sep 01, 1983
GENTAMICIN SULFATE
ALPHARMA US PHARMS EQ 0.1% BASE A062471 001 Sep 27, 1983
BAUSCH AND LOMB EQ 0.1% BASE A064056 001 Apr 29, 1994
PHARMADERM EQ 1MG BASE/GM A062530 001 Jul 05, 1984
INJECTABLE; INJECTION
APOGEN
KING PHARMS EQ 10MG BASE/ML A062289 001
EQ 40MG BASE/ML A062289 002
BRISTAGEN
BRISTOL EQ 40MG BASE/ML A062288 001
GARAMYCIN
SCHERING EQ 1MG BASE/ML A061716 002
EQ 10MG BASE/ML A061739 001
EQ 40MG BASE/ML A061716 001
GENTAFAIR
PHARMAFAIR EQ 40MG BASE/ML A062493 001 Aug 28, 1985
GENTAMICIN
INTL MEDICATION EQ 1MG BASE/ML A062325 003 Jun 23, 1982
EQ 40MG BASE/ML A062325 001
EQ 100MG BASE/100ML A062325 004 Jun 23, 1982
GENTAMICIN SULFATE
ABBOTT EQ 1.2MG BASE/ML A062413 001 Aug 11, 1983
EQ 1.4MG BASE/ML A062413 002 Aug 11, 1983
EQ 1.6MG BASE/ML A062413 003 Aug 11, 1983
EQ 1.8MG BASE/ML A062413 004 Aug 11, 1983
EQ 2MG BASE/ML A062413 005 Aug 11, 1983
EQ 60MG BASE/100ML A062413 006 Aug 11, 1983
EQ 70MG BASE/100ML A062413 007 Aug 11, 1983
EQ 80MG BASE/100ML A062413 008 Aug 11, 1983
EQ 90MG BASE/100ML A062413 009 Aug 11, 1983
EQ 100MG BASE/100ML A062413 010 Aug 11, 1983
BAXTER HLTHCARE EQ 10MG BASE/ML A062251 002
EQ 40MG BASE/ML A062251 001
KALAPHARM EQ 40MG BASE/ML A062354 001 Apr 05, 1982
PHARM SPEC EQ 40MG BASE/ML A062340 001 Mar 28, 1983
SOLOPAK EQ 10MG BASE/ML A062507 001 Jun 06, 1985
EQ 40MG BASE/ML A062507 002 Jun 06, 1985
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DISCONTINUED DRUG PRODUCT LIST 6 - 143 (of 324)

GENTAMICIN SULFATE
INJECTABLE; INJECTION
GENTAMICIN SULFATE
TEVA PARENTERAL EQ 10MG BASE/ML A063149 001 Nov 21, 1991
EQ 40MG BASE/ML A063106 002 Nov 21, 1991
WATSON LABS EQ 10MG BASE/ML A062318 002
EQ 40MG BASE/ML A062318 001
WYETH AYERST EQ 10MG BASE/ML A062264 001
EQ 40MG BASE/ML A062264 002
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA EQ 1.2MG BASE/ML A062588 001 Jan 06, 1986
EQ 1.4MG BASE/ML A062588 002 Jan 06, 1986
EQ 1.6MG BASE/ML A062588 003 Jan 06, 1986
EQ 1.8MG BASE/ML A062588 004 Jan 06, 1986
EQ 2MG BASE/ML A062588 005 Jan 06, 1986
EQ 60MG BASE/100ML A062588 006 Jan 06, 1986
EQ 70MG BASE/100ML A062588 007 Jan 06, 1986
EQ 80MG BASE/100ML A062588 008 Jan 06, 1986
EQ 90MG BASE/100ML A062588 009 Jan 06, 1986
EQ 100MG BASE/100ML A062588 010 Jan 06, 1986
U-GENCIN
PHARMACIA AND UPJOHN EQ 10MG BASE/ML A062248 001
EQ 40MG BASE/ML A062248 002
INJECTABLE; INTRATHECAL
GARAMYCIN
SCHERING EQ 2MG BASE/ML N050505 001
OINTMENT; OPHTHALMIC
GARAMYCIN
SCHERING EQ 0.3% BASE N050425 001
GENTACIDIN
NOVARTIS EQ 0.3% BASE A062501 001 Jul 26, 1984
GENTAFAIR
PHARMAFAIR EQ 3MG BASE/GM A062443 001 May 26, 1983
OINTMENT; TOPICAL
GARAMYCIN
SCHERING EQ 0.1% BASE A060463 001
GENTAFAIR
PHARMAFAIR EQ 0.1% BASE A062444 001 May 26, 1983
GENTAMICIN SULFATE
ALPHARMA US PHARMS EQ 0.1% BASE A062496 001 Mar 14, 1984
BAUSCH AND LOMB EQ 0.1% BASE A064054 001 Apr 29, 1994
PHARMADERM EQ 0.1% BASE A062534 001 Oct 10, 1984
SOLUTION/DROPS; OPHTHALMIC
GARAMYCIN
SCHERING EQ 0.3% BASE N050039 002
GENTACIDIN
NOVARTIS EQ 0.3% BASE A062480 001 Mar 30, 1984
GENTAFAIR
PHARMAFAIR EQ 0.3% BASE A062440 001 May 03, 1983
GENTAMICIN SULFATE
ALCON UNIVERSAL EQ 0.3% BASE A062523 001 Nov 25, 1985
PACO EQ 3MG BASE/ML A062932 001 Nov 07, 1988

GENTIAN VIOLET
SUPPOSITORY; VAGINAL

GVS

SAVAGE LABS 0.4% A083513 001


TAMPON; VAGINAL

GENAPAX

KEY PHARMS 5MG A085017 001


GLATIRAMER ACETATE
FOR SOLUTION; SUBCUTANEOUS
COPAXONE
TEVA 20MG/VIAL N020622 001 Dec 20, 1996
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DISCONTINUED DRUG PRODUCT LIST 6 - 144 (of 324)

GLIMEPIRIDE
TABLET; ORAL
GLIMEPIRIDE
RANBAXY 3MG A077366 001 Oct 06, 2005
6MG A077366 002 Oct 06, 2005
VINTAGE 1MG A077370 001 Dec 23, 2005
2MG A077370 002 Dec 23, 2005
4MG A077370 003 Dec 23, 2005
8MG A077370 004 Dec 23, 2005

GLIPIZIDE
TABLET; ORAL
GLIPIZIDE
ENDO PHARMS 5MG A074378 001 Nov 28, 1994
10MG A074378 002 Nov 28, 1994
PLIVA 5MG A074619 001 Apr 04, 1997
10MG A074619 002 Apr 04, 1997
SANDOZ 5MG A074542 001 Jun 20, 1995
10MG A074542 002 Jun 20, 1995
TEVA 5MG A074387 001 Mar 04, 1996
10MG A074387 002 Mar 04, 1996
GLUCOTROL
PFIZER 2.5MG N017783 003 May 11, 1993

GLUCAGON HYDROCHLORIDE
INJECTABLE; INJECTION
GLUCAGON
LILLY EQ 1MG BASE/VIAL N012122 001
EQ 10MG BASE/VIAL N012122 002

GLUTETHIMIDE
CAPSULE; ORAL
DORIDEN
SANOFI AVENTIS US 500MG N009519 008
TABLET; ORAL
DORIDEN
SANOFI AVENTIS US 250MG N009519 002
500MG N009519 005
GLUTETHIMIDE
HALSEY 250MG A089458 001 Oct 10, 1986
500MG A089459 001 Oct 10, 1986
LANNETT 250MG A083475 001
500MG A085571 001
SANDOZ 500MG A083234 002
UCB INC 500MG A085171 001
VITARINE 500MG A087297 001
WATSON LABS 500MG A084362 001
500MG A085763 001

GLYBURIDE
TABLET; ORAL
GLYBURIDE (MICRONIZED)
SANDOZ 1.5MG A075174 001 Jun 22, 1998
3MG A075174 002 Jun 22, 1998
SANOFI AVENTIS US 1.5MG N020055 001 Apr 17, 1992
3MG N020055 002 Apr 17, 1992
6MG N020055 003 Mar 08, 2000
GLYNASE
PHARMACIA AND UPJOHN 4.5MG N020051 003 Sep 24, 1993
MICRONASE
PHARMACIA AND UPJOHN 1.25MG N017498 001 May 01, 1984
2.5MG N017498 002 May 01, 1984
5MG N017498 003 May 01, 1984
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DISCONTINUED DRUG PRODUCT LIST 6 - 145 (of 324)

GLYCINE
SOLUTION; IRRIGATION
GLYCINE 1.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 1.5GM/100ML N018522 001 Feb 19, 1982
HOSPIRA 1.5GM/100ML N017633 001

GLYCOPYRROLATE
INJECTABLE; INJECTION
GLYCOPYRROLATE
ABRAXIS PHARM 0.2MG/ML A088475 001 Jun 12, 1984
HOSPIRA 0.2MG/ML A089393 001 Jun 15, 1988
TEVA PARENTERAL 0.2MG/ML A081169 001 Sep 10, 1991
WATSON LABS 0.2MG/ML A086947 001 Jun 24, 1983
ROBINUL
ROBINS AH 0.2MG/ML N014764 001
TABLET; ORAL
GLYCOPYRROLATE
WATSON LABS 1MG A085562 001
1MG A086902 001
2MG A085563 001
2MG A086178 001
2MG A086900 001

GONADORELIN ACETATE
INJECTABLE; INJECTION
LUTREPULSE KIT
FERRING 0.8MG/VIAL N019687 001 Oct 10, 1989
3.2MG/VIAL N019687 002 Oct 10, 1989

GONADORELIN HYDROCHLORIDE
INJECTABLE; INJECTION
FACTREL
BAXTER HLTHCARE CORP EQ 0.1MG BASE/VIAL N018123 001 Sep 30, 1982
EQ 0.2MG BASE/VIAL N018123 002 Sep 30, 1982
EQ 0.5MG BASE/VIAL N018123 003 Sep 30, 1982

GONADOTROPIN, CHORIONIC
INJECTABLE; INJECTION
A.P.L.
FERRING 5,000 UNITS/VIAL N017055 001

10,000 UNITS/VIAL N017055 002


20,000 UNITS/VIAL N017055 003


CHORIONIC GONADOTROPIN
APP PHARMS 5,000 UNITS/VIAL N017067 001

15,000 UNITS/VIAL N017067 004


20,000 UNITS/VIAL N017067 003


BEL MAR 5,000 UNITS/VIAL N017054 001


10,000 UNITS/VIAL N017054 002


FERRING 2,000 UNITS/VIAL N017016 009 Dec 27, 1984


2,000 UNITS/VIAL N017016 011 Feb 16, 1990
5,000 UNITS/VIAL N017016 006
15,000 UNITS/VIAL N017016 010 Feb 15, 1985
20,000 UNITS/VIAL N017016 004
FOLLUTEIN
BRISTOL MYERS SQUIBB 10,000 UNITS/VIAL N017056 001

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


SOLUTION/DROPS; OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
IPHARM 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A062818 001 Oct 11, 1988
UNITS/ML
WATSON LABS 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A062788 001 Jun 11, 1987
UNITS/ML
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 146 (of 324)

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


SOLUTION/DROPS; OPHTHALMIC
NEOMYCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDIN
PHARMAFAIR 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A062383 001 Aug 31, 1982
UNITS/ML
NEO-POLYCIN
DOW PHARM 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A060427 001
UNITS/ML

GRANISETRON HYDROCHLORIDE
INJECTABLE; INJECTION
KYTRIL
ROCHE EQ 3MG BASE/ML N020239 001 Dec 29, 1993
SOLUTION; ORAL
KYTRIL
ROCHE EQ 2MG BASE/10ML N021238 001 Jun 27, 2001
TABLET; ORAL
KYTRIL
ROCHE EQ 2MG BASE N020305 002 Jun 15, 1998

GREPAFLOXACIN HYDROCHLORIDE
TABLET; ORAL

RAXAR

OTSUKA EQ 200MG BASE N020695 001 Nov 06, 1997


EQ 400MG BASE N020695 002 May 14, 1998
EQ 600MG BASE N020695 003 May 14, 1998

GRISEOFULVIN, MICROCRYSTALLINE
CAPSULE; ORAL

GRISACTIN

WYETH AYERST 125MG N050051 002


250MG N050051 001


SUSPENSION; ORAL

GRIFULVIN V

JOHNSON AND JOHNSON 125MG/5ML N050448 001


TABLET; ORAL

FULVICIN-U/F

SCHERING 250MG A060569 002


500MG A060569 001


GRIFULVIN V

J AND J 125MG A060618 001


250MG A060618 002


500MG A060618 003


ORTHONEUTROGENA 125MG A062279 001


250MG A062279 002


GRISACTIN

WYETH AYERST 500MG A060212 001


GRISEOFULVIN, ULTRAMICROCRYSTALLINE
TABLET; ORAL
FULVICIN P/G
SCHERING 125MG A061996 001
250MG A061996 002
FULVICIN P/G 165
SCHERING 165MG A061996 003 Apr 06, 1982
FULVICIN P/G 330
SCHERING 330MG A061996 004 Apr 06, 1982
GRISACTIN ULTRA
WYETH AYERST 125MG A062178 001
165MG A062438 001 Nov 17, 1983
250MG A062178 002
330MG A062438 002 Nov 17, 1983
ULTRAGRIS-165
PLIVA 165MG A062645 001 Jun 30, 1992
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 147 (of 324)

GRISEOFULVIN, ULTRAMICROCRYSTALLINE
TABLET; ORAL
ULTRAGRIS-330
PLIVA 330MG A062646 001 Jun 30, 1992

GUANABENZ ACETATE
TABLET; ORAL
GUANABENZ ACETATE
SANDOZ EQ 4MG BASE A074517 001 Sep 30, 1998
EQ 8MG BASE A074517 002 Sep 30, 1998
TEVA PHARMS EQ 4MG BASE A074267 001 Jun 01, 1994
EQ 8MG BASE A074267 002 Jun 01, 1994
WATSON LABS EQ 4MG BASE A074025 001 Feb 28, 1994
EQ 8MG BASE A074025 002 Feb 28, 1994
WYTENSIN
WYETH AYERST EQ 4MG BASE N018587 001 Sep 07, 1982
EQ 8MG BASE N018587 002 Sep 07, 1982
EQ 16MG BASE N018587 003 Sep 07, 1982

GUANADREL SULFATE
TABLET; ORAL
HYLOREL
PHARMACIA AND UPJOHN 10MG N018104 001 Dec 29, 1982
25MG N018104 002 Dec 29, 1982

GUANETHIDINE MONOSULFATE
TABLET; ORAL
GUANETHIDINE MONOSULFATE
WATSON LABS EQ 10MG SULFATE A086113 001 Mar 26, 1985
EQ 25MG SULFATE A086114 001 Mar 26, 1985
ISMELIN
NOVARTIS EQ 10MG SULFATE N012329 001
EQ 25MG SULFATE N012329 002

GUANETHIDINE MONOSULFATE; HYDROCHLOROTHIAZIDE


TABLET; ORAL
ESIMIL
NOVARTIS 10MG;25MG N013553 001

GUANFACINE HYDROCHLORIDE
TABLET; ORAL
GUANFACINE HYDROCHLORIDE
WATSON LABS EQ 1MG BASE A074762 001 Jun 25, 1997
EQ 2MG BASE A074762 002 Jun 25, 1997
TENEX
PROMIUS PHARMA EQ 3MG BASE N019032 003 Nov 07, 1988

HALAZEPAM
TABLET; ORAL
PAXIPAM
SCHERING 20MG N017736 003
40MG N017736 004

HALCINONIDE
CREAM; TOPICAL
HALOG
WESTWOOD SQUIBB 0.025% N017818 001
HALOG-E
RANBAXY 0.1% N018234 001
OINTMENT; TOPICAL
HALOG
BRISTOL MYERS SQUIBB 0.025% N018125 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 148 (of 324)

HALOFANTRINE HYDROCHLORIDE
TABLET; ORAL
HALFAN
GLAXOSMITHKLINE 250MG N020250 001 Jul 24, 1992

HALOPERIDOL
TABLET; ORAL
HALDOL
ORTHO MCNEIL 0.5MG N015921 001
1MG N015921 002
2MG N015921 003
5MG N015921 004
10MG N015921 005
20MG N015921 006 Feb 02, 1982
HALDOL SOLUTAB
ORTHO MCNEIL PHARM 1MG N017079 001
HALOPERIDOL
DURAMED PHARMS BARR 0.5MG A071216 001 Dec 04, 1986
1MG A071217 001 Dec 04, 1986
2MG A071218 001 Dec 04, 1986
5MG A071219 001 Dec 04, 1986
10MG A071220 001 Jul 07, 1987
20MG A071221 001 Jul 07, 1987
LEDERLE 0.5MG A072727 001 Sep 19, 1989
1MG A072728 001 Sep 19, 1989
2MG A072729 001 Sep 19, 1989
5MG A072730 001 Sep 19, 1989
10MG A072731 001 Sep 19, 1989
20MG A072732 001 Sep 19, 1989
MUTUAL PHARM 0.5MG A071156 001 Jan 02, 1987
1MG A071157 001 Jan 02, 1987
2MG A071172 001 Jan 02, 1987
5MG A071212 001 Jan 07, 1988
10MG A071173 001 Jan 07, 1988
20MG A071177 001 Jan 07, 1988
PAR PHARM 20MG A071328 001 Jul 20, 1987
PUREPAC PHARM 0.5MG A071071 001 Nov 03, 1986
1MG A071072 001 Nov 03, 1986
2MG A071073 001 Nov 03, 1986
5MG A071074 001 Nov 03, 1986
10MG A071075 001 Aug 04, 1987
20MG A071076 001 Aug 04, 1987
QUANTUM PHARMICS 0.5MG A071255 001 Feb 17, 1987
1MG A071269 001 Feb 17, 1987
2MG A071256 001 Feb 17, 1987
5MG A071257 001 Feb 17, 1987
ROXANE 0.5MG A071128 001 Feb 17, 1987
1MG A071129 001 Feb 17, 1987
2MG A071130 001 Feb 17, 1987
5MG A071131 001 Feb 17, 1987
10MG A071132 001 May 12, 1987
20MG A071133 001 May 12, 1987
ROYCE LABS 0.5MG A071722 001 Dec 24, 1987
1MG A071723 001 Dec 24, 1987
2MG A071724 001 Dec 24, 1987
5MG A071725 001 Dec 24, 1987
10MG A072121 001 Dec 24, 1987
20MG A072122 001 Dec 24, 1987
SCS 0.5MG A070720 001 Jun 10, 1986
1MG A070721 001 Jun 10, 1986
2MG A070722 001 Jun 10, 1986
5MG A070723 001 Jun 10, 1986
10MG A070724 001 Jun 10, 1986
20MG A070725 001 Sep 24, 1986
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 149 (of 324)

HALOPERIDOL
TABLET; ORAL
HALOPERIDOL
VINTAGE 0.5MG A071233 001 Nov 03, 1986
1MG A071234 001 Nov 03, 1986
2MG A071235 001 Nov 03, 1986
5MG A071236 001 Nov 03, 1986
10MG A071237 001 Jul 20, 1987
WATSON LABS 0.5MG A070981 001 Mar 06, 1987
0.5MG A071571 001 Jun 03, 1988
1MG A070982 001 Mar 06, 1987
1MG A071572 001 Jun 03, 1988
2MG A070983 001 Mar 06, 1987
2MG A071573 001 Jun 03, 1988
5MG A070984 001 Mar 06, 1987
5MG A071374 001 Jun 03, 1988
10MG A071375 001 Jun 03, 1988
10MG A072113 001 Aug 27, 1991
20MG A071376 001 Jun 03, 1988
20MG A072353 001 Aug 27, 1991

HALOPERIDOL DECANOATE
INJECTABLE; INJECTION
HALOPERIDOL DECANOATE
HOSPIRA EQ 50MG BASE/ML A075176 001 Feb 09, 2000
EQ 100MG BASE/ML A075176 002 Feb 09, 2000
SANDOZ EQ 50MG BASE/ML A076463 001 Jun 24, 2005
EQ 100MG BASE/ML A076463 002 Jun 24, 2005

HALOPERIDOL LACTATE
CONCENTRATE; ORAL
HALDOL
ORTHO MCNEIL EQ 2MG BASE/ML N015922 001
HALOPERIDOL
ALPHARMA EQ 2MG BASE/ML A070318 001 Apr 11, 1986
MORTON GROVE EQ 2MG BASE/ML A070710 001 Mar 07, 1986
SCS EQ 2MG BASE/ML A070726 001 Jun 10, 1986
TEVA EQ 2MG BASE/ML A071015 001 Aug 25, 1987
HALOPERIDOL INTENSOL
ROXANE EQ 2MG BASE/ML A072045 001 Apr 12, 1988
INJECTABLE; INJECTION
HALOPERIDOL
ABRAXIS PHARM EQ 5MG BASE/ML A071187 001 Jan 20, 1987
MARSAM PHARMS LLC EQ 5MG BASE/ML A072516 001 Feb 25, 1993
EQ 5MG BASE/ML A072517 001 Feb 25, 1993
SANDOZ EQ 5MG BASE/ML A076464 001 Sep 29, 2004
SMITH AND NEPHEW EQ 5MG BASE/ML A070802 001 Dec 14, 1987
SOLOPAK EQ 5MG BASE/ML A070800 001 Dec 14, 1987
EQ 5MG BASE/ML A070801 001 Dec 14, 1987
EQ 5MG BASE/ML A070864 001 Dec 14, 1987
WATSON LABS EQ 5MG BASE/ML A070713 001 May 17, 1988
EQ 5MG BASE/ML A070714 001 May 17, 1988
EQ 5MG BASE/ML A070744 001 May 17, 1988
SOLUTION; ORAL
HALOPERIDOL LACTATE
ACTAVIS MID ATLANTIC EQ 1MG BASE/ML A074536 001 Nov 02, 1995

HALOPROGIN
CREAM; TOPICAL

HALOTEX

WESTWOOD SQUIBB 1% N016942 001


SOLUTION; TOPICAL

HALOTEX

WESTWOOD SQUIBB 1% N016943 001


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 150 (of 324)

HALOTHANE
LIQUID; INHALATION
FLUOTHANE
WYETH AYERST 99.99% N011338 001
HALOTHANE
BH 99.99% A084977 001
HALOCARBON 99.99% A080810 001
HOSPIRA 99.99% A083254 001

HEPARIN CALCIUM
INJECTABLE; INJECTION
CALCIPARINE
SANOFI AVENTIS US 25,000 UNITS/ML N018237 001

HEPARIN SODIUM
INJECTABLE; INJECTION
HEPARIN LOCK FLUSH
HOSPIRA 100 UNITS/ML N005264 010
INTL MEDICATION 10 UNITS/ML A086357 001
500 UNITS/ML A086357 002
LUITPOLD 10 UNITS/ML A089063 001 Oct 09, 1985
100 UNITS/ML A089064 001 Oct 09, 1985
PARKE DAVIS 10 UNITS/ML N017346 006
SMITH AND NEPHEW 10 UNITS/ML A087904 001 Apr 20, 1983
10 UNITS/ML A087958 001 Apr 20, 1983
10 UNITS/ML A088458 001 Jul 26, 1984
10 UNITS/ML A088580 001 Oct 25, 1984
100 UNITS/ML A087906 001 Apr 20, 1983
100 UNITS/ML A087959 001 Apr 20, 1983
100 UNITS/ML A088460 001 Jul 26, 1984
100 UNITS/ML A088581 001 Oct 25, 1984
SOLOPAK 10 UNITS/ML A087903 001 Apr 20, 1983
10 UNITS/ML A088457 001 Oct 25, 1984
100 UNITS/ML A087905 001 Apr 20, 1983
100 UNITS/ML A088459 001 Jul 26, 1984
HEPARIN SODIUM
ABRAXIS PHARM 1,000 UNITS/ML N017033 001
1,000 UNITS/ML N017979 001
5,000 UNITS/ML N017979 003
10,000 UNITS/ML N017979 002
AKORN 1,000 UNITS/ML N017486 001
5,000 UNITS/ML N017486 002
10,000 UNITS/ML N017486 003
20,000 UNITS/ML N017486 004
40,000 UNITS/ML N017486 005
APP PHARMS 1,000 UNITS/ML N017651 005
5,000 UNITS/ML N017029 002
10,000 UNITS/ML N017651 003
20,000 UNITS/ML N017651 008
BAXTER HLTHCARE 5,000 UNITS/0.5ML N017037 013 Apr 07, 1986
BAXTER HLTHCARE CORP 1,000 UNITS/ML N017007 001
2,500 UNITS/ML N017007 007
5,000 UNITS/ML N017007 002
5,000 UNITS/0.5ML N017007 010
7,500 UNITS/ML N017007 003
10,000 UNITS/ML N017007 004
15,000 UNITS/ML N017007 005
20,000 UNITS/ML N017007 006
CHAMBERLIN PARENTERL 1,000 UNITS/ML N017130 001
5,000 UNITS/ML N017130 002
10,000 UNITS/ML N017130 003
20,000 UNITS/ML N017130 004
DELL LABS 1,000 UNITS/ML N017540 001
5,000 UNITS/ML N017540 002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 151 (of 324)

HEPARIN SODIUM
INJECTABLE; INJECTION
HEPARIN SODIUM
DELL LABS 10,000 UNITS/ML N017540 003
20,000 UNITS/ML N017540 004
40,000 UNITS/ML N017540 005
HOSPIRA 2,500 UNITS/ML A088099 001 Apr 28, 1983
10,000 UNITS/ML A040095 001 Jul 26, 1996
LILLY 1,000 UNITS/ML N005521 001
10,000 UNITS/ML N005521 002
20,000 UNITS/ML N005521 004
LUITPOLD 1,000 UNITS/ML A087452 001 Oct 31, 1983
MARSAM PHARMS LLC 1,000 UNITS/ML A040007 001 Jun 07, 1996
1,000 UNITS/ML A040008 001 Oct 10, 1995
ORGANON USA INC 1,000 UNITS/ML N000552 008
5,000 UNITS/ML N000552 009
10,000 UNITS/ML N000552 010
PARKE DAVIS 1,000 UNITS/ML N017346 001
5,000 UNITS/ML N017346 002
7,500 UNITS/ML N017346 003
10,000 UNITS/ML N017346 004
20,000 UNITS/ML N017346 005
PHARM SPEC 1,000 UNITS/ML N017780 001
5,000 UNITS/ML N017780 002
10,000 UNITS/ML N017780 003
20,000 UNITS/ML N017780 004
40,000 UNITS/ML N017780 005
PHARMACIA AND UPJOHN 1,000 UNITS/ML N004570 001
5,000 UNITS/ML N004570 002
10,000 UNITS/ML N004570 003
SMITH AND NEPHEW 1,000 UNITS/ML A088239 001 Jul 26, 1984
SOLOPAK 1,000 UNITS/ML A087043 001
5,000 UNITS/ML A087077 001
5,000 UNITS/0.5ML A087395 001
10,000 UNITS/ML A087107 001
10,000 UNITS/0.5ML A087363 001
WATSON LABS 1,000 UNITS/ML N017064 002
2,500 UNITS/ML N017064 015
3,000 UNITS/ML N017064 016
4,000 UNITS/ML N017064 017
5,000 UNITS/ML N017064 003
6,000 UNITS/ML N017064 018
7,500 UNITS/ML N017064 019
10,000 UNITS/ML N017064 004
20,000 UNITS/ML N017064 005
40,000 UNITS/ML N017064 006
HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
MCGAW 200 UNITS/100ML N019130 001 Dec 31, 1984
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 200 UNITS/100ML N019042 001 Mar 29, 1985
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5%
HOSPIRA 10,000 UNITS/100ML N018911 006 Jan 30, 1985
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2,000 UNITS/100ML N018814 002 Jul 09, 1985
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%
HOSPIRA 10,000 UNITS/100ML N018911 001 Jan 30, 1985
10,000 UNITS/100ML N018916 005 Jan 31, 1984
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%
HOSPIRA 10,000 UNITS/100ML N018911 003 Jan 30, 1985
10,000 UNITS/100ML N018916 002 Jan 31, 1984
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5%
HOSPIRA 5,000 UNITS/100ML N018911 007 Jan 30, 1985
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 5,000 UNITS/100ML N019802 001 Jul 20, 1992
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 152 (of 324)

HEPARIN SODIUM
INJECTABLE; INJECTION
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%
HOSPIRA 5,000 UNITS/100ML N018911 005 Jan 30, 1985
5,000 UNITS/100ML N018916 003 Jan 31, 1984
HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
MCGAW 200 UNITS/100ML N019130 003 Dec 31, 1984
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 200 UNITS/100ML N019042 002 Mar 29, 1985
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%
HOSPIRA 5,000 UNITS/100ML N018911 009 Jan 30, 1985
10,000 UNITS/100ML N018911 008 Jan 30, 1985
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5,000 UNITS/100ML N019134 001 Mar 29, 1985
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 5,000 UNITS/100ML N019802 005 Jul 20, 1992
10,000 UNITS/100ML N019802 002 Jul 20, 1992
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9%
HOSPIRA 5,000 UNITS/100ML N018911 004 Jan 30, 1985
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 5,000 UNITS/100ML N019135 001 Mar 29, 1985
5,000 UNITS/100ML N019802 003 Jul 20, 1992
HOSPIRA 5,000 UNITS/100ML N018916 009 Jan 31, 1984
HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE 500 UNITS/100ML N018609 003 Apr 28, 1982
HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
MCGAW 1,000 UNITS/100ML N019130 002 Dec 31, 1984
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%
HOSPIRA 100 UNITS/ML N018911 002 Jan 30, 1985
100 UNITS/ML N018916 004 Jan 31, 1984
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%
HOSPIRA 1,000 UNITS/100ML N018916 001 Jan 31, 1984
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 1,000 UNITS/100ML N019042 004 Mar 29, 1985
HEPARIN SODIUM PRESERVATIVE FREE
MARSAM PHARMS LLC 1,000 UNITS/ML A089464 001 Jun 03, 1986
PHARMA SERVE NY 1,000 UNITS/ML A086129 001
LIPO-HEPIN
3M 1,000 UNITS/0.5ML N017027 001
1,000 UNITS/ML N017027 006
5,000 UNITS/0.5ML N017027 002
5,000 UNITS/ML N017027 008
7,500 UNITS/0.5ML N017027 010
10,000 UNITS/0.5ML N017027 003
10,000 UNITS/ML N017027 009
15,000 UNITS/0.5ML N017027 011
20,000 UNITS/0.5ML N017027 004
20,000 UNITS/ML N017027 007
40,000 UNITS/ML N017027 005
LIQUAEMIN LOCK FLUSH
ORGANON USA INC 100 UNITS/ML N000552 007
LIQUAEMIN SODIUM
ORGANON USA INC 1,000 UNITS/ML N000552 004
5,000 UNITS/ML N000552 003
10,000 UNITS/ML N000552 005
20,000 UNITS/ML N000552 001
40,000 UNITS/ML N000552 002
LIQUAEMIN SODIUM PRESERVATIVE FREE
ORGANON USA INC 1,000 UNITS/ML N000552 011 Apr 11, 1986
5,000 UNITS/ML N000552 012 Apr 11, 1986
10,000 UNITS/ML N000552 013 Apr 11, 1986
PANHEPRIN
HOSPIRA 1,000 UNITS/ML N005264 004
5,000 UNITS/ML N005264 006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 153 (of 324)

HEPARIN SODIUM
INJECTABLE; INJECTION
PANHEPRIN
HOSPIRA 10,000 UNITS/ML N005264 007
20,000 UNITS/ML N005264 008
40,000 UNITS/ML N005264 009
SODIUM HEPARIN
ABRAXIS PHARM 5,000 UNITS/ML N017033 002
10,000 UNITS/ML N017033 003
20,000 UNITS/ML N017033 004
BAXTER HLTHCARE 1,000 UNITS/ML N017036 001 Mar 04, 1988

HETACILLIN
FOR SUSPENSION; ORAL
VERSAPEN
BRISTOL EQ 112.5MG AMPICIL/ML A061398 001
EQ 112.5MG AMPICIL/5ML N050060 001
EQ 112.5MG AMPICIL/ML N050060 003
EQ 225MG AMPICIL/5ML A061398 002

HETACILLIN POTASSIUM
CAPSULE; ORAL
VERSAPEN-K
BRISTOL EQ 225MG AMPICIL A061396 001
EQ 450MG AMPICIL A061396 002

HEXACHLOROPHENE
AEROSOL; TOPICAL
SEPTISOL
VESTAL LABS 0.23% N017424 001
TURGEX
XTTRIUM 3% N018375 001
EMULSION; TOPICAL
HEXA-GERM
HUNTINGTON LABS 3% N017411 001
PHISOHEX
SANOFI AVENTIS US 3% N008402 001
SOY-DOME
BAYER PHARMS 3% N017405 001
TURGEX
XTTRIUM 3% N019055 001 Nov 30, 1984
SOAP; TOPICAL
GAMOPHEN
ARBROOK 2% N006270 003
SOLUTION; TOPICAL
DIAL
DIAL 0.25% N017421 002
GERMA-MEDICA
HUNTINGTON LABS 1% N017412 001
GERMA-MEDICA "MG"
HUNTINGTON LABS 0.25% N017412 002
SEPTI-SOFT
CALGON 0.25% N017460 001
SEPTISOL
VESTAL LABS 0.25% N017423 001
SPONGE; TOPICAL
E-Z SCRUB
BECTON DICKINSON 450MG N017452 001
HEXASCRUB
PROF DSPLS 3% N018363 001
PHISO-SCRUB
SANOFI AVENTIS US 3% N017446 001
SCRUBTEAM SURGICAL SPONGEBRUSH
3M 330MG N017413 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 154 (of 324)

HEXAFLUORENIUM BROMIDE
INJECTABLE; INJECTION
MYLAXEN
MEDPOINTE PHARM HLC 20MG/ML N009789 003

HEXOCYCLIUM METHYLSULFATE
TABLET; ORAL
TRAL
ABBOTT 25MG N010599 001

HEXYLCAINE HYDROCHLORIDE
SOLUTION; TOPICAL
CYCLAINE
MERCK 5% N008472 001

HISTAMINE PHOSPHATE
INJECTABLE; INJECTION
HISTAMINE PHOSPHATE
LILLY EQ 0.1MG BASE/ML N000734 003
EQ 0.2MG BASE/ML N000734 002
EQ 1MG BASE/ML N000734 001

HISTRELIN ACETATE
INJECTABLE; INJECTION
SUPPRELIN
SHIRE EQ 0.2MG BASE/ML N019836 001 Dec 24, 1991
EQ 0.5MG BASE/ML N019836 002 Dec 24, 1991
EQ 1MG BASE/ML N019836 003 Dec 24, 1991

HOMATROPINE METHYLBROMIDE
TABLET; ORAL
HOMAPIN-10
MISSION PHARMA 10MG A086308 001
HOMAPIN-5
MISSION PHARMA 5MG A086309 001
TABLET, CHEWABLE; ORAL
EQUIPIN
MISSION PHARMA 3MG A086310 001

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE


SYRUP; ORAL
HYCODAN
ENDO PHARMS 1.5MG/5ML;5MG/5ML N005213 002 Jul 26, 1988
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
IVAX SUB TEVA PHARMS 1.5MG/5ML;5MG/5ML A040285 001 Jul 19, 1999
HYDROPANE
HALSEY 1.5MG/5ML;5MG/5ML A088066 001 Jun 28, 1985
TABLET; ORAL
HOMATROPRINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
ACTAVIS TOTOWA 1.5MG;5MG A040295 001 Dec 01, 2000
HYCODAN
ENDO PHARMS 1.5MG;5MG N005213 001 Jul 26, 1988

HYALURONIDASE
INJECTABLE; INJECTION
VITRASE
ISTA PHARMS 6,200 UNITS/VIAL N021640 001 May 05, 2004
WYDASE
BAXTER HLTHCARE 150 UNITS/ML N006343 002
150 UNITS/VIAL N006343 006
1,500 UNITS/VIAL N006343 005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 155 (of 324)

HYDRALAZINE HYDROCHLORIDE
INJECTABLE; INJECTION
APRESOLINE
NOVARTIS 20MG/ML N008303 003
HYDRALAZINE HYDROCHLORIDE
ABRAXIS PHARM 20MG/ML A089532 001 Aug 11, 1987
SMITH AND NEPHEW 20MG/ML A088518 001 Apr 20, 1984
SOLOPAK 20MG/ML A088517 001 Aug 22, 1985
TEVA PARENTERAL 20MG/ML A040373 001 Feb 23, 2000
TABLET; ORAL
APRESOLINE
NOVARTIS 10MG N008303 004
25MG N008303 001
50MG N008303 002
100MG N008303 005
DRALZINE
TEVA 25MG A084301 001
HYDRALAZINE HYDROCHLORIDE
ACTAVIS TOTOWA 25MG A088560 001 Oct 04, 1984
50MG A088649 001 Oct 18, 1984
ASCOT 25MG A088310 001 Dec 19, 1984
50MG A088311 001 Dec 19, 1984
HALSEY 10MG A089218 001 Jan 22, 1986
25MG A089130 001 Jan 15, 1986
50MG A089222 001 Jan 22, 1986
100MG A089178 001 Jan 15, 1986
IMPAX LABS 25MG A084922 001
50MG A084923 001
IVAX SUB TEVA PHARMS 10MG A084443 001
25MG A084437 001
50MG A084469 002
100MG A084581 001
MUTUAL PHARM 10MG A088728 001 Apr 11, 1985
10MG A089359 001 Jul 25, 1986
25MG A084106 002
25MG A089258 001 May 05, 1986
50MG A084107 002
50MG A089259 001 May 05, 1986
100MG A088729 001 Apr 11, 1985
PUREPAC PHARM 25MG A088177 001 Jul 29, 1983
50MG A088178 001 Aug 15, 1983
QUANTUM PHARMICS 10MG A088671 001 May 01, 1984
25MG A088657 001 Jun 15, 1984
50MG A088652 001 May 08, 1984
100MG A088686 001 May 01, 1984
SANDOZ 10MG A083241 001
25MG A083560 001
50MG A083561 001
50MG A085088 001
SUPERPHARM 10MG A088787 001 Aug 28, 1984
25MG A088788 001 Aug 28, 1984
50MG A088789 001 Aug 28, 1984
TG UNITED LABS 10MG A088846 001 Feb 26, 1985
25MG A088847 001 Feb 26, 1985
50MG A088848 001 Feb 26, 1985
100MG A088849 001 Feb 26, 1985
USL PHARMA 25MG A087780 001 Mar 29, 1982
50MG A087751 001 Mar 29, 1982
VANGARD 25MG A087712 001
50MG A087908 001 May 07, 1982
VITARINE 25MG A086088 001
WATSON LABS 25MG A085532 002 May 24, 1982
50MG A085533 002 May 25, 1982
WEST WARD 25MG A088240 001 May 27, 1983
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 156 (of 324)

HYDRALAZINE HYDROCHLORIDE
TABLET; ORAL
HYDRALAZINE HYDROCHLORIDE
WEST WARD 50MG A088241 001 May 27, 1983

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE


CAPSULE; ORAL
APRESAZIDE
NOVARTIS 25MG;25MG A084735 001
50MG;50MG A084810 001
100MG;50MG A084811 001
HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
SOLVAY 25MG;25MG A087608 001 Feb 08, 1982
50MG;50MG A087213 001 Feb 08, 1982
100MG;50MG A087609 001 Feb 08, 1982
SUPERPHARM 25MG;25MG A089200 001 Feb 09, 1987
50MG;50MG A089201 001 Feb 09, 1987
WATSON LABS 25MG;25MG A085457 001 Mar 04, 1982
50MG;50MG A085446 001 Mar 04, 1982
100MG;50MG A085440 001 Mar 04, 1982
HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50
IVAX PHARMS 100MG;50MG A088358 001 Apr 10, 1984
HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25
IVAX PHARMS 25MG;25MG A088356 001 Apr 10, 1984
HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50
IVAX PHARMS 50MG;50MG A088357 001 Apr 10, 1984
HYDRA-ZIDE
PAR PHARM 100MG;50MG A088961 001 Oct 21, 1985
TABLET; ORAL
APRESOLINE-ESIDRIX
NOVARTIS 25MG;15MG N012026 002
HYDRALAZINE AND HYDROCHLORTHIAZIDE
WATSON LABS 25MG;15MG A085827 001
HYDROCHLOROTHIAZIDE W/ HYDRALAZINE
WATSON LABS 25MG;15MG A085373 001

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE


TABLET; ORAL
CAM-AP-ES
TG UNITED LABS 25MG;15MG;0.1MG A084897 001
HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE AND RESERPINE
IVAX SUB TEVA PHARMS 25MG;15MG;0.1MG A084291 001
HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE
MYLAN 25MG;15MG;0.1MG A087085 001
HYDRALAZINE, HYDROCHLOROTHIAZIDE W/ RESERPINE
WATSON LABS 25MG;15MG;0.1MG A085771 001
HYDRAP-ES
SANDOZ 25MG;15MG;0.1MG A084876 001
HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE
WATSON LABS 25MG;15MG;0.1MG A083770 001
HYDROSERPINE PLUS (R-H-H)
IVAX SUB TEVA PHARMS 25MG;15MG;0.1MG A083877 001
RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
MUTUAL PHARM 25MG;15MG;0.1MG A088570 001 Apr 10, 1984
SOLVAY 25MG;15MG;0.1MG A088376 001 Oct 28, 1983
WATSON LABS 25MG;15MG;0.1MG A085549 001
25MG;15MG;0.1MG A087556 001
RESERPINE, HYDROCHLOROTHIAZIDE, AND HYDRALAZINE HYDROCHLORIDE
LEDERLE 25MG;15MG;0.1MG A087709 001 May 13, 1982
SER-A-GEN
SOLVAY 25MG;15MG;0.1MG A087210 001
SER-AP-ES
NOVARTIS 25MG;15MG;0.1MG N012193 005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 157 (of 324)

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE


TABLET; ORAL
UNIPRES
SOLVAY 25MG;15MG;0.1MG A085893 001
25MG;15MG;0.1MG A086298 001

HYDRALAZINE HYDROCHLORIDE; RESERPINE


TABLET; ORAL
DRALSERP
SANDOZ 25MG;0.1MG A084617 001
SERPASIL-APRESOLINE
NOVARTIS 25MG;0.1MG N009296 004
50MG;0.2MG N009296 002

HYDROCHLOROTHIAZIDE
SOLUTION; ORAL
HYDROCHLOROTHIAZIDE
MORTON GROVE 50MG/5ML A089661 001 Jun 20, 1988
ROXANE 50MG/5ML A088587 001 Jul 02, 1984
HYDROCHLOROTHIAZIDE INTENSOL
ROXANE 100MG/ML A088588 001 Jul 02, 1984
TABLET; ORAL
ESIDRIX
NOVARTIS 25MG N011793 005
50MG N011793 008
100MG N011793 009
HYDROCHLOROTHIAZIDE
ABC HOLDING 50MG A085672 001
ALRA 25MG A086369 001
50MG A083554 001
ASCOT 25MG A087539 001 Feb 03, 1982
50MG A087540 001 Feb 03, 1982
BARR 50MG A084771 001
DAVA PHARMS INC 100MG A087060 001
ELKINS SINN 50MG A085152 002
HEATHER 50MG A084135 001
IMPAX LABS 25MG A084029 001
50MG A083607 002
100MG A085098 001
INWOOD LABS 25MG A084776 001
25MG A085067 001
50MG A084776 002
IVAX SUB TEVA PHARMS 50MG A084658 001
100MG A085022 001
MAST MM 25MG A086192 001
50MG A086192 002
MUTUAL PHARM 25MG A083972 001
50MG A083972 002
100MG A083972 003
MYLAN 25MG A084880 001
50MG A085112 001
PVT FORM 50MG A086597 001
ROXANE 25MG A085004 001
50MG A084536 002
50MG A085005 001
SANDOZ 25MG A083899 001
25MG A087565 001 Mar 09, 1982
50MG A084912 001
SOLVAY 25MG A085323 001
SUPERPHARM 25MG A088827 001 Dec 28, 1984
50MG A088828 001 Dec 28, 1984
100MG A088829 001 Dec 28, 1984
TEVA 25MG A088924 001 Feb 07, 1985
50MG A088923 001 Feb 07, 1985
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 158 (of 324)

HYDROCHLOROTHIAZIDE
TABLET; ORAL
HYDROCHLOROTHIAZIDE
TG UNITED LABS 25MG A085683 001
50MG A083965 001
USL PHARMA 25MG A087827 001 Apr 19, 1982
50MG A087752 001 Apr 19, 1982
VANGARD 25MG A087638 001
50MG A087610 001
WARNER CHILCOTT 25MG A087586 001 May 03, 1982
50MG A087587 001 May 03, 1982
WATSON LABS 25MG A083458 001
25MG A085232 002
50MG A083232 001
50MG A083456 001
50MG A085233 001
50MG A086087 001
50MG A086594 001
100MG A081190 001 Jan 24, 1992
100MG A085099 001
100MG A087002 001
WEST WARD 25MG A084899 001
WHITEWORTH TOWN PLSN 25MG A083809 002
50MG A083809 001
100MG A085347 001
HYDRO-D
HALSEY 25MG A086504 001
50MG A083891 002
HYDRODIURIL
MERCK 25MG N011835 003
50MG N011835 006
100MG N011835 007
ORETIC
ABBOTT 25MG N011971 001
ZIDE
SOLVAY 50MG A083925 001

HYDROCHLOROTHIAZIDE; IRBESARTAN
TABLET; ORAL
AVALIDE
SANOFI AVENTIS US 12.5MG;75MG N020758 001 Sep 30, 1997

HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE


TABLET; ORAL
NORMOZIDE
SCHERING 25MG;100MG N019046 001 Apr 06, 1987
25MG;200MG N019046 002 Apr 06, 1987
25MG;300MG N019046 003 Apr 06, 1987
25MG;400MG N019046 004 Apr 06, 1987
TRANDATE HCT
GLAXOSMITHKLINE 25MG;100MG N019174 001 Apr 10, 1987
25MG;200MG N019174 002 Apr 10, 1987
25MG;300MG N019174 003 Apr 10, 1987
25MG;400MG N019174 004 Apr 10, 1987

HYDROCHLOROTHIAZIDE; LISINOPRIL
TABLET; ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDE
SANDOZ 12.5MG;10MG A075926 001 Jul 01, 2002
12.5MG;20MG A075926 002 Jul 01, 2002
25MG;20MG A075926 003 Jul 01, 2002
PRINZIDE
MERCK 25MG;20MG N019778 002 Feb 16, 1989
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 159 (of 324)

HYDROCHLOROTHIAZIDE; METHYLDOPA
TABLET; ORAL
ALDORIL 15
MERCK 15MG;250MG N013402 001
ALDORIL 25
MERCK 25MG;250MG N013402 002
ALDORIL D30
MERCK 30MG;500MG N013402 003
ALDORIL D50
MERCK 50MG;500MG N013402 004
METHYLDOPA AND HYDROCHLOROTHIAZIDE
CLONMEL HLTHCARE 15MG;250MG A072507 001 Jun 02, 1989
25MG;250MG A072508 001 Jun 02, 1989
30MG;500MG A072509 001 Jun 02, 1989
50MG;500MG A072510 001 Jun 02, 1989
IVAX SUB TEVA PHARMS 15MG;250MG A071458 001 Mar 08, 1988
25MG;250MG A071459 001 Mar 08, 1988
30MG;500MG A071460 001 Mar 08, 1988
50MG;500MG A071461 001 Mar 08, 1988
PAR PHARM 15MG;250MG A070616 001 Feb 02, 1987
25MG;250MG A070612 001 Feb 02, 1987
30MG;500MG A070613 001 Feb 02, 1987
50MG;500MG A070614 001 Feb 02, 1987
PARKE DAVIS 15MG;250MG A071897 001 Nov 23, 1987
25MG;250MG A071898 001 Nov 23, 1987
30MG;500MG A071899 001 Nov 23, 1987
50MG;500MG A071900 001 Nov 23, 1987
PUREPAC PHARM 15MG;250MG A070853 001 Oct 08, 1986
25MG;250MG A070688 001 Apr 24, 1986
30MG;500MG A070854 001 Oct 08, 1986
50MG;500MG A070689 001 Apr 24, 1986
SANDOZ 15MG;250MG A070182 001 Jan 15, 1986
15MG;250MG A070829 001 Mar 09, 1987
25MG;250MG A070183 001 Jan 15, 1986
25MG;250MG A070830 001 Mar 09, 1987
30MG;500MG A070543 001 Jan 15, 1986
50MG;500MG A070544 001 Jan 15, 1986
TEVA 15MG;250MG A071819 001 Apr 08, 1988
25MG;250MG A071820 001 Apr 08, 1988
30MG;500MG A071821 001 Apr 08, 1988
50MG;500MG A071822 001 Apr 08, 1988
WATSON LABS 15MG;250MG A070365 001 Mar 19, 1986
15MG;250MG A070958 001 Feb 06, 1989
15MG;250MG A071920 001 Aug 29, 1988
25MG;250MG A070366 001 Apr 16, 1986
25MG;250MG A070959 001 Jan 19, 1989
25MG;250MG A071921 001 Aug 29, 1988
30MG;500MG A070367 001 Mar 19, 1986
30MG;500MG A071069 001 Jan 19, 1989
30MG;500MG A071922 001 Aug 29, 1988
50MG;500MG A070368 001 Apr 16, 1986
50MG;500MG A070960 001 Feb 06, 1989
50MG;500MG A071923 001 Aug 29, 1988

HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE


TABLET, EXTENDED RELEASE; ORAL
DUTOPROL
ASTRAZENECA 12.5MG;EQ 25MG TARTRATE N021956 001 Aug 28, 2006
12.5MG;EQ 50MG TARTRATE N021956 002 Aug 28, 2006
12.5MG;EQ 100MG TARTRATE N021956 003 Aug 28, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 160 (of 324)

HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE


TABLET; ORAL
LOPRESSOR HCT
NOVARTIS 50MG;100MG N018303 003 Dec 31, 1984

HYDROCHLOROTHIAZIDE; PINDOLOL
TABLET; ORAL
VISKAZIDE
NOVARTIS 25MG;5MG N018872 001 Jul 22, 1987
25MG;10MG N018872 002 Jul 22, 1987

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE


CAPSULE, EXTENDED RELEASE; ORAL
INDERIDE LA 120/50
WYETH AYERST 50MG;120MG N019059 002 Jul 03, 1985
INDERIDE LA 160/50
WYETH AYERST 50MG;160MG N019059 003 Jul 03, 1985
INDERIDE LA 80/50
WYETH AYERST 50MG;80MG N019059 001 Jul 03, 1985
TABLET; ORAL
INDERIDE-80/25
AKRIMAX PHARMS 25MG;80MG N018031 002
PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE
DURAMED PHARMS BARR 25MG;40MG A071126 001 Mar 02, 1987
25MG;80MG A071127 001 Mar 02, 1987
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ACTAVIS ELIZABETH 25MG;40MG A070851 001 May 15, 1986
25MG;80MG A070852 001 May 15, 1986
BARR 25MG;40MG A070704 001 Oct 01, 1986
25MG;80MG A070705 001 Oct 01, 1986
IVAX SUB TEVA PHARMS 25MG;40MG A071552 001 Dec 01, 1988
25MG;80MG A071553 001 Dec 01, 1988
SANDOZ 25MG;40MG A071060 001 Aug 26, 1987
25MG;80MG A071061 001 Aug 26, 1987
WARNER CHILCOTT 25MG;40MG A071771 001 Jan 26, 1988
25MG;80MG A071772 001 Jan 26, 1988
WATSON LABS 25MG;40MG A071498 001 Dec 18, 1991
25MG;80MG A071501 001 Dec 18, 1991

HYDROCHLOROTHIAZIDE; RESERPINE
TABLET; ORAL
H.R.-50
WHITEWORTH TOWN PLSN 50MG;0.125MG A085338 001
HYDROCHLOROTHIAZIDE W/ RESERPINE
IVAX SUB TEVA PHARMS 25MG;0.1MG A083572 001
25MG;0.125MG A083571 001
50MG;0.1MG A083568 001
50MG;0.125MG A083573 001
PHARMERAL 25MG;0.125MG A085421 001
50MG;0.125MG A085420 001
ROXANE 50MG;0.125MG A084603 001
WATSON LABS 25MG;0.125MG A084466 001
25MG;0.125MG A085317 001
25MG;0.125MG A086330 002
50MG;0.125MG A083666 001
50MG;0.125MG A084467 001
50MG;0.125MG A086331 001
HYDROPRES 25
MERCK 25MG;0.125MG N011958 002
HYDROPRES 50
MERCK 50MG;0.125MG N011958 003
HYDRO-RESERP
ABC HOLDING 50MG;0.125MG A084714 002 Jun 29, 1982
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 161 (of 324)

HYDROCHLOROTHIAZIDE; RESERPINE
TABLET; ORAL
HYDRO-SERP "25"
SANDOZ 25MG;0.125MG A084827 001
HYDRO-SERP "50"
SANDOZ 50MG;0.125MG A085213 001
RESERPINE AND HYDROCHLOROTHIAZIDE
BARR 25MG;0.125MG A084580 001
50MG;0.125MG A084579 001
SANDOZ 50MG;0.125MG A088200 001 Jan 31, 1984
RESERPINE AND HYDROCHLOROTHIAZIDE-50
WEST WARD 50MG;0.125MG A088189 001 May 10, 1984
SERPASIL-ESIDRIX #1
NOVARTIS 25MG;0.1MG N011878 003
SERPASIL-ESIDRIX #2
NOVARTIS 50MG;0.1MG N011878 005

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
TABLET; ORAL
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
ASCOT 25MG;25MG A088025 001 Nov 23, 1984
MUTUAL PHARM 25MG;25MG A087267 001
PUREPAC PHARM 25MG;25MG A087999 001 Nov 06, 1985
SANDOZ 25MG;25MG A086881 001
SUPERPHARM 25MG;25MG A089137 001 Aug 26, 1985
SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
IVAX PHARMS 25MG;25MG A087004 002 May 24, 1982
LEDERLE 25MG;25MG A087511 001
PARKE DAVIS 25MG;25MG A087948 001 Feb 22, 1983
PUREPAC PHARM 25MG;25MG A088054 001 Aug 18, 1983
UPSHER SMITH 25MG;25MG A087553 001
USL PHARMA 25MG;25MG A087651 001
VANGARD 25MG;25MG A087655 001
WATSON LABS 25MG;25MG A085974 001
25MG;25MG A086026 001

HYDROCHLOROTHIAZIDE; TIMOLOL MALEATE


TABLET; ORAL
TIMOLIDE 10-25
MERCK 25MG;10MG N018061 001

HYDROCHLOROTHIAZIDE; TRIAMTERENE
CAPSULE; ORAL
DYAZIDE
GLAXOSMITHKLINE 25MG;50MG N016042 002
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
BARR 25MG;37.5MG A074970 001 Jan 06, 1998
NOVARTIS 25MG;37.5MG A074857 001 Sep 09, 1997
VITARINE 25MG;50MG A071737 001 Feb 12, 1988
TABLET; ORAL
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
AM THERAP 50MG;75MG A072022 001 Apr 17, 1988
QUANTUM PHARMICS 50MG;75MG A071980 001 Apr 17, 1988

HYDROCODONE BITARTRATE; PHENYLPROPANOLAMINE HYDROCHLORIDE


SYRUP; ORAL
CODAMINE
ALPHARMA US PHARMS 5MG/5ML;25MG/5ML A075103 001 Sep 29, 2000
HYCOMINE
ENDO PHARMS 5MG/5ML;25MG/5ML N019410 001 Aug 17, 1990
HYCOMINE PEDIATRIC
ENDO PHARMS 2.5MG/5ML;12.5MG/5ML N019411 001 Aug 17, 1990
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 162 (of 324)

HYDROCORTAMATE HYDROCHLORIDE
OINTMENT; TOPICAL
MAGNACORT
PFIZER 0.5% N010554 001

HYDROCORTISONE
AEROSOL; TOPICAL
AEROSEB-HC
ALLERGAN HERBERT 0.5% A085805 001
CREAM; TOPICAL
CORT-DOME
BAYER PHARMS 0.5% N009585 003
1% N009585 001
DERMACORT
MONARCH PHARMS 1% A083011 002
ELDECORT
VALEANT PHARM INTL 1% A080459 001
2.5% A084055 001
FLEXICORT
WESTWOOD SQUIBB 0.5% A087136 003 Apr 08, 1982
1% A087136 002 Apr 08, 1982
2.5% A087136 001 Apr 08, 1982
HC #1
BAYER PHARMS 0.5% A080438 001
HC #4
BAYER PHARMS 1% A080438 002
HC (HYDROCORTISONE)
C AND M PHARMA 0.5% A080482 003
1% A080482 004
H-CORT
PHARM ASSOC 0.5% A086823 001
HI-COR
C AND M PHARMA 2.5% A080483 001
HYDROCORTISONE
ALPHARMA US PHARMS 2.5% A089754 001 Feb 01, 1989
ALTANA 0.5% A080848 002
1% A080848 003
AMBIX 1% A086080 001
2.5% A086271 001
EVERYLIFE 0.5% A080452 001
1% A080452 002
G AND W LABS 1% A084059 001
INGRAM PHARM 0.5% A080456 002
1% A080456 003
IVAX PHARMS 1% A085733 001
NASKA 1% A089706 001 Mar 10, 1988
PERRIGO NEW YORK 0.5% A084970 002
1% A085026 001
PHARMADERM 1% A088845 001 Feb 27, 1986
2.5% A089413 001 Dec 16, 1986
PHARMAFAIR 1% A087838 001 Jul 28, 1982
STIEFEL 1% A086170 001
SYOSSET 0.5% A085527 001
TARO 0.5% A086154 001
TEVA 0.5% A080400 002
1% A080400 003
1% A085191 001
2.5% A080400 004
TOPIDERM 1% A089273 001 Feb 17, 1989
USL PHARMA 1% A088027 001 Sep 27, 1983
2.5% A088029 001 Sep 27, 1983
WHITEWORTH TOWN PLSN 1% A080496 002
NOGENIC HC
IVAX PHARMS 1% A087427 001 Apr 04, 1988
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 163 (of 324)

HYDROCORTISONE
CREAM; TOPICAL
NUTRACORT
CORIA 0.5% A080442 002
1% A080442 003
PENECORT
ALLERGAN HERBERT 1% A088216 001 Jun 06, 1984
PROCTOCORT
MONARCH PHARMS 1% A083011 001
SYNACORT
MEDICIS 0.5% A087459 001
GEL; TOPICAL
NUTRACORT
HEALTHPOINT 1% A084698 001
PENECORT
ALLERGAN HERBERT 1% A088215 001 Jun 06, 1984
INJECTABLE; INJECTION
CORTEF
PHARMACIA AND UPJOHN 50MG/ML N009864 001
LOTION; TOPICAL
ACTICORT
BAKER NORTON 1% A086535 001
BALNEOL-HC
SOLVAY 1% A088041 001 Dec 03, 1982
BETA-HC
BETA DERMAC 1% A089495 001 Jan 25, 1988
CETACORT
CORIA 0.5% A080426 002
1% A080426 001
CORT-DOME
BAYER PHARMS 0.5% N009895 003
1% N009895 001
DERMACORT
SOLVAY 0.5% A084573 002
1% A086462 001
EPICORT
BLULINE 0.5% A083219 002
GLYCORT
HERAN 1% A087489 001 Oct 03, 1983
H-CORT
PHARM ASSOC 0.5% A086824 001
HYDROCORTISONE
ALPHARMA US PHARMS 0.5% A087317 001 Jun 07, 1982
1% A087315 001 Jun 07, 1982
MERICON 0.5% A085282 001
1% A085282 002 Feb 26, 1987
NASKA 1% A089705 001 Apr 25, 1988
PERRIGO NEW YORK 0.5% A085662 001
1% A085663 001
TARO 1% A089024 001 Feb 12, 1986
NUTRACORT
CORIA 0.5% A080443 002
OINTMENT; TOPICAL
CORTRIL
PFIZER GLOBAL 1% N009176 001
2.5% N009176 002
HC (HYDROCORTISONE)
C AND M PHARMA 0.5% A080481 001
1% A080481 002
HYDROCORTISONE
ALTANA 0.5% A080489 002
1% A080489 003
AMBIX 1% A086079 001
2.5% A086272 001
NASKA 1% A089704 001 Mar 10, 1988
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DISCONTINUED DRUG PRODUCT LIST 6 - 164 (of 324)

HYDROCORTISONE
OINTMENT; TOPICAL
HYDROCORTISONE
PERRIGO NEW YORK 0.5% A084969 003
1% A085028 001
PHARMADERM 1% A088842 001 Feb 09, 1987
TARO 0.5% A086256 001
USL PHARMA 1% A088061 001 Sep 27, 1983
2.5% A088039 001 Sep 27, 1983
HYTONE
DERMIK LABS 1% A080474 003
2.5% A080474 004
PENECORT
ALLERGAN HERBERT 2.5% A088217 001 Jun 06, 1984
POWDER; FOR RX COMPOUNDING
H-CORT
TORCH 100% A087834 001 Mar 29, 1982
HYDROCORTISONE
PADDOCK 100% A088082 001 Apr 08, 1983
SOLUTION; TOPICAL
PENECORT
ALLERGAN HERBERT 1% A088214 001 Jun 06, 1984
TEXACORT
JSJ PHARMS 1% A080425 001
2.5% A081271 001 Apr 17, 1992
TABLET; ORAL
CORTRIL
PFIZER 10MG N009127 005
20MG N009127 003
HYDROCORTISONE
BARR 20MG A083999 001
ELKINS SINN 20MG A080624 001
FERRANTE 10MG A080568 001
20MG A080568 002
IMPAX LABS 20MG A080781 001
INWOOD LABS 20MG A080732 001
LANNETT 20MG A085070 001
NEXGEN PHARMA INC 20MG A083140 001
PANRAY 10MG N009659 001
20MG N009659 002
PARKE DAVIS 20MG A084243 001
PUREPAC PHARM 10MG A084247 003 Aug 31, 1982
20MG A080395 001
20MG A084247 002
ROXANE 10MG A088539 001 Mar 21, 1984
SANDOZ 20MG A080642 002
WATSON LABS 20MG A080355 001
WHITEWORTH TOWN PLSN 10MG A080344 001
20MG A080344 002
HYDROCORTONE
MERCK 10MG N008506 007
20MG N008506 011
TABLET; VAGINAL
CORTRIL
PFIPHARMECS 10MG N009796 001

HYDROCORTISONE ACETATE
CREAM; TOPICAL
HEMSOL-HC
ABLE 1% A081274 001 Jun 19, 1992
HYDROCORTISONE ACETATE
CENCI 1% A080419 001 Jan 25, 1982
PARKE DAVIS 1% A089914 001 Jan 03, 1989
PUREPAC PHARM 0.5% A086050 001
1% A086052 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 165 (of 324)

HYDROCORTISONE ACETATE
INJECTABLE; INJECTION
CORTEF ACETATE
PHARMACIA AND UPJOHN 50MG/ML N009378 002
CORTRIL
PFIZER 25MG/ML N009164 001
HYDROCORTISONE ACETATE
AKORN 25MG/ML N009637 001
50MG/ML N009637 002
BEL MAR 25MG/ML A083739 001
50MG/ML A083739 002
WATSON LABS 25MG/ML A083128 001
25MG/ML A083759 001
50MG/ML A083759 002
50MG/ML A085214 001
HYDROCORTONE
MERCK 25MG/ML N008228 001
50MG/ML N008228 004
LOTION; TOPICAL
DRICORT
INGRAM PHARM 0.5% A086207 001
OINTMENT; OPHTHALMIC
HYDROCORTISONE ACETATE
ALTANA 0.5% A080828 001
OINTMENT; OPHTHALMIC, OTIC
HYDROCORTONE
MERCK 1.5% N009018 003
OINTMENT; TOPICAL
CORTEF ACETATE
PHARMACIA AND UPJOHN 1% N008917 002
2.5% N008917 001

HYDROCORTISONE ACETATE; NEOMYCIN SULFATE


CREAM; TOPICAL
NEO-CORTEF
PHARMACIA AND UPJOHN 1%;EQ 3.5MG BASE/GM A061049 001
2.5%;EQ 3.5MG BASE/GM A061049 002
OINTMENT; OPHTHALMIC
NEO-CORTEF
PHARMACIA AND UPJOHN 0.5%;EQ 3.5MG BASE/GM A060610 001
1.5%;EQ 3.5MG BASE/GM A060610 002
OINTMENT; TOPICAL
NEO-CORTEF
PHARMACIA AND UPJOHN 0.5%;EQ 3.5MG BASE/GM A060751 001
1%;EQ 3.5MG BASE/GM A060751 002
2.5%;EQ 3.5MG BASE/GM A060751 003
SUSPENSION/DROPS; OPHTHALMIC
COR-OTICIN
AKORN 1.5%;EQ 3.5MG BASE/ML A060188 001
NEO-CORTEF
PHARMACIA AND UPJOHN 0.5%;EQ 3.5MG BASE/ML A060612 002
1.5%;EQ 3.5MG BASE/ML A060612 001

HYDROCORTISONE ACETATE; OXYTETRACYCLINE HYDROCHLORIDE


SUSPENSION; OPHTHALMIC
TERRA-CORTRIL
PFIZER 1.5%;EQ 5MG BASE/ML A061016 001

HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE


AEROSOL, METERED; TOPICAL
HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1%
BOCA PHARMA 1%;1% A089440 001 May 17, 1988
LOTION; TOPICAL
PRAMOSONE
FERNDALE LABS 0.5%;1% A083213 002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 166 (of 324)

HYDROCORTISONE BUTYRATE
CREAM; TOPICAL
LOCOID
YAMANOUCHI 0.1% N018795 001 Jan 07, 1983
OINTMENT; TOPICAL
LOCOID
YAMANOUCHI 0.1% N019106 001 Jul 03, 1984
SOLUTION; TOPICAL
LOCOID
YAMANOUCHI 0.1% N019819 001 Sep 15, 1988

HYDROCORTISONE CYPIONATE
SUSPENSION; ORAL
CORTEF
PHARMACIA AND UPJOHN EQ 10MG BASE/5ML N009900 001

HYDROCORTISONE SODIUM PHOSPHATE


INJECTABLE; INJECTION
HYDROCORTONE
MERCK EQ 50MG BASE/ML N012052 001

HYDROCORTISONE SODIUM SUCCINATE


INJECTABLE; INJECTION
A-HYDROCORT
ABBOTT EQ 100MG BASE/VIAL A085928 001
EQ 100MG BASE/VIAL A089577 001 Apr 11, 1989
EQ 250MG BASE/VIAL A089578 001 Apr 11, 1989
EQ 500MG BASE/VIAL A089579 001 Apr 11, 1989
EQ 1GM BASE/VIAL A089580 001 Apr 11, 1989
HOSPIRA EQ 100MG BASE/VIAL A085929 001
HYDROCORTISONE SODIUM SUCCINATE
ABRAXIS PHARM EQ 100MG BASE/VIAL A088667 001 Jun 08, 1984
EQ 100MG BASE/VIAL A088712 001 Jun 08, 1984
EQ 250MG BASE/VIAL A088668 001 Jun 08, 1984
EQ 500MG BASE/VIAL A088669 001 Jun 08, 1984
EQ 1GM BASE/VIAL A088670 001 Jun 08, 1984
BAXTER HLTHCARE EQ 100MG BASE/VIAL A086619 001
EQ 250MG BASE/VIAL A087567 001
EQ 500MG BASE/VIAL A087568 001
EQ 1GM BASE/VIAL A087569 001
INTL MEDICATION EQ 100MG BASE/VIAL A087532 001 Mar 19, 1982
WATSON LABS EQ 100MG BASE/VIAL A084737 002
EQ 100MG BASE/VIAL A084738 001
EQ 250MG BASE/VIAL A084737 001
EQ 500MG BASE/VIAL A084747 001
EQ 1GM BASE/VIAL A084748 001

HYDROCORTISONE VALERATE
CREAM; TOPICAL
HYDROCORTISONE VALERATE
TEVA PHARMS 0.2% A074489 001 Aug 12, 1998

HYDROCORTISONE; NEOMYCIN SULFATE


CREAM; TOPICAL
NEO-CORT-DOME
BAYER PHARMS 0.5%;EQ 3.5MG BASE/GM N050237 006 Jun 05, 1984
1%;EQ 3.5MG BASE/GM N050237 005 Jun 05, 1984

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


SOLUTION/DROPS; OTIC
NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE
PHARMAFAIR 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062394 001 Sep 29, 1982
OTOCORT
WATSON LABS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A060730 002
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DISCONTINUED DRUG PRODUCT LIST 6 - 167 (of 324)

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE


SUSPENSION/DROPS; OPHTHALMIC
CORTISPORIN
MONARCH PHARMS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N050169 001
NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE
PHARMAFAIR 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062623 001 Sep 24, 1985
SUSPENSION/DROPS; OTIC
NEOMYCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONE
PHARMAFAIR 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062617 001 Sep 18, 1985
OTICAIR
PHARMAFAIR 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062399 001 Nov 18, 1982
OTOBIONE
SCHERING 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A061816 001
OTOCORT
WATSON LABS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062521 001 Jul 11, 1985

HYDROCORTISONE; POLYMYXIN B SULFATE


SOLUTION/DROPS; OTIC
OTOBIOTIC
SCHERING 5MG/ML;EQ 10,000 UNITS BASE/ML A062302 001
PYOCIDIN
FOREST LABS 5MG/ML;EQ 10,000 UNITS BASE/ML A061606 001

HYDROCORTISONE; TETRACYCLINE HYDROCHLORIDE


OINTMENT; OPHTHALMIC
ACHROMYCIN
LEDERLE 1.5%;1% N050272 001

HYDROCORTISONE; UREA
CREAM; TOPICAL
ALPHADERM
BIOGLAN 1%;10% A086008 001
CALMURID HC
PHARMACIA AND UPJOHN 1%;10% A083947 001

HYDROFLUMETHIAZIDE
TABLET; ORAL
DIUCARDIN
WYETH AYERST 50MG A083383 001
HYDROFLUMETHIAZIDE
WATSON LABS 50MG A088031 001 Apr 06, 1983
50MG A088528 001 Aug 15, 1984

HYDROFLUMETHIAZIDE; RESERPINE
TABLET; ORAL
HYDROFLUMETHIAZIDE AND RESERPINE
USL PHARMA 50MG;0.125MG A088195 001 Oct 26, 1983
WATSON LABS 25MG;0.125MG A088127 001 Mar 22, 1983
50MG;0.125MG A088110 001 Mar 22, 1983
RESERPINE AND HYDROFLUMETHIAZIDE
IVAX PHARMS 50MG;0.125MG A088932 001 Jan 11, 1985
PAR PHARM 50MG;0.125MG A088907 001 Sep 20, 1985
SALUTENSIN
SHIRE 50MG;0.125MG N012359 003
SALUTENSIN-DEMI
SHIRE 25MG;0.125MG N012359 004

HYDROMORPHONE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
PALLADONE
PURDUE PHARMA LP 12MG N021044 001 Sep 24, 2004
16MG N021044 002 Sep 24, 2004
24MG N021044 003 Sep 24, 2004
32MG N021044 004 Sep 24, 2004
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DISCONTINUED DRUG PRODUCT LIST 6 - 168 (of 324)

HYDROMORPHONE HYDROCHLORIDE
INJECTABLE; INJECTION
HYDROMORPHONE HYDROCHLORIDE
WATSON LABS 10MG/ML A074317 001 Aug 23, 1995

HYDROXOCOBALAMIN
INJECTABLE; INJECTION
ALPHAREDISOL
MERCK 1MG/ML A080778 001
HYDROXOCOBALAMIN
ABRAXIS PHARM 1MG/ML A084921 001
WATSON LABS 1MG/ML A085528 001
HYDROXOMIN
BEL MAR 1MG/ML A084629 001

HYDROXYAMPHETAMINE HYDROBROMIDE
SOLUTION/DROPS; OPHTHALMIC
PAREDRINE
AKORN 1% N000004 004

HYDROXYPROGESTERONE CAPROATE
INJECTABLE; INJECTION
DELALUTIN
BRISTOL MYERS SQUIBB 125MG/ML N010347 004
125MG/ML N016911 001
250MG/ML N010347 002
250MG/ML N016911 002
HYDROXYPROGESTERONE CAPROATE
AKORN 125MG/ML N018004 001
WATSON LABS 125MG/ML N017439 001
250MG/ML N017439 002

HYDROXYSTILBAMIDINE ISETHIONATE
INJECTABLE; INJECTION
HYDROXYSTILBAMIDINE ISETHIONATE
SANOFI AVENTIS US 225MG/AMP N009166 001

HYDROXYUREA
CAPSULE; ORAL
HYDROXYUREA
BARR 250MG A075143 002 Sep 21, 2000
DURAMED PHARMS BARR 250MG A075020 002 Jun 26, 2000
500MG A075020 001 Jul 30, 1998
ROXANE 500MG A074476 001 Aug 18, 1995
TABLET; ORAL
HYDROXYUREA
BARR 1GM A075734 001 Aug 29, 2000

HYDROXYZINE HYDROCHLORIDE
INJECTABLE; INJECTION
HYDROXYZINE
BAXTER HLTHCARE 50MG/ML A085551 002
HYDROXYZINE HYDROCHLORIDE
ALTANA 25MG/ML A087273 001 Apr 20, 1982
50MG/ML A087273 002 Apr 20, 1982
APP PHARMS 25MG/ML A088184 001 Mar 31, 1983
50MG/ML A088185 001 Mar 31, 1983
BAXTER HLTHCARE 25MG/ML A085551 001
HOSPIRA 25MG/ML A087416 001
50MG/ML A086821 001
50MG/ML A087546 001
PHARMAFAIR 25MG/ML A088862 001 Feb 14, 1986
25MG/ML A089106 001 Feb 14, 1986
50MG/ML A088881 001 Feb 14, 1986
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 169 (of 324)

HYDROXYZINE HYDROCHLORIDE
INJECTABLE; INJECTION
HYDROXYZINE HYDROCHLORIDE
PHARMAFAIR 50MG/ML A089107 001 Feb 14, 1986
SMITH AND NEPHEW 25MG/ML A087592 001
SOLOPAK 25MG/ML A086822 001
25MG/ML A087591 001
50MG/ML A087310 001
50MG/ML A087593 001
50MG/ML A087595 001
50MG/ML A087596 001
WATSON LABS 25MG/ML A085778 001
25MG/ML A087274 001
50MG/ML A085779 001
50MG/ML A087274 002
WYETH AYERST 25MG/ML A086258 001
50MG/ML A086258 002
ORGATRAX
ORGANON USA INC 25MG/ML A087014 001
50MG/ML A087014 002
VISTARIL
PFIZER 25MG/ML N011111 001
50MG/ML N011111 002
SYRUP; ORAL
ATARAX
ROERIG 10MG/5ML N010485 001
HYDROXYZINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC 10MG/5ML A086880 001
ALPHARMA US PHARMS 10MG/5ML A088785 001 Feb 03, 1988
KV PHARM 10MG/5ML A087730 001 Jul 01, 1982
TABLET; ORAL
ATARAX
PFIZER 10MG N010392 001
25MG N010392 004
50MG N010392 006
100MG N010392 005
HYDROXYZINE HYDROCHLORIDE
ABLE 10MG A040559 001 Jul 22, 2004
25MG A040562 001 Jul 22, 2004
50MG A040563 001 Jul 22, 2004
ACTAVIS TOTOWA 10MG A089071 001 Jul 22, 1986
25MG A089072 001 Jul 22, 1986
50MG A089073 001 Jul 22, 1986
HALSEY 10MG A089366 001 May 02, 1988
25MG A089117 001 May 02, 1988
50MG A089396 001 May 02, 1988
IVAX PHARMS 10MG A087216 001
25MG A087410 001
50MG A087411 001
KV PHARM 10MG A087819 001 Jun 23, 1982
25MG A087820 001 Jun 23, 1982
50MG A087821 001 Jun 23, 1982
100MG A087822 001 Jun 23, 1982
MUTUAL PHARM 10MG A088409 001 Nov 15, 1983
25MG A087857 001 Apr 18, 1983
50MG A087860 001 Apr 18, 1983
100MG A087862 001 Apr 18, 1983
PLIVA 100MG A081054 001 Sep 25, 1995
PUREPAC PHARM 10MG A088120 001 Sep 25, 1984
25MG A088121 001 Sep 25, 1984
50MG A088122 001 Sep 25, 1984
QUANTUM PHARMICS 10MG A088540 001 Oct 22, 1985
25MG A088551 001 Oct 22, 1985
50MG A088529 001 Oct 22, 1985
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 170 (of 324)

HYDROXYZINE HYDROCHLORIDE
TABLET; ORAL
HYDROXYZINE HYDROCHLORIDE
SANDOZ 10MG A087246 002
10MG A087869 001 Dec 20, 1982
25MG A085247 001
25MG A087870 001 Dec 20, 1982
50MG A087245 001
50MG A087871 001 Dec 20, 1982
SUPERPHARM 10MG A088794 001 Dec 05, 1984
25MG A088795 001 Dec 05, 1984
50MG A088796 001 Dec 05, 1984
USL PHARMA 10MG A089121 001 Mar 20, 1986
25MG A089122 001 Mar 20, 1986
50MG A089123 001 Mar 20, 1986
VINTAGE 10MG A087602 001 Jan 22, 1982
25MG A087603 001 Jan 22, 1982
50MG A087604 001 Jan 22, 1982
WATSON LABS 10MG A086827 001
25MG A086829 001
50MG A086836 001

HYDROXYZINE PAMOATE
CAPSULE; ORAL
HYDROXYZINE PAMOATE
DURAMED PHARMS BARR EQ 25MG HCL A088593 001 Feb 29, 1984
EQ 50MG HCL A088594 001 Feb 29, 1984
EQ 100MG HCL A088595 001 Feb 29, 1984
PAR PHARM EQ 25MG HCL A087656 001 Jun 11, 1982
EQ 25MG HCL A089145 001 Mar 17, 1986
EQ 50MG HCL A087657 001 Jun 11, 1982
EQ 50MG HCL A089146 001 Mar 17, 1986
EQ 100MG HCL A087658 001 Jun 11, 1982
SANDOZ EQ 25MG HCL A081127 001 Jun 28, 1991
EQ 50MG HCL A081128 001 Jun 28, 1991
EQ 100MG HCL A081129 001 Jun 28, 1991
SUPERPHARM EQ 25MG HCL A089031 001 Jan 02, 1987
EQ 50MG HCL A089032 001 Jan 02, 1987
EQ 100MG HCL A089033 001 Jan 02, 1987
VANGARD EQ 25MG HCL A088392 001 Sep 19, 1983
EQ 50MG HCL A088393 001 Sep 19, 1983
WATSON LABS EQ 25MG HCL A086698 001
EQ 25MG HCL A086840 001 Jul 01, 1982
EQ 50MG HCL A086695 001
EQ 50MG HCL A086705 001 Jul 01, 1982
EQ 50MG HCL A087767 001 Aug 16, 1982
EQ 100MG HCL A086697 001
EQ 100MG HCL A086728 001 Oct 05, 1982
EQ 100MG HCL A087790 001 Aug 16, 1982
HY-PAM "25"
TEVA EQ 25MG HCL A088713 001 Mar 04, 1985
VISTARIL
PFIZER EQ 100MG HCL N011459 006

IBANDRONATE SODIUM
TABLET; ORAL
BONIVA
ROCHE EQ 2.5MG BASE N021455 001 May 16, 2003

IBUPROFEN
CAPSULE; ORAL
MIDOL
BAYER 200MG A070626 001 Sep 02, 1987
200MG A071002 001 Sep 02, 1987
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 171 (of 324)

IBUPROFEN
SUSPENSION; ORAL
CHILDREN'S ADVIL
WYETH CONS 100MG/5ML N019833 002 Sep 19, 1989
IBU
ABBOTT 100MG/5ML N019784 001 Dec 18, 1989
MOTRIN
MCNEIL CONSUMER 100MG/5ML N019842 001 Sep 19, 1989
SUSPENSION/DROPS; ORAL
MOTRIN
MCNEIL 40MG/ML N020476 001 May 25, 1995
TABLET; ORAL
ACHES-N-PAIN
LEDERLE 200MG A071065 001 May 28, 1987
CAP-PROFEN
PERRIGO 200MG A072097 001 Dec 08, 1987
IBU
BASF 400MG A070083 001 Feb 22, 1985
400MG N018197 001
600MG A070088 001 Feb 08, 1985
600MG A070099 001 Mar 29, 1985
800MG A070745 001 Jul 23, 1986
IBUPRIN
PLIVA 200MG A071773 001 Jul 16, 1987
IBUPROFEN
ABBOTT 600MG A070556 001 Jun 14, 1985
800MG A071264 001 Jul 25, 1986
HALSEY 200MG A071027 001 Sep 29, 1987
300MG A071028 001 Mar 23, 1987
400MG A071029 001 Mar 23, 1987
600MG A071030 001 Mar 23, 1987
800MG A072137 001 Feb 05, 1988
IVAX SUB TEVA PHARMS 200MG A071144 001 Jan 20, 1987
200MG A071154 001 Oct 27, 1987
200MG A072040 001 Apr 29, 1988
200MG A072901 001 Dec 19, 1991
200MG A072903 001 Dec 19, 1991
400MG A071145 001 Sep 23, 1986
600MG A071146 001 Sep 23, 1986
800MG A071769 001 May 08, 1987
LEDERLE 400MG A070629 001 Sep 19, 1986
600MG A070630 001 Sep 19, 1986
LEINER 300MG A071266 001 Oct 15, 1986
MCNEIL 400MG A070081 001 Jun 16, 1986
600MG A070476 001 Jun 16, 1986
MUTUAL PHARM 200MG A070493 001 Dec 24, 1985
200MG A070908 001 Sep 26, 1986
200MG A071462 001 Oct 02, 1986
400MG A070079 001 Jul 24, 1985
600MG A070080 001 Jul 24, 1985
800MG A071448 001 Feb 18, 1987
MYLAN 200MG A071870 001 May 05, 1988
400MG A070045 001 Sep 24, 1985
600MG A070057 001 Sep 24, 1985
800MG A071999 001 Dec 03, 1987
PAR PHARM 200MG A071575 001 May 08, 1987
300MG A070328 001 Aug 06, 1985
400MG A070329 001 Aug 06, 1985
600MG A070330 001 Aug 06, 1985
800MG A070986 001 Jul 25, 1986
PERRIGO 200MG A072098 001 Dec 08, 1987
PLIVA 400MG A071666 001 Jun 18, 1987
600MG A071667 001 Jun 18, 1987
800MG A071668 001 Jun 18, 1987
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 172 (of 324)

IBUPROFEN
TABLET; ORAL
IBUPROFEN
PUREPAC PHARM 200MG A071122 001 Oct 03, 1986
200MG A071664 001 Feb 03, 1987
300MG A071123 001 Sep 19, 1986
400MG A071124 001 Sep 19, 1986
600MG A071125 001 Sep 19, 1986
800MG A071964 001 Feb 01, 1988
SANDOZ 200MG A070733 001 Sep 19, 1986
300MG A070734 001 Jun 12, 1986
400MG A070735 001 Jun 12, 1986
400MG A072064 001 Jan 14, 1988
600MG A070736 001 Jun 12, 1986
600MG A072065 001 Jan 14, 1988
800MG A071938 001 Jan 14, 1988
800MG A072169 001 Dec 11, 1987
SUPERPHARM 600MG A070709 001 Apr 25, 1986
TEVA 200MG A073141 001 May 29, 1992
400MG A073343 001 Jun 30, 1992
600MG A073344 001 Jun 30, 1992
800MG A073345 001 Jun 30, 1992
VINTAGE PHARMS 200MG A072249 001 Jan 10, 1989
WATSON LABS 200MG A071765 001 Sep 04, 1987
200MG A071905 001 Mar 08, 1988
300MG A071338 001 Dec 01, 1986
400MG A070038 001 Sep 06, 1985
600MG A070041 001 Sep 06, 1985
800MG A071547 001 Jul 02, 1987
800MG A071911 001 Oct 13, 1987
IBU-TAB
ALRA 800MG A071965 001 Aug 11, 1988
MEDIPREN
MCNEIL 200MG A070475 001 Feb 06, 1986
200MG A071215 001 Jun 26, 1986
MIDOL
BAYER 200MG A070591 001 Sep 02, 1987
200MG A071001 001 Sep 02, 1987
MOTRIN
MCNEIL CONSUMER 300MG N017463 003
400MG N017463 002
600MG N017463 004
800MG N017463 005 May 22, 1985
MCNEIL PED 100MG N020418 001 Nov 16, 1994
NUPRIN
BRISTOL MYERS 200MG A072035 001 Feb 16, 1988
200MG A072036 001 Feb 16, 1988
MCNEIL 200MG N019012 001 May 18, 1984
200MG N019012 002 Jul 29, 1987
RUFEN
BASF 600MG N018197 002 Mar 05, 1984
TABLET, CHEWABLE; ORAL
MOTRIN
MCNEIL PED 50MG N020135 001 Nov 16, 1994
100MG N020135 002 Nov 16, 1994

IDARUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION
IDAMYCIN
PHARMACIA AND UPJOHN 5MG/VIAL N050661 002 Sep 27, 1990
10MG/VIAL N050661 001 Sep 27, 1990
20MG/VIAL N050661 003 Apr 25, 1995
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DISCONTINUED DRUG PRODUCT LIST 6 - 173 (of 324)

IDOXURIDINE
OINTMENT; OPHTHALMIC

STOXIL

GLAXOSMITHKLINE 0.5% N015868 001


SOLUTION/DROPS; OPHTHALMIC

STOXIL

GLAXOSMITHKLINE 0.1% N013934 001


IFOSFAMIDE
INJECTABLE; INJECTION
IFEX
BAXTER HLTHCARE 1GM/VIAL N019763 001 Dec 30, 1988
3GM/VIAL N019763 002 Dec 30, 1988

IMATINIB MESYLATE
CAPSULE; ORAL
GLEEVEC
NOVARTIS EQ 50MG BASE N021335 001 May 10, 2001
EQ 100MG BASE N021335 002 May 10, 2001

IMIPRAMINE HYDROCHLORIDE
CONCENTRATE; ORAL
IMIPRAMINE HYDROCHLORIDE
NOVARTIS 25MG/ML A086765 001
INJECTABLE; INJECTION
TOFRANIL
NOVARTIS 12.5MG/ML N011838 002
TABLET; ORAL
IMIPRAMINE HYDROCHLORIDE
LEDERLE 10MG A086269 001
25MG A086267 001
50MG A086268 001
PAR PHARM 25MG A089497 001 Jul 14, 1987
50MG A088276 001 Oct 21, 1983
ROXANE 10MG A083799 001
25MG A083799 002
50MG A083799 003
SANDOZ 10MG A085200 001
25MG A084869 002
50MG A085133 001
TEVA 10MG A083729 001
25MG A083729 004
50MG A083729 003
USL PHARMA 25MG A087776 001 Feb 10, 1982
VANGARD 10MG A088036 001 Nov 03, 1982
25MG A087619 001 Feb 09, 1982
50MG A087631 001 Jan 04, 1982
WATSON LABS 10MG A085220 001
10MG A085875 001
25MG A084252 002
25MG A085878 001
50MG A085221 001
50MG A085877 001
WEST WARD 25MG A088222 001 May 26, 1983
50MG A088223 001 May 26, 1983
JANIMINE
ABBOTT 10MG N017895 001
25MG N017895 002
50MG N017895 003
PRAMINE
ALRA 10MG A083827 001
25MG A083827 002
50MG A083827 003
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DISCONTINUED DRUG PRODUCT LIST 6 - 174 (of 324)

IMIPRAMINE HYDROCHLORIDE
TABLET; ORAL
PRESAMINE
SANOFI AVENTIS US 10MG N011836 006
25MG N011836 003
50MG N011836 007

INAMRINONE LACTATE
INJECTABLE; INJECTION
AMRINONE LACTATE
HOSPIRA EQ 5MG BASE/ML A074616 001 Aug 03, 1998
INOCOR
SANOFI AVENTIS US EQ 5MG BASE/ML N018700 001 Jul 31, 1984

INDAPAMIDE
TABLET; ORAL
INDAPAMIDE
CADISTA PHARMS 1.25MG A075201 001 Dec 04, 1998
2.5MG A075201 002 Dec 04, 1998
TEVA 1.25MG A074498 002 Feb 12, 1998
1.25MG A074665 001 Apr 04, 1997
2.5MG A074498 001 Oct 31, 1996
2.5MG A074665 002 Apr 04, 1997
LOZOL
SANOFI AVENTIS US 1.25MG N018538 002 Apr 29, 1993
2.5MG N018538 001 Jul 06, 1983

INDECAINIDE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL
DECABID
LILLY EQ 50MG BASE N019693 001 Dec 29, 1989
EQ 75MG BASE N019693 002 Dec 29, 1989
EQ 100MG BASE N019693 003 Dec 29, 1989

INDINAVIR SULFATE
CAPSULE; ORAL
CRIXIVAN
MERCK SHARP DOHME EQ 333MG BASE N020685 005 Dec 17, 1998

INDOCYANINE GREEN
INJECTABLE; INJECTION
IC-GREEN
AKORN 10MG/VIAL N011525 003
40MG/VIAL N011525 004
50MG/VIAL N011525 002

INDOMETHACIN
CAPSULE; ORAL
INDOCIN
IROKO PHARMS 25MG N016059 001
50MG N016059 002
INDO-LEMMON
TEVA 25MG A070266 001 Nov 07, 1985
50MG A070267 001 Nov 07, 1985
INDOMETHACIN
ABLE 25MG A076666 001 Dec 17, 2003
50MG A076666 002 Dec 17, 2003
DURAMED PHARMS BARR 25MG A070326 001 Oct 18, 1985
50MG A070327 001 Oct 18, 1985
HALSEY 25MG A070782 001 Jun 03, 1987
50MG A070635 001 Jun 03, 1987
HERITAGE PHARMS INC 25MG N018851 001 May 18, 1984
50MG N018851 002 May 18, 1984
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DISCONTINUED DRUG PRODUCT LIST 6 - 175 (of 324)

INDOMETHACIN
CAPSULE; ORAL
INDOMETHACIN
IVAX SUB TEVA PHARMS 25MG N018730 001 May 04, 1984
50MG N018730 002 May 04, 1984
MUTUAL PHARM 25MG A070067 001 Oct 03, 1986
25MG A070899 001 Feb 09, 1987
50MG A070068 001 Oct 03, 1986
50MG A070900 001 Feb 09, 1987
MYLAN 50MG N018858 002 Apr 20, 1984
PARKE DAVIS 25MG N018806 001 Nov 23, 1984
50MG N018806 002 Nov 23, 1984
PIONEER PHARMS 25MG A070813 001 Aug 11, 1986
50MG A070592 001 Aug 11, 1986
PLIVA 25MG A071148 001 Mar 18, 1987
50MG A071149 001 Mar 18, 1987
ROXANE 25MG A070353 001 Jun 18, 1985
50MG A070354 001 Jun 18, 1985
SUPERPHARM 25MG A070487 001 Oct 10, 1986
50MG A070488 001 Oct 10, 1986
TEVA 25MG A071342 001 Apr 18, 1988
50MG A071343 001 Apr 18, 1988
VINTAGE 25MG N018829 002 Aug 06, 1984
50MG A070651 001 Mar 05, 1986
50MG N018829 001 Aug 06, 1984
WATSON LABS 25MG A070529 001 Oct 18, 1985
25MG A070784 001 Aug 20, 1986
25MG A072996 001 Jul 31, 1991
25MG N018690 001 Jul 31, 1984
50MG A070530 001 Oct 18, 1985
50MG A070785 001 Aug 20, 1986
50MG A071635 001 May 18, 1987
50MG A072997 001 Jul 31, 1991
50MG N018690 002 Jul 31, 1984
CAPSULE, EXTENDED RELEASE; ORAL
INDOCIN SR
IROKO PHARMS 75MG N018185 001 Feb 23, 1982
INDOMETHACIN
ABLE 75MG A076114 001 Feb 06, 2002
INWOOD LABS 75MG A072410 001 Mar 15, 1989
SUPPOSITORY; RECTAL
INDOCIN
IROKO PHARMS 50MG N017814 001 Aug 13, 1984
SUSPENSION; ORAL
INDOMETHACIN
ROXANE 25MG/5ML A071412 001 Mar 18, 1987

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT


INJECTABLE; SUBCUTANEOUS
NOVOLOG MIX 50/50
NOVO NORDISK INC 50 UNITS/ML;50 UNITS/ML N021810 001 Aug 26, 2008

INSULIN PORK
INJECTABLE; INJECTION
ILETIN I
LILLY 500 UNITS/ML N017931 001
INSULIN
NOVO NORDISK INC 40 UNITS/ML N017926 001
REGULAR INSULIN
NOVO NORDISK INC 100 UNITS/ML N017926 003
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DISCONTINUED DRUG PRODUCT LIST 6 - 176 (of 324)

INSULIN PURIFIED BEEF


INJECTABLE; INJECTION

REGULAR ILETIN II

LILLY 100 UNITS/ML N018478 001


INSULIN PURIFIED PORK


INJECTABLE; INJECTION

ILETIN II

LILLY 500 UNITS/ML N018344 002


REGULAR ILETIN II (PORK)

LILLY 100 UNITS/ML N018344 001


REGULAR PURIFIED PORK INSULIN


NOVO NORDISK INC 100 UNITS/ML N018381 001


VELOSULIN

NOVO NORDISK INC 100 UNITS/ML N018193 001


INSULIN PURIFIED PORK; INSULIN SUSP ISOPHANE PURIFIED PORK


INJECTABLE; INJECTION

INSULIN NORDISK MIXTARD (PORK)

NOVO NORDISK INC 30 UNITS/ML;70 UNITS/ML N018195 001


INSULIN RECOMBINANT HUMAN


INJECTABLE; INJECTION
HUMULIN BR
LILLY 100 UNITS/ML N019529 001 Apr 28, 1986
VELOSULIN BR
NOVO NORDISK INC 100 UNITS/ML N021028 001 Jul 19, 1999
POWDER; INHALATION
EXUBERA
PFIZER 1MG/INH N021868 001 Jan 27, 2006
3MG/INH N021868 002 Jan 27, 2006

INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN


INJECTABLE; INJECTION
HUMULIN 50/50
LILLY 50 UNITS/ML;50 UNITS/ML N020100 001 Apr 29, 1992

INSULIN RECOMBINANT PURIFIED HUMAN


INJECTABLE; INJECTION
NOVOLIN R
NOVO NORDISK INC 100 UNITS/ML N018778 001 Aug 30, 1983
VELOSULIN BR HUMAN
NOVO NORDISK INC 100 UNITS/ML N019450 001 May 30, 1986

INSULIN RECOMBINANT PURIFIED HUMAN; INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED


HUMAN
INJECTABLE; INJECTION
MIXTARD HUMAN 70/30
BAYER PHARMS 30 UNITS/ML;70 UNITS/ML N019585 001 Mar 11, 1988
NOVOLIN 70/30
NOVO NORDISK INC 30 UNITS/ML;70 UNITS/ML N019441 001 Jul 11, 1986

INSULIN SUSP ISOPHANE BEEF


INJECTABLE; INJECTION

NPH INSULIN

NOVO NORDISK INC 40 UNITS/ML N017929 001


100 UNITS/ML N017929 003


INSULIN SUSP ISOPHANE BEEF/PORK


INJECTABLE; INJECTION

NPH ILETIN I (BEEF-PORK)

LILLY 40 UNITS/ML N017936 001


100 UNITS/ML N017936 002


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DISCONTINUED DRUG PRODUCT LIST 6 - 177 (of 324)

INSULIN SUSP ISOPHANE PURIFIED BEEF


INJECTABLE; INJECTION
NPH ILETIN II
LILLY 100 UNITS/ML N018479 001

INSULIN SUSP ISOPHANE PURIFIED PORK


INJECTABLE; INJECTION
INSULIN INSULATARD NPH NORDISK
NOVO NORDISK INC 100 UNITS/ML N018194 001
NPH ILETIN II (PORK)
LILLY 100 UNITS/ML N018345 001
NPH PURIFIED PORK ISOPHANE INSULIN
NOVO NORDISK INC 100 UNITS/ML N018623 001

INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED HUMAN


INJECTABLE; INJECTION
INSULATARD NPH HUMAN
NOVO NORDISK INC 100 UNITS/ML N019449 001 May 30, 1986
NOVOLIN N
NOVO NORDISK INC 100 UNITS/ML N019065 001 Jan 23, 1985

INSULIN SUSP PROTAMINE ZINC BEEF/PORK


INJECTABLE; INJECTION
PROTAMINE ZINC & ILETIN I (BEEF-PORK)
LILLY 40 UNITS/ML N017932 001
100 UNITS/ML N017932 002

INSULIN SUSP PROTAMINE ZINC PURIFIED BEEF


INJECTABLE; INJECTION
PROTAMINE ZINC AND ILETIN II
LILLY 100 UNITS/ML N018476 001
PROTAMINE ZINC INSULIN
BRISTOL MYERS SQUIBB 40 UNITS/ML N017928 001
100 UNITS/ML N017928 003

INSULIN SUSP PROTAMINE ZINC PURIFIED PORK


INJECTABLE; INJECTION
PROTAMINE ZINC AND ILETIN II (PORK)
LILLY 100 UNITS/ML N018346 001

INSULIN ZINC SUSP BEEF


INJECTABLE; INJECTION
LENTE INSULIN
NOVO NORDISK INC 40 UNITS/ML N017998 001
100 UNITS/ML N017998 003

INSULIN ZINC SUSP EXTENDED BEEF


INJECTABLE; INJECTION
ULTRALENTE INSULIN
NOVO NORDISK INC 100 UNITS/ML N017997 003

INSULIN ZINC SUSP EXTENDED PURIFIED BEEF


INJECTABLE; INJECTION
ULTRALENTE
NOVO NORDISK INC 100 UNITS/ML N018385 001

INSULIN ZINC SUSP EXTENDED RECOMBINANT HUMAN


INJECTABLE; INJECTION
HUMULIN U
LILLY 40 UNITS/ML N019571 001 Jun 10, 1987
100 UNITS/ML N019571 002 Jun 10, 1987
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DISCONTINUED DRUG PRODUCT LIST 6 - 178 (of 324)

INSULIN ZINC SUSP PROMPT BEEF


INJECTABLE; INJECTION
SEMILENTE INSULIN
NOVO NORDISK INC 100 UNITS/ML N017996 003

INSULIN ZINC SUSP PROMPT PURIFIED PORK


INJECTABLE; INJECTION
SEMILENTE
NOVO NORDISK INC 100 UNITS/ML N018382 001

INSULIN ZINC SUSP PURIFIED BEEF


INJECTABLE; INJECTION
LENTE ILETIN II
LILLY 100 UNITS/ML N018477 001

INSULIN ZINC SUSP PURIFIED BEEF/PORK


INJECTABLE; INJECTION
LENTARD
NOVO NORDISK INC 100 UNITS/ML N018384 001

INSULIN ZINC SUSP PURIFIED PORK


INJECTABLE; INJECTION
LENTE
NOVO NORDISK INC 100 UNITS/ML N018383 001
LENTE ILETIN II (PORK)
LILLY 100 UNITS/ML N018347 001

INSULIN ZINC SUSP RECOMBINANT HUMAN


INJECTABLE; INJECTION
HUMULIN L
LILLY 100 UNITS/ML N019377 002 Sep 30, 1985
NOVOLIN L
NOVO NORDISK INC 100 UNITS/ML N019965 001 Jun 25, 1991

INSULIN ZINC SUSP SEMISYNTHETIC PURIFIED HUMAN


INJECTABLE; INJECTION
NOVOLIN L
NOVO NORDISK INC 100 UNITS/ML N018777 001 Aug 30, 1983

INULIN
INJECTABLE; INJECTION
INULIN AND SODIUM CHLORIDE
ISO TEX 100MG/ML N002282 001

INVERT SUGAR
INJECTABLE; INJECTION
TRAVERT 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 10GM/100ML N016717 001

IOBENGUANE SULFATE I-131


INJECTABLE; INJECTION
IOBENGUANE SULFATE I 131
PHARMALUCENCE 2.3mCi/ML N020084 001 Mar 25, 1994

IOCETAMIC ACID
TABLET; ORAL
CHOLEBRINE
MALLINCKRODT 750MG N017129 001

IODAMIDE MEGLUMINE
INJECTABLE; INJECTION
RENOVUE-65
BRACCO 65% N017902 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 179 (of 324)

IODAMIDE MEGLUMINE
INJECTABLE; INJECTION
RENOVUE-DIP
BRACCO 24% N017903 001

IODIPAMIDE MEGLUMINE
INJECTABLE; INJECTION
CHOLOGRAFIN MEGLUMINE
BRACCO 10.3% N009321 007

IODIPAMIDE SODIUM
INJECTABLE; INJECTION
CHOLOGRAFIN SODIUM
BRACCO 20% N009321 001

IODOHIPPURATE SODIUM, I-123


INJECTABLE; INJECTION
NEPHROFLOW
GE HEALTHCARE 1mCi/ML N018289 001 Dec 28, 1984

IODOHIPPURATE SODIUM, I-131


INJECTABLE; INJECTION
HIPPURAN I 131
MALLINCKRODT 0.25mCi/ML N016666 001
HIPPUTOPE
BRACCO 1-2mCi/VIAL N015419 002
IODOHIPPURATE SODIUM I 131
PHARMALUCENCE 0.2mCi/ML N017313 001

IODOXAMATE MEGLUMINE
INJECTABLE; INJECTION
CHOLOVUE
BRACCO 9.9% N018077 001
40.3% N018076 001

IOFETAMINE HYDROCHLORIDE I-123


INJECTABLE; INJECTION
SPECTAMINE
IMP 1mCi/ML N019432 001 Dec 24, 1987

IOHEXOL
INJECTABLE; INJECTION
OMNIPAQUE 210
GE HEALTHCARE 45.3% N018956 006 Jun 30, 1989
SOLUTION; URETHRAL
OMNIPAQUE 70
GE HEALTHCARE 15.1% N018956 007 Jun 01, 1994

IOPAMIDOL
INJECTABLE; INJECTION
IOPAMIDOL
BAXTER HLTHCARE 41% A074629 001 Nov 06, 1996
51% A074629 004 Mar 31, 1998
61% A074629 002 Nov 06, 1996
76% A074629 003 Nov 06, 1996
HOSPIRA 61% A074734 001 Dec 10, 1996
76% A074734 002 Dec 10, 1996
IOPAMIDOL-200
COOK IMAGING 41% A074881 001 Jul 28, 2000
IOPAMIDOL-250
COOK IMAGING 51% A074881 002 Jul 28, 2000
IOPAMIDOL-300
ABBOTT 61% A074638 001 Apr 30, 1997
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 180 (of 324)

IOPAMIDOL
INJECTABLE; INJECTION
IOPAMIDOL-300
COOK IMAGING 61% A074881 003 Jul 28, 2000
IOPAMIDOL-370
COOK IMAGING 76% A074881 004 Jul 28, 2000
ISOVUE-128
BRACCO 26% N018735 005 Oct 21, 1986
ISOVUE-200
BRACCO 41% N020327 001 Oct 12, 1994

IOPANOIC ACID
TABLET; ORAL
TELEPAQUE
GE HEALTHCARE 500MG N008032 001

IOPHENDYLATE
INJECTABLE; INJECTION
PANTOPAQUE
ALCON 100% N005319 001

IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM


INJECTABLE; INJECTION
VASCORAY
MALLINCKRODT 52%;26% N016783 001

IOTHALAMATE SODIUM
INJECTABLE; INJECTION
ANGIO-CONRAY
MALLINCKRODT 80% N013319 001
CONRAY 325
MALLINCKRODT 54.3% N017685 001
CONRAY 400
MALLINCKRODT 66.8% N014295 001

IOTHALAMATE SODIUM, I-125


INJECTABLE; INJECTION
GLOFIL-125
ISOTEX 250-300uCi/ML N017279 001

IOTROLAN
INJECTABLE; INTRATHECAL
OSMOVIST 190
BAYER HLTHCARE 40.6% N019580 001 Dec 07, 1989
OSMOVIST 240
BAYER HLTHCARE 51.3% N019580 002 Dec 07, 1989

IOVERSOL
INJECTABLE; INJECTION
OPTIRAY 240
MALLINCKRODT 51% N020923 001 May 28, 1998
OPTIRAY 320
MALLINCKRODT 68% N020923 002 May 29, 1998

IPODATE CALCIUM
GRANULE; ORAL
ORAGRAFIN CALCIUM
BRACCO 3GM/PACKET N012968 001

IPODATE SODIUM
CAPSULE; ORAL
BILIVIST
BAYER HLTHCARE 500MG A087768 001 Aug 11, 1982
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DISCONTINUED DRUG PRODUCT LIST 6 - 181 (of 324)

IPODATE SODIUM
CAPSULE; ORAL
ORAGRAFIN SODIUM
BRACCO 500MG N012967 001

IPRATROPIUM BROMIDE
AEROSOL, METERED; INHALATION
ATROVENT
BOEHRINGER INGELHEIM 0.018MG/INH N019085 001 Dec 29, 1986
SOLUTION; INHALATION
ATROVENT
BOEHRINGER INGELHEIM 0.02% N020228 001 Sep 29, 1993
IPRATROPIUM BROMIDE
PHARMASCIENCE INC 0.02% A075507 001 Jan 19, 2001
ROXANE 0.02% A075867 001 Jul 22, 2002

IRON DEXTRAN
INJECTABLE; INJECTION
IRON DEXTRAN
SANOFI AVENTIS US EQ 50MG IRON/ML N010787 002

IRON SUCROSE
INJECTABLE; INTRAVENOUS
VENOFER
LUITPOLD EQ 50MG BASE/2.5ML (EQ 20MG BASE/ML) N021135 002 Mar 20, 2005
EQ 75MG BASE/3.75ML (EQ 20MG BASE/ML) N021135 003 Mar 29, 2005

ISOETHARINE HYDROCHLORIDE
SOLUTION; INHALATION
BETA-2
NEPHRON 1% A086711 001
BRONKOSOL
SANOFI AVENTIS US 0.25% N012339 009
1% N012339 008
ISOETHARINE HYDROCHLORIDE
ALPHARMA US PHARMS 1% A087101 001
ASTRAZENECA 0.062% A087937 001 Nov 15, 1982
0.062% A089614 001 Jun 13, 1991
0.125% A087938 001 Nov 15, 1982
0.125% A089615 001 Jun 13, 1991
0.167% A088470 001 Mar 14, 1984
0.167% A089616 001 Jun 13, 1991
0.2% A088471 001 Mar 14, 1984
0.2% A089617 001 Jun 13, 1991
0.25% A088472 001 Mar 14, 1984
0.25% A089618 001 Jun 13, 1991
BAXTER HLTHCARE 0.08% A088144 001 Jul 29, 1983
0.14% A088145 001 Mar 26, 1984
0.25% A088146 001 Aug 01, 1983
DEY 0.08% A088187 001 Dec 03, 1982
0.1% A087389 001
0.17% A087390 001
0.25% A088188 001 Dec 03, 1982
1% A086763 001
INTL MEDICATION 0.077% A086651 001
0.08% A086651 002
0.1% A086651 003
0.143% A086651 004
0.167% A086651 005
0.2% A086651 006
0.25% A086651 007
1% A086651 008
PARKE DAVIS 0.5% A085997 001
1% A085889 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 182 (of 324)

ISOETHARINE HYDROCHLORIDE
SOLUTION; INHALATION
ISOETHARINE HYDROCHLORIDE
ROXANE 0.1% A087396 001
0.125% A087025 001
0.167% A088226 001 Sep 16, 1983
0.2% A087324 001
0.25% A088275 001 Jun 03, 1983
1% A086899 001
ISOETHARINE HYDROCHLORIDE S/F
DEY 0.08% A089817 001 Nov 22, 1988
0.1% A089818 001 Nov 22, 1988
0.17% A089819 001 Nov 22, 1988
0.25% A089820 001 Nov 22, 1988
1% A089252 001 Sep 15, 1986

ISOETHARINE MESYLATE
AEROSOL, METERED; INHALATION
BRONKOMETER
SANOFI AVENTIS US 0.34MG/INH N012339 007
ISOETHARINE MESYLATE
ALPHARMA US PHARMS 0.34MG/INH A087858 001 Aug 21, 1984

ISOFLURANE
LIQUID; INHALATION
ISOFLURANE
MARSAM PHARMS LLC 99.9% A074393 001 May 12, 1995

ISOFLUROPHATE
OINTMENT; OPHTHALMIC
FLOROPRYL
MERCK 0.025% N010656 001

ISONIAZID
INJECTABLE; INJECTION
NYDRAZID
SANDOZ 100MG/ML N008662 001
RIMIFON
ROCHE 25MG/ML N008420 002
100MG/ML N008420 003
SYRUP; ORAL
ISONIAZID
MIKART 50MG/5ML A081118 001 Jul 21, 1997
LANIAZID
LANNETT 50MG/5ML A089243 001 Feb 03, 1986
RIMIFON
ROCHE 50MG/5ML N008420 001
TABLET; ORAL
DOW-ISONIAZID
DOW PHARM 300MG A080330 002
HYZYD
MEDPOINTE PHARM HLC 100MG A080134 003
300MG A080134 004
INH
NOVARTIS 300MG A080935 001
ISONIAZID
DURAMED PHARMS BARR 100MG A088231 001 Mar 17, 1983
300MG A088119 001 Mar 17, 1983
HALSEY 50MG A083632 001
IMPAX LABS 100MG A080153 001
IVAX SUB TEVA PHARMS 100MG A080270 001
300MG A083610 001
LILLY 100MG N008499 002
300MG N008499 003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 183 (of 324)

ISONIAZID
TABLET; ORAL
ISONIAZID
MK LABS 100MG A080941 001
MUTUAL PHARM 100MG A080136 001
300MG A083633 001
NEXGEN PHARMA INC 100MG A084050 001
PANRAY 50MG N008428 001
100MG N008428 002
300MG N008428 003
PERRIGO 100MG A083060 001
PHARMAVITE 100MG A085091 001
PHOENIX LABS NY 50MG A080368 001
100MG A080368 002
PUREPAC PHARM 50MG A080132 003 Jul 14, 1982
100MG A080132 004 Jul 14, 1982
WATSON LABS 50MG A080522 001
100MG A080401 001
100MG A080523 001
100MG A085790 001
300MG A083178 001
300MG A085784 001
WHITEWORTH TOWN PLSN 100MG A080120 002
LANIAZID
LANNETT 50MG A080140 001
100MG A080140 002
300MG A089776 001 Jun 13, 1988
NYDRAZID
BRISTOL MYERS SQUIBB 100MG N008392 003
STANOZIDE
EVERYLIFE 100MG A080126 001
300MG A080126 002

ISOPROPAMIDE IODIDE
TABLET; ORAL
DARBID
GLAXOSMITHKLINE EQ 5MG BASE N010744 001

ISOPROTERENOL HYDROCHLORIDE
AEROSOL, METERED; INHALATION
ISOPROTERENOL HYDROCHLORIDE
3M 0.12MG/INH N010375 004
ALPHARMA US PHARMS 0.12MG/INH A085904 001
ISUPREL
SANOFI AVENTIS US 0.103MG/INH N011178 001
DISC; INHALATION
NORISODRINE AEROTROL
ABBOTT 0.25% N016814 001
INJECTABLE; INJECTION
ISOPROTERENOL HYDROCHLORIDE
ABRAXIS PHARM 0.2MG/ML A083431 001
BAXTER HLTHCARE 0.2MG/ML A083486 001
HOSPIRA 0.02MG/ML A083283 001
0.2MG/ML A083346 001
SOLUTION; INHALATION
AEROLONE
LILLY 0.25% N007245 001
ISOPROTERENOL HYDROCHLORIDE
ARMOUR PHARM 0.031% A087935 001 Nov 18, 1982
0.062% A087936 001 Nov 18, 1982
DEY 0.5% A086764 001 Jan 04, 1982
PARKE DAVIS 0.25% A085994 001
0.5% A085540 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 184 (of 324)

ISOPROTERENOL HYDROCHLORIDE
SOLUTION; INHALATION
ISUPREL
SANOFI AVENTIS US 0.5% N006327 002
1% N006327 003
VAPO-ISO
FISONS 0.5% N016813 001
TABLET; RECTAL, SUBLINGUAL
ISUPREL
SANOFI AVENTIS US 10MG N006328 001
15MG N006328 002

ISOPROTERENOL HYDROCHLORIDE; PHENYLEPHRINE BITARTRATE


AEROSOL, METERED; INHALATION
DUO-MEDIHALER
3M 0.16MG/INH;0.24MG/INH N013296 001

ISOPROTERENOL SULFATE
AEROSOL, METERED; INHALATION
MEDIHALER-ISO
3M 0.08MG/INH N010375 003
POWDER; INHALATION
NORISODRINE
ABBOTT 10% N006905 003
25% N006905 002

ISOSORBIDE
SOLUTION; ORAL
ISMOTIC
ALCON 100GM/220ML N017063 001

ISOSORBIDE DINITRATE
CAPSULE, EXTENDED RELEASE; ORAL
ISORDIL
WYETH AYERST 40MG N012882 002 Jul 29, 1988
TABLET; ORAL
ISOSORBIDE DINITRATE
MUTUAL PHARM 5MG A086166 002 Sep 19, 1986
10MG A086169 001 Sep 19, 1986
20MG A086167 001 Sep 19, 1986
30MG A087564 001 Sep 18, 1986
SUPERPHARM 5MG A089190 001 Feb 17, 1987
10MG A089191 001 Feb 17, 1987
20MG A089192 001 Feb 17, 1987
SORBITRATE
ASTRAZENECA 5MG N016192 001 Apr 01, 1996
10MG N016192 002 Apr 01, 1996
20MG A086405 002 Aug 21, 1990
30MG A088124 001 Aug 21, 1990
40MG A088125 001 Aug 21, 1990
TABLET; SUBLINGUAL
ISORDIL
BIOVAIL 2.5MG N012940 004 Jul 29, 1988
5MG N012940 003 Jul 29, 1988
10MG N012940 005 Jul 29, 1988
ISOSORBIDE DINITRATE
MUTUAL PHARM 2.5MG A084204 001 Sep 18, 1986
5MG A086168 001 Sep 18, 1986
10MG A087545 001 Sep 18, 1986
SANDOZ 2.5MG A086225 001 Feb 19, 1988
5MG A086222 001 Feb 19, 1988
SORBITRATE
ASTRAZENECA 2.5MG N016191 002 Apr 01, 1996
5MG N016191 001 Apr 01, 1996
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 185 (of 324)

ISOSORBIDE DINITRATE
TABLET, CHEWABLE; ORAL
SORBITRATE
ASTRAZENECA 5MG N016776 002 Apr 01, 1996
10MG N016776 003 Apr 01, 1996
TABLET, EXTENDED RELEASE; ORAL
ISORDIL
WYETH AYERST 40MG N012882 001 Jul 29, 1988

ISOSORBIDE MONONITRATE
TABLET, EXTENDED RELEASE; ORAL
IMDUR
SCHERING PLOUGH 30MG N020225 001 Aug 12, 1993
60MG N020225 002 Aug 12, 1993
120MG N020225 003 Mar 30, 1995
ISOSORBIDE MONONITRATE
IVAX SUB TEVA PHARMS 30MG A075448 002 Aug 07, 2001
60MG A075448 001 Jun 19, 2000
120MG A075448 003 Aug 07, 2001

ISOTRETINOIN
CAPSULE; ORAL
ACCUTANE
HOFFMANN LA ROCHE 10MG N018662 002 May 07, 1982
20MG N018662 004 Mar 28, 1983
40MG N018662 003 May 07, 1982

ISRADIPINE
CAPSULE; ORAL
DYNACIRC
SMITHKLINE BEECHAM 2.5MG N019546 001 Dec 20, 1990
5MG N019546 002 Dec 20, 1990

IVERMECTIN
TABLET; ORAL
STROMECTOL
MERCK 6MG N050742 001 Nov 22, 1996

KANAMYCIN SULFATE
CAPSULE; ORAL
KANTREX
APOTHECON EQ 500MG BASE A060516 001
EQ 500MG BASE A061911 001
EQ 500MG BASE A062726 001 Mar 06, 1987
INJECTABLE; INJECTION
KANAMYCIN
BAXTER HLTHCARE EQ 75MG BASE/2ML A062324 001
EQ 500MG BASE/2ML A062324 002
EQ 1GM BASE/3ML A062324 003
KANAMYCIN SULFATE
ABRAXIS PHARM EQ 75MG BASE/2ML A062504 001 Apr 05, 1984
EQ 500MG BASE/2ML A062504 002 Apr 05, 1984
EQ 1GM BASE/3ML A062504 003 Apr 05, 1984
INTL MEDICATION EQ 500MG BASE/2ML A062466 001 Sep 30, 1983
EQ 1GM BASE/3ML A062466 002 Sep 30, 1983
LOCH EQ 75MG BASE/2ML A063021 001 Jul 31, 1992
EQ 500MG BASE/2ML A063022 001 Jul 31, 1992
EQ 1GM BASE/3ML A063025 001 Jul 31, 1992
PHARMAFAIR EQ 75MG BASE/2ML A062668 001 May 07, 1987
EQ 500MG BASE/2ML A062672 001 May 07, 1987
EQ 1GM BASE/3ML A062669 001 May 07, 1987
SOLOPAK EQ 75MG BASE/2ML A062605 003 Feb 26, 1986
EQ 500MG BASE/2ML A062605 001 Feb 26, 1986
EQ 1GM BASE/3ML A062605 002 Feb 26, 1986
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 186 (of 324)

KANAMYCIN SULFATE
INJECTABLE; INJECTION
KANAMYCIN SULFATE
WARNER CHILCOTT EQ 1GM BASE/3ML A063092 001 Oct 11, 1989
WATSON LABS EQ 1GM BASE/3ML A062520 003 May 09, 1985
KANTREX
APOTHECON EQ 75MG BASE/2ML A061655 003
EQ 75MG BASE/2ML A061901 003
EQ 75MG BASE/2ML A062564 001 Sep 21, 1984
EQ 500MG BASE/2ML A061655 001
EQ 500MG BASE/2ML A061901 001
EQ 500MG BASE/2ML A062564 002 Sep 21, 1984
EQ 1GM BASE/3ML A061655 002
EQ 1GM BASE/3ML A061901 002
EQ 1GM BASE/3ML A062564 003 Sep 21, 1984
KLEBCIL
KING PHARMS EQ 75MG BASE/2ML A062170 001
EQ 500MG BASE/2ML A062170 002
EQ 1GM BASE/3ML A062170 003

KETOCONAZOLE
CREAM; TOPICAL
NIZORAL
JANSSEN PHARMA 2% N019084 001 Dec 31, 1985
SUSPENSION; ORAL
NIZORAL
JANSSEN PHARMA 100MG/5ML A070767 001 Nov 07, 1986
TABLET; ORAL
KETOCONAZOLE
AAIPHARMA LLC 200MG A075341 001 Jul 27, 1999
TEVA 200MG A074971 001 Jun 15, 1999

KETOPROFEN
CAPSULE; ORAL
KETOPROFEN
SANDOZ 50MG A074024 001 Dec 29, 1995
75MG A074024 002 Dec 29, 1995
TEVA 25MG A073515 001 Dec 22, 1992
ORUDIS
WYETH AYERST 25MG N018754 001 Jul 31, 1987
50MG N018754 002 Jan 09, 1986
75MG N018754 003 Jan 09, 1986
CAPSULE, EXTENDED RELEASE; ORAL
ORUVAIL
WYETH PHARMS INC 100MG N019816 003 Feb 08, 1995
150MG N019816 002 Feb 08, 1995
200MG N019816 001 Sep 24, 1993
TABLET; ORAL
ACTRON
BAYER 12.5MG N020499 001 Oct 06, 1995
KETOPROFEN
PERRIGO 12.5MG A075364 001 Feb 07, 2002
ORUDIS KT
WYETH CONS 12.5MG N020429 001 Oct 06, 1995

KETOROLAC TROMETHAMINE
INJECTABLE; INJECTION
KETOROLAC TROMETHAMINE
AMPHASTAR PHARM 15MG/ML A076209 001 Jul 21, 2004
30MG/ML A076209 002 Jul 21, 2004
APOTEX INC 30MG/ML A075626 001 Jul 24, 2001
30MG/ML A077201 001 Oct 14, 2005
APOTHECON 15MG/ML A075348 001 Nov 28, 2000
30MG/ML A075348 002 Nov 28, 2000
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 187 (of 324)

KETOROLAC TROMETHAMINE
INJECTABLE; INJECTION
KETOROLAC TROMETHAMINE
BEDFORD 15MG/ML A075230 002 Oct 25, 1999
30MG/ML A075230 001 Oct 25, 1999
GLAND PHARMA LTD 15MG/ML A076722 001 Jul 27, 2004
30MG/ML A076722 002 Jul 27, 2004
HOSPIRA 15MG/ML A074801 001 Jun 05, 1997
30MG/ML A074801 002 Jun 05, 1997
TORADOL
ROCHE PALO 15MG/ML N019698 001 Nov 30, 1989
30MG/ML N019698 002 Nov 30, 1989
TABLET; ORAL
KETOROLAC TROMETHAMINE
ROXANE 10MG A074790 001 Jun 26, 1997
WATSON LABS 10MG A074955 001 Sep 19, 1997
TORADOL
ROCHE PALO 10MG N019645 001 Dec 20, 1991

KRYPTON, KR-81M
GAS; INHALATION
MPI KRYPTON 81M GENERATOR
GE HEALTHCARE N/A N018088 001

LABETALOL HYDROCHLORIDE
INJECTABLE; INJECTION
LABETALOL HYDROCHLORIDE
APOTHECON 5MG/ML A075355 001 Nov 29, 1999
HOSPIRA 5MG/ML A075242 001 Sep 30, 1999
NORMODYNE
SCHERING 5MG/ML N018686 001 Aug 01, 1984
TRANDATE
PROMETHEUS LABS 5MG/ML N019425 001 Dec 31, 1985
TABLET; ORAL
LABETALOL HYDROCHLORIDE
APOTHECON 100MG A075223 001 Nov 20, 1998
200MG A075223 002 Nov 20, 1998
300MG A075223 003 Nov 20, 1998
MUTUAL PHARM 100MG A075215 001 Jul 29, 1999
200MG A075215 002 Jul 29, 1999
300MG A075215 003 Jul 29, 1999
TEVA 100MG A074989 001 Sep 30, 1998
200MG A074989 002 Sep 30, 1998
300MG A074989 003 Sep 30, 1998
NORMODYNE
SCHERING 100MG N018687 001 Aug 31, 1987
200MG N018687 002 Aug 01, 1984
300MG N018687 003 Aug 01, 1984
400MG N018687 004 Aug 01, 1984
TRANDATE
PROMETHEUS LABS 400MG N018716 004 Aug 01, 1984

LACTULOSE
SOLUTION; ORAL
CHRONULAC
SANOFI AVENTIS US 10GM/15ML N017884 001
DUPHALAC
SOLVAY 10GM/15ML A072372 001 Mar 22, 1989
EVALOSE
TEVA PHARMS 10GM/15ML A073497 001 May 28, 1993
LACTULOSE
MORTON GROVE 10GM/15ML A071841 001 Sep 22, 1988
PACO 10GM/15ML A073160 001 Aug 25, 1992
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 188 (of 324)

LACTULOSE
SOLUTION; ORAL
LAXILOSE
NOSTRUM LABS 10GM/15ML A073686 001 May 28, 1993
SOLUTION; ORAL, RECTAL
ACILAC
NOSTRUM LABS 10GM/15ML A073685 001 May 28, 1993
CEPHULAC
SANOFI AVENTIS US 10GM/15ML N017657 001
GENERLAC
MORTON GROVE 10GM/15ML A071842 001 Sep 27, 1988
HEPTALAC
TEVA PHARMS 10GM/15ML A073504 001 May 28, 1993
LACTULOSE
PACO 10GM/15ML A072029 001 Aug 25, 1992
ROXANE 10GM/15ML A073590 001 May 29, 1992
SOLVAY 10GM/15ML N017906 001
PORTALAC
SOLVAY 10GM/15ML A072374 001 Mar 22, 1989

LAMOTRIGINE
TABLET; ORAL
LAMICTAL
GLAXOSMITHKLINE 50MG N020241 006 Dec 27, 1994
250MG N020241 004 Dec 27, 1994
LAMOTRIGINE
MYLAN 25MG A077428 001 Jan 27, 2009
100MG A077428 002 Jan 27, 2009
150MG A077428 003 Jan 27, 2009
200MG A077428 004 Jan 27, 2009
TABLET, CHEWABLE; ORAL
LAMICTAL CD
GLAXOSMITHKLINE 100MG N020764 003 Aug 24, 1998
LAMOTRIGINE
SANDOZ 5MG A078409 002 Jan 22, 2009
25MG A078409 003 Jan 22, 2009

LANSOPRAZOLE
FOR SUSPENSION, DELAYED RELEASE; ORAL
PREVACID
TAKEDA PHARMS NA 15MG/PACKET N021281 001 May 03, 2001
30MG/PACKET N021281 002 May 03, 2001
INJECTABLE; INTRAVENOUS
PREVACID IV
TAKEDA PHARMS NA 30MG/VIAL N021566 001 May 27, 2004

LANSOPRAZOLE; NAPROXEN
CAPSULE, DELAYED REL PELLETS, TABLET; ORAL
PREVACID NAPRAPAC 250 (COPACKAGED)
TAKEDA PHARMS NA 15MG,N/A;N/A,250MG N021507 002 Nov 14, 2003
PREVACID NAPRAPAC 375 (COPACKAGED)
TAKEDA PHARMS NA 15MG,N/A;N/A,375MG N021507 003 Nov 14, 2003
CAPSULE, DELAYED REL PELLETS, TABLET; ORAL
PREVACID NAPRAPAC 500 (COPACKAGED)
TAKEDA PHARMS NA 15MG,N/A;N/A,500MG N021507 004 Nov 14, 2003

LANTHANUM CARBONATE
TABLET, CHEWABLE; ORAL
FOSRENOL
SHIRE EQ 250MG BASE N021468 001 Oct 26, 2004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 189 (of 324)

LEFLUNOMIDE
TABLET; ORAL
LEFLUNOMIDE
SANDOZ 10MG A077085 001 Sep 13, 2005
20MG A077085 002 Sep 13, 2005

LEUCOVORIN CALCIUM
FOR SOLUTION; ORAL
LEUCOVORIN CALCIUM
HOSPIRA EQ 60MG BASE/VIAL N008107 003 Jan 30, 1987
INJECTABLE; INJECTION
LEUCOVORIN CALCIUM
ABIC EQ 3MG BASE/ML A089352 001 Jun 01, 1988
EQ 50MG BASE/VIAL A089353 001 Jun 01, 1988
ABRAXIS PHARM EQ 50MG BASE/VIAL A088939 001 Dec 01, 1986
ELKINS SINN EQ 50MG BASE/VIAL A070480 001 Jan 02, 1987
EQ 100MG BASE/VIAL A081224 001 Jun 03, 1994
HOSPIRA EQ 3MG BASE/ML N008107 001
EQ 50MG BASE/VIAL N008107 002
EQ 100MG BASE/VIAL N008107 004 May 23, 1988
PHARMACHEMIE EQ 350MG BASE/VIAL A040262 001 Dec 15, 1999
PHARMACHEMIE USA EQ 50MG BASE/VIAL A089628 001 Apr 17, 1997
EQ 100MG BASE/VIAL A089915 001 Apr 17, 1997
LEUCOVORIN CALCIUM PRESERVATIVE FREE
HOSPIRA EQ 10MG BASE/ML A040147 001 Jun 25, 1997
TEVA PARENTERAL EQ 10MG BASE/ML A040332 001 Jun 28, 1999
WELLCOVORIN
GLAXOSMITHKLINE EQ 5MG BASE/ML A087439 001 Oct 19, 1982
EQ 25MG BASE/VIAL A089833 001 Jan 23, 1989
EQ 50MG BASE/VIAL A089465 001 Jan 23, 1989
EQ 100MG BASE/VIAL A089834 001 Jan 23, 1989
TABLET; ORAL
LEUCOVORIN CALCIUM
COREPHARMA EQ 5MG BASE A074544 001 Aug 28, 1997
EQ 25MG BASE A074544 002 Aug 28, 1997
PAR PHARM EQ 5MG BASE A071600 001 Oct 14, 1987
EQ 25MG BASE A071598 001 Oct 14, 1987
PHARMACHEMIE EQ 5MG BASE A073099 001 Mar 28, 1997
EQ 25MG BASE A073101 001 Mar 28, 1997
XANODYNE PHARM EQ 5MG BASE N018459 001 Jan 30, 1986
EQ 10MG BASE A071962 001 Nov 19, 1987
EQ 15MG BASE A071104 001 Mar 04, 1987
WELLCOVORIN
GLAXOSMITHKLINE EQ 5MG BASE N018342 001 Jul 08, 1983
EQ 25MG BASE N018342 002 Jul 08, 1983

LEUPROLIDE ACETATE
IMPLANT; IMPLANTATION
VIADUR
ORTHO MCNEIL JANSSEN EQ 65MG BASE N021088 001 Mar 03, 2000
INJECTABLE; INJECTION
LUPRON DEPOT-PED
ABBOTT LABS 3.75MG/VIAL,7.5MG/VIAL N020263 003 Apr 16, 1993
7.5MG/VIAL,7.5MG/VIAL N020263 004 Apr 16, 1993

LEVALLORPHAN TARTRATE
INJECTABLE; INJECTION
LORFAN
ROCHE 1MG/ML N010423 001

LEVAMISOLE HYDROCHLORIDE
TABLET; ORAL
ERGAMISOL
JANSSEN PHARMA EQ 50MG BASE N020035 001 Jun 18, 1990
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 190 (of 324)

LEVETIRACETAM
TABLET; ORAL
LEVETIRACETAM
MYLAN 250MG A078731 001 Feb 10, 2009
500MG A078731 002 Feb 10, 2009
750MG A078731 003 Feb 10, 2009
1GM A078731 004 Feb 10, 2009
WATSON LABS FLORIDA 250MG A077408 001 Mar 02, 2009
500MG A077408 002 Mar 02, 2009
750MG A077408 003 Mar 02, 2009

LEVOBETAXOLOL HYDROCHLORIDE
SUSPENSION/DROPS; OPHTHALMIC
BETAXON
ALCON EQ 0.5% BASE N021114 001 Feb 23, 2000

LEVOBUPIVACAINE HYDROCHLORIDE
INJECTABLE; INJECTION
CHIROCAINE
PURDUE PHARMA LP EQ 2.5MG BASE/ML N020997 001 Aug 05, 1999
EQ 5MG BASE/ML N020997 002 Aug 05, 1999
EQ 7.5MG BASE/ML N020997 003 Aug 05, 1999

LEVOCABASTINE HYDROCHLORIDE
SUSPENSION/DROPS; OPHTHALMIC
LIVOSTIN
NOVARTIS EQ 0.05% BASE N020219 001 Nov 10, 1993

LEVOCARNITINE
SOLUTION; ORAL
CARNITOR
SIGMA TAU 1GM/10ML N018948 002 Apr 27, 1988

LEVODOPA
CAPSULE; ORAL
BENDOPA
VALEANT PHARM INTL 100MG N016948 003
250MG N016948 001
500MG N016948 002
DOPAR
SHIRE 100MG N016913 003
250MG N016913 001
500MG N016913 002
LARODOPA
ROCHE 100MG N016912 002
250MG N016912 001
500MG N016912 006
TABLET; ORAL
DOPAR
SHIRE 250MG N016913 004
500MG N016913 005
LARODOPA
ROCHE 100MG N016912 005
250MG N016912 003
500MG N016912 004

LEVOMEPROMAZINE
INJECTABLE; INJECTION
LEVOPROME
IMMUNEX 20MG/ML N015865 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 191 (of 324)

LEVOMETHADYL ACETATE HYDROCHLORIDE


CONCENTRATE; ORAL
ORLAAM
ROXANE 10MG/ML N020315 001 Jul 09, 1993

LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE


INJECTABLE; INJECTION
ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN
SOLVAY 0.05MG/ML;2% A085010 001
CARBOCAINE W/ NEO-COBEFRIN
EASTMAN KODAK 0.05MG/ML;2% N012125 002
MEPIVACAINE HYDROCHLORIDE W/ LEVONORDEFRIN
GRAHAM CHEM 0.05MG/ML;2% A084850 002 Oct 21, 1983
POLOCAINE W/ LEVONORDEFRIN
DENTSPLY PHARM 0.05MG/ML;2% A089517 001 Apr 14, 1988

LEVONORDEFRIN; PROCAINE HYDROCHLORIDE; PROPOXYCAINE HYDROCHLORIDE


INJECTABLE; INJECTION
RAVOCAINE AND NOVOCAIN W/ NEO-COBEFRIN
EASTMAN KODAK 0.05MG/ML;2%;0.4% N008592 007

LEVONORGESTREL
IMPLANT; IMPLANTATION
LEVONORGESTREL
WYETH PHARMS INC 75MG/IMPLANT N020627 001 Aug 15, 1996
NORPLANT
POPULATION COUNCIL 36MG/IMPLANT N019897 001 Dec 10, 1990
NORPLANT II
POPULATION COUNCIL 75MG/IMPLANT N020544 001 Nov 01, 1996
NORPLANT SYSTEM IN PLASTIC CONTAINER
WYETH PHARMS INC 36MG/IMPLANT N020088 001 Dec 10, 1990
TABLET; ORAL
PLAN B
DURAMED 0.75MG N021045 001 Jul 28, 1999

LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS


CAPSULE; ORAL
NOVRAD
LILLY EQ 50MG BASE N012928 006
EQ 100MG BASE N012928 004
SUSPENSION; ORAL
NOVRAD
LILLY EQ 50MG BASE/5ML N012928 002

LEVORPHANOL TARTRATE
INJECTABLE; INJECTION
LEVO-DROMORAN
VALEANT PHARM INTL 2MG/ML N008719 001 Dec 19, 1991

LEVOTHYROXINE SODIUM**
CAPSULE; ORAL
TIROSINT
INST BIOCHIMIQUE 0.013MG N022121 001 Aug 01, 2007
0.025MG N021924 002 Oct 13, 2006
0.05MG N021924 003 Oct 13, 2006
0.075MG N021924 004 Oct 13, 2006
0.1MG N021924 005 Oct 13, 2006
0.125MG N021924 006 Oct 13, 2006
0.15MG N021924 007 Oct 13, 2006
TABLET; ORAL
LEVOLET
VINTAGE 0.025MG N021137 001 Jun 06, 2003
0.05MG N021137 002 Jun 06, 2003
0.075MG N021137 003 Jun 06, 2003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 192 (of 324)

LEVOTHYROXINE SODIUM**
TABLET; ORAL
LEVOLET
VINTAGE 0.088MG N021137 004 Jun 06, 2003
0.1MG N021137 005 Jun 06, 2003
0.112MG N021137 006 Jun 06, 2003
0.125MG N021137 007 Jun 06, 2003
0.137MG N021137 008 Jun 06, 2003
0.15MG N021137 009 Jun 06, 2003
0.175MG N021137 010 Jun 06, 2003
0.2MG N021137 011 Jun 06, 2003
0.3MG N021137 012 Jun 06, 2003
LEVOXYL
--> KING PHARMS --> 0.3MG N021301 012 May 25, 2001
NOVOTHYROX
MERCK KGAA 0.025MG N021292 001 May 31, 2002
0.05MG N021292 002 May 31, 2002
0.075MG N021292 003 May 31, 2002
0.088MG N021292 004 May 31, 2002
0.1MG N021292 005 May 31, 2002
0.112MG N021292 006 May 31, 2002
0.125MG N021292 007 May 31, 2002
0.137MG N021292 008 May 31, 2002
0.15MG N021292 009 May 31, 2002
0.175MG N021292 010 May 31, 2002
0.2MG N021292 011 May 31, 2002
0.3MG N021292 012 May 31, 2002

LIDOCAINE
AEROSOL; ORAL
XYLOCAINE
ASTRAZENECA 10% N014394 001
FILM, EXTENDED RELEASE; BUCCAL
DENTIPATCH
NOVEN 23MG/PATCH N020575 001 May 21, 1996
OINTMENT; TOPICAL
ALPHACAINE
CARLISLE 5% A084944 001
5% A084946 001
5% A084947 001
LIDOCAINE
GRAHAM CHEM 5% A080210 001
XYLOCAINE
ASTRAZENECA 5% N008048 001
PATCH; TOPICAL
DENTIPATCH
NOVEN 46.1MG/PATCH N020575 002 May 21, 1996
SOLUTION; TOPICAL
XYLOCAINE
ASTRAZENECA 5% N014127 001
SUPPOSITORY; RECTAL
XYLOCAINE
ASTRAZENECA 100MG N013077 001

LIDOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
ALPHACAINE HYDROCHLORIDE
CARLISLE 2% A084721 001
LIDOCAINE HYDROCHLORIDE
ABBOTT 10% A087980 001 Feb 02, 1983
20% A089362 001 May 25, 1988
ABRAXIS PHARM 1% A080390 001
1% A080420 001
1% A086761 001
1.5% A080420 005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 193 (of 324)

LIDOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
LIDOCAINE HYDROCHLORIDE
ABRAXIS PHARM 2% A080390 002
2% A080420 002
2% A080420 004
2% A086761 002
2% N017508 001
4% N017508 002
20% N017508 004
AKORN 1% A085037 001
2% A085037 002
BAXTER HLTHCARE 1% A080407 001
2% A080407 002
BEL MAR 1% A080710 001
2% A080760 001
DELL LABS 1% A083387 001
2% A083388 001
ELKINS SINN 0.5% A085131 001
4% A084626 001
GD SEARLE LLC 1% A083135 001
2% A083135 002
GRAHAM CHEM 2% A080504 001
HOSPIRA 1.5% A088330 001 May 17, 1984
2% A088331 001 May 17, 1984
INTL MEDICATION 1% N017701 002
2% N017701 001
1GM/VIAL N018543 001
2GM/VIAL N018543 002
MILES 1% A080414 001
2% A080414 002
WATSON LABS 1% A080377 001
1% A083627 001
2% A080377 002
2% A083627 002
WYETH AYERST 1% A083083 001
2% A083083 002
LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 100MG/100ML N018461 001
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 200MG/100ML N018967 001 Mar 30, 1984
LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%
HOSPIRA 200MG/100ML A083158 005
LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTT 200MG/100ML N018954 001 Jul 09, 1985
HOSPIRA 200MG/100ML N018388 001
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 400MG/100ML N018967 002 Mar 30, 1984
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%
HOSPIRA 400MG/100ML A083158 006
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 800MG/100ML N018967 003 Mar 30, 1984
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
HOSPIRA 1.5% A088326 001 Jul 31, 1984
10% A088367 001 Jul 31, 1984
20% A088368 001 Jul 31, 1984
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
BAXTER HLTHCARE 1% A084625 001
2% A084625 002
INTL MEDICATION 4% N017702 002
LIDOCATON
PHARMATON 2% A084727 001 Aug 17, 1983
XYLOCAINE
ASTRAZENECA 1% N010418 005
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DISCONTINUED DRUG PRODUCT LIST 6 - 194 (of 324)

LIDOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
XYLOCAINE
ASTRAZENECA 1.5% N010418 009
2% N010418 007
INJECTABLE; SPINAL
XYLOCAINE 1.5% W/ DEXTROSE 7.5%
APP PHARMS 1.5% N016297 001
XYLOCAINE 5% W/ GLUCOSE 7.5%
ASTRAZENECA 5% N010496 002 Jul 07, 1982
SOLUTION; ORAL
LIDOCAINE HYDROCHLORIDE VISCOUS
INTL MEDICATION 2% A086389 001 Feb 02, 1982
SOLUTION; TOPICAL
LARYNGOTRACHEAL ANESTHESIA KIT
KENDALL IL 4% A087931 001 Jun 10, 1983
LIDOCAINE HYDROCHLORIDE
PACO 4% A089688 001 Jun 30, 1989
LTA II KIT
HOSPIRA 4% A088542 001 Jul 31, 1984
PEDIATRIC LTA KIT
ABBOTT 2% A088572 001 Jul 31, 1984
SYSTEM; INTRADERMAL
ZINGO
ANESIVA 0.5MG N022114 001 Aug 16, 2007

LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE


INJECTABLE; INJECTION
TERRAMYCIN
PFIZER 2%;50MG/ML A060567 001
2%;125MG/ML A060567 002

LIDOCAINE; PRILOCAINE
DISC; TOPICAL
EMLA
ASTRAZENECA 2.5%;2.5% N020962 001 Feb 04, 1998

LINCOMYCIN HYDROCHLORIDE
CAPSULE; ORAL
LINCOCIN
PHARMACIA AND UPJOHN EQ 250MG BASE N050316 001
EQ 500MG BASE N050316 002
INJECTABLE; INJECTION
LINCOMYCIN HYDROCHLORIDE
WATSON LABS EQ 300MG BASE/ML A063180 001 Apr 16, 1991

LINDANE
CREAM; TOPICAL
KWELL
REED AND CARNRICK 1% A084218 001
1% N006309 001
LOTION; TOPICAL
GAMENE
SOLA BARNES HIND 1% A084989 001
KWELL
REED AND CARNRICK 1% A084218 002
1% N006309 003
LINDANE
OLTA PHARMS 1% A087313 001
SCABENE
STIEFEL 1% A086769 001
SHAMPOO; TOPICAL
GAMENE
SOLA BARNES HIND 1% A084988 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 195 (of 324)

LINDANE
SHAMPOO; TOPICAL
KWELL
REED AND CARNRICK 1% A084219 001
1% N010718 001
SCABENE
STIEFEL 1% A087940 001 Apr 08, 1983

LINEZOLID
TABLET; ORAL
ZYVOX
PHARMACIA AND UPJOHN 400MG N021130 001 Apr 18, 2000

LIOTHYRONINE SODIUM
TABLET; ORAL
LIOTHYRONINE SODIUM
WATSON LABS EQ 0.025MG BASE A085755 001 Jan 25, 1982
EQ 0.05MG BASE A085753 001 Feb 03, 1982

LIOTRIX (T4;T3)
TABLET; ORAL
EUTHROID-0.5
PARKE DAVIS 0.03MG;0.0075MG N016680 001
EUTHROID-1
PARKE DAVIS 0.06MG;0.015MG N016680 002
EUTHROID-2
PARKE DAVIS 0.12MG;0.03MG N016680 003
EUTHROID-3
PARKE DAVIS 0.18MG;0.045MG N016680 004
THYROLAR-5
FOREST LABS 0.25MG;0.0625MG N016807 006

LISINOPRIL
TABLET; ORAL
PRINIVIL
MERCK 2.5MG N019558 006 Jan 28, 1994

LITHIUM CARBONATE
CAPSULE; ORAL
LITHIUM CARBONATE
ABLE 150MG A076823 001 Jun 29, 2004
300MG A076121 001 Sep 27, 2001
300MG A076823 002 Jun 29, 2004
600MG A076823 003 Jun 29, 2004
USL PHARMA 300MG A072542 001 Feb 01, 1989
WATSON LABS 300MG A070407 001 Mar 19, 1987
LITHONATE
SOLVAY 300MG N016782 001
TABLET; ORAL
ESKALITH
JDS PHARMS 300MG N017971 001
LITHANE
BAYER PHARMS 300MG N018833 001 Jul 18, 1985
LITHIUM CARBONATE
PFIZER 300MG N016834 001
LITHOTABS
SOLVAY 300MG N016980 001
TABLET, EXTENDED RELEASE; ORAL
ESKALITH CR
JDS PHARMS 450MG N018152 001 Mar 29, 1982
LITHIUM CARBONATE
ABLE 300MG A076382 001 Apr 21, 2003
BARR 300MG A076170 001 Jun 10, 2002
450MG A076366 001 Aug 21, 2003
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DISCONTINUED DRUG PRODUCT LIST 6 - 196 (of 324)

LITHIUM CITRATE
SYRUP; ORAL
LITHONATE
SOLVAY EQ 300MG CARBONATE/5ML N017672 001

LOMEFLOXACIN HYDROCHLORIDE
TABLET; ORAL
MAXAQUIN
PHARMACIA EQ 400MG BASE N020013 001 Feb 21, 1992

LOPERAMIDE HYDROCHLORIDE
CAPSULE; ORAL
IMODIUM
MCNEIL PED 2MG N017690 001
LOPERAMIDE HYDROCHLORIDE
ROXANE 2MG A073080 001 Nov 27, 1991
SANDOZ 2MG A072993 001 Aug 28, 1992
TEVA 2MG A073122 001 Aug 30, 1991
SOLUTION; ORAL
IMODIUM
JANSSEN PHARMA 1MG/5ML N019037 001 Jul 31, 1984
LOPERAMIDE HYDROCHLORIDE
ALPHARMA US PHARMS 1MG/5ML A073187 001 Sep 15, 1992
DURAMED PHARMS BARR 1MG/5ML A074991 001 Dec 29, 1997
TEVA 1MG/5ML A073478 001 Jun 23, 1995
WATSON LABS 1MG/5ML A073062 001 May 28, 1993
TABLET; ORAL
LOPERAMIDE HYDROCHLORIDE
ABLE 2MG A073528 001 Nov 30, 1993
PERRIGO 2MG A074194 001 Oct 30, 1992

LORACARBEF
CAPSULE; ORAL
LORABID
KING PHARMS 200MG N050668 001 Dec 31, 1991
400MG N050668 002 Apr 05, 1996
FOR SUSPENSION; ORAL
LORABID
KING PHARMS 100MG/5ML N050667 001 Dec 31, 1991
200MG/5ML N050667 002 Dec 31, 1991

LORATADINE
SYRUP; ORAL
CLARITIN HIVES RELIEF
SCHERING PLOUGH 1MG/ML N020641 003 Nov 19, 2003
TABLET; ORAL
LORATADINE
PERRIGO 10MG N021512 001 Jun 24, 2004

LORATADINE; PSEUDOEPHEDRINE SULFATE


TABLET, EXTENDED RELEASE; ORAL
CLARITIN-D
SCHERING PLOUGH 5MG;120MG N019670 002 Nov 27, 2002

LORAZEPAM
INJECTABLE; INJECTION
LORAZEPAM
AKORN 2MG/ML A074974 001 Jul 23, 1998
BAXTER HLTHCARE 2MG/ML A074496 001 Sep 28, 1998
4MG/ML A074496 002 Sep 28, 1998
DAVA PHARMS INC 2MG/ML A074793 001 Mar 16, 2000
4MG/ML A074793 002 Mar 16, 2000
HOSPIRA 2MG/ML A074280 001 May 27, 1994
4MG/ML A074280 002 May 27, 1994
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 197 (of 324)

LORAZEPAM
INJECTABLE; INJECTION
LORAZEPAM
HOSPIRA 4MG/ML A074300 003 Mar 19, 1997
MARSAM PHARMS LLC 1MG/0.5ML A074551 003 Sep 12, 1996
2MG/ML A074535 001 Sep 12, 1996
2MG/ML A074551 001 Sep 12, 1996
4MG/ML A074535 002 Sep 12, 1996
4MG/ML A074551 002 Sep 12, 1996
TAYLOR 2MG/ML A075025 001 Jul 23, 1998
SOLUTION; ORAL
LORAZEPAM
ROXANE 0.5MG/5ML A074648 001 Mar 18, 1997
TABLET; ORAL
LORAZ
QUANTUM PHARMICS 0.5MG A070200 001 Aug 09, 1985
1MG A070201 001 Aug 09, 1985
2MG A070202 001 Aug 09, 1985
LORAZEPAM
AM THERAP 0.5MG A070727 001 Mar 07, 1986
1MG A070728 001 Mar 07, 1986
2MG A070729 001 Mar 07, 1986
HALSEY 0.5MG A071434 001 Sep 01, 1987
1MG A071435 001 Sep 01, 1987
2MG A071436 001 Sep 01, 1987
MUTUAL PHARM 0.5MG A070472 001 Dec 10, 1985
1MG A070473 001 Dec 10, 1985
2MG A070474 001 Dec 10, 1985
PAR PHARM 0.5MG A070675 001 Dec 01, 1986
1MG A070676 001 Dec 01, 1986
2MG A070677 001 Dec 01, 1986
SUPERPHARM 0.5MG A071245 001 Feb 09, 1987
1MG A071246 001 Feb 09, 1987
2MG A071247 001 Feb 09, 1987
USL PHARMA 1MG A070539 001 Dec 22, 1986
2MG A070540 001 Dec 22, 1986
WARNER CHILCOTT 1MG A071038 001 Jan 12, 1988
2MG A071039 001 Jan 12, 1988
WATSON LABS 0.5MG A071086 001 Mar 23, 1987
0.5MG A071117 001 Jul 24, 1986
1MG A071087 001 Mar 23, 1987
2MG A071088 001 Mar 23, 1987
2MG A071110 001 Jul 24, 1986

LOTEPREDNOL ETABONATE
SUSPENSION/DROPS; OPHTHALMIC
LOTEMAX
PHARMOS 0.5% N020841 001 Mar 09, 1998

LOVASTATIN
TABLET; ORAL
MEVACOR
MERCK 10MG N019643 002 Mar 28, 1991
TABLET, EXTENDED RELEASE; ORAL
ALTOPREV
ANDRX LABS LLC 10MG N021316 001 Jun 26, 2002

LOXAPINE HYDROCHLORIDE
CONCENTRATE; ORAL

LOXITANE C

WATSON LABS EQ 25MG BASE/ML N017658 001


INJECTABLE; INJECTION

LOXITANE IM

WATSON LABS EQ 50MG BASE/ML N018039 001


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 198 (of 324)

LOXAPINE SUCCINATE
CAPSULE; ORAL

LOXAPINE SUCCINATE

ACTAVIS TOTOWA EQ 5MG BASE A076868 001 Aug 04, 2005


EQ 10MG BASE A076868 002 Aug 04, 2005
EQ 25MG BASE A076868 003 Aug 04, 2005
EQ 50MG BASE A076868 004 Aug 04, 2005
LOXITANE
WATSON LABS EQ 5MG BASE N017525 001

EQ 10MG BASE N017525 002


EQ 25MG BASE N017525 003


EQ 50MG BASE N017525 004


TABLET; ORAL

LOXITANE

WATSON LABS EQ 10MG BASE N017525 006


EQ 25MG BASE N017525 007


EQ 50MG BASE N017525 008


LYPRESSIN
SOLUTION; NASAL

DIAPID

NOVARTIS 0.185MG/ML N016755 001


MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM


ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE; INJECTION
ISOLYTE S PH 7.4 IN PLASTIC CONTAINER
B BRAUN 30MG/100ML;37MG/100ML;0.82MG/100ML;370M N019006 001 Apr 04, 1984
G/100ML;530MG/100ML;500MG/100ML;12MG/10
0ML

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM


GLUCONATE
INJECTABLE; INJECTION
ISOLYTE S IN PLASTIC CONTAINER
B BRAUN 30MG/100ML;37MG/100ML;370MG/100ML;530MG N018252 001
/100ML;500MG/100ML
SOLUTION; IRRIGATION
PHYSIOSOL IN PLASTIC CONTAINER
HOSPIRA 14MG/100ML;37MG/100ML;222MG/100ML;526MG N018406 001
/100ML;502MG/100ML
SYNOVALYTE IN PLASTIC CONTAINER
BAXTER HLTHCARE 30MG/100ML;37MG/100ML;368MG/100ML;526MG N019326 001 Jan 25, 1985
/100ML;502MG/100ML

MANGAFODIPIR TRISODIUM
INJECTABLE; INJECTION
TESLASCAN
GE HEALTHCARE 37.9MG/ML N020652 001 Nov 26, 1997

MANGANESE CHLORIDE TETRAHYDRATE


FOR SOLUTION; ORAL
LUMENHANCE
BRACCO 3.49MG/GM N020686 001 Dec 19, 1997

MANGANESE SULFATE
INJECTABLE; INJECTION
MANGANESE SULFATE
ABRAXIS PHARM EQ 0.1MG MANGANESE/ML N019228 001 May 05, 1987

MANNITOL
INJECTABLE; INJECTION
MANNITOL 10%

HOSPIRA 10GM/100ML N016269 002

MILES 10GM/100ML N016472 002

30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 199 (of 324)

MANNITOL
INJECTABLE; INJECTION
MANNITOL 15%
HOSPIRA 15GM/100ML N016269 003
MILES 15GM/100ML N016472 005
MANNITOL 20%
HOSPIRA 20GM/100ML N016269 004
MILES 20GM/100ML N016472 004
MANNITOL 25%
ABRAXIS PHARM 12.5GM/50ML A086754 001
ASTRAZENECA 12.5GM/50ML A089239 001 May 06, 1987
12.5GM/50ML A089240 001 May 06, 1987
HOSPIRA 12.5GM/50ML N016269 005
MERCK 12.5GM/50ML N005620 001
WATSON LABS 12.5GM/50ML A087460 001 Jun 27, 1983
MANNITOL 5%
HOSPIRA 5GM/100ML N016269 001
SOLUTION; IRRIGATION
RESECTISOL
B BRAUN 5GM/100ML N016704 002

MANNITOL; SORBITOL
SOLUTION; IRRIGATION
SORBITOL-MANNITOL
HOSPIRA 540MG/100ML;2.7GM/100ML A080224 001
SORBITOL-MANNITOL IN PLASTIC CONTAINER
HOSPIRA 540MG/100ML;2.7GM/100ML N017636 001

MAPROTILINE HYDROCHLORIDE
TABLET; ORAL
LUDIOMIL
NOVARTIS 25MG N017543 001
50MG N017543 002
75MG N017543 003 Sep 30, 1982
MAPROTILINE HYDROCHLORIDE
AM THERAP 25MG A072129 001 Jan 14, 1988
50MG A072130 001 Jan 14, 1988
75MG A072131 001 Jan 14, 1988
WATSON LABS 25MG A071943 001 Dec 30, 1987
25MG A072162 001 Jun 01, 1988
50MG A071944 001 Dec 30, 1987
50MG A072163 001 Jun 01, 1988
75MG A071945 001 Dec 30, 1987
75MG A072164 001 Jun 01, 1988

MASOPROCOL
CREAM; TOPICAL
ACTINEX
UNIV AZ CANCER CTR 10% N019940 001 Sep 04, 1992

MAZINDOL
TABLET; ORAL
MAZANOR
WYETH AYERST 1MG N017980 002
2MG N017980 001
SANOREX
NOVARTIS 1MG N017247 001
2MG N017247 002

MEBENDAZOLE
TABLET, CHEWABLE; ORAL
VERMOX
MCNEIL PED 100MG N017481 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 200 (of 324)

MEBUTAMATE
TABLET; ORAL
DORMATE
MEDPOINTE PHARM HLC 600MG N017374 001

MECAMYLAMINE HYDROCHLORIDE
TABLET; ORAL
INVERSINE
TARGACEPT 2.5MG N010251 001

MECASERMIN RINFABATE RECOMBINANT


INJECTABLE; SUBCUTANEOUS
IPLEX
INSMED 36MG/0.6ML N021884 001 Dec 12, 2005

MECLIZINE HYDROCHLORIDE
TABLET; ORAL
ANTIVERT
PFIZER 50MG N010721 001 Jan 20, 1982
MECLIZINE HYDROCHLORIDE
ABC HOLDING 12.5MG A085253 001
25MG A085252 001
ANABOLIC 25MG A085891 001
BUNDY 12.5MG A084382 001
25MG A084872 001
IVAX SUB TEVA PHARMS 12.5MG A083784 001
12.5MG A084975 001
25MG A084657 001
KV PHARM 12.5MG A085524 001
25MG A085523 001
PLIVA 12.5MG A088732 001 Dec 11, 1985
25MG A088734 001 Dec 11, 1985
SUPERPHARM 12.5MG A089113 001 Aug 20, 1985
25MG A089114 001 Aug 20, 1985
UDL 12.5MG A088256 001 Jun 13, 1983
25MG A088257 001 Jun 13, 1983
VANGARD 12.5MG A087877 001 Apr 20, 1982
25MG A087620 001 Jan 04, 1982
WATSON LABS 12.5MG A085195 001
12.5MG A085269 001
TABLET, CHEWABLE; ORAL
ANTIVERT
PFIZER 25MG N010721 005
MECLIZINE HYDROCHLORIDE
IVAX SUB TEVA PHARMS 25MG A084976 001
NEXGEN PHARMA INC 25MG A086392 001
PLIVA 25MG A088733 001 Dec 11, 1985

MECLOCYCLINE SULFOSALICYLATE
CREAM; TOPICAL
MECLAN
JOHNSON AND JOHNSON 1% N050518 001

MECLOFENAMATE SODIUM
CAPSULE; ORAL
MECLODIUM
QUANTUM PHARMICS EQ 50MG BASE A071380 001 Jul 14, 1987
EQ 100MG BASE A071381 001 Jul 14, 1987
MECLOFENAMATE SODIUM
AM THERAP EQ 50MG BASE A071362 001 Feb 10, 1987
EQ 100MG BASE A071363 001 Feb 10, 1987
BARR EQ 50MG BASE A072848 001 Mar 20, 1989
EQ 100MG BASE A072809 001 Mar 20, 1989
PAR PHARM EQ 50MG BASE A072077 001 Mar 10, 1988
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 201 (of 324)

MECLOFENAMATE SODIUM
CAPSULE; ORAL
MECLOFENAMATE SODIUM
PAR PHARM EQ 100MG BASE A072078 001 Mar 10, 1988
SANDOZ EQ 50MG BASE A072262 001 Nov 29, 1988
EQ 100MG BASE A072263 001 Nov 29, 1988
USL PHARMA EQ 50MG BASE A071007 001 Mar 25, 1988
EQ 100MG BASE A071008 001 Mar 25, 1988
VITARINE EQ 50MG BASE A071710 001 Jun 15, 1988
EQ 100MG BASE A071684 001 Jun 15, 1988
WATSON LABS EQ 50MG BASE A070400 001 Nov 25, 1986
EQ 50MG BASE A071640 001 Aug 11, 1987
EQ 100MG BASE A070401 001 Nov 25, 1986
EQ 100MG BASE A071641 001 Aug 11, 1987
MECLOMEN
PARKE DAVIS EQ 50MG BASE N018006 001
EQ 100MG BASE N018006 002

MEDROXYPROGESTERONE ACETATE
INJECTABLE; INJECTION
DEPO-PROVERA
PHARMACIA AND UPJOHN 100MG/ML N012541 002
TABLET; ORAL
AMEN
AMARIN PHARMS 10MG A083242 001
CURRETAB
SOLVAY 10MG A085686 001
CYCRIN
ESI 2.5MG A081239 001 Oct 30, 1992
5MG A081240 001 Oct 30, 1992
10MG A089386 001 Sep 09, 1987
MEDROXYPROGESTERONE ACETATE
DURAMED PHARMS BARR 2.5MG A040311 001 Dec 01, 1999
5MG A040311 002 Dec 01, 1999
10MG A040311 003 Dec 01, 1999

MEDRYSONE
SUSPENSION; OPHTHALMIC
HMS
ALLERGAN 1% N016624 003

MEFLOQUINE HYDROCHLORIDE
TABLET; ORAL
LARIAM
ROCHE 250MG N019591 001 May 02, 1989
MEFLOQUINE HYDROCHLORIDE
US ARMY WALTER REED 250MG N019578 001 May 02, 1989

MEGESTROL ACETATE
TABLET; ORAL
MEGESTROL ACETATE
TEVA 40MG A074745 001 Feb 27, 1998
USL PHARMA 20MG A070646 001 Oct 02, 1987
40MG A070647 001 Oct 02, 1987

MELOXICAM
TABLET; ORAL
MELOXICAM
MUTUAL PHARM 7.5MG A077935 001 Jul 19, 2006
15MG A077935 002 Jul 19, 2006
ROXANE 7.5MG A077925 001 Jul 19, 2006
15MG A077925 002 Jul 19, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 202 (of 324)

MENADIOL SODIUM DIPHOSPHATE


INJECTABLE; INJECTION
KAPPADIONE
LILLY 10MG/ML N005725 001
SYNKAYVITE
ROCHE 5MG/ML N003718 004
10MG/ML N003718 006
37.5MG/ML N003718 008
TABLET; ORAL
SYNKAYVITE
ROCHE 5MG N003718 010

MENADIONE
TABLET; ORAL
MENADIONE
LILLY 5MG N002139 003

MENOTROPINS (FSH;LH)
INJECTABLE; INJECTION
HUMEGON
ORGANON USA INC 75 IU/VIAL;75 IU/VIAL N020328 001 Sep 01, 1994
150 IU/VIAL;150 IU/VIAL N020328 002 Sep 01, 1994
MENOTROPINS
FERRING 75 IU/VIAL;75 IU/VIAL A073598 001 Jan 30, 1997
150 IU/VIAL;150 IU/VIAL A073599 001 Jan 30, 1997
PERGONAL
SERONO 75 IU/AMP;75 IU/AMP N017646 001
150 IU/AMP;150 IU/AMP N017646 002 May 20, 1985
REPRONEX
FERRING 150 IU/VIAL;150 IU/VIAL N021047 002 Aug 27, 1999

MEPENZOLATE BROMIDE
SOLUTION; ORAL
CANTIL
SANOFI AVENTIS US 25MG/5ML N010679 004

MEPERIDINE HYDROCHLORIDE
INJECTABLE; INJECTION
DEMEROL
SANOFI AVENTIS US 25MG/ML N005010 007
50MG/ML N005010 002
75MG/ML N005010 009
100MG/ML N005010 003
MEPERIDINE HYDROCHLORIDE
ABBOTT 25MG/ML A080388 001
50MG/ML A080385 001
50MG/ML A080387 001
75MG/ML A080389 001
100MG/ML A080386 001
ASTRAZENECA 25MG/ML A089781 001 Mar 31, 1989
50MG/ML A089782 001 Mar 31, 1989
50MG/ML A089783 001 Mar 31, 1989
50MG/ML A089784 001 Mar 31, 1989
75MG/ML A089785 001 Mar 31, 1989
100MG/ML A089786 001 Mar 31, 1989
100MG/ML A089787 001 Mar 31, 1989
100MG/ML A089788 001 Mar 31, 1989
BAXTER HLTHCARE 25MG/ML A088279 001 Jun 15, 1984
50MG/ML A088280 001 Jun 15, 1984
75MG/ML A088281 001 Jun 15, 1984
100MG/ML A088282 001 Jun 15, 1984
INTL MEDICATION 10MG/ML A086332 001
PARKE DAVIS 50MG/ML A080364 002
75MG/ML A080364 003
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DISCONTINUED DRUG PRODUCT LIST 6 - 203 (of 324)

MEPERIDINE HYDROCHLORIDE
INJECTABLE; INJECTION
MEPERIDINE HYDROCHLORIDE
PARKE DAVIS 100MG/ML A080364 001
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
HOSPIRA 10MG/ML A040305 001 Mar 10, 1999
MALLINCKRODT 10MG/ML A040163 001 May 12, 1997
TABLET; ORAL
MEPERIDINE HYDROCHLORIDE
DURAMED PHARMS BARR 50MG A040318 001 Oct 05, 1999
100MG A040318 002 Oct 05, 1999
MUTUAL PHARM 50MG A080448 001
100MG A080448 002
WYETH AYERST 50MG A080454 001

MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE


INJECTABLE; INJECTION
MEPERGAN
BAXTER HLTHCARE CORP 25MG/ML;25MG/ML N011730 001

MEPHENTERMINE SULFATE
INJECTABLE; INJECTION
WYAMINE SULFATE
BAXTER HLTHCARE CORP EQ 15MG BASE/ML N008248 002
EQ 30MG BASE/ML N008248 001

MEPHENYTOIN
TABLET; ORAL
MESANTOIN
NOVARTIS 100MG N006008 001

MEPIVACAINE HYDROCHLORIDE
INJECTABLE; INJECTION
ARESTOCAINE HYDROCHLORIDE
SOLVAY 3% A084777 002 Apr 18, 1982
CARBOCAINE
EASTMAN KODAK 3% N012125 003
MEPIVACAINE HYDROCHLORIDE
GRAHAM CHEM 3% A083559 001
INTL MEDICATION 1% A087509 001 Oct 05, 1982

MEPREDNISONE
TABLET; ORAL
BETAPAR
SCHERING 4MG N016053 002

MEPROBAMATE
CAPSULE; ORAL
EQUANIL
WYETH AYERST 400MG N012455 002
CAPSULE, EXTENDED RELEASE; ORAL
MEPROSPAN
MEDPOINTE PHARM HLC 200MG N011284 001
400MG N011284 002
TABLET; ORAL
AMOSENE
FERNDALE LABS 400MG A084030 001
BAMATE
ALRA 200MG A080380 001
400MG A080380 002
EQUANIL
WYETH AYERST 200MG N010028 005
400MG N010028 004
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DISCONTINUED DRUG PRODUCT LIST 6 - 204 (of 324)

MEPROBAMATE
TABLET; ORAL
MEPRIAM
TEVA 400MG N016069 001
MEPROBAMATE
BARR 600MG A084230 001
ELKINS SINN 200MG N015426 002
400MG N015426 001
HEATHER 400MG N016928 003
600MG A084329 001
IMPAX LABS 200MG N014322 002
400MG N014322 001
IVAX SUB TEVA PHARMS 200MG N015438 001
400MG N015438 002
600MG A084181 001
IVC INDS 400MG A084153 001
LANNETT 200MG N014882 002
400MG N014882 001
LEDERLE 400MG A086299 001
LEE KM 400MG A089538 001 Nov 25, 1987
MALLARD 400MG N015072 002
MK LABS 200MG N014368 004
400MG N014368 002
MUTUAL PHARM 200MG A080699 001
400MG A080699 002
MYLAN 400MG A083618 001
NEXGEN PHARMA INC 200MG A084220 001
400MG A084589 001
PARKE DAVIS 200MG A084744 001
400MG A084744 002
PERRIGO 200MG A084546 001
400MG A084547 001
PHARMAVITE 400MG A084438 001
PUREPAC PHARM 200MG A084804 001
400MG A084804 002
PVT FORM 400MG N014601 001
ROXANE 600MG A084332 001
SANDOZ 200MG N014547 002
400MG A080655 001
400MG N014547 001
SCHERER LABS 400MG A083343 001
SOLVAY 200MG A084435 001
STANLABS PHARM 200MG N014474 002
400MG N014474 004
TABLICAPS 400MG A083494 001
USL PHARMA 200MG A087825 001 Mar 18, 1982
400MG A087826 001 Mar 18, 1982
VALEANT PHARM INTL 200MG N015139 006
400MG N015139 005
VANGARD 400MG A088011 001 Jul 14, 1982
WATSON LABS 200MG A085720 001
400MG A085721 001
600MG A084274 001
600MG A085719 001
WEST WARD 200MG N015417 003
400MG N015417 002
WHITEWORTH TOWN PLSN 200MG A083830 001
400MG A083442 001
MILTOWN
MEDPOINTE PHARM HLC 200MG N009698 004
400MG N009698 002
600MG A083919 001
NEURAMATE
HALSEY 200MG N014359 002
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DISCONTINUED DRUG PRODUCT LIST 6 - 205 (of 324)

MEPROBAMATE
TABLET; ORAL
NEURAMATE
HALSEY 400MG N014359 001
TRANMEP
SOLVAY 400MG A084369 001
400MG N016249 001

MERSALYL SODIUM; THEOPHYLLINE


INJECTABLE; INJECTION
MERSALYL-THEOPHYLLINE
WATSON LABS 100MG/ML;50MG/ML A084875 001

MESALAMINE
SUPPOSITORY; RECTAL
CANASA
AXCAN SCANDIPHARM 500MG N021252 001 Jan 05, 2001
ROWASA
ALAVEN PHARM 500MG N019919 001 Dec 18, 1990

MESORIDAZINE BESYLATE
CONCENTRATE; ORAL
SERENTIL
NOVARTIS EQ 25MG BASE/ML N016997 001
INJECTABLE; INJECTION
SERENTIL
NOVARTIS EQ 25MG BASE/ML N016775 001
TABLET; ORAL
SERENTIL
NOVARTIS EQ 10MG BASE N016774 001
EQ 25MG BASE N016774 002
EQ 50MG BASE N016774 003
EQ 100MG BASE N016774 004

MESTRANOL; NORETHINDRONE
TABLET; ORAL-20
NORINYL
WATSON LABS 0.1MG;2MG N013625 004
TABLET; ORAL-21
NORETHIN 1/50M-21
WATSON LABS 0.05MG;1MG A071539 001 Apr 12, 1988
NORETHINDRONE AND MESTRANOL
WATSON LABS 0.05MG;1MG A070758 001 Jul 01, 1988
NORINYL 1+50 21-DAY
WATSON LABS 0.05MG;1MG N013625 002
NORINYL 1+80 21-DAY
GD SEARLE LLC 0.08MG;1MG N016724 001
ORTHO-NOVUM 1/50 21
ORTHO MCNEIL PHARM 0.05MG;1MG N012728 004
ORTHO-NOVUM 1/80 21
ORTHO MCNEIL PHARM 0.08MG;1MG N016715 001
ORTHO-NOVUM 10-21
ORTHO MCNEIL PHARM 0.06MG;10MG N012728 001
ORTHO-NOVUM 2-21
ORTHO MCNEIL PHARM 0.1MG;2MG N012728 005
TABLET; ORAL-28
NORETHIN 1/50M-28
WATSON LABS 0.05MG;1MG A071540 001 Apr 12, 1988
NORETHINDRONE AND MESTRANOL
WATSON LABS 0.05MG;1MG A070759 001 Jul 01, 1988
NORINYL 1+80 28-DAY
GD SEARLE LLC 0.08MG;1MG N016725 001
ORTHO-NOVUM 1/50 28
ORTHO MCNEIL JANSSEN 0.05MG;1MG N016709 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 206 (of 324)

MESTRANOL; NORETHINDRONE
TABLET; ORAL-28
ORTHO-NOVUM 1/80 28
ORTHO MCNEIL PHARM 0.08MG;1MG N016715 002

MESTRANOL; NORETHYNODREL
TABLET; ORAL
ENOVID
GD SEARLE LLC 0.075MG;5MG N010976 008
0.15MG;9.85MG N010976 005
TABLET; ORAL-20
ENOVID
GD SEARLE LLC 0.075MG;5MG N010976 004
ENOVID-E
GD SEARLE LLC 0.1MG;2.5MG N010976 006
TABLET; ORAL-21
ENOVID-E 21
GD SEARLE LLC 0.1MG;2.5MG N010976 007

METAPROTERENOL SULFATE
AEROSOL, METERED; INHALATION
ALUPENT
BOEHRINGER INGELHEIM 0.65MG/INH N016402 001
SOLUTION; INHALATION
ALUPENT
BOEHRINGER INGELHEIM 0.4% N018761 002 Oct 10, 1986
0.6% N018761 001 Jun 30, 1983
5% N017659 001
METAPROTERENOL SULFATE
ASTRAZENECA 0.4% A071275 001 Jul 27, 1988
0.6% A071018 001 Jul 27, 1988
DEY 0.33% A071806 001 Aug 05, 1988
0.5% A071805 001 Aug 05, 1988
5% A070805 001 Aug 17, 1987
MORTON GROVE 5% A072190 001 Jun 07, 1988
PROMETA
MURO 5% A073340 001 Mar 30, 1992
SYRUP; ORAL
ALUPENT
BOEHRINGER INGELHEIM 10MG/5ML N017571 001
METAPROTERENOL SULFATE
MORTON GROVE 10MG/5ML A071656 001 Oct 13, 1987
10MG/5ML A074702 001 Mar 24, 1997
TEVA 10MG/5ML A072761 001 Feb 27, 1992
TEVA PHARMS 10MG/5ML A073034 001 Aug 30, 1991
PROMETA
MURO 10MG/5ML A072023 001 Sep 15, 1988
TABLET; ORAL
ALUPENT
BOEHRINGER INGELHEIM 10MG N015874 002
20MG N015874 001
METAPROTERENOL SULFATE
AM THERAP 10MG A072054 001 Jun 23, 1988
20MG A072055 001 Jun 23, 1988
TEVA 10MG A072519 001 Mar 30, 1990
20MG A072520 001 Mar 30, 1990
USL PHARMA 10MG A071013 001 Jan 25, 1988
20MG A071014 001 Jan 25, 1988

METARAMINOL BITARTRATE
INJECTABLE; INJECTION
ARAMINE
MERCK EQ 10MG BASE/ML N009509 002 Dec 22, 1987
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DISCONTINUED DRUG PRODUCT LIST 6 - 207 (of 324)

METARAMINOL BITARTRATE
INJECTABLE; INJECTION
METARAMINOL BITARTRATE
ABRAXIS PHARM EQ 10MG BASE/ML A080431 001
ELKINS SINN EQ 10MG BASE/ML A083363 001
GD SEARLE LLC EQ 10MG BASE/ML A086418 001
EQ 20MG BASE/ML A086418 002

METAXALONE
TABLET; ORAL
SKELAXIN
KING PHARMS 400MG N013217 001

METFORMIN HYDROCHLORIDE
TABLET; ORAL
GLUCOPHAGE
BRISTOL MYERS SQUIBB 625MG N020357 003 Nov 05, 1998
750MG N020357 004 Nov 05, 1998
METFORMIN HYDROCHLORIDE
BARR 500MG A075971 001 Jan 25, 2002
850MG A075971 002 Jan 25, 2002
1GM A075971 003 Jan 25, 2002
TEVA 500MG A076328 001 Dec 16, 2002
850MG A076328 002 Dec 16, 2002
1GM A076328 003 Dec 16, 2002
TABLET, EXTENDED RELEASE; ORAL
METFORMIN HYDROCHLORIDE
BARR 500MG A076496 001 Nov 25, 2005
MUTUAL PHARM 500MG A077124 001 Dec 21, 2005
SANDOZ 500MG A076223 001 Dec 14, 2004

METHACYCLINE HYDROCHLORIDE
CAPSULE; ORAL
RONDOMYCIN
MEDPOINTE PHARM HLC EQ 140MG BASE A060641 001
EQ 280MG BASE A060641 002
SYRUP; ORAL
RONDOMYCIN
MEDPOINTE PHARM HLC EQ 70MG BASE/5ML A060641 003

METHADONE HYDROCHLORIDE
SYRUP; ORAL
DOLOPHINE HYDROCHLORIDE
ROXANE 10MG/30ML N006134 004
TABLET; ORAL
METHADONE HYDROCHLORIDE
ROXANE 5MG A088108 001 Mar 08, 1983
10MG A088109 001 Mar 08, 1983
40MG A074081 001 Apr 28, 1995
SANDOZ 5MG A040241 001 May 29, 1998
TABLET, DISPERSIBLE; ORAL
WESTADONE
SANDOZ 2.5MG N017108 001
TABLET, EFFERVESCENT; ORAL
WESTADONE
SANDOZ 5MG N017108 002
10MG N017108 003
40MG N017108 004

METHAMPHETAMINE HYDROCHLORIDE
TABLET; ORAL
METHAMPEX
TEVA 10MG A083889 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 208 (of 324)

METHAMPHETAMINE HYDROCHLORIDE
TABLET; ORAL
METHAMPHETAMINE HYDROCHLORIDE
ABLE 5MG A040529 001 Feb 25, 2004
REXAR 5MG A084931 001
10MG A084931 002
TEVA 5MG A086359 001
TABLET, EXTENDED RELEASE; ORAL
DESOXYN
LUNDBECK INC 5MG N005378 004
10MG N005378 003
15MG N005378 005

METHANTHELINE BROMIDE
TABLET; ORAL
BANTHINE
SHIRE 50MG N007390 001

METHARBITAL
TABLET; ORAL
GEMONIL
ABBOTT 100MG N008322 001

METHAZOLAMIDE
TABLET; ORAL
METHAZOLAMIDE
APPLIED ANAL 25MG A040011 001 Jul 17, 1997
50MG A040011 002 Jul 17, 1997
SANDOZ 25MG A040102 001 Aug 28, 1996
50MG A040102 002 Aug 28, 1996
NEPTAZANE
LEDERLE 25MG N011721 002 Nov 25, 1991
50MG N011721 001

METHDILAZINE
TABLET, CHEWABLE; ORAL
TACARYL
WESTWOOD SQUIBB 3.6MG N011950 009

METHDILAZINE HYDROCHLORIDE
SYRUP; ORAL
METHDILAZINE HYDROCHLORIDE
ALPHARMA US PHARMS 4MG/5ML A087122 001
TACARYL
WESTWOOD SQUIBB 4MG/5ML N011950 007
TABLET; ORAL
TACARYL
WESTWOOD SQUIBB 8MG N011950 006

METHICILLIN SODIUM
INJECTABLE; INJECTION
STAPHCILLIN
APOTHECON EQ 900MG BASE/VIAL A061449 001
EQ 900MG BASE/VIAL N050117 001
EQ 3.6GM BASE/VIAL A061449 002
EQ 3.6GM BASE/VIAL N050117 002
EQ 5.4GM BASE/VIAL A061449 003
EQ 5.4GM BASE/VIAL N050117 003

METHIMAZOLE
TABLET; ORAL
METHIMAZOLE
CEDAR PHARMS 15MG A040619 003 Jul 12, 2005
20MG A040547 004 Feb 18, 2005
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DISCONTINUED DRUG PRODUCT LIST 6 - 209 (of 324)

METHIMAZOLE
TABLET; ORAL
METHIMAZOLE
MYLAN 20MG A040350 003 Jun 07, 2001
TAPAZOLE
KING PHARMS 5MG N007517 002
10MG N007517 004

METHIXENE HYDROCHLORIDE
TABLET; ORAL
TREST
NOVARTIS 1MG N013420 001

METHOCARBAMOL
INJECTABLE; INJECTION
METHOCARBAMOL
MARSAM PHARMS LLC 100MG/ML A089849 001 Dec 27, 1991
TABLET; ORAL
DELAXIN
FERNDALE LABS 500MG A085454 001
FORBAXIN
FOREST LABS 750MG A085136 001
METHOCARBAMOL
ABLE 500MG A040413 001 Mar 17, 2003
750MG A040413 002 Mar 17, 2003
AM THERAP 500MG A089417 001 Feb 11, 1987
750MG A089418 001 Feb 11, 1987
ASCOT 500MG A087660 001 Oct 27, 1982
750MG A087661 001 Oct 27, 1982
CLONMEL HLTHCARE 500MG A085961 001
750MG A085963 001
HEATHER 500MG A084675 001
750MG A084924 001
IMPAX LABS 500MG A084927 001
750MG A084928 001
INWOOD LABS 500MG A085137 001
IVAX SUB TEVA PHARMS 500MG A084648 001
750MG A084649 001
KV PHARM 500MG A085660 001
750MG A085658 001
MUTUAL PHARM 500MG A084488 001
750MG A084486 001
MYLAN 500MG A084259 001
750MG A084323 001
NYLOS 750MG A085033 001
PHARMERAL 500MG A084231 002
750MG A084471 001
PIONEER PHARMS 500MG A088731 001 Dec 13, 1985
750MG A089082 001 Dec 13, 1985
PUREPAC PHARM 500MG A085718 001
750MG A085718 002
ROXANE 500MG A088646 001 Feb 29, 1984
750MG A088647 001 Feb 29, 1984
SANDOZ 500MG A087283 001
750MG A087282 001
SOLCO HLTHCARE 500MG A086989 001
750MG A086988 001
SOLVAY 500MG A084448 001
750MG A084449 001
SUPERPHARM 500MG A087589 001 Jan 22, 1982
750MG A087590 001 Jan 22, 1982
TABLICAPS 500MG A084846 001
UPSHER SMITH 500MG A087453 001
750MG A087454 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 210 (of 324)

METHOCARBAMOL
TABLET; ORAL
METHOCARBAMOL
WATSON LABS 500MG A083605 001
750MG A083605 002

METHOHEXITAL SODIUM
INJECTABLE; INJECTION
BREVITAL SODIUM
JHP PHARMS 5GM/VIAL N011559 003

METHOTREXATE SODIUM
INJECTABLE; INJECTION
ABITREXATE
ABIC EQ 25MG BASE/ML A089161 001 Mar 10, 1987
EQ 50MG BASE/VIAL A089354 001 Jul 17, 1987
EQ 100MG BASE/VIAL A089355 001 Jul 17, 1987
EQ 250MG BASE/VIAL A089356 001 Jul 17, 1987
FOLEX
PHARMACIA AND UPJOHN EQ 25MG BASE/VIAL A087695 001 Apr 08, 1983
EQ 50MG BASE/VIAL A087695 002 Apr 08, 1983
EQ 100MG BASE/VIAL A087695 003 Apr 08, 1983
EQ 250MG BASE/VIAL A088954 001 Oct 24, 1985
FOLEX PFS
PHARMACIA AND UPJOHN EQ 25MG BASE/ML A081242 001 Aug 23, 1991
EQ 25MG BASE/ML A089180 001 Jan 03, 1986
METHOTREXATE LPF
HOSPIRA EQ 25MG BASE/ML N011719 007 Mar 31, 1982
METHOTREXATE PRESERVATIVE FREE
APP PHARMS EQ 25MG BASE/ML A040265 001 Feb 26, 1999
EQ 1GM BASE/VIAL A040266 001 Feb 26, 1999
HOSPIRA EQ 20MG BASE/2ML (EQ 10MG BASE/ML) N011719 014 Apr 13, 2005
EQ 500MG BASE/20ML (EQ 25MG BASE/ML) N011719 013 Apr 13, 2005
EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) N011719 011 Apr 13, 2005
METHOTREXATE SODIUM
ABRAXIS PHARM EQ 2.5MG BASE/ML A089323 001 Jun 13, 1986
EQ 20MG BASE/VIAL A088935 001 Oct 11, 1985
EQ 25MG BASE/ML A089263 001 Jun 13, 1986
EQ 25MG BASE/ML A089322 001 Jun 13, 1986
EQ 50MG BASE/VIAL A088936 001 Oct 11, 1985
EQ 100MG BASE/VIAL A088937 001 Oct 11, 1985
HOSPIRA EQ 2.5MG BASE/ML N011719 004
EQ 20MG BASE/VIAL N011719 001
EQ 25MG BASE/ML N011719 005
EQ 50MG BASE/VIAL N011719 003
EQ 100MG BASE/VIAL N011719 006
NORBROOK EQ 25MG BASE/ML A088648 001 May 09, 1986
PHARMACHEMIE USA EQ 25MG BASE/ML A089158 001 Jul 08, 1988
METHOTREXATE SODIUM PRESERVATIVE FREE
HOSPIRA EQ 1GM BASE/VIAL N011719 009 Apr 07, 1988
MEXATE
BRISTOL EQ 20MG BASE/VIAL A086358 001
EQ 50MG BASE/VIAL A086358 002
EQ 100MG BASE/VIAL A086358 003
EQ 250MG BASE/VIAL A086358 004
MEXATE-AQ
BRISTOL MYERS EQ 25MG BASE/ML A088760 001 Feb 14, 1985
MEXATE-AQ PRESERVED
BRISTOL MYERS SQUIBB EQ 25MG BASE/ML A089887 001 Apr 14, 1989
TABLET; ORAL
METHOTREXATE SODIUM
DURAMED PHARMS BARR EQ 2.5MG BASE A040233 001 Jun 17, 1999
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 211 (of 324)

METHOXAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
VASOXYL
GLAXOSMITHKLINE 10MG/ML N006772 002
20MG/ML N006772 001

METHOXSALEN
CAPSULE; ORAL
METHOXSALEN
SANDOZ 10MG A087781 001 Jun 08, 1982

METHSCOPOLAMINE BROMIDE
TABLET; ORAL
METHSCOPOLAMINE BROMIDE
PVT FORM 2.5MG A080970 001

METHYCLOTHIAZIDE
TABLET; ORAL
AQUATENSEN
MEDPOINTE PHARM HLC 5MG N017364 001
METHYCLOTHIAZIDE
IVAX PHARMS 2.5MG A087913 001 Jun 03, 1982
5MG A087786 001 May 18, 1982
MYLAN 2.5MG A087671 001 Aug 17, 1982
PAR PHARM 2.5MG A089135 001 Feb 12, 1986
5MG A089136 001 Feb 12, 1986
SANDOZ 2.5MG A089835 001 Aug 18, 1988
5MG A089837 001 Aug 18, 1988
USL PHARMA 5MG A088745 001 Mar 21, 1985
WATSON LABS 2.5MG A085487 001 Mar 11, 1982
2.5MG A088750 001 Sep 06, 1984
5MG A085476 001 Mar 11, 1982

METHYCLOTHIAZIDE; PARGYLINE HYDROCHLORIDE


TABLET; ORAL
EUTRON
ABBOTT 5MG;25MG N016047 001

METHYCLOTHIAZIDE; RESERPINE
TABLET; ORAL
DIUTENSEN-R
MEDPOINTE PHARM HLC 2.5MG;0.1MG N012708 005

METHYLDOPA
SUSPENSION; ORAL
ALDOMET
MERCK 250MG/5ML N018389 001
TABLET; ORAL
ALDOMET
MERCK 125MG N013400 003
250MG N013400 001
500MG N013400 002
METHYLDOPA
ACCORD HLTH 125MG A070070 003 Oct 15, 1985
DURAMED PHARMS BARR 250MG A071006 001 Dec 16, 1986
500MG A071009 001 Dec 16, 1986
HALSEY 125MG A071751 001 Mar 28, 1988
250MG A071752 001 Mar 28, 1988
500MG A071753 001 Mar 28, 1988
MUTUAL PHARM 125MG A070073 001 Oct 09, 1986
250MG A070060 001 Oct 09, 1986
500MG A070074 001 Oct 09, 1986
PAR PHARM 125MG A070535 001 Jan 02, 1987
250MG A070536 001 Jan 02, 1987
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 212 (of 324)

METHYLDOPA
TABLET; ORAL
METHYLDOPA
PAR PHARM 500MG A070537 001 Jan 02, 1987
PARKE DAVIS 125MG A070331 001 Apr 15, 1986
250MG A070332 001 Apr 15, 1986
500MG A070333 001 Apr 15, 1986
PLIVA 125MG A072126 001 Jul 07, 1988
250MG A072127 001 Jul 07, 1988
500MG A072128 001 Jul 07, 1988
PUREPAC PHARM 125MG A070749 001 Feb 07, 1986
250MG A070750 001 Feb 07, 1986
500MG A070452 001 Feb 07, 1986
ROXANE 125MG A070192 001 Apr 25, 1986
250MG A070193 001 Apr 25, 1986
500MG A070194 001 Apr 25, 1986
SANDOZ 125MG A071700 001 Mar 02, 1988
250MG N018934 001 Jun 29, 1984
500MG N018934 002 Jun 29, 1984
SUPERPHARM 250MG A070669 001 Jun 23, 1989
500MG A070670 001 Jun 23, 1989
TEVA 125MG A071105 001 Dec 05, 1986
250MG A071106 001 Dec 05, 1986
500MG A071067 001 Dec 05, 1986
WATSON LABS 125MG A070245 001 Feb 25, 1986
125MG A070260 001 Jun 24, 1985
250MG A070246 001 Feb 25, 1986
250MG A070261 001 Jun 24, 1985
250MG A070703 001 Jun 06, 1986
500MG A070247 001 Feb 25, 1986
500MG A070262 001 Jun 24, 1985

METHYLDOPATE HYDROCHLORIDE
INJECTABLE; INJECTION
ALDOMET
MERCK 50MG/ML N013401 001
METHYLDOPATE HYDROCHLORIDE
ABRAXIS PHARM 50MG/ML A070652 001 Jun 03, 1986
BAXTER HLTHCARE 50MG/ML A070291 001 Jul 01, 1986
HOSPIRA 50MG/ML A070691 001 Jun 19, 1987
50MG/ML A070698 001 Jun 15, 1987
50MG/ML A070699 001 Jun 15, 1987
50MG/ML A070849 001 Jun 19, 1987
MARSAM PHARMS LLC 50MG/ML A071812 001 Dec 22, 1987
SMITH AND NEPHEW 50MG/ML A070841 001 Jan 02, 1987

METHYLPHENIDATE HYDROCHLORIDE
TABLET; ORAL
METHYLPHENIDATE HYDROCHLORIDE
ABLE 5MG A040404 001 Mar 29, 2001
10MG A040404 002 Mar 29, 2001
20MG A040404 003 Mar 29, 2001
TABLET, EXTENDED RELEASE; ORAL
METHYLPHENIDATE HYDROCHLORIDE
ABLE 20MG A076032 001 May 09, 2001

METHYLPREDNISOLONE
TABLET; ORAL
MEDROL
PHARMACIA AND UPJOHN 2MG N011153 002
24MG N011153 005
METHYLPREDNISOLONE
HEATHER 4MG A085650 001
PAR PHARM 16MG A089207 001 Apr 25, 1988
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METHYLPREDNISOLONE
TABLET; ORAL
METHYLPREDNISOLONE
PAR PHARM 24MG A089208 001 Apr 25, 1988
32MG A089209 001 Apr 25, 1988
SANDOZ 4MG A087341 001
WATSON LABS 4MG A086161 001 Feb 09, 1982
16MG A086159 001 Feb 09, 1982

METHYLPREDNISOLONE ACETATE
ENEMA; RECTAL
MEDROL
PHARMACIA AND UPJOHN 40MG/BOT N018102 001
INJECTABLE; INJECTION
METHYLPREDNISOLONE ACETATE
AKORN 40MG/ML A086903 001 Oct 20, 1982
80MG/ML A086903 002 Oct 20, 1982
WATSON LABS 20MG/ML A085597 001
20MG/ML A087248 001
40MG/ML A085374 001
40MG/ML A085600 001
80MG/ML A085595 001
80MG/ML A086507 001
M-PREDROL
BEL MAR 40MG/ML A086666 001
80MG/ML A087135 001
OINTMENT; TOPICAL
MEDROL ACETATE
PHARMACIA AND UPJOHN 0.25% N012421 001
1% N012421 002

METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE


CREAM; TOPICAL
NEO-MEDROL ACETATE
PHARMACIA AND UPJOHN 0.25%;EQ 3.5MG BASE/GM A060611 002
1%;EQ 3.5MG BASE/GM A060611 001

METHYLPREDNISOLONE SODIUM SUCCINATE


INJECTABLE; INJECTION
A-METHAPRED
ABBOTT EQ 40MG BASE/VIAL A089573 001 Feb 22, 1991
EQ 125MG BASE/VIAL A089574 001 Feb 22, 1991
EQ 500MG BASE/VIAL A089575 001 Feb 22, 1991
EQ 1GM BASE/VIAL A089576 001 Feb 22, 1991
HOSPIRA EQ 40MG BASE/VIAL A085853 001
EQ 125MG BASE/VIAL A085855 001
EQ 500MG BASE/VIAL A085854 001
EQ 1GM BASE/VIAL A085852 001
METHYLPREDNISOLONE
ELKINS SINN EQ 125MG BASE/VIAL A086906 002
EQ 500MG BASE/VIAL A086906 003
EQ 1GM BASE/VIAL A086906 004
ORGANON USA INC EQ 500MG BASE/VIAL A087535 001 Jun 25, 1982
EQ 1GM BASE/VIAL A087535 002 Jun 25, 1982
METHYLPREDNISOLONE SODIUM SUCCINATE
ABRAXIS PHARM EQ 40MG BASE/VIAL A088676 001 Jun 08, 1984
EQ 40MG BASE/VIAL A089143 001 Mar 28, 1986
EQ 125MG BASE/VIAL A088677 001 Jun 08, 1984
EQ 125MG BASE/VIAL A089144 001 Mar 28, 1986
EQ 500MG BASE/VIAL A088678 001 Jun 08, 1984
EQ 500MG BASE/VIAL A089186 001 Mar 28, 1986
EQ 500MG BASE/VIAL A089187 001 Mar 28, 1986
EQ 1GM BASE/VIAL A088679 001 Jun 08, 1984
EQ 1GM BASE/VIAL A089188 001 Mar 28, 1986
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 214 (of 324)

METHYLPREDNISOLONE SODIUM SUCCINATE


INJECTABLE; INJECTION
METHYLPREDNISOLONE SODIUM SUCCINATE
ABRAXIS PHARM EQ 1GM BASE/VIAL A089189 001 Mar 28, 1986
ELKINS SINN EQ 40MG BASE/VIAL A086906 001
INTL MEDICATION EQ 40MG BASE/VIAL A087812 001 Feb 09, 1983
EQ 125MG BASE/VIAL A087813 001 Feb 09, 1983
EQ 500MG BASE/VIAL A087851 001 Feb 09, 1983
EQ 1GM BASE/VIAL A087852 001 Feb 09, 1983
TEVA PARENTERAL EQ 500MG BASE/VIAL A081267 001 Nov 30, 1992
EQ 1GM BASE/VIAL A081268 001 Nov 30, 1992
WATSON LABS EQ 40MG BASE/VIAL A086953 001 Jul 22, 1982
EQ 125MG BASE/VIAL A087030 001 Jul 22, 1982
EQ 500MG BASE/VIAL A088523 001 Jul 24, 1984
EQ 1GM BASE/VIAL A088524 001 Jul 24, 1984

METHYLPREDNISOLONE; NEOMYCIN SULFATE


OINTMENT; OPHTHALMIC
NEO-MEDROL
PHARMACIA AND UPJOHN 0.1%;EQ 3.5MG BASE/GM A060645 001

METHYLTESTOSTERONE
CAPSULE; ORAL
METHYLTESTOSTERONE
HEATHER 10MG A084967 001
VIRILON
STAR PHARMS FL 10MG A087750 001 Nov 24, 1982
TABLET; BUCCAL
ANDROID 5
VALEANT PHARM INTL 5MG A087222 001
ORETON
SCHERING 10MG A080281 001
TABLET; BUCCAL/SUBLINGUAL
METANDREN
NOVARTIS 5MG N003240 004
10MG N003240 005
METHYLTESTOSTERONE
IMPAX LABS 10MG A084287 001
LILLY 10MG A080256 001
PUREPAC PHARM 10MG A080308 001
10MG A080475 001
PVT FORM 5MG A083836 001
TABLICAPS 10MG A085125 001
USL PHARMA 10MG A080271 001
TABLET; ORAL
METANDREN
NOVARTIS 10MG N003240 001
25MG N003240 003
METHYLTESTOSTERONE
INWOOD LABS 10MG A080839 001
25MG A080973 001
KV PHARM 10MG A084312 001
LANNETT 10MG A087092 001 Nov 05, 1982
25MG A087111 001 Jan 27, 1983
LILLY 25MG A080256 002
PARKE DAVIS 10MG A084244 001
25MG A084241 001
PUREPAC PHARM 10MG A080309 001
10MG A080475 002
25MG A080310 001
25MG A080475 003
PVT FORM 5MG A080214 001
10MG A080214 002
25MG A080214 003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 215 (of 324)

METHYLTESTOSTERONE
TABLET; ORAL
METHYLTESTOSTERONE
TABLICAPS 10MG A080313 001
25MG A085270 001
WATSON LABS 10MG A080933 001
25MG A080931 001
WEST WARD 10MG A084331 001
25MG A084331 002
25MG A084642 001
ORETON METHYL
SCHERING 10MG N003158 001
25MG N003158 002

METHYPRYLON
CAPSULE; ORAL
NOLUDAR
ROCHE 300MG N009660 008
ELIXIR; ORAL
NOLUDAR
ROCHE 50MG/5ML N009660 007
TABLET; ORAL
NOLUDAR
ROCHE 50MG N009660 002
200MG N009660 004

METHYSERGIDE MALEATE
TABLET; ORAL
SANSERT
NOVARTIS 2MG N012516 001

METOCLOPRAMIDE HYDROCHLORIDE
CONCENTRATE; ORAL
METOCLOPRAMIDE INTENSOL
ROXANE EQ 10MG BASE/ML A072995 001 Jan 30, 1992
INJECTABLE; INJECTION
METOCLOPRAMIDE HYDROCHLORIDE
ABRAXIS PHARM EQ 10MG BASE/2ML A070293 001 Jan 24, 1986
BEDFORD EQ 5MG BASE/ML A072155 001 Mar 30, 1992
EQ 5MG BASE/ML A072244 001 Mar 30, 1992
EQ 5MG BASE/ML A072247 001 May 18, 1992
HOSPIRA EQ 5MG BASE/ML A070505 001 Jun 23, 1989
EQ 5MG BASE/ML A070506 001 Jun 22, 1989
EQ 5MG BASE/ML A070847 001 Nov 07, 1988
EQ 5MG BASE/ML A071291 001 Mar 03, 1989
EQ 5MG BASE/ML A071990 001 Jan 18, 1989
NORBROOK EQ 10MG BASE/2ML A070892 001 Aug 26, 1988
SMITH AND NEPHEW EQ 5MG BASE/ML A070623 001 Mar 02, 1987
EQ 10MG BASE/2ML A070622 001 Mar 02, 1987
REGLAN
BAXTER HLTHCARE CORP EQ 10MG BASE/ML N017862 004 May 28, 1987
SOLUTION; ORAL
METOCLOPRAMIDE HYDROCHLORIDE
ACTAVIS MID ATLANTIC EQ 5MG BASE/5ML A071340 001 Aug 18, 1988
MORTON GROVE EQ 5MG BASE/5ML A070949 001 Mar 06, 1987
PACO EQ 5MG BASE/5ML A071665 001 Dec 05, 1988
ROXANE EQ 5MG BASE/5ML A072038 001 Dec 05, 1988
TEVA EQ 5MG BASE/5ML A070819 001 Jul 10, 1987
EQ 5MG BASE/5ML A071315 001 Jun 30, 1993
REGLAN
ROBINS AH EQ 5MG BASE/5ML N018821 001 Mar 25, 1983
TABLET; ORAL
CLOPRA
QUANTUM PHARMICS EQ 5MG BASE A072384 001 Jun 02, 1988
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DISCONTINUED DRUG PRODUCT LIST 6 - 216 (of 324)

METOCLOPRAMIDE HYDROCHLORIDE
TABLET; ORAL
CLOPRA
QUANTUM PHARMICS EQ 10MG BASE A070294 001 Jul 29, 1985
CLOPRA-"YELLOW"
QUANTUM PHARMICS EQ 10MG BASE A070632 001 Oct 28, 1985
MAXOLON
KING PHARMS EQ 10MG BASE A070106 001 Mar 04, 1986
METOCLOPRAMIDE HYDROCHLORIDE
AMNEAL PHARMS NY EQ 10MG BASE A071213 001 Sep 24, 1986
CLONMEL HLTHCARE EQ 10MG BASE A072639 001 May 09, 1991
HALSEY EQ 10MG BASE A070906 001 Oct 28, 1986
MUTUAL PHARM EQ 10MG BASE A070660 001 Feb 10, 1987
EQ 10MG BASE A071536 001 Apr 28, 1993
PAR PHARM EQ 10MG BASE A070342 001 Mar 25, 1986
SANDOZ EQ 5MG BASE A072436 001 Jun 22, 1989
EQ 5MG BASE A074478 001 Oct 05, 1995
EQ 10MG BASE A070850 001 Feb 03, 1987
EQ 10MG BASE A072215 001 Jan 30, 1990
SCHERING EQ 10MG BASE A070598 001 Feb 02, 1987
SUPERPHARM EQ 10MG BASE A070926 001 Jun 26, 1987
USL PHARMA EQ 10MG BASE A070339 001 Jul 29, 1985
WATSON LABS EQ 10MG BASE A070363 001 Mar 02, 1987
EQ 10MG BASE A070453 001 Jun 06, 1986
EQ 10MG BASE A070645 001 May 11, 1987
TABLET, ORALLY DISINTEGRATING; ORAL
REGLAN ODT
ALAVEN PHARM EQ 5MG BASE N021793 001 Jun 10, 2005
EQ 10MG BASE N021793 002 Jun 10, 2005

METOCURINE IODIDE
INJECTABLE; INJECTION
METUBINE IODIDE
LILLY 2MG/ML N006632 003

METOLAZONE
TABLET; ORAL
DIULO
GD SEARLE LLC 2.5MG N018535 001
5MG N018535 002
10MG N018535 003
METOLAZONE
ROXANE 10MG A076482 002 Apr 29, 2004
WATSON LABS 10MG A076891 001 Jul 21, 2004
MYKROX
UCB INC 0.5MG N019532 001 Oct 30, 1987

METOPROLOL FUMARATE
TABLET, EXTENDED RELEASE; ORAL
LOPRESSOR
NOVARTIS EQ 100MG TARTRATE N019786 001 Dec 27, 1989
EQ 200MG TARTRATE N019786 002 Dec 27, 1989
EQ 300MG TARTRATE N019786 003 Dec 27, 1989
EQ 400MG TARTRATE N019786 004 Dec 27, 1989

METOPROLOL TARTRATE
TABLET; ORAL
METOPROLOL TARTRATE
APOTHECON 50MG A074258 001 Jan 27, 1994
100MG A074258 002 Jan 27, 1994
MYLAN 50MG A073666 001 Dec 21, 1993
100MG A073666 002 Dec 21, 1993
PUREPAC PHARM 50MG A074380 001 Jul 29, 1994
100MG A074380 002 Jul 29, 1994
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DISCONTINUED DRUG PRODUCT LIST 6 - 217 (of 324)

METOPROLOL TARTRATE
TABLET; ORAL
METOPROLOL TARTRATE
SOLCO HLTHCARE 50MG A074453 001 Apr 27, 1995
100MG A074453 002 Apr 27, 1995
TEVA 50MG A074143 001 Sep 30, 1994
100MG A074143 002 Sep 30, 1994
TEVA PHARMS 50MG A074333 001 Jan 27, 1994
100MG A074333 002 Jan 27, 1994

METRIZAMIDE
INJECTABLE; INJECTION
AMIPAQUE
GE HEALTHCARE 2.5GM/VIAL N017982 003 Sep 12, 1983
3.75GM/VIAL N017982 001
6.75GM/VIAL N017982 002
13.5GM/VIAL N017982 004 Sep 12, 1983

METRONIDAZOLE
CAPSULE; ORAL
METRONIDAZOLE
ABLE 375MG A076505 001 Nov 13, 2003
INJECTABLE; INJECTION
METRO I.V.
B BRAUN 500MG/100ML N018674 001 Aug 31, 1982
METRONIDAZOLE
ABBOTT 500MG/100ML N018889 001 Nov 18, 1983
ABRAXIS PHARM 500MG/100ML A070071 001 Dec 03, 1984
ELKINS SINN 500MG/100ML N018907 001 Mar 30, 1984
INTL MEDICATION 500MG/100ML A070004 001 May 08, 1985
WATSON LABS 500MG/100ML A070042 001 Dec 20, 1984
500MG/100ML A070170 001 Apr 01, 1986
TABLET; ORAL
METROMIDOL
LABS AF 250MG A074523 001 Oct 24, 1996
500MG A074523 002 Oct 24, 1996
METRONIDAZOLE
ABLE 250MG A076519 001 Jun 27, 2003
500MG A076519 002 Jun 27, 2003
HALSEY 250MG A070021 001 Apr 02, 1985
500MG A070593 001 Feb 27, 1986
LNK 250MG N019029 001 Apr 10, 1984
MUTUAL PHARM 250MG N018818 001 Feb 16, 1983
500MG N018818 002 Feb 16, 1983
PAR PHARM 250MG A070040 001 Jan 29, 1985
250MG N018845 001 Aug 18, 1983
500MG A070039 001 Jan 29, 1985
500MG N018930 001 Aug 18, 1983
SANDOZ 250MG N018740 001 Oct 22, 1982
500MG N018740 002 Oct 22, 1982
SUPERPHARM 250MG A070008 001 Dec 11, 1984
500MG A070009 001 Dec 11, 1984
WATSON LABS 250MG N018599 001 Sep 17, 1982
500MG N018599 002 Feb 13, 1984
PROTOSTAT
ORTHO MCNEIL PHARM 250MG N018871 001 Mar 02, 1983
500MG N018871 002 Mar 02, 1983
SATRIC
SAVAGE LABS 250MG A070029 001 Mar 19, 1985
500MG A070731 001 Jun 08, 1987
TABLET, EXTENDED RELEASE; ORAL
METRONIDAZOLE
ABLE 750MG A076462 001 Jun 25, 2003
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METRONIDAZOLE HYDROCHLORIDE
INJECTABLE; INJECTION
METRONIDAZOLE HYDROCHLORIDE
ABRAXIS PHARM EQ 500MG BASE/VIAL A070295 001 Oct 15, 1985

METYRAPONE
TABLET; ORAL
METOPIRONE
NOVARTIS 250MG N012911 001

MEXILETINE HYDROCHLORIDE
CAPSULE; ORAL
MEXILETINE HYDROCHLORIDE
SANDOZ 150MG A074450 001 May 16, 1996
200MG A074450 002 May 16, 1996
250MG A074450 003 May 16, 1996
MEXITIL
BOEHRINGER INGELHEIM 150MG N018873 002 Dec 30, 1985
200MG N018873 003 Dec 30, 1985
250MG N018873 004 Dec 30, 1985

MEZLOCILLIN SODIUM MONOHYDRATE


INJECTABLE; INJECTION
MEZLIN
BAYER PHARMS EQ 1GM BASE/VIAL A062333 001
EQ 1GM BASE/VIAL A062372 005 Jan 13, 1983
EQ 1GM BASE/VIAL N050549 001
EQ 2GM BASE/VIAL A062333 002
EQ 2GM BASE/VIAL A062372 001 May 13, 1982
EQ 2GM BASE/VIAL N050549 002
EQ 3GM BASE/VIAL A062333 003
EQ 3GM BASE/VIAL A062372 002 May 13, 1982
EQ 3GM BASE/VIAL A062697 001 Jan 22, 1987
EQ 3GM BASE/VIAL N050549 003
EQ 4GM BASE/VIAL A062333 004
EQ 4GM BASE/VIAL A062372 003 May 13, 1982
EQ 4GM BASE/VIAL A062697 002 Jan 22, 1987
EQ 4GM BASE/VIAL N050549 004
EQ 20GM BASE/VIAL A062372 004 Mar 02, 1988
EQ 20GM BASE/VIAL N050549 005 Mar 02, 1988

MICONAZOLE
INJECTABLE; INJECTION
MONISTAT
JANSSEN PHARMA 10MG/ML N018040 001

MICONAZOLE NITRATE
CREAM; TOPICAL
MONISTAT-DERM
ORTHONEUTROGENA 2% N017494 001
CREAM; VAGINAL
MICONAZOLE NITRATE
TEVA 2% A074136 001 Jan 04, 1995
TEVA PHARMS 2% A074030 001 Oct 30, 1992
LOTION; TOPICAL
MONISTAT-DERM
JOHNSON AND JOHNSON 2% N017739 001
TAMPON; VAGINAL
MONISTAT 5
PERSONAL PRODS 100MG N018592 001 Oct 27, 1989
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MIDAZOLAM HYDROCHLORIDE
INJECTABLE; INJECTION
MIDAZOLAM HYDROCHLORIDE
APOTHECON EQ 1MG BASE/ML A075620 001 Nov 01, 2000
EQ 5MG BASE/ML A075620 002 Nov 01, 2000
EQ 5MG BASE/ML A075641 001 Oct 19, 2000
ASTRAZENECA EQ 5MG BASE/ML A075263 001 Jun 26, 2000
BEDFORD EQ 5MG BASE/ML A075249 001 Jun 23, 2000
BEN VENUE EQ 5MG BASE/ML A075455 001 Jun 20, 2000
HOSPIRA EQ 1MG BASE/ML A075396 001 Jun 20, 2000
EQ 5MG BASE/ML A075396 002 Jun 20, 2000
EQ 5MG BASE/ML A075409 001 Jun 20, 2000
EQ 5MG BASE/ML A075484 001 Jun 20, 2000
VERSED
HLR EQ 1MG BASE/ML N018654 002 May 26, 1987
EQ 5MG BASE/ML N018654 001 Dec 20, 1985
SYRUP; ORAL
VERSED
ROCHE EQ 2MG BASE/ML N020942 001 Oct 15, 1998

MILRINONE LACTATE
INJECTABLE; INJECTION
MILRINONE LACTATE
BAXTER HLTHCARE CORP EQ 1MG BASE/ML A075852 001 May 28, 2002
BIONICHE PHARMA EQ 1MG BASE/ML A076428 001 Jun 16, 2003
HOSPIRA EQ 1MG BASE/ML A075830 001 May 28, 2002
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A075510 001 May 28, 2002
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A076259 001 Aug 08, 2002
PRIMACOR
SANOFI AVENTIS US EQ 1MG BASE/ML N019436 001 Dec 31, 1987
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER
SANOFI AVENTIS US EQ 10MG BASE/100ML N020343 001 Aug 09, 1994
EQ 15MG BASE/100ML N020343 002 Aug 09, 1994

MINOCYCLINE HYDROCHLORIDE
CAPSULE; ORAL
DYNACIN
MEDICIS EQ 50MG BASE A063066 001 Aug 14, 1990
MINOCIN
TRIAX PHARMS EQ 50MG BASE N050315 002
EQ 100MG BASE N050315 001
TRIAX PHARMS LLC EQ 75MG BASE N050649 003 Feb 12, 2001
INJECTABLE; INJECTION
MINOCIN
LEDERLE EQ 100MG BASE/VIAL A062139 001
SUSPENSION; ORAL
MINOCIN
TRIAX PHARMS EQ 50MG BASE/5ML N050445 001
TABLET; ORAL
MINOCYCLINE HYDROCHLORIDE
TRIAX PHARMS EQ 50MG BASE N050451 003 Aug 10, 1982
EQ 100MG BASE N050451 002 Aug 10, 1982

MINOXIDIL
SOLUTION; TOPICAL
MINOXIDIL (FOR MEN)
COPLEY PHARM 2% A074500 001 May 23, 1996
TEVA 2% A074589 001 Apr 05, 1996
MINOXIDIL EXTRA STRENGTH (FOR MEN)
TEVA 5% A075619 001 Nov 17, 2000
TABLET; ORAL
LONITEN
PHARMACIA AND UPJOHN 2.5MG N018154 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 220 (of 324)

MINOXIDIL
TABLET; ORAL
LONITEN
PHARMACIA AND UPJOHN 10MG N018154 003
MINODYL
QUANTUM PHARMICS 2.5MG A072153 001 Jul 13, 1988
10MG A071534 001 Mar 19, 1987
MINOXIDIL
ROYCE LABS 2.5MG A071799 001 Nov 10, 1987
10MG A071796 001 Nov 10, 1987
USL PHARMA 2.5MG A071537 001 Dec 16, 1988

MIRTAZAPINE
TABLET; ORAL
MIRTAZAPINE
IVAX SUB TEVA PHARMS 15MG A076244 001 Dec 22, 2003
30MG A076244 002 Dec 22, 2003
45MG A076244 003 Dec 22, 2003
ROXANE 15MG A076270 001 Jun 19, 2003
30MG A076270 002 Jun 19, 2003
45MG A076270 003 Jun 19, 2003
SANDOZ 15MG A076189 001 Jun 19, 2003
30MG A076189 002 Jun 19, 2003
45MG A076189 003 Jun 19, 2003

MITOMYCIN
INJECTABLE; INJECTION
MITOMYCIN
HOSPIRA 20MG/VIAL A064106 001 Nov 29, 1995
MITOZYTREX
SUPERGEN 5MG/VIAL N050763 001 Nov 14, 2002
MUTAMYCIN
BRISTOL 5MG/VIAL N050450 001
20MG/VIAL N050450 002

MITOXANTRONE HYDROCHLORIDE
INJECTABLE; INJECTION
NOVANTRONE
EMD SERONO EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) N019297 002 Dec 23, 1987
EQ 30MG BASE/15ML (EQ 2MG BASE/ML) N019297 003 Dec 23, 1987

MIVACURIUM CHLORIDE
INJECTABLE; INJECTION
MIVACRON
ABBOTT EQ 2MG BASE/ML N020098 001 Jan 22, 1992
MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTT EQ 0.5MG BASE/ML N020098 002 Jan 22, 1992
EQ 50MG BASE/100ML N020098 003 Jan 22, 1992

MOLINDONE HYDROCHLORIDE
CAPSULE; ORAL
MOBAN
ENDO PHARMS 5MG N017111 001
10MG N017111 002
25MG N017111 003
CONCENTRATE; ORAL
MOBAN
ENDO PHARMS 20MG/ML N017938 001
TABLET; ORAL
MOBAN
ENDO PHARMS 100MG N017111 008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 221 (of 324)

MONOBENZONE
CREAM; TOPICAL
BENOQUIN
VALEANT PHARM INTL 20% N008173 003

MONOCTANOIN
LIQUID; PERFUSION, BILIARY
MOCTANIN
ETHITEK 100% N019368 001 Oct 29, 1985

MORICIZINE HYDROCHLORIDE
TABLET; ORAL
ETHMOZINE
SHIRE 200MG N019753 001 Jun 19, 1990
250MG N019753 002 Jun 19, 1990
300MG N019753 003 Jun 19, 1990

MORPHINE SULFATE
INJECTABLE; INJECTION
MORPHINE SULFATE
HOSPIRA 0.5MG/ML N019917 001 Oct 30, 1992
MALLINCKRODT 1MG/ML N020631 001 Jul 03, 1996
2MG/ML N020631 002 Jul 03, 1996
INJECTABLE, LIPOSOMAL; EPIDURAL
DEPODUR
PACIRA PHARMS INC 20MG/2ML (10MG/ML) N021671 003 May 18, 2004
TABLET, EXTENDED RELEASE; ORAL
MORPHINE SULFATE
AB GENERICS 15MG A074862 001 Jul 07, 1998
30MG A074862 002 Jul 07, 1998
60MG A074862 003 Jul 07, 1998
100MG A074769 001 Jul 02, 1998
200MG A074769 002 Jul 02, 1998
CLONMEL HLTHCARE 15MG A075407 001 Jan 28, 2000

MOXALACTAM DISODIUM
INJECTABLE; INJECTION
MOXAM
LILLY EQ 250MG BASE/VIAL N050550 001
EQ 500MG BASE/VIAL N050550 002
EQ 1GM BASE/VIAL N050550 003
EQ 2GM BASE/VIAL N050550 004
EQ 10GM BASE/VIAL N050550 008

NABUMETONE
TABLET; ORAL
NABUMETONE
COPLEY PHARM 750MG A075179 001 Jun 06, 2000
SANDOZ 500MG A075590 001 Feb 25, 2002
750MG A075590 002 Feb 25, 2002
RELAFEN
SMITHKLINE BEECHAM 500MG N019583 001 Dec 24, 1991
750MG N019583 002 Dec 24, 1991

NADOLOL
TABLET; ORAL
CORGARD
KING PHARMS 120MG N018063 003
160MG N018063 004
NADOLOL
IVAX SUB TEVA PHARMS 120MG A074255 002 Jan 24, 1996
160MG A074255 003 Jan 24, 1996
TEVA PHARMS 80MG A074368 001 Aug 31, 1994
120MG A074368 002 Aug 31, 1994
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DISCONTINUED DRUG PRODUCT LIST 6 - 222 (of 324)

NADOLOL
TABLET; ORAL
NADOLOL
TEVA PHARMS 160MG A074368 003 Aug 31, 1994

NAFCILLIN SODIUM
CAPSULE; ORAL
UNIPEN
WYETH AYERST EQ 250MG BASE N050111 001
FOR SOLUTION; ORAL
UNIPEN
WYETH AYERST EQ 250MG BASE/5ML N050199 001
INJECTABLE; INJECTION
NAFCILLIN SODIUM
APOTHECON EQ 500MG BASE/VIAL A061984 001
EQ 1GM BASE/VIAL A061984 002
EQ 2GM BASE/VIAL A061984 003
EQ 4GM BASE/VIAL A061984 005
MARSAM PHARMS LLC EQ 500MG BASE/VIAL A062844 001 Oct 26, 1988
EQ 1GM BASE/VIAL A062844 002 Oct 26, 1988
EQ 1.5GM BASE/VIAL A062844 003 Oct 26, 1988
EQ 2GM BASE/VIAL A062844 004 Oct 26, 1988
EQ 4GM BASE/VIAL A062844 005 Oct 26, 1988
EQ 10GM BASE/VIAL A063008 001 Sep 29, 1988
SANDOZ EQ 500MG BASE/VIAL A062527 001 Aug 02, 1984
NALLPEN
GLAXOSMITHKLINE EQ 500MG BASE/VIAL A061999 001
EQ 1GM BASE/VIAL A061999 002
EQ 1GM BASE/VIAL A062755 001 Dec 19, 1986
EQ 2GM BASE/VIAL A061999 003
EQ 2GM BASE/VIAL A062755 002 Dec 19, 1986
EQ 10GM BASE/VIAL A061999 004
UNIPEN
WYETH AYERST EQ 500MG BASE/VIAL A062717 001 Dec 16, 1986
EQ 500MG BASE/VIAL N050320 001
EQ 1GM BASE/VIAL A062717 002 Dec 16, 1986
EQ 2GM BASE/VIAL A062717 004 Dec 16, 1986
EQ 2GM BASE/VIAL N050320 003
EQ 4GM BASE/VIAL N050320 004
EQ 10GM BASE/VIAL N050320 005
EQ 20GM BASE/VIAL N050320 006
UNIPEN IN PLASTIC CONTAINER
WYETH AYERST EQ 1GM BASE/VIAL N050320 002
TABLET; ORAL
UNIPEN
WYETH AYERST EQ 500MG BASE N050462 001

NALBUPHINE HYDROCHLORIDE
INJECTABLE; INJECTION
NALBUPHINE
ABRAXIS PHARM 10MG/ML A070751 001 Jul 02, 1986
20MG/ML A070752 001 Sep 24, 1986
NALBUPHINE HYDROCHLORIDE
ABBOTT 1.5MG/ML N020200 001 Mar 12, 1993
20MG/ML A070917 001 Feb 03, 1989
ASTRAZENECA 10MG/ML A072070 001 Apr 10, 1989
10MG/ML A072071 001 Apr 10, 1989
10MG/ML A072072 001 Apr 10, 1989
20MG/ML A072073 001 Apr 10, 1989
20MG/ML A072074 001 Apr 10, 1989
20MG/ML A072075 001 Apr 10, 1989
BARR 10MG/ML A074471 001 Mar 19, 1998
20MG/ML A074471 002 Mar 19, 1998
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 223 (of 324)

NALBUPHINE HYDROCHLORIDE
INJECTABLE; INJECTION
NUBAIN
ENDO PHARMS 10MG/ML N018024 001
20MG/ML N018024 002 May 27, 1982

NALIDIXIC ACID
SUSPENSION; ORAL
NEGGRAM
SANOFI AVENTIS US 250MG/5ML N017430 001
TABLET; ORAL
NALIDIXIC ACID
MUTUAL PHARM 250MG A070270 001 Jun 29, 1988
500MG A070271 001 Jun 29, 1988
1GM A070272 001 Jun 29, 1988
WATSON LABS 250MG A071936 001 Jun 29, 1988
500MG A072061 001 Jun 29, 1988
1GM A071919 001 Jun 29, 1988

NALMEFENE HYDROCHLORIDE
INJECTABLE; INJECTION
REVEX
BAXTER HLTHCARE CORP EQ 0.1MG BASE/ML N020459 001 Apr 17, 1995
EQ 1MG BASE/ML N020459 002 Apr 17, 1995

NALOXONE HYDROCHLORIDE
INJECTABLE; INJECTION
NALOXONE
BAXTER HLTHCARE 0.4MG/ML A070298 001 Sep 24, 1986
0.4MG/ML A070299 001 Sep 24, 1986
0.4MG/ML A070496 001 Sep 24, 1986
WYETH AYERST 0.02MG/ML A070188 001 Sep 24, 1986
0.02MG/ML A070189 001 Sep 24, 1986
0.4MG/ML A070190 001 Sep 24, 1986
0.4MG/ML A070191 001 Sep 24, 1986
NALOXONE HYDROCHLORIDE
ABRAXIS PHARM 0.02MG/ML A070648 001 Nov 17, 1986
0.02MG/ML A070661 001 Nov 17, 1986
0.4MG/ML A070649 001 Nov 17, 1986
1MG/ML A071604 001 Dec 16, 1988
ASTRAZENECA 0.02MG/ML A072081 001 Apr 11, 1989
0.02MG/ML A072082 001 Apr 11, 1989
0.02MG/ML A072083 001 Apr 11, 1989
0.02MG/ML A072084 001 Apr 11, 1989
0.02MG/ML A072085 001 Apr 11, 1989
0.4MG/ML A072086 001 Apr 11, 1989
0.4MG/ML A072087 001 Apr 11, 1989
0.4MG/ML A072088 001 Apr 11, 1989
0.4MG/ML A072089 001 Apr 11, 1989
0.4MG/ML A072090 001 Apr 11, 1989
1MG/ML A072091 001 Apr 11, 1989
1MG/ML A072092 001 Apr 11, 1989
1MG/ML A072093 001 Apr 11, 1989
BAXTER HLTHCARE 0.02MG/ML A071272 001 May 24, 1988
1MG/ML A071273 001 May 24, 1988
1MG/ML A071274 001 May 24, 1988
1MG/ML A071287 001 May 24, 1988
HOSPIRA 0.02MG/ML A070171 001 Sep 24, 1986
0.02MG/ML A070252 001 Jan 16, 1987
0.02MG/ML A070253 001 Jan 16, 1987
0.4MG/ML A070255 001 Jan 07, 1987
INTL MEDICATION 0.4MG/ML A070417 001 Sep 24, 1986
1MG/ML A072115 001 Apr 27, 1988
MARSAM PHARMS LLC 0.4MG/ML A071811 001 Jul 19, 1988
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 224 (of 324)

NALOXONE HYDROCHLORIDE
INJECTABLE; INJECTION
NALOXONE HYDROCHLORIDE
SMITH AND NEPHEW 0.02MG/ML A071671 001 Nov 17, 1987
0.4MG/ML A071681 001 Nov 17, 1987
0.4MG/ML A071682 001 Nov 17, 1987
SOLOPAK 0.02MG/ML A071672 001 Nov 17, 1987
0.4MG/ML A071683 001 Nov 17, 1987
WATSON LABS 0.4MG/ML A071339 001 Nov 18, 1987
NARCAN
BRISTOL MYERS SQUIBB 0.4MG/ML A071083 001 Jul 28, 1988
1MG/ML A071084 001 Jul 28, 1988
1MG/ML A071311 001 Jul 28, 1988
ENDO PHARMS 0.02MG/ML N016636 002
0.4MG/ML N016636 001
1MG/ML N016636 003 Jun 14, 1982

NANDROLONE DECANOATE
INJECTABLE; INJECTION
DECA-DURABOLIN
ORGANON USA INC 50MG/ML N013132 001 Jun 12, 1986
100MG/ML N013132 002 Jun 12, 1986
200MG/ML N013132 003 Jun 12, 1986
NANDROLONE DECANOATE
ABRAXIS PHARM 100MG/ML A088290 001 Oct 03, 1983
200MG/ML A088317 001 Oct 14, 1983
AKORN 100MG/ML A087519 001 Sep 28, 1983
WATSON LABS 50MG/ML A086385 001 Jan 13, 1984
50MG/ML A087598 001 Oct 06, 1983
50MG/ML A088554 001 Feb 10, 1986
100MG/ML A086598 001 Jan 13, 1984
100MG/ML A087599 001 Oct 06, 1983
200MG/ML A088128 001 Dec 05, 1983

NANDROLONE PHENPROPIONATE
INJECTABLE; INJECTION
DURABOLIN
ORGANON USA INC 25MG/ML N011891 001
50MG/ML N011891 002
NANDROLONE PHENPROPIONATE
WATSON LABS 25MG/ML A086386 001 Jun 17, 1983
50MG/ML A087488 001 Jun 17, 1983

NAPHAZOLINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
NAFAZAIR
PHARMAFAIR 0.1% A088101 001 Apr 15, 1983
NAPHCON FORTE
ALCON 0.1% A080229 001
OPCON
BAUSCH AND LOMB 0.1% A087506 001
VASOCON
NOVARTIS 0.1% A080235 002 Mar 24, 1983

NAPROXEN
TABLET; ORAL
NAPROXEN
BAXTER HLTHCARE 250MG A074105 001 Dec 21, 1993
375MG A074105 002 Dec 21, 1993
500MG A074105 003 Dec 21, 1993
HAMILTON PHARMS 250MG A074110 001 Oct 30, 1992
375MG A074110 002 Oct 30, 1992
500MG A074110 003 Oct 30, 1992
IVAX SUB TEVA PHARMS 250MG A074111 001 Feb 28, 1995
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DISCONTINUED DRUG PRODUCT LIST 6 - 225 (of 324)

NAPROXEN
TABLET; ORAL
NAPROXEN
IVAX SUB TEVA PHARMS 375MG A074111 002 Feb 28, 1995
500MG A074111 003 Feb 28, 1995
PLIVA 250MG A074182 001 Jun 27, 1996
375MG A074182 002 Jun 27, 1996
500MG A074182 003 Jun 27, 1996
PUREPAC PHARM 250MG A074263 001 Dec 21, 1993
375MG A074263 002 Dec 21, 1993
500MG A074263 003 Dec 21, 1993
ROXANE 250MG A074211 001 Feb 28, 1994
375MG A074211 002 Feb 28, 1994
500MG A074211 003 Feb 28, 1994
TEVA 250MG A074129 001 Dec 21, 1993
250MG A074216 001 Apr 11, 1996
375MG A074129 002 Dec 21, 1993
375MG A074216 002 Apr 11, 1996
500MG A074129 003 Dec 21, 1993
500MG A074216 003 Apr 11, 1996
TEVA PHARMS 250MG A074207 001 Dec 21, 1993
375MG A074207 002 Dec 21, 1993
500MG A074207 003 Dec 21, 1993
WATSON LABS 250MG A074163 001 Feb 10, 1995
375MG A074163 002 Feb 10, 1995
500MG A074163 003 Feb 10, 1995

NAPROXEN SODIUM
TABLET; ORAL
NAPROXEN SODIUM
ABLE EQ 250MG BASE A076544 001 Aug 22, 2003
EQ 500MG BASE A076544 002 Aug 22, 2003
HAMILTON PHARMS EQ 250MG BASE A074106 001 Aug 31, 1993
EQ 500MG BASE A074106 002 Aug 31, 1993
IVAX SUB TEVA PHARMS EQ 250MG BASE A074230 001 Mar 14, 1995
EQ 500MG BASE A074230 002 Mar 14, 1995
MYLAN EQ 250MG BASE A074367 001 Aug 31, 1994
EQ 500MG BASE A074367 002 Aug 31, 1994
PLIVA EQ 250MG BASE A074242 001 Jun 20, 1996
EQ 500MG BASE A074242 002 Jun 20, 1996
PUREPAC PHARM EQ 250MG BASE A074319 001 Mar 20, 1995
EQ 500MG BASE A074319 002 Mar 20, 1995
ROXANE EQ 250MG BASE A074257 001 Dec 21, 1993
EQ 500MG BASE A074257 002 Dec 21, 1993
TEVA EQ 250MG BASE A074142 001 Dec 21, 1993
EQ 500MG BASE A074142 002 Dec 21, 1993
TEVA PHARMS EQ 250MG BASE A074289 001 Jan 27, 1994
EQ 500MG BASE A074289 002 Jan 27, 1994
WATSON LABS EQ 250MG BASE A074195 001 Dec 21, 1993
EQ 500MG BASE A074195 002 Dec 21, 1993
TABLET, EXTENDED RELEASE; ORAL
NAPROXEN SODIUM
WATSON LABS FLORIDA EQ 375MG BASE A075416 002 Apr 23, 2003
EQ 500MG BASE A075416 001 Aug 27, 2002

NEDOCROMIL SODIUM
AEROSOL, METERED; INHALATION
TILADE
KING PHARMS 1.75MG/INH N019660 001 Dec 30, 1992
SOLUTION; INHALATION
TILADE
SANOFI AVENTIS US 0.5% N020750 001 Oct 01, 1997
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 226 (of 324)

NEFAZODONE HYDROCHLORIDE
TABLET; ORAL
NEFAZODONE HYDROCHLORIDE
MYLAN 100MG A076129 002 Sep 16, 2003
150MG A076129 003 Sep 16, 2003
200MG A076129 004 Sep 16, 2003
250MG A076129 005 Sep 16, 2003
ROXANE 50MG A076196 001 Sep 16, 2003
100MG A076196 002 Sep 16, 2003
150MG A076196 003 Sep 16, 2003
200MG A076196 004 Sep 16, 2003
250MG A076196 005 Sep 16, 2003
SANDOZ 50MG A076072 001 Sep 16, 2003
100MG A076072 002 Sep 16, 2003
150MG A076072 003 Sep 16, 2003
200MG A076072 004 Sep 16, 2003
250MG A076072 005 Sep 16, 2003
WATSON LABS 100MG A076073 002 Sep 16, 2003
150MG A076073 003 Sep 16, 2003
200MG A076073 004 Sep 16, 2003
250MG A076073 005 Sep 16, 2003
SERZONE
BRISTOL MYERS SQUIBB 50MG N020152 001 Dec 22, 1994
100MG N020152 002 Dec 22, 1994
150MG N020152 003 Dec 22, 1994
200MG N020152 004 Dec 22, 1994
250MG N020152 005 Dec 22, 1994
300MG N020152 006 Dec 22, 1994

NEOMYCIN SULFATE
SOLUTION; ORAL
MYCIFRADIN
PHARMACIA AND UPJOHN EQ 87.5MG BASE/5ML N050285 001
TABLET; ORAL
MYCIFRADIN
PHARMACIA AND UPJOHN EQ 350MG BASE A060520 001
NEOBIOTIC
PFIZER EQ 350MG BASE A060475 001
NEOMYCIN SULFATE
BRISTOL MYERS SQUIBB 500MG A060365 001
LANNETT 500MG A060607 001
LILLY 500MG A060385 001
ROXANE 500MG A062173 001
SANDOZ 500MG A061586 001

NEOMYCIN SULFATE; POLYMYXIN B SULFATE


CREAM; TOPICAL
NEOSPORIN
GLAXOSMITHKLINE EQ 3.5MG BASE/GM;10,000 UNITS/GM N050176 002 Jan 14, 1985
OINTMENT; OPHTHALMIC
STATROL
ALCON EQ 3.5MG BASE/GM;10,000 UNITS/GM N050344 002
SOLUTION/DROPS; OPHTHALMIC
STATROL
ALCON EQ 3.5MG BASE/ML;16,250 UNITS/ML A062339 001 Nov 30, 1984
EQ 3.5MG BASE/ML;16,250 UNITS/ML N050456 001

NEOMYCIN SULFATE; PREDNISOLONE ACETATE


OINTMENT; OPHTHALMIC
NEO-DELTA-CORTEF
PHARMACIA AND UPJOHN EQ 3.5MG BASE/GM;0.25% A061039 002
EQ 3.5MG BASE/GM;0.5% A061039 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 227 (of 324)

NEOMYCIN SULFATE; PREDNISOLONE ACETATE


SUSPENSION/DROPS; OPHTHALMIC
NEO-DELTA-CORTEF
PHARMACIA AND UPJOHN EQ 3.5MG BASE/ML;0.25% A061037 001

NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE


OINTMENT; OPHTHALMIC
NEO-HYDELTRASOL
MERCK EQ 3.5MG BASE/GM;EQ 0.25% PHOSPHATE N050378 001

NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE


CREAM; TOPICAL
MYTREX A
SAVAGE LABS EQ 3.5MG BASE/GM;0.1% A062598 001 Jul 21, 1986
NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE
FOUGERA EQ 3.5MG BASE/GM;0.1% A062600 001 Jul 21, 1986
PHARMADERM EQ 3.5MG BASE/GM;0.1% A062595 001 Jul 21, 1986
OINTMENT; TOPICAL
MYTREX A
SAVAGE LABS EQ 3.5MG BASE/GM;0.1% A062609 001 May 23, 1986
NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE
FOUGERA EQ 3.5MG BASE/GM;0.1% A062608 001 May 23, 1986
PHARMADERM EQ 3.5MG BASE/GM;0.1% A062607 001 May 23, 1986

NETILMICIN SULFATE
INJECTABLE; INJECTION
NETROMYCIN
SCHERING EQ 10MG BASE/ML N050544 001 Feb 28, 1983
EQ 25MG BASE/ML N050544 002 Feb 28, 1983
EQ 100MG BASE/ML N050544 003 Feb 28, 1983

NIACIN
CAPSULE; ORAL
WAMPOCAP
MEDPOINTE PHARM HLC 500MG N011073 003
TABLET; ORAL
NIACIN
EVERYLIFE 500MG A083203 001
HALSEY 500MG A083453 001
IMPAX LABS 500MG A083115 001
IVAX SUB TEVA PHARMS 500MG A083180 001
MK LABS 500MG A083525 001
PUREPAC PHARM 500MG A083271 001
SANDOZ 500MG A083306 001
TABLICAPS 500MG A084237 001
WATSON LABS 500MG A083136 001
500MG A083305 001
500MG A085172 001
WEST WARD 500MG A083718 001
NICOLAR
SANOFI AVENTIS US 500MG A083823 001
TABLET, EXTENDED RELEASE; ORAL
NIACIN
BARR 500MG A076378 001 Apr 26, 2005
750MG A076378 002 Apr 26, 2005
1GM A076250 001 Apr 14, 2005
NIASPAN
ABBOTT 375MG N020381 001 Jul 28, 1997
NIASPAN TITRATION STARTER PACK
ABBOTT 375MG;500MG;750MG N020381 005 Jul 28, 1997
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DISCONTINUED DRUG PRODUCT LIST 6 - 228 (of 324)

NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; TYROSINE


SUSPENSION; ORAL
TPN
INTL MINERALS 15MG/5ML;3.75MG/5ML;600MG/5ML N008378 003

NICLOSAMIDE
TABLET, CHEWABLE; ORAL
NICLOCIDE
BAYER PHARMS 500MG N018669 001 May 14, 1982

NICOTINE
FILM, EXTENDED RELEASE; TRANSDERMAL
NICOTROL
MCNEIL CONS 15MG/16HR N020536 001 Jul 03, 1996
PROSTEP
AVEVA 11MG/24HR N019983 003 Dec 23, 1998
22MG/24HR N019983 004 Dec 23, 1998

NICOTINE POLACRILEX
GUM, CHEWING; BUCCAL
NICOTINE POLACRILEX
WATSON LABS EQ 2MG BASE A076568 001 Jul 29, 2004
EQ 4MG BASE A076569 002 Jul 29, 2004

NIFEDIPINE
CAPSULE; ORAL
ADALAT
BAYER PHARMS 10MG N019478 001 Nov 27, 1985
20MG N019478 002 Sep 17, 1986
NIFEDIPINE
CATALENT 20MG A074045 001 Apr 30, 1992
CHASE LABS NJ 10MG A072409 001 Jul 04, 1990
20MG A073421 001 Jun 19, 1991
TEVA 10MG A072651 001 Feb 19, 1992
PROCARDIA
PFIZER 20MG N018482 002 Jul 24, 1986
TABLET, EXTENDED RELEASE; ORAL
NIFEDIPINE
MARTEC USA LLC 90MG A075414 003 Mar 23, 2004
MYLAN 30MG A075108 001 Dec 17, 1999

NILUTAMIDE
TABLET; ORAL
NILANDRON
SANOFI AVENTIS US 50MG N020169 001 Sep 19, 1996

NIMODIPINE
CAPSULE; ORAL
NIMOTOP
BAYER PHARMS 30MG N018869 001 Dec 28, 1988

NISOLDIPINE
TABLET, EXTENDED RELEASE; ORAL
SULAR
SCIELE PHARMA INC 10MG N020356 001 Feb 02, 1995
20MG N020356 002 Feb 02, 1995
30MG N020356 003 Feb 02, 1995
40MG N020356 004 Feb 02, 1995

NITROFURANTOIN
CAPSULE; ORAL
NITROFURANTOIN
WATSON LABS 50MG A084326 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 229 (of 324)

NITROFURANTOIN
CAPSULE; ORAL
NITROFURANTOIN
WATSON LABS 100MG A084326 002
TABLET; ORAL
FURADANTIN
PROCTER AND GAMBLE 50MG N008693 001
100MG N008693 002
FURALAN
LANNETT 50MG A080017 001
100MG A080017 002
NITROFURANTOIN
ELKINS SINN 50MG A080003 001
100MG A080003 002
IVAX SUB TEVA PHARMS 50MG A080078 002
100MG A080078 001
SANDOZ 50MG A080043 001
100MG A080043 002
WATSON LABS 50MG A080447 001
50MG A085797 001
100MG A080447 002
100MG A085796 001
WHITEWORTH TOWN PLSN 100MG A084085 002

NITROFURANTOIN SODIUM
INJECTABLE; INJECTION
IVADANTIN
PROCTER AND GAMBLE EQ 180MG BASE/VIAL N012402 001

NITROFURANTOIN, MACROCRYSTALLINE
CAPSULE; ORAL
NITROFURANTOIN
MYLAN 100MG A074967 002 Jul 09, 1997
SANDOZ 25MG A074336 001 Jan 25, 1995
50MG A074336 002 Jan 25, 1995
100MG A074336 003 Jan 25, 1995
NITROFURANTOIN MACROCRYSTALLINE
WATSON LABS 50MG A070248 001 Jun 24, 1988
100MG A070249 001 Jun 24, 1988

NITROFURAZONE
CREAM; TOPICAL
FURACIN
SHIRE 0.2% A083789 001
DRESSING; TOPICAL
ACTIN-N
SHERWOOD MEDCL 0.2% N017343 001
OINTMENT; TOPICAL
FURACIN
SHIRE 0.2% N005795 001
NITROFURAZONE
AMBIX 0.2% A086077 001
LANNETT 0.2% A084393 001
PERRIGO NEW YORK 0.2% A084968 001
TARO 0.2% A086156 001
WENDT 0.2% A086766 001
POWDER; TOPICAL
FURACIN
SHIRE 0.2% A083791 001
SOLUTION; TOPICAL
NITROFURAZONE
PERRIGO NEW YORK 0.2% A085130 001
WENDT 0.2% A087081 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 230 (of 324)

NITROGLYCERIN
AEROSOL; SUBLINGUAL
NITROLINGUAL
POHL BOSKAMP 0.4MG/SPRAY N018705 001 Oct 31, 1985
FILM, EXTENDED RELEASE; TRANSDERMAL
NITROGLYCERIN
MYLAN TECHNOLOGIES 0.1MG/HR A074992 004 Nov 12, 1999
0.2MG/HR A074992 003 Nov 12, 1999
0.4MG/HR A074992 002 Nov 12, 1999
0.6MG/HR A074992 001 Nov 12, 1999
TRANSDERM-NITRO
NOVARTIS 0.1MG/HR N020144 001 Feb 27, 1996
0.2MG/HR N020144 002 Feb 27, 1996
0.4MG/HR N020144 003 Feb 27, 1996
0.6MG/HR N020144 004 Feb 27, 1996
0.8MG/HR N020144 005 Feb 27, 1996
INJECTABLE; INJECTION
NITRO IV
POHL BOSKAMP 5MG/ML N018672 002 Aug 30, 1983
NITRO-BID
SANOFI AVENTIS US 5MG/ML N018621 001 Jan 05, 1982
10MG/ML A071159 001 Feb 28, 1990
NITROGLYCERIN
ABRAXIS PHARM 5MG/ML A070077 001 Dec 13, 1985
5MG/ML A071203 001 May 08, 1987
INTL MEDICATION 5MG/ML A070026 001 Sep 10, 1985
LUITPOLD 5MG/ML A071492 001 May 24, 1988
SMITH AND NEPHEW 5MG/ML A070633 001 Jun 19, 1986
5MG/ML A070634 001 Jun 19, 1986
NITROGLYCERIN IN DEXTROSE 5%
HOSPIRA 0.1MG/ML A074083 001 Oct 26, 1994
NITROL
RORER 0.8MG/ML N018774 001 Jan 19, 1983
NITRONAL
POHL BOSKAMP 1MG/ML N018672 001 Aug 30, 1983
NITROSTAT
PARKE DAVIS 0.8MG/ML N018588 001
5MG/ML A070863 001 Jan 08, 1987
5MG/ML N018588 002 Dec 23, 1983
10MG/ML A070871 001 Jan 08, 1987
10MG/ML A070872 001 Jan 08, 1987
TRIDIL
HOSPIRA 0.5MG/ML N018537 002 Jun 16, 1983
5MG/ML N018537 001

NIZATIDINE
CAPSULE; ORAL
NIZATIDINE
ZENITH GOLDLINE 150MG A075461 001 Jul 08, 2002
300MG A075461 002 Jul 08, 2002

NONOXYNOL-9
AEROSOL; VAGINAL
DELFEN
PERSONAL PRODS 12.5% N014349 002

NOREPINEPHRINE BITARTRATE; PROCAINE HYDROCHLORIDE; PROPOXYCAINE HYDROCHLORIDE


INJECTABLE; INJECTION
RAVOCAINE AND NOVOCAIN W/ LEVOPHED
EASTMAN KODAK EQ 0.033MG BASE/ML;2%;0.4% N008592 003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 231 (of 324)

NORETHINDRONE
TABLET; ORAL
NORLUTIN
PARKE DAVIS 5MG N010895 002

NORETHINDRONE ACETATE
TABLET; ORAL
NORLUTATE
PARKE DAVIS 5MG N012184 002

NORFLOXACIN
SOLUTION/DROPS; OPHTHALMIC
CHIBROXIN
MERCK 0.3% N019757 001 Jun 17, 1991

NORGESTREL
TABLET; ORAL
OVRETTE
WYETH PHARMS INC 0.075MG N017031 001

NORTRIPTYLINE HYDROCHLORIDE
CAPSULE; ORAL
AVENTYL HYDROCHLORIDE
LILLY EQ 10MG BASE N014684 001
EQ 25MG BASE N014684 002
NORTRIPTYLINE HYDROCHLORIDE
SANDOZ EQ 10MG BASE A074054 001 Dec 31, 1992
EQ 10MG BASE A074835 001 Jun 30, 1997
EQ 25MG BASE A074054 002 Dec 31, 1992
EQ 25MG BASE A074835 002 Jun 30, 1997
EQ 50MG BASE A074054 003 Dec 31, 1992
EQ 50MG BASE A074835 003 Jun 30, 1997
EQ 75MG BASE A074054 004 Dec 31, 1992
EQ 75MG BASE A074835 004 Jun 30, 1997
TEVA EQ 10MG BASE A073667 001 Apr 11, 1996
EQ 25MG BASE A073667 002 Apr 11, 1996
EQ 50MG BASE A073667 003 Apr 11, 1996
EQ 75MG BASE A073667 004 Apr 11, 1996

NOVOBIOCIN SODIUM
CAPSULE; ORAL
ALBAMYCIN
PHARMACIA AND UPJOHN EQ 250MG BASE N050339 001

NYSTATIN
CREAM; TOPICAL
CANDEX
BAYER PHARMS 100,000 UNITS/GM A061810 001
MYKINAC
ALPHARMA US PHARMS 100,000 UNITS/GM A062387 001 Jul 29, 1982
NILSTAT
LEDERLE 100,000 UNITS/GM A061445 001
NYSTATIN
TARO 100,000 UNITS/GM A062457 001 Jul 28, 1983
TEVA 100,000 UNITS/GM A061966 001
LOTION; TOPICAL
CANDEX
BAYER PHARMS 100,000 UNITS/ML N050233 001
OINTMENT; TOPICAL
MYCOSTATIN
WESTWOOD SQUIBB 100,000 UNITS/GM A060571 001
MYKINAC
ALPHARMA US PHARMS 100,000 UNITS/GM A062731 001 Sep 22, 1986
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 232 (of 324)

NYSTATIN
OINTMENT; TOPICAL
NILSTAT
LEDERLE 100,000 UNITS/GM A061444 001
PASTILLE; ORAL
MYCOSTATIN
BRISTOL MYERS SQUIBB 200,000 UNITS N050619 001 Apr 09, 1987
POWDER; ORAL
BARSTATIN 100
BARLAN 100% A062489 001 Apr 27, 1988
NILSTAT
DAVA PHARMS INC 100% N050576 001 Dec 22, 1983
NYSTATIN
PADDOCK 100% A062613 001 Nov 26, 1985
SUPPOSITORY; VAGINAL
NYSERT
PROCTER AND GAMBLE 100,000 UNITS N050478 001
SUSPENSION; ORAL
MYCOSTATIN
APOTHECON 100,000 UNITS/ML A061533 001
NYSTATIN
ALPHARMA US PHARMS 100,000 UNITS/ML A062571 001 Oct 29, 1985
MORTON GROVE 100,000 UNITS/ML A062835 001 Nov 19, 1987
PHARMADERM 100,000 UNITS/ML A062518 001 Jul 06, 1984
PHARMAFAIR 100,000 UNITS/ML A062541 001 Jan 16, 1985
ROXANE 100,000 UNITS/ML A062832 001 Dec 27, 1991
TEVA 100,000 UNITS/ML A062670 001 Jun 18, 1987
100,000 UNITS/ML A062776 001 Dec 17, 1987
NYSTEX
SAVAGE LABS 100,000 UNITS/ML A062519 001 Jul 06, 1984
TABLET; ORAL
MYCOSTATIN
BRISTOL MYERS SQUIBB 500,000 UNITS A060574 001
NILSTAT
LEDERLE 500,000 UNITS A061151 001
NYSTATIN
PAR PHARM 500,000 UNITS A062474 001 Dec 22, 1983
QUANTUM PHARMICS 500,000 UNITS A062525 001 Oct 29, 1984
SANDOZ 500,000 UNITS A062065 001
USL PHARMA 500,000 UNITS A062524 001 Nov 26, 1985
WATSON LABS 500,000 UNITS A062402 001 Dec 16, 1982
TABLET; VAGINAL
KOROSTATIN
HOLLAND RANTOS 100,000 UNITS A061718 001
MYCOSTATIN
BRISTOL MYERS SQUIBB 100,000 UNITS A060577 001
NILSTAT
LEDERLE 100,000 UNITS A061325 001
NYSTATIN
FOUGERA 100,000 UNITS A062459 001 Nov 09, 1983
PHARMADERM 100,000 UNITS A062460 001 Nov 09, 1983
QUANTUM PHARMICS 100,000 UNITS A062509 001 Apr 03, 1984
SANDOZ 100,000 UNITS A061965 001
TEVA 100,000 UNITS A062502 001 Dec 23, 1983
WATSON LABS 100,000 UNITS A062176 001

NYSTATIN; TRIAMCINOLONE ACETONIDE


CREAM; TOPICAL
MYCOLOG-II
APOTHECON 100,000 UNITS/GM;0.1% A060576 002 May 01, 1985
100,000 UNITS/GM;0.1% A062606 001 May 15, 1985
MYCO-TRIACET II
TEVA 100,000 UNITS/GM;0.1% A061954 002 Sep 20, 1985
MYTREX F
SAVAGE LABS 100,000 UNITS/GM;0.1% A062597 001 Oct 08, 1985
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 233 (of 324)

NYSTATIN; TRIAMCINOLONE ACETONIDE


CREAM; TOPICAL
NYSTATIN AND TRIAMCINOLONE ACETONIDE
ALPHARMA US PHARMS 100,000 UNITS/GM;0.1% A063010 001 Dec 20, 1988
PERRIGO NEW YORK 100,000 UNITS/GM;0.1% A062186 002 Jun 06, 1985
PHARMAFAIR 100,000 UNITS/GM;0.1% A062657 001 Jul 30, 1986
TARO 100,000 UNITS/GM;0.1% A062347 001 Mar 30, 1987
NYSTATIN-TRIAMCINOLONE ACETONIDE
PHARMADERM 100,000 UNITS/GM;0.1% A062596 001 Oct 08, 1985
OINTMENT; TOPICAL
MYCOLOG-II
APOTHECON 100,000 UNITS/GM;0.1% A060572 001 Jun 28, 1985
MYCO-TRIACET II
TEVA 100,000 UNITS/GM;0.1% A062045 002 Nov 26, 1985
MYTREX F
SAVAGE LABS 100,000 UNITS/GM;0.1% A062601 001 Oct 09, 1985
NYSTATIN AND TRIAMCINOLONE ACETONIDE
PERRIGO NEW YORK 100,000 UNITS/GM;0.1% A062280 002 Oct 10, 1985
PHARMAFAIR 100,000 UNITS/GM;0.1% A062656 001 Jul 30, 1986
NYSTATIN-TRIAMCINOLONE ACETONIDE
PHARMADERM 100,000 UNITS/GM;0.1% A062603 001 Oct 09, 1985

OFLOXACIN
INJECTABLE; INJECTION
FLOXIN
ORTHO MCNEIL PHARM 20MG/ML N020087 002 Mar 31, 1992
40MG/ML N020087 003 Mar 31, 1992
FLOXIN IN DEXTROSE 5%
ORTHO MCNEIL PHARM 400MG/100ML N020087 001 Mar 31, 1992
FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ORTHO MCNEIL PHARM 4MG/ML N020087 004 Mar 31, 1992
400MG/100ML N020087 005 Mar 31, 1992
OFLOXACIN
BEDFORD 40MG/ML A075762 001 Jan 16, 2002
TABLET; ORAL
FLOXIN
ORTHO MCNEIL JANSSEN 200MG N019735 001 Dec 28, 1990
300MG N019735 002 Dec 28, 1990
400MG N019735 003 Dec 28, 1990
OFLOXACIN
PAR PHARM 200MG A076093 001 Sep 02, 2003
300MG A076093 002 Sep 02, 2003
400MG A076093 003 Sep 02, 2003

ONDANSETRON HYDROCHLORIDE
INJECTABLE; INJECTION
ONDANSETRON HYDROCHLORIDE
HOSPIRA EQ 2MG BASE/ML A076695 001 Dec 26, 2006
TEVA EQ 2MG BASE/ML A076876 001 Nov 22, 2006
ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
HOSPIRA EQ 0.64MG BASE/ML A076978 001 Feb 26, 2007
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
HOSPIRA EQ 2MG BASE/ML A076696 001 Dec 26, 2006
TEVA EQ 2MG BASE/ML A076759 001 Nov 22, 2006

ORPHENADRINE CITRATE
TABLET, EXTENDED RELEASE; ORAL
NORFLEX
GRACEWAY 100MG N012157 001
ORPHENADRINE CITRATE
ASCOT 100MG A088067 001 Apr 06, 1983
SANDOZ 100MG A085046 001
WATSON LABS 100MG A084303 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 234 (of 324)

ORPHENADRINE HYDROCHLORIDE
TABLET; ORAL
DISIPAL
3M 50MG N010653 001

OXACILLIN SODIUM
CAPSULE; ORAL
BACTOCILL
GLAXOSMITHKLINE EQ 250MG BASE A061336 001
EQ 250MG BASE A062241 001
EQ 500MG BASE A061336 002
EQ 500MG BASE A062241 002
OXACILLIN SODIUM
APOTHECON EQ 250MG BASE A061450 002
EQ 500MG BASE A061450 001
TEVA EQ 250MG BASE A062222 001
EQ 500MG BASE A062222 002
PROSTAPHLIN
APOTHECON EQ 500MG BASE N050118 002
FOR SOLUTION; ORAL
BACTOCILL
GLAXOSMITHKLINE EQ 250MG BASE/5ML A062321 001
OXACILLIN SODIUM
APOTHECON EQ 250MG BASE/5ML A061457 001
TEVA EQ 250MG BASE/5ML A062252 001
PROSTAPHLIN
APOTHECON EQ 250MG BASE/5ML N050194 001
INJECTABLE; INJECTION
BACTOCILL
GLAXOSMITHKLINE EQ 500MG BASE/VIAL A061334 009 Mar 26, 1982
EQ 1GM BASE/VIAL A061334 006 Mar 26, 1982
EQ 1GM BASE/VIAL A062736 001 Dec 19, 1986
EQ 2GM BASE/VIAL A061334 007 Mar 26, 1982
EQ 2GM BASE/VIAL A062736 002 Dec 19, 1986
EQ 4GM BASE/VIAL A061334 008 Mar 26, 1982
EQ 10GM BASE/VIAL A061334 010
OXACILLIN SODIUM
APOTHECON EQ 250MG BASE/VIAL N050195 001
EQ 500MG BASE/VIAL N050195 002
EQ 1GM BASE/VIAL N050195 003
EQ 2GM BASE/VIAL N050195 004
EQ 4GM BASE/VIAL N050195 005
ELKINS SINN EQ 250MG BASE/VIAL A062711 001 Feb 03, 1989
EQ 500MG BASE/VIAL A062711 002 Feb 03, 1989
EQ 1GM BASE/VIAL A062711 003 Feb 03, 1989
EQ 2GM BASE/VIAL A062711 004 Feb 03, 1989
EQ 4GM BASE/VIAL A062711 005 Feb 03, 1989
EQ 10GM BASE/VIAL A062711 006 Feb 03, 1989
IBI EQ 125MG BASE/VIAL A062798 003 Dec 11, 1995
EQ 250MG BASE/VIAL A062798 004 Dec 11, 1995
EQ 500MG BASE/VIAL A062798 005 Dec 11, 1995
EQ 1GM BASE/VIAL A062798 001 Dec 11, 1995
EQ 2GM BASE/VIAL A062798 002 Dec 11, 1995
MARSAM PHARMS LLC EQ 10GM BASE/VIAL A062984 001 Sep 29, 1988
SANDOZ EQ 250MG BASE/VIAL A061490 001
EQ 500MG BASE/VIAL A061490 002
WATSON LABS EQ 250MG BASE/VIAL A062856 001 Oct 26, 1988
EQ 500MG BASE/VIAL A062856 002 Oct 26, 1988
EQ 1GM BASE/VIAL A062856 003 Oct 26, 1988
EQ 2GM BASE/VIAL A062856 004 Oct 26, 1988
EQ 4GM BASE/VIAL A062856 005 Oct 26, 1988
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 235 (of 324)

OXALIPLATIN
INJECTABLE; IV (INFUSION)
ELOXATIN
SANOFI AVENTIS US 50MG/VIAL N021492 001 Aug 09, 2002
100MG/VIAL N021492 002 Aug 09, 2002

OXAMNIQUINE
CAPSULE; ORAL
VANSIL
PFIZER 250MG N018069 001

OXANDROLONE
TABLET; ORAL
OXANDROLONE
ROXANE 2.5MG A077249 001 Jul 10, 2007
10MG A077249 002 Jul 10, 2007

OXAPROZIN
TABLET; ORAL
OXAPROZIN
MYLAN 600MG A075851 001 Aug 17, 2001
SANDOZ 600MG A075842 001 Apr 12, 2001
600MG A075850 001 Apr 27, 2001

OXAPROZIN POTASSIUM
TABLET; ORAL
DAYPRO ALTA
GD SEARLE 600MG N020776 001 Oct 17, 2002

OXAZEPAM
CAPSULE; ORAL
OXAZEPAM
AM THERAP 10MG A071955 001 Mar 03, 1988
15MG A071956 001 Mar 03, 1988
30MG A071957 001 Mar 03, 1988
MUTUAL PHARM 10MG A071026 002 Aug 10, 1987
15MG A071026 003 Aug 10, 1987
30MG A071026 001 Aug 10, 1987
MYLAN 10MG A071713 001 Oct 20, 1987
15MG A071714 001 Oct 20, 1987
30MG A071715 001 Oct 20, 1987
SERAX
ALPHARMA US PHARMS 10MG N015539 002
15MG N015539 004
30MG N015539 006
ZAXOPAM
QUANTUM PHARMICS 10MG A070650 001 Mar 01, 1988
15MG A070640 001 Mar 01, 1988
30MG A070641 001 Mar 01, 1988
TABLET; ORAL
OXAZEPAM
MUTUAL PHARM 15MG A070683 001 Jan 16, 1987
PARKE DAVIS 15MG A071508 001 Feb 02, 1987
WATSON LABS 15MG A071494 001 Apr 21, 1987
SERAX
ALPHARMA US PHARMS 15MG N015539 008

OXPRENOLOL HYDROCHLORIDE
CAPSULE; ORAL
TRASICOR
NOVARTIS 20MG N018166 001 Dec 28, 1983
40MG N018166 002 Dec 28, 1983
80MG N018166 003 Dec 28, 1983
160MG N018166 004 Dec 28, 1983
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 236 (of 324)

OXTRIPHYLLINE
SOLUTION; ORAL
CHOLEDYL
PARKE DAVIS 100MG/5ML N009268 012 Nov 27, 1984
OXTRIPHYLLINE
MORTON GROVE 100MG/5ML A088243 001 Dec 05, 1983
SYRUP; ORAL
CHOLEDYL
PARKE DAVIS 50MG/5ML N009268 011
OXTRIPHYLLINE PEDIATRIC
MORTON GROVE 50MG/5ML A088242 001 Dec 05, 1983
TABLET, DELAYED RELEASE; ORAL
CHOLEDYL
PARKE DAVIS 100MG N009268 003
200MG N009268 007
OXTRIPHYLLINE
WATSON LABS 100MG A087866 001 Aug 25, 1983
200MG A087835 001 Aug 25, 1983

OXYBUTYNIN CHLORIDE
SYRUP; ORAL
DITROPAN
ORTHO MCNEIL JANSSEN 5MG/5ML N018211 001
TABLET; ORAL
OXYBUTYNIN CHLORIDE
QUANTUM PHARMICS 5MG A072296 001 Dec 08, 1988
USL PHARMA 5MG A070746 001 Mar 10, 1988
WATSON LABS 5MG A072485 001 Apr 19, 1989

OXYCODONE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL
OXYCODONE HYDROCHLORIDE
TEVA 10MG A076610 001 Dec 06, 2005
20MG A076610 002 Dec 06, 2005
40MG A076610 003 Dec 06, 2005
80MG A076168 001 Mar 23, 2004
OXYCONTIN
PURDUE PHARMA LP 160MG N020553 005 Mar 15, 2000
ROXICODONE
ROXANE 10MG N020932 001 Oct 26, 1998
30MG N020932 002 Oct 26, 1998

OXYMORPHONE HYDROCHLORIDE
INJECTABLE; INJECTION
OPANA
ENDO PHARMS 1.5MG/ML N011707 001
SUPPOSITORY; RECTAL
NUMORPHAN
ENDO PHARMS 5MG N011738 004

OXYPHENBUTAZONE
TABLET; ORAL
OXYPHENBUTAZONE
WATSON LABS 100MG A088399 001 Sep 17, 1984
TANDEARIL
NOVARTIS 100MG N012542 004 Sep 03, 1982

OXYPHENCYCLIMINE HYDROCHLORIDE
TABLET; ORAL
DARICON
PFIZER 10MG N011612 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 237 (of 324)

OXYPHENONIUM BROMIDE
TABLET; ORAL
ANTRENYL
NOVARTIS 5MG N008492 002

OXYTETRACYCLINE
TABLET; ORAL
TERRAMYCIN
PFIZER 250MG N050287 001

OXYTETRACYCLINE CALCIUM
SYRUP; ORAL
TERRAMYCIN
PFIZER EQ 125MG BASE/5ML A060595 001

OXYTETRACYCLINE HYDROCHLORIDE
CAPSULE; ORAL
OXY-KESSO-TETRA
FERRANTE EQ 250MG BASE A060179 001
OXYTETRACYCLINE HYDROCHLORIDE
IMPAX LABS EQ 250MG BASE A060760 001
PROTER EQ 250MG BASE A060869 001
PUREPAC PHARM EQ 250MG BASE A060634 001
WEST WARD EQ 250MG BASE A060770 001
TERRAMYCIN
PFIZER EQ 125MG BASE N050286 001
EQ 250MG BASE N050286 002
INJECTABLE; INJECTION
TERRAMYCIN
PFIZER EQ 250MG BASE/VIAL A060586 001
EQ 500MG BASE/VIAL A060586 002

OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE


OINTMENT; OTIC

TERRAMYCIN W/ POLYMYXIN

PFIZER EQ 5MG BASE/GM;10,000 UNITS/GM A061841 001

TABLET; VAGINAL

TERRAMYCIN-POLYMYXIN

PFIZER EQ 100MG BASE;100,000 UNITS A061009 001

OXYTOCIN
INJECTABLE; INJECTION
OXYTOCIN 10 USP UNITS IN DEXTROSE 5%
ABBOTT 1USP UNITS/100ML N019185 004 Mar 29, 1985
2USP UNITS/100ML N019185 003 Mar 29, 1985
OXYTOCIN 20 USP UNITS IN DEXTROSE 5%
ABBOTT 2USP UNITS/100ML N019185 002 Mar 29, 1985
OXYTOCIN 5 USP UNITS IN DEXTROSE 5%
ABBOTT 1USP UNITS/100ML N019185 001 Mar 29, 1985
SYNTOCINON
NOVARTIS 10USP UNITS/ML N018245 001
SOLUTION; NASAL
SYNTOCINON
NOVARTIS 40USP UNITS/ML N012285 001

PACLITAXEL
INJECTABLE; INJECTION
PACLITAXEL
HOSPIRA 6MG/ML A076233 001 Aug 01, 2002
TEVA PARENTERAL 6MG/ML A075297 001 Jan 25, 2002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 238 (of 324)

PALIPERIDONE
TABLET, EXTENDED RELEASE; ORAL
INVEGA
ORTHO MCNEIL JANSSEN 12MG N021999 004 Dec 19, 2006

PAMIDRONATE DISODIUM
INJECTABLE; INJECTION
AREDIA
NOVARTIS 60MG/VIAL N020036 003 May 06, 1993

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
CAPSULE; ORAL
COTAZYM
ORGANON USA INC 30,000USP UNITS;8,000USP N020580 001 Dec 09, 1996
UNITS;30,000USP UNITS

PANCURONIUM BROMIDE
INJECTABLE; INJECTION

PANCURONIUM BROMIDE

ASTRAZENECA 1MG/ML A072210 001 Mar 31, 1988


2MG/ML A072211 001 Mar 31, 1988
2MG/ML A072212 001 Mar 31, 1988
2MG/ML A072213 001 Mar 31, 1988
HOSPIRA 2MG/ML A072321 001 Jan 19, 1989
PAVULON
ORGANON USA INC 1MG/ML N017015 002
2MG/ML N017015 001

PARAMETHADIONE
CAPSULE; ORAL

PARADIONE

ABBOTT 150MG N006800 003

300MG N006800 001

SOLUTION; ORAL

PARADIONE

ABBOTT
300MG/ML N006800 002

PARAMETHASONE ACETATE
TABLET; ORAL

HALDRONE

LILLY 1MG N012772 005

2MG N012772 006

PARGYLINE HYDROCHLORIDE
TABLET; ORAL

EUTONYL

ABBOTT 10MG N013448 002

25MG N013448 003

50MG N013448 004

PAROMOMYCIN SULFATE
CAPSULE; ORAL
HUMATIN

KING PHARMS EQ 250MG BASE A062310 001

PARKEDALE EQ 250MG BASE A060521 001

SYRUP; ORAL

HUMATIN

PARKE DAVIS EQ 125MG BASE/5ML A060522 001

PAROXETINE HYDROCHLORIDE
CAPSULE; ORAL
PAXIL
GLAXOSMITHKLINE EQ 10MG BASE N020885 001 Oct 09, 1998

EQ 20MG BASE N020885 002 Oct 09, 1998

30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 239 (of 324)

PAROXETINE HYDROCHLORIDE
CAPSULE; ORAL
PAXIL
GLAXOSMITHKLINE EQ 30MG BASE N020885 003 Oct 09, 1998
EQ 40MG BASE N020885 004 Oct 09, 1998
TABLET; ORAL
PAROXETINE HYDROCHLORIDE
ROXANE EQ 10MG BASE A078026 001 Jun 29, 2007
EQ 20MG BASE A078026 002 Jun 29, 2007
EQ 30MG BASE A078026 003 Jun 29, 2007
EQ 40MG BASE A078026 004 Jun 29, 2007
SANDOZ EQ 10MG BASE A075566 001 Mar 08, 2004
EQ 20MG BASE A075566 002 Mar 08, 2004
EQ 30MG BASE A075566 003 Mar 08, 2004
EQ 40MG BASE A075566 004 Mar 08, 2004
TEVA PHARMS EQ 10MG BASE A077082 001 Jun 29, 2007
EQ 20MG BASE A077082 002 Jun 29, 2007
EQ 30MG BASE A077082 003 Jun 29, 2007
EQ 40MG BASE A077082 004 Jun 29, 2007
PAXIL
GLAXOSMITHKLINE EQ 50MG BASE N020031 004 Dec 29, 1992

PEMOLINE
TABLET; ORAL
CYLERT
ABBOTT 18.75MG N016832 001
37.5MG N016832 002
75MG N016832 003
PEMOLINE
ACTAVIS TOTOWA 18.75MG A075595 001 Feb 28, 2000
37.5MG A075595 002 Feb 28, 2000
75MG A075595 003 Feb 28, 2000
MALLINCKRODT 18.75MG A075726 003 Mar 30, 2001
37.5MG A075726 002 Mar 30, 2001
75MG A075726 001 Mar 30, 2001
SANDOZ 18.75MG A075286 001 Dec 27, 1999
37.5MG A075286 002 Jun 30, 1999
75MG A075286 003 Jun 30, 1999
TEVA PHARMS 18.75MG A075030 003 Feb 22, 2000
37.5MG A075030 001 Jan 29, 1999
75MG A075030 002 Jan 29, 1999
VINTAGE PHARMS 18.75MG A075328 001 Apr 19, 2000
37.5MG A075328 002 Apr 19, 2000
75MG A075328 003 Apr 19, 2000
WATSON LABS 18.75MG A075287 001 Jun 13, 2001
37.5MG A075287 002 Sep 18, 2000
75MG A075287 003 Sep 18, 2000
TABLET, CHEWABLE; ORAL
CYLERT
ABBOTT 37.5MG N017703 001
PEMOLINE
ACTAVIS TOTOWA 37.5MG A075678 001 Jul 26, 2000
TEVA PHARMS 37.5MG A075555 001 Feb 18, 2000

PENBUTOLOL SULFATE
TABLET; ORAL
LEVATOL
SCHWARZ PHARMA 10MG N018976 001 Dec 30, 1987

PENICILLAMINE
CAPSULE; ORAL
CUPRIMINE
ATON 125MG N019853 002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 240 (of 324)

PENICILLIN G BENZATHINE
INJECTABLE; INJECTION

BICILLIN L-A

WYETH AYERST 300,000 UNITS/ML N050131 001

SUSPENSION; ORAL

BICILLIN

WYETH AYERST 300,000 UNITS/5ML N050126 002

TABLET; ORAL

BICILLIN

WYETH AYERST 200,000 UNITS N050128 001

PENICILLIN G POTASSIUM
FOR SOLUTION; ORAL
PENICILLIN
TEVA 200,000 UNITS/5ML A060307 002
400,000 UNITS/5ML A060307 004
PENICILLIN G POTASSIUM
MYLAN 200,000 UNITS/5ML A060752 003
250,000 UNITS/5ML A060752 002
400,000 UNITS/5ML A060752 001
PUREPAC PHARM 250,000 UNITS/5ML A061740 001
400,000 UNITS/5ML A061740 002
PENICILLIN-2
TEVA 250,000 UNITS/5ML A060307 003
PENTIDS '200'
APOTHECON 200,000 UNITS/5ML A062149 001
PENTIDS '400'
APOTHECON 400,000 UNITS/5ML A062149 002
PFIZERPEN G
PFIZER 400,000 UNITS/5ML A060587 001
INJECTABLE; INJECTION
PENICILLIN G POTASSIUM
APOTHECON 1,000,000 UNITS/VIAL A060362 001
5,000,000 UNITS/VIAL A060362 003
10,000,000 UNITS/VIAL A060362 004
20,000,000 UNITS/VIAL A060362 002
CONSOLIDATED PHARM 500,000 UNITS/VIAL A060806 001
1,000,000 UNITS/VIAL A060806 002
5,000,000 UNITS/VIAL A060806 003
10,000,000 UNITS/VIAL A060806 004
LILLY 200,000 UNITS/VIAL A060384 004
500,000 UNITS/VIAL A060384 003
1,000,000 UNITS/VIAL A060384 002
5,000,000 UNITS/VIAL A060384 001
20,000,000 UNITS/VIAL A060384 005
20,000,000 UNITS/VIAL A060601 001
MARSAM PHARMS LLC 1,000,000 UNITS/VIAL A062991 001 Sep 13, 1988
5,000,000 UNITS/VIAL A062991 002 Sep 13, 1988
10,000,000 UNITS/VIAL A062991 003 Sep 13, 1988
20,000,000 UNITS/VIAL A062991 004 Sep 13, 1988
PARKE DAVIS 1,000,000 UNITS/VIAL A062003 001
5,000,000 UNITS/VIAL A062003 002
PFIZER 20,000,000 UNITS/VIAL A060074 003
SANDOZ 1,000,000 UNITS/VIAL A065079 001 Aug 30, 2002
PFIZERPEN
PFIZER 1,000,000 UNITS/VIAL A060657 001
TABLET; ORAL
PENICILLIN G POTASSIUM
APOTHECON 250,000 UNITS A060392 003
IVAX SUB TEVA PHARMS 400,000 UNITS A060073 004
LILLY 250,000 UNITS A060403 001
MYLAN 200,000 UNITS A060781 001
250,000 UNITS A060781 002
400,000 UNITS A060781 003
500,000 UNITS A060781 005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 241 (of 324)

PENICILLIN G POTASSIUM
TABLET; ORAL
PENICILLIN G POTASSIUM
MYLAN 800,000 UNITS A060781 004
PUREPAC PHARM 200,000 UNITS A061588 001
250,000 UNITS A061588 002
400,000 UNITS A061588 003
TEVA 200,000 UNITS A060306 001
250,000 UNITS A060306 002
400,000 UNITS A060306 003
500,000 UNITS A060306 004
WYETH AYERST 200,000 UNITS A060413 001
250,000 UNITS A060413 002
400,000 UNITS A060413 003
PENTIDS '200'
APOTHECON 200,000 UNITS A062155 001
PENTIDS '250'
APOTHECON 250,000 UNITS A062155 002
PENTIDS '400'
APOTHECON 400,000 UNITS A060392 004
400,000 UNITS A062155 003
PENTIDS '800'
APOTHECON 800,000 UNITS A060392 005
800,000 UNITS A062155 004
PFIZERPEN G
PFIZER 50,000 UNITS A060075 001
100,000 UNITS A060075 002
200,000 UNITS A060075 003
250,000 UNITS A060075 004
400,000 UNITS A060075 005
800,000 UNITS A060075 006

PENICILLIN G PROCAINE
INJECTABLE; INJECTION
DURACILLIN A.S.
LILLY 300,000 UNITS/ML A060093 001
PENICILLIN G PROCAINE
CONSOLIDATED PHARM 300,000 UNITS/ML A060800 001
600,000 UNITS/1.2ML A060800 002
PARKE DAVIS 300,000 UNITS/ML A062029 001
PFIZER 300,000 UNITS/VIAL A060099 001
1,500,000 UNITS/VIAL A060099 002
PFIZERPEN-AS
PFIZER 300,000 UNITS/ML A060286 001
600,000 UNITS/ML A060286 002

PENICILLIN G SODIUM
INJECTABLE; IM-IV
PENICILLIN G SODIUM
MARSAM PHARMS LLC 5,000,000 UNITS/VIAL A063014 001 Sep 13, 1988
INJECTABLE; INJECTION
PENICILLIN G SODIUM
BRISTOL MYERS SQUIBB 5,000,000 UNITS/VIAL A061935 001
COPANOS 5,000,000 UNITS/VIAL A061051 001
PHARMACIA AND UPJOHN 1,000,000 UNITS/VIAL A061046 001

PENICILLIN V
FOR SUSPENSION; ORAL
V-CILLIN
LILLY 125MG/0.6ML A060002 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 242 (of 324)

PENICILLIN V POTASSIUM
FOR SOLUTION; ORAL
BEEPEN-VK
GLAXOSMITHKLINE EQ 125MG BASE/5ML
A062270
001
EQ 250MG BASE/5ML
A062270
002
BETAPEN-VK

APOTHECON
EQ 125MG BASE/5ML
A061149
001
EQ 250MG BASE/5ML
A061149
002
LEDERCILLIN VK
LEDERLE EQ 125MG BASE/5ML
A060136
001
EQ 250MG BASE/5ML
A060136
002
PENAPAR-VK
PARKE DAVIS EQ 125MG BASE/5ML
A062002
001
EQ 250MG BASE/5ML
A062002
002
PENICILLIN V POTASSIUM
AM ANTIBIOTICS EQ 125MG BASE/5ML A061529 001
EQ 250MG BASE/5ML A061529 002
MYLAN EQ 125MG BASE/5ML A061624 002
EQ 250MG BASE/5ML A061624 001
PUREPAC PHARM EQ 125MG BASE/5ML A061758 001
EQ 250MG BASE/5ML A061758 002
PEN-VEE K
WYETH AYERST EQ 125MG BASE/5ML A060007 001
EQ 250MG BASE/5ML A060007 002
PFIZERPEN VK

PFIZER
EQ 125MG BASE/5ML A061815 001
EQ 250MG BASE/5ML A061815 002
V-CILLIN K

LILLY
EQ 125MG BASE/5ML A060004 001
EQ 250MG BASE/5ML A060004 002
VEETIDS

APOTHECON
EQ 125MG BASE/5ML A061410 001
EQ 250MG BASE/5ML A061410 002
VEETIDS '125'
APOTHECON EQ 125MG BASE/5ML A061206 001
EQ 125MG BASE/5ML A062153 001
VEETIDS '250'
APOTHECON EQ 250MG BASE/5ML A061206 002
EQ 250MG BASE/5ML A062153 002
TABLET; ORAL
BEEPEN-VK
GLAXOSMITHKLINE EQ 250MG BASE A062273 001
EQ 500MG BASE A062273 002
BETAPEN-VK

BRISTOL
EQ 250MG BASE A061150 001
EQ 500MG BASE A061150 002
LEDERCILLIN VK
LEDERLE EQ 250MG BASE A060134 001
EQ 500MG BASE A060134 002
PENAPAR-VK
PARKE DAVIS EQ 250MG BASE A062001 001
EQ 500MG BASE A062001 002
PENICILLIN V POTASSIUM
AM ANTIBIOTICS EQ 250MG BASE A061528 001
EQ 500MG BASE A061528 002
IVAX SUB TEVA PHARMS EQ 125MG BASE A060518 001
EQ 250MG BASE A060518 002
EQ 500MG BASE A060518 003
MYLAN EQ 250MG BASE A061530 001
EQ 500MG BASE A061530 002
PUREPAC PHARM EQ 125MG BASE A061571 001
EQ 250MG BASE A061571 002
EQ 500MG BASE A061571 003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 243 (of 324)

PENICILLIN V POTASSIUM
TABLET; ORAL
PEN-VEE K
WYETH AYERST EQ 125MG BASE A060006 001
EQ 250MG BASE A060006 002
EQ 500MG BASE A060006 003
PFIZERPEN VK
PFIZER EQ 250MG BASE A061836 001
EQ 500MG BASE A061836 002
UTICILLIN VK
PHARMACIA AND UPJOHN EQ 250MG BASE A061651 001
EQ 500MG BASE A061651 002
V-CILLIN K
LILLY EQ 125MG BASE A060003 001
EQ 250MG BASE A060003 002
EQ 500MG BASE A060003 003
VEETIDS
APOTHECON EQ 250MG BASE A061411 001
EQ 500MG BASE A061411 002
VEETIDS '250'
APOTHECON EQ 250MG BASE A061164 001
EQ 250MG BASE A062156 002
VEETIDS '500'
APOTHECON EQ 500MG BASE A061164 002
EQ 500MG BASE A062156 001

PENTAGASTRIN
INJECTABLE; INJECTION
PEPTAVLON
WYETH AYERST 0.25MG/ML N017048 001

PENTAMIDINE ISETHIONATE
FOR SOLUTION; INHALATION
NEBUPENT
APP PHARMS 600MG/VIAL N019887 002 Mar 22, 1996
INJECTABLE; INJECTION
PENTACARINAT
ARMOUR PHARM 300MG/VIAL A073447 001 Apr 28, 1994
PENTAMIDINE ISETHIONATE
BAXTER HLTHCARE 300MG/VIAL A073617 001 Dec 18, 1995
HOSPIRA 300MG/VIAL A073479 001 Jun 30, 1992

PENTAZOCINE HYDROCHLORIDE
TABLET; ORAL
TALWIN 50
SANOFI AVENTIS US EQ 50MG BASE N016732 001

PENTETATE CALCIUM TRISODIUM YB-169


INJECTABLE; INJECTION
YTTERBIUM YB 169 DTPA
3M 2mCi/ML N017518 001

PENTOBARBITAL
ELIXIR; ORAL
NEMBUTAL
OVATION PHARMS 18.2MG/5ML A083244 001

PENTOBARBITAL SODIUM
CAPSULE; ORAL
NEMBUTAL SODIUM
OVATION PHARMS 30MG A084095 001
50MG A084093 001
100MG A083245 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 244 (of 324)

PENTOBARBITAL SODIUM
CAPSULE; ORAL
PENTOBARBITAL SODIUM
LANNETT 50MG A085937 001
100MG A085915 001
VITARINE 100MG A083284 001
WHITEWORTH TOWN PLSN 100MG A083338 001
SODIUM PENTOBARBITAL
ANABOLIC 100MG A084590 001
ELKINS SINN 100MG A083368 001
EVERYLIFE 100MG A083259 001
HALSEY 100MG A084677 001
IVAX SUB TEVA PHARMS 50MG A083461 001
100MG A083461 002
PARKE DAVIS 100MG A084156 001
PERRIGO 100MG A084560 001
PUREPAC PHARM 100MG A083301 001
VALEANT PHARM INTL 100MG A083264 001
WATSON LABS 100MG A085791 001
WYETH AYERST 100MG A083239 001
INJECTABLE; INJECTION
PENTOBARBITAL SODIUM
ELKINS SINN 50MG/ML A083270 001
SODIUM PENTOBARBITAL
WYETH AYERST 50MG/ML A083261 001
SUPPOSITORY; RECTAL
NEMBUTAL
OVATION PHARMS 30MG A083247 001 Jan 25, 1982
60MG A083247 002 Jan 25, 1982
120MG A083247 003 Jan 25, 1982
200MG A083247 004 Jan 25, 1982
TABLET; ORAL
PENTOBARBITAL SODIUM
VITARINE 100MG A083285 001
SODIUM PENTOBARBITAL
NEXGEN PHARMA INC 100MG A084238 001

PENTOLINIUM TARTRATE
INJECTABLE; INJECTION
ANSOLYSEN
WYETH AYERST 10MG/ML N009372 001

PENTOXIFYLLINE
TABLET, EXTENDED RELEASE; ORAL
PENTOXIFYLLINE
ACTAVIS ELIZABETH 400MG A074878 001 Jul 09, 1997
HERITAGE PHARMS INC 400MG A074877 001 Jul 08, 1997
TEVA 400MG A075199 001 Sep 03, 1999

PERFLUBRON
LIQUID; ORAL
IMAGENT
ALLIANCE PHARM 100% N020091 001 Aug 13, 1993

PERFLUOROPOLYMETHYLISOPROPYL ETHER; POLYTETRAFLUOROETHYLENE


PASTE; TOPICAL
SKIN EXPOSURE REDUCTION PASTE AGAINST CHEMICAL WARFARE AGENTS
US ARMY 50%;50% N021084 001 Feb 17, 2000

PERGOLIDE MESYLATE
TABLET; ORAL
PERGOLIDE MESYLATE
IVAX SUB TEVA PHARMS EQ 0.05MG BASE A076094 001 Sep 04, 2003
EQ 0.25MG BASE A076094 002 Sep 04, 2003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 245 (of 324)

PERGOLIDE MESYLATE
TABLET; ORAL
PERGOLIDE MESYLATE
IVAX SUB TEVA PHARMS EQ 1MG BASE A076094 003 Sep 04, 2003
PAR PHARM EQ 0.05MG BASE A076061 001 Nov 27, 2002
EQ 0.25MG BASE A076061 002 Nov 27, 2002
EQ 1MG BASE A076061 003 Nov 27, 2002
PERMAX
VALEANT PHARM INTL EQ 0.05MG BASE N019385 001 Dec 30, 1988
EQ 0.25MG BASE N019385 002 Dec 30, 1988
EQ 1MG BASE N019385 003 Dec 30, 1988

PERMETHRIN
LOTION; TOPICAL
NIX
GLAXOSMITHKLINE 1% N019435 001 Mar 31, 1986

PERPHENAZINE
CONCENTRATE; ORAL
TRILAFON
SCHERING 16MG/5ML N011557 001
INJECTABLE; INJECTION
TRILAFON
SCHERING 5MG/ML N011213 002
SYRUP; ORAL
TRILAFON
SCHERING 2MG/5ML N011294 002
TABLET; ORAL
PERPHENAZINE
IVAX PHARMS 2MG A089707 001 Sep 10, 1987
4MG A089708 001 Sep 10, 1987
8MG A089456 001 Sep 10, 1987
16MG A089457 001 Sep 10, 1987
TRILAFON
SCHERING 2MG N010775 001
4MG N010775 002
8MG N010775 003
16MG N010775 004
TABLET, EXTENDED RELEASE; ORAL
TRILAFON
SCHERING 8MG N011361 002

PHENACEMIDE
TABLET; ORAL
PHENURONE
ABBOTT 500MG N007707 001

PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE


TABLET; ORAL
AZO GANTANOL
ROCHE 100MG;500MG N013294 001 Sep 10, 1987

PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE; TRIMETHOPRIM


TABLET; ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PENAZOPYRIDINE HYDROCHLORIDE
ABLE 200MG,N/A,N/A;N/A,800MG,160MG N021105 001 Jun 26, 2001

PHENAZOPYRIDINE HYDROCHLORIDE; SULFISOXAZOLE


TABLET; ORAL
AZO GANTRISIN
ROCHE 50MG;500MG N019358 001 Aug 31, 1990
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 246 (of 324)

PHENDIMETRAZINE TARTRATE
CAPSULE; ORAL
PHENAZINE
MAST MM 35MG A086523 001
35MG A086524 001
35MG A086525 001
PHENDIMETRAZINE TARTRATE
SANDOZ 35MG A085633 001
35MG A085694 001
35MG A085695 001
35MG A085702 001
VITARINE 35MG A085634 001
35MG A085645 001
35MG A085670 001
35MG A086403 001
35MG A086408 001
35MG A086410 001
35MG A087424 001
SPRX-3
SOLVAY 35MG A085897 001
STATOBEX
TEVA 35MG A085507 001
X-TROZINE
SHIRE RICHWOOD 35MG A087394 001 Sep 22, 1982
CAPSULE, EXTENDED RELEASE; ORAL
MELFIAT-105
NUMARK 105MG A087487 001 Oct 13, 1982
PHENDIMETRAZINE TARTRATE
GRAHAM DM 105MG A087214 001 May 26, 1982
105MG A088020 001 Aug 16, 1982
105MG A088028 001 Aug 16, 1982
105MG A088062 001 Sep 13, 1982
105MG A088063 001 Sep 10, 1982
105MG A088111 001 Oct 18, 1982
SANDOZ 105MG A087378 001
SPRX-105
NUMARK 105MG A088024 001 Dec 22, 1982
X-TROZINE L.A.
SHIRE RICHWOOD 105MG A087371 001 Aug 24, 1982
TABLET; ORAL
ADPHEN
FERNDALE LABS 35MG A083655 001
ALPHAZINE
SANDOZ 35MG A085034 001
CAM-METRAZINE
ABC HOLDING 35MG A085511 001
CAMALL 35MG A085756 001
TG UNITED LABS 35MG A083922 001
35MG A085318 001
35MG A085320 001
35MG A085321 001
DI-METREX
PVT FORM 35MG A085698 001
MELFIAT
NUMARK 35MG A083790 002
METRA
FOREST PHARMS 35MG A083754 001
PHENAZINE
MAST MM 35MG A087305 001
PHENAZINE-35
ABC HOLDING 35MG A085512 001
PHENDIMETRAZINE TARTRATE
BARR 35MG A083644 001
35MG A083684 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 247 (of 324)

PHENDIMETRAZINE TARTRATE
TABLET; ORAL
PHENDIMETRAZINE TARTRATE
BARR 35MG A083686 001
35MG A083687 001
35MG A084831 001
35MG A084834 001
35MG A084835 001
FERNDALE LABS 35MG A086834 001 Sep 15, 1983
INWOOD LABS 35MG A084740 001
35MG A084741 001
35MG A084742 001
35MG A084743 001
IVAX PHARMS 35MG A085611 001
35MG A085612 001
IVAX SUB TEVA PHARMS 35MG A083682 001
KV PHARM 35MG A084138 001
35MG A084141 001
35MG A085525 001
MFG CHEMISTS 35MG A085914 001
NEXGEN PHARMA INC 35MG A086020 001
NUMARK 35MG A083790 001
PVT FORM 35MG A085199 001
35MG A085697 001
SANDOZ 35MG A085402 001
35MG A085497 001
35MG A085830 001
35MG A086365 001
35MG A086370 001
SOLVAY 35MG A083993 001
TG UNITED LABS 35MG A085761 001
35MG A085941 001 Jun 27, 1983
USL PHARMA 35MG A083805 001
35MG A084398 001
35MG A084399 001
VITARINE 35MG A085519 001
35MG A086005 001
35MG A086106 001
WATSON LABS 35MG A085767 001
35MG A085768 001
35MG A085770 001
35MG A085773 001
PLEGINE
WYETH AYERST 35MG N012248 001
STATOBEX
TEVA 35MG A086013 001
STATOBEX-G
TEVA 35MG A085095 001
X-TROZINE
SHIRE RICHWOOD 35MG A086550 001
35MG A086551 001
35MG A086552 001
35MG A086553 001
35MG A086554 001

PHENINDIONE
TABLET; ORAL
HEDULIN
SANOFI AVENTIS US 50MG N008767 002

PHENMETRAZINE HYDROCHLORIDE
TABLET; ORAL
PRELUDIN
BOEHRINGER INGELHEIM 25MG N010460 005
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 248 (of 324)

PHENMETRAZINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL
PRELUDIN
BOEHRINGER INGELHEIM 50MG N011752 004
75MG N011752 003

PHENPROCOUMON
TABLET; ORAL
LIQUAMAR
ORGANON USA INC 3MG N011228 001

PHENSUXIMIDE
CAPSULE; ORAL
MILONTIN
PARKE DAVIS 500MG N008855 004

PHENTERMINE HYDROCHLORIDE
CAPSULE; ORAL
FASTIN
GLAXOSMITHKLINE 30MG N017352 001
OBESTIN-30
FERNDALE LABS 30MG A087144 001
OBY-TRIM
SHIRE RICHWOOD 30MG A087764 001 Mar 18, 1982
ONA-MAST
MAST MM 30MG A086511 001
30MG A086516 001
PHENTERMINE HYDROCHLORIDE
ABC HOLDING 30MG A085411 001
ABLE 15MG A040497 001 Mar 13, 2003
30MG A040403 001 Aug 30, 2001
30MG A040427 001 Aug 30, 2001
CAMALL 15MG A086735 001
30MG A087226 001
DURAMED PHARMS BARR 30MG A088948 001 Apr 25, 1986
IVAX PHARMS 30MG A086329 001
MUTUAL PHARM 37.5MG A040527 001 Oct 23, 2003
SANDOZ 30MG A087208 001
30MG A087223 001
37.5MG A088414 001 Oct 19, 1983
TEVA 30MG A086911 001
30MG A087126 001
30MG A087777 001 Nov 01, 1985
30MG A088612 001 Apr 04, 1984
30MG A088613 001 Apr 09, 1984
30MG A088614 001 Apr 09, 1984
TG UNITED INC 30MG A040083 001 Mar 07, 1997
TG UNITED LABS 18.75MG A088576 001 May 23, 1984
30MG A085417 001
30MG A086732 002
30MG A087215 001
37.5MG A087915 001 Dec 22, 1983
37.5MG A087918 001 Dec 22, 1983
37.5MG A087930 001 Oct 14, 1983
37.5MG A088610 001 Jun 04, 1984
37.5MG A088611 001 Jun 04, 1984
37.5MG A088625 001 Aug 23, 1984
USL PHARMA 30MG A084487 001 Apr 09, 1982
30MG A088430 001 Mar 27, 1984
30MG A088797 001 Dec 10, 1984
VITARINE 30MG A087202 001
30MG A087235 001
WATSON LABS 30MG A086740 001 Mar 21, 1985
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DISCONTINUED DRUG PRODUCT LIST 6 - 249 (of 324)

PHENTERMINE HYDROCHLORIDE
TABLET; ORAL
ONA-MAST
MAST MM 8MG A086260 001
PHENTERMINE HYDROCHLORIDE
ABLE 37.5MG A040402 001 Aug 30, 2001
IVAX PHARMS 8MG A085553 001
SANDOZ 8MG A085671 001
8MG A085689 001
TG UNITED LABS 8MG A083923 001
8MG A085319 001
37.5MG A087805 001 Dec 06, 1982
37.5MG A088596 001 Apr 04, 1984
USL PHARMA 8MG A083804 001
37.5MG A088910 001 Jul 17, 1985
37.5MG A088917 001 Jul 17, 1985
VITARINE 8MG A086453 001
8MG A086456 001
WATSON LABS 8MG A085739 001
TORA
SOLVAY 8MG A084035 001

PHENTERMINE RESIN COMPLEX


CAPSULE, EXTENDED RELEASE; ORAL
IONAMIN
UCB INC EQ 15MG BASE N011613 004
EQ 30MG BASE N011613 002
PHENTERMINE RESIN 30
QUANTUM PHARMICS EQ 30MG BASE A089120 001 Feb 04, 1988

PHENYL AMINOSALICYLATE
POWDER; ORAL

PHENY-PAS-TEBAMIN

PHARM RES ASSOC 50% N011695 002

TABLET; ORAL

PHENY-PAS-TEBAMIN

PHARM RES ASSOC 500MG N011695 003

PHENYLBUTAZONE
CAPSULE; ORAL
AZOLID
SANOFI AVENTIS US 100MG A087260 001
BUTAZOLIDIN
NOVARTIS 100MG N008319 009
PHENYLBUTAZONE
IVAX PHARMS 100MG A088218 001 Jun 24, 1983
MUTUAL PHARM 100MG A088994 001 Dec 04, 1985
SANDOZ 100MG A087774 001 Jun 16, 1982
WATSON LABS 100MG A087756 001 Dec 17, 1982
TABLET; ORAL
AZOLID
SANOFI AVENTIS US 100MG A087091 001
BUTAZOLIDIN
NOVARTIS 100MG N008319 008
PHENYLBUTAZONE
MUTUAL PHARM 100MG A088863 001 Dec 04, 1985
SANDOZ 100MG A084339 001
WATSON LABS 100MG A086151 001
100MG A087674 001 Apr 21, 1982

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE


SYRUP; ORAL
PHENERGAN VC
ANI PHARMS 5MG/5ML;6.25MG/5ML N008604 003 Apr 02, 1984
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DISCONTINUED DRUG PRODUCT LIST 6 - 250 (of 324)

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE


SYRUP; ORAL
PHERAZINE VC
HALSEY 5MG/5ML;6.25MG/5ML A088868 001 Mar 02, 1987
PROMETHAZINE VC PLAIN
CENCI 5MG/5ML;6.25MG/5ML A088815 001 Nov 22, 1985
MORTON GROVE 5MG/5ML;6.25MG/5ML A088897 001 Jan 04, 1985

PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE


SOLUTION/DROPS; OPHTHALMIC
PREFRIN-A
ALLERGAN 0.12%;0.1% N007953 001

PHENYTOIN
SUSPENSION; ORAL
DILANTIN-30
PARKE DAVIS 30MG/5ML N008762 002
PHENYTOIN
ACTAVIS MID ATLANTIC 125MG/5ML A089892 001 Sep 25, 1992

PHENYTOIN SODIUM
CAPSULE; ORAL
DIPHENYLAN SODIUM
LANNETT 30MG PROMPT A080857 001
100MG PROMPT A080857 002
EXTENDED PHENYTOIN SODIUM
BARR 100MG EXTENDED A040435 001 Jun 20, 2003
PLIVA 100MG EXTENDED A089441 001 Dec 18, 1986
PHENYTEX
WATSON LABS 100MG EXTENDED A088711 001 Dec 21, 1984
PHENYTOIN SODIUM
PHARMERAL 100MG PROMPT A085435 001
WATSON LABS 100MG PROMPT A085894 001
PROMPT PHENYTOIN SODIUM
IVAX SUB TEVA PHARMS 100MG PROMPT A080259 001
WATSON LABS 100MG PROMPT A080905 001
INJECTABLE; INJECTION
DILANTIN
PARKE DAVIS 50MG/ML N010151 001
PHENYTOIN SODIUM
APP PHARMS 50MG/ML A089003 001 May 31, 1985
MARSAM PHARMS LLC 50MG/ML A089501 001 Oct 13, 1987
50MG/ML A089779 001 Nov 27, 1992
SMITH AND NEPHEW 50MG/ML A088519 001 Dec 19, 1984
50MG/ML A088521 001 Dec 18, 1984
SOLOPAK 50MG/ML A088520 001 Dec 17, 1984
WARNER CHILCOTT 50MG/ML A089900 001 Mar 30, 1990
WATSON LABS 50MG/ML A085434 001

PHYTONADIONE
INJECTABLE; INJECTION
AQUAMEPHYTON
ATON 1MG/0.5ML N012223 002
10MG/ML N012223 001
KONAKION
ROCHE 1MG/0.5ML N011745 001
10MG/ML N011745 003
PHYTONADIONE
GLAXOSMITHKLINE 1MG/0.5ML A084060 001
10MG/ML A084060 002
VITAMIN K1
HOSPIRA 10MG/ML A087956 001 Jul 25, 1983
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DISCONTINUED DRUG PRODUCT LIST 6 - 251 (of 324)

PILOCARPINE
INSERT, EXTENDED RELEASE; OPHTHALMIC
OCUSERT PILO-20
AKORN 5MG N017431 001
OCUSERT PILO-40
AKORN 11MG N017548 001

PINACIDIL
CAPSULE, EXTENDED RELEASE; ORAL
PINDAC
LEO PHARM 12.5MG N019456 001 Dec 28, 1989
25MG N019456 002 Dec 28, 1989

PINDOLOL
TABLET; ORAL
PINDOLOL
GENPHARM 5MG A074013 001 Sep 24, 1992
10MG A074018 001 Sep 24, 1992
IVAX SUB TEVA PHARMS 5MG A073687 001 Feb 26, 1993
10MG A073687 002 Feb 26, 1993
MUTUAL PHARM 5MG A074063 001 Jan 27, 1994
10MG A074063 002 Jan 27, 1994
NOSTRUM LABS 5MG A074474 001 Oct 28, 1996
10MG A074474 002 Oct 28, 1996
PUREPAC PHARM 5MG A074125 001 Apr 28, 1993
10MG A074125 002 Apr 28, 1993
SANDOZ 5MG A073608 001 Mar 29, 1993
10MG A073609 001 Mar 29, 1993
TEVA 5MG A073661 001 Oct 31, 1993
5MG A074123 001 Apr 17, 1997
10MG A073661 002 Oct 31, 1993
10MG A074123 002 Apr 17, 1997
VISKEN
NOVARTIS 5MG N018285 001 Sep 03, 1982
10MG N018285 002 Sep 03, 1982

PIPECURONIUM BROMIDE
INJECTABLE; INJECTION
ARDUAN
ORGANON USA INC 10MG/VIAL N019638 001 Jun 26, 1990

PIPERACETAZINE
TABLET; ORAL
QUIDE
DOW PHARM 10MG N013615 001
25MG N013615 002

PIPERACILLIN SODIUM
INJECTABLE; INJECTION
PIPRACIL
WYETH PHARMS INC EQ 2GM BASE/VIAL A062750 001 Oct 13, 1987
EQ 2GM BASE/VIAL N050545 002
EQ 3GM BASE/VIAL A062750 002 Oct 13, 1987
EQ 3GM BASE/VIAL N050545 003
EQ 4GM BASE/VIAL A062750 003 Oct 13, 1987
EQ 4GM BASE/VIAL N050545 004
EQ 40GM BASE/VIAL N050545 006 Sep 30, 1985

PIPERAZINE CITRATE
SYRUP; ORAL
ANTEPAR
GLAXOSMITHKLINE EQ 500MG BASE/5ML N009102 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 252 (of 324)

PIPERAZINE CITRATE
SYRUP; ORAL
BRYREL
SANOFI AVENTIS US EQ 500MG BASE/5ML N017796 001
MULTIFUGE
BLULINE EQ 500MG BASE/5ML N009452 001
PIPERAZINE CITRATE
ALPHARMA US PHARMS EQ 500MG BASE/5ML A080774 001
LANNETT EQ 500MG BASE/5ML A080963 001
LUITPOLD EQ 500MG BASE/5ML A080671 001
VERMIDOL
SOLVAY EQ 500MG BASE/5ML A080992 001
TABLET; ORAL
ANTEPAR
GLAXOSMITHKLINE EQ 500MG BASE N009102 003
PIPERAZINE CITRATE
IMPAX LABS EQ 250MG BASE A080874 001

PIPOBROMAN
TABLET; ORAL
VERCYTE
ABBOTT 10MG N016245 001
25MG N016245 002

PIRBUTEROL ACETATE
AEROSOL, METERED; INHALATION
MAXAIR
GRACEWAY EQ 0.2MG BASE/INH N019009 001 Dec 30, 1986

PIROXICAM
CAPSULE; ORAL
PIROXICAM
EGIS 10MG A074808 001 Jul 08, 1997
20MG A074808 002 Jul 08, 1997
GENPHARM 10MG A074043 001 Sep 22, 1992
20MG A074043 002 Sep 22, 1992
IVAX SUB TEVA PHARMS 10MG A074148 001 Jun 03, 1996
20MG A074148 002 Jun 03, 1996
MUTUAL PHARM 20MG A073536 001 Mar 12, 1993
ROXANE 10MG A073651 001 Feb 26, 1993
20MG A073651 002 Feb 26, 1993
SCS 10MG A074036 001 May 29, 1992
20MG A074036 002 May 29, 1992
TEVA 10MG A073637 001 Jan 28, 1994
20MG A073638 001 Jan 28, 1994
TEVA PHARMS 10MG A074103 001 Aug 28, 1992
20MG A074103 002 Aug 28, 1992

PLICAMYCIN
INJECTABLE; INJECTION
MITHRACIN
PFIZER 2.5MG/VIAL N050109 001

POLYESTRADIOL PHOSPHATE
INJECTABLE; INJECTION
ESTRADURIN
WYETH AYERST 40MG/AMP N010753 001

POLYETHYLENE GLYCOL 3350


FOR SOLUTION; ORAL
POLYETHYLENE GLYCOL 3350
TEVA PHARMS 17GM/SCOOPFUL A077445 001 May 04, 2006
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POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE;


SODIUM SULFATE
SOLUTION; ORAL
OCL
HOSPIRA 6GM/100ML;75MG/100ML;168MG/100ML;146MG/ N019284 001 Apr 30, 1986
100ML;1.29GM/100ML

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE;


SODIUM SULFATE ANHYDROUS
FOR SOLUTION; ORAL
COLYTE
ALAVEN PHARM 120GM/PACKET;1.49GM/PACKET;3.36GM/PACKE N018983 005 Oct 26, 1984
T;2.92GM/PACKET;11.36GM/PACKET
227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC N018983 004 Oct 26, 1984
KET;5.53GM/PACKET;21.5GM/PACKET
360GM/PACKET;4.47GM/PACKET;10.08GM/PACK N018983 006 Oct 26, 1984
ET;8.76GM/PACKET;34.08GM/PACKET
FOR SUSPENSION; ORAL
CO-LAV
BOCA PHARMA 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ A073428 001 Jan 28, 1992
BOT;22.72GM/BOT
COLOVAGE
DYNAPHARM 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC A071320 001 Apr 20, 1988
KET;5.53GM/PACKET;21.5GM/PACKET
E-Z-EM PREP LYTE
E Z EM 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A071278 001 Nov 21, 1988
BOT;22.74GM/BOT
GLYCOPREP
GOLDLINE 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A072319 001 Dec 23, 1988
BOT;22.74GM/BOT
GO-EVAC
BOCA PHARMA 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A073433 001 Apr 28, 1992
BOT;22.74GM/BOT
PEG-LYTE
SANDOZ 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A073098 001 Aug 31, 1993
BOT;22.74GM/BOT

POLYMYXIN B SULFATE
INJECTABLE; INJECTION
AEROSPORIN
GLAXOSMITHKLINE EQ 500,000 U BASE/VIAL A062036 001
POWDER; FOR RX COMPOUNDING
POLYMYXIN B SULFATE
PADDOCK 100,000,000 UNITS/BOT A062455 001 Jul 27, 1983

POLYTHIAZIDE
TABLET; ORAL

RENESE

PFIZER 1MG N012845 001


2MG N012845 002


4MG N012845 003


POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDE


CAPSULE; ORAL

MINIZIDE

PFIZER 0.5MG;EQ 1MG BASE N017986 001


0.5MG;EQ 2MG BASE N017986 002


0.5MG;EQ 5MG BASE N017986 003


POLYTHIAZIDE; RESERPINE
TABLET; ORAL

RENESE-R

PFIZER 2MG;0.25MG N013636 001


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POTASSIUM AMINOSALICYLATE
CAPSULE; ORAL

PASKALIUM

GLENWOOD 500MG N009395 004


POWDER; ORAL

POTASSIUM AMINOSALICYLATE

HEXCEL 100% A080098 001


TABLET; ORAL

PASKALIUM

GLENWOOD 1GM N009395 003


POTASSIUM CHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
K-LEASE
SAVAGE LABS 8MEQ A073398 001 Jan 28, 1992
10MEQ A072427 001 Mar 28, 1990
MICRO-K
KV PHARM 8MEQ N018238 001
MICRO-K 10
KV PHARM 10MEQ N018238 002 May 14, 1984
POTASSIUM CHLORIDE
KV PHARM 10MEQ A070980 001 Feb 17, 1987
TEVA 8MEQ A073531 001 Apr 26, 1996
10MEQ A073532 001 Apr 26, 1996
FOR SUSPENSION, EXTENDED RELEASE; ORAL
MICRO-K LS
KV PHARM 20MEQ/PACKET N019561 003 Aug 26, 1988
INJECTABLE; INJECTION
POTASSIUM CHLORIDE
ABRAXIS PHARM 2MEQ/ML A080204 001
2MEQ/ML A084290 001
2MEQ/ML A086713 001
2MEQ/ML A086714 001
2MEQ/ML A087787 001 Apr 20, 1982
2MEQ/ML A087885 001 Feb 03, 1983
AKORN 2MEQ/ML A088286 001 Sep 05, 1985
APP PHARMS 2MEQ/ML A087817 001 Oct 20, 1982
BAXTER HLTHCARE 2MEQ/ML A080203 001
GD SEARLE LLC 1MEQ/ML A086219 001
2MEQ/ML A086219 002
2MEQ/ML A086220 002
3MEQ/ML A086219 003
3MEQ/ML A086220 001
4MEQ/ML A086219 004
HOSPIRA 1MEQ/ML A080205 003
1MEQ/ML A083345 003
1.5MEQ/ML A083345 001
2MEQ/ML A083345 002
2.4MEQ/ML A080205 004
3.2MEQ/ML A080205 005
LILLY 2MEQ/ML N007865 002
LUITPOLD 2MEQ/ML A080221 001
2MEQ/ML A080736 001
2MEQ/ML A087584 001
2MEQ/ML A087585 001
MILES 1MEQ/ML A080195 002
2MEQ/ML A080195 001
3MEQ/ML A080195 003
4MEQ/ML A080195 004
PHARMA SERVE NY 2MEQ/ML A086297 001
2MEQ/ML A087362 001 Mar 08, 1983
WATSON LABS 2MEQ/ML A086208 001
2MEQ/ML A089163 001 Mar 10, 1988
2MEQ/ML A089421 001 Jan 02, 1987
3MEQ/ML A086210 001
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POTASSIUM CHLORIDE
TABLET, EXTENDED RELEASE; ORAL
K+8
FUTURE PAK 8MEQ A070998 001 Jan 25, 1993
KAON CL
SAVAGE LABS 6.7MEQ N017046 001
POTASSIUM CHLORIDE
COPLEY PHARM 8MEQ A070618 001 Sep 09, 1987
SLOW-K
NOVARTIS 8MEQ N017476 002
TEN-K
NOVARTIS 10MEQ N019381 001 Apr 16, 1986

POTASSIUM CHLORIDE; SODIUM CHLORIDE


INJECTABLE; INJECTION
POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 37MG/100ML;900MG/100ML N019708 001 Sep 29, 1989
POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 75MG/100ML;900MG/100ML N019708 002 Sep 29, 1989
POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 110MG/100ML;900MG/100ML N019708 003 Sep 29, 1989
POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 220MG/100ML;900MG/100ML N019708 005 Sep 29, 1989
POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 300MG/100ML;900MG/100ML N019708 006 Sep 29, 1989
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
B BRAUN 75MG/100ML;900MG/100ML N018722 001 Nov 09, 1982
BAXTER HLTHCARE 75MG/100ML;900MG/100ML N017648 004
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
B BRAUN 150MG/100ML;900MG/100ML N018722 002 Nov 09, 1982
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER
B BRAUN 220MG/100ML;900MG/100ML N018722 003 Nov 09, 1982
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 300MG/100ML;900MG/100ML N018722 004 Nov 09, 1982

POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE


INJECTABLE; INJECTION
THAM-E
HOSPIRA 370MG/VIAL;1.75GM/VIAL;36GM/VIAL N013025 001

POTASSIUM CITRATE
FOR SOLUTION; ORAL
POTASSIUM CITRATE
MISSION PHARMA 10MEQ/PACKET N019647 002 Oct 13, 1988
20MEQ/PACKET N019647 001 Oct 13, 1988

POTASSIUM IODIDE
SOLUTION; ORAL
POTASSIUM IODIDE
ROXANE 1GM/ML N018551 001 Feb 19, 1982
TABLET; ORAL
THYRO-BLOCK
MEDPOINTE PHARM HLC 130MG N018307 001

POTASSIUM PERCHLORATE
CAPSULE; ORAL
PERCHLORACAP
MALLINCKRODT 200MG N017551 001

POVIDONE-IODINE
SOLUTION; TOPICAL
E-Z PREP
CLINIPAD 10% N019382 001 Jul 25, 1989
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POVIDONE-IODINE
SPONGE; TOPICAL
E-Z PREP
CLINIPAD 5% N019382 002 Jul 25, 1989
E-Z PREP 220
CLINIPAD 5% N019382 003 Jul 25, 1989

PRALIDOXIME CHLORIDE
INJECTABLE; INJECTION
PRALIDOXIME CHLORIDE
BAXTER HLTHCARE CORP 300MG/ML N018799 001 Dec 13, 1982
TABLET; ORAL
PROTOPAM CHLORIDE
WYETH AYERST 500MG N014122 002

PRAMIPEXOLE DIHYDROCHLORIDE
TABLET; ORAL
MIRAPEX
BOEHRINGER INGELHEIM 1.25MG N020667 004 Jul 01, 1997

PRAZEPAM
CAPSULE; ORAL
CENTRAX
PARKE DAVIS 5MG N018144 001
10MG N018144 002
20MG N018144 003 May 10, 1982
PRAZEPAM
USL PHARMA 5MG A070427 001 Nov 06, 1987
10MG A070428 001 Nov 06, 1987
TABLET; ORAL
CENTRAX
PARKE DAVIS 10MG N017415 001

PRAZOSIN HYDROCHLORIDE
CAPSULE; ORAL
PRAZOSIN HYDROCHLORIDE
AM THERAP EQ 1MG BASE A072782 001 May 16, 1989
EQ 2MG BASE A072783 001 May 16, 1989
EQ 5MG BASE A072784 001 May 16, 1989
CLONMEL HLTHCARE EQ 1MG BASE A072705 001 May 16, 1989
EQ 2MG BASE A072706 001 May 16, 1989
EQ 5MG BASE A072707 001 May 16, 1989
PUREPAC PHARM EQ 1MG BASE A072991 001 May 16, 1989
EQ 2MG BASE A072921 001 May 16, 1989
EQ 5MG BASE A072992 001 May 16, 1989
SANDOZ EQ 1MG BASE A072576 001 May 16, 1989
EQ 2MG BASE A072577 001 May 16, 1989
EQ 5MG BASE A072578 001 May 16, 1989
WATSON LABS EQ 5MG BASE A072609 001 May 16, 1989
TABLET, EXTENDED RELEASE; ORAL
MINIPRESS XL
PFIZER 2.5MG N019775 001 Jan 29, 1992
5MG N019775 002 Jan 29, 1992

PREDNISOLONE
CREAM; TOPICAL
METI-DERM
SCHERING 0.5% N010209 002
SYRUP; ORAL
PREDNISOLONE
TEVA PHARMS 15MG/5ML A040322 001 Jan 19, 2000
WE PHARMS 15MG/5ML A040192 001 May 28, 1998
PRELONE
MURO 5MG/5ML A089654 001 Jan 17, 1989
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DISCONTINUED DRUG PRODUCT LIST 6 - 257 (of 324)

PREDNISOLONE
TABLET; ORAL
CORTALONE
HALSEY 1MG A080304 003
2.5MG A080304 002
5MG A080304 001
DELTA-CORTEF
PHARMACIA AND UPJOHN 5MG N009987 004
FERNISOLONE-P
FERNDALE LABS 5MG A083941 001
PREDNISOLONE
BARR 5MG A084426 002
BUNDY 5MG A083675 001
ELKINS SINN 5MG A080625 001
EVERYLIFE 1MG A084439 001
2.5MG A084439 002
5MG A084439 003
FERRANTE 2.5MG A080562 001
5MG A080562 002
HEATHER 5MG A080326 001
IMPAX LABS 5MG A080780 001
INWOOD LABS 5MG A080748 001
IVAX SUB TEVA PHARMS 5MG A080378 001
LANNETT 5MG A080531 002
MARSHALL PHARMA 5MG A080307 001
PANRAY 1MG A080351 001
5MG A080351 002
PERRIGO 5MG A084542 001
PHOENIX LABS NY 5MG A080322 001
PUREPAC PHARM 5MG A080325 001
PVT FORM 5MG A080211 001
ROXANE 5MG A080327 002
SANDOZ 5MG A080339 001
5MG A084773 001
SPERTI 1MG A080358 001
2.5MG A080358 002
5MG A080358 003
SUPERPHARM 5MG A088892 001 Feb 26, 1985
TABLICAPS 5MG A085170 001
TEVA 5MG A080398 001
UDL 5MG A087987 001 Jan 18, 1983
VALEANT PHARM INTL 5MG A080236 001
VITARINE 5MG A080534 001
WATSON LABS 5MG A085085 002
5MG A085415 001
5MG A085416 001
WEST WARD 5MG A080324 001
WHITEWORTH TOWN PLSN 5MG A080342 001
STERANE
PFIZER 5MG N009996 001

PREDNISOLONE ACETATE
INJECTABLE; INJECTION
METICORTELONE
SCHERING 25MG/ML N010255 002
PREDNISOLONE ACETATE
AKORN 25MG/ML A083032 001
50MG/ML A084492 001
BEL MAR 25MG/ML A083738 001
50MG/ML A083738 002
CENT PHARMS 25MG/ML A084717 001
50MG/ML A084717 002
WATSON LABS 25MG/ML A083398 001
25MG/ML A083654 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 258 (of 324)

PREDNISOLONE ACETATE
INJECTABLE; INJECTION
PREDNISOLONE ACETATE
WATSON LABS 40MG/ML A083767 001
50MG/ML A083764 001
50MG/ML A085781 001
STERANE
PFIZER 25MG/ML N011446 001
SUSPENSION; ORAL
FLO-PRED
TARO EQ 5MG BASE/5ML N022067 001 Jan 17, 2008
SUSPENSION/DROPS; OPHTHALMIC
ECONOPRED
ALCON 0.125% N017468 001

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM


OINTMENT; OPHTHALMIC
CETAPRED
ALCON 0.25%;10% A087771 001 Aug 06, 1993
METIMYD
SCHERING 0.5%;10% N010210 002 Sep 09, 1984
PREDSULFAIR
PHARMAFAIR 0.5%;10% A088032 001 Apr 15, 1983
VASOCIDIN
NOVARTIS 0.5%;10% A088791 001 Oct 05, 1984
SUSPENSION; OPHTHALMIC
ISOPTO CETAPRED
ALCON 0.25%;10% A087547 001
SUSPENSION/DROPS; OPHTHALMIC
METIMYD
SCHERING 0.5%;10% N010210 001
PREDAMIDE
AKORN 0.5%;10% A088059 001 Jul 29, 1983
PREDSULFAIR
PHARMAFAIR 0.5%;10% A088007 001 Apr 19, 1983
PREDSULFAIR II
PHARMAFAIR 0.2%;10% A088837 001 Dec 24, 1985
SULPHRIN
BAUSCH AND LOMB 0.5%;10% A088089 001 Dec 28, 1982

PREDNISOLONE SODIUM PHOSPHATE


INJECTABLE; INJECTION
HYDELTRASOL
MERCK EQ 20MG PHOSPHATE/ML N011583 002
PREDNISOLONE SODIUM PHOSPHATE
WATSON LABS EQ 20MG PHOSPHATE/ML A080517 001
OINTMENT; OPHTHALMIC, OTIC
HYDELTRASOL
MERCK EQ 0.25% PHOSPHATE N011028 001
SOLUTION; ORAL
PREDNISOLONE SODIUM PHOSPHATE
WE PHARMS EQ 5MG BASE/5ML A075181 001 Dec 23, 2002
SOLUTION/DROPS; OPHTHALMIC
INFLAMASE FORTE
NOVARTIS EQ 0.9% PHOSPHATE A080751 002
INFLAMASE MILD
NOVARTIS EQ 0.11% PHOSPHATE A080751 001
METRETON
SCHERING EQ 0.5% PHOSPHATE A083834 001
PREDAIR
PHARMAFAIR EQ 0.11% PHOSPHATE A088415 001 Feb 29, 1984
PREDAIR FORTE
PHARMAFAIR EQ 0.9% PHOSPHATE A088165 001 Mar 28, 1983
PREDNISOLONE SODIUM PHOSPHATE
AKORN EQ 0.11% PHOSPHATE A083358 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 259 (of 324)

PREDNISOLONE SODIUM PHOSPHATE


SOLUTION/DROPS; OPHTHALMIC
PREDNISOLONE SODIUM PHOSPHATE
AKORN EQ 0.9% PHOSPHATE A083358 002
ALCON UNIVERSAL EQ 0.11% PHOSPHATE A081043 001 Oct 24, 1991
EQ 0.9% PHOSPHATE A081044 001 Oct 24, 1991
BAUSCH AND LOMB EQ 0.11% PHOSPHATE A040065 001 Jul 29, 1994
SOLA BARNES HIND EQ 0.11% PHOSPHATE A084171 001
EQ 0.9% PHOSPHATE A084168 001
EQ 0.9% PHOSPHATE A084169 001
EQ 0.9% PHOSPHATE A084172 001

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM


SOLUTION/DROPS; OPHTHALMIC
SULSTER
AKORN EQ 0.23% PHOSPHATE;10% A074511 001 Jul 30, 1996

PREDNISOLONE TEBUTATE
INJECTABLE; INJECTION
HYDELTRA-TBA
MERCK 20MG/ML N010562 001
PREDNISOLONE TEBUTATE
WATSON LABS 20MG/ML A083362 001 Feb 17, 1984

PREDNISONE
SOLUTION; ORAL
PREDNISONE
MORTON GROVE 5MG/5ML A089726 001 Aug 02, 1988
SYRUP; ORAL
LIQUID PRED
MURO 5MG/5ML A087611 002 Sep 07, 1982
TABLET; ORAL
CORTAN
HALSEY 20MG A087480 001
DELTA-DOME
BAYER PHARMS 5MG A080293 001
DELTASONE
PHARMACIA AND UPJOHN 2.5MG N009986 005
5MG N009986 002
10MG N009986 006
20MG N009986 007
50MG N009986 008
FERNISONE
FERNDALE LABS 5MG A083364 001
METICORTEN
SCHERING 1MG N009766 002
5MG N009766 001
ORASONE
SOLVAY 1MG A083009 001
5MG A083009 002
10MG A083009 003
20MG A083009 004
50MG A085999 001
PARACORT
PARKE DAVIS 5MG N010962 002
PREDNICEN-M
SCHWARZ PHARMA 5MG A084655 001
PREDNISONE
AM THERAP 5MG A089387 001 Nov 06, 1986
10MG A089388 001 Nov 06, 1986
20MG A089389 001 Nov 06, 1986
AMNEAL PHARMS NY 5MG A089597 001 Oct 05, 1987
10MG A089598 001 Oct 05, 1987
20MG A089599 001 Oct 05, 1987
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 260 (of 324)

PREDNISONE
TABLET; ORAL
PREDNISONE
BUNDY 5MG A083676 001
DURAMED PHARMS BARR 5MG A088394 001 Oct 04, 1983
10MG A088395 001 Oct 04, 1983
20MG A088396 001 Oct 04, 1983
ELKINS SINN 5MG A080491 001
20MG A085811 001
EVERYLIFE 1MG A084440 001
2.5MG A084440 002
5MG A084440 003
FERRANTE 2.5MG A080563 001
5MG A080563 002
HALSEY 5MG A080300 001
HEATHER 5MG A080320 001
10MG A084341 001
20MG A084417 001
20MG A085543 001
50MG A086946 001
IMPAX LABS 5MG A080782 001
INWOOD LABS 1MG A080328 001
2.5MG A080306 001
5MG A080279 001
IVAX SUB TEVA PHARMS 5MG A080283 001
10MG A084133 001
20MG A084134 001
KV PHARM 5MG A084236 001
LANNETT 5MG A080514 001
20MG A084275 001
LEDERLE 5MG A086968 001
MARSHALL PHARMA 5MG A080301 001
MUTUAL PHARM 5MG A080701 001
10MG A086595 001
20MG A084634 001
50MG A086596 001
NYLOS 5MG A085115 001
PANRAY 1MG A080350 001
2.5MG A080350 002
5MG A080350 003
PERRIGO 5MG A083059 001
PHARMAVITE 5MG A084662 002
PHOENIX LABS NY 5MG A080321 001
20MG A083807 001
PUREPAC PHARM 5MG A080353 001
10MG A086062 001
20MG A086061 001
PVT FORM 20MG A085151 001
REXALL 5MG A080232 001
ROXANE 20MG N017109 001
25MG A087833 001 May 04, 1982
SANDOZ 5MG A080336 002
5MG A084774 001
10MG A089983 001 Jan 12, 1989
20MG A085813 001
50MG A089984 001 Jan 12, 1989
SCHERER LABS 5MG A080371 001
SPERTI 1MG A080359 001
2.5MG A080359 002
5MG A080359 003
SUPERPHARM 5MG A088865 001 Oct 25, 1984
10MG A088866 001 Oct 25, 1984
20MG A088867 001 Oct 25, 1984
TEVA 5MG A080397 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 261 (of 324)

PREDNISONE
TABLET; ORAL
PREDNISONE
UDL 5MG A087984 001 Jan 18, 1983
10MG A087985 001 Jan 18, 1983
20MG A087986 001 Jan 18, 1983
UPSHER SMITH 5MG A087471 001
20MG A087470 001
VALEANT PHARM INTL 5MG A080237 001
VANGARD 5MG A087682 001 Jan 15, 1982
20MG A087701 001 Jan 15, 1982
VITARINE 5MG A080334 001
5MG A080506 001
WATSON LABS 5MG A085084 002
10MG A087773 001 Jul 13, 1982
20MG A086813 001
50MG A086867 001
50MG A087772 001 Jul 13, 1982
WEST WARD 50MG A088465 001 Jun 01, 1984
WHITEWORTH TOWN PLSN 2.5MG A084913 001
5MG A080343 001
10MG A089028 001 Jul 24, 1986
20MG A084913 002
SERVISONE
LEDERLE 5MG A080223 001

PRILOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
CITANEST
ASTRAZENECA 1% N014763 004
2% N014763 005
3% N014763 003
CITANEST PLAIN
ASTRAZENECA 4% N014763 007

PRIMIDONE
SUSPENSION; ORAL

MYSOLINE

XCEL PHARMS 250MG/5ML N010401 001


TABLET; ORAL

PRIMIDONE

WATSON LABS 250MG A085052 001


PROBENECID
TABLET; ORAL
BENEMID
MERCK 500MG N007898 004
PROBENECID
LEDERLE 500MG A086917 001
WATSON LABS 500MG A086150 002 Apr 23, 1982

PROBUCOL
TABLET; ORAL
LORELCO
SANOFI AVENTIS US 250MG N017535 001
500MG N017535 002 Jul 06, 1988

PROCAINAMIDE HYDROCHLORIDE
CAPSULE; ORAL
PROCAINAMIDE HYDROCHLORIDE
ASCOT 250MG A087542 001 Jan 08, 1982
375MG A087697 001 Mar 01, 1983
500MG A087543 001 Jan 08, 1982
IVAX SUB TEVA PHARMS 250MG A084604 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 262 (of 324)

PROCAINAMIDE HYDROCHLORIDE
CAPSULE; ORAL
PROCAINAMIDE HYDROCHLORIDE
IVAX SUB TEVA PHARMS 375MG A084595 001
500MG A084606 001
LANNETT 250MG A083693 001
500MG A084696 001
LEDERLE 250MG A086942 001
375MG A086952 001
500MG A086943 001
ROXANE 250MG A088989 001 Apr 26, 1985
500MG A088990 001 Apr 26, 1985
SANDOZ 250MG A089219 001 Jul 01, 1986
375MG A089220 001 Jul 01, 1986
500MG A089221 001 Jul 01, 1986
VANGARD 250MG A087643 001 Jun 01, 1982
500MG A087875 001 Jun 01, 1982
WATSON LABS 250MG A083287 001
250MG A083795 001
250MG A085167 001
375MG A084403 001
375MG A087020 001
500MG A084280 001
500MG A084357 001
500MG A087021 001
PROCAN
PARKE DAVIS 250MG A085804 001
375MG A087502 001
500MG A085079 001
PROCAPAN
PANRAY 250MG A083553 002
PRONESTYL
APOTHECON 250MG N007335 001
375MG N007335 004
500MG N007335 003
INJECTABLE; INJECTION
PROCAINAMIDE HYDROCHLORIDE
ABRAXIS PHARM 100MG/ML A089415 001 Nov 17, 1986
500MG/ML A089416 001 Nov 17, 1986
BAXTER HLTHCARE 100MG/ML A089029 001 Apr 17, 1986
500MG/ML A089030 001 Apr 17, 1986
HOSPIRA 500MG/ML A089537 001 Aug 25, 1987
PHARMAFAIR 100MG/ML A088824 001 Nov 20, 1985
500MG/ML A088830 001 Nov 20, 1985
SMITH AND NEPHEW 100MG/ML A088530 001 Mar 04, 1985
500MG/ML A088531 001 Mar 04, 1985
SOLOPAK 500MG/ML A088532 001 Mar 04, 1985
WARNER CHILCOTT 100MG/ML A089528 001 May 03, 1988
500MG/ML A089529 001 May 03, 1988
WATSON LABS 100MG/ML A087079 001
500MG/ML A087080 001
PRONESTYL
APOTHECON 100MG/ML N007335 002
500MG/ML N007335 005
TABLET; ORAL
PRONESTYL
APOTHECON 250MG N017371 001
375MG N017371 002
500MG N017371 003
TABLET, EXTENDED RELEASE; ORAL
PROCAINAMIDE HYDROCHLORIDE
COPLEY PHARM 500MG A088974 001 Jul 22, 1985
750MG A089438 001 Mar 23, 1987
1GM A040111 001 Dec 13, 1996
INWOOD LABS 500MG A089840 001 Mar 06, 1989
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 263 (of 324)

PROCAINAMIDE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL
PROCAINAMIDE HYDROCHLORIDE
PLIVA 250MG A088958 001 Dec 02, 1985
500MG A088959 001 Dec 02, 1985
SANDOZ 250MG A089369 001 Aug 14, 1987
500MG A089284 001 Jun 23, 1986
500MG A089370 001 Jan 09, 1987
750MG A089371 001 Aug 14, 1987
WATSON LABS 250MG A088533 001 Dec 03, 1984
250MG A089026 001 Oct 22, 1985
500MG A088534 001 Dec 03, 1984
500MG A089027 001 Oct 22, 1985
750MG A088535 001 Nov 03, 1984
750MG A089042 001 Oct 22, 1985
1GM A089520 001 Jan 15, 1987
PROCAN SR
PARKE DAVIS 250MG A086468 001
PARKEDALE 500MG A086065 001
750MG A087510 001 Apr 01, 1982
1GM A088489 001 Jan 16, 1985
PROCANBID
KING PHARMS 500MG N020545 001 Jan 31, 1996
1GM N020545 002 Jan 31, 1996
PRONESTYL-SR
APOTHECON 500MG A087361 001

PROCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
NOVOCAIN
HOSPIRA 1% A085362 003
2% A085362 004
10% A086797 001
PROCAINE HYDROCHLORIDE
ABRAXIS PHARM 1% A080384 002
1% A080421 001
2% A080384 003
2% A080421 002
BEL MAR 1% A080711 001
2% A080756 001
ELKINS SINN 1% A083315 001
2% A083315 002
GD SEARLE LLC 1% A086202 001
2% A086202 002
HOSPIRA 1% A080416 001
2% A080416 002
MILES 1% A080415 001
2% A080415 002
WATSON LABS 1% A083535 001
2% A080658 002
2% A083535 002

PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE


INJECTABLE; INJECTION
ACHROMYCIN
LEDERLE 40MG/VIAL;100MG/VIAL N050276 001
40MG/VIAL;250MG/VIAL N050276 003
TETRACYN
PFIZER 40MG/VIAL;100MG/VIAL A060285 002
40MG/VIAL;250MG/VIAL A060285 003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 264 (of 324)

PROCAINE MERETHOXYLLINE; THEOPHYLLINE


INJECTABLE; INJECTION
DICURIN PROCAINE
LILLY 100MG/ML;50MG/ML N008869 001

PROCHLORPERAZINE
SUPPOSITORY; RECTAL
COMPAZINE
GLAXOSMITHKLINE 2.5MG N011127 003
5MG N011127 001
25MG N011127 002
PROCHLORPERAZINE
ABLE 2.5MG A040407 001 Jul 11, 2001
5MG A040407 002 Jul 11, 2001
25MG A040407 003 Jul 11, 2001

PROCHLORPERAZINE EDISYLATE
CONCENTRATE; ORAL
COMPAZINE
GLAXOSMITHKLINE EQ 10MG BASE/ML N011276 001
PROCHLORPERAZINE
ALPHARMA US PHARMS EQ 10MG BASE/ML A087153 001 Jun 08, 1982
PROCHLORPERAZINE EDISYLATE
MORTON GROVE EQ 10MG BASE/ML A088598 001 Oct 25, 1984
INJECTABLE; INJECTION
COMPAZINE
GLAXOSMITHKLINE EQ 5MG BASE/ML N010742 002
PROCHLORPERAZINE
BAXTER HLTHCARE EQ 5MG BASE/ML A087759 001 Oct 01, 1982
PROCHLORPERAZINE EDISYLATE
BAXTER HLTHCARE EQ 5MG BASE/ML A089523 001 May 03, 1988
HOSPIRA EQ 5MG BASE/ML A089703 001 Apr 07, 1988
MARSAM PHARMS LLC EQ 5MG BASE/ML A089675 001 Dec 05, 1988
SMITH AND NEPHEW EQ 5MG BASE/ML A089251 001 Dec 04, 1986
TEVA PARENTERAL EQ 5MG BASE/ML A040505 001 May 30, 2003
WATSON LABS EQ 5MG BASE/ML A089530 001 Jul 08, 1987
EQ 5MG BASE/ML A089605 001 Jul 08, 1987
EQ 5MG BASE/ML A089606 001 Jul 08, 1987
WYETH AYERST EQ 5MG BASE/ML A086348 001
SYRUP; ORAL
COMPAZINE
GLAXOSMITHKLINE EQ 5MG BASE/5ML N011188 001
PROCHLORPERAZINE EDISYLATE
ALPHARMA US PHARMS EQ 5MG BASE/5ML A087154 001 Sep 01, 1982
MORTON GROVE EQ 5MG BASE/5ML A088597 001 Oct 25, 1984

PROCHLORPERAZINE MALEATE
CAPSULE, EXTENDED RELEASE; ORAL
COMPAZINE
GLAXOSMITHKLINE EQ 10MG BASE N011000 001
EQ 10MG BASE N021019 001 Oct 06, 1999
EQ 15MG BASE N011000 002
EQ 15MG BASE N021019 002 Oct 06, 1999
EQ 30MG BASE N011000 003
EQ 75MG BASE N011000 004
TABLET; ORAL
COMPAZINE
GLAXOSMITHKLINE EQ 5MG BASE N010571 001
EQ 10MG BASE N010571 002
EQ 25MG BASE N010571 003
PROCHLORPERAZINE
WATSON LABS EQ 5MG BASE A085580 001
EQ 10MG BASE A085178 001
EQ 25MG BASE A085579 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 265 (of 324)

PROCHLORPERAZINE MALEATE
TABLET; ORAL
PROCHLORPERAZINE MALEATE
DURAMED PHARMS BARR EQ 5MG BASE A089484 001 Jan 20, 1987
EQ 10MG BASE A089485 001 Jan 20, 1987
EQ 25MG BASE A089486 001 Jan 20, 1987
IVAX SUB TEVA PHARMS EQ 5MG BASE A040162 001 Jan 20, 1998
EQ 10MG BASE A040162 002 Jan 20, 1998
SANDOZ EQ 25MG BASE A040101 003 Jul 19, 1996

PROCYCLIDINE HYDROCHLORIDE
TABLET; ORAL
KEMADRIN
MONARCH PHARMS 2MG N009818 005
5MG N009818 003

PROGESTERONE
CAPSULE; ORAL
PROMETRIUM
UNIMED PHARMS LLC 300MG N019781 003 Oct 15, 1999
INJECTABLE; INJECTION
PROGESTERONE
LILLY 25MG/ML N009238 002
50MG/ML N009238 001
INSERT, EXTENDED RELEASE; INTRAUTERINE
PROGESTASERT
ALZA 38MG N017553 001

PROMAZINE HYDROCHLORIDE
CONCENTRATE; ORAL
SPARINE
WYETH AYERST 30MG/ML N010942 001
100MG/ML N010942 004
INJECTABLE; INJECTION
PROMAZINE HYDROCHLORIDE
WATSON LABS 25MG/ML A084510 001
50MG/ML A084517 001
SPARINE
BAXTER HLTHCARE CORP 25MG/ML N010349 008
50MG/ML N010349 006
SYRUP; ORAL
SPARINE
WYETH AYERST 10MG/5ML N010942 003
TABLET; ORAL
SPARINE
WYETH AYERST 10MG N010348 006
25MG N010348 001
50MG N010348 002
100MG N010348 003
200MG N010348 004

PROMETHAZINE HYDROCHLORIDE
INJECTABLE; INJECTION
PHENERGAN
WYETH AYERST 25MG/ML N008857 002
50MG/ML N008857 003
PROMETHAZINE HYDROCHLORIDE
ABBOTT 25MG/ML A084223 001
50MG/ML A084222 001
AKORN 25MG/ML A083955 002
50MG/ML A083955 001
BEDFORD LABS 25MG/ML A040524 001 Mar 17, 2004
50MG/ML A040524 002 Mar 17, 2004
BIONICHE PHARMA 25MG/ML A040471 001 Nov 21, 2002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 266 (of 324)

PROMETHAZINE HYDROCHLORIDE
INJECTABLE; INJECTION
PROMETHAZINE HYDROCHLORIDE
HOSPIRA 50MG/ML A040372 002 Jun 08, 2000
50MG/ML A083838 002
MARSAM PHARMS LLC 25MG/ML A089463 001 May 02, 1988
50MG/ML A089477 001 May 02, 1988
SANDOZ 25MG/ML A040593 001 Nov 08, 2006
50MG/ML A040593 002 Nov 08, 2006
WATSON LABS 25MG/ML A083532 001
25MG/ML A084591 001
50MG/ML A080629 002
50MG/ML A083532 002
ZIPAN-25
ALTANA 25MG/ML A083997 001
ZIPAN-50
ALTANA 50MG/ML A083997 002
SUPPOSITORY; RECTAL
PHENERGAN
VICTORY PHARMA 12.5MG N010926 002
25MG N010926 001
50MG N011689 001
PROMETHACON
POLYMEDICA 25MG A084901 001
50MG A084902 001
PROMETHAZINE HYDROCHLORIDE
ABLE 12.5MG A040504 001 Apr 11, 2003
25MG A040504 002 Apr 11, 2003
50MG A040449 001 Feb 27, 2003
SYRUP; ORAL
MYMETHAZINE FORTIS
USL PHARMA 25MG/5ML A087996 001 Jan 18, 1983
PROMETH FORTIS
ALPHARMA US PHARMS 25MG/5ML A084772 001
PROMETH PLAIN
ACTAVIS MID ATLANTIC 6.25MG/5ML A085953 001
PROMETHAZINE
CENCI 6.25MG/5ML A089013 001 Sep 20, 1985
PROMETHAZINE HYDROCHLORIDE
KV PHARM 6.25MG/5ML A085388 001
25MG/5ML A085385 001
PHARM ASSOC 6.25MG/5ML A087518 001
WHITEWORTH TOWN PLSN 6.25MG/5ML A086395 001
PROMETHAZINE HYDROCHLORIDE PLAIN
ANI PHARMS 6.25MG/5ML N008381 004 Apr 18, 1984
25MG/5ML N008381 003
TABLET; ORAL
PHENERGAN
WYETH PHARMS INC 12.5MG N007935 002
25MG N007935 003
50MG N007935 004
PROMETHAZINE HYDROCHLORIDE
ABBOTT 12.5MG A084160 001
25MG A084166 001
50MG A084539 001
ABLE 12.5MG A040558 001 Jul 01, 2004
25MG A040558 002 Jul 01, 2004
50MG A040558 003 Jul 01, 2004
IMPAX LABS 25MG A084214 002 Jul 07, 1982
IVAX SUB TEVA PHARMS 12.5MG A083604 001
25MG A083603 001
50MG A083613 001
LANNETT 12.5MG A080949 001
25MG A080949 002
50MG A080949 003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 267 (of 324)

PROMETHAZINE HYDROCHLORIDE
TABLET; ORAL
PROMETHAZINE HYDROCHLORIDE
MUTUAL PHARM 12.5MG A084555 001
25MG A084554 001
50MG A084557 001
PVT FORM 12.5MG A083214 001
25MG A083658 001
SANDOZ 12.5MG A084176 002 May 22, 2009
12.5MG A084233 001
25MG A085146 001
50MG A085146 002
TABLICAPS 12.5MG A084080 001
25MG A084027 001
TEVA 25MG A089109 001 Sep 10, 1985
WATSON LABS 12.5MG A083401 001
12.5MG A083712 001
12.5MG A085986 001
25MG A083204 001
25MG A085684 001
50MG A083403 001
50MG A085664 001
REMSED
BRISTOL MYERS SQUIBB 25MG A083176 002
50MG A083176 001

PROPANTHELINE BROMIDE
INJECTABLE; INJECTION
PRO-BANTHINE
GD SEARLE LLC 30MG/VIAL N008843 001
TABLET; ORAL
PRO-BANTHINE
SHIRE 7.5MG N008732 003
15MG N008732 002
PROPANTHELINE BROMIDE
ASCOT 15MG A087663 001 Oct 25, 1982
HEATHER 15MG A085780 001
IMPAX LABS 15MG A084541 002
MYLAN 15MG A083706 001
PAR PHARM 15MG A088377 001 Dec 08, 1983
PVT FORM 15MG A080977 001
ROXANE 7.5MG A080927 001
15MG A080927 002
SANDOZ 15MG A080928 001
TABLICAPS 15MG A084428 001
WATSON LABS 15MG A083029 002
15MG A083151 001

PROPARACAINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
KAINAIR
PHARMAFAIR 0.5% A088087 001 Jun 07, 1983
PARACAINE
OPTOPICS 0.5% A087681 001 Aug 05, 1982
PROPARACAINE HYDROCHLORIDE
SOLA BARNES HIND 0.5% A084144 001
0.5% A084151 001

PROPIOLACTONE
SOLUTION; IRRIGATION
BETAPRONE
FOREST LABS N/A N011657 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 268 (of 324)

PROPIOMAZINE HYDROCHLORIDE
INJECTABLE; INJECTION
LARGON
BAXTER HLTHCARE CORP 20MG/ML N012382 002

PROPOFOL
INJECTABLE; INJECTION
DIPRIVAN
APP PHARMS 10MG/ML N019627 001 Oct 02, 1989
PROPOFOL
BEDFORD 10MG/ML A074848 001 Apr 19, 2005

PROPOXYPHENE HYDROCHLORIDE
CAPSULE; ORAL
DARVON
XANODYNE PHARM 32MG N010997 001
KESSO-GESIC
MK LABS 65MG A083544 001
PROPHENE 65
HALSEY 65MG A083538 002
PROPOXYPHENE HYDROCHLORIDE
ALRA 65MG A083184 001
IMPAX LABS 65MG A083317 001
IVAX SUB TEVA PHARMS 32MG A083597 001
MUTUAL PHARM 65MG A083186 001
MYLAN 32MG A083528 001
65MG A083299 001
NEXGEN PHARMA INC 65MG A083185 001
PUREPAC PHARM 65MG A083278 001
PVT FORM 32MG A083464 001
65MG A083113 001
ROXANE 32MG A083089 001
65MG A083089 002
SANDOZ 32MG A084014 001
65MG A083125 002
65MG A083688 001
65MG A083870 002
65MG A086495 001
VALEANT PHARM INTL 65MG A080783 001
WATSON LABS 65MG A080908 002
65MG A085190 001
WHITEWORTH TOWN PLSN 65MG A084551 001
PROPOXYPHENE HYDROCHLORIDE 65
WARNER CHILCOTT 65MG A083786 001

PROPOXYPHENE NAPSYLATE
SUSPENSION; ORAL
DARVON-N
AAIPHARMA LLC 50MG/5ML N016861 001

PROPRANOLOL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
PROPRANOLOL HYDROCHLORIDE
INWOOD LABS 60MG A072499 001 Apr 11, 1989
80MG A072500 001 Apr 11, 1989
120MG A072501 001 Apr 11, 1989
160MG A072502 001 Apr 11, 1989
CONCENTRATE; ORAL
PROPRANOLOL HYDROCHLORIDE INTENSOL
ROXANE 80MG/ML A071388 001 May 15, 1987
INJECTABLE; INJECTION
PROPRANOLOL HYDROCHLORIDE
SMITH AND NEPHEW 1MG/ML A070135 001 Apr 15, 1986
1MG/ML A070137 001 Apr 15, 1986
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DISCONTINUED DRUG PRODUCT LIST 6 - 269 (of 324)

PROPRANOLOL HYDROCHLORIDE
INJECTABLE; INJECTION
PROPRANOLOL HYDROCHLORIDE
SOLOPAK 1MG/ML A070136 001 Apr 15, 1986
SOLUTION; ORAL
PROPRANOLOL HYDROCHLORIDE
MORTON GROVE 20MG/5ML A071984 001 Mar 03, 1989
40MG/5ML A071985 001 Mar 03, 1989
SUSPENSION; ORAL
INDERAL
WYETH AYERST 10MG/ML N019536 001 Dec 12, 1986
TABLET; ORAL
INDERAL
AKRIMAX PHARMS 10MG N016418 001
20MG N016418 003
90MG N016418 010 Oct 18, 1982
PROPRANOLOL HYDROCHLORIDE
AMNEAL PHARMS NY 10MG A071368 001 May 05, 1987
20MG A071369 001 May 05, 1987
40MG A071370 001 May 05, 1987
80MG A071371 001 May 05, 1987
CLONMEL HLTHCARE 10MG A070125 001 Jul 30, 1985
20MG A070126 001 Jul 30, 1985
40MG A070127 001 Jul 30, 1985
60MG A071495 001 Dec 31, 1987
80MG A070128 001 Jul 30, 1985
90MG A071496 001 Dec 31, 1987
DURAMED PHARMS BARR 10MG A070306 001 Sep 09, 1985
20MG A070307 001 Sep 09, 1985
40MG A070308 001 Sep 09, 1985
60MG A070309 001 Oct 01, 1986
80MG A070310 001 Sep 09, 1985
90MG A071327 001 Oct 01, 1986
IVAX SUB TEVA PHARMS 10MG A072063 001 Jul 29, 1988
20MG A072066 001 Jul 29, 1988
40MG A072067 001 Jul 29, 1988
60MG A072068 001 Jul 29, 1988
80MG A072069 001 Jul 29, 1988
LEDERLE 10MG A072117 001 Jun 23, 1988
20MG A072118 001 Jun 23, 1988
40MG A072119 001 Jun 23, 1988
80MG A072120 001 Jun 23, 1988
MUTUAL PHARM 10MG A070319 001 Oct 22, 1985
20MG A070320 001 Oct 22, 1985
40MG A070103 001 Oct 22, 1985
60MG A070321 001 Sep 24, 1986
80MG A070322 001 Aug 04, 1986
MYLAN 60MG A072275 001 Jun 09, 1989
PAR PHARM 90MG A071288 001 Oct 22, 1986
PLIVA 90MG A071977 001 Apr 06, 1988
PUREPAC PHARM 10MG A070814 001 Nov 03, 1986
20MG A070815 001 Nov 03, 1986
40MG A070816 001 Nov 03, 1986
60MG A070817 001 Nov 03, 1986
80MG A070757 001 Nov 03, 1986
ROXANE 10MG A070516 001 Jul 07, 1986
20MG A070517 001 Jul 07, 1986
40MG A070518 001 Jul 07, 1986
60MG A070519 001 Sep 24, 1986
80MG A070520 001 Jul 07, 1986
90MG A070521 001 Sep 24, 1986
SANDOZ 10MG A070663 001 Jun 13, 1986
10MG A071658 001 Jul 05, 1988
20MG A070664 001 Jun 13, 1986
20MG A071687 001 Jul 05, 1988
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 270 (of 324)

PROPRANOLOL HYDROCHLORIDE
TABLET; ORAL
PROPRANOLOL HYDROCHLORIDE
SANDOZ 40MG A070665 001 Jun 13, 1986
40MG A071688 001 Jul 05, 1988
60MG A070666 001 Oct 10, 1986
60MG A072197 001 Jul 05, 1988
80MG A070667 001 Jun 13, 1986
80MG A071689 001 Jul 05, 1988
90MG A072198 001 Jul 05, 1988
SCHERING 10MG A070120 001 Aug 06, 1985
20MG A070121 001 Aug 06, 1985
40MG A070122 001 Aug 06, 1985
60MG A070123 001 Oct 29, 1986
80MG A070124 001 Aug 06, 1985
SUPERPHARM 10MG A071515 001 Jun 08, 1988
20MG A071516 001 Jun 08, 1988
40MG A071517 001 Jun 08, 1988
80MG A071518 001 Jun 08, 1988
TEVA 10MG A070232 001 Oct 07, 1987
20MG A070233 001 Jun 23, 1986
40MG A070234 001 Jun 23, 1986
VINTAGE 10MG A070217 001 Aug 01, 1986
20MG A070218 001 Aug 01, 1986
40MG A070219 001 Aug 01, 1986
60MG A070220 001 Sep 24, 1986
80MG A070221 001 Apr 14, 1986
WARNER CHILCOTT 10MG A070438 001 Sep 15, 1986
20MG A070439 001 Sep 15, 1986
40MG A070440 001 Sep 15, 1986
60MG A070441 001 Sep 24, 1986
80MG A070442 001 Sep 15, 1986
WATSON LABS 10MG A070140 001 Jul 30, 1985
10MG A070378 001 Mar 19, 1987
10MG A070548 001 Jul 10, 1986
20MG A070141 001 Jul 30, 1985
20MG A070379 001 Mar 19, 1987
20MG A070549 001 Apr 11, 1986
40MG A070142 001 Jul 30, 1985
40MG A070380 001 Mar 19, 1987
40MG A070550 001 Apr 11, 1986
60MG A070143 001 Jan 15, 1987
60MG A070381 001 Mar 19, 1987
60MG A071098 001 Oct 06, 1986
60MG A071791 001 Jul 15, 1987
80MG A070144 001 Jul 30, 1985
80MG A070382 001 Mar 19, 1987
80MG A070551 001 Jul 10, 1986
90MG A071183 001 Oct 06, 1986
90MG A071792 001 Jul 15, 1987

PROPYLIODONE
SUSPENSION; INTRATRACHEAL
DIONOSIL AQUEOUS
GLAXOSMITHKLINE 50% N009309 001
DIONOSIL OILY
GLAXOSMITHKLINE 60% N009309 002

PROPYLTHIOURACIL
TABLET; ORAL
PROPYLTHIOURACIL
ABBOTT 50MG A084075 001
ANABOLIC 50MG A080285 001
HALSEY 50MG A080015 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 271 (of 324)

PROPYLTHIOURACIL
TABLET; ORAL
PROPYLTHIOURACIL
IMPAX LABS 50MG A080159 001
IVAX SUB TEVA PHARMS 50MG A080215 001
LANNETT 50MG A080016 001
LILLY 50MG N006213 001
MUTUAL PHARM 50MG A083982 001
PERRIGO 50MG A084543 001
TABLICAPS 50MG A080840 001
WATSON LABS 50MG A080932 001
50MG A085201 001

PROTAMINE SULFATE
INJECTABLE; INJECTION
PROTAMINE SULFATE
BAXTER HLTHCARE 10MG/ML A089474 001 Nov 05, 1986
10MG/ML A089475 001 Nov 05, 1986
LILLY 10MG/ML N006460 002
PHARMACIA AND UPJOHN 50MG/VIAL N007413 001
250MG/VIAL N007413 002 Aug 02, 1984

PROTEIN HYDROLYSATE
INJECTABLE; INJECTION
AMINOSOL 5%
ABBOTT 5% N005932 012 Jan 31, 1985
HYPROTIGEN 5%
B BRAUN 5% N006170 003 Jan 10, 1984

PROTIRELIN
INJECTABLE; INJECTION
THYPINONE
ABBOTT 0.5MG/ML N017638 001
THYREL TRH
FERRING 0.5MG/ML N018087 001

PROTOKYLOL HYDROCHLORIDE
TABLET; ORAL
VENTAIRE
SANOFI AVENTIS US 2MG A083459 001

PROTRIPTYLINE HYDROCHLORIDE
TABLET; ORAL
VIVACTIL
ODYSSEY PHARMS 5MG N016012 001
10MG N016012 002

PSEUDOEPHEDRINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
NOVAFED
SANOFI AVENTIS US 120MG N017603 001
SUDAFED 12 HOUR
GLAXOSMITHKLINE 120MG N017941 002

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE


CAPSULE, EXTENDED RELEASE; ORAL
ACTIFED
GLAXOSMITHKLINE 120MG;5MG N018996 001 Jun 17, 1985
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES
KV PHARM 120MG;5MG A071798 001 Mar 16, 1989
SYRUP; ORAL
ACTAHIST
CENCI 30MG/5ML;1.25MG/5ML A088344 001 Feb 09, 1984
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DISCONTINUED DRUG PRODUCT LIST 6 - 272 (of 324)

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE


SYRUP; ORAL
HISTAFED
CENCI 30MG/5ML;1.25MG/5ML A088283 001 Apr 20, 1984
MYFED
USL PHARMA 30MG/5ML;1.25MG/5ML A088116 001 Mar 04, 1983
TRILITRON
NEWTRON PHARMS 30MG/5ML;1.25MG/5ML A088474 001 Feb 12, 1985
TABLET; ORAL
ALLERFED
PVT FORM 60MG;2.5MG A088860 001 Jan 31, 1985
CORPHED
SANDOZ 60MG;2.5MG A088602 001 Apr 11, 1985
PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE
SANDOZ 60MG;2.5MG A088193 001 May 17, 1983
TRILITRON
NEWTRON PHARMS 60MG;2.5MG A088515 001 Jan 09, 1985
TRIPHED
TEVA 60MG;2.5MG A088630 001 May 17, 1984
TRIPROLIDINE AND PSEUDOEPHEDRINE
WATSON LABS 60MG;2.5MG A088318 002 Jan 13, 1984
WEST WARD 60MG;2.5MG A088117 001 Apr 19, 1983
TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
IVAX SUB TEVA PHARMS 60MG;2.5MG A085273 001 Dec 12, 1984
SUPERPHARM 60MG;2.5MG A088578 001 Feb 21, 1985
TABLET, EXTENDED RELEASE; ORAL
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES
KV PHARM 120MG;5MG A072758 001 Nov 25, 1991

PSEUDOEPHEDRINE POLISTIREX
SUSPENSION, EXTENDED RELEASE; ORAL
PSEUDO-12
UCB INC EQ 60MG HCL/5ML N019401 001 Jun 19, 1987

PYRIDOSTIGMINE BROMIDE
TABLET; ORAL
PYRIDOSTIGMINE BROMIDE
BARR 30MG A040512 002 Jul 20, 2005
60MG A040512 001 Oct 08, 2003
SOLVAY 30MG A089572 001 Nov 27, 1990
US ARMY 30MG N020414 001 Feb 05, 2003

PYRIDOXINE HYDROCHLORIDE
INJECTABLE; INJECTION
HEXA-BETALIN
LILLY 100MG/ML A080854 001
PYRIDOXINE HYDROCHLORIDE
AKORN 100MG/ML A087967 001 Oct 01, 1982
BEL MAR 100MG/ML A080761 001
DELL LABS 50MG/ML A083771 001
100MG/ML A083772 001
ELKINS SINN 100MG/ML A080581 001
LUITPOLD 100MG/ML A080669 001
WATSON LABS 100MG/ML A080572 001
100MG/ML A083760 001

PYRILAMINE MALEATE
TABLET; ORAL
PYRILAMINE MALEATE
IMPAX LABS 25MG A080808 001
WATSON LABS 25MG A085231 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 273 (of 324)

PYRIMETHAMINE; SULFADOXINE
TABLET; ORAL
FANSIDAR
ROCHE 25MG;500MG N018557 001

PYRITHIONE ZINC
LOTION; TOPICAL
HEAD & SHOULDERS CONDITIONER
PROCTER AND GAMBLE 0.3% N019412 002 Mar 10, 1986

PYRVINIUM PAMOATE
SUSPENSION; ORAL

POVAN

PARKE DAVIS EQ 50MG BASE/5ML N011964 001

TABLET; ORAL

POVAN

PARKE DAVIS EQ 50MG BASE N012485 002

QUAZEPAM
TABLET; ORAL
DORAL
QUESTCOR PHARMS 7.5MG N018708 003 Feb 26, 1987

QUETIAPINE FUMARATE
TABLET; ORAL
SEROQUEL
ASTRAZENECA EQ 150MG BASE N020639 004 Dec 20, 1998

QUINESTROL
TABLET; ORAL
ESTROVIS
PARKE DAVIS 0.1MG N016768 002
0.2MG N016768 003

QUINETHAZONE
TABLET; ORAL
HYDROMOX
LEDERLE 50MG N013264 001

QUINETHAZONE; RESERPINE
TABLET; ORAL
HYDROMOX R
LEDERLE 50MG;0.125MG N013927 001

QUINIDINE GLUCONATE
TABLET; ORAL
QUINACT
BAYER HLTHCARE 266MG A085978 001
400MG A086099 001
TABLET, EXTENDED RELEASE; ORAL
DURAQUIN
WARNER CHILCOTT 330MG N017917 001
QUINAGLUTE
BAYER HLTHCARE 324MG N016647 001
QUINALAN
LANNETT 324MG A088081 001 Feb 10, 1986
QUINATIME
WATSON LABS 324MG A087448 001
QUINIDINE GLUCONATE
ASCOT 324MG A088582 001 Jun 17, 1985
HALSEY 324MG A089476 001 Apr 10, 1987
ROXANE 324MG A088431 001 Jan 06, 1984
SANDOZ 324MG A089894 001 Dec 15, 1988
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 274 (of 324)

QUINIDINE GLUCONATE
TABLET, EXTENDED RELEASE; ORAL
QUINIDINE GLUCONATE
SUPERPHARM 324MG A089164 001 Nov 21, 1985
WATSON LABS 324MG A087785 001 Jan 24, 1983

QUINIDINE POLYGALACTURONATE
TABLET; ORAL
CARDIOQUIN
PHARM RES ASSOC 275MG N011642 002

QUINIDINE SULFATE
CAPSULE; ORAL
CIN-QUIN
SOLVAY 200MG A085296 001
300MG A085297 001
QUINIDINE SULFATE
LILLY 200MG A085103 001
TABLET; ORAL
CIN-QUIN
SOLVAY 100MG A085299 001
200MG A084932 001
300MG A085298 001
QUINIDINE SULFATE
BARR 200MG A084177 001
CLONMEL HLTHCARE 200MG A087011 001
ELKINS SINN 200MG A083622 001
EVERYLIFE 200MG A083439 001
HALSEY 200MG A083583 001
IMPAX LABS 200MG A083347 001
IVAX SUB TEVA PHARMS 200MG A084549 001
KING PHARMS 200MG A085175 001
KV PHARM 200MG A085276 001
LANNETT 200MG A083743 001
LEDERLE 200MG A086176 001
LEINER 200MG A083808 001
LILLY 200MG A085038 001
MUTUAL PHARM 100MG A081029 001 Apr 14, 1989
PERRIGO 200MG A085322 001
PHARMAVITE 200MG A084627 001
PUREPAC PHARM 200MG A084003 001
ROXANE 200MG A083640 001
300MG A085632 001
SANDOZ 200MG A084631 001
200MG A084914 001
300MG A089839 001 Sep 29, 1988
SCHERER LABS 200MG A085068 001
SUPERPHARM 200MG A088973 001 Apr 10, 1985
USL PHARMA 200MG A087837 001 Apr 14, 1982
VALEANT PHARM INTL 200MG A083393 001
VANGARD 200MG A087909 001 Jul 13, 1982
VINTAGE PHARMS 200MG A083963 001
WARNER CHILCOTT 200MG A083879 001
WATSON LABS 100MG A085584 001
200MG A085140 002
WEST WARD 200MG A083862 001
WHITEWORTH TOWN PLSN 200MG A085444 001
QUINORA
KEY PHARMS 200MG A083576 001
SCHERING 300MG A085222 001
TABLET, EXTENDED RELEASE; ORAL
QUINIDEX
WYETH PHARMS INC 300MG N012796 002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 275 (of 324)

RABEPRAZOLE SODIUM
TABLET, DELAYED RELEASE; ORAL
ACIPHEX
EISAI INC 10MG N020973 001 May 29, 2002
RABEPRAZOLE SODIUM
TEVA 20MG A076822 001 Feb 21, 2007

RANITIDINE BISMUTH CITRATE


TABLET; ORAL
TRITEC
GLAXOSMITHKLINE 400MG N020559 001 Aug 08, 1996

RANITIDINE HYDROCHLORIDE
CAPSULE; ORAL
RANITIDINE HYDROCHLORIDE
GENPHARM EQ 150MG BASE A075564 001 Oct 27, 2000
EQ 300MG BASE A075564 002 Oct 27, 2000
TEVA EQ 150MG BASE A075557 001 Oct 31, 2003
EQ 300MG BASE A075557 002 Oct 31, 2003
ZANTAC 150
GLAXOSMITHKLINE EQ 150MG BASE N020095 001 Mar 08, 1994
ZANTAC 300
GLAXOSMITHKLINE EQ 300MG BASE N020095 002 Mar 08, 1994
GRANULE, EFFERVESCENT; ORAL
ZANTAC 150
GLAXOSMITHKLINE EQ 150MG BASE/PACKET N020251 002 Mar 31, 1994
INJECTABLE; INJECTION
RANITIDINE HYDROCHLORIDE
BEDFORD EQ 25MG BASE/ML A074764 001 Nov 19, 2004
ZANTAC IN PLASTIC CONTAINER
GLAXOSMITHKLINE EQ 50MG BASE/100ML N019593 001 Dec 17, 1986
TABLET; ORAL
RANITIDINE HYDROCHLORIDE
BOEHRINGER INGELHEIM EQ 150MG BASE A074662 001 Aug 29, 1997
EQ 300MG BASE A074662 002 Aug 29, 1997
MYLAN EQ 150MG BASE A074552 001 Jul 30, 1998
EQ 300MG BASE A074552 002 Jul 30, 1998
RANBAXY EQ 75MG BASE A075132 001 Jan 14, 2000
EQ 75MG BASE A075254 001 Jan 14, 2000
EQ 150MG BASE A075000 001 Jan 30, 1998
EQ 150MG BASE A075439 001 Apr 19, 2000
EQ 300MG BASE A075000 002 Jan 30, 1998
EQ 300MG BASE A075439 002 Apr 19, 2000
SANDOZ EQ 75MG BASE A075519 001 Sep 26, 2002
TABLET, EFFERVESCENT; ORAL
ZANTAC 150
GLAXOSMITHKLINE EQ 150MG BASE N020251 001 Mar 31, 1994
ZANTAC 75
BOEHRINGER INGELHEIM EQ 75MG BASE N020745 001 Feb 26, 1998

RAPACURONIUM BROMIDE
INJECTABLE; INJECTION
RAPLON
ORGANON USA INC 100MG/VIAL N020984 001 Aug 18, 1999
200MG/VIAL N020984 002 Aug 18, 1999

RAUWOLFIA SERPENTINA
TABLET; ORAL
HIWOLFIA
BOWMAN PHARMS 50MG N009276 003
50MG N009276 005
100MG N009276 004
HYSERPIN
PHYS PRODS VA 50MG N010581 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 276 (of 324)

RAUWOLFIA SERPENTINA
TABLET; ORAL
KOGLUCOID
PANRAY 50MG N009278 001
100MG N009278 002
RAUDIXIN
APOTHECON 50MG N008842 001
100MG N008842 002
RAUSERPIN
FERNDALE LABS 50MG N009926 002
100MG N009926 004
RAUVAL
PAL PAK 50MG N009108 002
100MG N009108 004
RAUWOLFIA SERPENTINA
BUNDY 50MG N009477 001
100MG N009477 002
HALSEY 50MG A080498 001
100MG A080498 002
IMPAX LABS 50MG N009273 001
100MG N009273 002
IVAX SUB TEVA PHARMS 50MG N011521 001
100MG N011521 002
PUREPAC PHARM 50MG A080842 001
100MG A080842 002
PVT FORM 50MG A080583 001
100MG A080583 002
SOLVAY 50MG A080500 001
100MG A080500 002
TABLICAPS 50MG A083867 001
100MG A083444 001
VALEANT PHARM INTL 50MG N009668 001
100MG N009668 002
WATSON LABS 50MG A080907 001
100MG A080914 001
WOLFINA
FOREST PHARMS 50MG N009255 008
100MG N009255 006

RESCINNAMINE
CAPSULE; ORAL
CINNASIL
PANRAY 0.5MG A084736 001
TABLET; ORAL
MODERIL
PFIZER 0.25MG N010686 003
0.5MG N010686 006

RESERPINE
ELIXIR; ORAL
SERPASIL
NOVARTIS 0.2MG/4ML N009115 005
INJECTABLE; INJECTION
SANDRIL
LILLY 2.5MG/ML N010012 001
SERPASIL
NOVARTIS 2.5MG/ML N009434 002
TABLET; ORAL
HISERPIA
BOWMAN PHARMS 0.1MG N009631 002
0.25MG N009631 004
RAU-SED
BRISTOL MYERS SQUIBB 0.1MG N009357 001
0.25MG N009357 004
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 277 (of 324)

RESERPINE
TABLET; ORAL
RAU-SED
BRISTOL MYERS SQUIBB 0.5MG N009357 006
1MG N009357 008
RESERPINE
BARR 0.25MG A080721 002
BELL PHARMA 0.1MG A083058 001
0.25MG A083058 002
BUNDY 0.1MG N009663 001
0.25MG N009663 003
ELKINS SINN 0.1MG A083145 001
0.25MG A083145 002
EVERYLIFE 0.1MG N010441 001
0.25MG N010441 002
0.5MG N010441 003
1MG N010441 004
HALSEY 0.1MG A080457 002
0.25MG A080457 001
1MG A080457 003
IMPAX LABS 0.1MG N009627 001
0.25MG N009627 002
IVAX SUB TEVA PHARMS 0.1MG N011185 001
0.25MG N011185 002
MARSHALL PHARMA 0.1MG A080492 001
0.25MG A080492 002
MK LABS 0.1MG A080525 002
0.25MG A080525 001
MYLAN 1MG A084974 001
PHARMAVITE 0.25MG A084663 001
PUREPAC PHARM 0.1MG A080753 002
0.25MG A080753 001
PVT FORM 0.1MG A086117 001
0.25MG A080582 001
0.25MG A085775 001
1MG A080582 002
REXALL 0.25MG A080637 001
ROXANE 0.1MG N009859 001
0.25MG N009859 002
SOLVAY 0.25MG A080446 001
TABLICAPS 0.25MG A085207 001
TEVA 0.1MG A089020 001 Mar 07, 1985
0.25MG A089019 001 Mar 07, 1985
VALEANT PHARM INTL 0.1MG N009667 001
0.25MG N009667 002
WATSON LABS 0.1MG A080679 001
0.25MG A080393 001
0.25MG A085401 001
1MG A080749 001
WEST WARD 0.1MG A080975 001
0.25MG A080975 002
1MG A080975 003
WHITEWORTH TOWN PLSN 0.1MG A080723 001
0.25MG A080723 002
1MG A080723 003
SANDRIL
LILLY 0.1MG N009376 004
0.25MG N009376 001
SERPANRAY
PANRAY 0.1MG N009391 001
0.25MG N009391 002
1MG N009391 004
SERPASIL
NOVARTIS 0.1MG N009115 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 278 (of 324)

RESERPINE
TABLET; ORAL
SERPASIL
NOVARTIS 0.25MG N009115 003
1MG N009115 004
SERPATE
VALE 0.1MG N009453 001
0.25MG N009453 002
SERPIVITE
VITARINE 0.25MG N009645 002

RESERPINE; TRICHLORMETHIAZIDE
TABLET; ORAL
METATENSIN #2
SANOFI AVENTIS US 0.1MG;2MG N012972 001
METATENSIN #4
SANOFI AVENTIS US 0.1MG;4MG N012972 002
NAQUIVAL
SCHERING 0.1MG;4MG N012265 003
TRICHLORMETHIAZIDE W/ RESERPINE
WATSON LABS 0.1MG;4MG A085248 001

RIBAVIRIN
TABLET; ORAL
COPEGUS
ROCHE 400MG N021511 002 Jun 21, 2005

RIMANTADINE HYDROCHLORIDE
SYRUP; ORAL
FLUMADINE
FOREST LABS 50MG/5ML N019650 001 Sep 17, 1993

RISEDRONATE SODIUM
TABLET; ORAL
ACTONEL
PROCTER AND GAMBLE 75MG N020835 004 Apr 16, 2007

RISPERIDONE
TABLET; ORAL
RISPERDAL
ORTHO MCNEIL JANSSEN 5MG N020272 005 Dec 29, 1993

RITODRINE HYDROCHLORIDE
INJECTABLE; INJECTION
RITODRINE HYDROCHLORIDE
ABRAXIS PHARM 10MG/ML A071188 001 Jul 23, 1987
15MG/ML A071189 001 Jul 23, 1987
HOSPIRA 10MG/ML A071618 001 Feb 28, 1991
15MG/ML A071619 001 Feb 28, 1991
RITODRINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 30MG/100ML A071438 001 Jan 22, 1991
YUTOPAR
ASTRAZENECA 10MG/ML N018580 001
15MG/ML N018580 002
TABLET; ORAL
YUTOPAR
ASTRAZENECA 10MG N018555 001

RITONAVIR
CAPSULE; ORAL
NORVIR
ABBOTT 100MG N020680 001 Mar 01, 1996
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ROCURONIUM BROMIDE
INJECTABLE; INJECTION
ZEMURON
SCHERING 10MG/ML (10MG/ML) N020214 002 Mar 17, 1994

ROFECOXIB
SUSPENSION; ORAL
VIOXX
MERCK 12.5MG/5ML N021052 001 May 20, 1999
25MG/5ML N021052 002 May 20, 1999
TABLET; ORAL
VIOXX
MERCK 12.5MG N021042 001 May 20, 1999
25MG N021042 002 May 20, 1999
50MG N021042 003 Feb 25, 2000

ROPINIROLE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL
REQUIP XL
SMITHKLINE BEECHAM EQ 3MG BASE N022008 002 Jun 13, 2008

ROSE BENGAL SODIUM, I-131


INJECTABLE; INJECTION
ROBENGATOPE
BRACCO 0.5mCi/VIAL N016224 001
1mCi/VIAL N016224 002
2mCi/VIAL N016224 003
SODIUM ROSE BENGAL I 131
SORIN 0.5mCi/ML N017318 001

ROTIGOTINE
FILM, EXTENDED RELEASE; TRANSDERMAL
NEUPRO
SCHWARZ BIOSCIENCES 2MG/24HR N021829 001 May 09, 2007
4MG/24HR N021829 002 May 09, 2007
6MG/24HR N021829 003 May 09, 2007

RUFINAMIDE
TABLET; ORAL
BANZEL
EISAI INC 100MG N021911 001 Nov 14, 2008

SAFFLOWER OIL
INJECTABLE; INJECTION
LIPOSYN 10%
ABBOTT 10% (10GM/100ML) N018203 001
LIPOSYN 20%
ABBOTT 20% (20GM/100ML) N018614 001

SALMETEROL XINAFOATE
AEROSOL, METERED; INHALATION
SEREVENT
GLAXOSMITHKLINE EQ 0.021MG BASE/INH N020236 001 Feb 04, 1994

SAQUINAVIR
CAPSULE; ORAL
FORTOVASE
HLR 200MG N020828 001 Nov 07, 1997

SARALASIN ACETATE
INJECTABLE; INJECTION
SARENIN
PROCTER AND GAMBLE EQ 0.6MG BASE/ML N018009 001
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SECOBARBITAL SODIUM
CAPSULE; ORAL
SECOBARBITAL SODIUM
ANABOLIC 100MG A084422 001
BARR 100MG A084225 001
EVERYLIFE 100MG A085895 001
HALSEY 100MG A084676 001
IVAX PHARMS 100MG A085869 001
KV PHARM 100MG A085285 001
LANNETT 50MG A085909 001
100MG A085903 001
PARKE DAVIS 100MG A084762 001
PERRIGO 100MG A084561 001
PUREPAC PHARM 100MG A085867 001
VALEANT PHARM INTL 100MG A085477 001
VITARINE 100MG A085898 001
100MG A086273 001
WATSON LABS 100MG A085792 001
WEST WARD 100MG A084926 001
WHITEWORTH TOWN PLSN 100MG A085798 001
WYETH AYERST 100MG A086390 001
INJECTABLE; INJECTION
SECOBARBITAL SODIUM
ELKINS SINN 100MG/VIAL A083281 001
WYETH AYERST 50MG/ML A083262 001
SECONAL SODIUM
LILLY 50MG/ML N007392 002
SUPPOSITORY; RECTAL
SECONAL SODIUM
LILLY 30MG A086530 001
60MG A086530 002
120MG A086530 003
200MG A086530 004

SECRETIN
INJECTABLE; INJECTION
SECRETIN-FERRING
FERRING 75CU/VIAL N018290 001

SECRETIN SYNTHETIC PORCINE


FOR SOLUTION; INTRAVENOUS
SECREFLO
CHIRHOCLIN 16MCG/VIAL N021136 001 Apr 04, 2002

SELEGILINE HYDROCHLORIDE
CAPSULE; ORAL
SELEGILINE HYDROCHLORIDE
AAIPHARMA LLC 5MG A075145 001 Sep 15, 2003
TABLET; ORAL
SELEGILINE HYDROCHLORIDE
ENDO PHARMS 5MG A074565 001 Aug 02, 1996
IVAX SUB TEVA PHARMS 5MG A074756 001 Nov 25, 1998
SIEGFRIED 5MG A074672 001 Apr 01, 1997
SOMERSET 5MG N019334 001 Jun 05, 1989
TEVA 5MG A074537 001 Aug 02, 1996
5MG A074744 001 Jan 27, 1997

SELENIUM SULFIDE
LOTION/SHAMPOO; TOPICAL
EXSEL
ALLERGAN HERBERT 2.5% A083892 001
SELENIUM SULFIDE
IVAX PHARMS 2.5% A085777 001
TARO 2.5% A086209 001
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SELENOMETHIONINE, SE-75
INJECTABLE; INJECTION
SELENOMETHIONINE SE 75
GE HEALTHCARE 250uCi/ML N017257 001
MALLINCKRODT 100uCi/ML N017098 001
PHARMALUCENCE 500uCi/ML N017322 001
SETHOTOPE
BRACCO 85-550uCi/ML N017047 001

SERACTIDE ACETATE
INJECTABLE; INJECTION
ACTHAR GEL-SYNTHETIC
ARMOUR PHARM 40 UNITS/ML N017861 001
80 UNITS/ML N017861 002

SERMORELIN ACETATE
INJECTABLE; INJECTION
GEREF
EMD SERONO EQ 0.05MG BASE/AMP N019863 001 Dec 28, 1990
EQ 0.5MG BASE/VIAL N020443 001 Sep 26, 1997
EQ 1MG BASE/VIAL N020443 002 Sep 26, 1997

SERTRALINE HYDROCHLORIDE
TABLET; ORAL
SERTRALINE HYDROCHLORIDE
ACTAVIS ELIZABETH EQ 25MG BASE A077345 001 Feb 06, 2007
EQ 50MG BASE A077345 002 Feb 06, 2007
EQ 100MG BASE A077345 003 Feb 06, 2007
MUTUAL PHARM EQ 25MG BASE A077818 001 Feb 06, 2007
EQ 50MG BASE A077818 002 Feb 06, 2007
EQ 100MG BASE A077818 003 Feb 06, 2007
WATSON LABS EQ 25MG BASE A077162 001 Feb 06, 2007
EQ 50MG BASE A077162 002 Feb 06, 2007
EQ 100MG BASE A077162 003 Feb 06, 2007
ZOLOFT
PFIZER EQ 150MG BASE N019839 003 Dec 30, 1991
EQ 200MG BASE N019839 004 Dec 30, 1991

SEVELAMER HYDROCHLORIDE
CAPSULE; ORAL
RENAGEL
GENZYME 403MG N020926 001 Oct 30, 1998

SILVER SULFADIAZINE
DRESSING; TOPICAL
SILDAFLO
FRANKLIN PHARMS 1% N019608 001 Nov 30, 1989

SIMETHICONE-CELLULOSE
SUSPENSION; ORAL
SONORX
BRACCO 7.5MG/ML N020773 001 Oct 29, 1998

SIMVASTATIN
TABLET, ORALLY DISINTEGRATING; ORAL
SIMVASTATIN
SYNTHON PHARMS 10MG N021961 001 Oct 09, 2007
20MG N021961 002 Oct 09, 2007
40MG N021961 003 Oct 09, 2007
80MG N021961 004 Oct 09, 2007
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SIROLIMUS
TABLET; ORAL
RAPAMUNE
WYETH PHARMS INC 5MG N021110 003 Feb 23, 2004

SODIUM BENZOATE; SODIUM PHENYLACETATE


SOLUTION; ORAL
UCEPHAN
B BRAUN 100MG/ML;100MG/ML N019530 001 Dec 23, 1987

SODIUM BICARBONATE
INJECTABLE; INJECTION
SODIUM BICARBONATE IN PLASTIC CONTAINER
ABBOTT 0.9MEQ/ML N019443 001 Jun 03, 1986
1MEQ/ML N019443 002 Jun 03, 1986

SODIUM BICARBONATE; TARTARIC ACID


GRANULE, EFFERVESCENT; ORAL
BAROS
LAFAYETTE PHARMS 460MG/GM;420MG/GM N018509 001 Aug 07, 1985

SODIUM CHLORIDE
INJECTABLE; INJECTION
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ABRAXIS PHARM 9MG/ML A088909 001 Feb 07, 1985
SODIUM CHLORIDE
ABBOTT 20GM/100ML N017013 001
B BRAUN 20GM/100ML N017038 001
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 450MG/100ML N018184 001
MILES 450MG/100ML N018503 001
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ABBOTT 9MG/ML N019218 001 Jul 13, 1984
MILES 900MG/100ML N018502 001
SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER
ABRAXIS PHARM 234MG/ML N019329 001 Apr 22, 1987
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
B BRAUN 3GM/100ML N019635 003 Mar 09, 1988
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML N019635 004 Mar 09, 1988
SOLUTION; IRRIGATION
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
BAXTER HLTHCARE 450MG/100ML N018497 001 Feb 19, 1982
SODIUM CHLORIDE IN PLASTIC CONTAINER
MILES 900MG/100ML N018247 001

SODIUM CHROMATE CR-51


INJECTABLE; INJECTION
CHROMITOPE SODIUM
BRACCO 2mCi/VIAL N013993 002
SODIUM CHROMATE CR 51
MALLINCKRODT 100uCi/ML N016708 001

SODIUM FLUORIDE, F-18


INJECTABLE; INTRAVENOUS
FLUORINE F-18
GE HEALTHCARE 2mCi/ML N017042 001

SODIUM IODIDE, I-123


CAPSULE; ORAL
SODIUM IODIDE I 123
SYNCOR PHARMS 400uCi N018671 003 May 27, 1982
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SODIUM IODIDE, I-131


CAPSULE; ORAL
IODOTOPE
BRACCO 1-130mCi N010929 001
1-150mCi N010929 003
SODIUM IODIDE I 131
CIS 50uCi N017316 001
100uCi N017316 002
MALLINCKRODT 0.8-100mCi N016515 002
SOLUTION; ORAL
IODOTOPE
BRACCO 7-106mCi/BOT N010929 002
SODIUM IODIDE I 131
CIS 50mCi/ML N017315 001

SODIUM LACTATE
INJECTABLE; INJECTION
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
B BRAUN 1.87GM/100ML N018186 001
HOSPIRA 1.87GM/100ML N018249 001

SODIUM MONOFLUOROPHOSPHATE
GEL; DENTAL
EXTRA-STRENGTH AIM
CHESEBROUGH PONDS 1.2% N019518 002 Aug 06, 1986
PASTE; DENTAL
EXTRA-STRENGTH AIM
CHESEBROUGH PONDS 1.2% N019518 001 Jun 03, 1987

SODIUM NITROPRUSSIDE
INJECTABLE; INJECTION
NIPRIDE
ROCHE 50MG/VIAL N017546 001
NITROPRESS
ABBOTT 50MG/VIAL A071555 001 Nov 16, 1987
50MG/VIAL N018450 001
HOSPIRA 50MG/VIAL A070566 001 Jun 09, 1986
SODIUM NITROPRUSSIDE
ABRAXIS PHARM 50MG/VIAL A070031 001 Jan 17, 1985
BAXTER HLTHCARE 50MG/VIAL N018581 001 Jul 28, 1982

SODIUM PHOSPHATE, P-32


SOLUTION; INJECTION, ORAL
PHOSPHOTOPE
BRACCO 1-8mCi/VIAL N010927 001
SODIUM PHOSPHATE P 32
MALLINCKRODT 0.67mCi/ML N011777 001
1.5mCi/VIAL N011777 002

SODIUM POLYSTYRENE SULFONATE


POWDER; ORAL, RECTAL
SODIUM POLYSTYRENE SULFONATE
MORTON GROVE 453.6GM/BOT A088786 001 Sep 11, 1984
SUSPENSION; ORAL, RECTAL
SODIUM POLYSTYRENE SULFONATE
MORTON GROVE 15GM/60ML A088717 001 Sep 11, 1984
ROXANE 15GM/60ML A088453 001 Nov 17, 1983

SODIUM SUCCINATE
INJECTABLE; INJECTION
SODIUM SUCCINATE
ELKINS SINN 30% A080516 001
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SODIUM TETRADECYL SULFATE


INJECTABLE; INJECTION
SOTRADECOL
ELKINS SINN 1% N005970 004
3% N005970 005

SODIUM THIOSULFATE
INJECTABLE; INJECTION
SODIUM THIOSULFATE
US ARMY 250MG/ML N020166 001 Feb 14, 1992

SOMATREM
INJECTABLE; INJECTION
PROTROPIN
GENENTECH 5MG/VIAL N019107 001 Oct 17, 1985
10MG/VIAL N019107 002 Oct 24, 1989

SOMATROPIN
INJECTABLE; INJECTION
ASELLACRIN 10
SERONO 10 IU/VIAL N017726 001
ASELLACRIN 2
SERONO 2 IU/VIAL N017726 002 Jul 21, 1983
CRESCORMON
GENENTECH 4 IU/VIAL N017992 001

SOMATROPIN RECOMBINANT
INJECTABLE; INJECTION
ACCRETROPIN
CANGENE 5MG/ML (5MG/ML) N021538 001 Jan 23, 2008
BIO-TROPIN
FERRING 4.8MG/VIAL N019774 001 May 25, 1995
HUMATROPE
LILLY 2MG/VIAL N019640 001 Jun 23, 1987
NORDITROPIN
NOVO NORDISK INC 4MG/VIAL N019721 001 May 08, 1995
8MG/VIAL N019721 002 May 08, 1995
NUTROPIN DEPOT
GENENTECH 13.5MG/VIAL N021075 001 Dec 22, 1999
18MG/VIAL N021075 002 Dec 22, 1999
22.5MG/VIAL N021075 003 Dec 22, 1999
SAIZEN
EMD SERONO 4MG/VIAL N019764 005 Jan 16, 2007
6MG/VIAL N019764 001 Oct 08, 1996
SEROSTIM
EMD SERONO 8.8MG/VIAL N020604 004 Sep 06, 2001
ZORBTIVE
EMD SERONO 4MG/VIAL N021597 001 Dec 01, 2003
5MG/VIAL N021597 002 Dec 01, 2003
6MG/VIAL N021597 003 Dec 01, 2003
INJECTABLE; SUBCUTANEOUS
SEROSTIM LQ
EMD SERONO 6MG/0.5ML (6MG/0.5ML) N020604 005 Feb 11, 2005

SORBITOL
SOLUTION; IRRIGATION
SORBITOL 3% IN PLASTIC CONTAINER
BAXTER HLTHCARE 3GM/100ML N018512 001 May 27, 1982

SOTALOL HYDROCHLORIDE
TABLET; ORAL
BETAPACE
BAYER HLTHCARE 320MG N019865 004 Oct 30, 1992
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SOTALOL HYDROCHLORIDE
TABLET; ORAL
BETAPACE AF
BAYER HLTHCARE 40MG N021151 006 Apr 02, 2003
60MG N021151 007 Apr 02, 2003
100MG N021151 005 Mar 14, 2003
SOTALOL HYDROCHLORIDE
MUTUAL PHARM 80MG A075515 001 Oct 15, 2001
80MG A076576 001 Apr 08, 2004
120MG A075515 004 Oct 15, 2001
120MG A076576 002 Apr 08, 2004
160MG A075515 002 Oct 15, 2001
160MG A076576 003 Apr 08, 2004
240MG A075515 003 Oct 15, 2001
WATSON LABS 80MG A075238 001 Jul 13, 2000
120MG A075238 002 Jul 13, 2000
160MG A075238 003 Jul 13, 2000
240MG A075238 004 Jul 13, 2000

SOYBEAN OIL
INJECTABLE; INJECTION
SOYACAL 10%
ALPHA THERA 10% N018465 001 Jun 29, 1983
SOYACAL 20%
ALPHA THERA 20% N018786 001 Jun 29, 1983
TRAVAMULSION 10%
BAXTER HLTHCARE 10% N018660 001 Feb 26, 1982
TRAVAMULSION 20%
BAXTER HLTHCARE 20% N018758 001 Feb 15, 1983

SPARFLOXACIN
TABLET; ORAL
ZAGAM
MYLAN 200MG N020677 001 Dec 19, 1996

SPECTINOMYCIN HYDROCHLORIDE
INJECTABLE; INJECTION
TROBICIN
PHARMACIA AND UPJOHN EQ 4GM BASE/VIAL N050347 002

SPIRAPRIL HYDROCHLORIDE
TABLET; ORAL
RENORMAX
SCHERING 3MG N020240 001 Dec 29, 1994
6MG N020240 002 Dec 29, 1994
12MG N020240 003 Dec 29, 1994
24MG N020240 004 Dec 29, 1994

SPIRONOLACTONE
TABLET; ORAL
SPIRONOLACTONE
ASCOT 25MG A087687 001 Oct 20, 1982
IVAX PHARMS 25MG A087108 001
LEDERLE 25MG A087634 001
MUTUAL PHARM 25MG A087265 001
MYLAN 25MG A087086 001
PUREPAC PHARM 25MG A087998 001 Oct 14, 1983
25MG A088053 001 Aug 25, 1983
SUPERPHARM 25MG A089364 001 Nov 07, 1986
UPSHER SMITH 25MG A087554 001
VANGARD 25MG A087648 001 Feb 01, 1982
WARNER CHILCOTT 25MG A087952 001 Nov 18, 1982
WATSON LABS 25MG A086898 002 Mar 02, 1982
25MG A087078 001
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STANOZOLOL
TABLET; ORAL
WINSTROL
LUNDBECK INC 2MG N012885 001 May 14, 1984

STAVUDINE
CAPSULE; ORAL
ZERIT
BRISTOL MYERS SQUIBB 5MG N020412 001 Jun 24, 1994
CAPSULE, EXTENDED RELEASE; ORAL
ZERIT XR
BRISTOL MYERS SQUIBB 37.5MG N021453 001 Dec 31, 2002
50MG N021453 002 Dec 31, 2002
75MG N021453 003 Dec 31, 2002
100MG N021453 004 Dec 31, 2002

STREPTOMYCIN SULFATE
INJECTABLE; INJECTION
STREPTOMYCIN SULFATE
COPANOS EQ 500MG BASE/ML A060684 001
LILLY EQ 1GM BASE/VIAL A060107 001
EQ 1GM BASE/2ML A060404 001
EQ 5GM BASE/VIAL A060107 002
PFIZER EQ 1GM BASE/VIAL A060076 001
EQ 5GM BASE/VIAL A060076 002

SUCCINYLCHOLINE CHLORIDE
INJECTABLE; INJECTION
ANECTINE
SANDOZ 50MG/ML N008453 003
500MG/VIAL N008453 001
1GM/VIAL N008453 004
QUELICIN PRESERVATIVE FREE
HOSPIRA 50MG/ML N008845 002
SUCCINYLCHOLINE CHLORIDE
INTL MEDICATION 100MG/VIAL A085400 001 Feb 04, 1982
ORGANON USA INC 20MG/ML A080997 001
SUCOSTRIN
APOTHECON 20MG/ML N008847 001
100MG/ML N008847 003

SUFENTANIL CITRATE
INJECTABLE; INJECTION
SUFENTANIL CITRATE
WATSON LABS EQ 0.05MG BASE/ML A074406 001 Dec 15, 1995

SULFACETAMIDE SODIUM
OINTMENT; OPHTHALMIC
BLEPH-10
ALLERGAN 10% A084015 001
SODIUM SULAMYD
SCHERING 10% N005963 002
SULFAIR 10
PHARMAFAIR 10% A088000 001 Dec 22, 1982
SOLUTION/DROPS; OPHTHALMIC
BLEPH-30
ALLERGAN 30% A080028 002
ISOPTO CETAMIDE
ALCON 15% A080020 002
OCUSULF-10
MIZA PHARMS USA 10% A080660 001
OCUSULF-30
MIZA PHARMS USA 30% A080660 002
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SULFACETAMIDE SODIUM
SOLUTION/DROPS; OPHTHALMIC
SODIUM SULAMYD
SCHERING 10% N005963 001
30% N005963 003
SODIUM SULFACETAMIDE
AKORN 10% A083021 001
15% A083021 002
30% A083021 003
SOLA BARNES HIND 10% A084143 001
10% A084145 001
30% A084146 001
30% A084147 001
SULF-10
NOVARTIS 10% A080025 001
SULF-15
NOVARTIS 15% A089047 001 Oct 31, 1995
SULFACEL-15
OPTOPICS 15% A080024 001
SULFACETAMIDE SODIUM
AKORN 10% A040215 001 May 25, 1999
30% A040216 001 May 25, 1999
ALCON 30% A089068 001 May 05, 1987
PHARMAFAIR 10% A088947 001 May 17, 1985
SULFAIR 10
PHARMAFAIR 10% A087949 001 Dec 13, 1982
SULFAIR FORTE
PHARMAFAIR 30% A088385 001 Oct 13, 1983
SULFAIR-15
PHARMAFAIR 15% A088186 001 May 25, 1983
SULTEN-10
BAUSCH AND LOMB 10% A087818 001 Feb 03, 1983

SULFACYTINE
TABLET; ORAL
RENOQUID
GLENWOOD 250MG N017569 001

SULFADIAZINE
TABLET; ORAL
SULFADIAZINE
ABBOTT 300MG N004125 005
EVERYLIFE 500MG A080088 001
IMPAX LABS 500MG A080081 001
LANNETT 500MG A080084 001
LEDERLE 500MG N004054 001
LILLY 500MG N004122 002

SULFADIAZINE SODIUM
INJECTABLE; INJECTION
SULFADIAZINE SODIUM
LEDERLE 250MG/ML N004054 002

SULFADIAZINE; SULFAMERAZINE
SUSPENSION; ORAL
SULFONAMIDES DUPLEX
LILLY 250MG/5ML;250MG/5ML N006317 007

SULFAMETER
TABLET; ORAL
SULLA
BAYER HLTHCARE 500MG N016000 002
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SULFAMETHIZOLE
TABLET; ORAL
MICROSUL
FOREST PHARMS 1GM A086012 001
PROKLAR
FOREST PHARMS 500MG A080273 001
THIOSULFIL
WYETH AYERST 250MG N008565 001
500MG N008565 004

SULFAMETHOXAZOLE
SUSPENSION; ORAL
GANTANOL
ROCHE 500MG/5ML N013664 002
TABLET; ORAL
GANTANOL
ROCHE 500MG N012715 002
GANTANOL-DS
ROCHE 1GM N012715 003
SULFAMETHOXAZOLE
ASCOT 500MG A087662 001 Oct 20, 1982
BARR 500MG A087189 001 Jul 25, 1983
HEATHER 500MG A086163 001
SANDOZ 500MG A085844 001
WATSON LABS 500MG A085053 001
1GM A086000 001
UROBAK
SHIONOGI 500MG A087307 001

SULFAMETHOXAZOLE; TRIMETHOPRIM
INJECTABLE; INJECTION
BACTRIM
MUTUAL PHARM 80MG/ML;16MG/ML N018374 001
SEPTRA
MONARCH PHARMS 80MG/ML;16MG/ML N018452 001
SULFAMETHOXAZOLE AND TRIMETHOPRIM
ABRAXIS PHARM 80MG/ML;16MG/ML A070223 001 Dec 29, 1987
BAXTER HLTHCARE 80MG/ML;16MG/ML A070627 001 Dec 29, 1987
80MG/ML;16MG/ML A070628 001 Dec 29, 1987
BEDFORD 80MG/ML;16MG/ML A072383 001 Apr 29, 1992
HOSPIRA 80MG/ML;16MG/ML A073199 001 Sep 11, 1992
WATSON LABS 80MG/ML;16MG/ML A071556 001 Dec 29, 1987
SUSPENSION; ORAL
BACTRIM
MUTUAL PHARM 200MG/5ML;40MG/5ML N017560 001
BACTRIM PEDIATRIC
MUTUAL PHARM 200MG/5ML;40MG/5ML N017560 002
SEPTRA
MONARCH PHARMS 200MG/5ML;40MG/5ML N017598 001
SEPTRA GRAPE
MONARCH PHARMS 200MG/5ML;40MG/5ML N017598 002 Feb 12, 1986
SULFAMETHOXAZOLE AND TRIMETHOPRIM
TEVA 200MG/5ML;40MG/5ML A070028 001 Jun 02, 1987
200MG/5ML;40MG/5ML N018812 001 Jan 28, 1983
200MG/5ML;40MG/5ML N018812 002 Jun 10, 1983
SULFATRIM
ACTAVIS MID ATLANTIC 200MG/5ML;40MG/5ML N018615 002 Jan 07, 1983
SULMEPRIM
USL PHARMA 200MG/5ML;40MG/5ML A070063 001 Aug 01, 1986
SULMEPRIM PEDIATRIC
USL PHARMA 200MG/5ML;40MG/5ML A070064 001 Aug 01, 1986
TRIMETH/SULFA
ALPHARMA US PHARMS 200MG/5ML;40MG/5ML A072289 001 May 23, 1988
200MG/5ML;40MG/5ML A072398 001 May 23, 1988
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 289 (of 324)

SULFAMETHOXAZOLE; TRIMETHOPRIM
SUSPENSION; ORAL
TRIMETH/SULFA
NASKA 200MG/5ML;40MG/5ML A072399 001 May 23, 1988
TABLET; ORAL
COTRIM
TEVA 400MG;80MG A070034 001 May 16, 1985
COTRIM D.S.
TEVA 800MG;160MG A070048 001 Mar 18, 1985
SULFAMETHOXAZOLE AND TRIMETHOPRIM
AMNEAL PHARMS NY 400MG;80MG A071299 001 Oct 27, 1987
800MG;160MG A071300 001 Oct 27, 1987
HEATHER 400MG;80MG N018946 001 Aug 10, 1984
800MG;160MG N018946 002 Aug 10, 1984
MARTEC USA LLC 400MG;80MG A072408 001 Dec 07, 1988
MUTUAL PHARM 400MG;80MG A070006 001 Nov 14, 1984
400MG;80MG A071016 001 Aug 25, 1986
PLIVA 400MG;80MG A070215 001 Sep 10, 1985
800MG;160MG A070216 001 Sep 10, 1985
ROXANE 400MG;80MG A072768 001 Aug 30, 1991
SANDOZ 400MG;80MG A070889 001 Nov 13, 1986
400MG;80MG N018598 003 May 19, 1982
800MG;160MG A070890 001 Nov 13, 1986
TEVA 400MG;80MG N018242 001
800MG;160MG N018242 002
USL PHARMA 400MG;80MG A070203 001 Nov 08, 1985
800MG;160MG A070204 001 Nov 08, 1985
WATSON LABS 400MG;80MG A070002 001 Nov 07, 1984
400MG;80MG N018852 001 May 09, 1983
800MG;160MG A070000 001 Nov 07, 1984
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
MARTEC USA LLC 800MG;160MG A072417 001 Dec 07, 1988
MUTUAL PHARM 800MG;160MG A070007 001 Nov 14, 1984
ROXANE 800MG;160MG A072769 001 Aug 30, 1991
WATSON LABS 800MG;160MG N018854 001 May 09, 1983
SULFATRIM-DS
SUPERPHARM 800MG;160MG A070066 001 Jun 24, 1985
SULFATRIM-SS
SUPERPHARM 400MG;80MG A070065 002 Jun 24, 1985
UROPLUS DS
SHIONOGI 800MG;160MG A071816 001 Sep 28, 1987
UROPLUS SS
SHIONOGI 400MG;80MG A071815 001 Sep 28, 1987

SULFANILAMIDE
CREAM; VAGINAL
SULFANILAMIDE
TEVA 15% A088718 001 Sep 19, 1985
SUPPOSITORY; VAGINAL
AVC
AZUR PHARMA 1.05GM N006530 004 Jan 27, 1987

SULFAPHENAZOLE
SUSPENSION; ORAL

SULFABID

PHARM RES ASSOC 500MG/5ML N013093 001


TABLET; ORAL

SULFABID

PURDUE FREDERICK 500MG N013092 002


SULFAPYRIDINE
TABLET; ORAL
SULFAPYRIDINE
LILLY 500MG N000159 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 290 (of 324)

SULFASALAZINE
SUSPENSION; ORAL
AZULFIDINE
PHARMACIA AND UPJOHN 250MG/5ML N018605 001
TABLET; ORAL
S.A.S.-500
SOLVAY 500MG A083450 001
SULFASALAZINE
HERITAGE PHARMS INC 500MG A080197 001
MUTUAL PHARM 500MG A089590 001 Oct 19, 1987
SANDOZ 500MG A086184 001
SUPERPHARM 500MG A089339 001 Oct 26, 1987
WATSON LABS 500MG A084964 001
TABLET, DELAYED RELEASE; ORAL
SULFASALAZINE
WATSON LABS 500MG A088052 001 May 24, 1983

SULFINPYRAZONE
CAPSULE; ORAL
ANTURANE
NOVARTIS 200MG N011556 004
SULFINPYRAZONE
BARR 200MG A087666 001 Sep 17, 1982
IVAX PHARMS 200MG A087770 001 Nov 19, 1982
PAR PHARM 200MG A088934 001 Sep 06, 1985
VANGARD 200MG A088666 001 Feb 17, 1984
TABLET; ORAL
ANTURANE
NOVARTIS 100MG N011556 003
SULFINPYRAZONE
BARR 100MG A087665 001 Sep 17, 1982
IVAX PHARMS 100MG A087769 001 Jun 01, 1982
PAR PHARM 100MG A088933 001 Sep 06, 1985
WATSON LABS 100MG A087667 001 May 26, 1982

SULFISOXAZOLE
TABLET; ORAL
GANTRISIN
ROCHE 500MG N006525 001
SOSOL
MK LABS 500MG A080036 001
SOXAZOLE
ALRA 500MG A080366 001
SULFALAR
PARKE DAVIS 500MG A084955 001
SULFISOXAZOLE
BARR 500MG A084031 001
HEATHER 500MG A080189 001
IMPAX LABS 500MG A080109 001
LANNETT 500MG A080085 001
LEDERLE 500MG A087649 001
PHARMERAL 500MG A084385 001
PUREPAC PHARM 500MG A080087 001
ROXANE 500MG A080082 001
SANDOZ 500MG A085628 001
VALEANT PHARM INTL 500MG A080268 002
VITARINE 500MG A087332 001
WATSON LABS 500MG A085534 001
WEST WARD 500MG A080379 001
SULSOXIN
SOLVAY 500MG A080040 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 291 (of 324)

SULFISOXAZOLE ACETYL
EMULSION; ORAL

LIPO GANTRISIN

ROCHE EQ 1GM BASE/5ML N009182 009


SUSPENSION; ORAL

GANTRISIN PEDIATRIC

ROCHE EQ 500MG BASE/5ML N009182 004


SYRUP; ORAL

GANTRISIN

ROCHE EQ 500MG BASE/5ML N009182 002


SULFISOXAZOLE DIOLAMINE
INJECTABLE; INJECTION
GANTRISIN
ROCHE EQ 400MG BASE/ML N006917 001
OINTMENT; OPHTHALMIC
GANTRISIN
ROCHE EQ 4% BASE N008414 002
SOLUTION/DROPS; OPHTHALMIC
GANTRISIN
ROCHE EQ 4% BASE N007757 002
SULFISOXAZOLE DIOLAMINE
SOLA BARNES HIND EQ 4% BASE A084148 001

SULFOXONE SODIUM
TABLET, DELAYED RELEASE; ORAL
DIASONE SODIUM
ABBOTT 165MG N006044 003

SULFUR
POWDER; TOPICAL
BENSULFOID
POYTHRESS 33.32% N002918 001

SULINDAC
TABLET; ORAL
CLINORIL
MERCK 150MG N017911 001
SULINDAC
HERITAGE PHARMS INC 150MG A073262 002 Sep 06, 1991
200MG A073262 001 Sep 06, 1991
SANDOZ 150MG A072712 001 Aug 30, 1991
200MG A072713 001 Aug 30, 1991
TEVA 150MG A072972 001 Feb 28, 1992
200MG A072973 001 Feb 28, 1992

SUPROFEN
SOLUTION/DROPS; OPHTHALMIC
PROFENAL
ALCON 1% N019387 001 Dec 23, 1988

SUTILAINS
OINTMENT; TOPICAL
TRAVASE
ABBOTT 82,000 UNITS/GM N012828 001

TALBUTAL
TABLET; ORAL
LOTUSATE
SANOFI AVENTIS US 120MG N009410 005
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DISCONTINUED DRUG PRODUCT LIST 6 - 292 (of 324)

TAMOXIFEN CITRATE
SOLUTION; ORAL
SOLTAMOX
ROSEMONT EQ 10MG BASE/5ML N021807 001 Oct 29, 2005
TABLET; ORAL
NOLVADEX
ASTRAZENECA EQ 10MG BASE N017970 001
EQ 20MG BASE N017970 002 Mar 21, 1994
TAMOXIFEN CITRATE
IVAX SUB TEVA PHARMS EQ 10MG BASE A075740 001 Feb 20, 2003
EQ 20MG BASE A075740 002 Feb 20, 2003
PHARMACHEMIE EQ 10MG BASE A074539 001 Mar 31, 2003
ROXANE EQ 10MG BASE A076027 001 Feb 20, 2003
EQ 20MG BASE A076027 002 Feb 20, 2003
TEVA EQ 10MG BASE A074504 001 Apr 28, 2003
EQ 20MG BASE A074504 002 Apr 28, 2003

TECHNETIUM TC-99M ALBUMIN AGGREGATED


INJECTABLE; INJECTION
TC 99M-LUNGAGGREGATE
GE HEALTHCARE 5mCi/ML N017848 001

TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT


INJECTABLE; INJECTION
A-N STANNOUS AGGREGATED ALBUMIN
SYNCOR PHARMS N/A N017916 001
AN-MAA
PHARMALUCENCE N/A N017792 001
LUNGAGGREGATE REAGENT
GE HEALTHCARE N/A N017838 001
MACROTEC
BRACCO N/A N017833 001
TECHNESCAN MAA
MALLINCKRODT N/A N017842 001
TECHNETIUM TC 99M MAA
GE HEALTHCARE N/A N017773 001

TECHNETIUM TC-99M ALBUMIN COLLOID KIT


INJECTABLE; INJECTION
MICROLITE
PHARMALUCENCE N/A N018263 001 Mar 25, 1983

TECHNETIUM TC-99M ALBUMIN KIT


INJECTABLE; INJECTION
TECHNETIUM TC 99M HSA
GE HEALTHCARE N/A N017775 001

TECHNETIUM TC-99M ALBUMIN MICROSPHERES KIT


INJECTABLE; INJECTION
INSTANT MICROSPHERES
3M N/A N017832 001

TECHNETIUM TC-99M APCITIDE


INJECTABLE; INJECTION
ACUTECT
CIS BIO INTL SA N/A N020887 001 Sep 14, 1998

TECHNETIUM TC-99M DEPREOTIDE


INJECTABLE; INJECTION
NEO TECT KIT
CIS BIO INTL SA N/A N021012 001 Aug 03, 1999
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DISCONTINUED DRUG PRODUCT LIST 6 - 293 (of 324)

TECHNETIUM TC-99M ETIDRONATE KIT


INJECTABLE; INJECTION
CINTICHEM TECHNETIUM 99M HEDSPA
GE HEALTHCARE N/A N017653 001
MPI STANNOUS DIPHOSPHONATE
GE HEALTHCARE N/A N017667 001
OSTEOSCAN
MALLINCKRODT N/A N017454 001
TECHNETIUM TC 99M DIPHOSPHONATE-TIN KIT
GE HEALTHCARE N/A N017562 001

TECHNETIUM TC-99M FERPENTETATE KIT


INJECTABLE; INJECTION
RENOTEC
BRACCO N/A N017045 001

TECHNETIUM TC-99M GLUCEPTATE KIT


INJECTABLE; INJECTION
GLUCOSCAN
BRISTOL MYERS SQUIBB N/A N017907 001
TECHNESCAN GLUCEPTATE
DRAXIMAGE N/A N018272 001 Jan 27, 1982

TECHNETIUM TC-99M LIDOFENIN KIT


INJECTABLE; INJECTION
TECHNESCAN HIDA
DRAXIMAGE N/A N018489 001 Oct 31, 1986

TECHNETIUM TC-99M MEDRONATE KIT


INJECTABLE; INJECTION
AMERSCAN MDP KIT
GE HEALTHCARE N/A N018335 001 Aug 05, 1982
DRAXIMAGE MDP-25
DRAXIMAGE N/A N018035 002 Feb 27, 2004
OSTEOLITE
PHARMALUCENCE N/A N017972 001
TECHNETIUM TC 99M MPI MDP
GE HEALTHCARE N/A N018141 001
N/A N018141 002 Jun 12, 1989

TECHNETIUM TC-99M PENTETATE KIT


INJECTABLE; INJECTION
MPI DTPA KIT - CHELATE
GE HEALTHCARE N/A N017255 001

TECHNETIUM TC-99M POLYPHOSPHATE KIT


INJECTABLE; INJECTION
SODIUM POLYPHOSPHATE-TIN KIT
GE HEALTHCARE N/A N017664 001

TECHNETIUM TC-99M PYRO/TRIMETA PHOSPHATES KIT


INJECTABLE; INJECTION
PYROLITE
PHARMALUCENCE N/A N017684 001

TECHNETIUM TC-99M PYROPHOSPHATE KIT


INJECTABLE; INJECTION
PHOSPHOTEC
BRACCO N/A N017680 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 294 (of 324)

TECHNETIUM TC-99M RED BLOOD CELL KIT


INJECTABLE; INJECTION
RBC-SCAN
CADEMA N/A N020063 001 Jun 11, 1992

TECHNETIUM TC-99M SESTAMIBI KIT


INJECTABLE; INJECTION
MIRALUMA
LANTHEUS MEDCL N/A N019785 003 May 23, 1997

TECHNETIUM TC-99M SODIUM PERTECHNETATE


SOLUTION; INJECTION, ORAL
SODIUM PERTECHNETATE TC 99M
GE HEALTHCARE 2-100mCi/ML N017471 001
MALLINCKRODT 10-60mCi/ML N017725 001
PHARMALUCENCE 12mCi/ML N017321 001
24mCi/ML N017321 002
48mCi/ML N017321 003

TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR


SOLUTION; INJECTION, ORAL
MINITEC
BRACCO 0.22-2.22 CI/GENERATOR N017339 001
TECHNETIUM TC 99M GENERATOR
GE HEALTHCARE 830-16600mCi/GENERATOR N017693 001

TECHNETIUM TC-99M SULFUR COLLOID


SOLUTION; INJECTION, ORAL

TECHNETIUM TC 99M SULFUR COLLOID


GE HEALTHCARE 4mCi/ML N017456 001


SOLUTION; ORAL

TECHNETIUM TC 99M SULFUR COLLOID


MALLINCKRODT 3mCi/ML N017724 001


TECHNETIUM TC-99M SULFUR COLLOID KIT


SOLUTION; INJECTION, ORAL
TECHNECOLL
MALLINCKRODT N/A N017059 001
TECHNETIUM TC 99M TSC
GE HEALTHCARE N/A N017784 001
TESULOID
BRACCO N/A N016923 001

TECHNETIUM TC-99M TEBOROXIME KIT


INJECTABLE; INJECTION
CARDIOTEC
BRACCO N/A N019928 001 Dec 19, 1990

TEGASEROD MALEATE
TABLET; ORAL
ZELNORM
NOVARTIS EQ 2MG BASE N021200 001 Jul 24, 2002
EQ 6MG BASE N021200 002 Jul 24, 2002

TEMAZEPAM
CAPSULE; ORAL
TEMAZ
QUANTUM PHARMICS 15MG A070564 001 Oct 15, 1985
30MG A070547 001 Oct 15, 1985
TEMAZEPAM
DURAMED PHARMS BARR 15MG A071708 001 Sep 29, 1988
30MG A071709 001 Sep 29, 1988
MUTUAL PHARM 15MG A071174 001 Jul 10, 1986
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DISCONTINUED DRUG PRODUCT LIST 6 - 295 (of 324)

TEMAZEPAM
CAPSULE; ORAL
TEMAZEPAM
MUTUAL PHARM 30MG A071175 001 Jul 10, 1986
USL PHARMA 15MG A070489 001 Jul 07, 1986
30MG A070490 001 Jul 07, 1986
WATSON LABS 15MG A070383 001 Mar 23, 1987
30MG A070384 001 Mar 23, 1987

TERAZOSIN HYDROCHLORIDE
CAPSULE; ORAL
TERAZOSIN HYDROCHLORIDE
MYLAN TECHNOLOGIES EQ 1MG BASE A075384 001 Dec 01, 2000
EQ 2MG BASE A075384 002 Dec 01, 2000
EQ 5MG BASE A075384 003 Dec 01, 2000
EQ 10MG BASE A075384 004 Dec 01, 2000
SANDOZ EQ 1MG BASE A075667 001 Jul 28, 2000
EQ 2MG BASE A075667 002 Jul 28, 2000
EQ 5MG BASE A075667 003 Jul 28, 2000
EQ 10MG BASE A075667 004 Jul 28, 2000
TABLET; ORAL
TERAZOSIN HYDROCHLORIDE
IVAX SUB TEVA PHARMS EQ 1MG BASE A074530 001 Apr 21, 2000
EQ 2MG BASE A074530 002 Apr 21, 2000
EQ 5MG BASE A074530 003 Apr 21, 2000
EQ 10MG BASE A074530 004 Apr 21, 2000
SANDOZ EQ 1MG BASE A074315 001 Dec 31, 1998
EQ 1MG BASE A074657 001 Apr 28, 2000
EQ 2MG BASE A074315 002 Dec 31, 1998
EQ 2MG BASE A074657 002 Apr 28, 2000
EQ 5MG BASE A074315 003 Dec 31, 1998
EQ 5MG BASE A074657 003 Apr 28, 2000
EQ 10MG BASE A074315 004 Dec 31, 1998
EQ 10MG BASE A074657 004 Apr 28, 2000
TEVA EQ 1MG BASE A074446 001 May 18, 2000
EQ 2MG BASE A074446 002 May 18, 2000
EQ 5MG BASE A074446 003 May 18, 2000
EQ 10MG BASE A074446 004 May 18, 2000

TERBINAFINE HYDROCHLORIDE
CREAM; TOPICAL
LAMISIL
NOVARTIS 1% N020192 001 Dec 30, 1992

TERBUTALINE SULFATE
AEROSOL, METERED; INHALATION
BRETHAIRE
NOVARTIS 0.2MG/INH N018762 001 Aug 17, 1984
BRICANYL
SANOFI AVENTIS US 0.2MG/INH N018000 001 Mar 19, 1985
INJECTABLE; INJECTION
BRETHINE
AAIPHARMA LLC 1MG/ML N018571 001
BRICANYL
SANOFI AVENTIS US 1MG/ML N017466 001
TABLET; ORAL
BRETHINE
AAIPHARMA LLC 2.5MG N017849 001
5MG N017849 002
BRICANYL
SANOFI AVENTIS US 2.5MG N017618 001
5MG N017618 002
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DISCONTINUED DRUG PRODUCT LIST 6 - 296 (of 324)

TERIPARATIDE ACETATE
INJECTABLE; INJECTION
PARATHAR
SANOFI AVENTIS US 200 UNITS/VIAL N019498 001 Dec 23, 1987

TESTOLACTONE
INJECTABLE; INJECTION
TESLAC
BRISTOL MYERS SQUIBB 100MG/ML N016119 001
TABLET; ORAL
TESLAC
BRISTOL MYERS SQUIBB 50MG N016118 001
250MG N016118 002

TESTOSTERONE
FILM, EXTENDED RELEASE; TRANSDERMAL
TESTODERM
ALZA 4MG/24HR N019762 001 Oct 12, 1993
6MG/24HR N019762 002 Oct 12, 1993
TESTODERM TTS
ALZA 5MG/24HR N020791 001 Dec 18, 1997
GEL; TRANSDERMAL
TESTOSTERONE
PAR PHARM 1% (2.5GM/PACKET) A076744 001 May 23, 2007
1% (5GM/PACKET) A076744 002 May 23, 2007
WATSON LABS 1% (2.5GM/PACKET) A076737 001 Jan 27, 2006
1% (5GM/PACKET) A076737 002 Jan 27, 2006
INJECTABLE; INJECTION
TESTOSTERONE
WATSON LABS 25MG/ML A086420 001 May 10, 1983
50MG/ML A086419 001 Aug 23, 1983
100MG/ML A086417 001 Jul 07, 1983

TESTOSTERONE CYPIONATE
INJECTABLE; INJECTION
DEPO-TESTOSTERONE
PHARMACIA AND UPJOHN 50MG/ML A085635 001
TESTOSTERONE CYPIONATE
WATSON LABS 100MG/ML A084401 001
100MG/ML A086029 001
200MG/ML A084401 002

TESTOSTERONE ENANTHATE
INJECTABLE; INJECTION
DELATESTRYL
ENDO PHARM 200MG/ML N009165 001
TESTOSTERONE ENANTHATE
WATSON LABS 100MG/ML A083667 001
100MG/ML A085599 001
200MG/ML A083667 002

TESTOSTERONE PROPIONATE
INJECTABLE; INJECTION
TESTOSTERONE PROPIONATE
BEL MAR 25MG/ML A080741 001
50MG/ML A080742 001
100MG/ML A080743 001
ELKINS SINN 25MG/ML A080276 001
LILLY 50MG/ML A080254 002
WATSON LABS 25MG/ML A080188 001
25MG/ML A085490 001
50MG/ML A080188 002
50MG/ML A085490 002
100MG/ML A080188 003
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DISCONTINUED DRUG PRODUCT LIST 6 - 297 (of 324)

TESTOSTERONE PROPIONATE
INJECTABLE; INJECTION
TESTOSTERONE PROPIONATE
WATSON LABS 100MG/ML A083595 003

TETRACYCLINE HYDROCHLORIDE
CAPSULE; ORAL
ACHROMYCIN V
HERITAGE PHARMS INC 250MG N050278 003
500MG N050278 001
BRISTACYCLINE
BRISTOL 250MG A061658 001
250MG A061888 001
500MG A061658 002
500MG A061888 002
CYCLOPAR
WARNER CHILCOTT 250MG A061725 001
250MG A062175 001
250MG A062332 001
500MG A061725 002
500MG A062332 002
PANMYCIN
PHARMACIA AND UPJOHN 250MG A060347 001
RETET
SOLVAY 250MG A061443 001
500MG A061443 002
ROBITET
WYETH AYERST 250MG A061734 001
500MG A061734 002
SUMYCIN
APOTHECON 100MG A060429 002
125MG A060429 004
250MG A060429 001
500MG A060429 003
TETRACHEL
ANGUS 250MG A060343 001
500MG A060343 003
TETRACYCLINE HYDROCHLORIDE
ABBOTT 250MG A061802 001
500MG A061802 002
ELKINS SINN 250MG A060059 001
FERRANTE 125MG A060173 001
250MG A060173 002
HEATHER 250MG A061148 001
500MG A061148 002
LABS ATRAL 250MG A062752 001 Aug 12, 1988
500MG A062752 002 Aug 12, 1988
MAST MM 250MG A062085 001
MUTUAL PHARM 250MG A060736 001
500MG A060736 002
MYLAN 250MG A060783 001
500MG A060783 002
PUREPAC PHARM 250MG A060290 001
500MG A060290 002
PVT FORM 250MG A062686 001 Jul 24, 1986
500MG A062686 002 Jul 24, 1986
ROXANE 500MG A061214 002
SANDOZ 250MG A061471 001
SUPERPHARM 250MG A062540 001 Mar 21, 1985
500MG A062540 002 Mar 21, 1985
VALEANT PHARM INTL 250MG A060471 001
500MG A060471 002
WARNER CHILCOTT 250MG A062300 001
500MG A062300 002
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 298 (of 324)

TETRACYCLINE HYDROCHLORIDE
CAPSULE; ORAL
TETRACYCLINE HYDROCHLORIDE
WATSON LABS 250MG A062103 001
250MG A062343 001
500MG A062103 002
500MG A062343 002
WEST WARD 250MG A060768 001
500MG A060768 002
WYETH AYERST 250MG A061685 001
500MG A061685 002
TETRACYN
PFIPHARMECS 250MG A060082 003
500MG A060082 004
FIBER, EXTENDED RELEASE; PERIODONTAL
ACTISITE
ON SITE 12.7MG/FIBER N050653 001 Mar 25, 1994
FOR SOLUTION; TOPICAL
TOPICYCLINE
SHIRE 2.2MG/ML N050493 001
INJECTABLE; INJECTION
ACHROMYCIN
LEDERLE 250MG/VIAL N050273 002
500MG/VIAL N050273 003
TETRACYN
PFIZER 250MG/VIAL A060096 001
500MG/VIAL A060096 002
OINTMENT; OPHTHALMIC
ACHROMYCIN
STORZ 10MG/GM N050266 001
SUSPENSION; ORAL
ACHROMYCIN V
LEDERLE 125MG/5ML N050263 002
TETRACYCLINE HYDROCHLORIDE
ALPHARMA US PHARMS 125MG/5ML A060633 001
FERRANTE 125MG/5ML A060174 001
PROTER 125MG/5ML A060446 001
PUREPAC PHARM 125MG/5ML A060291 001
TETRACYN
PFIPHARMECS 125MG/5ML A060095 001
TETRAMED
IVAX SUB TEVA PHARMS 125MG/5ML A061468 001
SUSPENSION/DROPS; OPHTHALMIC
ACHROMYCIN
STORZ 1% N050268 001
TABLET; ORAL
PANMYCIN
PHARMACIA AND UPJOHN 250MG A061705 001
500MG A061705 002
SUMYCIN
PAR PHARM 50MG A061147 003
100MG A061147 002

TETRACYCLINE PHOSPHATE COMPLEX


CAPSULE; ORAL
TETREX
BRISTOL EQ 100MG HCL A061653 001
EQ 250MG HCL A061653 002
EQ 250MG HCL A061889 002
EQ 250MG HCL N050212 002
EQ 500MG HCL A061653 003
EQ 500MG HCL A061889 001
EQ 500MG HCL N050212 003
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 299 (of 324)

THALLOUS CHLORIDE, TL-201


INJECTABLE; INJECTION
THALLOUS CHLORIDE TL 201
BRACCO 1mCi/ML N018548 001 Dec 30, 1982
TRACE LIFE 1mCi/ML A075569 001 Nov 21, 2001

THEOPHYLLINE
CAPSULE; ORAL
BRONKODYL
SANOFI AVENTIS US 100MG A085264 001
200MG A085264 002
ELIXOPHYLLIN
FOREST LABS 100MG A085545 001 Jul 31, 1984
200MG A083921 001 Jul 31, 1984
SOMOPHYLLIN-T
FISONS 100MG A087155 001 Feb 25, 1985
200MG A087155 002 Feb 25, 1985
250MG A087155 003 Feb 25, 1985
THEOPHYLLINE
KV PHARM 100MG A085263 001
200MG A085263 002
SCHERER RP 100MG A084731 002 Nov 07, 1986
200MG A084731 001 Nov 07, 1986
250MG A084731 003 Nov 07, 1986
CAPSULE, EXTENDED RELEASE; ORAL
AEROLATE III
FLEMING PHARMS 65MG A085075 003 Nov 24, 1986
AEROLATE JR
FLEMING PHARMS 130MG A085075 002 Nov 24, 1986
AEROLATE SR
FLEMING PHARMS 260MG A085075 001 Nov 24, 1986
ELIXOPHYLLIN SR
FOREST LABS 125MG A086826 001 Jan 29, 1985
250MG A086826 002 Jan 29, 1985
SLO-BID
SANOFI AVENTIS US 50MG A088269 001 Jan 31, 1985
75MG A089539 001 May 10, 1989
100MG A087892 001 Jan 31, 1985
125MG A089540 001 May 10, 1989
200MG A087893 001 Jan 31, 1985
300MG A087894 001 Jan 31, 1985
SLO-PHYLLIN
SANOFI AVENTIS US 60MG A085206 001 May 24, 1982
125MG A085203 001 May 24, 1982
250MG A085205 001 May 24, 1982
SOMOPHYLLIN-CRT
GRAHAM DM 50MG A087763 001 Feb 27, 1985
100MG A087194 001
200MG A088382 001 Feb 27, 1985
250MG A087193 001
300MG A088383 001 Feb 27, 1985
THEOBID
WHITBY 260MG A085983 001 Mar 20, 1985
THEOBID JR.
WHITBY 130MG A087854 001 Mar 20, 1985
THEOCLEAR L.A.-130
SCHWARZ PHARMA 130MG A086569 001 May 27, 1982
THEOCLEAR L.A.-260
SCHWARZ PHARMA 260MG A086569 002 May 27, 1982
THEO-DUR
SCHERING 50MG A088022 001 Sep 10, 1985
75MG A088015 001 Sep 10, 1985
125MG A088016 001 Sep 10, 1985
200MG A087995 001 Sep 10, 1985
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 300 (of 324)

THEOPHYLLINE
CAPSULE, EXTENDED RELEASE; ORAL
THEOPHYLLINE
CENT PHARMS 125MG A088654 001 Feb 12, 1985
250MG A088689 001 Feb 12, 1985
HOSPIRA 100MG A089976 001 Jan 04, 1995
200MG A089977 001 Jan 04, 1995
300MG A089932 001 Jan 04, 1995
SANDOZ 260MG A087462 001 May 11, 1982
THEOPHYLLINE-SR
SCHERER RP 300MG A088255 001 Jun 12, 1986
THEOPHYL-SR
ORTHO MCNEIL PHARM 125MG A086480 001 Feb 08, 1985
250MG A086471 001 Feb 08, 1985
THEOVENT
SCHERING 125MG A087010 001 Jan 31, 1985
250MG A087910 001 Jan 31, 1985
ELIXIR; ORAL
ELIXOMIN
CENCI 80MG/15ML A088303 001 Jan 25, 1984
LANOPHYLLIN
LANNETT 80MG/15ML A084578 001
THEOLIXIR
PANRAY 80MG/15ML A084559 001
THEOPHYL-225
ORTHO MCNEIL PHARM 112.5MG/15ML A086485 001
THEOPHYLLINE
ALPHARMA US PHARMS 80MG/15ML A089223 001 May 27, 1988
CENCI 80MG/15ML A087679 001 Apr 15, 1982
HALSEY 80MG/15ML A085169 001
MORTON GROVE 80MG/15ML A086748 001
PERRIGO 80MG/15ML A085952 001
PHARM ASSOC 80MG/15ML A086720 001
PRECISION DOSE 80MG/15ML A085863 001
ROXANE 80MG/15ML A084739 001
TARO 80MG/15ML A089626 001 Oct 28, 1988
INJECTABLE; INJECTION
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 40MG/100ML N019083 001 Nov 07, 1984
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 80MG/100ML N019083 002 Nov 07, 1984
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 160MG/100ML N019083 003 Nov 07, 1984
THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 200MG/100ML N019212 001 Nov 07, 1984
200MG/100ML N019826 004 Aug 14, 1992
THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 4MG/ML N019212 003 Nov 07, 1984
400MG/100ML N019212 002 Nov 07, 1984
400MG/100ML N019826 005 Aug 14, 1992
SOLUTION; ORAL
AEROLATE
FLEMING PHARMS 150MG/15ML A089141 001 Dec 03, 1986
THEOLAIR
3M 80MG/15ML A086107 001
THEOPHYLLINE
ROXANE 80MG/15ML A087449 001 Sep 15, 1983
SUSPENSION; ORAL
ELIXICON
FOREST LABS 100MG/5ML A085502 001
SYRUP; ORAL
ACCURBRON
SANOFI AVENTIS US 150MG/15ML A088746 001 Nov 22, 1985
AQUAPHYLLIN
FERNDALE LABS 80MG/15ML A087917 001 Jan 18, 1983
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 301 (of 324)

THEOPHYLLINE
SYRUP; ORAL
SLO-PHYLLIN
SANOFI AVENTIS US 80MG/15ML A085187 001
THEOCLEAR-80
CENT PHARMS 80MG/15ML A087095 001 Mar 01, 1982
THEOPHYLLINE
ALPHARMA US PHARMS 80MG/15ML A086001 001
150MG/15ML A086545 001
TABLET; ORAL
QUIBRON-T
MONARCH PHARMS 300MG A088656 001 Aug 22, 1985
SLO-PHYLLIN
SANOFI AVENTIS US 100MG A085202 001
200MG A085204 001
THEOCLEAR-100
CENT PHARMS 100MG A085353 002
THEOCLEAR-200
CENT PHARMS 200MG A085353 001
THEOPHYL-225
ORTHO MCNEIL PHARM 225MG A084726 001
TABLET, CHEWABLE; ORAL
THEOPHYL
ORTHO MCNEIL PHARM 100MG A086506 001 Sep 12, 1985
TABLET, EXTENDED RELEASE; ORAL
DURAPHYL
FOREST LABS 100MG A088503 001 Apr 03, 1985
200MG A088504 001 Apr 03, 1985
300MG A088505 001 Apr 03, 1985
LABID
PROCTER AND GAMBLE 250MG A087225 001
QUIBRON-T/SR
MONARCH PHARMS 300MG A087563 001 Jun 21, 1983
SUSTAIRE
ROERIG 100MG A085665 001
300MG A085665 002
THEO-DUR
SCHERING 100MG A085328 001
200MG A086998 001
300MG A085328 002
450MG A089131 001 Jun 25, 1986
THEOLAIR-SR
3M 200MG A088369 001 Jul 16, 1987
250MG A086363 002 Jul 16, 1987
300MG A088364 001 Jul 16, 1987
500MG A089132 001 Jul 16, 1987
THEOPHYLLINE
ABLE 300MG A040548 001 Apr 30, 2004
400MG A040543 001 Apr 27, 2004
450MG A040546 001 Apr 30, 2004
600MG A040539 001 Apr 27, 2004
T-PHYL
PHARM RES ASSOC 200MG A088253 001 Aug 17, 1983
UNI-DUR
SCHERING 400MG A089822 001 Jan 04, 1995
600MG A089823 001 Jan 04, 1995

THEOPHYLLINE SODIUM GLYCINATE


ELIXIR; ORAL
SYNOPHYLATE
CENT PHARMS EQ 165MG BASE/15ML N006333 008
TABLET; ORAL
ASBRON
NOVARTIS EQ 150MG BASE A085148 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 302 (of 324)

THIABENDAZOLE
SUSPENSION; ORAL

MINTEZOL

MERCK 500MG/5ML N016097 001


TABLET, CHEWABLE; ORAL

MINTEZOL

MERCK 500MG N016096 001


THIAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
BETALIN S
LILLY 100MG/ML A080853 001
THIAMINE HYDROCHLORIDE
ABRAXIS PHARM 100MG/ML A080509 001
AKORN 100MG/ML A087968 001 Oct 01, 1982
BAXTER HLTHCARE 100MG/ML A080575 001
BEL MAR 100MG/ML A080718 001
200MG/ML A080712 001
DELL LABS 100MG/ML A083775 001
LUITPOLD 100MG/ML A080667 001
PARKE DAVIS 100MG/ML A080770 001
WATSON LABS 100MG/ML A083534 001
200MG/ML A083534 002
WYETH AYERST 100MG/ML A080553 001

THIAMYLAL SODIUM
INJECTABLE; INJECTION
SURITAL
PARKEDALE 1GM/VIAL N007600 003
5GM/VIAL N007600 005
10GM/VIAL N007600 009

THIETHYLPERAZINE MALATE
INJECTABLE; INJECTION
TORECAN
NOVARTIS 5MG/ML N012754 002

THIETHYLPERAZINE MALEATE
SUPPOSITORY; RECTAL

TORECAN

NOVARTIS 10MG N013247 001


TABLET; ORAL

TORECAN

NOVARTIS 10MG N012753 001


THIOPENTAL SODIUM
SUSPENSION; RECTAL
PENTOTHAL
ABBOTT 400MG/GM N011679 001

THIORIDAZINE
SUSPENSION; ORAL
MELLARIL-S
NOVARTIS EQ 25MG HCL/5ML N017923 001
EQ 100MG HCL/5ML N017923 002

THIORIDAZINE HYDROCHLORIDE
CONCENTRATE; ORAL
MELLARIL
NOVARTIS 30MG/ML N011808 012
100MG/ML N011808 018
THIORIDAZINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC 100MG/ML A088229 001 Aug 23, 1983
ALPHARMA US PHARMS 30MG/ML A087766 001 Apr 26, 1983
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 303 (of 324)

THIORIDAZINE HYDROCHLORIDE
CONCENTRATE; ORAL
THIORIDAZINE HYDROCHLORIDE
HI TECH PHARMA 30MG/ML A040125 001 Aug 16, 1996
100MG/ML A040126 001 Aug 16, 1996
MORTON GROVE 30MG/ML A088258 001 Jul 25, 1983
100MG/ML A088227 001 Jul 05, 1983
PHARM ASSOC 30MG/ML A040187 001 Aug 28, 1997
100MG/ML A040213 001 May 29, 1998
SANDOZ 30MG/ML A088307 001 Nov 23, 1983
100MG/ML A088308 001 Nov 23, 1983
TEVA PHARMS 30MG/ML A089602 001 Nov 09, 1987
100MG/ML A089603 001 Nov 09, 1987
THIORIDAZINE HYDROCHLORIDE INTENSOL
ROXANE 30MG/ML A088941 001 Dec 16, 1985
100MG/ML A088942 001 Dec 16, 1985
TABLET; ORAL
MELLARIL
NOVARTIS 10MG N011808 003
15MG N011808 016
25MG N011808 006
50MG N011808 011
100MG N011808 009
150MG N011808 017
200MG N011808 015
THIORIDAZINE HYDROCHLORIDE
IVAX PHARMS 10MG A088270 001 Apr 14, 1983
15MG A088271 001 Apr 14, 1983
25MG A088272 001 Apr 14, 1983
50MG A088194 001 Apr 14, 1983
100MG A088273 001 Oct 03, 1983
MUTUAL PHARM 10MG A088375 001 Nov 18, 1983
15MG A088461 001 Nov 18, 1983
25MG A087264 001 Nov 18, 1983
50MG A088370 001 Nov 18, 1983
100MG A088379 001 Nov 16, 1983
150MG A088737 001 Sep 26, 1984
200MG A088738 001 Oct 16, 1984
MYLAN 10MG A088332 001 Jun 27, 1983
25MG A088333 001 Jun 27, 1983
50MG A088334 001 Jun 27, 1983
100MG A088335 001 Nov 18, 1983
PAR PHARM 10MG A088351 001 Dec 05, 1983
15MG A088352 001 Dec 05, 1983
25MG A088336 001 Dec 05, 1983
50MG A088322 001 Dec 05, 1983
100MG A088480 001 Dec 29, 1983
150MG A089764 001 Feb 09, 1988
200MG A089765 001 Feb 09, 1988
ROXANE 10MG A088663 001 Mar 15, 1984
25MG A088664 001 Mar 15, 1984
50MG A088665 001 Mar 15, 1984
100MG A089048 001 Feb 26, 1985
SANDOZ 10MG A088131 001 Aug 30, 1983
15MG A088132 001 Aug 30, 1983
25MG A088133 001 Aug 30, 1983
50MG A088134 001 Aug 30, 1983
100MG A088135 001 Nov 20, 1984
150MG A088136 001 Sep 17, 1986
200MG A088137 001 Sep 17, 1986
SUPERPHARM 10MG A089103 001 Jul 02, 1985
25MG A089104 001 Jul 02, 1985
50MG A089105 001 Jul 02, 1985
TEVA 10MG A088493 001 May 17, 1985
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 304 (of 324)

THIORIDAZINE HYDROCHLORIDE
TABLET; ORAL
THIORIDAZINE HYDROCHLORIDE
TEVA 100MG A088456 001 May 17, 1985
WATSON LABS 10MG A088412 001 Sep 12, 1983
10MG A088476 001 Nov 08, 1983
10MG A088561 001 May 11, 1984
15MG A088345 001 Jul 28, 1983
15MG A088477 001 Nov 08, 1983
15MG A088562 001 May 11, 1984
25MG A088296 001 Jul 28, 1983
25MG A088478 001 Nov 08, 1983
25MG A088567 001 May 11, 1984
25MG A088755 001 Jul 24, 1984
50MG A088323 001 Jul 28, 1983
50MG A088479 001 Nov 08, 1983
50MG A088563 001 May 11, 1984
100MG A088284 001 Aug 25, 1983
100MG A088564 001 May 11, 1984
100MG A088736 001 Jul 24, 1984
150MG A088410 001 Mar 05, 1984
150MG A088869 001 Jun 28, 1985
200MG A088381 001 Mar 14, 1984
200MG A088872 001 Apr 26, 1985
WEST WARD 10MG A088658 001 Mar 26, 1984
15MG A088659 001 Mar 26, 1984
25MG A088660 001 Mar 26, 1984
50MG A088661 001 Mar 26, 1984

THIOTEPA
INJECTABLE; INJECTION
THIOPLEX
IMMUNEX 15MG/VIAL N020058 001 Dec 22, 1994
THIOTEPA
IMMUNEX 15MG/VIAL N011683 001

THIOTHIXENE
CAPSULE; ORAL
NAVANE
PFIZER 20MG N016584 005
THIOTHIXENE
AM THERAP 1MG A071884 001 Aug 12, 1987
2MG A071885 001 Aug 12, 1987
5MG A071886 001 Aug 12, 1987
10MG A071887 001 Aug 12, 1987
20MG A072200 001 Dec 17, 1987
WATSON LABS 1MG A070600 001 Jun 05, 1987
2MG A071626 001 Jun 25, 1987
5MG A071627 001 Jun 25, 1987
10MG A070603 001 Jun 05, 1987
10MG A071628 001 Jun 25, 1987

THIOTHIXENE HYDROCHLORIDE
CONCENTRATE; ORAL
NAVANE
PFIZER EQ 5MG BASE/ML N016758 001
THIOTHIXENE HYDROCHLORIDE
ALPHARMA US PHARMS EQ 5MG BASE/ML A070969 001 Oct 16, 1987
PACO EQ 1MG BASE/ML A071917 001 Sep 20, 1989
EQ 5MG BASE/ML A071939 001 Dec 16, 1988
TEVA EQ 5MG BASE/ML A071184 001 Jun 22, 1987
TEVA PHARMS EQ 5MG BASE/ML A071554 001 Oct 16, 1987
THIOTHIXENE HYDROCHLORIDE INTENSOL
ROXANE EQ 5MG BASE/ML A073494 001 Jun 30, 1992
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DISCONTINUED DRUG PRODUCT LIST 6 - 305 (of 324)

THIOTHIXENE HYDROCHLORIDE
INJECTABLE; INJECTION
NAVANE
PFIZER EQ 2MG BASE/ML N016904 001
EQ 10MG BASE/VIAL N016904 002

THYROGLOBULIN
TABLET; ORAL
PROLOID
PARKE DAVIS 16MG N002245 009
32MG N002245 005
65MG N002245 002
100MG N002245 008
130MG N002245 010
200MG N002245 007
325MG N002245 004
THYROGLOBULIN
IMPAX LABS 64.8MG A080151 001

THYROTROPIN
INJECTABLE; INJECTION
THYTROPAR
SANOFI AVENTIS US 10 IU/VIAL N008682 001

TIAGABINE HYDROCHLORIDE
TABLET; ORAL
GABITRIL
CEPHALON 20MG N020646 004 Sep 30, 1997

TICARCILLIN DISODIUM
INJECTABLE; INJECTION
TICAR
GLAXOSMITHKLINE EQ 1GM BASE/VIAL N050497 001
EQ 3GM BASE/VIAL A062690 001 Dec 19, 1986
EQ 3GM BASE/VIAL N050497 002
EQ 6GM BASE/VIAL N050497 003
EQ 20GM BASE/VIAL N050497 004
EQ 30GM BASE/VIAL N050497 005 Apr 04, 1984

TICLOPIDINE HYDROCHLORIDE
TABLET; ORAL
TICLID
ROCHE PALO 125MG N019979 001 Mar 24, 1993
250MG N019979 002 Oct 31, 1991
TICLOPIDINE HYDROCHLORIDE
MYLAN 250MG A075316 001 Nov 02, 1999
SANDOZ 250MG A075318 001 Aug 20, 1999
WATSON LABS 250MG A075309 001 Apr 26, 2000

TIMOLOL MALEATE
SOLUTION/DROPS; OPHTHALMIC
TIMOLOL MALEATE
AKORN EQ 0.25% BASE A074465 001 Mar 25, 1997
FOUGERA EQ 0.25% BASE A074667 001 Mar 25, 1997
EQ 0.5% BASE A074668 001 Mar 25, 1997
TABLET; ORAL
BLOCADREN
MERCK 5MG N018017 001
10MG N018017 002
20MG N018017 004
TIMOLOL MALEATE
QUANTUM PHARMICS 5MG A072466 001 May 19, 1989
10MG A072467 001 May 19, 1989
20MG A072468 001 May 19, 1989
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 306 (of 324)

TIMOLOL MALEATE
TABLET; ORAL
TIMOLOL MALEATE
SANDOZ 5MG A072550 001 Apr 13, 1989
10MG A072551 001 Apr 13, 1989
20MG A072552 001 Apr 13, 1989
TEVA 5MG A072648 001 Jun 16, 1993
10MG A072649 001 Jun 16, 1993
20MG A072650 001 Jun 16, 1993
USL PHARMA 5MG A072001 001 Apr 11, 1989
10MG A072002 001 Apr 11, 1989
20MG A072003 001 Apr 11, 1989
WATSON LABS 5MG A072269 001 Apr 11, 1989
5MG A072917 001 Jul 31, 1991
10MG A072270 001 Apr 11, 1989
10MG A072918 001 Jul 31, 1991
20MG A072271 001 Apr 11, 1989
20MG A072919 001 Jul 31, 1991

TIOCONAZOLE
CREAM; TOPICAL
TZ-3
PFIZER 1% N018682 001 Feb 18, 1983

TIROFIBAN HYDROCHLORIDE
INJECTABLE; INJECTION
AGGRASTAT
MEDICURE EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) N020912 001 May 14, 1998
EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) N020913 001 May 14, 1998

TIZANIDINE HYDROCHLORIDE
TABLET; ORAL
TIZANIDINE HYDROCHLORIDE
BARR EQ 2MG BASE A076371 001 Apr 09, 2003
EQ 4MG BASE A076371 002 Apr 09, 2003
IVAX SUB TEVA PHARMS EQ 2MG BASE A076321 001 Sep 30, 2004
EQ 4MG BASE A076321 002 Sep 30, 2004
ZANAFLEX
ACORDA EQ 2MG BASE N020397 002 Feb 04, 2000

TOBRAMYCIN
SOLUTION/DROPS; OPHTHALMIC
TOBRAMYCIN
ALCON UNIVERSAL 0.3% A063176 001 May 25, 1994

TOBRAMYCIN SULFATE
INJECTABLE; INJECTION
NEBCIN
LILLY EQ 10MG BASE/ML A062008 004
EQ 10MG BASE/ML A062707 001 Apr 29, 1987
EQ 10MG BASE/ML N050477 005
EQ 40MG BASE/ML A062008 001
EQ 1.2GM BASE/VIAL N050519 001
TOBRAMYCIN SULFATE
APOTHECON EQ 40MG BASE/ML A064021 002 May 31, 1994
EQ 40MG BASE/ML A064026 001 May 31, 1994
ASTRAZENECA EQ 10MG BASE/ML A063119 001 Oct 31, 1994
EQ 40MG BASE/ML A063120 001 Oct 31, 1994
EQ 40MG BASE/ML A063121 001 Oct 31, 1994
EQ 40MG BASE/ML A063122 001 Oct 31, 1994
BAXTER HLTHCARE EQ 10MG BASE/ML A063113 001 Apr 26, 1991
EQ 10MG BASE/ML A063128 001 Nov 27, 1991
EQ 40MG BASE/ML A063118 001 Jul 29, 1991
EQ 40MG BASE/ML A063127 001 Nov 27, 1991
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 307 (of 324)

TOBRAMYCIN SULFATE
INJECTABLE; INJECTION
TOBRAMYCIN SULFATE
HOSPIRA EQ 40MG BASE/ML A063161 001 May 29, 1991
MARSAM PHARMS LLC EQ 40MG BASE/ML A062945 002 Aug 09, 1989

TOCAINIDE HYDROCHLORIDE
TABLET; ORAL
TONOCARD
ASTRAZENECA 400MG N018257 001 Nov 09, 1984
600MG N018257 002 Nov 09, 1984

TOLAZAMIDE
TABLET; ORAL
TOLAZAMIDE
AMNEAL PHARMS NY 250MG A071270 001 Sep 23, 1986
500MG A071271 001 Sep 23, 1986
BARR 100MG A070162 001 Jan 14, 1986
250MG A070163 001 Jan 14, 1986
500MG A070164 001 Jan 14, 1986
DURAMED PHARMS BARR 100MG A070165 001 Jan 10, 1986
250MG A070166 001 Jan 10, 1986
500MG A070167 001 Jan 10, 1986
IVAX SUB TEVA PHARMS 100MG N018894 001 Nov 02, 1984
250MG N018894 002 Nov 02, 1984
500MG N018894 003 Nov 02, 1984
MUTUAL PHARM 100MG A071357 001 Jul 16, 1987
250MG A071358 001 Jul 16, 1987
500MG A071359 001 Jul 16, 1987
PAR PHARM 100MG A070159 001 Jan 06, 1986
250MG A070160 001 Jan 06, 1986
500MG A070161 001 Jan 06, 1986
SANDOZ 100MG A071633 001 Dec 09, 1987
250MG A070289 001 Mar 13, 1986
500MG A070290 001 Mar 13, 1986
SUPERPHARM 250MG A070763 001 Jun 16, 1986
500MG A070764 001 Jun 16, 1986
USL PHARMA 100MG A071355 001 Jan 11, 1988
250MG A070168 001 Apr 02, 1986
500MG A070169 001 Apr 02, 1986
WATSON LABS 100MG A070242 001 Aug 01, 1986
100MG A070513 001 Jan 09, 1986
250MG A070243 001 Aug 01, 1986
500MG A070244 001 Aug 01, 1986
TOLINASE
PHARMACIA AND UPJOHN 100MG N015500 002
250MG N015500 004
500MG N015500 005

TOLAZOLINE HYDROCHLORIDE
INJECTABLE; INJECTION
PRISCOLINE
NOVARTIS 25MG/ML N006403 005 Feb 22, 1985

TOLBUTAMIDE
TABLET; ORAL
ORINASE
PHARMACIA AND UPJOHN 250MG N010670 002
500MG N010670 001
TOLBUTAMIDE
ALRA 500MG A086141 001
ASCOT 500MG A087541 001 Mar 01, 1983
BARR 500MG A087121 001
CLONMEL HLTHCARE 500MG A086926 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 308 (of 324)

TOLBUTAMIDE
TABLET; ORAL
TOLBUTAMIDE
IVAX PHARMS 500MG A087093 001
PARKE DAVIS 500MG A086047 001
PUREPAC PHARM 500MG A088950 001 Jun 17, 1985
SANDOZ 500MG A086574 001
500MG N012678 001
SUPERPHARM 500MG A088893 001 Nov 19, 1984
VANGARD 500MG A087876 001 Apr 20, 1982
WATSON LABS 250MG A089110 001 May 29, 1987
500MG A089111 001 May 29, 1987

TOLBUTAMIDE SODIUM
INJECTABLE; INJECTION
ORINASE DIAGNOSTIC
PHARMACIA AND UPJOHN EQ 1GM BASE/VIAL N012095 001

TOLMETIN SODIUM
CAPSULE; ORAL
TOLMETIN SODIUM
IVAX SUB TEVA PHARMS EQ 400MG BASE A073392 001 Jan 24, 1992
MUTUAL PHARM EQ 400MG BASE A073311 001 Nov 27, 1991
SANDOZ EQ 400MG BASE A073462 001 Apr 30, 1992
TEVA EQ 400MG BASE A073519 001 May 29, 1992
TABLET; ORAL
TOLMETIN SODIUM
ACTAVIS ELIZABETH EQ 600MG BASE A073527 001 Jun 30, 1992
SANDOZ EQ 200MG BASE A073588 001 Jul 31, 1992
EQ 600MG BASE A074002 001 Sep 27, 1993
TEVA EQ 600MG BASE A074729 001 Feb 27, 1997

TOLVAPTAN
TABLET; ORAL
SAMSCA
OTSUKA AMERICA PHARM 60MG N022275 003 May 19, 2009

TOPIRAMATE
CAPSULE; ORAL
TOPAMAX SPRINKLE
ORTHO MCNEIL JANSSEN 50MG N020844 003 Oct 26, 1998
TOPIRAMATE
BARR 15MG A076448 001 Apr 15, 2009
25MG A076448 002 Apr 15, 2009
TABLET; ORAL
TOPAMAX
ORTHO MCNEIL JANSSEN 300MG N020505 003 Dec 24, 1996
400MG N020505 006 Dec 24, 1996
TOPIRAMATE
BARR 25MG A076315 001 Mar 27, 2009
100MG A076315 002 Mar 27, 2009
200MG A076315 003 Mar 27, 2009

TORSEMIDE
INJECTABLE; INJECTION
DEMADEX
ROCHE 50MG/5ML (10MG/ML) N020137 002 Aug 23, 1993
20MG/2ML (10MG/ML) N020137 001 Aug 23, 1993

TRAMADOL HYDROCHLORIDE
TABLET; ORAL
TRAMADOL HYDROCHLORIDE
ASTA 50MG A075974 001 Jul 12, 2002
IVAX SUB TEVA PHARMS 50MG A075963 001 Jul 03, 2002
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DISCONTINUED DRUG PRODUCT LIST 6 - 309 (of 324)

TRAMADOL HYDROCHLORIDE
TABLET; ORAL
ULTRAM
ORTHO MCNEIL JANSSEN 100MG N020281 001 Mar 03, 1995
TABLET, ORALLY DISINTEGRATING; ORAL
TRAMADOL HYDROCHLORIDE
VICTORY PHARMA 50MG N021693 001 May 05, 2005

TRANEXAMIC ACID
TABLET; ORAL
CYKLOKAPRON
PHARMACIA AND UPJOHN 500MG N019280 001 Dec 30, 1986

TRAZODONE HYDROCHLORIDE
TABLET; ORAL
DESYREL
APOTHECON 50MG N018207 001
100MG N018207 002
150MG N018207 003 Mar 25, 1985
300MG N018207 004 Nov 07, 1988
TRAZODONE HYDROCHLORIDE
AM THERAP 50MG A071139 001 Oct 29, 1986
100MG A071140 001 Oct 29, 1986
MYLAN 50MG A071405 001 Feb 27, 1991
100MG A071406 001 Feb 27, 1991
QUANTUM PHARMICS 100MG A070921 001 Dec 01, 1986
SANDOZ 50MG A072484 001 Apr 30, 1990
100MG A072483 001 Apr 30, 1990
TEVA 150MG A074357 001 Apr 30, 1997
USL PHARMA 50MG A070491 001 Apr 29, 1987
100MG A070492 001 Apr 29, 1987
WATSON LABS 50MG A071112 001 Nov 17, 1986
100MG A071113 001 Nov 17, 1986
TRIALODINE
QUANTUM PHARMICS 50MG A070942 001 Dec 01, 1986

TRETINOIN
SOLUTION; TOPICAL
TRETINOIN
TEVA PHARMS 0.05% A074873 001 Jun 19, 1998
SWAB; TOPICAL
RETIN-A
JOHNSON AND JOHNSON 0.05% N016921 002

TRIAMCINOLONE
TABLET; ORAL
ARISTOCORT
ASTELLAS 1MG N011161 009
2MG N011161 004
4MG N011161 007
8MG N011161 011
16MG N011161 010
KENACORT
BRISTOL MYERS SQUIBB 1MG N011283 003
2MG N011283 008
4MG N011283 006
8MG N011283 010
TRIAMCINOLONE
BARR 2MG A084286 001
2MG A084318 001
4MG A084267 001
4MG A084319 001
8MG A084268 001
8MG A084320 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 310 (of 324)

TRIAMCINOLONE
TABLET; ORAL
TRIAMCINOLONE
IMPAX LABS 4MG A084340 001
IVAX SUB TEVA PHARMS 4MG A083750 001
MYLAN 2MG A084406 001
PUREPAC PHARM 2MG A084020 002
4MG A084020 003
ROXANE 2MG A084708 001
4MG A084709 001
8MG A084707 001
SANDOZ 4MG A085601 001
TEVA 4MG A084775 001
WATSON LABS 4MG A084270 001
4MG A085834 001

TRIAMCINOLONE ACETONIDE
AEROSOL, METERED; NASAL
NASACORT
SANOFI AVENTIS US 0.055MG/INH N019798 001 Jul 11, 1991
CREAM; TOPICAL
ARISTOCORT
ASTELLAS 0.025% A083017 003
0.1% A083016 004
0.5% A083015 002
ARISTOCORT A
ASTELLAS 0.025% A083017 004
0.025% A088818 001 Oct 16, 1984
0.1% A083016 005
0.1% A088819 001 Oct 16, 1984
0.5% A083015 003
0.5% A088820 001 Oct 16, 1984
FLUTEX
IVAX PHARMS 0.025% A085539 001
0.1% A085539 002
0.5% A085539 003
KENALOG
APOTHECON 0.5% A083943 001
KENALOG-H
APOTHECON 0.1% A086240 001
TRIACET
TEVA 0.1% A084908 002
TRIACORT
SOLVAY 0.1% A087113 001
TRIAMCINOLONE ACETONIDE
ALPHARMA US PHARMS 0.025% A087797 001 Jun 07, 1982
AMBIX 0.025% A087932 001 May 09, 1983
G AND W LABS 0.1% A089798 001 May 31, 1991
MORTON GROVE 0.025% A088094 001 Sep 01, 1983
0.1% A088095 001 Sep 01, 1983
0.5% A088096 001 Sep 01, 1983
PHARMADERM 0.025% A087990 001 Jul 07, 1983
0.1% A087991 001 Jul 07, 1983
0.5% A087992 001 Jul 07, 1983
PHARMAFAIR 0.025% A087921 001 Aug 10, 1982
0.1% A087912 001 Aug 10, 1982
0.5% A087922 001 Aug 10, 1982
TARO 0.025% A040038 001 Oct 26, 1994
TOPIDERM 0.025% A089274 001 Feb 21, 1989
0.1% A089275 001 Feb 21, 1989
0.5% A089276 001 Feb 21, 1989
TRIATEX
IVAX PHARMS 0.025% A087430 001 Nov 01, 1988
0.1% A087429 001 Nov 01, 1988
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DISCONTINUED DRUG PRODUCT LIST 6 - 311 (of 324)

TRIAMCINOLONE ACETONIDE
CREAM; TOPICAL
TRIATEX
IVAX PHARMS 0.5% A087428 001 Nov 01, 1988
TRYMEX
SAVAGE LABS 0.025% A088196 001 Mar 25, 1983
0.1% A088197 001 Mar 25, 1983
0.5% A088198 001 Mar 25, 1983
GEL; TOPICAL
ARISTOGEL
ASTELLAS 0.1% A083380 001
INJECTABLE; INJECTION
TRIAMCINOLONE ACETONIDE
PARNELL 3MG/ML N019503 001 Oct 16, 1987
WATSON LABS 40MG/ML A085825 001
LOTION; TOPICAL
KENALOG
APOTHECON 0.025% A084343 001
0.1% A084343 002
BRISTOL MYERS SQUIBB 0.025% N011602 003
0.1% N011602 001
TRIAMCINOLONE ACETONIDE
ALPHARMA US PHARMS 0.025% A087191 001 Sep 08, 1982
0.1% A087192 001 Sep 08, 1982
OINTMENT; TOPICAL
ARISTOCORT
ASTELLAS 0.1% A080750 004
0.5% A080745 002
ARISTOCORT A
ASTELLAS 0.1% A080750 003
0.1% A088780 001 Oct 01, 1984
0.5% A080745 003
0.5% A088781 001 Oct 05, 1984
FLUTEX
IVAX PHARMS 0.025% A087375 001 Nov 01, 1988
0.1% A087377 001 Nov 01, 1988
0.5% A087376 001 Nov 01, 1988
KENALOG
APOTHECON 0.5% A083944 001
TRIAMCINOLONE ACETONIDE
ALPHARMA US PHARMS 0.5% A089913 001 Dec 23, 1988
G AND W LABS 0.025% A089795 001 Dec 23, 1988
0.1% A089796 001 Dec 23, 1988
MORTON GROVE 0.025% A088090 001 Sep 01, 1983
0.1% A088091 001 Sep 01, 1983
0.5% A088092 001 Sep 01, 1983
PHARMADERM 0.025% A088692 001 Aug 02, 1984
0.1% A088690 001 Aug 02, 1984
TRYMEX
SAVAGE LABS 0.025% A088693 001 Aug 02, 1984
0.1% A088691 001 Aug 02, 1984
PASTE; DENTAL
KENALOG IN ORABASE
APOTHECON 0.1% N012097 001
ORALONE
TARO 0.1% A071383 001 Jul 06, 1987
SPRAY, METERED; NASAL
ALLERNAZE
LUPIN ATLANTIS 0.05MG/SPRAY N020120 001 Feb 04, 2000
NASACORT HFA
SANOFI AVENTIS US 0.055MG/SPRAY N020784 001 Apr 07, 2004
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DISCONTINUED DRUG PRODUCT LIST 6 - 312 (of 324)

TRIAMCINOLONE DIACETATE
INJECTABLE; INJECTION
ARISTOCORT
SANDOZ 25MG/ML N011685 003
40MG/ML N012802 001
TRIAMCINOLONE DIACETATE
AKORN 25MG/ML A085122 001
40MG/ML A086394 001
WATSON LABS 40MG/ML A084072 001
40MG/ML A085529 001
SYRUP; ORAL
ARISTOCORT
ASTELLAS 2MG/5ML N011960 004
KENACORT
BRISTOL MYERS SQUIBB EQ 4MG BASE/5ML N012515 001

TRIAZOLAM
TABLET; ORAL
HALCION
PHARMACIA AND UPJOHN 0.5MG N017892 002 Nov 15, 1982

TRICHLORMETHIAZIDE
TABLET; ORAL
METAHYDRIN
SANOFI AVENTIS US 2MG N012594 001 Jun 16, 1988
4MG N012594 002 Jun 16, 1988
NAQUA
SCHERING 2MG N012265 001
4MG N012265 002
TRICHLOREX
LANNETT 4MG A083436 001
4MG A085630 001
TRICHLORMAS
MAST MM 4MG A086259 001
TRICHLORMETHIAZIDE
IMPAX LABS 4MG A083967 001
PAR PHARM 2MG A087007 001
4MG A087005 001
SANDOZ 4MG A086171 001
TG UNITED LABS 4MG A085568 001
WATSON LABS 2MG A083847 001
2MG A086458 001
4MG A083462 001
4MG A083855 001
4MG A085962 001

TRICLOFOS SODIUM
SOLUTION; ORAL

TRICLOS

SANOFI AVENTIS US 1.5GM/15ML N016830 001

TABLET; ORAL

TRICLOS

SANOFI AVENTIS US 750MG N016809 002

TRIDIHEXETHYL CHLORIDE
INJECTABLE; INJECTION
PATHILON
LEDERLE 10MG/ML N009729 001
TABLET; ORAL
PATHILON
LEDERLE 25MG N009489 005
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DISCONTINUED DRUG PRODUCT LIST 6 - 313 (of 324)

TRIFLUOPERAZINE HYDROCHLORIDE
CONCENTRATE; ORAL
STELAZINE
GLAXOSMITHKLINE EQ 10MG BASE/ML N011552 006
TRIFLUOPERAZINE HYDROCHLORIDE
MORTON GROVE EQ 10MG BASE/ML A088143 001 Jul 26, 1983
SANDOZ EQ 10MG BASE/ML A085787 001 Apr 15, 1982
INJECTABLE; INJECTION
STELAZINE
GLAXOSMITHKLINE EQ 2MG BASE/ML N011552 005
TABLET; ORAL
STELAZINE
GLAXOSMITHKLINE EQ 1MG BASE N011552 001
EQ 2MG BASE N011552 002
EQ 5MG BASE N011552 003
EQ 10MG BASE N011552 004
TRIFLUOPERAZINE HYDROCHLORIDE
DURAMED PHARMS BARR EQ 1MG BASE A088967 001 Apr 23, 1985
EQ 2MG BASE A088968 001 Apr 23, 1985
EQ 5MG BASE A088969 001 Apr 23, 1985
EQ 10MG BASE A088970 001 Apr 23, 1985
IVAX PHARMS EQ 1MG BASE A087612 001 Nov 19, 1982
EQ 2MG BASE A087613 001 Nov 19, 1982
EQ 5MG BASE A087328 001 Nov 19, 1982
EQ 10MG BASE A087614 001 Nov 19, 1982
SANDOZ EQ 1MG BASE A040153 001 Oct 25, 1996
EQ 2MG BASE A040153 002 Oct 25, 1996
EQ 5MG BASE A040153 003 Oct 25, 1996
EQ 10MG BASE A040153 004 Oct 25, 1996
WATSON LABS EQ 1MG BASE A085975 001 Jun 23, 1988
EQ 2MG BASE A085976 001 Jun 23, 1988
EQ 5MG BASE A085973 001 Jun 23, 1988
EQ 10MG BASE A088710 001 Jun 23, 1988

TRIFLUPROMAZINE
SUSPENSION; ORAL
VESPRIN
APOTHECON EQ 50MG HCL/5ML N011491 004

TRIFLUPROMAZINE HYDROCHLORIDE
INJECTABLE; INJECTION
VESPRIN
APOTHECON 3MG/ML N011325 005
10MG/ML N011325 004
20MG/ML N011325 001
TABLET; ORAL
VESPRIN
BRISTOL MYERS SQUIBB 10MG N011123 001
25MG N011123 002
50MG N011123 003

TRIHEXYPHENIDYL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
ARTANE
LEDERLE 5MG N006773 010
5MG N012947 001
ELIXIR; ORAL
ARTANE
LEDERLE 2MG/5ML N006773 009
TRIHEXYPHENIDYL HYDROCHLORIDE
PHARM VENTURES 2MG/5ML A089514 001 Apr 07, 1989
TABLET; ORAL
ARTANE
LEDERLE 2MG N006773 005
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DISCONTINUED DRUG PRODUCT LIST 6 - 314 (of 324)

TRIHEXYPHENIDYL HYDROCHLORIDE
TABLET; ORAL
ARTANE
LEDERLE 5MG N006773 003
TREMIN
SCHERING 2MG A080381 001
5MG A080381 003
TRIHEXYPHENIDYL HYDROCHLORIDE
NYLOS 5MG A085622 001
VANGARD 2MG A088035 001 Jul 30, 1982
WATSON LABS 2MG A085117 001
5MG A085105 001

TRILOSTANE
CAPSULE; ORAL
MODRASTANE
BIOENVISION 30MG N018719 002 Dec 31, 1984
60MG N018719 001 Dec 31, 1984

TRIMEPRAZINE TARTRATE
CAPSULE, EXTENDED RELEASE; ORAL
TEMARIL
ALLERGAN HERBERT EQ 5MG BASE N011316 004
SYRUP; ORAL
TEMARIL
ALLERGAN HERBERT EQ 2.5MG BASE/5ML N011316 003
TRIMEPRAZINE TARTRATE
ALPHARMA US PHARMS EQ 2.5MG BASE/5ML A085015 001 Feb 18, 1982
MORTON GROVE EQ 2.5MG BASE/5ML A088285 001 Apr 11, 1985
TABLET; ORAL
TEMARIL
ALLERGAN HERBERT EQ 2.5MG BASE N011316 001

TRIMETHADIONE
CAPSULE; ORAL

TRIDIONE

ABBOTT 300MG N005856 005

SOLUTION; ORAL

TRIDIONE

ABBOTT 200MG/5ML N005856 002

TRIMETHAPHAN CAMSYLATE
INJECTABLE; INJECTION
ARFONAD
ROCHE 50MG/ML N008983 001

TRIMETHOBENZAMIDE HYDROCHLORIDE
INJECTABLE; INJECTION
TRIMETHOBENZAMIDE HYDROCHLORIDE
SMITH AND NEPHEW 100MG/ML A088960 001 Apr 04, 1986
100MG/ML A089043 001 Apr 04, 1986
SOLOPAK 100MG/ML A089094 001 Apr 04, 1986
WATSON LABS 100MG/ML A086577 001 Oct 19, 1982
100MG/ML A087939 001 Dec 28, 1982

TRIMETHOPRIM
TABLET; ORAL
PROLOPRIM
MONARCH PHARMS 100MG N017943 001
200MG N017943 003 Jul 14, 1982
TRIMETHOPRIM
MUTUAL PHARM 100MG A070494 001 Jan 22, 1986
200MG A070495 001 Sep 24, 1986
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DISCONTINUED DRUG PRODUCT LIST 6 - 315 (of 324)

TRIMETHOPRIM
TABLET; ORAL
TRIMPEX
ROCHE 100MG N017952 001
TRIMPEX 200
ROCHE 200MG N017952 002 Nov 09, 1982

TRIMETHOPRIM HYDROCHLORIDE
SOLUTION; ORAL
PRIMSOL
FSC EQ 25MG BASE/5ML A074374 001 Jun 23, 1995

TRIMETREXATE GLUCURONATE
INJECTABLE; INJECTION
NEUTREXIN
MEDIMMUNE ONCOLOGY EQ 25MG BASE/VIAL N020326 001 Dec 17, 1993
EQ 200MG BASE/VIAL N020326 002 Jul 31, 1998

TRIMIPRAMINE MALEATE
CAPSULE; ORAL
TRIMIPRAMINE MALEATE
USL PHARMA EQ 25MG BASE A071283 001 Dec 08, 1987
EQ 50MG BASE A071284 001 Dec 08, 1987
EQ 100MG BASE A071285 001 Dec 08, 1987

TRIOXSALEN
TABLET; ORAL
TRISORALEN
VALEANT PHARM INTL 5MG N012697 001

TRIPELENNAMINE CITRATE
ELIXIR; ORAL
PBZ
NOVARTIS EQ 25MG HCL/5ML N005914 004

TRIPELENNAMINE HYDROCHLORIDE
TABLET; ORAL
PBZ
NOVARTIS 25MG A083149 001
50MG N005914 002
TRIPELENNAMINE HYDROCHLORIDE
ANABOLIC 50MG A083037 001
BARR 50MG A080744 001
HEATHER 50MG A083989 001
IMPAX LABS 50MG A080785 001
LANNETT 50MG A083557 001
NYLOS 50MG A085412 001
PARKE DAVIS 25MG A083625 001
50MG A083626 001
WATSON LABS 50MG A080713 001
50MG A080790 001
50MG A085188 001
TABLET, EXTENDED RELEASE; ORAL
PBZ-SR
NOVARTIS 50MG N010533 002
100MG N010533 001

TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)


CREAM; VAGINAL
GYNE-SULF
G AND W LABS 3.7%;2.86%;3.42% A088607 001 Jun 09, 1986
SULTRIN
ORTHO MCNEIL PHARM 3.7%;2.86%;3.42% N005794 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 316 (of 324)

TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)


CREAM; VAGINAL
TRIPLE SULFA
ALPHARMA US PHARMS 3.7%;2.86%;3.42% A087864 001 Sep 01, 1982
FOUGERA 3.7%;2.86%;3.42% A086424 001
PERRIGO NEW YORK 3.7%;2.86%;3.42% A087285 001 Nov 15, 1982
TRYSUL
SAVAGE LABS 3.7%;2.86%;3.42% A087887 001 Jul 23, 1982
VAGILIA
TEVA 3.7%;2.86%;3.42% A088821 001 Nov 09, 1987
TABLET; VAGINAL
SULTRIN
ORTHO MCNEIL PHARM 184MG;143.75MG;172.5MG N005794 002
TRIPLE SULFA
FOUGERA 184MG;143.75MG;172.5MG A088463 001 Jan 03, 1985
PHARMADERM 184MG;143.75MG;172.5MG A088462 001 Jan 03, 1985

TRIPROLIDINE HYDROCHLORIDE
SYRUP; ORAL
ACTIDIL
GLAXOSMITHKLINE 1.25MG/5ML N011496 002 Jul 01, 1983
MYIDYL
USL PHARMA 1.25MG/5ML A087963 001 Jan 18, 1983
TRIPROLIDINE HYDROCHLORIDE
ALPHARMA US PHARMS 1.25MG/5ML A085940 001
HALSEY 1.25MG/5ML A088735 001 Jan 17, 1985
PHARM ASSOC 1.25MG/5ML A087514 001 Feb 10, 1982
TABLET; ORAL
ACTIDIL
GLAXOSMITHKLINE 2.5MG N011110 002 Jul 01, 1983
TRIPROLIDINE HYDROCHLORIDE
VITARINE 2.5MG A085610 001
WATSON LABS 2.5MG A085094 001

TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)
SUSPENSION; ORAL
LANTRISUL
LANNETT 167MG/5ML;167MG/5ML;167MG/5ML A080123 002
NEOTRIZINE
LILLY 167MG/5ML;167MG/5ML;167MG/5ML N006317 012
SULFALOID
FOREST PHARMS 167MG/5ML;167MG/5ML;167MG/5ML A080100 001
SULFOSE
WYETH AYERST 167MG/5ML;167MG/5ML;167MG/5ML A080013 002
TERFONYL
BRISTOL MYERS SQUIBB 167MG/5ML;167MG/5ML;167MG/5ML N006904 002
TRIPLE SULFA
ALPHARMA US PHARMS 167MG/5ML;167MG/5ML;167MG/5ML A080280 001
TRIPLE SULFAS
LEDERLE 167MG/5ML;167MG/5ML;167MG/5ML N006920 003
TABLET; ORAL
NEOTRIZINE
LILLY 167MG;167MG;167MG N006317 011
SULFALOID
FOREST PHARMS 167MG;167MG;167MG A080099 001
SULFA-TRIPLE #2
IMPAX LABS 167MG;167MG;167MG A080079 001
SULFOSE
WYETH AYERST 167MG;167MG;167MG A080013 001
TERFONYL
BRISTOL MYERS SQUIBB 167MG;167MG;167MG N006904 001
TRIPLE SULFA
PUREPAC PHARM 167MG;167MG;167MG A080086 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 317 (of 324)

TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)
TABLET; ORAL
TRIPLE SULFAS
LEDERLE 167MG;167MG;167MG N006920 002
TRIPLE SULFOID
PAL PAK 167MG;167MG;167MG A080094 001

TROGLITAZONE
TABLET; ORAL
PRELAY
SANKYO 200MG N020719 001 Jan 29, 1997
300MG N020719 003 Aug 04, 1997
400MG N020719 002 Jan 29, 1997
REZULIN
PFIZER PHARMS 200MG N020720 001 Jan 29, 1997
300MG N020720 003 Aug 04, 1997
400MG N020720 002 Jan 29, 1997

TROLAMINE POLYPEPTIDE OLEATE CONDENSATE


SOLUTION/DROPS; OTIC
CERUMENEX
PHARM RES ASSOC 10% N011340 002

TROLEANDOMYCIN
CAPSULE; ORAL

TAO

PFIZER EQ 250MG BASE N050336 002

SUSPENSION; ORAL

TAO

PFIZER EQ 125MG BASE/5ML N050332 001

TROPICAMIDE
SOLUTION/DROPS; OPHTHALMIC
MYDRIACYL
ALCON 0.5% N012111 002
1% N012111 004
MYDRIAFAIR
PHARMAFAIR 0.5% A088274 001 Sep 16, 1983
1% A088230 001 Sep 16, 1983
TROPICAMIDE
AKORN 1% A088447 001 Aug 28, 1985
ALCON UNIVERSAL 1% A089172 001 Dec 28, 1990
MIZA PHARMS USA 0.5% A087636 001 Jul 30, 1982
1% A087637 001 Aug 09, 1982
WATSON LABS 0.5% A089171 001 Dec 28, 1990

TROVAFLOXACIN MESYLATE
TABLET; ORAL
TROVAN
PFIZER EQ 100MG BASE N020759 001 Dec 18, 1997
EQ 200MG BASE N020759 002 Dec 18, 1997

TUBOCURARINE CHLORIDE
INJECTABLE; INJECTION
TUBOCURARINE CHLORIDE
BRISTOL MYERS SQUIBB 3MG/ML N005657 001
HOSPIRA 3MG/ML N006095 001
LILLY 3MG/ML N006325 001

TYROPANOATE SODIUM
CAPSULE; ORAL
BILOPAQUE
GE HEALTHCARE 750MG N013731 001
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DISCONTINUED DRUG PRODUCT LIST 6 - 318 (of 324)

UNDECOYLIUM CHLORIDE; UNDECOYLIUM CHLORIDE IODINE COMPLEX


SOLUTION; TOPICAL
VIRAC REX
CHESEBROUGH PONDS 0.5%;1.8% N011914 001

URACIL MUSTARD
CAPSULE; ORAL
URACIL MUSTARD
SHIRE 1MG N012892 001

UREA
INJECTABLE; INJECTION
STERILE UREA
HOSPIRA 40GM/VIAL N017698 001
UREAPHIL
HOSPIRA 40GM/VIAL N012154 001

UREA, C-13
FOR SOLUTION; ORAL
HELICOSOL
METABOLIC SOLUTIONS 125MG/VIAL N021092 001 Dec 17, 1999
MERETEK UBT KIT (W/ PRANACTIN)
OTSUKA AMERICA 125MG/VIAL N020586 001 Sep 17, 1996
PYLORI-CHEK BREATH TEST
DXS DEVICES 100MG/VIAL N020900 001 Feb 04, 1999

UROFOLLITROPIN
INJECTABLE; INTRAMUSCULAR
METRODIN
SERONO 75 IU/AMP N019415 002 Sep 18, 1986
150 IU/AMP N019415 003 Sep 18, 1986
INJECTABLE; SUBCUTANEOUS
FERTINEX
SERONO 75 IU/AMP N019415 005 Aug 23, 1996
150 IU/AMP N019415 004 Aug 23, 1996

UROKINASE
INJECTABLE; INJECTION
KINLYTIC
MICROBIX BIOSYSTEMS 5,000 IU/VIAL N021846 003
9,000 IU/VIAL N021846 002
250,000 IU/VIAL N021846 001

URSODIOL
CAPSULE; ORAL
ACTIGALL
WATSON PHARMS 150MG N019594 001 Dec 31, 1987

VALDECOXIB
TABLET; ORAL
BEXTRA
GD SEARLE 10MG N021341 002 Nov 16, 2001
20MG N021341 003 Nov 16, 2001

VALPROIC ACID
CAPSULE; ORAL
VALPROIC ACID
PAR PHARM 250MG A070431 001 Feb 28, 1986
SCHERER RP 250MG A070195 001 Jul 02, 1987
USL PHARMA 250MG A070631 001 Jun 11, 1987
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 319 (of 324)

VALSARTAN
CAPSULE; ORAL
DIOVAN
NOVARTIS 80MG N020665 001 Dec 23, 1996
160MG N020665 002 Dec 23, 1996

VANCOMYCIN HYDROCHLORIDE
FOR SOLUTION; ORAL
VANCOCIN HYDROCHLORIDE
VIROPHARMA EQ 250MG BASE/5ML A061667 002 Jul 13, 1983
EQ 500MG BASE/6ML A061667 001
VANCOLED
LEDERLE EQ 250MG BASE/5ML A063321 002 Oct 15, 1993
EQ 500MG BASE/6ML A063321 003 Oct 15, 1993
INJECTABLE; INJECTION
VANCOCIN HYDROCHLORIDE
VIROPHARMA EQ 500MG BASE/VIAL A060180 001
EQ 500MG BASE/VIAL A062476 001 Mar 15, 1984
EQ 500MG BASE/VIAL A062716 001 Mar 13, 1987
EQ 500MG BASE/VIAL A062812 001 Nov 17, 1987
EQ 1GM BASE/VIAL A060180 002 Mar 21, 1986
EQ 1GM BASE/VIAL A062476 002 Mar 21, 1986
EQ 1GM BASE/VIAL A062716 002 Mar 13, 1987
EQ 1GM BASE/VIAL A062812 002 Nov 17, 1987
EQ 10GM BASE/VIAL A062812 003 Nov 17, 1987
VANCOLED
BAXTER HLTHCARE EQ 500MG BASE/VIAL A062682 001 Jul 22, 1986
EQ 1GM BASE/VIAL A062682 002 Mar 30, 1988
EQ 2GM BASE/VIAL A062682 003 May 11, 1988
EQ 5GM BASE/VIAL A062682 004 May 11, 1988
EQ 10GM BASE/VIAL A062682 005 May 11, 1988
VANCOMYCIN HYDROCHLORIDE
BAXTER HLTHCARE EQ 500MG BASE/VIAL A062879 001 Aug 02, 1988
EQ 1GM BASE/VIAL A062879 002 Aug 02, 1988
VANCOR
PHARMACIA AND UPJOHN EQ 500MG BASE/VIAL A062956 001 Aug 01, 1988
EQ 1GM BASE/VIAL A062956 002 Aug 01, 1988

VASOPRESSIN TANNATE
INJECTABLE; INJECTION
PITRESSIN TANNATE
PARKE DAVIS 5PRESSOR UNITS/ML N003402 001

VECURONIUM BROMIDE
INJECTABLE; INJECTION
NORCURON
ORGANON USA INC 10MG/VIAL N018776 002 Apr 30, 1984
20MG/VIAL N018776 003 Jan 03, 1992
VECURONIUM BROMIDE
BAXTER HLTHCARE 10MG/VIAL A075218 001 Aug 23, 1999
20MG/VIAL A075218 002 Aug 23, 1999
HOSPIRA 4MG/VIAL A075558 001 Sep 11, 2001

VENLAFAXINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
EFFEXOR XR
WYETH PHARMS INC EQ 100MG BASE N020699 003 Oct 20, 1997
TABLET; ORAL
EFFEXOR
WYETH PHARMS INC EQ 12.5MG BASE N020151 001 Dec 28, 1993
VENLAFAXINE HYDROCHLORIDE
SANDOZ EQ 25MG BASE A077515 001 Jun 13, 2008
EQ 37.5MG BASE A077515 002 Jun 13, 2008
EQ 50MG BASE A077515 003 Jun 13, 2008
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 320 (of 324)

VENLAFAXINE HYDROCHLORIDE
TABLET; ORAL
VENLAFAXINE HYDROCHLORIDE
SANDOZ EQ 75MG BASE A077515 004 Jun 13, 2008
EQ 100MG BASE A077515 005 Jun 13, 2008

VERAPAMIL HYDROCHLORIDE
INJECTABLE; INJECTION
CALAN
GD SEARLE LLC 2.5MG/ML N018925 001 Mar 30, 1984
2.5MG/ML N019038 001 Mar 30, 1984
ISOPTIN
FSC 2.5MG/ML N018485 001
VERAPAMIL HYDROCHLORIDE
ABRAXIS PHARM 2.5MG/ML A070348 001 May 01, 1986
BEDFORD 2.5MG/ML A072888 001 Jul 28, 1995
HOSPIRA 2.5MG/ML A070739 001 May 06, 1987
2.5MG/ML A070740 001 May 06, 1987
LUITPOLD 2.5MG/ML A070225 001 Nov 12, 1985
MARSAM PHARMS LLC 2.5MG/ML A072233 001 Feb 26, 1993
2.5MG/ML A073485 001 Sep 27, 1993
SMITH AND NEPHEW 2.5MG/ML A070696 001 Jul 31, 1987
2.5MG/ML A070697 001 Jul 31, 1987
SOLOPAK 2.5MG/ML A070695 001 Jul 31, 1987
TABLET; ORAL
CALAN
GD SEARLE LLC 160MG N018817 004 Feb 23, 1988
ISOPTIN
FSC 40MG N018593 003 Nov 23, 1987
80MG N018593 001 Mar 08, 1982
120MG N018593 002 Mar 08, 1982
VERAPAMIL HYDROCHLORIDE
HERITAGE PHARMS INC 80MG A071880 001 Apr 05, 1988
120MG A071881 001 Apr 05, 1988
MUTUAL PHARM 80MG A070482 001 Sep 24, 1986
80MG A071489 002 Jan 13, 1988
120MG A070483 001 Sep 24, 1986
120MG A071489 001 Jan 13, 1988
PLIVA 40MG A072751 001 Feb 23, 1996
80MG A072124 001 Jan 26, 1989
120MG A072125 001 Jan 26, 1989
SANDOZ 40MG A073168 001 Jul 31, 1992
80MG A071423 001 May 24, 1988
120MG A071424 001 May 25, 1988
WARNER CHILCOTT 80MG A070340 001 Sep 24, 1986
120MG A070341 001 Sep 24, 1986
WATSON LABS 40MG A072799 001 Apr 28, 1989
TABLET, EXTENDED RELEASE; ORAL
VERAPAMIL HYDROCHLORIDE
PLIVA 240MG A072922 001 Mar 01, 1996

VERATRUM VIRIDE
TABLET; ORAL
VERTAVIS
MEDPOINTE PHARM HLC 130CSR UNIT N005691 002

VIDARABINE
INJECTABLE; INJECTION

VIRA-A

PARKEDALE EQ 187.4MG BASE/ML N050523 001


OINTMENT; OPHTHALMIC

VIRA-A

PARKEDALE 3% N050486 001


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 321 (of 324)

VINBLASTINE SULFATE
INJECTABLE; INJECTION
VELBAN
LILLY 10MG/VIAL N012665 001
VINBLASTINE SULFATE
ABRAXIS PHARM 10MG/VIAL A089011 001 Nov 18, 1985
HOSPIRA 10MG/VIAL A089565 001 Aug 18, 1987

VINCRISTINE SULFATE
INJECTABLE; INJECTION
ONCOVIN
LILLY 1MG/VIAL N014103 001
1MG/ML N014103 003 Mar 07, 1984
5MG/VIAL N014103 002
VINCASAR PFS
TEVA PARENTERAL 1MG/ML A071426 001 Jul 17, 1987
VINCREX
BRISTOL MYERS SQUIBB 5MG/VIAL A070867 001 Jul 12, 1988
VINCRISTINE SULFATE
ABIC 1MG/ML A070873 001 Feb 19, 1987
ABRAXIS PHARM 1MG/ML A070411 001 Sep 10, 1986
APP PHARMS 1MG/ML A076296 001 Dec 20, 2002
HOSPIRA 1MG/VIAL A071559 001 Apr 11, 1988
2MG/VIAL A071560 001 Apr 11, 1988
5MG/VIAL A071561 001 Apr 11, 1988

VIOMYCIN SULFATE
INJECTABLE; INJECTION
VIOCIN SULFATE
PFIZER EQ 1GM BASE/VIAL A061086 001
EQ 5GM BASE/VIAL A061086 002

VITAMIN A
CAPSULE; ORAL
AQUASOL A
ASTRAZENECA 25,000USP UNITS A083080 002
50,000USP UNITS A083080 001
VITAMIN A
BANNER PHARMACAPS 50,000USP UNITS A083973 001
CHASE CHEM 50,000 IU A083351 001
EVERYLIFE 50,000 IU A083134 001
IMPAX LABS 50,000USP UNITS A080952 001
WEST WARD 50,000USP UNITS A080985 001

VITAMIN A PALMITATE
CAPSULE; ORAL
AFAXIN
STERLING WINTHROP EQ 50,000 UNITS BASE A083187 001
ALPHALIN
LILLY EQ 50,000 UNITS BASE A080883 001
DEL-VI-A
DEL RAY LABS EQ 50,000 UNITS BASE A080830 001
VI-DOM-A
BAYER PHARMS EQ 50,000 UNITS BASE A080972 001
VITAMIN A
BANNER PHARMACAPS EQ 50,000 UNITS BASE A080702 001
BRISTOL MYERS SQUIBB EQ 50,000 UNITS BASE A080860 001
CHASE CHEM EQ 50,000 UNITS BASE A080746 001
EQ 50,000 UNITS BASE A083207 001
ELKINS SINN EQ 50,000 UNITS BASE A085479 001
EVERYLIFE EQ 50,000 UNITS BASE A080943 001
EQ 50,000 UNITS BASE A083114 001
IMPAX LABS EQ 50,000 UNITS BASE A080953 001
EQ 50,000 UNITS BASE A080955 001
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 322 (of 324)

VITAMIN A PALMITATE
CAPSULE; ORAL
VITAMIN A
IVAX SUB TEVA PHARMS EQ 50,000 UNITS BASE A083035 001
EQ 50,000 UNITS BASE A083190 001
MK LABS EQ 25,000 UNITS BASE A083457 002
EQ 50,000 UNITS BASE A083457 001
WEST WARD EQ 50,000 UNITS BASE A080967 001
WHARTON LABS EQ 50,000 UNITS BASE A083665 001
VITAMIN A PALMITATE
ARCUM EQ 50,000 UNITS BASE A083311 001
EQ 50,000 UNITS BASE A083321 001
BANNER PHARMACAPS EQ 50,000 UNITS BASE A083948 001
EQ 50,000 UNITS BASE A083981 001
VITAMIN A SOLUBILIZED
TEVA EQ 50,000 UNITS BASE A080921 001
INJECTABLE; INJECTION
VITAMIN A PALMITATE
BEL MAR EQ 50,000 UNITS BASE/ML A080819 001

WARFARIN POTASSIUM
TABLET; ORAL
ATHROMBIN-K
PHARM RES ASSOC 2MG N011771 007
5MG N011771 004
10MG N011771 005
25MG N011771 006

WARFARIN SODIUM
INJECTABLE; INJECTION
COUMADIN
BRISTOL MYERS SQUIBB 50MG/VIAL N009218 020
75MG/VIAL N009218 012
TABLET; ORAL
ATHROMBIN
PHARM RES ASSOC 5MG N011771 003
10MG N011771 002
25MG N011771 001
PANWARFIN
ABBOTT 2MG N017020 001
2.5MG N017020 002
5MG N017020 003
7.5MG N017020 004
10MG N017020 005
WARFARIN SODIUM
USL PHARMA 2MG A088719 001 Jun 27, 1985
2.5MG A088720 001 Aug 06, 1985
5MG A088721 001 Jul 02, 1985
WATSON LABS 2MG A086123 001 Aug 17, 1982
2.5MG A086120 001 Aug 17, 1982
5MG A086119 001 Aug 17, 1982
7.5MG A086118 001 Aug 17, 1982
10MG A086122 001 Aug 17, 1982

WATER FOR INJECTION, STERILE


LIQUID; N/A
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
ABRAXIS PHARM 100% A089099 001 Dec 29, 1987
100% A089100 001 Dec 29, 1987
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
B BRAUN 100% N019077 001 Mar 02, 1984
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 323 (of 324)

WATER FOR IRRIGATION, STERILE


LIQUID; IRRIGATION
STERILE WATER IN PLASTIC CONTAINER
MILES 100% N018246 001

XENON XE 127
GAS; INHALATION
XENON XE 127
MALLINCKRODT 5mCi/VIAL N018536 001 Oct 01, 1982
10mCi/VIAL N018536 002 Oct 01, 1982

XENON XE 133
GAS; INHALATION
XENON XE 133
GE HEALTHCARE 1 CI/AMP N017256 002
10mCi/VIAL N017687 002
20mCi/VIAL N017687 003
GEN ELECTRIC 5-100 CI/CYLINDER N017550 001
0.25-5 CI/AMP N017550 003
XENON XE 133-V.S.S.
GE HEALTHCARE 10mCi/VIAL N017687 001
INJECTABLE; INJECTION
XENON XE 133
GE HEALTHCARE 1.3-1.7 CI/AMP N017256 001
LANTHEUS MEDCL 6.3mCi/ML N017283 001
SOLUTION; INHALATION, INJECTION
XENEISOL
MALLINCKRODT 18-25mCi/AMP N017262 002

XYLOSE
POWDER; ORAL
XYLO-PFAN
SAVAGE LABS 25GM/BOT N017605 001
XYLOSE
LYNE 25GM/BOT N018856 001 Mar 26, 1987

ZALCITABINE
TABLET; ORAL
HIVID
ROCHE 0.375MG N020199 001 Jun 19, 1992
0.75MG N020199 002 Jun 19, 1992

ZALEPLON
CAPSULE; ORAL
ZALEPLON
SANDOZ 5MG A078095 001 Jun 06, 2008
10MG A078095 002 Jun 06, 2008

ZICONOTIDE
INJECTABLE; INTRATHECAL
PRIALT
ELAN PHARMS 200MCG/2ML (100MCG/ML) N021060 003 Dec 28, 2004

ZIDOVUDINE
TABLET; ORAL
RETROVIR
VIIV HLTHCARE 200MG N020518 001 Dec 19, 1995
ZIDOVUDINE
AUROBINDO PHARMA 60MG N022294 001 Jul 23, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST 6 - 324 (of 324)

ZILEUTON
TABLET; ORAL
ZYFLO
CRITICAL 300MG N020471 001 Dec 09, 1996

ZINC SULFATE
INJECTABLE; INJECTION
ZINC SULFATE
ABRAXIS PHARM EQ 1MG ZINC/ML N019229 002 May 05, 1987

ZOLEDRONIC ACID
INJECTABLE; IV (INFUSION)
ZOMETA
NOVARTIS EQ 4MG BASE/VIAL N021223 001 Aug 20, 2001

ZOLPIDEM TARTRATE
TABLET; ORAL
ZOLPIDEM TARTRATE
MUTUAL PHARMA 5MG A077288 001 Apr 23, 2007
10MG A077288 002 Apr 23, 2007
PAR PHARM 5MG A076062 001 Apr 23, 2007
10MG A076062 002 Apr 23, 2007
SYNTHON PHARMS 5MG A077540 001 Apr 23, 2007
10MG A077540 002 Apr 23, 2007
TABLET, ORALLY DISINTEGRATING; ORAL
TOVALT ODT
BIOVAIL LABS INTL 5MG N021412 001 Apr 25, 2007
10MG N021412 002 Apr 25, 2007

ZONISAMIDE
CAPSULE; ORAL
ZONISAMIDE
MUTUAL PHARM 25MG A077635 001 Dec 22, 2005
50MG A077635 002 Dec 22, 2005
100MG A077635 003 Dec 22, 2005
ROXANE 25MG A077648 001 Dec 22, 2005
50MG A077648 002 Dec 22, 2005
100MG A077648 003 Dec 22, 2005
TEVA PHARMS 25MG A077641 003 Dec 22, 2005
50MG A077641 002 Dec 22, 2005
100MG A077641 001 Dec 22, 2005
WATSON LABS 25MG A077650 001 Apr 20, 2006
50MG A077650 002 Apr 20, 2006
100MG A077650 003 Apr 20, 2006
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

7-1

ORPHAN PRODUCT DESIGNATIONS AND APPROVALS LIST

The list of List of Orphan Designations and Approvals is available at:

http://www.fda.gov/orphan/designat/list.htm

30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

8-1

DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY

ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION


ACETAMINOPHEN; ASPIRIN; ASPIRIN; CAFFEINE;


BUTALBITAL CARISOPRODOL
CAPSULE OR TABLET; ORAL TABLET; ORAL
160-165MG; 160-165MG; 50MG 160MG; 32MG; 200MG

ACETAMINOPHEN; ASPIRIN; ASPIRIN; CAFFEINE;


BUTALBITAL CARISOPRODOL;
CAPSULE OR TABLET; ORAL CODEINE PHOSPHATE
325MG; 325MG; 50MG TABLET; ORAL
160MG; 32MG;
200MG; 16MG
ACETAMINOPHEN; ASPIRIN;
BUTALBITAL; CAFFEINE
CAPSULE OR TABLET; ORAL ASPIRIN;
160-165MG; 160-165MG; 50MG; 40MG CARISOPRODOL
TABLET; ORAL
325MG; 200MG
ACETAMINOPHEN; ASPIRIN;
BUTALBITAL; CAFFEINE
CAPSULE OR TABLET; ORAL ASPIRIN;
325MG; 325MG; 50MG; 40MG CARISOPRODOL;
CODEINE PHOSPHATE
TABLET; ORAL
ACETAMINOPHEN; BUTALBITAL 325MG; 200MG; 16MG
CAPSULE OR TABLET; ORAL
325MG; 50MG
650MG; 50MG ASPIRIN; MEPROBAMATE
TABLET; ORAL
325MG; 200MG
ACETAMINOPHEN; BUTALBITAL;
CAFFEINE
CAPSULE OR TABLET; ORAL ASPIRIN;
325MG; 50MG; 40MG METHOCARBAMOL
650MG; 50MG; 40MG TABLET; ORAL
500MG; 50MG; 40MG 325MG; 400MG

AMINOPHYLLINE CHLOROTHIAZIDE
TABLET; ORAL TABLET; ORAL
100MG; 200MG 250MG

ASPIRIN; BUTALBITAL HYDROXYZINE


CAPSULE OR TABLET; ORAL HYDROCHLORIDE
325MG; 50MG TABLET; ORAL
650MG; 50MG 10MG; 25MG;
50MG; 100MG

ASPIRIN; BUTALBITAL; CAFFEINE


CAPSULE OR TABLET; ORAL PREDNISONE
325MG; 50MG; 40MG TABLET; ORAL
650MG; 50MG; 40MG 1MG; 2.5MG;
5MG; 10MG;
20MG; 25MG; 50MG
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 1


** 8 **
8-MOP, METHOXSALEN

** A **
ABELCET, AMPHOTERICIN B
ABILIFY, ARIPIPRAZOLE
ABLAVAR, GADOFOSVESET TRISODIUM
ABRAXANE, PACLITAXEL
ABREVA, DOCOSANOL (OTC)
ACANYA, BENZOYL PEROXIDE
ACCOLATE, ZAFIRLUKAST
ACCUNEB, ALBUTEROL SULFATE
ACCUPRIL, QUINAPRIL HYDROCHLORIDE
ACCURETIC, HYDROCHLOROTHIAZIDE
ACEON, PERINDOPRIL ERBUMINE
ACEPHEN, ACETAMINOPHEN (OTC)
ACETADOTE, ACETYLCYSTEINE
ACETAMINOPHEN, ACETAMINOPHEN (OTC)
ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL
ACIPHEX, RABEPRAZOLE SODIUM
ACLOVATE, ALCLOMETASONE DIPROPIONATE
ACTHREL, CORTICORELIN OVINE TRIFLUTATE
ACTIGALL, URSODIOL
ACTIQ, FENTANYL CITRATE
ACTIVELLA, ESTRADIOL
ACTONEL, RISEDRONATE SODIUM
ACTOPLUS MET XR, METFORMIN HYDROCHLORIDE
ACTOPLUS MET, METFORMIN HYDROCHLORIDE
ACTOS, PIOGLITAZONE HYDROCHLORIDE
ACULAR LS, KETOROLAC TROMETHAMINE
ACULAR PRESERVATIVE FREE, KETOROLAC TROMETHAMINE
ACULAR, KETOROLAC TROMETHAMINE
ACUVAIL, KETOROLAC TROMETHAMINE
ACYCLOVIR AND HYDROCORTISONE, ACYCLOVIR
ACZONE, DAPSONE
ADAGEN, PEGADEMASE BOVINE
ADALAT CC, NIFEDIPINE
ADCIRCA, TADALAFIL
ADDERALL 10, AMPHETAMINE ASPARTATE
ADDERALL 12.5, AMPHETAMINE ASPARTATE
ADDERALL 15, AMPHETAMINE ASPARTATE
ADDERALL 20, AMPHETAMINE ASPARTATE
ADDERALL 30, AMPHETAMINE ASPARTATE
ADDERALL 5, AMPHETAMINE ASPARTATE
ADDERALL 7.5, AMPHETAMINE ASPARTATE
ADDERALL XR 10, AMPHETAMINE ASPARTATE
ADDERALL XR 15, AMPHETAMINE ASPARTATE
ADDERALL XR 20, AMPHETAMINE ASPARTATE
ADDERALL XR 25, AMPHETAMINE ASPARTATE
ADDERALL XR 30, AMPHETAMINE ASPARTATE
ADDERALL XR 5, AMPHETAMINE ASPARTATE
ADENOCARD, ADENOSINE
ADENOSCAN, ADENOSINE
ADREVIEW, IOBENGUANE SULFATE I 123
ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE
ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE
ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE
ADVAIR HFA, FLUTICASONE PROPIONATE
ADVICOR, LOVASTATIN
ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)
ADVIL COLD AND SINUS, IBUPROFEN (OTC)
ADVIL LIQUI-GELS, IBUPROFEN (OTC)
ADVIL MIGRAINE LIQUI-GELS, IBUPROFEN (OTC)
ADVIL PM, DIPHENHYDRAMINE CITRATE (OTC)
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 2


** A **
ADVIL PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)
ADVIL, IBUPROFEN (OTC)
AEROBID, FLUNISOLIDE
AEROSPAN HFA, FLUNISOLIDE
AFINITOR, EVEROLIMUS
AFRINOL, PSEUDOEPHEDRINE SULFATE (OTC)
AGENERASE, AMPRENAVIR
AGGRASTAT, TIROFIBAN HYDROCHLORIDE
AGGRENOX, ASPIRIN
AGRYLIN, ANAGRELIDE HYDROCHLORIDE
AK-FLUOR 10%, FLUORESCEIN SODIUM
AK-FLUOR 25%, FLUORESCEIN SODIUM
AKINETON, BIPERIDEN HYDROCHLORIDE
AKNE-MYCIN, ERYTHROMYCIN
AKTEN, LIDOCAINE HYDROCHLORIDE
ALAMAST, PEMIROLAST POTASSIUM
ALAVERT, LORATADINE (OTC)
ALAWAY, KETOTIFEN FUMARATE (OTC)
ALBENZA, ALBENDAZOLE
ALCOHOL 10% AND DEXTROSE 5%, ALCOHOL
ALCOHOL 5% AND DEXTROSE 5%, ALCOHOL
ALDACTAZIDE, HYDROCHLOROTHIAZIDE
ALDACTONE, SPIRONOLACTONE
ALDARA, IMIQUIMOD
ALEVE, NAPROXEN SODIUM (OTC)
ALEVE-D SINUS & COLD, NAPROXEN SODIUM (OTC)
ALFENTA, ALFENTANIL HYDROCHLORIDE
ALIMTA, PEMETREXED DISODIUM
ALINIA, NITAZOXANIDE
ALKERAN, MELPHALAN
ALKERAN, MELPHALAN HYDROCHLORIDE
ALLEGRA D 24 HOUR, FEXOFENADINE HYDROCHLORIDE
ALLEGRA, FEXOFENADINE HYDROCHLORIDE
ALLEGRA-D 12 HOUR, FEXOFENADINE HYDROCHLORIDE
ALLI, ORLISTAT (OTC)
ALLOPURINOL, ALLOPURINOL
ALOCRIL, NEDOCROMIL SODIUM
ALOMIDE, LODOXAMIDE TROMETHAMINE
ALOPRIM, ALLOPURINOL SODIUM
ALORA, ESTRADIOL
ALOXI, PALONOSETRON HYDROCHLORIDE
ALPHAGAN P, BRIMONIDINE TARTRATE
ALREX, LOTEPREDNOL ETABONATE
ALTABAX, RETAPAMULIN
ALTACE, RAMIPRIL
ALTOPREV, LOVASTATIN
ALVESCO, CICLESONIDE
AMARYL, GLIMEPIRIDE
AMBIEN CR, ZOLPIDEM TARTRATE
AMBIEN, ZOLPIDEM TARTRATE
AMBISOME, AMPHOTERICIN B
AMERGE, NARATRIPTAN HYDROCHLORIDE
AMICAR, AMINOCAPROIC ACID
AMIDATE, ETOMIDATE
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER, GLYCINE
AMINOHIPPURATE SODIUM, AMINOHIPPURATE SODIUM
AMINOSYN 10% (PH6), AMINO ACIDS
AMINOSYN 10%, AMINO ACIDS
AMINOSYN 3.5% M, AMINO ACIDS
AMINOSYN 3.5%, AMINO ACIDS
AMINOSYN 5%, AMINO ACIDS
AMINOSYN 7% (PH6), AMINO ACIDS
AMINOSYN 7% W/ ELECTROLYTES, AMINO ACIDS
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 3


** A **
AMINOSYN 7%, AMINO ACIDS
AMINOSYN 8.5% (PH6), AMINO ACIDS
AMINOSYN 8.5% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN 8.5%, AMINO ACIDS
AMINOSYN II 10% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 10% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN II 10%, AMINO ACIDS
AMINOSYN II 15% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 7%, AMINO ACIDS
AMINOSYN II 8.5% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN II 8.5%, AMINO ACIDS
AMINOSYN-HBC 7%, AMINO ACIDS
AMINOSYN-HF 8%, AMINO ACIDS
AMINOSYN-PF 10%, AMINO ACIDS
AMINOSYN-PF 7%, AMINO ACIDS
AMINOSYN-RF 5.2%, AMINO ACIDS
AMITIZA, LUBIPROSTONE
AMMONIA N 13, AMMONIA, N-13
AMMONUL, SODIUM BENZOATE
AMPHADASE, HYALURONIDASE
AMPHOTEC, AMPHOTERICIN B
AMRIX, CYCLOBENZAPRINE HYDROCHLORIDE
ANADROL-50, OXYMETHOLONE
ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE
ANAPROX DS, NAPROXEN SODIUM
ANAPROX, NAPROXEN SODIUM
ANCOBON, FLUCYTOSINE
ANDRODERM, TESTOSTERONE
ANDROGEL, TESTOSTERONE
AN-DTPA, TECHNETIUM TC-99M PENTETATE KIT
ANECTINE, SUCCINYLCHOLINE CHLORIDE
ANGELIQ, DROSPIRENONE
ANGIOMAX, BIVALIRUDIN
ANSAID, FLURBIPROFEN
AN-SULFUR COLLOID, TECHNETIUM TC-99M SULFUR COLLOID KIT
ANTARA (MICRONIZED), FENOFIBRATE
ANTHELIOS 20, AVOBENZONE (OTC)
ANTHELIOS 40, AVOBENZONE (OTC)
ANTHELIOS SX, AVOBENZONE (OTC)
ANTIVERT, MECLIZINE HYDROCHLORIDE
ANTIZOL, FOMEPIZOLE
ANZEMET, DOLASETRON MESYLATE
APHTHASOL, AMLEXANOX
APIDRA SOLOSTAR, INSULIN GLULISINE RECOMBINANT
APIDRA, INSULIN GLULISINE RECOMBINANT
APLENZIN, BUPROPION HYDROBROMIDE
APOKYN, APOMORPHINE HYDROCHLORIDE
APRISO, MESALAMINE
APTIVUS, TIPRANAVIR
AQUASOL A, VITAMIN A PALMITATE
ARALEN, CHLOROQUINE PHOSPHATE
ARAVA, LEFLUNOMIDE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 4


** A **
AREDIA, PAMIDRONATE DISODIUM
ARESTIN, MINOCYCLINE HYDROCHLORIDE
ARGATROBAN, ARGATROBAN
ARICEPT ODT, DONEPEZIL HYDROCHLORIDE
ARICEPT, DONEPEZIL HYDROCHLORIDE
ARIMIDEX, ANASTROZOLE
ARISTOSPAN, TRIAMCINOLONE HEXACETONIDE
ARIXTRA, FONDAPARINUX SODIUM
AROMASIN, EXEMESTANE
ARRANON, NELARABINE
ARTHROTEC, DICLOFENAC SODIUM
ASACOL HD, MESALAMINE
ASACOL, MESALAMINE
ASMANEX TWISTHALER, MOMETASONE FUROATE
ASTELIN, AZELASTINE HYDROCHLORIDE
ASTEPRO, AZELASTINE HYDROCHLORIDE
ATACAND HCT, CANDESARTAN CILEXETIL
ATACAND, CANDESARTAN CILEXETIL
ATIVAN, LORAZEPAM
ATRALIN, TRETINOIN
ATRIDOX, DOXYCYCLINE HYCLATE
ATRIPLA, EFAVIRENZ
ATROPEN, ATROPINE
ATROPINE SULFATE ANSYR PLASTIC SYRINGE, ATROPINE SULFATE
ATROVENT HFA, IPRATROPIUM BROMIDE
ATROVENT, IPRATROPIUM BROMIDE
AVAGARD, ALCOHOL (OTC)
AVAGE, TAZAROTENE
AVALIDE, HYDROCHLOROTHIAZIDE
AVANDAMET, METFORMIN HYDROCHLORIDE
AVANDARYL, GLIMEPIRIDE
AVANDIA, ROSIGLITAZONE MALEATE
AVAPRO, IRBESARTAN
AVC, SULFANILAMIDE
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, MOXIFLOXACIN HYDROCHLORIDE
AVELOX, MOXIFLOXACIN HYDROCHLORIDE
AVENTYL HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
AVINZA, MORPHINE SULFATE
AVITA, TRETINOIN
AVODART, DUTASTERIDE
AXERT, ALMOTRIPTAN MALATE
AXID AR, NIZATIDINE (OTC)
AXID, NIZATIDINE
AYGESTIN, NORETHINDRONE ACETATE
AZACTAM IN PLASTIC CONTAINER, AZTREONAM
AZACTAM, AZTREONAM
AZASITE, AZITHROMYCIN
AZELEX, AZELAIC ACID
AZILECT, RASAGILINE MESYLATE
AZITHROMYCIN, AZITHROMYCIN
AZMACORT, TRIAMCINOLONE ACETONIDE
AZOPT, BRINZOLAMIDE
AZOR, AMLODIPINE BESYLATE
AZULFIDINE EN-TABS, SULFASALAZINE
AZULFIDINE, SULFASALAZINE

** B **
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER, WATER FOR INJECTION, STERILE
BACTOCILL IN PLASTIC CONTAINER, OXACILLIN SODIUM
BACTRIM DS, SULFAMETHOXAZOLE
BACTRIM, SULFAMETHOXAZOLE
BACTROBAN, MUPIROCIN
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 5


** B **
BACTROBAN, MUPIROCIN CALCIUM
BAL, DIMERCAPROL
BANZEL, RUFINAMIDE
BARACLUDE, ENTECAVIR
BECONASE AQ, BECLOMETHASONE DIPROPIONATE MONOHYDRATE
BENADRYL PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE
BENADRYL, DIPHENHYDRAMINE HYDROCHLORIDE
BENICAR HCT, HYDROCHLOROTHIAZIDE
BENICAR, OLMESARTAN MEDOXOMIL
BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE
BENTYL, DICYCLOMINE HYDROCHLORIDE
BENZACLIN, BENZOYL PEROXIDE
BENZAMYCIN PAK, BENZOYL PEROXIDE
BENZAMYCIN, BENZOYL PEROXIDE
BEPREVE, BEPOTASTINE BESILATE
BESIVANCE, BESIFLOXACIN HYDROCHLORIDE
BETADINE, POVIDONE-IODINE
BETAGAN, LEVOBUNOLOL HYDROCHLORIDE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
BETAPACE AF, SOTALOL HYDROCHLORIDE
BETAPACE, SOTALOL HYDROCHLORIDE
BETA-VAL, BETAMETHASONE VALERATE
BETIMOL, TIMOLOL
BETOPTIC S, BETAXOLOL HYDROCHLORIDE
BETOPTIC, BETAXOLOL HYDROCHLORIDE
BIAXIN XL, CLARITHROMYCIN
BIAXIN, CLARITHROMYCIN
BICILLIN C-R 900/300, PENICILLIN G BENZATHINE
BICILLIN C-R, PENICILLIN G BENZATHINE
BICILLIN L-A, PENICILLIN G BENZATHINE
BICNU, CARMUSTINE
BIDIL, HYDRALAZINE HYDROCHLORIDE
BILTRICIDE, PRAZIQUANTEL
BIOSCRUB, CHLORHEXIDINE GLUCONATE (OTC)
BLENOXANE, BLEOMYCIN SULFATE
BLEPHAMIDE, PREDNISOLONE ACETATE
BONIVA, IBANDRONATE SODIUM
BRANCHAMIN 4% IN PLASTIC CONTAINER, AMINO ACIDS
BRAVELLE, UROFOLLITROPIN
BREATHTEK UBT FOR H-PYLORI, UREA, C-13
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER, BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE, BRETYLIUM TOSYLATE
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE
BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE
BREVIBLOC, ESMOLOL HYDROCHLORIDE
BREVICON 28-DAY, ETHINYL ESTRADIOL
BREVITAL SODIUM, METHOHEXITAL SODIUM
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE
BRONCHO SALINE, SODIUM CHLORIDE (OTC)
BROVANA, ARFORMOTEROL TARTRATE
BSS PLUS, CALCIUM CHLORIDE
BSS, CALCIUM CHLORIDE
BUPHENYL, SODIUM PHENYLBUTYRATE
BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
BUPRENEX, BUPRENORPHINE HYDROCHLORIDE
BUSPAR, BUSPIRONE HYDROCHLORIDE
BUSULFEX, BUSULFAN
BUTISOL SODIUM, BUTABARBITAL SODIUM
BYETTA, EXENATIDE SYNTHETIC
BYSTOLIC, NEBIVOLOL HYDROCHLORIDE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 6


** C **
CADUET, AMLODIPINE BESYLATE
CAFCIT, CAFFEINE CITRATE
CALAN, VERAPAMIL HYDROCHLORIDE
CALCIJEX, CALCITRIOL
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
CALCIUM DISODIUM VERSENATE, EDETATE CALCIUM DISODIUM
CALDOLOR, IBUPROFEN
CALOMIST, CYANOCOBALAMIN
CAMBIA, DICLOFENAC POTASSIUM
CAMPRAL, ACAMPROSATE CALCIUM
CAMPTOSAR, IRINOTECAN HYDROCHLORIDE
CANASA, MESALAMINE
CANCIDAS, CASPOFUNGIN ACETATE
CANTIL, MEPENZOLATE BROMIDE
CAPASTAT SULFATE, CAPREOMYCIN SULFATE
CAPEX, FLUOCINOLONE ACETONIDE
CAPITAL SOLEIL 15, AVOBENZONE (OTC)
CAPOTEN, CAPTOPRIL
CAPOZIDE 25/15, CAPTOPRIL
CAPOZIDE 25/25, CAPTOPRIL
CAPOZIDE 50/15, CAPTOPRIL
CAPOZIDE 50/25, CAPTOPRIL
CARAC, FLUOROURACIL
CARAFATE, SUCRALFATE
CARBATROL, CARBAMAZEPINE
CARBOCAINE, MEPIVACAINE HYDROCHLORIDE
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE SR, NICARDIPINE HYDROCHLORIDE
CARDENE, NICARDIPINE HYDROCHLORIDE
CARDIOGEN-82, RUBIDIUM CHLORIDE RB-82
CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT
CARDIZEM CD, DILTIAZEM HYDROCHLORIDE
CARDIZEM LA, DILTIAZEM HYDROCHLORIDE
CARDIZEM, DILTIAZEM HYDROCHLORIDE
CARDURA XL, DOXAZOSIN MESYLATE
CARDURA, DOXAZOSIN MESYLATE
CARNITOR SF, LEVOCARNITINE
CARNITOR, LEVOCARNITINE
CASODEX, BICALUTAMIDE
CATAFLAM, DICLOFENAC POTASSIUM
CATAPRES, CLONIDINE HYDROCHLORIDE
CATAPRES-TTS-1, CLONIDINE
CATAPRES-TTS-2, CLONIDINE
CATAPRES-TTS-3, CLONIDINE
CAVERJECT IMPULSE, ALPROSTADIL
CAVERJECT, ALPROSTADIL
CEDAX, CEFTIBUTEN DIHYDRATE
CEENU, LOMUSTINE
CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM
CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE
CEFTIN, CEFUROXIME AXETIL
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, CEFUROXIME SODIUM
CEFZIL, CEFPROZIL
CELEBREX, CELECOXIB
CELESTONE SOLUSPAN, BETAMETHASONE ACETATE
CELESTONE, BETAMETHASONE
CELEXA, CITALOPRAM HYDROBROMIDE
CELLCEPT, MYCOPHENOLATE MOFETIL
CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 7


** C **
CELONTIN, METHSUXIMIDE
CENESTIN, ESTROGENS, CONJUGATED SYNTHETIC A
CENTANY, MUPIROCIN
CEREBYX, FOSPHENYTOIN SODIUM
CEREDASE, ALGLUCERASE
CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT
CEREZYME, IMIGLUCERASE
CERVIDIL, DINOPROSTONE
CESAMET, NABILONE
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CETRAXAL, CIPROFLOXACIN HYDROCHLORIDE
CETROTIDE, CETRORELIX
CHANTIX, VARENICLINE TARTRATE
CHEMET, SUCCIMER
CHG SCRUB, CHLORHEXIDINE GLUCONATE (OTC)
CHILDREN'S ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)
CHILDREN'S ADVIL COLD, IBUPROFEN (OTC)
CHILDREN'S ADVIL, IBUPROFEN (OTC)
CHILDREN'S ADVIL-FLAVORED, IBUPROFEN (OTC)
CHILDREN'S CLARITIN, LORATADINE (OTC)
CHILDREN'S ELIXSURE, IBUPROFEN (OTC)
CHILDREN'S MOTRIN COLD, IBUPROFEN (OTC)
CHILDREN'S MOTRIN, IBUPROFEN (OTC)
CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CHIRHOSTIM, SECRETIN SYNTHETIC HUMAN
CHLORAPREP ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP ONE-STEP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP WITH TINT, CHLORHEXIDINE GLUCONATE (OTC)
CHLORASCRUB MAXI SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
CHLORASCRUB SWAB, CHLORHEXIDINE GLUCONATE (OTC)
CHLORASCRUB SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC)
CHLOR-TRIMETON, CHLORPHENIRAMINE MALEATE (OTC)
CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT
CHOLOGRAFIN MEGLUMINE, IODIPAMIDE MEGLUMINE
CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC
CHROMIC CHLORIDE IN PLASTIC CONTAINER, CHROMIC CHLORIDE
CHROMITOPE SODIUM, SODIUM CHROMATE CR-51
CIALIS, TADALAFIL
CIDA-STAT, CHLORHEXIDINE GLUCONATE (OTC)
CILOXAN, CIPROFLOXACIN HYDROCHLORIDE
CIPRO HC, CIPROFLOXACIN HYDROCHLORIDE
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPRO XR, CIPROFLOXACIN
CIPRO, CIPROFLOXACIN
CIPRO, CIPROFLOXACIN HYDROCHLORIDE
CIPRODEX, CIPROFLOXACIN
CIS-MDP, TECHNETIUM TC-99M MEDRONATE KIT
CIS-PYRO, TECHNETIUM TC-99M PYROPHOSPHATE KIT
CITANEST FORTE DENTAL, EPINEPHRINE BITARTRATE
CITANEST PLAIN DENTAL, PRILOCAINE HYDROCHLORIDE
CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER, CEFOTAXIME SODIUM
CLAFORAN, CEFOTAXIME SODIUM
CLARINEX D 24 HOUR, DESLORATADINE
CLARINEX, DESLORATADINE
CLARINEX-D 12 HOUR, DESLORATADINE
CLARITIN HIVES RELIEF REDITAB, LORATADINE (OTC)
CLARITIN HIVES RELIEF, LORATADINE (OTC)
CLARITIN REDITABS, LORATADINE (OTC)
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 8


** C **
CLARITIN, LORATADINE (OTC)
CLARITIN-D 24 HOUR, LORATADINE (OTC)
CLEOCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE
CLEOCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLEOCIN T, CLINDAMYCIN PHOSPHATE
CLEOCIN, CLINDAMYCIN PHOSPHATE
CLEVIPREX, CLEVIDIPINE BUTYRATE
CLIMARA PRO, ESTRADIOL
CLIMARA, ESTRADIOL
CLINDAGEL, CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE
CLINDESSE, CLINDAMYCIN PHOSPHATE
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX E 2.75/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 2.75/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 4.25/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 4.25/20 SULFITE-FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 4.25/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 4.25/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 5/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 5/15 SULFITE-FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 5/20 SULFITE-FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 5/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINORIL, SULINDAC
CLOBEX, CLOBETASOL PROPIONATE
CLODERM, CLOCORTOLONE PIVALATE
CLOLAR, CLOFARABINE
CLOMID, CLOMIPHENE CITRATE
CLONIDINE, CLONIDINE
CLOZARIL, CLOZAPINE
COARTEM, ARTEMETHER
CODEINE SULFATE, CODEINE SULFATE
COGENTIN, BENZTROPINE MESYLATE
COGNEX, TACRINE HYDROCHLORIDE
COLAZAL, BALSALAZIDE DISODIUM
COLCRYS, COLCHICINE
COLESTID, COLESTIPOL HYDROCHLORIDE
COLGATE TOTAL, SODIUM FLUORIDE (OTC)
COLY-MYCIN M, COLISTIMETHATE SODIUM
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 9


** C **
COLY-MYCIN S, COLISTIN SULFATE
COLYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350
COLYTE, POLYETHYLENE GLYCOL 3350
COLYTE-FLAVORED, POLYETHYLENE GLYCOL 3350
COMBIGAN, BRIMONIDINE TARTRATE
COMBIPATCH, ESTRADIOL
COMBIVENT, ALBUTEROL SULFATE
COMBIVIR, LAMIVUDINE
COMBUNOX, IBUPROFEN
COMMIT, NICOTINE POLACRILEX (OTC)
COMTAN, ENTACAPONE
CONCERTA, METHYLPHENIDATE HYDROCHLORIDE
CONDYLOX, PODOFILOX
CONRAY 30, IOTHALAMATE MEGLUMINE
CONRAY 43, IOTHALAMATE MEGLUMINE
CONRAY, IOTHALAMATE MEGLUMINE
COPAXONE, GLATIRAMER ACETATE
COPEGUS, RIBAVIRIN
CORDARONE, AMIODARONE HYDROCHLORIDE
CORDRAN SP, FLURANDRENOLIDE
CORDRAN, FLURANDRENOLIDE
COREG CR, CARVEDILOL PHOSPHATE
COREG, CARVEDILOL
CORGARD, NADOLOL
CORLOPAM, FENOLDOPAM MESYLATE
CORTEF, HYDROCORTISONE
CORTENEMA, HYDROCORTISONE
CORTIFOAM, HYDROCORTISONE ACETATE
CORTISPORIN, BACITRACIN ZINC
CORTISPORIN, HYDROCORTISONE
CORTISPORIN, HYDROCORTISONE ACETATE
CORTROSYN, COSYNTROPIN
CORVERT, IBUTILIDE FUMARATE
CORZIDE, BENDROFLUMETHIAZIDE
COSMEGEN, DACTINOMYCIN
COSOPT, DORZOLAMIDE HYDROCHLORIDE
COSYNTROPIN, COSYNTROPIN
COUMADIN, WARFARIN SODIUM
COVERA-HS, VERAPAMIL HYDROCHLORIDE
COZAAR, LOSARTAN POTASSIUM
CREON, LIPASE
CRESTOR, ROSUVASTATIN CALCIUM
CRINONE, PROGESTERONE
CRIXIVAN, INDINAVIR SULFATE
CUBICIN, DAPTOMYCIN
CUPRIC CHLORIDE IN PLASTIC CONTAINER, CUPRIC CHLORIDE
CUPRIMINE, PENICILLAMINE
CUROSURF, PORACTANT ALFA
CUTIVATE, FLUTICASONE PROPIONATE
CYANOKIT, HYDROXOCOBALAMIN
CYCLESSA, DESOGESTREL
CYCLOSET, BROMOCRIPTINE MESYLATE
CYKLOKAPRON, TRANEXAMIC ACID
CYMBALTA, DULOXETINE HYDROCHLORIDE
CYSTADANE, BETAINE HYDROCHLORIDE
CYSTAGON, CYSTEAMINE BITARTRATE
CYSTO-CONRAY II, IOTHALAMATE MEGLUMINE
CYSTOGRAFIN DILUTE, DIATRIZOATE MEGLUMINE
CYSTOGRAFIN, DIATRIZOATE MEGLUMINE
CYTOMEL, LIOTHYRONINE SODIUM
CYTOTEC, MISOPROSTOL

** D **
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 10


** D **
D.H.E. 45, DIHYDROERGOTAMINE MESYLATE
DACOGEN, DECITABINE
DALMANE, FLURAZEPAM HYDROCHLORIDE
DANTRIUM, DANTROLENE SODIUM
DARAPRIM, PYRIMETHAMINE
DARVOCET-N 100, ACETAMINOPHEN
DARVOCET-N 50, ACETAMINOPHEN
DARVON, PROPOXYPHENE HYDROCHLORIDE
DARVON-N, PROPOXYPHENE NAPSYLATE
DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE
DAYPRO, OXAPROZIN
DAYTRANA, METHYLPHENIDATE
DDAVP (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE
DDAVP, DESMOPRESSIN ACETATE
DECLOMYCIN, DEMECLOCYCLINE HYDROCHLORIDE
DEFINITY, PERFLUTREN
DELATESTRYL, TESTOSTERONE ENANTHATE
DELESTROGEN, ESTRADIOL VALERATE
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELSYM, DEXTROMETHORPHAN POLISTIREX (OTC)
DEMADEX, TORSEMIDE
DEMEROL, MEPERIDINE HYDROCHLORIDE
DEMSER, METYROSINE
DENAVIR, PENCICLOVIR SODIUM
DENDRID, IDOXURIDINE
DEPACON, VALPROATE SODIUM
DEPAKENE, VALPROIC ACID
DEPAKOTE ER, DIVALPROEX SODIUM
DEPAKOTE, DIVALPROEX SODIUM
DEPEN, PENICILLAMINE
DEPOCYT, CYTARABINE
DEPODUR, MORPHINE SULFATE
DEPO-MEDROL, METHYLPREDNISOLONE ACETATE
DEPO-PROVERA, MEDROXYPROGESTERONE ACETATE
DEPO-SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE
DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE
DERMATOP E EMOLLIENT, PREDNICARBATE
DERMATOP, PREDNICARBATE
DERMOTIC, FLUOCINOLONE ACETONIDE
DESFERAL, DEFEROXAMINE MESYLATE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DESOGEN, DESOGESTREL
DESONATE, DESONIDE
DESONIDE, DESONIDE
DESOWEN, DESONIDE
DESOXYN, METHAMPHETAMINE HYDROCHLORIDE
DETROL LA, TOLTERODINE TARTRATE
DETROL, TOLTERODINE TARTRATE
DEXEDRINE, DEXTROAMPHETAMINE SULFATE
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 11


** D **
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 25%, DEXTROSE
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND ELECTROLYTE NO 75 IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K), DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K), DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K), DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER,
DEXTROSE
DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 60% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE
DIABETA, GLYBURIDE
DIABINESE, CHLORPROPAMIDE
DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 12


** D **
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIAMOX, ACETAZOLAMIDE
DIAMOX, ACETAZOLAMIDE SODIUM
DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIASTAT ACUDIAL, DIAZEPAM
DIASTAT, DIAZEPAM
DIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDE
DIDREX, BENZPHETAMINE HYDROCHLORIDE
DIDRONEL, ETIDRONATE DISODIUM
DIFFERIN, ADAPALENE
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
DIFLUCAN IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
DIFLUCAN, FLUCONAZOLE
DIGOXIN, DIGOXIN
DILACOR XR, DILTIAZEM HYDROCHLORIDE
DILANTIN-125, PHENYTOIN
DILATRATE-SR, ISOSORBIDE DINITRATE
DILAUDID, HYDROMORPHONE HYDROCHLORIDE
DILAUDID-HP, HYDROMORPHONE HYDROCHLORIDE
DIOVAN HCT, HYDROCHLOROTHIAZIDE
DIOVAN, VALSARTAN
DIPENTUM, OLSALAZINE SODIUM
DIPRIVAN, PROPOFOL
DIPROLENE AF, BETAMETHASONE DIPROPIONATE
DIPROLENE, BETAMETHASONE DIPROPIONATE
DISOPHROL, DEXBROMPHENIRAMINE MALEATE (OTC)
DITROPAN XL, OXYBUTYNIN CHLORIDE
DITROPAN, OXYBUTYNIN CHLORIDE
DIURIL, CHLOROTHIAZIDE
DIURIL, CHLOROTHIAZIDE SODIUM
DIVIGEL, ESTRADIOL
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%, DOBUTAMINE HYDROCHLORIDE
DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%, DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE
DOPRAM, DOXAPRAM HYDROCHLORIDE
DORAL, QUAZEPAM
DORIBAX, DORIPENEM
DORYX, DOXYCYCLINE HYCLATE
DOVONEX, CALCIPOTRIENE
DOXIL, DOXORUBICIN HYDROCHLORIDE
DRAXIMAGE MDP-10, TECHNETIUM TC-99M MEDRONATE KIT
DRISDOL, ERGOCALCIFEROL
DRIXORAL PLUS, ACETAMINOPHEN (OTC)
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 13


** D **
DRIXORAL, DEXBROMPHENIRAMINE MALEATE (OTC)
DROXIA, HYDROXYUREA
DTIC-DOME, DACARBAZINE
DTPA, TECHNETIUM TC-99M PENTETATE KIT
DUAC, BENZOYL PEROXIDE
DUETACT, GLIMEPIRIDE
DUODOTE, ATROPINE
DUONEB, ALBUTEROL SULFATE
DURACLON, CLONIDINE HYDROCHLORIDE
DURAGESIC-100, FENTANYL
DURAGESIC-12, FENTANYL
DURAGESIC-25, FENTANYL
DURAGESIC-50, FENTANYL
DURAGESIC-75, FENTANYL
DURAMORPH PF, MORPHINE SULFATE
DURAPREP, IODINE POVACRYLEX (OTC)
DUREZOL, DIFLUPREDNATE
DURICEF, CEFADROXIL/CEFADROXIL HEMIHYDRATE
DYAZIDE, HYDROCHLOROTHIAZIDE
DYNACIRC CR, ISRADIPINE
DYNA-HEX, CHLORHEXIDINE GLUCONATE (OTC)
DYRENIUM, TRIAMTERENE

** E **
E.E.S., ERYTHROMYCIN ETHYLSUCCINATE
EC-NAPROSYN, NAPROXEN
EDECRIN, ETHACRYNATE SODIUM
EDECRIN, ETHACRYNIC ACID
EDEX, ALPROSTADIL
EDLUAR, ZOLPIDEM TARTRATE
EFFEXOR XR, VENLAFAXINE HYDROCHLORIDE
EFFEXOR, VENLAFAXINE HYDROCHLORIDE
EFFIENT, PRASUGREL HYDROCHLORIDE
EFUDEX, FLUOROURACIL
ELDEPRYL, SELEGILINE HYDROCHLORIDE
ELESTAT, EPINASTINE HYDROCHLORIDE
ELESTRIN, ESTRADIOL
ELIDEL, PIMECROLIMUS
ELIGARD, LEUPROLIDE ACETATE
ELIMITE, PERMETHRIN
ELLENCE, EPIRUBICIN HYDROCHLORIDE
ELLIOTTS B SOLUTION, CALCIUM CHLORIDE
ELMIRON, PENTOSAN POLYSULFATE SODIUM
ELOCON, MOMETASONE FUROATE
ELOXATIN, OXALIPLATIN
EMADINE, EMEDASTINE DIFUMARATE
EMBEDA, MORPHINE SULFATE
EMCYT, ESTRAMUSTINE PHOSPHATE SODIUM
EMEND, APREPITANT
EMEND, FOSAPREPITANT DIMEGLUMINE
EMLA, LIDOCAINE
EMSAM, SELEGILINE
EMTRIVA, EMTRICITABINE
ENABLEX, DARIFENACIN HYDROBROMIDE
ENDOMETRIN, PROGESTERONE
ENDOSOL EXTRA, CALCIUM CHLORIDE
ENDURON, METHYCLOTHIAZIDE
ENJUVIA, ESTROGENS, CONJUGATED SYNTHETIC B
ENLON-PLUS, ATROPINE SULFATE
ENTEREG, ALVIMOPAN
ENTOCORT EC, BUDESONIDE
EOVIST, GADOXETATE DISODIUM
EPIDUO, ADAPALENE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 14


** E **
EPIPEN JR., EPINEPHRINE
EPIPEN, EPINEPHRINE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
EPIVIR, LAMIVUDINE
EPIVIR-HBV, LAMIVUDINE
EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM
EPZICOM, ABACAVIR SULFATE
EQUETRO, CARBAMAZEPINE
ERAXIS, ANIDULAFUNGIN
ERTACZO, SERTACONAZOLE NITRATE
ERYC, ERYTHROMYCIN
ERYGEL, ERYTHROMYCIN
ERYPED, ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE
ESKALITH, LITHIUM CARBONATE
ESTRADERM, ESTRADIOL
ESTRASORB, ESTRADIOL HEMIHYDRATE
ESTRING, ESTRADIOL
ESTROGEL, ESTRADIOL
ESTROSTEP FE, ETHINYL ESTRADIOL
ETHAMOLIN, ETHANOLAMINE OLEATE
ETHIODOL, ETHIODIZED OIL
ETHRANE, ENFLURANE
ETHYOL, AMIFOSTINE
ETOPOPHOS PRESERVATIVE FREE, ETOPOSIDE PHOSPHATE
EURAX, CROTAMITON
EVAMIST, ESTRADIOL
EVISTA, RALOXIFENE HYDROCHLORIDE
EVOCLIN, CLINDAMYCIN PHOSPHATE
EVOXAC, CEVIMELINE HYDROCHLORIDE
EXCEDRIN (MIGRAINE), ACETAMINOPHEN (OTC)
EXELDERM, SULCONAZOLE NITRATE
EXELON, RIVASTIGMINE
EXELON, RIVASTIGMINE TARTRATE
EXFORGE HCT, AMLODIPINE
EXFORGE, AMLODIPINE BESYLATE
EXIDINE, CHLORHEXIDINE GLUCONATE (OTC)
EXJADE, DEFERASIROX
EXTINA, KETOCONAZOLE
EXTRANEAL, ICODEXTRIN
E-Z SCRUB 201, POVIDONE-IODINE (OTC)
E-Z SCRUB 241, POVIDONE-IODINE (OTC)

** F **
FACTIVE, GEMIFLOXACIN MESYLATE
FAMVIR, FAMCICLOVIR
FANAPT, ILOPERIDONE
FARESTON, TOREMIFENE CITRATE
FASLODEX, FULVESTRANT
FAZACLO ODT, CLOZAPINE
FELBATOL, FELBAMATE
FELDENE, PIROXICAM
FEMARA, LETROZOLE
FEMCON FE, ETHINYL ESTRADIOL
FEMHRT, ETHINYL ESTRADIOL
FEMRING, ESTRADIOL ACETATE
FEMSTAT 3, BUTOCONAZOLE NITRATE (OTC)
FEMTRACE, ESTRADIOL ACETATE
FENOGLIDE, FENOFIBRATE
FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE
FENTANYL CITRATE, FENTANYL CITRATE
FENTORA, FENTANYL CITRATE
FERAHEME, FERUMOXYTOL
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 15


** F **
FERIDEX I.V., FERUMOXIDES
FERRLECIT, SODIUM FERRIC GLUCONATE COMPLEX
FIBRICOR, FENOFIBRIC ACID
FINACEA, AZELAIC ACID
FIORICET W/ CODEINE, ACETAMINOPHEN
FIORINAL W/CODEINE, ASPIRIN
FIORINAL, ASPIRIN
FIRMAGON, DEGARELIX ACETATE
FLAGYL ER, METRONIDAZOLE
FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE
FLAGYL I.V., METRONIDAZOLE HYDROCHLORIDE
FLAGYL, METRONIDAZOLE
FLAREX, FLUOROMETHOLONE ACETATE
FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE
FLECTOR, DICLOFENAC EPOLAMINE
FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE
FLOLAN, EPOPROSTENOL SODIUM
FLOMAX, TAMSULOSIN HYDROCHLORIDE
FLONASE, FLUTICASONE PROPIONATE
FLO-PRED, PREDNISOLONE ACETATE
FLOVENT DISKUS 100, FLUTICASONE PROPIONATE
FLOVENT DISKUS 250, FLUTICASONE PROPIONATE
FLOVENT DISKUS 50, FLUTICASONE PROPIONATE
FLOVENT HFA, FLUTICASONE PROPIONATE
FLOXIN OTIC, OFLOXACIN
FLUDARA, FLUDARABINE PHOSPHATE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
FLUDEOXYGLUCOSE F 18, FLUDEOXYGLUCOSE F-18
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
FLUMADINE, RIMANTADINE HYDROCHLORIDE
FLUOCINONIDE, FLUOCINONIDE
FLUORESCITE, FLUORESCEIN SODIUM
FLUOROPLEX, FLUOROURACIL
FLUOROURACIL, FLUOROURACIL
FLUXID, FAMOTIDINE
FML FORTE, FLUOROMETHOLONE
FML, FLUOROMETHOLONE
FOCALIN XR, DEXMETHYLPHENIDATE HYDROCHLORIDE
FOCALIN, DEXMETHYLPHENIDATE HYDROCHLORIDE
FOLLISTIM AQ, FOLLITROPIN ALFA/BETA
FOLOTYN, PRALATREXATE
FORADIL CERTIHALER, FORMOTEROL FUMARATE
FORADIL, FORMOTEROL FUMARATE
FORANE, ISOFLURANE
FORTAMET, METFORMIN HYDROCHLORIDE
FORTAZ IN PLASTIC CONTAINER, CEFTAZIDIME SODIUM
FORTAZ, CEFTAZIDIME
FORTEO, TERIPARATIDE RECOMBINANT HUMAN
FORTICAL, CALCITONIN SALMON RECOMBINANT
FOSAMAX PLUS D, ALENDRONATE SODIUM
FOSAMAX, ALENDRONATE SODIUM
FOSCAVIR, FOSCARNET SODIUM
FOSRENOL, LANTHANUM CARBONATE
FRAGMIN, DALTEPARIN SODIUM
FREAMINE HBC 6.9%, AMINO ACIDS
FREAMINE III 10%, AMINO ACIDS
FREAMINE III 3% W/ ELECTROLYTES, AMINO ACIDS
FREAMINE III 8.5% W/ ELECTROLYTES, AMINO ACIDS
FREAMINE III 8.5%, AMINO ACIDS
FROVA, FROVATRIPTAN SUCCINATE
FURADANTIN, NITROFURANTOIN
FUROSEMIDE, FUROSEMIDE
FUSILEV, LEVOLEUCOVORIN CALCIUM
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 16


** F **
FUZEON, ENFUVIRTIDE

** G **
GABITRIL, TIAGABINE HYDROCHLORIDE
GALLIUM CITRATE GA 67, GALLIUM CITRATE, GA-67
GALZIN, ZINC ACETATE
GANIRELIX ACETATE INJECTION, GANIRELIX ACETATE
GANITE, GALLIUM NITRATE
GASTROCROM, CROMOLYN SODIUM
GASTROGRAFIN, DIATRIZOATE MEGLUMINE
GASTROMARK, FERUMOXSIL
GAVISCON, ALUMINUM HYDROXIDE (OTC)
GELNIQUE, OXYBUTYNIN CHLORIDE
GEMZAR, GEMCITABINE HYDROCHLORIDE
GENOTROPIN PRESERVATIVE FREE, SOMATROPIN RECOMBINANT
GENOTROPIN, SOMATROPIN RECOMBINANT
GEODON, ZIPRASIDONE HYDROCHLORIDE
GEODON, ZIPRASIDONE MESYLATE
GLEEVEC, IMATINIB MESYLATE
GLIADEL, CARMUSTINE
GLUCAGEN, GLUCAGON HYDROCHLORIDE RECOMBINANT
GLUCAGON, GLUCAGON RECOMBINANT
GLUCOPHAGE XR, METFORMIN HYDROCHLORIDE
GLUCOPHAGE, METFORMIN HYDROCHLORIDE
GLUCOTROL XL, GLIPIZIDE
GLUCOTROL, GLIPIZIDE
GLUCOVANCE, GLYBURIDE
GLUMETZA, METFORMIN HYDROCHLORIDE
GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE
GLYNASE, GLYBURIDE
GLYSET, MIGLITOL
GOLYTELY, POLYETHYLENE GLYCOL 3350
GONAL-F RFF PEN, FOLLITROPIN ALFA/BETA
GONAL-F RFF, FOLLITROPIN ALFA/BETA
GONAL-F, FOLLITROPIN ALFA/BETA
GRIS-PEG, GRISEOFULVIN, ULTRAMICROCRYSTALLINE
GUANIDINE HYDROCHLORIDE, GUANIDINE HYDROCHLORIDE
GYNAZOLE-1, BUTOCONAZOLE NITRATE
GYNE-LOTRIMIN 3 COMBINATION PACK, CLOTRIMAZOLE (OTC)
GYNE-LOTRIMIN 3, CLOTRIMAZOLE (OTC)
GYNE-LOTRIMIN COMBINATION PACK, CLOTRIMAZOLE (OTC)
GYNE-LOTRIMIN, CLOTRIMAZOLE (OTC)

** H **
H.P. ACTHAR GEL, CORTICOTROPIN
HABITROL, NICOTINE (OTC)
HALCION, TRIAZOLAM
HALDOL, HALOPERIDOL DECANOATE
HALDOL, HALOPERIDOL LACTATE
HALFLYTELY, BISACODYL
HALOG, HALCINONIDE
HECTOROL, DOXERCALCIFEROL
HELIDAC, BISMUTH SUBSALICYLATE
HEMABATE, CARBOPROST TROMETHAMINE
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 17


** H **
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
HEPARIN SODIUM, HEPARIN SODIUM
HEPATAMINE 8%, AMINO ACIDS
HEPATASOL 8%, AMINO ACIDS
HEPATOLITE, TECHNETIUM TC-99M DISOFENIN KIT
HEPSERA, ADEFOVIR DIPIVOXIL
HERPLEX, IDOXURIDINE
HEXABRIX, IOXAGLATE MEGLUMINE
HEXALEN, ALTRETAMINE
HIBICLENS, CHLORHEXIDINE GLUCONATE (OTC)
HIBISTAT, CHLORHEXIDINE GLUCONATE (OTC)
HICON, SODIUM IODIDE, I-131
HIPREX, METHENAMINE HIPPURATE
HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT
HUMALOG MIX 50/50 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 50/50, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 75/25 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 75/25, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG PEN, INSULIN LISPRO RECOMBINANT
HUMALOG, INSULIN LISPRO RECOMBINANT
HUMATROPE, SOMATROPIN RECOMBINANT
HUMULIN 70/30 PEN, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)
HUMULIN R PEN, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN R, INSULIN RECOMBINANT HUMAN
HUMULIN R, INSULIN RECOMBINANT HUMAN (OTC)
HYCAMTIN, TOPOTECAN HYDROCHLORIDE
HYDASE, HYALURONIDASE
HYDERGINE, ERGOLOID MESYLATES
HYDREA, HYDROXYUREA
HYLENEX RECOMBINANT, HYALURONIDASE RECOMBINANT HUMAN
HYPAQUE, DIATRIZOATE SODIUM
HYTRIN, TERAZOSIN HYDROCHLORIDE
HYZAAR, HYDROCHLOROTHIAZIDE

** I **
IC-GREEN, INDOCYANINE GREEN
IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE
IDKIT:HP, UREA C-13
IFEX/MESNEX KIT, IFOSFAMIDE
IMITREX STATDOSE, SUMATRIPTAN SUCCINATE
IMITREX, SUMATRIPTAN
IMITREX, SUMATRIPTAN SUCCINATE
IMODIUM A-D EZ CHEWS, LOPERAMIDE HYDROCHLORIDE (OTC)
IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE (OTC)
IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC)
IMODIUM, LOPERAMIDE HYDROCHLORIDE
IMPLANON, ETONOGESTREL
IMURAN, AZATHIOPRINE
INAPSINE, DROPERIDOL
INCRELEX, MECASERMIN RECOMBINANT
INDERAL LA, PROPRANOLOL HYDROCHLORIDE
INDERAL, PROPRANOLOL HYDROCHLORIDE
INDERIDE-40/25, HYDROCHLOROTHIAZIDE
INDICLOR, INDIUM IN-111 CHLORIDE
INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE
INDIUM IN-111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 18


** I **
INDOCIN, INDOMETHACIN
INDOCIN, INDOMETHACIN SODIUM
INDOMETHACIN, INDOMETHACIN
INFANTS' FEVERALL, ACETAMINOPHEN (OTC)
INFASURF PRESERVATIVE FREE, CALFACTANT
INFED, IRON DEXTRAN
INFUMORPH, MORPHINE SULFATE
INFUVITE ADULT, ALPHA-TOCOPHEROL ACETATE
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), ASCORBIC ACID
INFUVITE PEDIATRIC, ASCORBIC ACID
INNOHEP, TINZAPARIN SODIUM
INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE
INOMAX, NITRIC OXIDE
INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
INSPRA, EPLERENONE
INTAL, CROMOLYN SODIUM
INTEGRILIN, EPTIFIBATIDE
INTELENCE, ETRAVIRINE
INTRALIPID 10%, SOYBEAN OIL
INTRALIPID 20%, SOYBEAN OIL
INTRALIPID 30%, SOYBEAN OIL
INTUNIV, GUANFACINE HYDROCHLORIDE
INVANZ, ERTAPENEM SODIUM
INVEGA SUSTENNA, PALIPERIDONE PALMITATE
INVEGA, PALIPERIDONE
INVIRASE, SAQUINAVIR MESYLATE
IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
IONOSOL T AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
IOPIDINE, APRACLONIDINE HYDROCHLORIDE
IOSAT, POTASSIUM IODIDE (OTC)
IPRIVASK, DESIRUDIN RECOMBINANT
IQUIX, LEVOFLOXACIN
IRESSA, GEFITINIB
ISENTRESS, RALTEGRAVIR POTASSIUM
ISMO, ISOSORBIDE MONONITRATE
ISOLYTE E IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ISOLYTE E IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE S IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
ISOLYTE S PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
ISONIAZID, ISONIAZID
ISOPTIN SR, VERAPAMIL HYDROCHLORIDE
ISORDIL, ISOSORBIDE DINITRATE
ISOVUE-200, IOPAMIDOL
ISOVUE-250, IOPAMIDOL
ISOVUE-300, IOPAMIDOL
ISOVUE-370, IOPAMIDOL
ISOVUE-M 200, IOPAMIDOL
ISOVUE-M 300, IOPAMIDOL
ISTALOL, TIMOLOL MALEATE
ISTODAX, ROMIDEPSIN
ISUPREL, ISOPROTERENOL HYDROCHLORIDE
IVY BLOCK, BENTOQUATAM (OTC)
IXEMPRA KIT, IXABEPILONE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 19


** J **
JANUMET, METFORMIN HYDROCHLORIDE
JANUVIA, SITAGLIPTIN PHOSPHATE
JEANATOPE, ALBUMIN IODINATED I-125 SERUM
JENLOGA, CLONIDINE HYDROCHLORIDE
JUNIOR STRENGTH ADVIL, IBUPROFEN (OTC)
JUNIOR STRENGTH MOTRIN, IBUPROFEN (OTC)

** K **
KADIAN, MORPHINE SULFATE
KALETRA, LOPINAVIR
KAON CL-10, POTASSIUM CHLORIDE
KAPIDEX, DEXLANSOPRAZOLE
KAYEXALATE, SODIUM POLYSTYRENE SULFONATE
KEFLEX, CEPHALEXIN
KEMSTRO, BACLOFEN
KENALOG, TRIAMCINOLONE ACETONIDE
KENALOG-10, TRIAMCINOLONE ACETONIDE
KENALOG-40, TRIAMCINOLONE ACETONIDE
KEPPRA XR, LEVETIRACETAM
KEPPRA, LEVETIRACETAM
KETALAR, KETAMINE HYDROCHLORIDE
KETEK, TELITHROMYCIN
KINEVAC, SINCALIDE
KLARON, SULFACETAMIDE SODIUM
KLONOPIN, CLONAZEPAM
KLOR-CON, POTASSIUM CHLORIDE
KLOTRIX, POTASSIUM CHLORIDE
K-TAB, POTASSIUM CHLORIDE
KUVAN, SAPROPTERIN DIHYDROCHLORIDE
KYTRIL, GRANISETRON HYDROCHLORIDE

** L **
LAC-HYDRIN, AMMONIUM LACTATE
LACRISERT, HYDROXYPROPYL CELLULOSE
LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LAMICTAL CD, LAMOTRIGINE
LAMICTAL ODT, LAMOTRIGINE
LAMICTAL XR, LAMOTRIGINE
LAMICTAL, LAMOTRIGINE
LAMISIL AT, TERBINAFINE (OTC)
LAMISIL AT, TERBINAFINE HYDROCHLORIDE (OTC)
LAMISIL, TERBINAFINE
LAMISIL, TERBINAFINE HYDROCHLORIDE
LAMISIL, TERBINAFINE HYDROCHLORIDE (OTC)
LAMPRENE, CLOFAZIMINE
LANOXICAPS, DIGOXIN
LANOXIN PEDIATRIC, DIGOXIN
LANOXIN, DIGOXIN
LANTUS, INSULIN GLARGINE RECOMBINANT
LASIX, FUROSEMIDE
LATISSE, BIMATOPROST
LESCOL XL, FLUVASTATIN SODIUM
LESCOL, FLUVASTATIN SODIUM
LETAIRIS, AMBRISENTAN
LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM
LEUKERAN, CHLORAMBUCIL
LEUSTATIN, CLADRIBINE
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
LEVAQUIN, LEVOFLOXACIN
LEVATOL, PENBUTOLOL SULFATE
LEVEMIR, INSULIN DETEMIR RECOMBINANT
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 20


** L **
LEVITRA, VARDENAFIL HYDROCHLORIDE
LEVO-DROMORAN, LEVORPHANOL TARTRATE
LEVOPHED, NOREPINEPHRINE BITARTRATE
LEVO-T, LEVOTHYROXINE SODIUM
LEVOTHROID, LEVOTHYROXINE SODIUM
LEVOXYL, LEVOTHYROXINE SODIUM
LEVULAN, AMINOLEVULINIC ACID HYDROCHLORIDE
LEXAPRO, ESCITALOPRAM OXALATE
LEXISCAN, REGADENOSON
LEXIVA, FOSAMPRENAVIR CALCIUM
LEXXEL, ENALAPRIL MALEATE
LIALDA, MESALAMINE
LIDEX, FLUOCINONIDE
LIDEX-E, FLUOCINONIDE
LIDOCAINE AND TETRACAINE, LIDOCAINE
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
LIDODERM, LIDOCAINE
LIDOPEN, LIDOCAINE HYDROCHLORIDE
LIMBITROL DS, AMITRIPTYLINE HYDROCHLORIDE
LIMBITROL, AMITRIPTYLINE HYDROCHLORIDE
LINCOCIN, LINCOMYCIN HYDROCHLORIDE
LIORESAL, BACLOFEN
LIPITOR, ATORVASTATIN CALCIUM
LIPOFEN, FENOFIBRATE
LIPOSYN II 10%, SAFFLOWER OIL
LIPOSYN II 20%, SAFFLOWER OIL
LIPOSYN III 10%, SOYBEAN OIL
LIPOSYN III 20%, SOYBEAN OIL
LIPOSYN III 30%, SOYBEAN OIL
LITHIUM CARBONATE, LITHIUM CARBONATE
LITHIUM CITRATE, LITHIUM CITRATE
LITHOBID, LITHIUM CARBONATE
LITHOSTAT, ACETOHYDROXAMIC ACID
LIVALO, PITAVASTATIN CALCIUM
LO/OVRAL-28, ETHINYL ESTRADIOL
LOCOID LIPOCREAM, HYDROCORTISONE BUTYRATE
LOCOID, HYDROCORTISONE BUTYRATE
LODOSYN, CARBIDOPA
LOESTRIN 21 1.5/30, ETHINYL ESTRADIOL
LOESTRIN 21 1/20, ETHINYL ESTRADIOL
LOESTRIN 24 FE, ETHINYL ESTRADIOL
LOESTRIN FE 1.5/30, ETHINYL ESTRADIOL
LOESTRIN FE 1/20, ETHINYL ESTRADIOL
LOMOTIL, ATROPINE SULFATE
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
LOPID, GEMFIBROZIL
LOPRESSOR HCT, HYDROCHLOROTHIAZIDE
LOPRESSOR, METOPROLOL TARTRATE
LOPROX, CICLOPIROX
LORATADINE, LORATADINE (OTC)
LOSEASONIQUE, ETHINYL ESTRADIOL
LOTEMAX, LOTEPREDNOL ETABONATE
LOTENSIN HCT, BENAZEPRIL HYDROCHLORIDE
LOTENSIN, BENAZEPRIL HYDROCHLORIDE
LOTREL, AMLODIPINE BESYLATE
LOTRIMIN ULTRA, BUTENAFINE HYDROCHLORIDE (OTC)
LOTRISONE, BETAMETHASONE DIPROPIONATE
LOTRONEX, ALOSETRON HYDROCHLORIDE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 21


** L **
LOVAZA, OMEGA-3-ACID ETHYL ESTERS
LOVENOX (PRESERVATIVE FREE), ENOXAPARIN SODIUM
LOVENOX, ENOXAPARIN SODIUM
LUMIGAN, BIMATOPROST
LUNESTA, ESZOPICLONE
LUPRON DEPOT, LEUPROLIDE ACETATE
LUPRON DEPOT-3, LEUPROLIDE ACETATE
LUPRON DEPOT-4, LEUPROLIDE ACETATE
LUPRON DEPOT-PED, LEUPROLIDE ACETATE
LUPRON, LEUPROLIDE ACETATE
LUSEDRA, FOSPROPOFOL DISODIUM
LUVERIS, LUTROPIN ALFA
LUVOX CR, FLUVOXAMINE MALEATE
LUVOX, FLUVOXAMINE MALEATE
LUXIQ, BETAMETHASONE VALERATE
LYBREL, ETHINYL ESTRADIOL
LYMPHAZURIN, ISOSULFAN BLUE
LYOPHILIZED CYTOXAN, CYCLOPHOSPHAMIDE
LYRICA, PREGABALIN
LYSODREN, MITOTANE
LYSTEDA, TRANEXAMIC ACID

** M **
M.V.I. ADULT (PHARMACY BULK PACKAGE), ASCORBIC ACID
M.V.I. ADULT, ASCORBIC ACID
M.V.I. PEDIATRIC, ASCORBIC ACID
M.V.I.-12 (WITHOUT VITAMIN K), ASCORBIC ACID
MACROBID, NITROFURANTOIN
MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE
MACUGEN, PEGAPTANIB SODIUM
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE, MAGNESIUM HYDROXIDE
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE
MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE
MAGNESIUM SULFATE, MAGNESIUM SULFATE
MAGNEVIST, GADOPENTETATE DIMEGLUMINE
MALARONE PEDIATRIC, ATOVAQUONE
MALARONE, ATOVAQUONE
MANGANESE CHLORIDE IN PLASTIC CONTAINER, MANGANESE CHLORIDE
MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER, MANNITOL
MANNITOL 10%, MANNITOL
MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%, MANNITOL
MANNITOL 15%, MANNITOL
MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 20%, MANNITOL
MANNITOL 25%, MANNITOL
MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%, MANNITOL
MANNITOL 5%, MANNITOL
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
MARCAINE, BUPIVACAINE HYDROCHLORIDE
MARINOL, DRONABINOL
MARPLAN, ISOCARBOXAZID
MATULANE, PROCARBAZINE HYDROCHLORIDE
MAVIK, TRANDOLAPRIL
MAXAIR, PIRBUTEROL ACETATE
MAXALT, RIZATRIPTAN BENZOATE
MAXALT-MLT, RIZATRIPTAN BENZOATE
MAXIDEX, DEXAMETHASONE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 22


** M **
MAXIPIME, CEFEPIME HYDROCHLORIDE
MAXITROL, DEXAMETHASONE
MAXZIDE, HYDROCHLOROTHIAZIDE
MAXZIDE-25, HYDROCHLOROTHIAZIDE
MD-76R, DIATRIZOATE MEGLUMINE
MDP-BRACCO, TECHNETIUM TC-99M MEDRONATE KIT
MEDROL, METHYLPREDNISOLONE
MEGACE ES, MEGESTROL ACETATE
MEGACE, MEGESTROL ACETATE
MEGATOPE, ALBUMIN IODINATED I-131 SERUM
MEMBRANEBLUE, TRYPAN BLUE
MENOPUR, LUTEINIZING HORMONE
MENOSTAR, ESTRADIOL
MEN'S ROGAINE, MINOXIDIL (OTC)
MENTAX, BUTENAFINE HYDROCHLORIDE
MENTAX-TC, BUTENAFINE HYDROCHLORIDE
MEPHYTON, PHYTONADIONE
MEPRON, ATOVAQUONE
MERIDIA, SIBUTRAMINE HYDROCHLORIDE
MERREM I.V., MEROPENEM
MESNEX, MESNA
MESTINON, PYRIDOSTIGMINE BROMIDE
METADATE CD, METHYLPHENIDATE HYDROCHLORIDE
METAGLIP, GLIPIZIDE
METASTRON, STRONTIUM CHLORIDE, SR-89
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METHADOSE, METHADONE HYDROCHLORIDE
METHERGINE, METHYLERGONOVINE MALEATE
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
METHOTREXATE SODIUM, METHOTREXATE SODIUM
METHYLIN, METHYLPHENIDATE HYDROCHLORIDE
METOPIRONE, METYRAPONE
METOZOLV ODT, METOCLOPRAMIDE HYDROCHLORIDE
METRO I.V. IN PLASTIC CONTAINER, METRONIDAZOLE
METROCREAM, METRONIDAZOLE
METROGEL, METRONIDAZOLE
METROGEL-VAGINAL, METRONIDAZOLE
METROLOTION, METRONIDAZOLE
METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE
METRONIDAZOLE, METRONIDAZOLE
METVIXIA, METHYL AMINOLEVULINATE HYDROCHLORIDE
MEVACOR, LOVASTATIN
MIACALCIN, CALCITONIN, SALMON
MICARDIS HCT, HYDROCHLOROTHIAZIDE
MICARDIS, TELMISARTAN
MICRONOR, NORETHINDRONE
MICROZIDE, HYDROCHLOROTHIAZIDE
MIDAMOR, AMILORIDE HYDROCHLORIDE
MIDOL LIQUID GELS, IBUPROFEN (OTC)
MIFEPREX, MIFEPRISTONE
MIGRANAL, DIHYDROERGOTAMINE MESYLATE
MINIPRESS, PRAZOSIN HYDROCHLORIDE
MINIRIN, DESMOPRESSIN ACETATE
MINOCIN, MINOCYCLINE HYDROCHLORIDE
MIOCHOL-E, ACETYLCHOLINE CHLORIDE
MIOSTAT, CARBACHOL
MIRALAX, POLYETHYLENE GLYCOL 3350 (OTC)
MIRAPEX, PRAMIPEXOLE DIHYDROCHLORIDE
MIRCETTE, DESOGESTREL
MIRENA, LEVONORGESTREL
MOBAN, MOLINDONE HYDROCHLORIDE
MOBIC, MELOXICAM
MODICON 28, ETHINYL ESTRADIOL
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 23


** M **
MONISTAT 1 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MONISTAT 3 COMBINATION PACK (PREFILLED), MICONAZOLE NITRATE (OTC)
MONISTAT 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MONISTAT 3, MICONAZOLE NITRATE
MONISTAT 3, MICONAZOLE NITRATE (OTC)
MONISTAT 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MONISTAT 7, MICONAZOLE NITRATE (OTC)
MONISTAT-3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MONODOX, DOXYCYCLINE
MONOKET, ISOSORBIDE MONONITRATE
MONOPRIL, FOSINOPRIL SODIUM
MONUROL, FOSFOMYCIN TROMETHAMINE
MORPHINE SULFATE, MORPHINE SULFATE
MOTOFEN, ATROPINE SULFATE
MOTRIN IB, IBUPROFEN (OTC)
MOTRIN MIGRAINE PAIN, IBUPROFEN (OTC)
MOVIPREP, ASCORBIC ACID
MOXATAG, AMOXICILLIN
MOZOBIL, PLERIXAFOR
MPI DMSA KIDNEY REAGENT, TECHNETIUM TC-99M SUCCIMER KIT
MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM
MS CONTIN, MORPHINE SULFATE
MUCINEX D, GUAIFENESIN (OTC)
MUCINEX DM, DEXTROMETHORPHAN HYDROBROMIDE (OTC)
MUCINEX, GUAIFENESIN (OTC)
MULTAQ, DRONEDARONE HYDROCHLORIDE
MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE
MULTIHANCE, GADOBENATE DIMEGLUMINE
MUSE, ALPROSTADIL
MUSTARGEN, MECHLORETHAMINE HYDROCHLORIDE
MYAMBUTOL, ETHAMBUTOL HYDROCHLORIDE
MYCAMINE, MICAFUNGIN SODIUM
MYCELEX, CLOTRIMAZOLE
MYCELEX-7 COMBINATION PACK, CLOTRIMAZOLE (OTC)
MYCELEX-7, CLOTRIMAZOLE (OTC)
MYCOBUTIN, RIFABUTIN
MYFORTIC, MYCOPHENOLIC ACID
MYLERAN, BUSULFAN
MYLOTARG, GEMTUZUMAB OZOGAMICIN
MYOVIEW 30ML, TECHNETIUM TC-99M TETROFOSMIN KIT
MYOVIEW, TECHNETIUM TC-99M TETROFOSMIN KIT
MYSOLINE, PRIMIDONE
MYTELASE, AMBENONIUM CHLORIDE

** N **
NAFTIN, NAFTIFINE HYDROCHLORIDE
NALFON, FENOPROFEN CALCIUM
NALLPEN IN PLASTIC CONTAINER, NAFCILLIN SODIUM
NAMENDA, MEMANTINE HYDROCHLORIDE
NAPHCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)
NAPRELAN, NAPROXEN SODIUM
NAPROSYN, NAPROXEN
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
NARDIL, PHENELZINE SULFATE
NAROPIN, ROPIVACAINE HYDROCHLORIDE MONOHYDRATE
NASACORT AQ, TRIAMCINOLONE ACETONIDE
NASAREL, FLUNISOLIDE
NASCOBAL, CYANOCOBALAMIN
NASONEX, MOMETASONE FUROATE MONOHYDRATE
NATACYN, NATAMYCIN
NATRECOR, NESIRITIDE RECOMBINANT
NAVANE, THIOTHIXENE
NAVELBINE, VINORELBINE TARTRATE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 24


** N **
NAVSTEL, CALCIUM CHLORIDE
NEBUPENT, PENTAMIDINE ISETHIONATE
NEGGRAM, NALIDIXIC ACID
NEOPAP, ACETAMINOPHEN (OTC)
NEOPROFEN, IBUPROFEN LYSINE
NEORAL, CYCLOSPORINE
NEPHRAMINE 5.4%, AMINO ACIDS
NESACAINE, CHLOROPROCAINE HYDROCHLORIDE
NESACAINE-MPF, CHLOROPROCAINE HYDROCHLORIDE
NEUROLITE, TECHNETIUM TC-99M BICISATE KIT
NEURONTIN, GABAPENTIN
NEVANAC, NEPAFENAC
NEXAVAR, SORAFENIB TOSYLATE
NEXCEDE, KETOPROFEN (OTC)
NEXIUM IV, ESOMEPRAZOLE SODIUM
NEXIUM, ESOMEPRAZOLE MAGNESIUM
NEXTERONE, AMIODARONE HYDROCHLORIDE
NIASPAN, NIACIN
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
NICODERM CQ, NICOTINE (OTC)
NICORETTE (MINT), NICOTINE POLACRILEX (OTC)
NICORETTE, NICOTINE POLACRILEX (OTC)
NICOTROL, NICOTINE
NILANDRON, NILUTAMIDE
NILSTAT, NYSTATIN
NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE
NIMBEX, CISATRACURIUM BESYLATE
NIPENT, PENTOSTATIN
NIRAVAM, ALPRAZOLAM
NITRO-DUR, NITROGLYCERIN
NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN
NITROGLYCERIN, NITROGLYCERIN
NITROLINGUAL PUMPSPRAY, NITROGLYCERIN
NITROMIST, NITROGLYCERIN
NITROSTAT, NITROGLYCERIN
NIX, PERMETHRIN (OTC)
NIZORAL A-D, KETOCONAZOLE (OTC)
NIZORAL, KETOCONAZOLE
NORDETTE-28, ETHINYL ESTRADIOL
NORDITROPIN NORDIFLEX, SOMATROPIN RECOMBINANT
NORDITROPIN, SOMATROPIN RECOMBINANT
NORFLEX, ORPHENADRINE CITRATE
NORGESIC FORTE, ASPIRIN
NORGESIC, ASPIRIN
NORINYL 1+35 21-DAY, ETHINYL ESTRADIOL
NORINYL 1+35 28-DAY, ETHINYL ESTRADIOL
NORINYL 1+50 28-DAY, MESTRANOL
NORITATE, METRONIDAZOLE
NORMOCARB HF 25, MAGNESIUM CHLORIDE
NORMOCARB HF 35, MAGNESIUM CHLORIDE
NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
NORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
NOROXIN, NORFLOXACIN
NORPACE CR, DISOPYRAMIDE PHOSPHATE
NORPACE, DISOPYRAMIDE PHOSPHATE
NORPRAMIN, DESIPRAMINE HYDROCHLORIDE
NOR-QD, NORETHINDRONE
NORVASC, AMLODIPINE BESYLATE
NORVIR, RITONAVIR
NOVAMINE 11.4%, AMINO ACIDS
NOVAMINE 15%, AMINO ACIDS
NOVANTRONE, MITOXANTRONE HYDROCHLORIDE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 25


** N **
NOVOLIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)
NOVOLIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)
NOVOLIN R, INSULIN RECOMBINANT HUMAN (OTC)
NOVOLOG MIX 70/30, INSULIN ASPART PROTAMINE RECOMBINANT
NOVOLOG, INSULIN ASPART RECOMBINANT
NOXAFIL, POSACONAZOLE
NUCYNTA, TAPENTADOL HYDROCHLORIDE
NULYTELY, POLYETHYLENE GLYCOL 3350
NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350
NUTRESTORE, GLUTAMINE
NUTRILIPID 10%, SOYBEAN OIL
NUTRILIPID 20%, SOYBEAN OIL
NUTROPIN AQ PEN, SOMATROPIN RECOMBINANT
NUTROPIN AQ, SOMATROPIN RECOMBINANT
NUTROPIN, SOMATROPIN RECOMBINANT
NUVARING, ETHINYL ESTRADIOL
NUVIGIL, ARMODAFINIL

** O **
OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT
OCUCLEAR, OXYMETAZOLINE HYDROCHLORIDE (OTC)
OCUFEN, FLURBIPROFEN SODIUM
OCUFLOX, OFLOXACIN
OCUPRESS, CARTEOLOL HYDROCHLORIDE
OFORTA, FLUDARABINE PHOSPHATE
OLUX E, CLOBETASOL PROPIONATE
OLUX, CLOBETASOL PROPIONATE
OMEPRAZOLE, OMEPRAZOLE (OTC)
OMNARIS, CICLESONIDE
OMNICEF, CEFDINIR
OMNIPAQUE 140, IOHEXOL
OMNIPAQUE 180, IOHEXOL
OMNIPAQUE 240, IOHEXOL
OMNIPAQUE 300, IOHEXOL
OMNIPAQUE 350, IOHEXOL
OMNIPRED, PREDNISOLONE ACETATE
OMNISCAN, GADODIAMIDE
OMNITROPE, SOMATROPIN RECOMBINANT
ONDANSETRON HYDROCHLORIDE AND SODIUM CHLORIDE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE
ONGLYZA, SAXAGLIPTIN HYDROCHLORIDE
ONSOLIS, FENTANYL CITRATE
OPANA ER, OXYMORPHONE HYDROCHLORIDE
OPANA, OXYMORPHONE HYDROCHLORIDE
OPCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)
OPHTHAINE, PROPARACAINE HYDROCHLORIDE
OPHTHETIC, PROPARACAINE HYDROCHLORIDE
OPTICROM, CROMOLYN SODIUM
OPTIMARK IN PLASTIC CONTAINER, GADOVERSETAMIDE
OPTIMARK, GADOVERSETAMIDE
OPTIPRANOLOL, METIPRANOLOL HYDROCHLORIDE
OPTIRAY 160, IOVERSOL
OPTIRAY 240, IOVERSOL
OPTIRAY 300, IOVERSOL
OPTIRAY 320, IOVERSOL
OPTIRAY 350, IOVERSOL
OPTISON, ALBUMIN HUMAN
OPTIVAR, AZELASTINE HYDROCHLORIDE
ORACEA, DOXYCYCLINE
ORAMORPH SR, MORPHINE SULFATE
ORAP, PIMOZIDE
ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE
ORAQIX, LIDOCAINE
ORAVERSE, PHENTOLAMINE MESYLATE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 26


** O **
ORETIC, HYDROCHLOROTHIAZIDE
ORFADIN, NITISINONE
ORTHO CYCLEN-28, ETHINYL ESTRADIOL
ORTHO EVRA, ETHINYL ESTRADIOL
ORTHO TRI-CYCLEN LO, ETHINYL ESTRADIOL
ORTHO TRI-CYCLEN, ETHINYL ESTRADIOL
ORTHO-CEPT, DESOGESTREL
ORTHO-NOVUM 1/35-28, ETHINYL ESTRADIOL
ORTHO-NOVUM 7/7/7-28, ETHINYL ESTRADIOL
OSMITROL 10% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 10% IN WATER, MANNITOL
OSMITROL 15% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 15% IN WATER, MANNITOL
OSMITROL 20% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 20% IN WATER, MANNITOL
OSMITROL 5% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 5% IN WATER, MANNITOL
OSMOPREP, SODIUM PHOSPHATE, DIBASIC ANHYDROUS
OVCON-35, ETHINYL ESTRADIOL
OVCON-50, ETHINYL ESTRADIOL
OVIDE, MALATHION
OVIDREL, CHORIOGONADOTROPIN ALFA
OXALIPLATIN, OXALIPLATIN
OXANDRIN, OXANDROLONE
OXILAN-300, IOXILAN
OXILAN-350, IOXILAN
OXISTAT, OXICONAZOLE NITRATE
OXSORALEN, METHOXSALEN
OXSORALEN-ULTRA, METHOXSALEN
OXYCONTIN, OXYCODONE HYDROCHLORIDE
OXYTOCIN, OXYTOCIN
OXYTROL, OXYBUTYNIN
OZURDEX, DEXAMETHASONE

** P **
PAMELOR, NORTRIPTYLINE HYDROCHLORIDE
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PAMINE FORTE, METHSCOPOLAMINE BROMIDE
PAMINE, METHSCOPOLAMINE BROMIDE
PANDEL, HYDROCORTISONE PROBUTATE
PANRETIN, ALITRETINOIN
PARAFON FORTE DSC, CHLORZOXAZONE
PARAGARD T 380A, COPPER
PARAPLATIN, CARBOPLATIN
PAREMYD, HYDROXYAMPHETAMINE HYDROBROMIDE
PARLODEL, BROMOCRIPTINE MESYLATE
PARNATE, TRANYLCYPROMINE SULFATE
PATADAY, OLOPATADINE HYDROCHLORIDE
PATANASE, OLOPATADINE HYDROCHLORIDE
PATANOL, OLOPATADINE HYDROCHLORIDE
PAXIL CR, PAROXETINE HYDROCHLORIDE
PAXIL, PAROXETINE HYDROCHLORIDE
PCE, ERYTHROMYCIN
PEDIAPRED, PREDNISOLONE SODIUM PHOSPHATE
PEDIATRIC ADVIL, IBUPROFEN (OTC)
PEGANONE, ETHOTOIN
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER, PENICILLIN G POTASSIUM
PENLAC, CICLOPIROX
PENNSAID, DICLOFENAC SODIUM
PENTAM, PENTAMIDINE ISETHIONATE
PENTASA, MESALAMINE
PENTETATE CALCIUM TRISODIUM, PENTETATE CALCIUM TRISODIUM
PENTETATE ZINC TRISODIUM, PENTETATE ZINC TRISODIUM
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 27


** P **
PEPCID AC (GELTAB), FAMOTIDINE (OTC)
PEPCID AC, FAMOTIDINE (OTC)
PEPCID COMPLETE, CALCIUM CARBONATE (OTC)
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE
PEPCID PRESERVATIVE FREE, FAMOTIDINE
PEPCID, FAMOTIDINE
PERCODAN, ASPIRIN
PERFOROMIST, FORMOTEROL FUMARATE
PERIDEX, CHLORHEXIDINE GLUCONATE
PERIOCHIP, CHLORHEXIDINE GLUCONATE
PERIOSTAT, DOXYCYCLINE HYCLATE
PERSANTINE, DIPYRIDAMOLE
PEXEVA, PAROXETINE MESYLATE
PHARMASEAL SCRUB CARE, CHLORHEXIDINE GLUCONATE (OTC)
PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE
PHISOHEX, HEXACHLOROPHENE
PHOSLO GELCAPS, CALCIUM ACETATE
PHOSPHOLINE IODIDE, ECHOTHIOPHATE IODIDE
PHOTOFRIN, PORFIMER SODIUM
PHYSIOLYTE IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PHYSIOSOL PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PILOPINE HS, PILOCARPINE HYDROCHLORIDE
PITOCIN, OXYTOCIN
PLAN B ONE-STEP, LEVONORGESTREL
PLAN B ONE-STEP, LEVONORGESTREL (OTC)
PLAN B, LEVONORGESTREL
PLAN B, LEVONORGESTREL (OTC)
PLAQUENIL, HYDROXYCHLOROQUINE SULFATE
PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
PLASMA-LYTE 56 IN PLASTIC CONTAINER, MAGNESIUM ACETATE TETRAHYDRATE
PLASMA-LYTE A IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PLASMA-LYTE R IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PLATINOL, CISPLATIN
PLATINOL-AQ, CISPLATIN
PLAVIX, CLOPIDOGREL BISULFATE
PLEGISOL IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PLETAL, CILOSTAZOL
POLY-PRED, NEOMYCIN SULFATE
POLYTRIM, POLYMYXIN B SULFATE
PONSTEL, MEFENAMIC ACID
POTASSIUM ACETATE IN PLASTIC CONTAINER, POTASSIUM ACETATE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 28


** P **
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM
CHLORIDE
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM
CHLORIDE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM
CHLORIDE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 29


** P **
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM
CHLORIDE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM
CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM
CHLORIDE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
POVIDONE IODINE, POVIDONE-IODINE (OTC)
PRALIDOXIME CHLORIDE, PRALIDOXIME CHLORIDE
PRANDIMET, METFORMIN HYDROCHLORIDE
PRANDIN, REPAGLINIDE
PRAVACHOL, PRAVASTATIN SODIUM
PRECEDEX, DEXMEDETOMIDINE
PRECOSE, ACARBOSE
PRED FORTE, PREDNISOLONE ACETATE
PRED MILD, PREDNISOLONE ACETATE
PRED-G, GENTAMICIN SULFATE
PREFEST, ESTRADIOL
PREGNYL, GONADOTROPIN, CHORIONIC
PREMARIN, ESTROGENS, CONJUGATED
PREMPHASE 14/14, ESTROGENS, CONJUGATED
PREMPRO, ESTROGENS, CONJUGATED
PRE-OP II, HEXACHLOROPHENE
PRE-OP, HEXACHLOROPHENE
PREPIDIL, DINOPROSTONE
PREVACID 24 HR, LANSOPRAZOLE (OTC)
PREVACID, LANSOPRAZOLE
PREVPAC, AMOXICILLIN
PREZISTA, DARUNAVIR ETHANOLATE
PRIALT, ZICONOTIDE
PRIFTIN, RIFAPENTINE
PRILOSEC OTC, OMEPRAZOLE MAGNESIUM (OTC)
PRILOSEC, OMEPRAZOLE
PRILOSEC, OMEPRAZOLE MAGNESIUM
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
PRIMAQUINE, PRIMAQUINE PHOSPHATE
PRIMAXIN, CILASTATIN SODIUM
PRINIVIL, LISINOPRIL
PRINZIDE, HYDROCHLOROTHIAZIDE
PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 30


** P **
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISTIQ, DESVENLAFAXINE SUCCINATE
PROAIR HFA, ALBUTEROL SULFATE
PROAMATINE, MIDODRINE HYDROCHLORIDE
PROCALAMINE, AMINO ACIDS
PROCARDIA XL, NIFEDIPINE
PROCARDIA, NIFEDIPINE
PROFERDEX, IRON DEXTRAN
PROGESTERONE, PROGESTERONE
PROGLYCEM, DIAZOXIDE
PROGRAF, TACROLIMUS
PROHANCE MULTIPACK, GADOTERIDOL
PROHANCE, GADOTERIDOL
PROMACTA, ELTROMBOPAG OLAMINE
PROMETRIUM, PROGESTERONE
PROPECIA, FINASTERIDE
PROPINE, DIPIVEFRIN HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
PROPYLTHIOURACIL, PROPYLTHIOURACIL
PROQUIN XR, CIPROFLOXACIN HYDROCHLORIDE
PROSCAR, FINASTERIDE
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS
PROSTIN E2, DINOPROSTONE
PROSTIN VR PEDIATRIC, ALPROSTADIL
PROTONIX IV, PANTOPRAZOLE SODIUM
PROTONIX, PANTOPRAZOLE SODIUM
PROTOPAM CHLORIDE, PRALIDOXIME CHLORIDE
PROTOPIC, TACROLIMUS
PROVENTIL-HFA, ALBUTEROL SULFATE
PROVERA, MEDROXYPROGESTERONE ACETATE
PROVIGIL, MODAFINIL
PROVOCHOLINE, METHACHOLINE CHLORIDE
PROZAC WEEKLY, FLUOXETINE HYDROCHLORIDE
PROZAC, FLUOXETINE HYDROCHLORIDE
PSORCON, DIFLORASONE DIACETATE
PULMICORT FLEXHALER, BUDESONIDE
PULMICORT RESPULES, BUDESONIDE
PULMICORT, BUDESONIDE
PULMOLITE, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT
PURINETHOL, MERCAPTOPURINE
PYLERA, BISMUTH SUBCITRATE POTASSIUM
PYTEST KIT, UREA, C-14
PYTEST, UREA, C-14

** Q **
QUADRAMET, SAMARIUM SM 153 LEXIDRONAM PENTASODIUM
QUALAQUIN, QUININE SULFATE
QUELICIN PRESERVATIVE FREE, SUCCINYLCHOLINE CHLORIDE
QUELICIN, SUCCINYLCHOLINE CHLORIDE
QUESTRAN LIGHT, CHOLESTYRAMINE
QUESTRAN, CHOLESTYRAMINE
QUINIDINE GLUCONATE, QUINIDINE GLUCONATE
QUIXIN, LEVOFLOXACIN
QUTENZA, CAPSAICIN
QVAR 40, BECLOMETHASONE DIPROPIONATE
QVAR 80, BECLOMETHASONE DIPROPIONATE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 31


** R **
RADIOGARDASE (PRUSSIAN BLUE), FERRIC HEXACYANOFERRATE(II)
RANEXA, RANOLAZINE
RAPAFLO, SILODOSIN
RAPAMUNE, SIROLIMUS
RAZADYNE ER, GALANTAMINE HYDROBROMIDE
RAZADYNE, GALANTAMINE HYDROBROMIDE
REBETOL, RIBAVIRIN
RECLAST, ZOLEDRONIC ACID
REFLUDAN, LEPIRUDIN RECOMBINANT
REGITINE, PHENTOLAMINE MESYLATE
REGLAN, METOCLOPRAMIDE HYDROCHLORIDE
REGONOL, PYRIDOSTIGMINE BROMIDE
RELENZA, ZANAMIVIR
RELISTOR, METHYLNALTREXONE BROMIDE
RELPAX, ELETRIPTAN HYDROBROMIDE
REMERON SOLTAB, MIRTAZAPINE
REMERON, MIRTAZAPINE
REMODULIN, TREPROSTINIL SODIUM
RENACIDIN, CITRIC ACID
RENAGEL, SEVELAMER HYDROCHLORIDE
RENAMIN W/O ELECTROLYTES, AMINO ACIDS
RENOGRAFIN-76, DIATRIZOATE MEGLUMINE
RENOVA, TRETINOIN
RENVELA, SEVELAMER CARBONATE
REPRONEX, LUTEINIZING HORMONE
REQUIP XL, ROPINIROLE HYDROCHLORIDE
REQUIP, ROPINIROLE HYDROCHLORIDE
RESCRIPTOR, DELAVIRDINE MESYLATE
RESCULA, UNOPROSTONE ISOPROPYL
RESECTISOL IN PLASTIC CONTAINER, MANNITOL
RESERPINE, RESERPINE
RESTASIS, CYCLOSPORINE
RESTORIL, TEMAZEPAM
RETIN-A MICRO, TRETINOIN
RETIN-A, TRETINOIN
RETISERT, FLUOCINOLONE ACETONIDE
RETROVIR, ZIDOVUDINE
REVATIO, SILDENAFIL CITRATE
REVIA, NALTREXONE HYDROCHLORIDE
REVLIMID, LENALIDOMIDE
REYATAZ, ATAZANAVIR SULFATE
R-GENE 10, ARGININE HYDROCHLORIDE
RHINOCORT, BUDESONIDE
RID MOUSSE, PIPERONYL BUTOXIDE (OTC)
RIDAURA, AURANOFIN
RIFADIN, RIFAMPIN
RIFATER, ISONIAZID
RILUTEK, RILUZOLE
RIMACTANE, RIFAMPIN
RIMSO-50, DIMETHYL SULFOXIDE
RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
RIOMET, METFORMIN HYDROCHLORIDE
RISPERDAL CONSTA, RISPERIDONE
RISPERDAL, RISPERIDONE
RITALIN LA, METHYLPHENIDATE HYDROCHLORIDE
RITALIN, METHYLPHENIDATE HYDROCHLORIDE
RITALIN-SR, METHYLPHENIDATE HYDROCHLORIDE
ROBAXIN, METHOCARBAMOL
ROBAXIN-750, METHOCARBAMOL
ROBINUL FORTE, GLYCOPYRROLATE
ROBINUL, GLYCOPYRROLATE
ROCALTROL, CALCITRIOL
ROGAINE (FOR MEN), MINOXIDIL (OTC)
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 32


** R **
ROGAINE (FOR WOMEN), MINOXIDIL (OTC)
ROGAINE EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
ROMAZICON, FLUMAZENIL
ROWASA, MESALAMINE
ROXICODONE, OXYCODONE HYDROCHLORIDE
ROZEREM, RAMELTEON
RYTHMOL SR, PROPAFENONE HYDROCHLORIDE
RYTHMOL, PROPAFENONE HYDROCHLORIDE
RYZOLT, TRAMADOL HYDROCHLORIDE

** S **
SABRIL, VIGABATRIN
SAIZEN, SOMATROPIN RECOMBINANT
SALAGEN, PILOCARPINE HYDROCHLORIDE
SALONPAS, MENTHOL (OTC)
SALURON, HYDROFLUMETHIAZIDE
SAMSCA, TOLVAPTAN
SANCTURA XR, TROSPIUM CHLORIDE
SANCTURA, TROSPIUM CHLORIDE
SANCUSO, GRANISETRON
SANDIMMUNE, CYCLOSPORINE
SANDOSTATIN LAR, OCTREOTIDE ACETATE
SANDOSTATIN, OCTREOTIDE ACETATE
SAPHRIS, ASENAPINE MALEATE
SARAFEM, FLUOXETINE HYDROCHLORIDE
SAVELLA, MILNACIPRAN HYDROCHLORIDE
SCLEROSOL, TALC
SEASONALE, ETHINYL ESTRADIOL
SEASONIQUE, ETHINYL ESTRADIOL
SECTRAL, ACEBUTOLOL HYDROCHLORIDE
SELSUN, SELENIUM SULFIDE
SELZENTRY, MARAVIROC
SEMPREX-D, ACRIVASTINE
SENSIPAR, CINACALCET HYDROCHLORIDE
SENSORCAINE, BUPIVACAINE HYDROCHLORIDE
SEPTOCAINE, ARTICAINE HYDROCHLORIDE
SEPTRA DS, SULFAMETHOXAZOLE
SEPTRA, SULFAMETHOXAZOLE
SEREVENT, SALMETEROL XINAFOATE
SEROPHENE, CLOMIPHENE CITRATE
SEROQUEL XR, QUETIAPINE FUMARATE
SEROQUEL, QUETIAPINE FUMARATE
SEROSTIM, SOMATROPIN RECOMBINANT
SERPALAN, RESERPINE
SFROWASA, MESALAMINE
SHADE UVAGUARD, AVOBENZONE (OTC)
SILVADENE, SILVER SULFADIAZINE
SIMCOR, NIACIN
SINE-AID IB, IBUPROFEN (OTC)
SINEMET CR, CARBIDOPA
SINEMET, CARBIDOPA
SINGULAIR, MONTELUKAST SODIUM
SINOGRAFIN, DIATRIZOATE MEGLUMINE
SKELAXIN, METAXALONE
SKELID, TILUDRONATE DISODIUM
SODIUM ACETATE IN PLASTIC CONTAINER, SODIUM ACETATE ANHYDROUS
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM IODIDE I 123, SODIUM IODIDE, I-123
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 33


** S **
SODIUM IODIDE I 131, SODIUM IODIDE, I-131
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE
SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE
SODIUM LACTATE IN PLASTIC CONTAINER, SODIUM LACTATE
SODIUM PHOSPHATES IN PLASTIC CONTAINER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
SOLAGE, MEQUINOL
SOLARAZE, DICLOFENAC SODIUM
SOLODYN, MINOCYCLINE HYDROCHLORIDE
SOLU-CORTEF, HYDROCORTISONE SODIUM SUCCINATE
SOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATE
SOMA COMPOUND W/ CODEINE, ASPIRIN
SOMA COMPOUND, ASPIRIN
SOMA, CARISOPRODOL
SOMATULINE DEPOT, LANREOTIDE ACETATE
SOMAVERT, PEGVISOMANT
SONATA, ZALEPLON
SORBITOL 3% IN PLASTIC CONTAINER, SORBITOL
SORBITOL 3.3% IN PLASTIC CONTAINER, SORBITOL
SORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOL
SORIATANE, ACITRETIN
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
SPECTRACEF, CEFDITOREN PIVOXIL
SPIRIVA, TIOTROPIUM BROMIDE MONOHYDRATE
SPORANOX, ITRACONAZOLE
SPRYCEL, DASATINIB
SSD AF, SILVER SULFADIAZINE
SSD, SILVER SULFADIAZINE
STADOL PRESERVATIVE FREE, BUTORPHANOL TARTRATE
STADOL, BUTORPHANOL TARTRATE
STALEVO 100, CARBIDOPA
STALEVO 125, CARBIDOPA
STALEVO 150, CARBIDOPA
STALEVO 200, CARBIDOPA
STALEVO 50, CARBIDOPA
STALEVO 75, CARBIDOPA
STARLIX, NATEGLINIDE
STAVZOR, VALPROIC ACID
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, WATER FOR INJECTION, STERILE
STERILE WATER IN PLASTIC CONTAINER, WATER FOR IRRIGATION, STERILE
STERILE WATER, WATER FOR IRRIGATION, STERILE
STIMATE, DESMOPRESSIN ACETATE
STRATTERA, ATOMOXETINE HYDROCHLORIDE
STRIANT, TESTOSTERONE
STROMECTOL, IVERMECTIN
SUBLIMAZE PRESERVATIVE FREE, FENTANYL CITRATE
SUBOXONE, BUPRENORPHINE HYDROCHLORIDE
SUBUTEX, BUPRENORPHINE HYDROCHLORIDE
SUCRAID, SACROSIDASE
SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)
SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE
SULAR, NISOLDIPINE
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE
SULFAMYLON, MAFENIDE ACETATE
SULFATRIM PEDIATRIC, SULFAMETHOXAZOLE
SUMAVEL DOSEPRO, SUMATRIPTAN SUCCINATE
SUPPRELIN LA, HISTRELIN ACETATE
SUPRANE, DESFLURANE
SURMONTIL, TRIMIPRAMINE MALEATE
SURVANTA, BERACTANT
SUSTIVA, EFAVIRENZ
SUTENT, SUNITINIB MALATE
SYMBICORT, BUDESONIDE
SYMBYAX, FLUOXETINE HYDROCHLORIDE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 34


** S **
SYMLIN, PRAMLINTIDE ACETATE
SYMMETREL, AMANTADINE HYDROCHLORIDE
SYNALAR, FLUOCINOLONE ACETONIDE
SYNALGOS-DC, ASPIRIN
SYNAREL, NAFARELIN ACETATE
SYNERA, LIDOCAINE
SYNERCID, DALFOPRISTIN
SYNTHETIC CONJUGATED ESTROGENS A, ESTROGENS, CONJUGATED SYNTHETIC A
SYNTHROID, LEVOTHYROXINE SODIUM
SYPRINE, TRIENTINE HYDROCHLORIDE

** T **
TACLONEX SCALP, BETAMETHASONE DIPROPIONATE
TACLONEX, BETAMETHASONE DIPROPIONATE
TAGAMET HB, CIMETIDINE (OTC)
TAGAMET, CIMETIDINE
TALACEN, ACETAMINOPHEN
TALC, TALC
TALWIN NX, NALOXONE HYDROCHLORIDE
TALWIN, PENTAZOCINE LACTATE
TAMBOCOR, FLECAINIDE ACETATE
TAMIFLU, OSELTAMIVIR PHOSPHATE
TARCEVA, ERLOTINIB HYDROCHLORIDE
TARGRETIN, BEXAROTENE
TARKA, TRANDOLAPRIL
TASIGNA, NILOTINIB HYDROCHLORIDE MONOHYDRATE
TASMAR, TOLCAPONE
TAVIST ALLERGY/SINUS/HEADACHE, ACETAMINOPHEN (OTC)
TAVIST-1, CLEMASTINE FUMARATE (OTC)
TAXOL, PACLITAXEL
TAXOTERE, DOCETAXEL
TAZORAC, TAZAROTENE
TECHNELITE, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
TECHNESCAN MAG3, TECHNETIUM TC-99M MERTIATIDE KIT
TECHNESCAN PYP KIT, TECHNETIUM TC-99M PYROPHOSPHATE KIT
TECHNESCAN, TECHNETIUM TC-99M OXIDRONATE KIT
TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT
TECHNETIUM TC-99M PENTETATE KIT, TECHNETIUM TC-99M PENTETATE KIT
TEGRETOL, CARBAMAZEPINE
TEGRETOL-XR, CARBAMAZEPINE
TEKTURNA HCT, ALISKIREN HEMIFUMARATE
TEKTURNA, ALISKIREN HEMIFUMARATE
TEMODAR, TEMOZOLOMIDE
TEMOVATE E, CLOBETASOL PROPIONATE
TEMOVATE, CLOBETASOL PROPIONATE
TENEX, GUANFACINE HYDROCHLORIDE
TENORETIC 100, ATENOLOL
TENORETIC 50, ATENOLOL
TENORMIN, ATENOLOL
TENSILON PRESERVATIVE FREE, EDROPHONIUM CHLORIDE
TENSILON, EDROPHONIUM CHLORIDE
TENUATE DOSPAN, DIETHYLPROPION HYDROCHLORIDE
TENUATE, DIETHYLPROPION HYDROCHLORIDE
TERAZOL 3, TERCONAZOLE
TERAZOL 7, TERCONAZOLE
TERCONAZOLE, TERCONAZOLE
TESSALON, BENZONATATE
TESTIM, TESTOSTERONE
TEVETEN HCT, EPROSARTAN MESYLATE
TEVETEN, EPROSARTAN MESYLATE
TEV-TROPIN, SOMATROPIN RECOMBINANT
THALITONE, CHLORTHALIDONE
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE, TL-201
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 35


** T **
THALOMID, THALIDOMIDE
THAM, TROMETHAMINE
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THERMAZENE, SILVER SULFADIAZINE
THIOGUANINE, THIOGUANINE
THYROGEN, THYROTROPIN ALFA
THYROLAR-0.25, LIOTHYRONINE SODIUM
THYROLAR-0.5, LIOTHYRONINE SODIUM
THYROLAR-1, LIOTHYRONINE SODIUM
THYROLAR-2, LIOTHYRONINE SODIUM
THYROLAR-3, LIOTHYRONINE SODIUM
TIAZAC, DILTIAZEM HYDROCHLORIDE
TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE
TIKOSYN, DOFETILIDE
TIMENTIN IN PLASTIC CONTAINER, CLAVULANATE POTASSIUM
TIMENTIN, CLAVULANATE POTASSIUM
TIMOLOL MALEATE, TIMOLOL MALEATE
TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE
TIMOPTIC, TIMOLOL MALEATE
TIMOPTIC-XE, TIMOLOL MALEATE
TINDAMAX, TINIDAZOLE
TIOPRONIN, TIOPRONIN
TIS-U-SOL IN PLASTIC CONTAINER, MAGNESIUM SULFATE
TIS-U-SOL, MAGNESIUM SULFATE
TOBI, TOBRAMYCIN
TOBRADEX ST, DEXAMETHASONE
TOBRADEX, DEXAMETHASONE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
TOBREX, TOBRAMYCIN
TODAY, NONOXYNOL-9 (OTC)
TOFRANIL-PM, IMIPRAMINE PAMOATE
TOLECTIN 600, TOLMETIN SODIUM
TOLECTIN DS, TOLMETIN SODIUM
TOLECTIN, TOLMETIN SODIUM
TOPAMAX, TOPIRAMATE
TOPICORT LP, DESOXIMETASONE
TOPICORT, DESOXIMETASONE
TOPROL-XL, METOPROLOL SUCCINATE
TORISEL, TEMSIROLIMUS
TOTECT, DEXRAZOXANE HYDROCHLORIDE
TOVIAZ, FESOTERODINE FUMARATE
TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE
TRACLEER, BOSENTAN
TRANDATE, LABETALOL HYDROCHLORIDE
TRANSDERM SCOP, SCOPOLAMINE
TRANXENE, CLORAZEPATE DIPOTASSIUM
TRASYLOL, APROTININ
TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 10% W/O ELECTROLYTES, AMINO ACIDS
TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 3.5% W/ ELECTROLYTES, AMINO ACIDS
TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 5.5% W/ ELECTROLYTES, AMINO ACIDS
TRAVASOL 5.5% W/O ELECTROLYTES, AMINO ACIDS
TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 8.5% W/ ELECTROLYTES, AMINO ACIDS
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 36


** T **
TRAVASOL 8.5% W/O ELECTROLYTES, AMINO ACIDS
TRAVATAN Z, TRAVOPROST
TRAVATAN, TRAVOPROST
TREANDA, BENDAMUSTINE HYDROCHLORIDE
TRECATOR, ETHIONAMIDE
TRELSTAR DEPOT, TRIPTORELIN PAMOATE
TRELSTAR LA, TRIPTORELIN PAMOATE
TRENTAL, PENTOXIFYLLINE
TREXIMET, NAPROXEN SODIUM
TRICOR, FENOFIBRATE
TRIDIONE, TRIMETHADIONE
TRIESENCE, TRIAMCINOLONE ACETONIDE
TRIGLIDE, FENOFIBRATE
TRILEPTAL, OXCARBAZEPINE
TRILIPIX, CHOLINE FENOFIBRATE
TRI-LUMA, FLUOCINOLONE ACETONIDE
TRIMETHOPRIM, TRIMETHOPRIM
TRI-NORINYL 28-DAY, ETHINYL ESTRADIOL
TRIOSTAT, LIOTHYRONINE SODIUM
TRISENOX, ARSENIC TRIOXIDE
TRIVAGIZOLE 3, CLOTRIMAZOLE (OTC)
TRIVARIS, TRIAMCINOLONE ACETONIDE
TRIZIVIR, ABACAVIR SULFATE
TROBICIN, SPECTINOMYCIN HYDROCHLORIDE
TROPHAMINE 10%, AMINO ACIDS
TROPHAMINE, AMINO ACIDS
TRUSOPT, DORZOLAMIDE HYDROCHLORIDE
TRUVADA, EMTRICITABINE
TUSSIONEX PENNKINETIC, CHLORPHENIRAMINE POLISTIREX
TWINJECT 0.15, EPINEPHRINE
TWINJECT 0.3, EPINEPHRINE
TWYNSTA, AMLODIPINE BESYLATE
TYGACIL, TIGECYCLINE
TYKERB, LAPATINIB DITOSYLATE
TYLENOL (CAPLET), ACETAMINOPHEN (OTC)
TYLENOL (GELTAB), ACETAMINOPHEN (OTC)
TYVASO, TREPROSTINIL SODIUM
TYZEKA, TELBIVUDINE

** U **
ULESFIA, BENZYL ALCOHOL
ULORIC, FEBUXOSTAT
ULTANE, SEVOFLURANE
ULTIVA, REMIFENTANIL HYDROCHLORIDE
ULTRACET, ACETAMINOPHEN
ULTRAM ER, TRAMADOL HYDROCHLORIDE
ULTRAM, TRAMADOL HYDROCHLORIDE
ULTRATAG, TECHNETIUM TC-99M RED BLOOD CELL KIT
ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
ULTRAVATE, HALOBETASOL PROPIONATE
ULTRAVIST (PHARMACY BULK), IOPROMIDE
ULTRAVIST 150, IOPROMIDE
ULTRAVIST 240, IOPROMIDE
ULTRAVIST 300 IN PLASTIC CONTAINER, IOPROMIDE
ULTRAVIST 300, IOPROMIDE
ULTRAVIST 370, IOPROMIDE
UNASYN, AMPICILLIN SODIUM
UNIRETIC, HYDROCHLOROTHIAZIDE
UNISOM, DOXYLAMINE SUCCINATE (OTC)
UNITHROID, LEVOTHYROXINE SODIUM
UNIVASC, MOEXIPRIL HYDROCHLORIDE
UREX, METHENAMINE HIPPURATE
URISPAS, FLAVOXATE HYDROCHLORIDE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 37


** U **
UROCIT-K, POTASSIUM CITRATE
UROXATRAL, ALFUZOSIN HYDROCHLORIDE
URSO 250, URSODIOL
URSO FORTE, URSODIOL
UVADEX, METHOXSALEN

** V **
VAGIFEM, ESTRADIOL
VAGISTAT-1, TIOCONAZOLE (OTC)
VALCYTE, VALGANCICLOVIR HYDROCHLORIDE
VALIUM, DIAZEPAM
VALSTAR PRESERVATIVE FREE, VALRUBICIN
VALTREX, VALACYCLOVIR HYDROCHLORIDE
VALTROPIN, SOMATROPIN RECOMBINANT
VALTURNA, ALISKIREN HEMIFUMARATE
VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE
VANCOCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VANDAZOLE, METRONIDAZOLE
VANIQA, EFLORNITHINE HYDROCHLORIDE
VANOS, FLUOCINONIDE
VANTAS, HISTRELIN ACETATE
VANTIN, CEFPODOXIME PROXETIL
VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, CONIVAPTAN HYDROCHLORIDE
VASERETIC, ENALAPRIL MALEATE
VASOCIDIN, PREDNISOLONE SODIUM PHOSPHATE
VASOCON-A, ANTAZOLINE PHOSPHATE (OTC)
VASOTEC, ENALAPRIL MALEATE
VECTICAL, CALCITRIOL
VELCADE, BORTEZOMIB
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
VENOFER, IRON SUCROSE
VENTAVIS, ILOPROST
VENTOLIN HFA, ALBUTEROL SULFATE
VEPESID, ETOPOSIDE
VERAMYST, FLUTICASONE FUROATE
VERDESO, DESONIDE
VEREGEN, SINECATECHINS
VERELAN PM, VERAPAMIL HYDROCHLORIDE
VERELAN, VERAPAMIL HYDROCHLORIDE
VESANOID, TRETINOIN
VESICARE, SOLIFENACIN SUCCINATE
VEXOL, RIMEXOLONE
VFEND, VORICONAZOLE
VIAGRA, SILDENAFIL CITRATE
VIBATIV, TELAVANCIN HYDROCHLORIDE
VIBRAMYCIN, DOXYCYCLINE
VIBRAMYCIN, DOXYCYCLINE CALCIUM
VIBRAMYCIN, DOXYCYCLINE HYCLATE
VIBRA-TABS, DOXYCYCLINE HYCLATE
VICOPROFEN, HYDROCODONE BITARTRATE
VIDAZA, AZACITIDINE
VIDEX EC, DIDANOSINE
VIDEX, DIDANOSINE
VIGAMOX, MOXIFLOXACIN HYDROCHLORIDE
VIMPAT, LACOSAMIDE
VIRACEPT, NELFINAVIR MESYLATE
VIRAMUNE, NEVIRAPINE
VIRAZOLE, RIBAVIRIN
VIREAD, TENOFOVIR DISOPROXIL FUMARATE
VIROPTIC, TRIFLURIDINE
VISICOL, SODIUM PHOSPHATE, DIBASIC ANHYDROUS
VISINE L.R., OXYMETAZOLINE HYDROCHLORIDE (OTC)
VISINE-A, NAPHAZOLINE HYDROCHLORIDE (OTC)
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 38


** V **
VISIONBLUE, TRYPAN BLUE
VISIPAQUE 270, IODIXANOL
VISIPAQUE 320, IODIXANOL
VISTARIL, HYDROXYZINE PAMOATE
VISTIDE, CIDOFOVIR
VISUDYNE, VERTEPORFIN
VITRASE, HYALURONIDASE
VITRASERT, GANCICLOVIR
VIVELLE, ESTRADIOL
VIVELLE-DOT, ESTRADIOL
VIVITROL, NALTREXONE
VOLTAREN, DICLOFENAC SODIUM
VOLTAREN-XR, DICLOFENAC SODIUM
VOSOL HC, ACETIC ACID, GLACIAL
VOSOL, ACETIC ACID, GLACIAL
VOTRIENT, PAZOPANIB HYDROCHLORIDE
VUMON, TENIPOSIDE
VUSION, MICONAZOLE NITRATE
VYTORIN, EZETIMIBE
VYVANSE, LISDEXAMFETAMINE DIMESYLATE

** W **
WELCHOL, COLESEVELAM HYDROCHLORIDE
WELLBUTRIN SR, BUPROPION HYDROCHLORIDE
WELLBUTRIN XL, BUPROPION HYDROCHLORIDE
WELLBUTRIN, BUPROPION HYDROCHLORIDE
WESTCORT, HYDROCORTISONE VALERATE

** X **
XALATAN, LATANOPROST
XANAX XR, ALPRAZOLAM
XANAX, ALPRAZOLAM
XELODA, CAPECITABINE
XENAZINE, TETRABENAZINE
XENICAL, ORLISTAT
XENON XE 133, XENON XE 133
XIBROM, BROMFENAC SODIUM
XIFAXAN, RIFAXIMIN
XOLEGEL, KETOCONAZOLE
XOPENEX HFA, LEVALBUTEROL TARTRATE
XOPENEX, LEVALBUTEROL HYDROCHLORIDE
XYLOCAINE 4% PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
XYLOCAINE DENTAL WITH EPINEPHRINE, EPINEPHRINE
XYLOCAINE DENTAL, LIDOCAINE HYDROCHLORIDE
XYLOCAINE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
XYLOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE
XYLOCAINE W/ EPINEPHRINE, EPINEPHRINE
XYLOCAINE, LIDOCAINE HYDROCHLORIDE
XYREM, SODIUM OXYBATE
XYZAL, LEVOCETIRIZINE DIHYDROCHLORIDE

** Y **
YASMIN, DROSPIRENONE
YAZ, DROSPIRENONE

** Z **
ZADITOR, KETOTIFEN FUMARATE (OTC)
ZANAFLEX, TIZANIDINE HYDROCHLORIDE
ZANOSAR, STREPTOZOCIN
ZANTAC 150, RANITIDINE HYDROCHLORIDE
ZANTAC 150, RANITIDINE HYDROCHLORIDE (OTC)
ZANTAC 25, RANITIDINE HYDROCHLORIDE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

APPENDIX A - PRODUCT NAME INDEX A - 39


** Z **
ZANTAC 300, RANITIDINE HYDROCHLORIDE
ZANTAC 75, RANITIDINE HYDROCHLORIDE (OTC)
ZANTAC IN PLASTIC CONTAINER, RANITIDINE HYDROCHLORIDE
ZANTAC, RANITIDINE HYDROCHLORIDE
ZARONTIN, ETHOSUXIMIDE
ZAROXOLYN, METOLAZONE
ZAVESCA, MIGLUSTAT
ZEBETA, BISOPROLOL FUMARATE
ZEGERID OTC, OMEPRAZOLE (OTC)
ZEGERID, MAGNESIUM HYDROXIDE
ZEGERID, OMEPRAZOLE
ZELAPAR, SELEGILINE HYDROCHLORIDE
ZEMPLAR, PARICALCITOL
ZEMURON, ROCURONIUM BROMIDE
ZENPEP, LIPASE
ZERIT, STAVUDINE
ZESTORETIC, HYDROCHLOROTHIAZIDE
ZESTRIL, LISINOPRIL
ZETIA, EZETIMIBE
ZIAC, BISOPROLOL FUMARATE
ZIAGEN, ABACAVIR SULFATE
ZIANA, CLINDAMYCIN PHOSPHATE
ZINACEF IN PLASTIC CONTAINER, CEFUROXIME SODIUM
ZINACEF, CEFUROXIME SODIUM
ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE
ZINECARD, DEXRAZOXANE HYDROCHLORIDE
ZIPSOR, DICLOFENAC POTASSIUM
ZIRGAN, GANCICLOVIR
ZITHROMAX, AZITHROMYCIN
ZMAX, AZITHROMYCIN
ZOCOR, SIMVASTATIN
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE
ZOFRAN ODT, ONDANSETRON
ZOFRAN PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ZOFRAN, ONDANSETRON HYDROCHLORIDE
ZOLADEX, GOSERELIN ACETATE
ZOLINZA, VORINOSTAT
ZOLOFT, SERTRALINE HYDROCHLORIDE
ZOLPIMIST, ZOLPIDEM TARTRATE
ZOMETA, ZOLEDRONIC ACID
ZOMIG, ZOLMITRIPTAN
ZOMIG-ZMT, ZOLMITRIPTAN
ZONALON, DOXEPIN HYDROCHLORIDE
ZONEGRAN, ZONISAMIDE
ZORBTIVE, SOMATROPIN RECOMBINANT
ZOSYN IN PLASTIC CONTAINER, PIPERACILLIN SODIUM
ZOSYN, PIPERACILLIN SODIUM
ZOVIRAX, ACYCLOVIR
ZOVIRAX, ACYCLOVIR SODIUM
ZYBAN, BUPROPION HYDROCHLORIDE
ZYFLO CR, ZILEUTON
ZYFLO, ZILEUTON
ZYLET, LOTEPREDNOL ETABONATE
ZYLOPRIM, ALLOPURINOL
ZYMAR, GATIFLOXACIN
ZYPREXA RELPREVV, OLANZAPINE PAMOATE
ZYPREXA ZYDIS, OLANZAPINE
ZYPREXA, OLANZAPINE
ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
ZYRTEC, CETIRIZINE HYDROCHLORIDE
ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE (OTC)
ZYVOX, LINEZOLID
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 1

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** 3 **
3M
* 3M CO
PERIDEX, CHLORHEXIDINE GLUCONATE
* 3M HEALTH CARE INC
AVAGARD, ALCOHOL (OTC)

DURAPREP, IODINE POVACRYLEX (OTC)

* 3M PHARMACEUTICALS INC
PROVENTIL-HFA, ALBUTEROL SULFATE
ABBOTT
* ABBOTT LABORATORIES
ADVICOR, LOVASTATIN
AKINETON, BIPERIDEN HYDROCHLORIDE
AZMACORT, TRIAMCINOLONE ACETONIDE
BIAXIN XL, CLARITHROMYCIN
BIAXIN, CLARITHROMYCIN
DEPAKOTE ER, DIVALPROEX SODIUM
DEPAKOTE, DIVALPROEX SODIUM
KALETRA, LOPINAVIR
NIASPAN, NIACIN
NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE
NIMBEX, CISATRACURIUM BESYLATE
NORVIR, RITONAVIR
OMNICEF, CEFDINIR
SIMCOR, NIACIN
SYNTHROID, LEVOTHYROXINE SODIUM
TEVETEN HCT, EPROSARTAN MESYLATE
TEVETEN, EPROSARTAN MESYLATE
ULTANE, SEVOFLURANE

ZEMPLAR, PARICALCITOL

* ABBOTT LABORATORIES HOSP PRODUCTS DIV


CALCIJEX, CALCITRIOL
* ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
BIAXIN, CLARITHROMYCIN
DEPACON, VALPROATE SODIUM
DEPAKENE, VALPROIC ACID
DEPAKOTE, DIVALPROEX SODIUM
E.E.S., ERYTHROMYCIN ETHYLSUCCINATE
ENDURON, METHYCLOTHIAZIDE
ERYPED, ERYTHROMYCIN ETHYLSUCCINATE
HYTRIN, TERAZOSIN HYDROCHLORIDE
K-TAB, POTASSIUM CHLORIDE
MAVIK, TRANDOLAPRIL
MERIDIA, SIBUTRAMINE HYDROCHLORIDE
NORVIR, RITONAVIR
ORETIC, HYDROCHLOROTHIAZIDE
PCE, ERYTHROMYCIN
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
TARKA, TRANDOLAPRIL
TRICOR, FENOFIBRATE
TRIDIONE, TRIMETHADIONE
VICOPROFEN, HYDROCODONE BITARTRATE

ZEMPLAR, PARICALCITOL

ABBOTT LABS
* ABBOTT ENDOCRINE INC SUB ABBOTT LABORATORIES
LUPRON DEPOT, LEUPROLIDE ACETATE
LUPRON DEPOT-3, LEUPROLIDE ACETATE
LUPRON DEPOT-4, LEUPROLIDE ACETATE
LUPRON DEPOT-PED, LEUPROLIDE ACETATE

LUPRON, LEUPROLIDE ACETATE


* ABBOTT LABORATORIES
TRILIPIX, CHOLINE FENOFIBRATE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 2

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
ABRAXIS BIOSCIENCE
* ABRAXIS BIOSCIENCE LLC
ABRAXANE, PACLITAXEL
ABRAXIS PHARM
* ABRAXIS PHARMACEUTICAL PRODUCTS
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

ACADEMIC PHARMS
* ACADEMIC PHARMACEUTICALS INC
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
ACORDA
* ACORDA THERAPEUTICS INC
ZANAFLEX, TIZANIDINE HYDROCHLORIDE
ACTAVIS ELIZABETH
* ACTAVIS ELIZABETH LLC
KADIAN, MORPHINE SULFATE
ACTAVIS MID ATLANTIC
* ACTAVIS MID ATLANTIC LLC
ACETAMINOPHEN, ACETAMINOPHEN (OTC)
INFANTS' FEVERALL, ACETAMINOPHEN (OTC)

SULFATRIM PEDIATRIC, SULFAMETHOXAZOLE

ACTAVIS TOTOWA
* ACTAVIS TOTOWA LLC
RIMACTANE, RIFAMPIN
ACTELION
* ACTELION LTD
EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM

TRACLEER, BOSENTAN

ACTELION PHARMS LTD


* ACTELION PHARMACEUTICALS LTD
VENTAVIS, ILOPROST

ZAVESCA, MIGLUSTAT

ADOLOR
* ADOLOR CORP
ENTEREG, ALVIMOPAN
AGOURON
* AGOURON PHARMACEUTICALS INC
VIRACEPT, NELFINAVIR MESYLATE
AKORN
* AKORN INC
AK-FLUOR 10%, FLUORESCEIN SODIUM
AK-FLUOR 25%, FLUORESCEIN SODIUM
AKTEN, LIDOCAINE HYDROCHLORIDE
ALFENTA, ALFENTANIL HYDROCHLORIDE
BAL, DIMERCAPROL
CAPASTAT SULFATE, CAPREOMYCIN SULFATE
ENDOSOL EXTRA, CALCIUM CHLORIDE
IC-GREEN, INDOCYANINE GREEN
PAREMYD, HYDROXYAMPHETAMINE HYDROBROMIDE
SUBLIMAZE PRESERVATIVE FREE, FENTANYL CITRATE

SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE

AKORN INC
* AKORN INC
INAPSINE, DROPERIDOL
AKRIMAX PHARMS
* AKRIMAX PHARMACEUTICALS LLC
INDERAL LA, PROPRANOLOL HYDROCHLORIDE

INDERAL, PROPRANOLOL HYDROCHLORIDE

30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 3

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* AKRIMAX PHARMACEUTICALS LLC
INDERIDE-40/25, HYDROCHLOROTHIAZIDE
LO/OVRAL-28, ETHINYL ESTRADIOL

NITROMIST, NITROGLYCERIN

ALARA PHARM
* ALARA PHARMACEUTICAL CORPORATION
LEVO-T, LEVOTHYROXINE SODIUM
ALAVEN PHARM
* ALAVEN PHARMACEUTICAL LLC
ANADROL-50, OXYMETHOLONE
COLYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350
COLYTE, POLYETHYLENE GLYCOL 3350
COLYTE-FLAVORED, POLYETHYLENE GLYCOL 3350
REGLAN, METOCLOPRAMIDE HYDROCHLORIDE
ROWASA, MESALAMINE

SFROWASA, MESALAMINE

ALCON
* ALCON INC
AZOPT, BRINZOLAMIDE
CILOXAN, CIPROFLOXACIN HYDROCHLORIDE
CIPRO HC, CIPROFLOXACIN HYDROCHLORIDE
CIPRODEX, CIPROFLOXACIN
FLUORESCITE, FLUORESCEIN SODIUM
NAVSTEL, CALCIUM CHLORIDE
NEVANAC, NEPAFENAC
PATADAY, OLOPATADINE HYDROCHLORIDE
PATANASE, OLOPATADINE HYDROCHLORIDE
TOBRADEX ST, DEXAMETHASONE
TRAVATAN Z, TRAVOPROST
TRAVATAN, TRAVOPROST
TRIESENCE, TRIAMCINOLONE ACETONIDE

VIGAMOX, MOXIFLOXACIN HYDROCHLORIDE


* ALCON LABORATORIES INC


ALOMIDE, LODOXAMIDE TROMETHAMINE
BETADINE, POVIDONE-IODINE
BETOPTIC S, BETAXOLOL HYDROCHLORIDE
BETOPTIC, BETAXOLOL HYDROCHLORIDE
BSS PLUS, CALCIUM CHLORIDE
BSS, CALCIUM CHLORIDE
DENDRID, IDOXURIDINE
EMADINE, EMEDASTINE DIFUMARATE
FLAREX, FLUOROMETHOLONE ACETATE
IOPIDINE, APRACLONIDINE HYDROCHLORIDE
MAXIDEX, DEXAMETHASONE
MIOSTAT, CARBACHOL
NAPHCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)
NATACYN, NATAMYCIN
OMNIPRED, PREDNISOLONE ACETATE
PATANOL, OLOPATADINE HYDROCHLORIDE
PILOPINE HS, PILOCARPINE HYDROCHLORIDE
TOBRADEX, DEXAMETHASONE
TOBREX, TOBRAMYCIN

VEXOL, RIMEXOLONE

ALCON RES
* ALCON RESEARCH LTD
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE
ALKERMES
* ALKERMES INC
VIVITROL, NALTREXONE
ALLEGIANCE HLTHCARE
* ALLEGIANCE HEALTHCARE CORP
POVIDONE IODINE, POVIDONE-IODINE (OTC)
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 4

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** A **
ALLERGAN
* ALLERGAN
ACULAR LS, KETOROLAC TROMETHAMINE

ALPHAGAN P, BRIMONIDINE TARTRATE


* ALLERGAN INC
ACULAR PRESERVATIVE FREE, KETOROLAC TROMETHAMINE
ACULAR, KETOROLAC TROMETHAMINE
ACUVAIL, KETOROLAC TROMETHAMINE
ACZONE, DAPSONE
ALOCRIL, NEDOCROMIL SODIUM
ALPHAGAN P, BRIMONIDINE TARTRATE
AVAGE, TAZAROTENE
AZELEX, AZELAIC ACID
COMBIGAN, BRIMONIDINE TARTRATE
ELESTAT, EPINASTINE HYDROCHLORIDE
ELIMITE, PERMETHRIN
LATISSE, BIMATOPROST
LUMIGAN, BIMATOPROST
OCUFLOX, OFLOXACIN
OPTICROM, CROMOLYN SODIUM
OZURDEX, DEXAMETHASONE
POLYTRIM, POLYMYXIN B SULFATE
RESTASIS, CYCLOSPORINE
SANCTURA XR, TROSPIUM CHLORIDE
SANCTURA, TROSPIUM CHLORIDE
TAZORAC, TAZAROTENE
TRIVARIS, TRIAMCINOLONE ACETONIDE

ZYMAR, GATIFLOXACIN

* ALLERGAN PHARMACEUTICAL
BETAGAN, LEVOBUNOLOL HYDROCHLORIDE
BLEPHAMIDE, PREDNISOLONE ACETATE
FML FORTE, FLUOROMETHOLONE
FML, FLUOROMETHOLONE
HERPLEX, IDOXURIDINE
OCUFEN, FLURBIPROFEN SODIUM
OPHTHETIC, PROPARACAINE HYDROCHLORIDE
POLY-PRED, NEOMYCIN SULFATE
PRED FORTE, PREDNISOLONE ACETATE
PRED MILD, PREDNISOLONE ACETATE
PRED-G, GENTAMICIN SULFATE

PROPINE, DIPIVEFRIN HYDROCHLORIDE


ALLERGAN HERBERT
* ALLERGAN HERBERT SKIN CARE DIV ALLERGAN INC
FLUOROPLEX, FLUOROURACIL
ALLOS
* ALLOS THERAPEUTICS INC
FOLOTYN, PRALATREXATE
ALPHARMA KING
* ALPHARMA PHARMACEUTICALS LLC KING PHARMACEUTICALS
EMBEDA, MORPHINE SULFATE
ALTANA
* ALTANA INC
CUTIVATE, FLUTICASONE PROPIONATE
OXISTAT, OXICONAZOLE NITRATE
TEMOVATE E, CLOBETASOL PROPIONATE
TEMOVATE, CLOBETASOL PROPIONATE

TERCONAZOLE, TERCONAZOLE

ALTERNA TCHP LLC


* ALTERNA TCHP LLC
CHILDREN'S ELIXSURE, IBUPROFEN (OTC)
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 5

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** A **
ALZA
* ALZA CORP
SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)
AMAG PHARMS INC
* AMAG PHARMACEUTICALS INC
FERAHEME, FERUMOXYTOL
FERIDEX I.V., FERUMOXIDES

GASTROMARK, FERUMOXSIL

AMGEN
* AMGEN INC
SENSIPAR, CINACALCET HYDROCHLORIDE
AMPHASTAR
* AMPHASTAR PHARMACEUTICALS INC
CORTROSYN, COSYNTROPIN
AMPHASTAR PHARM
* AMPHASTAR PHARMACEUTICAL INC
AMPHADASE, HYALURONIDASE
AMYLIN
* AMYLIN PHARMACEUTICALS INC
BYETTA, EXENATIDE SYNTHETIC

SYMLIN, PRAMLINTIDE ACETATE


ANBEX
* ANBEX INC
IOSAT, POTASSIUM IODIDE (OTC)
ANDRX LABS LLC
* ANDRX LABS LLC
ALTOPREV, LOVASTATIN

FORTAMET, METFORMIN HYDROCHLORIDE


ANESTA AG
* ANESTA AG
AMRIX, CYCLOBENZAPRINE HYDROCHLORIDE
ANI PHARMS
* ANI PHARMACEUTICALS INC
CORTENEMA, HYDROCORTISONE
APOTHECON
* APOTHECON INC DIV BRISTOL MYERS SQUIBB
CAPOZIDE 25/15, CAPTOPRIL
CAPOZIDE 25/25, CAPTOPRIL
CAPOZIDE 50/15, CAPTOPRIL
CAPOZIDE 50/25, CAPTOPRIL
KENALOG, TRIAMCINOLONE ACETONIDE
KENALOG-10, TRIAMCINOLONE ACETONIDE
KENALOG-40, TRIAMCINOLONE ACETONIDE
KLOTRIX, POTASSIUM CHLORIDE
OPHTHAINE, PROPARACAINE HYDROCHLORIDE
STADOL PRESERVATIVE FREE, BUTORPHANOL TARTRATE

STADOL, BUTORPHANOL TARTRATE


APP PHARMS
* APP PHARMACEUTICALS LLC
CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC
DIPRIVAN, PROPOFOL
EMLA, LIDOCAINE
FUROSEMIDE, FUROSEMIDE
HEPARIN SODIUM IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
HEPARIN SODIUM, HEPARIN SODIUM
NAROPIN, ROPIVACAINE HYDROCHLORIDE MONOHYDRATE
NEBUPENT, PENTAMIDINE ISETHIONATE

NESACAINE, CHLOROPROCAINE HYDROCHLORIDE


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 6

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** A **
* APP PHARMACEUTICALS LLC
NESACAINE-MPF, CHLOROPROCAINE HYDROCHLORIDE
OXYTOCIN, OXYTOCIN
PENTAM, PENTAMIDINE ISETHIONATE
SENSORCAINE, BUPIVACAINE HYDROCHLORIDE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
XYLOCAINE 4% PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
XYLOCAINE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
XYLOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE
XYLOCAINE W/ EPINEPHRINE, EPINEPHRINE

XYLOCAINE, LIDOCAINE HYDROCHLORIDE

AR HOLDING CO INC
* AR HOLDING CO INC
COLCRYS, COLCHICINE
FIBRICOR, FENOFIBRIC ACID

QUALAQUIN, QUININE SULFATE

ASCEND
* ASCEND THERAPEUTICS INC
ESTROGEL, ESTRADIOL
ASTELLAS
* ASTELLAS PHARMA US INC
ADENOCARD, ADENOSINE
ADENOSCAN, ADENOSINE
AMBISOME, AMPHOTERICIN B
LEXISCAN, REGADENOSON
MYCAMINE, MICAFUNGIN SODIUM
PROGRAF, TACROLIMUS
PROTOPIC, TACROLIMUS
VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, CONIVAPTAN HYDROCHLORIDE
VESICARE, SOLIFENACIN SUCCINATE
ASTRAZENECA
* ASTRAZENECA LP
ENTOCORT EC, BUDESONIDE
FOSCAVIR, FOSCARNET SODIUM
NEXIUM IV, ESOMEPRAZOLE SODIUM
NEXIUM, ESOMEPRAZOLE MAGNESIUM
PRILOSEC OTC, OMEPRAZOLE MAGNESIUM (OTC)
PRILOSEC, OMEPRAZOLE
PRILOSEC, OMEPRAZOLE MAGNESIUM
PULMICORT FLEXHALER, BUDESONIDE
PULMICORT RESPULES, BUDESONIDE
RHINOCORT, BUDESONIDE
SEROQUEL, QUETIAPINE FUMARATE
SYMBICORT, BUDESONIDE
TENORMIN, ATENOLOL

TOPROL-XL, METOPROLOL SUCCINATE

* ASTRAZENECA PHARMACEUTICALS LP
ATACAND HCT, CANDESARTAN CILEXETIL
ATACAND, CANDESARTAN CILEXETIL
FASLODEX, FULVESTRANT
LEXXEL, ENALAPRIL MALEATE
PULMICORT, BUDESONIDE
SEROQUEL XR, QUETIAPINE FUMARATE
TENORETIC 100, ATENOLOL
TENORETIC 50, ATENOLOL
ZOMIG, ZOLMITRIPTAN

ZOMIG-ZMT, ZOLMITRIPTAN

* ASTRAZENECA UK LTD
ACCOLATE, ZAFIRLUKAST
ARIMIDEX, ANASTROZOLE
CASODEX, BICALUTAMIDE
IRESSA, GEFITINIB

MERREM I.V., MEROPENEM

30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 7

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** A **
* ASTRAZENECA UK LTD
ZESTORETIC, HYDROCHLOROTHIAZIDE
ZESTRIL, LISINOPRIL

ZOLADEX, GOSERELIN ACETATE


ATON
* ATON PHARMA INC
CUPRIMINE, PENICILLAMINE
DEMSER, METYROSINE
EDECRIN, ETHACRYNATE SODIUM
EDECRIN, ETHACRYNIC ACID
LACRISERT, HYDROXYPROPYL CELLULOSE
MEPHYTON, PHYTONADIONE
SYPRINE, TRIENTINE HYDROCHLORIDE
TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE
TIMOPTIC, TIMOLOL MALEATE

TIMOPTIC-XE, TIMOLOL MALEATE


AUXILIUM PHARMS
* AUXILIUM PHARMACEUTICALS
TESTIM, TESTOSTERONE
AXCAN
* AXCAN PHARMA US INC
BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE
BENTYL, DICYCLOMINE HYDROCHLORIDE
CARAFATE, SUCRALFATE
PHOTOFRIN, PORFIMER SODIUM
URSO 250, URSODIOL

URSO FORTE, URSODIOL


AXCAN SCANDIPHARM
* AXCAN SCANDIPHARM INC
CANASA, MESALAMINE

PYLERA, BISMUTH SUBCITRATE POTASSIUM


AZUR PHARMA
* AZUR PHARMA INTERNATIONAL LTD
AVC, SULFANILAMIDE

GASTROCROM, CROMOLYN SODIUM


AZUR PHARMA II
* AZUR PHARMA INTERNATIONAL II LTD
ELESTRIN, ESTRADIOL
AZUR PHARMA INTL
* AZUR PHARMA INTERNATIONAL III LTD
FAZACLO ODT, CLOZAPINE
B BRAUN
* B BRAUN MEDICAL INC
ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL
ALCOHOL 10% AND DEXTROSE 5%, ALCOHOL
ALCOHOL 5% AND DEXTROSE 5%, ALCOHOL
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER, BRETYLIUM TOSYLATE
CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, CEFUROXIME SODIUM
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 8

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** B **
* B BRAUN MEDICAL INC
DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%, DOPAMINE HYDROCHLORIDE
FREAMINE HBC 6.9%, AMINO ACIDS
FREAMINE III 10%, AMINO ACIDS
FREAMINE III 3% W/ ELECTROLYTES, AMINO ACIDS
FREAMINE III 8.5% W/ ELECTROLYTES, AMINO ACIDS
FREAMINE III 8.5%, AMINO ACIDS
GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPATAMINE 8%, AMINO ACIDS
ISOLYTE E IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ISOLYTE E IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE S IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
ISOLYTE S PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
HYDROCHLORIDE
MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER, MANNITOL
MANNITOL 10%, MANNITOL
MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%, MANNITOL
MANNITOL 15%, MANNITOL
MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 20%, MANNITOL
MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%, MANNITOL
MANNITOL 5%, MANNITOL
METRO I.V. IN PLASTIC CONTAINER, METRONIDAZOLE
NEPHRAMINE 5.4%, AMINO ACIDS
NUTRILIPID 10%, SOYBEAN OIL
NUTRILIPID 20%, SOYBEAN OIL
PHYSIOLYTE IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

CONTAINER, DEXTROSE

30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 9

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** B **
* B BRAUN MEDICAL INC
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC

CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 10

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** B **
* B BRAUN MEDICAL INC
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE


POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
PROCALAMINE, AMINO ACIDS
RESECTISOL IN PLASTIC CONTAINER, MANNITOL
RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE
SORBITOL 3.3% IN PLASTIC CONTAINER, SORBITOL
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, WATER FOR INJECTION, STERILE
STERILE WATER IN PLASTIC CONTAINER, WATER FOR IRRIGATION, STERILE
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
TROPHAMINE 10%, AMINO ACIDS
TROPHAMINE, AMINO ACIDS
BALLARD MEDCL
* BALLARD MEDICAL PRODUCTS INC
PYTEST KIT, UREA, C-14

PYTEST, UREA, C-14


BANNER PHARMACAPS
* BANNER PHARMACAPS INC
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
MIDOL LIQUID GELS, IBUPROFEN (OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

STAVZOR, VALPROIC ACID


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 11

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** B **
BAUSCH AND LOMB
* BAUSCH AND LOMB INC
ALAWAY, KETOTIFEN FUMARATE (OTC)
ALREX, LOTEPREDNOL ETABONATE
BESIVANCE, BESIFLOXACIN HYDROCHLORIDE
LOTEMAX, LOTEPREDNOL ETABONATE
OPCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)
RETISERT, FLUOCINOLONE ACETONIDE
VITRASERT, GANCICLOVIR

ZYLET, LOTEPREDNOL ETABONATE


* BAUSCH AND LOMB PHARMACEUTICALS INC


OPTIPRANOLOL, METIPRANOLOL HYDROCHLORIDE
BAXTER HLTHCARE
* BAXTER HEALTHCARE CORP
ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER, GLYCINE
BACTOCILL IN PLASTIC CONTAINER, OXACILLIN SODIUM
BRANCHAMIN 4% IN PLASTIC CONTAINER, AMINO ACIDS
CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX E 2.75/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC
CONTAINER, AMINO ACIDS
CLINIMIX E 2.75/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC
CONTAINER, AMINO ACIDS
CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,
AMINO ACIDS
CLINIMIX E 4.25/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC
CONTAINER, AMINO ACIDS
CLINIMIX E 4.25/20 SULFITE-FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC
CONTAINER, AMINO ACIDS
CLINIMIX E 4.25/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC
CONTAINER, AMINO ACIDS
CLINIMIX E 4.25/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,
AMINO ACIDS
CLINIMIX E 5/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER,
AMINO ACIDS
CLINIMIX E 5/15 SULFITE-FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER,
AMINO ACIDS
CLINIMIX E 5/20 SULFITE-FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER,
AMINO ACIDS
CLINIMIX E 5/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER,
AMINO ACIDS
CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER,
AMINO ACIDS
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND ELECTROLYTE NO 75 IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 12

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** B **
* BAXTER HEALTHCARE CORP
DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER,

DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER,

DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER,

DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER,

DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER,

DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER,

DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC

CONTAINER, DEXTROSE

DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 60% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE

DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE

EXTRANEAL, ICODEXTRIN

FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE

HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPATASOL 8%, AMINO ACIDS

IFEX/MESNEX KIT, IFOSFAMIDE

LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

HYDROCHLORIDE

LYOPHILIZED CYTOXAN, CYCLOPHOSPHAMIDE


MESNEX, MESNA

NALLPEN IN PLASTIC CONTAINER, NAFCILLIN SODIUM


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 13

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** B **
* BAXTER HEALTHCARE CORP
NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN
ONDANSETRON HYDROCHLORIDE AND SODIUM CHLORIDE IN PLASTIC CONTAINER, ONDANSETRON
HYDROCHLORIDE
OSMITROL 10% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 10% IN WATER, MANNITOL
OSMITROL 15% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 15% IN WATER, MANNITOL
OSMITROL 20% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 20% IN WATER, MANNITOL
OSMITROL 5% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 5% IN WATER, MANNITOL
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER, PENICILLIN G POTASSIUM
PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
PLASMA-LYTE 56 IN PLASTIC CONTAINER, MAGNESIUM ACETATE TETRAHYDRATE
PLASMA-LYTE A IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PLASMA-LYTE R IN PLASTIC CONTAINER, CALCIUM CHLORIDE
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM
CHLORIDE
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
CALCIUM CHLORIDE
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
CALCIUM CHLORIDE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
CALCIUM CHLORIDE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
CALCIUM CHLORIDE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
CALCIUM CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
CALCIUM CHLORIDE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE

RENAMIN W/O ELECTROLYTES, AMINO ACIDS


RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE


SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE


SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE


SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER, SODIUM CHLORIDE


SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 14

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** B **
* BAXTER HEALTHCARE CORP
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE
SORBITOL 3% IN PLASTIC CONTAINER, SORBITOL
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, WATER FOR INJECTION, STERILE
STERILE WATER IN PLASTIC CONTAINER, WATER FOR IRRIGATION, STERILE
STERILE WATER, WATER FOR IRRIGATION, STERILE
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
TIS-U-SOL IN PLASTIC CONTAINER, MAGNESIUM SULFATE
TIS-U-SOL, MAGNESIUM SULFATE
TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 10% W/O ELECTROLYTES, AMINO ACIDS
TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 3.5% W/ ELECTROLYTES, AMINO ACIDS
TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 5.5% W/ ELECTROLYTES, AMINO ACIDS
TRAVASOL 5.5% W/O ELECTROLYTES, AMINO ACIDS
TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 8.5% W/ ELECTROLYTES, AMINO ACIDS
TRAVASOL 8.5% W/O ELECTROLYTES, AMINO ACIDS

VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE

* BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE


DOPRAM, DOXAPRAM HYDROCHLORIDE
DURAMORPH PF, MORPHINE SULFATE
FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE
HEPARIN SODIUM, HEPARIN SODIUM
INFUMORPH, MORPHINE SULFATE

ROBINUL, GLYCOPYRROLATE

* BAXTER HEALTHCARE INTERNATI0NAL SPECIALTY THERAPIES DIV


PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS
BAXTER HLTHCARE CORP
* BAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE
ATIVAN, LORAZEPAM
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE
BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE
BREVIBLOC, ESMOLOL HYDROCHLORIDE
ETHRANE, ENFLURANE
FORANE, ISOFLURANE
OXYTOCIN, OXYTOCIN
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
PROTOPAM CHLORIDE, PRALIDOXIME CHLORIDE
REGLAN, METOCLOPRAMIDE HYDROCHLORIDE
ROBAXIN, METHOCARBAMOL

SUPRANE, DESFLURANE

BAYER
* BAYER HEALTHCARE LLC
ALEVE, NAPROXEN SODIUM (OTC)
ALEVE-D SINUS & COLD, NAPROXEN SODIUM (OTC)

FEMSTAT 3, BUTOCONAZOLE NITRATE (OTC)

BAYER HLTHCARE
* BAYER HEALTHCARE PHARMACEUTICALS INC
ADALAT CC, NIFEDIPINE
ANGELIQ, DROSPIRENONE
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, MOXIFLOXACIN HYDROCHLORIDE
AVELOX, MOXIFLOXACIN HYDROCHLORIDE
BETAPACE AF, SOTALOL HYDROCHLORIDE
BETAPACE, SOTALOL HYDROCHLORIDE
BILTRICIDE, PRAZIQUANTEL
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPRO XR, CIPROFLOXACIN

CIPRO, CIPROFLOXACIN

30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 15

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** B **
* BAYER HEALTHCARE PHARMACEUTICALS INC
CIPRO, CIPROFLOXACIN HYDROCHLORIDE
CLIMARA PRO, ESTRADIOL
CLIMARA, ESTRADIOL
DTIC-DOME, DACARBAZINE
EOVIST, GADOXETATE DISODIUM
LEVITRA, VARDENAFIL HYDROCHLORIDE
MAGNEVIST, GADOPENTETATE DIMEGLUMINE
MENOSTAR, ESTRADIOL
MIRENA, LEVONORGESTREL
MYCELEX, CLOTRIMAZOLE
NEXAVAR, SORAFENIB TOSYLATE
PRECOSE, ACARBOSE
REFLUDAN, LEPIRUDIN RECOMBINANT
TRASYLOL, APROTININ
ULTRAVIST (PHARMACY BULK), IOPROMIDE
ULTRAVIST 150, IOPROMIDE
ULTRAVIST 240, IOPROMIDE
ULTRAVIST 300 IN PLASTIC CONTAINER, IOPROMIDE
ULTRAVIST 300, IOPROMIDE
ULTRAVIST 370, IOPROMIDE
YASMIN, DROSPIRENONE

YAZ, DROSPIRENONE

BAYER PHARMS
* BAYER PHARMACEUTICALS CORP
MYCELEX-7 COMBINATION PACK, CLOTRIMAZOLE (OTC)

MYCELEX-7, CLOTRIMAZOLE (OTC)


BEAUFOUR IPSEN
* BEAUFOUR IPSEN PHARMA
SOMATULINE DEPOT, LANREOTIDE ACETATE
BECTON DICKINSON
* BECTON DICKINSON AND CO
E-Z SCRUB 201, POVIDONE-IODINE (OTC)

E-Z SCRUB 241, POVIDONE-IODINE (OTC)


BEDFORD
* BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM


BIOMARIN PHARM
* BIOMARIN PHARMACEUTICAL INC
KUVAN, SAPROPTERIN DIHYDROCHLORIDE
BIONICHE PHARMA
* BIONICHE PHARMA USA LLC
ALOPRIM, ALLOPURINOL SODIUM
ENLON-PLUS, ATROPINE SULFATE

RIMSO-50, DIMETHYL SULFOXIDE


BIONICHE TEORANTA
* BIONICHE TEORANTA
ULTIVA, REMIFENTANIL HYDROCHLORIDE
BIOVAIL
* BIOVAIL CORP INTERNATIONAL
TIAZAC, DILTIAZEM HYDROCHLORIDE
* BIOVAIL LABORATORIES INC
ATIVAN, LORAZEPAM
CARDIZEM CD, DILTIAZEM HYDROCHLORIDE

ISORDIL, ISOSORBIDE DINITRATE


BIOVAIL AMERICAS
* BIOVAIL AMERICAS CORP
XENAZINE, TETRABENAZINE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 16

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** B **
BIOVAIL LABS INTL
* BIOVAIL LABORATORIES INTERNATIONAL SRL
APLENZIN, BUPROPION HYDROBROMIDE
CARDIZEM LA, DILTIAZEM HYDROCHLORIDE
CARDIZEM, DILTIAZEM HYDROCHLORIDE
ULTRAM ER, TRAMADOL HYDROCHLORIDE
VASERETIC, ENALAPRIL MALEATE
VASOTEC, ENALAPRIL MALEATE

WELLBUTRIN XL, BUPROPION HYDROCHLORIDE


BLAIREX
* BLAIREX LABORATORIES INC
BRONCHO SALINE, SODIUM CHLORIDE (OTC)
BOEHRINGER INGELHEIM
* BOEHRINGER INGELHEIM
CATAPRES, CLONIDINE HYDROCHLORIDE
CATAPRES-TTS-1, CLONIDINE
CATAPRES-TTS-2, CLONIDINE
CATAPRES-TTS-3, CLONIDINE
MICARDIS HCT, HYDROCHLOROTHIAZIDE
MICARDIS, TELMISARTAN
MIRAPEX, PRAMIPEXOLE DIHYDROCHLORIDE
ZANTAC 150, RANITIDINE HYDROCHLORIDE (OTC)

ZANTAC 75, RANITIDINE HYDROCHLORIDE (OTC)

* BOEHRINGER INGELHEIM PHARMACEUTICALS INC


AGGRENOX, ASPIRIN
APTIVUS, TIPRANAVIR
ATROVENT HFA, IPRATROPIUM BROMIDE
ATROVENT, IPRATROPIUM BROMIDE
COMBIVENT, ALBUTEROL SULFATE
FLOMAX, TAMSULOSIN HYDROCHLORIDE
MOBIC, MELOXICAM
PERSANTINE, DIPYRIDAMOLE
SPIRIVA, TIOTROPIUM BROMIDE MONOHYDRATE
TWYNSTA, AMLODIPINE BESYLATE

VIRAMUNE, NEVIRAPINE

BRACCO
* BRACCO DIAGNOSTICS INC
CARDIOGEN-82, RUBIDIUM CHLORIDE RB-82
CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT
CHOLOGRAFIN MEGLUMINE, IODIPAMIDE MEGLUMINE
CHROMITOPE SODIUM, SODIUM CHROMATE CR-51
CYSTOGRAFIN DILUTE, DIATRIZOATE MEGLUMINE
CYSTOGRAFIN, DIATRIZOATE MEGLUMINE
GASTROGRAFIN, DIATRIZOATE MEGLUMINE
ISOVUE-200, IOPAMIDOL
ISOVUE-250, IOPAMIDOL
ISOVUE-300, IOPAMIDOL
ISOVUE-370, IOPAMIDOL
ISOVUE-M 200, IOPAMIDOL
ISOVUE-M 300, IOPAMIDOL
KINEVAC, SINCALIDE
MDP-BRACCO, TECHNETIUM TC-99M MEDRONATE KIT
MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE
MULTIHANCE, GADOBENATE DIMEGLUMINE
PROHANCE MULTIPACK, GADOTERIDOL
PROHANCE, GADOTERIDOL
RENOGRAFIN-76, DIATRIZOATE MEGLUMINE

SINOGRAFIN, DIATRIZOATE MEGLUMINE


BRAINTREE
* BRAINTREE LABORATORIES INC
AXID, NIZATIDINE

GOLYTELY, POLYETHYLENE GLYCOL 3350


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 17

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** B **
* BRAINTREE LABORATORIES INC
HALFLYTELY, BISACODYL
NULYTELY, POLYETHYLENE GLYCOL 3350

NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350


BRISTOL
* BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
BICNU, CARMUSTINE
BRISTOL MYERS
* BRISTOL MYERS CO
PLATINOL, CISPLATIN
PLATINOL-AQ, CISPLATIN
QUESTRAN LIGHT, CHOLESTYRAMINE

QUESTRAN, CHOLESTYRAMINE

BRISTOL MYERS SQUIBB


* BRISTOL MYERS SQUIBB
AZACTAM, AZTREONAM
BARACLUDE, ENTECAVIR
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
GLUCOVANCE, GLYBURIDE
LYSODREN, MITOTANE
MEGACE, MEGESTROL ACETATE

PRAVACHOL, PRAVASTATIN SODIUM


* BRISTOL MYERS SQUIBB CO


AZACTAM IN PLASTIC CONTAINER, AZTREONAM
CEENU, LOMUSTINE
DROXIA, HYDROXYUREA
GLUCOPHAGE XR, METFORMIN HYDROCHLORIDE
HYDREA, HYDROXYUREA
IXEMPRA KIT, IXABEPILONE
METAGLIP, GLIPIZIDE
ONGLYZA, SAXAGLIPTIN HYDROCHLORIDE
PARAPLATIN, CARBOPLATIN
REYATAZ, ATAZANAVIR SULFATE
SPRYCEL, DASATINIB
SUSTIVA, EFAVIRENZ
VEPESID, ETOPOSIDE

VIDEX EC, DIDANOSINE


* BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE


BLENOXANE, BLEOMYCIN SULFATE
BUSPAR, BUSPIRONE HYDROCHLORIDE
CEFZIL, CEFPROZIL
ETOPOPHOS PRESERVATIVE FREE, ETOPOSIDE PHOSPHATE
GLUCOPHAGE, METFORMIN HYDROCHLORIDE
MAXIPIME, CEFEPIME HYDROCHLORIDE
MONOPRIL, FOSINOPRIL SODIUM
TAXOL, PACLITAXEL
VIDEX, DIDANOSINE
VUMON, TENIPOSIDE

ZERIT, STAVUDINE

* BRISTOL MYERS SQUIBB PHARMA CO


COUMADIN, WARFARIN SODIUM
LODOSYN, CARBIDOPA
SINEMET CR, CARBIDOPA
SINEMET, CARBIDOPA

SUSTIVA, EFAVIRENZ

BRYAN
* BRYAN CORP
SCLEROSOL, TALC

TALC, TALC

30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 18

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **
CANYON
* CANYON PHARMACEUTICALS INC
IPRIVASK, DESIRUDIN RECOMBINANT
CARACO
* CARACO PHARMACEUTICAL LABORATORIES LTD
FLUMADINE, RIMANTADINE HYDROCHLORIDE

SYNALGOS-DC, ASPIRIN

CELGENE
* CELGENE CORP
INNOHEP, TINZAPARIN SODIUM
REVLIMID, LENALIDOMIDE
THALOMID, THALIDOMIDE

VIDAZA, AZACITIDINE

CENTOCOR ORTHO
* CENTOCOR ORTHO BIOTECH INC
PREZISTA, DARUNAVIR ETHANOLATE
CEPHALON
* CEPHALON INC
ACTIQ, FENTANYL CITRATE
FENTORA, FENTANYL CITRATE
GABITRIL, TIAGABINE HYDROCHLORIDE
NUVIGIL, ARMODAFINIL
PROVIGIL, MODAFINIL
TREANDA, BENDAMUSTINE HYDROCHLORIDE

TRISENOX, ARSENIC TRIOXIDE


CHATTEM
* CHATTEM INC
SELSUN, SELENIUM SULFIDE

UNISOM, DOXYLAMINE SUCCINATE (OTC)


CHIRHOCLIN
* CHIRHOCLIN INC
CHIRHOSTIM, SECRETIN SYNTHETIC HUMAN
CIPHER PHARMS INC
* CIPHER PHARMACEUTICALS INC
LIPOFEN, FENOFIBRATE
COLGATE PALMOLIVE
* COLGATE PALMOLIVE
COLGATE TOTAL, SODIUM FLUORIDE (OTC)
COLUMBIA LABS
* COLUMBIA LABORATORIES INC
CRINONE, PROGESTERONE

STRIANT, TESTOSTERONE

CONNECTICS
* CONNECTICS CORP
LUXIQ, BETAMETHASONE VALERATE
CONNETICS
* CONNETICS CORP
OLUX, CLOBETASOL PROPIONATE
CONTROLLED THERAP
* CONTROLLED THERAPEUTICS (SCOTLAND) LTD
CERVIDIL, DINOPROSTONE
CORNERSTONE
* CORNERSTONE BIOPHARMA INC
SPECTRACEF, CEFDITOREN PIVOXIL
CORNERSTONE THERAP
* CORNERSTONE THERAPEUTICS INC
CUROSURF, PORACTANT ALFA
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 19

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** C **
CP PHARMS
* CP PHARMACEUTICALS CV
LYRICA, PREGABALIN
CPPI CV
* CP PHARMACEUTICALS INTERNATIONAL CV
SUTENT, SUNITINIB MALATE
CRITICAL
* CRITICAL THERAPEUTICS INC
ZYFLO CR, ZILEUTON

ZYFLO, ZILEUTON

CSL BEHRING
* CSL BEHRING LLC
STIMATE, DESMOPRESSIN ACETATE
CUBIST
* CUBIST PHARMACEUTICALS INC
CUBICIN, DAPTOMYCIN
CUMBERLAND PHARMS
* CUMBERLAND PHARMACEUTICALS INC
ACETADOTE, ACETYLCYSTEINE

CALDOLOR, IBUPROFEN

CYPRESS BIOSCIENCE
* CYPRESS BIOSCIENCE INC
SAVELLA, MILNACIPRAN HYDROCHLORIDE
DAIICHI
* DAIICHI PHARMACEUTICAL CORP
FLOXIN OTIC, OFLOXACIN
DAIICHI SANKYO
* DAIICHI SANKYO INC
AZOR, AMLODIPINE BESYLATE
BENICAR HCT, HYDROCHLOROTHIAZIDE
BENICAR, OLMESARTAN MEDOXOMIL

WELCHOL, COLESEVELAM HYDROCHLORIDE


DAIICHI SANKYO CO
* DAIICHI SANKYO CO LTD
EVOXAC, CEVIMELINE HYDROCHLORIDE
DANCO LABS LLC
* DANCO LABORATORIES LLC
MIFEPREX, MIFEPRISTONE
DAVA PHARMS INC
* DAVA PHARMACEUTICALS INC
FUROSEMIDE, FUROSEMIDE
METHOTREXATE SODIUM, METHOTREXATE SODIUM

PROPYLTHIOURACIL, PROPYLTHIOURACIL

DAVIS AND GECK


* DAVIS AND GECK DIV AMERICAN CYANAMID CO
PRE-OP II, HEXACHLOROPHENE

PRE-OP, HEXACHLOROPHENE

DENTSPLY PHARM
* DENTSPLY PHARMACEUTICAL
CITANEST FORTE DENTAL, EPINEPHRINE BITARTRATE
CITANEST PLAIN DENTAL, PRILOCAINE HYDROCHLORIDE
ORAQIX, LIDOCAINE
XYLOCAINE DENTAL WITH EPINEPHRINE, EPINEPHRINE

XYLOCAINE DENTAL, LIDOCAINE HYDROCHLORIDE


DEPOMED INC
* DEPOMED INC
GLUMETZA, METFORMIN HYDROCHLORIDE

PROQUIN XR, CIPROFLOXACIN HYDROCHLORIDE


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 20

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** D **
DEPROCO
* DEPROCO INC
SEPTOCAINE, ARTICAINE HYDROCHLORIDE
DEXCEL PHARMA
* DEXCEL PHARMA TECHNOLOGIES LTD
OMEPRAZOLE, OMEPRAZOLE (OTC)

PERIOCHIP, CHLORHEXIDINE GLUCONATE


DEY
* DEY LP
ACCUNEB, ALBUTEROL SULFATE

DUONEB, ALBUTEROL SULFATE


DEY LP
* DEY LP
PERFOROMIST, FORMOTEROL FUMARATE
DIALYSIS SUPS
* DIALYSIS SUPPLIES INC
NORMOCARB HF 25, MAGNESIUM CHLORIDE

NORMOCARB HF 35, MAGNESIUM CHLORIDE


DORC
* DORC INTERNATIONAL BV
MEMBRANEBLUE, TRYPAN BLUE

VISIONBLUE, TRYPAN BLUE


DOW PHARM SCI


* DOW PHARMACEUTICAL SCIENCES
ACANYA, BENZOYL PEROXIDE
DOW PHARM SCIENCES
* DOW PHARMACEUTICAL SCIENCES INC
AKNE-MYCIN, ERYTHROMYCIN
ATRALIN, TRETINOIN

CLODERM, CLOCORTOLONE PIVALATE


DR REDDYS LA
* DR REDDYS LABORATORIES LOUISIANA LLC
SSD AF, SILVER SULFADIAZINE

SSD, SILVER SULFADIAZINE


DRAXIMAGE
* DRAXIMAGE INC
DRAXIMAGE MDP-10, TECHNETIUM TC-99M MEDRONATE KIT
DTPA, TECHNETIUM TC-99M PENTETATE KIT
HICON, SODIUM IODIDE, I-131
TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT
DURAMED
* DURAMED PHARMACEUTICALS INC
CENESTIN, ESTROGENS, CONJUGATED SYNTHETIC A
ENJUVIA, ESTROGENS, CONJUGATED SYNTHETIC B
LOSEASONIQUE, ETHINYL ESTRADIOL
MIRCETTE, DESOGESTREL
NORDETTE-28, ETHINYL ESTRADIOL
PLAN B ONE-STEP, LEVONORGESTREL
PLAN B ONE-STEP, LEVONORGESTREL (OTC)
PLAN B, LEVONORGESTREL
PLAN B, LEVONORGESTREL (OTC)

REVIA, NALTREXONE HYDROCHLORIDE


DURAMED PHARMS BARR


* DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
DIAMOX, ACETAZOLAMIDE
DIAMOX, ACETAZOLAMIDE SODIUM
ZEBETA, BISOPROLOL FUMARATE

ZIAC, BISOPROLOL FUMARATE


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 21

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** D **
DURAMED RES
* DURAMED RESEARCH INC
ADDERALL 10, AMPHETAMINE ASPARTATE
ADDERALL 12.5, AMPHETAMINE ASPARTATE
ADDERALL 15, AMPHETAMINE ASPARTATE
ADDERALL 20, AMPHETAMINE ASPARTATE
ADDERALL 30, AMPHETAMINE ASPARTATE
ADDERALL 5, AMPHETAMINE ASPARTATE
ADDERALL 7.5, AMPHETAMINE ASPARTATE
AYGESTIN, NORETHINDRONE ACETATE
PARAGARD T 380A, COPPER
PREFEST, ESTRADIOL
SEASONALE, ETHINYL ESTRADIOL
SEASONIQUE, ETHINYL ESTRADIOL

SYNTHETIC CONJUGATED ESTROGENS A, ESTROGENS, CONJUGATED SYNTHETIC A


DUSA
* DUSA PHARMACEUTICALS INC
LEVULAN, AMINOLEVULINIC ACID HYDROCHLORIDE
EBEWE PHARMA
* EBEWE PHARMA GES MBH NFG KG
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
ECOLAB
* ECOLAB INC
CHG SCRUB, CHLORHEXIDINE GLUCONATE (OTC)

CIDA-STAT, CHLORHEXIDINE GLUCONATE (OTC)


EISAI INC
* EISAI INC
ACIPHEX, RABEPRAZOLE SODIUM
ARICEPT ODT, DONEPEZIL HYDROCHLORIDE
ARICEPT, DONEPEZIL HYDROCHLORIDE
BANZEL, RUFINAMIDE
DACOGEN, DECITABINE
FRAGMIN, DALTEPARIN SODIUM
GLIADEL, CARMUSTINE
HEXALEN, ALTRETAMINE
LUSEDRA, FOSPROPOFOL DISODIUM
PANRETIN, ALITRETINOIN
SALAGEN, PILOCARPINE HYDROCHLORIDE
TARGRETIN, BEXAROTENE

ZONEGRAN, ZONISAMIDE

EKR THERAP
* EKR THERAPEUTICS INC
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE SR, NICARDIPINE HYDROCHLORIDE

CARDENE, NICARDIPINE HYDROCHLORIDE


ELAN DRUG
* ELAN DRUG DELIVERY INC
VERELAN PM, VERAPAMIL HYDROCHLORIDE

VERELAN, VERAPAMIL HYDROCHLORIDE


ELAN PHARMS
* ELAN PHARMACEUTICALS INC
PRIALT, ZICONOTIDE
ELI LILLY AND CO
* ELI LILLY AND CO
EFFIENT, PRASUGREL HYDROCHLORIDE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 22

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** E **
ELI LILLY CO
* ELI LILLY CO
ADCIRCA, TADALAFIL

ZYPREXA RELPREVV, OLANZAPINE PAMOATE


EMD SERONO
* EMD SERONO INC
CETROTIDE, CETRORELIX
GONAL-F RFF PEN, FOLLITROPIN ALFA/BETA
GONAL-F RFF, FOLLITROPIN ALFA/BETA
GONAL-F, FOLLITROPIN ALFA/BETA
LUVERIS, LUTROPIN ALFA
NOVANTRONE, MITOXANTRONE HYDROCHLORIDE
OVIDREL, CHORIOGONADOTROPIN ALFA
SAIZEN, SOMATROPIN RECOMBINANT
SEROPHENE, CLOMIPHENE CITRATE
SEROSTIM, SOMATROPIN RECOMBINANT

ZORBTIVE, SOMATROPIN RECOMBINANT


ENDO PHARM
* ENDO PHARMACEUTICAL SOLUTIONS INC
DELATESTRYL, TESTOSTERONE ENANTHATE
SUPPRELIN LA, HISTRELIN ACETATE
VALSTAR PRESERVATIVE FREE, VALRUBICIN

VANTAS, HISTRELIN ACETATE


ENDO PHARMS
* ENDO PHARMACEUTICALS INC
FROVA, FROVATRIPTAN SUCCINATE
MOBAN, MOLINDONE HYDROCHLORIDE
OPANA ER, OXYMORPHONE HYDROCHLORIDE
OPANA, OXYMORPHONE HYDROCHLORIDE
PERCODAN, ASPIRIN

SYMMETREL, AMANTADINE HYDROCHLORIDE


ENTURIA INC
* ENTURIA INC
CHLORAPREP ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP ONE-STEP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP WITH TINT, CHLORHEXIDINE GLUCONATE (OTC)


ENZON
* ENZON INC
ABELCET, AMPHOTERICIN B
ENZON PHARMS
* ENZON PHARMACEUTICALS INC
ADAGEN, PEGADEMASE BOVINE
EURAND
* EURAND INC
ZENPEP, LIPASE
EUSA PHARMA USA
* EUSA PHARMA (USA) INC
QUADRAMET, SAMARIUM SM 153 LEXIDRONAM PENTASODIUM
EXALENZ BIOSCIENCE
* EXALENZ BIOSCIENCE LTD
IDKIT:HP, UREA C-13
EYETECH INC
* EYETECH INC
MACUGEN, PEGAPTANIB SODIUM
FALCON PHARMS
* FALCON PHARMACEUTICALS LTD
MAXITROL, DEXAMETHASONE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 23

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** F **
* FALCON PHARMACEUTICALS LTD
TIMOLOL MALEATE, TIMOLOL MALEATE

TOBREX, TOBRAMYCIN

FEINSTEIN
* FEINSTEIN INSTITUTE MEDICAL RESEARCH
AMMONIA N 13, AMMONIA, N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18


FERRING
* FERRING PHARMACEUTICALS INC
ACTHREL, CORTICORELIN OVINE TRIFLUTATE
BRAVELLE, UROFOLLITROPIN
CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
ENDOMETRIN, PROGESTERONE
FIRMAGON, DEGARELIX ACETATE
MENOPUR, LUTEINIZING HORMONE
MINIRIN, DESMOPRESSIN ACETATE
REPRONEX, LUTEINIZING HORMONE

TEV-TROPIN, SOMATROPIN RECOMBINANT


FLEMING
* FLEMING AND CO
CALOMIST, CYANOCOBALAMIN
FOREST LABS
* FOREST LABORATORIES INC
AEROSPAN HFA, FLUNISOLIDE
BYSTOLIC, NEBIVOLOL HYDROCHLORIDE
CAMPRAL, ACAMPROSATE CALCIUM
CELEXA, CITALOPRAM HYDROBROMIDE
COMBUNOX, IBUPROFEN
LEXAPRO, ESCITALOPRAM OXALATE
NAMENDA, MEMANTINE HYDROCHLORIDE
TESSALON, BENZONATATE
THYROLAR-0.25, LIOTHYRONINE SODIUM
THYROLAR-0.5, LIOTHYRONINE SODIUM
THYROLAR-1, LIOTHYRONINE SODIUM
THYROLAR-2, LIOTHYRONINE SODIUM

THYROLAR-3, LIOTHYRONINE SODIUM


FOUGERA
* E FOUGERA DIV ALTANA INC
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE


FRESENIUS
* FRESENIUS KABI DEUTSCHLAND GMBH
INTRALIPID 10%, SOYBEAN OIL
INTRALIPID 20%, SOYBEAN OIL

INTRALIPID 30%, SOYBEAN OIL


* FRESENIUS USA INC


INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE


FRESENIUS MEDCL
* FRESENIUS MEDICAL CARE NORTH AMERICA
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 24

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** F **
* FRESENIUS MEDICAL CARE NORTH AMERICA
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM
CHLORIDE
DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE


DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE


DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE


PHOSLO GELCAPS, CALCIUM ACETATE


G AND W LABS
* G AND W LABORATORIES INC
ACEPHEN, ACETAMINOPHEN (OTC)
GALDERMA LABS
* GALDERMA LABORATORIES INC
CLOBEX, CLOBETASOL PROPIONATE

EPIDUO, ADAPALENE

GALDERMA LABS LP
* GALDERMA LABORATORIES L P
CLOBEX, CLOBETASOL PROPIONATE
* GALDERMA LABORATORIES LP
CAPEX, FLUOCINOLONE ACETONIDE
CLINDAGEL, CLINDAMYCIN PHOSPHATE
CLOBEX, CLOBETASOL PROPIONATE
DESOWEN, DESONIDE
DIFFERIN, ADAPALENE
LIDOCAINE AND TETRACAINE, LIDOCAINE
METROCREAM, METRONIDAZOLE
METROGEL, METRONIDAZOLE
METROLOTION, METRONIDAZOLE
METVIXIA, METHYL AMINOLEVULINATE HYDROCHLORIDE
ORACEA, DOXYCYCLINE
PERIOSTAT, DOXYCYCLINE HYCLATE
TRI-LUMA, FLUOCINOLONE ACETONIDE

VECTICAL, CALCITRIOL

GALEN LTD
* GALEN LTD
FEMRING, ESTRADIOL ACETATE
GAMBRO RENAL PRODS
* GAMBRO RENAL PRODUCTS
PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE


GD SEARLE
* GD SEARLE LLC
CELEBREX, CELECOXIB

DAYPRO, OXAPROZIN

GD SEARLE LLC
* GD SEARLE LLC
ALDACTAZIDE, HYDROCHLOROTHIAZIDE
ALDACTONE, SPIRONOLACTONE
ARTHROTEC, DICLOFENAC SODIUM
CALAN, VERAPAMIL HYDROCHLORIDE
COVERA-HS, VERAPAMIL HYDROCHLORIDE
CYTOTEC, MISOPROSTOL

FLAGYL ER, METRONIDAZOLE


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 25

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** G **
* GD SEARLE LLC
FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE
FLAGYL I.V., METRONIDAZOLE HYDROCHLORIDE
FLAGYL, METRONIDAZOLE
INSPRA, EPLERENONE
LOMOTIL, ATROPINE SULFATE
NORPACE CR, DISOPYRAMIDE PHOSPHATE
NORPACE, DISOPYRAMIDE PHOSPHATE

SYNAREL, NAFARELIN ACETATE

GE HEALTHCARE
* GE HEALTHCARE
ADREVIEW, IOBENGUANE SULFATE I 123
CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT
HYPAQUE, DIATRIZOATE SODIUM
INDICLOR, INDIUM IN-111 CHLORIDE
INDIUM IN-111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE
METASTRON, STRONTIUM CHLORIDE, SR-89
MPI DMSA KIDNEY REAGENT, TECHNETIUM TC-99M SUCCIMER KIT
MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM
MYOVIEW 30ML, TECHNETIUM TC-99M TETROFOSMIN KIT
MYOVIEW, TECHNETIUM TC-99M TETROFOSMIN KIT
OMNIPAQUE 140, IOHEXOL
OMNIPAQUE 180, IOHEXOL
OMNIPAQUE 240, IOHEXOL
OMNIPAQUE 300, IOHEXOL
OMNIPAQUE 350, IOHEXOL
OMNISCAN, GADODIAMIDE
OPTISON, ALBUMIN HUMAN
SODIUM IODIDE I 123, SODIUM IODIDE, I-123
TECHNETIUM TC-99M PENTETATE KIT, TECHNETIUM TC-99M PENTETATE KIT
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE, TL-201
VISIPAQUE 270, IODIXANOL

VISIPAQUE 320, IODIXANOL

GENENTECH
* GENENTECH INC
NUTROPIN AQ PEN, SOMATROPIN RECOMBINANT
NUTROPIN AQ, SOMATROPIN RECOMBINANT

NUTROPIN, SOMATROPIN RECOMBINANT

GENTA
* GENTA INC
GANITE, GALLIUM NITRATE
GENZYME
* GENZYME CORP
CEREDASE, ALGLUCERASE
CEREZYME, IMIGLUCERASE
CLOLAR, CLOFARABINE
FLUDARA, FLUDARABINE PHOSPHATE
HECTOROL, DOXERCALCIFEROL
MOZOBIL, PLERIXAFOR
RENAGEL, SEVELAMER HYDROCHLORIDE
RENVELA, SEVELAMER CARBONATE

THYROGEN, THYROTROPIN ALFA

GILEAD
* GILEAD SCIENCES INC
ATRIPLA, EFAVIRENZ
EMTRIVA, EMTRICITABINE
HEPSERA, ADEFOVIR DIPIVOXIL
LETAIRIS, AMBRISENTAN
RANEXA, RANOLAZINE
TRUVADA, EMTRICITABINE
VIREAD, TENOFOVIR DISOPROXIL FUMARATE

VISTIDE, CIDOFOVIR

30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 26

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** G **
GLAXO GRP LTD
* GLAXO GROUP LTD DBA GLAXOSMITHKLINE
ALTABAX, RETAPAMULIN
FLOVENT HFA, FLUTICASONE PROPIONATE

SEREVENT, SALMETEROL XINAFOATE


GLAXOSMITHKLINE
* GLAXOSMITHKLINE
ABREVA, DOCOSANOL (OTC)
ACLOVATE, ALCLOMETASONE DIPROPIONATE
ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE
ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE
ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE
ADVAIR HFA, FLUTICASONE PROPIONATE
AGENERASE, AMPRENAVIR
ALBENZA, ALBENDAZOLE
ALKERAN, MELPHALAN
ALKERAN, MELPHALAN HYDROCHLORIDE
AMERGE, NARATRIPTAN HYDROCHLORIDE
ARIXTRA, FONDAPARINUX SODIUM
AVODART, DUTASTERIDE
BACTROBAN, MUPIROCIN
BACTROBAN, MUPIROCIN CALCIUM
BECONASE AQ, BECLOMETHASONE DIPROPIONATE MONOHYDRATE
CEFTIN, CEFUROXIME AXETIL
DARAPRIM, PYRIMETHAMINE
DYAZIDE, HYDROCHLOROTHIAZIDE
EPIVIR-HBV, LAMIVUDINE
FLOLAN, EPOPROSTENOL SODIUM
FLONASE, FLUTICASONE PROPIONATE
FLOVENT DISKUS 100, FLUTICASONE PROPIONATE
FLOVENT DISKUS 250, FLUTICASONE PROPIONATE
FLOVENT DISKUS 50, FLUTICASONE PROPIONATE
FORTAZ IN PLASTIC CONTAINER, CEFTAZIDIME SODIUM
FORTAZ, CEFTAZIDIME
HYCAMTIN, TOPOTECAN HYDROCHLORIDE
IMITREX STATDOSE, SUMATRIPTAN SUCCINATE
IMITREX, SUMATRIPTAN
IMITREX, SUMATRIPTAN SUCCINATE
LAMICTAL CD, LAMOTRIGINE
LAMICTAL, LAMOTRIGINE
LANOXIN PEDIATRIC, DIGOXIN
LANOXIN, DIGOXIN
MALARONE PEDIATRIC, ATOVAQUONE
MALARONE, ATOVAQUONE
MEPRON, ATOVAQUONE
MYLERAN, BUSULFAN
NICORETTE (MINT), NICOTINE POLACRILEX (OTC)
NICORETTE, NICOTINE POLACRILEX (OTC)
PARNATE, TRANYLCYPROMINE SULFATE
PAXIL CR, PAROXETINE HYDROCHLORIDE
PAXIL, PAROXETINE HYDROCHLORIDE
PROMACTA, ELTROMBOPAG OLAMINE
RELENZA, ZANAMIVIR
REQUIP, ROPINIROLE HYDROCHLORIDE
TAGAMET HB, CIMETIDINE (OTC)
TAGAMET, CIMETIDINE
THIOGUANINE, THIOGUANINE
TIMENTIN IN PLASTIC CONTAINER, CLAVULANATE POTASSIUM
TIMENTIN, CLAVULANATE POTASSIUM
TREXIMET, NAPROXEN SODIUM
VALTREX, VALACYCLOVIR HYDROCHLORIDE
VENTOLIN HFA, ALBUTEROL SULFATE

VERAMYST, FLUTICASONE FUROATE


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 27

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** G **
* GLAXOSMITHKLINE
VOTRIENT, PAZOPANIB HYDROCHLORIDE
WELLBUTRIN SR, BUPROPION HYDROCHLORIDE
WELLBUTRIN, BUPROPION HYDROCHLORIDE
ZANTAC 150, RANITIDINE HYDROCHLORIDE
ZANTAC 25, RANITIDINE HYDROCHLORIDE
ZANTAC 300, RANITIDINE HYDROCHLORIDE
ZANTAC IN PLASTIC CONTAINER, RANITIDINE HYDROCHLORIDE
ZANTAC, RANITIDINE HYDROCHLORIDE
ZINACEF IN PLASTIC CONTAINER, CEFUROXIME SODIUM
ZINACEF, CEFUROXIME SODIUM
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE
ZOFRAN ODT, ONDANSETRON
ZOFRAN PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ZOFRAN, ONDANSETRON HYDROCHLORIDE
ZOVIRAX, ACYCLOVIR
ZOVIRAX, ACYCLOVIR SODIUM

ZYBAN, BUPROPION HYDROCHLORIDE


GLAXOSMITHKLINE CONS
* GLAXOSMITHKLINE CONSUMER HEALTHCARE
ALLI, ORLISTAT (OTC)
COMMIT, NICOTINE POLACRILEX (OTC)

NICORETTE, NICOTINE POLACRILEX (OTC)


GLENMARK GENERICS
* GLENMARK GENERICS INC USA
NILSTAT, NYSTATIN
GLOUCESTER PHARMS
* GLOUCESTER PHARMACEUTICALS INC
ISTODAX, ROMIDEPSIN
GRACEWAY
* GRACEWAY PHARMACEUTICALS LLC
ALDARA, IMIQUIMOD
CALCIUM DISODIUM VERSENATE, EDETATE CALCIUM DISODIUM
ESTRASORB, ESTRADIOL HEMIHYDRATE
MAXAIR, PIRBUTEROL ACETATE
METROGEL-VAGINAL, METRONIDAZOLE
NORFLEX, ORPHENADRINE CITRATE
NORGESIC FORTE, ASPIRIN
NORGESIC, ASPIRIN

TAMBOCOR, FLECAINIDE ACETATE


GRIFFEN
* KW GRIFFEN CO
BIOSCRUB, CHLORHEXIDINE GLUCONATE (OTC)
GTX INC
* GTX INC
FARESTON, TOREMIFENE CITRATE
GUERBET
* GUERBET LLC
HEXABRIX, IOXAGLATE MEGLUMINE
OXILAN-300, IOXILAN

OXILAN-350, IOXILAN

HALOZYME THERAP
* HALOZYME THERAPEUTICS INC
HYLENEX RECOMBINANT, HYALURONIDASE RECOMBINANT HUMAN
HAMELN PHARMS
* HAMELN PHARMACEUTICALS GMBH
PENTETATE CALCIUM TRISODIUM, PENTETATE CALCIUM TRISODIUM

PENTETATE ZINC TRISODIUM, PENTETATE ZINC TRISODIUM


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 28

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** H **
HELSINN HLTHCARE
* HELSINN HEALTHCARE SA
ALOXI, PALONOSETRON HYDROCHLORIDE
HEYL CHEMISCH
* HEYL CHEMISCH PHARMAZEUTISHE FABRIK
RADIOGARDASE (PRUSSIAN BLUE), FERRIC HEXACYANOFERRATE(II)
HI TECH PHARMA
* HI TECH PHARMACAL CO INC
VOSOL HC, ACETIC ACID, GLACIAL

VOSOL, ACETIC ACID, GLACIAL


HILL DERMAC
* HILL DERMACEUTICALS INC
DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE

DERMOTIC, FLUOCINOLONE ACETONIDE


HISAMITSU
* HISAMITSU PHARMACEUTICAL CO INC
SALONPAS, MENTHOL (OTC)
HLR
* HLR TECHNOLOGY
INVIRASE, SAQUINAVIR MESYLATE

ROMAZICON, FLUMAZENIL

HOFFMANN LA ROCHE
* HOFFMANN LA ROCHE INC
XELODA, CAPECITABINE

XENICAL, ORLISTAT

HOSPIRA
* HOSPIRA INC
ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL
AMIDATE, ETOMIDATE
AMINOSYN 10% (PH6), AMINO ACIDS
AMINOSYN 10%, AMINO ACIDS
AMINOSYN 3.5% M, AMINO ACIDS
AMINOSYN 3.5%, AMINO ACIDS
AMINOSYN 5%, AMINO ACIDS
AMINOSYN 7% (PH6), AMINO ACIDS
AMINOSYN 7% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN 7%, AMINO ACIDS
AMINOSYN 8.5% (PH6), AMINO ACIDS
AMINOSYN 8.5% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN 8.5%, AMINO ACIDS
AMINOSYN II 10% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 10% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN II 10%, AMINO ACIDS
AMINOSYN II 15% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 7%, AMINO ACIDS
AMINOSYN II 8.5% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN II 8.5%, AMINO ACIDS
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 29

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** H **
* HOSPIRA INC
AMINOSYN-HBC 7%, AMINO ACIDS
AMINOSYN-HF 8%, AMINO ACIDS
AMINOSYN-PF 10%, AMINO ACIDS
AMINOSYN-PF 7%, AMINO ACIDS
AMINOSYN-RF 5.2%, AMINO ACIDS
AQUASOL A, VITAMIN A PALMITATE
ATROPINE SULFATE ANSYR PLASTIC SYRINGE, ATROPINE SULFATE
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER, WATER FOR INJECTION, STERILE
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER, BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE, BRETYLIUM TOSYLATE
BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
CARBOCAINE, MEPIVACAINE HYDROCHLORIDE
CHROMIC CHLORIDE IN PLASTIC CONTAINER, CHROMIC CHLORIDE
CORLOPAM, FENOLDOPAM MESYLATE
CUPRIC CHLORIDE IN PLASTIC CONTAINER, CUPRIC CHLORIDE
DEMEROL, MEPERIDINE HYDROCHLORIDE
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 25%, DEXTROSE
DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%, DOBUTAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
ERYC, ERYTHROMYCIN
ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE
FENTANYL CITRATE, FENTANYL CITRATE
FUROSEMIDE, FUROSEMIDE
GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
IONOSOL T AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISUPREL, ISOPROTERENOL HYDROCHLORIDE
LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM
LEVOPHED, NOREPINEPHRINE BITARTRATE
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIPOSYN II 10%, SAFFLOWER OIL

LIPOSYN II 20%, SAFFLOWER OIL


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 30

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** H **
* HOSPIRA INC
LIPOSYN III 10%, SOYBEAN OIL
LIPOSYN III 20%, SOYBEAN OIL

LIPOSYN III 30%, SOYBEAN OIL


M.V.I. ADULT (PHARMACY BULK PACKAGE), ASCORBIC ACID


M.V.I. ADULT, ASCORBIC ACID
M.V.I. PEDIATRIC, ASCORBIC ACID
M.V.I.-12 (WITHOUT VITAMIN K), ASCORBIC ACID
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE
MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE
MANGANESE CHLORIDE IN PLASTIC CONTAINER, MANGANESE CHLORIDE
MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 25%, MANNITOL
MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
MARCAINE, BUPIVACAINE HYDROCHLORIDE
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
METHOTREXATE SODIUM, METHOTREXATE SODIUM
METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE
MORPHINE SULFATE, MORPHINE SULFATE
NITROGLYCERIN, NITROGLYCERIN
NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
NORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
NOVAMINE 11.4%, AMINO ACIDS
NOVAMINE 15%, AMINO ACIDS
PHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PHYSIOSOL PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PLEGISOL IN PLASTIC CONTAINER, CALCIUM CHLORIDE
POTASSIUM ACETATE IN PLASTIC CONTAINER, POTASSIUM ACETATE
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE


POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

CALCIUM CHLORIDE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE


POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 31

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** H **
* HOSPIRA INC
POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE


POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE


POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

CALCIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE


POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE


POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

PRECEDEX, DEXMEDETOMIDINE

QUELICIN PRESERVATIVE FREE, SUCCINYLCHOLINE CHLORIDE

QUELICIN, SUCCINYLCHOLINE CHLORIDE

RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

SODIUM ACETATE IN PLASTIC CONTAINER, SODIUM ACETATE ANHYDROUS

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM LACTATE IN PLASTIC CONTAINER, SODIUM LACTATE

SODIUM PHOSPHATES IN PLASTIC CONTAINER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

SORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOL

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, WATER FOR INJECTION, STERILE

STERILE WATER IN PLASTIC CONTAINER, WATER FOR IRRIGATION, STERILE

TALWIN, PENTAZOCINE LACTATE

THAM, TROMETHAMINE

THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE

ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE

HOSPIRA INC
* HOSPIRA INC
NIPENT, PENTOSTATIN
INO
* INO THERAPEUTICS INC
INOMAX, NITRIC OXIDE
INSIGHT PHARMS
* INSIGHT PHARMACEUTICALS CORP
NIX, PERMETHRIN (OTC)
INSPIRE
* INSPIRE PHARMACEUTICALS INC
AZASITE, AZITHROMYCIN
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 32

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** I **
INST BIOCHEM
* INSTITUT BIOCHEMIQUE SA
FLECTOR, DICLOFENAC EPOLAMINE
INTENDIS
* INTENDIS INC
DESONATE, DESONIDE

FINACEA, AZELAIC ACID


INTL MEDICATION
* INTERNATIONAL MEDICATION SYSTEM
FUROSEMIDE, FUROSEMIDE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE


IPR
* IPR PHARMACEUTICALS INC
CRESTOR, ROSUVASTATIN CALCIUM

ZOMIG, ZOLMITRIPTAN

IPSEN LTD
* IPSEN LTD
APOKYN, APOMORPHINE HYDROCHLORIDE
IROKO PHARMS
* IROKO PHARMACEUTICALS LLC
INDOCIN, INDOMETHACIN
ISO TEX
* ISO TEX DIAGNOSTICS INC
JEANATOPE, ALBUMIN IODINATED I-125 SERUM

MEGATOPE, ALBUMIN IODINATED I-131 SERUM


ISTA PHARMS
* ISTA PHARMACEUTICALS
BEPREVE, BEPOTASTINE BESILATE
ISTALOL, TIMOLOL MALEATE
VITRASE, HYALURONIDASE

XIBROM, BROMFENAC SODIUM


IVAX SUB TEVA PHARMS


* IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
FUROSEMIDE, FUROSEMIDE

METRONIDAZOLE, METRONIDAZOLE

JAZZ
* JAZZ PHARMACEUTICALS
LUVOX CR, FLUVOXAMINE MALEATE
LUVOX, FLUVOXAMINE MALEATE

XYREM, SODIUM OXYBATE


JHP PHARMS
* JHP PHARMACEUTICALS LLC
BREVITAL SODIUM, METHOHEXITAL SODIUM
COLY-MYCIN M, COLISTIMETHATE SODIUM
COLY-MYCIN S, COLISTIN SULFATE
DANTRIUM, DANTROLENE SODIUM
DELESTROGEN, ESTRADIOL VALERATE
KETALAR, KETAMINE HYDROCHLORIDE
PITOCIN, OXYTOCIN
TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE

TRIOSTAT, LIOTHYRONINE SODIUM


JOHNSON AND JOHNSON


* JOHNSON AND JOHNSON CONSUMER COMPANIES INC
RETIN-A, TRETINOIN
* JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES
MEN'S ROGAINE, MINOXIDIL (OTC)
ROGAINE (FOR MEN), MINOXIDIL (OTC)
ROGAINE (FOR WOMEN), MINOXIDIL (OTC)

ROGAINE EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 33

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** J **
* JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES
VISINE L.R., OXYMETAZOLINE HYDROCHLORIDE (OTC)

VISINE-A, NAPHAZOLINE HYDROCHLORIDE (OTC)

* JOHNSON AND JOHNSON HEALTHCARE PRODUCTS


MONISTAT 1 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MONISTAT 3 COMBINATION PACK (PREFILLED), MICONAZOLE NITRATE (OTC)
MONISTAT 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MONISTAT 3, MICONAZOLE NITRATE (OTC)
MONISTAT 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MONISTAT 7, MICONAZOLE NITRATE (OTC)

MONISTAT-3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

* JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT LLC


INVEGA SUSTENNA, PALIPERIDONE PALMITATE
KENDALL LP
* KENDALL CO LP
THERMAZENE, SILVER SULFADIAZINE
KEY PHARMS
* KEY PHARMACEUTICALS INC SUB SCHERING PLOUGH CORP
NITRO-DUR, NITROGLYCERIN
KING PHARMS
* KING PHARMACEUTICALS INC
ALTACE, RAMIPRIL
AVINZA, MORPHINE SULFATE
BICILLIN C-R 900/300, PENICILLIN G BENZATHINE
BICILLIN C-R, PENICILLIN G BENZATHINE
BICILLIN L-A, PENICILLIN G BENZATHINE
CORGARD, NADOLOL
CORZIDE, BENDROFLUMETHIAZIDE
CYTOMEL, LIOTHYRONINE SODIUM
INTAL, CROMOLYN SODIUM
LEVOXYL, LEVOTHYROXINE SODIUM
SILVADENE, SILVER SULFADIAZINE
SKELAXIN, METAXALONE
SYNERCID, DALFOPRISTIN

TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE


* KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC SUB KING PHARMACEUTICALS INC
SONATA, ZALEPLON
KOWA
* KOWA RESEARCH INSTITUTE INC
LIVALO, PITAVASTATIN CALCIUM
KOWA PHARMS
* KOWA PHARMACEUTICALS AMERICA INC
CAMBIA, DICLOFENAC POTASSIUM
KV PHARM
* KV PHARMACEUTICAL CO
CLINDESSE, CLINDAMYCIN PHOSPHATE
EVAMIST, ESTRADIOL

GYNAZOLE-1, BUTOCONAZOLE NITRATE


LANNETT
* LANNETT CO INC
SERPALAN, RESERPINE
LANTHEUS MEDCL
* LANTHEUS MEDICAL IMAGING INC
ABLAVAR, GADOFOSVESET TRISODIUM
CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT
DEFINITY, PERFLUTREN
GALLIUM CITRATE GA 67, GALLIUM CITRATE, GA-67
NEUROLITE, TECHNETIUM TC-99M BICISATE KIT
TECHNELITE, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE, TL-201

XENON XE 133, XENON XE 133


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 34

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** L **
LEO PHARM
* LEO PHARMACEUTICAL PRODUCTS LTD
DOVONEX, CALCIPOTRIENE

TACLONEX, BETAMETHASONE DIPROPIONATE


LEO PHARM PRODS


* LEO PHARMACEUTICAL PRODUCTS LTD
TACLONEX SCALP, BETAMETHASONE DIPROPIONATE
LG LIFE
* LG LIFE SCIENCES LTD
VALTROPIN, SOMATROPIN RECOMBINANT
LILLY
* ELI LILLY AND CO
ALIMTA, PEMETREXED DISODIUM
CIALIS, TADALAFIL
CYMBALTA, DULOXETINE HYDROCHLORIDE
EVISTA, RALOXIFENE HYDROCHLORIDE
FORTEO, TERIPARATIDE RECOMBINANT HUMAN
GEMZAR, GEMCITABINE HYDROCHLORIDE
GLUCAGON, GLUCAGON RECOMBINANT
HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT
HUMALOG MIX 50/50 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 50/50, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 75/25 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 75/25, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG PEN, INSULIN LISPRO RECOMBINANT
HUMALOG, INSULIN LISPRO RECOMBINANT
HUMATROPE, SOMATROPIN RECOMBINANT
HUMULIN 70/30 PEN, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)
HUMULIN R PEN, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN R, INSULIN RECOMBINANT HUMAN
HUMULIN R, INSULIN RECOMBINANT HUMAN (OTC)
PROZAC WEEKLY, FLUOXETINE HYDROCHLORIDE
QUINIDINE GLUCONATE, QUINIDINE GLUCONATE
STRATTERA, ATOMOXETINE HYDROCHLORIDE
SYMBYAX, FLUOXETINE HYDROCHLORIDE
ZYPREXA ZYDIS, OLANZAPINE

ZYPREXA, OLANZAPINE

* LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO


PROZAC, FLUOXETINE HYDROCHLORIDE

SARAFEM, FLUOXETINE HYDROCHLORIDE


LLOYD
* LLOYD INC
LEVOTHROID, LEVOTHYROXINE SODIUM
LOREAL USA
* LOREAL USA PRODUCTS INC
ANTHELIOS 20, AVOBENZONE (OTC)
ANTHELIOS 40, AVOBENZONE (OTC)
ANTHELIOS SX, AVOBENZONE (OTC)

CAPITAL SOLEIL 15, AVOBENZONE (OTC)


LUITPOLD
* LUITPOLD PHARMACEUTICALS INC
FUROSEMIDE, FUROSEMIDE

VENOFER, IRON SUCROSE


LUNDBECK INC
* LUNDBECK INC
CHEMET, SUCCIMER
COGENTIN, BENZTROPINE MESYLATE
COSMEGEN, DACTINOMYCIN

DESOXYN, METHAMPHETAMINE HYDROCHLORIDE


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 35

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** L **
* LUNDBECK INC
DIURIL, CHLOROTHIAZIDE SODIUM
INDOCIN, INDOMETHACIN SODIUM
MUSTARGEN, MECHLORETHAMINE HYDROCHLORIDE
NEOPROFEN, IBUPROFEN LYSINE
PEGANONE, ETHOTOIN
SABRIL, VIGABATRIN

TRANXENE, CLORAZEPATE DIPOTASSIUM


MALLINCKRODT
* MALLINCKRODT CHEMICAL INC
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHADOSE, METHADONE HYDROCHLORIDE


* MALLINCKRODT INC
METHYLIN, METHYLPHENIDATE HYDROCHLORIDE
OPTIMARK IN PLASTIC CONTAINER, GADOVERSETAMIDE
OPTIMARK, GADOVERSETAMIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE


* MALLINCKRODT MEDICAL INC


CONRAY 30, IOTHALAMATE MEGLUMINE
CONRAY 43, IOTHALAMATE MEGLUMINE
CONRAY, IOTHALAMATE MEGLUMINE
CYSTO-CONRAY II, IOTHALAMATE MEGLUMINE
GALLIUM CITRATE GA 67, GALLIUM CITRATE, GA-67
INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE
MD-76R, DIATRIZOATE MEGLUMINE
OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT
OPTIRAY 160, IOVERSOL
OPTIRAY 240, IOVERSOL
OPTIRAY 300, IOVERSOL
OPTIRAY 320, IOVERSOL
OPTIRAY 350, IOVERSOL
SODIUM IODIDE I 131, SODIUM IODIDE, I-131
TECHNESCAN MAG3, TECHNETIUM TC-99M MERTIATIDE KIT
TECHNESCAN PYP KIT, TECHNETIUM TC-99M PYROPHOSPHATE KIT
TECHNESCAN, TECHNETIUM TC-99M OXIDRONATE KIT
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE, TL-201
ULTRATAG, TECHNETIUM TC-99M RED BLOOD CELL KIT
ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

XENON XE 133, XENON XE 133

MAYNE PHARMA INTL


* MAYNE PHARMA INTERNATIONAL FAULDING PHARM
DORYX, DOXYCYCLINE HYCLATE
MCNEIL
* MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
CHILDREN'S MOTRIN, IBUPROFEN (OTC)
IMODIUM A-D EZ CHEWS, LOPERAMIDE HYDROCHLORIDE (OTC)
IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC)
MOTRIN IB, IBUPROFEN (OTC)
MOTRIN MIGRAINE PAIN, IBUPROFEN (OTC)

ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE (OTC)


MCNEIL CONS
* MCNEIL CONSUMER HEALTHCARE
BENADRYL PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE
BENADRYL, DIPHENHYDRAMINE HYDROCHLORIDE
CHILDREN'S MOTRIN COLD, IBUPROFEN (OTC)
CHILDREN'S MOTRIN, IBUPROFEN (OTC)
IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE (OTC)
IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC)
IMODIUM, LOPERAMIDE HYDROCHLORIDE
JUNIOR STRENGTH MOTRIN, IBUPROFEN (OTC)
NIZORAL A-D, KETOCONAZOLE (OTC)
SINE-AID IB, IBUPROFEN (OTC)

TYLENOL (CAPLET), ACETAMINOPHEN (OTC)


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 36

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** M **
* MCNEIL CONSUMER HEALTHCARE
TYLENOL (GELTAB), ACETAMINOPHEN (OTC)
MCNEIL CONSUMER
* MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

ZYRTEC, CETIRIZINE HYDROCHLORIDE


MCNEIL PED
* MCNEIL PEDIATRICS
FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE
MEAD JOHNSON
* MEAD JOHNSON AND CO
CAFCIT, CAFFEINE CITRATE
MEDA PHARMS
* MEDA PHARMACEUTICALS
EDLUAR, ZOLPIDEM TARTRATE
* MEDA PHARMACEUTICALS INC
ASTELIN, AZELASTINE HYDROCHLORIDE
ASTEPRO, AZELASTINE HYDROCHLORIDE
BUTISOL SODIUM, BUTABARBITAL SODIUM
CESAMET, NABILONE
DEMADEX, TORSEMIDE
DEPEN, PENICILLAMINE
FELBATOL, FELBAMATE
ONSOLIS, FENTANYL CITRATE

OPTIVAR, AZELASTINE HYDROCHLORIDE


* MEDA PHARMACEUTICALS MEDA PHARMACEUTICALS INC


ASTEPRO, AZELASTINE HYDROCHLORIDE
SOMA COMPOUND W/ CODEINE, ASPIRIN
SOMA COMPOUND, ASPIRIN

SOMA, CARISOPRODOL

MEDICINES CO
* THE MEDICINES CO
ANGIOMAX, BIVALIRUDIN

CLEVIPREX, CLEVIDIPINE BUTYRATE


MEDICIS
* MEDICIS PHARMACEUTICAL CORP
BUPHENYL, SODIUM PHENYLBUTYRATE
LIDEX, FLUOCINONIDE
LIDEX-E, FLUOCINONIDE
LOPROX, CICLOPIROX
SOLODYN, MINOCYCLINE HYDROCHLORIDE
SYNALAR, FLUOCINOLONE ACETONIDE
VANOS, FLUOCINONIDE

ZIANA, CLINDAMYCIN PHOSPHATE


MEDICURE
* MEDICURE INTERNATIONAL INC
AGGRASTAT, TIROFIBAN HYDROCHLORIDE
MEDIGENE
* MEDIGENE INC
VEREGEN, SINECATECHINS
MEDIMMUNE
* MEDIMMUNE
ETHYOL, AMIFOSTINE
MEDIVIR
* MEDIVIR AB
ACYCLOVIR AND HYDROCORTISONE, ACYCLOVIR
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 37

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** M **
MEDTRONIC
* MEDTRONIC INC
LIORESAL, BACLOFEN
MERCK
* MERCK AND CO INC
AMINOHIPPURATE SODIUM, AMINOHIPPURATE SODIUM
CANCIDAS, CASPOFUNGIN ACETATE
EMEND, APREPITANT
FOSAMAX PLUS D, ALENDRONATE SODIUM
FOSAMAX, ALENDRONATE SODIUM
HYZAAR, HYDROCHLOROTHIAZIDE
INVANZ, ERTAPENEM SODIUM
JANUMET, METFORMIN HYDROCHLORIDE
MAXALT, RIZATRIPTAN BENZOATE
MAXALT-MLT, RIZATRIPTAN BENZOATE
PRIMAXIN, CILASTATIN SODIUM
PROSCAR, FINASTERIDE
SINGULAIR, MONTELUKAST SODIUM
STROMECTOL, IVERMECTIN

ZOLINZA, VORINOSTAT

* MERCK RESEARCH LABORATORIES DIV MERCK CO INC


CLINORIL, SULINDAC
COSOPT, DORZOLAMIDE HYDROCHLORIDE
COZAAR, LOSARTAN POTASSIUM
MEVACOR, LOVASTATIN
NOROXIN, NORFLOXACIN
PEPCID AC (GELTAB), FAMOTIDINE (OTC)
PEPCID AC, FAMOTIDINE (OTC)
PEPCID COMPLETE, CALCIUM CARBONATE (OTC)
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE
PEPCID PRESERVATIVE FREE, FAMOTIDINE
PEPCID, FAMOTIDINE
PRINIVIL, LISINOPRIL
PRINZIDE, HYDROCHLOROTHIAZIDE
PROPECIA, FINASTERIDE
SINGULAIR, MONTELUKAST SODIUM
TRUSOPT, DORZOLAMIDE HYDROCHLORIDE

ZOCOR, SIMVASTATIN

MERCK AND CO INC


* MERCK AND CO INC
EMEND, FOSAPREPITANT DIMEGLUMINE

FOSAMAX, ALENDRONATE SODIUM


MERCK CO INC
* MERCK CO INC
JANUVIA, SITAGLIPTIN PHOSPHATE
MERCK SANTE SAS
* MERCK SANTE SAS
CYANOKIT, HYDROXOCOBALAMIN
MERCK SHARP DOHME
* MERCK SHARP AND DOHME CORP
CRIXIVAN, INDINAVIR SULFATE

ISENTRESS, RALTEGRAVIR POTASSIUM


MERIDIAN MEDCL
* MERIDIAN MEDICAL TECHNOLOGIES INC
DUODOTE, ATROPINE
MERIDIAN MEDCL TECHN
* MERIDIAN MEDICAL TECHNOLOGIES INC
ATROPEN, ATROPINE
EPIPEN JR., EPINEPHRINE
EPIPEN, EPINEPHRINE

LIDOPEN, LIDOCAINE HYDROCHLORIDE


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 38

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** M **
* MERIDIAN MEDICAL TECHNOLOGIES INC
MORPHINE SULFATE, MORPHINE SULFATE

PRALIDOXIME CHLORIDE, PRALIDOXIME CHLORIDE


MERZ PHARMS
* MERZ PHARMACEUTICALS LLC
ERYGEL, ERYTHROMYCIN

NAFTIN, NAFTIFINE HYDROCHLORIDE


METHAPHARM
* METHAPHARM INC
PROVOCHOLINE, METHACHOLINE CHLORIDE
MIDDLEBROOK PHARMS
* MIDDLEBROOK PHARMACEUTICALS INC
KEFLEX, CEPHALEXIN

MOXATAG, AMOXICILLIN

MILLENNIUM PHARMS
* MILLENNIUM PHARMACEUTICALS INC
VELCADE, BORTEZOMIB
MISSION PHARMA
* MISSION PHARMACAL CO
LITHOSTAT, ACETOHYDROXAMIC ACID
TINDAMAX, TINIDAZOLE
TIOPRONIN, TIOPRONIN

UROCIT-K, POTASSIUM CITRATE


MONARCH PHARMS
* MONARCH PHARMACEUTICALS INC
CORTISPORIN, BACITRACIN ZINC
CORTISPORIN, HYDROCORTISONE
CORTISPORIN, HYDROCORTISONE ACETATE
SEPTRA DS, SULFAMETHOXAZOLE
SEPTRA, SULFAMETHOXAZOLE
THALITONE, CHLORTHALIDONE

VIROPTIC, TRIFLURIDINE

MSP SINGAPORE
* MSP SINGAPORE CO LLC
VYTORIN, EZETIMIBE

ZETIA, EZETIMIBE

MUTUAL PHARM
* MUTUAL PHARMACEUTICAL CO INC
BACTRIM DS, SULFAMETHOXAZOLE

BACTRIM, SULFAMETHOXAZOLE

MYLAN
* MYLAN PHARMACEUTICALS INC
ALLOPURINOL, ALLOPURINOL
CYSTAGON, CYSTEAMINE BITARTRATE
FUROSEMIDE, FUROSEMIDE

INDOMETHACIN, INDOMETHACIN

MYLAN BERTEK
* MYLAN BERTEK PHARMACEUTICALS INC
AVITA, TRETINOIN
MAXZIDE, HYDROCHLOROTHIAZIDE
MAXZIDE-25, HYDROCHLOROTHIAZIDE
MENTAX, BUTENAFINE HYDROCHLORIDE

MENTAX-TC, BUTENAFINE HYDROCHLORIDE


NEUROGESX
* NEUROGESX INC
QUTENZA, CAPSAICIN
NEW RIVER
* NEW RIVER PHARMACEUTICALS INC
PROFERDEX, IRON DEXTRAN
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 39

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** N **
NITROMED
* NITROMED INC
BIDIL, HYDRALAZINE HYDROCHLORIDE
NOVADEL
* NOVADEL PHARMA INC
ZOLPIMIST, ZOLPIDEM TARTRATE
NOVALAR
* NOVALAR PHARMACEUTICALS INC
ORAVERSE, PHENTOLAMINE MESYLATE
NOVARTIS
* NOVARTIS CONSUMER HEALTH INC
DENAVIR, PENCICLOVIR SODIUM
EXCEDRIN (MIGRAINE), ACETAMINOPHEN (OTC)
HABITROL, NICOTINE (OTC)
LAMISIL AT, TERBINAFINE (OTC)
LAMISIL AT, TERBINAFINE HYDROCHLORIDE (OTC)
LAMISIL, TERBINAFINE
LAMISIL, TERBINAFINE HYDROCHLORIDE
LAMISIL, TERBINAFINE HYDROCHLORIDE (OTC)
NEXCEDE, KETOPROFEN (OTC)
PREVACID 24 HR, LANSOPRAZOLE (OTC)
TAVIST ALLERGY/SINUS/HEADACHE, ACETAMINOPHEN (OTC)
TRANSDERM SCOP, SCOPOLAMINE
VAGISTAT-1, TIOCONAZOLE (OTC)

VOLTAREN, DICLOFENAC SODIUM


* NOVARTIS PHARMACEUTICALS CORP


AFINITOR, EVEROLIMUS
AREDIA, PAMIDRONATE DISODIUM
CATAFLAM, DICLOFENAC POTASSIUM
CLOZARIL, CLOZAPINE
COARTEM, ARTEMETHER
COMBIPATCH, ESTRADIOL
DESFERAL, DEFEROXAMINE MESYLATE
DIOVAN HCT, HYDROCHLOROTHIAZIDE
DIOVAN, VALSARTAN
ELIDEL, PIMECROLIMUS
ENABLEX, DARIFENACIN HYDROBROMIDE
ESTRADERM, ESTRADIOL
EXELON, RIVASTIGMINE
EXELON, RIVASTIGMINE TARTRATE
EXFORGE HCT, AMLODIPINE
EXFORGE, AMLODIPINE BESYLATE
EXJADE, DEFERASIROX
FAMVIR, FAMCICLOVIR
FOCALIN XR, DEXMETHYLPHENIDATE HYDROCHLORIDE
FOCALIN, DEXMETHYLPHENIDATE HYDROCHLORIDE
FORADIL CERTIHALER, FORMOTEROL FUMARATE
FORADIL, FORMOTEROL FUMARATE
GLEEVEC, IMATINIB MESYLATE
HYDERGINE, ERGOLOID MESYLATES
LAMISIL, TERBINAFINE HYDROCHLORIDE
LAMPRENE, CLOFAZIMINE
LESCOL XL, FLUVASTATIN SODIUM
LESCOL, FLUVASTATIN SODIUM
LOPRESSOR HCT, HYDROCHLOROTHIAZIDE
LOPRESSOR, METOPROLOL TARTRATE
LOTENSIN HCT, BENAZEPRIL HYDROCHLORIDE
LOTENSIN, BENAZEPRIL HYDROCHLORIDE
LOTREL, AMLODIPINE BESYLATE
METHERGINE, METHYLERGONOVINE MALEATE
METOPIRONE, METYRAPONE

MIACALCIN, CALCITONIN, SALMON


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 40

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** N **
* NOVARTIS PHARMACEUTICALS CORP
MIOCHOL-E, ACETYLCHOLINE CHLORIDE
MYFORTIC, MYCOPHENOLIC ACID
NEORAL, CYCLOSPORINE
OCUPRESS, CARTEOLOL HYDROCHLORIDE
PARLODEL, BROMOCRIPTINE MESYLATE
RECLAST, ZOLEDRONIC ACID
REGITINE, PHENTOLAMINE MESYLATE
RITALIN LA, METHYLPHENIDATE HYDROCHLORIDE
RITALIN, METHYLPHENIDATE HYDROCHLORIDE
RITALIN-SR, METHYLPHENIDATE HYDROCHLORIDE
SANDIMMUNE, CYCLOSPORINE
SANDOSTATIN LAR, OCTREOTIDE ACETATE
SANDOSTATIN, OCTREOTIDE ACETATE
STARLIX, NATEGLINIDE
TASIGNA, NILOTINIB HYDROCHLORIDE MONOHYDRATE
TAVIST-1, CLEMASTINE FUMARATE (OTC)
TEGRETOL, CARBAMAZEPINE
TEGRETOL-XR, CARBAMAZEPINE
TEKTURNA HCT, ALISKIREN HEMIFUMARATE
TEKTURNA, ALISKIREN HEMIFUMARATE
TRILEPTAL, OXCARBAZEPINE
TYZEKA, TELBIVUDINE
VALTURNA, ALISKIREN HEMIFUMARATE
VASOCIDIN, PREDNISOLONE SODIUM PHOSPHATE
VASOCON-A, ANTAZOLINE PHOSPHATE (OTC)
VIVELLE, ESTRADIOL
VIVELLE-DOT, ESTRADIOL
VOLTAREN, DICLOFENAC SODIUM
VOLTAREN-XR, DICLOFENAC SODIUM
ZADITOR, KETOTIFEN FUMARATE (OTC)

ZOMETA, ZOLEDRONIC ACID


NOVARTIS PHARMS
* NOVARTIS PHARMACEUTICALS CORP
FEMARA, LETROZOLE

TOBI, TOBRAMYCIN

NOVEN THERAP
* NOVEN THERAPEUTICS LLC
ESKALITH, LITHIUM CARBONATE
LITHOBID, LITHIUM CARBONATE

PEXEVA, PAROXETINE MESYLATE


NOVO NORDISK
* NOVO NORDISK PHARMACEUTICALS INC
GLUCAGEN, GLUCAGON HYDROCHLORIDE RECOMBINANT
NOVO NORDISK INC
* NOVO NORDISK INC
ACTIVELLA, ESTRADIOL
LEVEMIR, INSULIN DETEMIR RECOMBINANT
NORDITROPIN NORDIFLEX, SOMATROPIN RECOMBINANT
NORDITROPIN, SOMATROPIN RECOMBINANT
NOVOLIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)
NOVOLIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)
NOVOLIN R, INSULIN RECOMBINANT HUMAN (OTC)
NOVOLOG MIX 70/30, INSULIN ASPART PROTAMINE RECOMBINANT
NOVOLOG, INSULIN ASPART RECOMBINANT
PRANDIMET, METFORMIN HYDROCHLORIDE
PRANDIN, REPAGLINIDE

VAGIFEM, ESTRADIOL

NUTRITIONAL RESTART
* NUTRITIONAL RESTART PHARMACEUTICAL LP
NUTRESTORE, GLUTAMINE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 41

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** N **
NUVO RES
* NUVO RESEARCH INC
PENNSAID, DICLOFENAC SODIUM
NYCOMED US
* NYCOMED US INC
ALVESCO, CICLESONIDE
CUTIVATE, FLUTICASONE PROPIONATE
OMNARIS, CICLESONIDE
PAMINE FORTE, METHSCOPOLAMINE BROMIDE
PAMINE, METHSCOPOLAMINE BROMIDE
SOLARAZE, DICLOFENAC SODIUM

ZONALON, DOXEPIN HYDROCHLORIDE


ODYSSEY PHARMS
* ODYSSEY PHARMACEUTICALS INC
SURMONTIL, TRIMIPRAMINE MALEATE
ONY
* ONY INC
INFASURF PRESERVATIVE FREE, CALFACTANT
ORAPHARMA
* ORAPHARMA INC
ARESTIN, MINOCYCLINE HYDROCHLORIDE
ORGANON USA INC
* ORGANON USA INC
CYCLESSA, DESOGESTREL
DESOGEN, DESOGESTREL
FOLLISTIM AQ, FOLLITROPIN ALFA/BETA
GANIRELIX ACETATE INJECTION, GANIRELIX ACETATE
IMPLANON, ETONOGESTREL
NUVARING, ETHINYL ESTRADIOL
PREGNYL, GONADOTROPIN, CHORIONIC
REMERON SOLTAB, MIRTAZAPINE
REMERON, MIRTAZAPINE

SAPHRIS, ASENAPINE MALEATE


ORION
* ORION CORP
COMTAN, ENTACAPONE
STALEVO 100, CARBIDOPA
STALEVO 125, CARBIDOPA
STALEVO 150, CARBIDOPA
STALEVO 200, CARBIDOPA
STALEVO 50, CARBIDOPA

STALEVO 75, CARBIDOPA


ORTHO BIOTECH
* ORTHO BIOTECH PRODUCTS LP
DOXIL, DOXORUBICIN HYDROCHLORIDE

LEUSTATIN, CLADRIBINE

ORTHO DERMATOLOGICS
* ORTHO DERMATOLOGICS
ERTACZO, SERTACONAZOLE NITRATE
RENOVA, TRETINOIN

RETIN-A MICRO, TRETINOIN


ORTHO MCNEIL JANSSEN


* ORTHO MCNEIL JANSSEN PHARMACEUTICAL INC
CONCERTA, METHYLPHENIDATE HYDROCHLORIDE
DORIBAX, DORIPENEM
HALDOL, HALOPERIDOL DECANOATE
RAZADYNE, GALANTAMINE HYDROBROMIDE
RISPERDAL, RISPERIDONE
TERAZOL 3, TERCONAZOLE

ULTRACET, ACETAMINOPHEN

30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 42

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** O **
* ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC
AXERT, ALMOTRIPTAN MALATE
DITROPAN XL, OXYBUTYNIN CHLORIDE
DITROPAN, OXYBUTYNIN CHLORIDE
DURAGESIC-100, FENTANYL
DURAGESIC-12, FENTANYL
DURAGESIC-25, FENTANYL
DURAGESIC-50, FENTANYL
DURAGESIC-75, FENTANYL
ELMIRON, PENTOSAN POLYSULFATE SODIUM
HALDOL, HALOPERIDOL LACTATE
INVEGA, PALIPERIDONE
LEVAQUIN, LEVOFLOXACIN
MICRONOR, NORETHINDRONE
MODICON 28, ETHINYL ESTRADIOL
NIZORAL, KETOCONAZOLE
NUCYNTA, TAPENTADOL HYDROCHLORIDE
ORTHO CYCLEN-28, ETHINYL ESTRADIOL
ORTHO EVRA, ETHINYL ESTRADIOL
ORTHO TRI-CYCLEN LO, ETHINYL ESTRADIOL
ORTHO TRI-CYCLEN, ETHINYL ESTRADIOL
ORTHO-CEPT, DESOGESTREL
ORTHO-NOVUM 1/35-28, ETHINYL ESTRADIOL
ORTHO-NOVUM 7/7/7-28, ETHINYL ESTRADIOL
PARAFON FORTE DSC, CHLORZOXAZONE
RAZADYNE ER, GALANTAMINE HYDROBROMIDE
RAZADYNE, GALANTAMINE HYDROBROMIDE
RISPERDAL CONSTA, RISPERIDONE
RISPERDAL, RISPERIDONE
SPORANOX, ITRACONAZOLE
TERAZOL 3, TERCONAZOLE
TERAZOL 7, TERCONAZOLE
TOLECTIN 600, TOLMETIN SODIUM
TOLECTIN DS, TOLMETIN SODIUM
TOLECTIN, TOLMETIN SODIUM
TOPAMAX, TOPIRAMATE
ULTRAM, TRAMADOL HYDROCHLORIDE

URISPAS, FLAVOXATE HYDROCHLORIDE


ORTHO MCNEIL PHARM


* ORTHO MCNEIL PHARMACEUTICAL INC
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

LEVAQUIN, LEVOFLOXACIN

OSCIENT
* OSCIENT PHARMACEUTICALS
ANTARA (MICRONIZED), FENOFIBRATE

FACTIVE, GEMIFLOXACIN MESYLATE


OSI PHARMS
* OSI PHARMACEUTICALS INC
TARCEVA, ERLOTINIB HYDROCHLORIDE
OSMOTICA PHARM
* OSMOTICA PHARMACEUTICAL CORP
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
OTSUKA
* OTSUKA PHARMACEUTICAL CO LTD
ABILIFY, ARIPIPRAZOLE

PLETAL, CILOSTAZOL

* OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION INC


ABILIFY, ARIPIPRAZOLE
OTSUKA AMERICA
* OTSUKA AMERICA PHARMACEUTICALS INC
BREATHTEK UBT FOR H-PYLORI, UREA, C-13
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 43

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** O **
OTSUKA AMERICA PHARM
* OTSUKA AMERICA PHARMACEUTICAL INC
SAMSCA, TOLVAPTAN
OTSUKA PHARM
* OTSUKA PHARMACEUTICAL CO LTD
BUSULFEX, BUSULFAN
PACIRA PHARMS INC
* PACIRA PHARMACEUTICALS INC
DEPOCYT, CYTARABINE

DEPODUR, MORPHINE SULFATE


PADDOCK LABS
* PADDOCK LABORATORIES INC
MIDAMOR, AMILORIDE HYDROCHLORIDE
PALADIN LABS
* PALADIN LABS USA INC
ANTIZOL, FOMEPIZOLE
PAR PHARM
* PAR PHARMACEUTICAL INC
CAPOTEN, CAPTOPRIL
MEGACE ES, MEGESTROL ACETATE

NASCOBAL, CYANOCOBALAMIN

PARKE DAVIS
* PARKE DAVIS DIV WARNER LAMBERT CO
CELONTIN, METHSUXIMIDE
CEREBYX, FOSPHENYTOIN SODIUM
DILANTIN-125, PHENYTOIN
NARDIL, PHENELZINE SULFATE
NEURONTIN, GABAPENTIN

ZARONTIN, ETHOSUXIMIDE

PAV NOVA
* PAV NOVA INC
TODAY, NONOXYNOL-9 (OTC)
PEDINOL
* PEDINOL PHARMACAL INC
GRIS-PEG, GRISEOFULVIN, ULTRAMICROCRYSTALLINE

NALFON, FENOPROFEN CALCIUM


PERRIGO NEW YORK


* PERRIGO NEW YORK INC
CENTANY, MUPIROCIN

DESONIDE, DESONIDE

PERSONAL PRODS
* PERSONAL PRODUCTS CO
MONISTAT 3, MICONAZOLE NITRATE
PFIZER
* PFIZER CENTRAL RESEARCH
DIFLUCAN, FLUCONAZOLE

ZITHROMAX, AZITHROMYCIN

* PFIZER CHEMICALS DIV PFIZER INC


DIFLUCAN, FLUCONAZOLE

ZITHROMAX, AZITHROMYCIN

* PFIZER INC
ANTIVERT, MECLIZINE HYDROCHLORIDE
ARGATROBAN, ARGATROBAN
CADUET, AMLODIPINE BESYLATE
CARDURA XL, DOXAZOSIN MESYLATE
CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

DIFLUCAN IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 44

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **
* PFIZER INC
GEODON, ZIPRASIDONE HYDROCHLORIDE
GEODON, ZIPRASIDONE MESYLATE
GLUCOTROL XL, GLIPIZIDE
GLUCOTROL, GLIPIZIDE
LIPITOR, ATORVASTATIN CALCIUM
NAVANE, THIOTHIXENE
NORVASC, AMLODIPINE BESYLATE
PROCARDIA, NIFEDIPINE
REVATIO, SILDENAFIL CITRATE
RID MOUSSE, PIPERONYL BUTOXIDE (OTC)
TOVIAZ, FESOTERODINE FUMARATE
UNASYN, AMPICILLIN SODIUM
VFEND, VORICONAZOLE

ZITHROMAX, AZITHROMYCIN

* PFIZER LABORATORIES DIV PFIZER INC


CARDURA, DOXAZOSIN MESYLATE
DIABINESE, CHLORPROPAMIDE
FELDENE, PIROXICAM
MINIPRESS, PRAZOSIN HYDROCHLORIDE
PROCARDIA XL, NIFEDIPINE
VIBRAMYCIN, DOXYCYCLINE
VIBRAMYCIN, DOXYCYCLINE CALCIUM
VIBRAMYCIN, DOXYCYCLINE HYCLATE
VIBRA-TABS, DOXYCYCLINE HYCLATE

VISTARIL, HYDROXYZINE PAMOATE


* PFIZER PHARMACEUTICALS INC


ZOLOFT, SERTRALINE HYDROCHLORIDE
* PFIZER PHARMACEUTICALS PRODUCTION CORP LTD
TIKOSYN, DOFETILIDE
PFIZER GLOBAL
* PFIZER GLOBAL RESEARCH DEVELOPMENT
ZMAX, AZITHROMYCIN
PFIZER INC
* PFIZER INC
CAMPTOSAR, IRINOTECAN HYDROCHLORIDE
CHANTIX, VARENICLINE TARTRATE
ELLENCE, EPIRUBICIN HYDROCHLORIDE
GEODON, ZIPRASIDONE HYDROCHLORIDE

NICOTROL, NICOTINE

PFIZER IRELAND
* PFIZER IRELAND PHARMACEUTICALS
RELPAX, ELETRIPTAN HYDROBROMIDE

VIAGRA, SILDENAFIL CITRATE


PFIZER PHARMS
* PFIZER PHARMACEUTICALS LTD
ACCUPRIL, QUINAPRIL HYDROCHLORIDE
ACCURETIC, HYDROCHLOROTHIAZIDE
LOPID, GEMFIBROZIL
NEURONTIN, GABAPENTIN

NITROSTAT, NITROGLYCERIN

PHARMACIA AND UPJOHN


* PHARMACIA AND UPJOHN
XANAX XR, ALPRAZOLAM
* PHARMACIA AND UPJOHN CO
ANSAID, FLURBIPROFEN
AROMASIN, EXEMESTANE
AZULFIDINE EN-TABS, SULFASALAZINE
AZULFIDINE, SULFASALAZINE
CAVERJECT IMPULSE, ALPROSTADIL
CAVERJECT, ALPROSTADIL
CLEOCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 45

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** P **
* PHARMACIA AND UPJOHN CO
CLEOCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLEOCIN T, CLINDAMYCIN PHOSPHATE
CLEOCIN, CLINDAMYCIN PHOSPHATE
COLESTID, COLESTIPOL HYDROCHLORIDE
CORTEF, HYDROCORTISONE
CORVERT, IBUTILIDE FUMARATE
CYKLOKAPRON, TRANEXAMIC ACID
DEPO-MEDROL, METHYLPREDNISOLONE ACETATE
DEPO-PROVERA, MEDROXYPROGESTERONE ACETATE
DETROL LA, TOLTERODINE TARTRATE
DETROL, TOLTERODINE TARTRATE
DIDREX, BENZPHETAMINE HYDROCHLORIDE
EMCYT, ESTRAMUSTINE PHOSPHATE SODIUM
ESTRING, ESTRADIOL
FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE
GENOTROPIN PRESERVATIVE FREE, SOMATROPIN RECOMBINANT
GENOTROPIN, SOMATROPIN RECOMBINANT
GLYNASE, GLYBURIDE
GLYSET, MIGLITOL
HALCION, TRIAZOLAM
HEMABATE, CARBOPROST TROMETHAMINE
IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE
LINCOCIN, LINCOMYCIN HYDROCHLORIDE
MEDROL, METHYLPREDNISOLONE
MYCOBUTIN, RIFABUTIN
NICOTROL, NICOTINE
PREPIDIL, DINOPROSTONE
PROSTIN E2, DINOPROSTONE
PROSTIN VR PEDIATRIC, ALPROSTADIL
PROVERA, MEDROXYPROGESTERONE ACETATE
R-GENE 10, ARGININE HYDROCHLORIDE
SOLU-CORTEF, HYDROCORTISONE SODIUM SUCCINATE
SOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATE
SOMAVERT, PEGVISOMANT
TROBICIN, SPECTINOMYCIN HYDROCHLORIDE
VANTIN, CEFPODOXIME PROXETIL
XALATAN, LATANOPROST
XANAX, ALPRAZOLAM
ZINECARD, DEXRAZOXANE HYDROCHLORIDE

ZYVOX, LINEZOLID

* PHARMACIA AND UPJOHN SUB PFIZER INC


DEPO-SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE
PHARMALUCENCE
* PHARMALUCENCE INC
AN-DTPA, TECHNETIUM TC-99M PENTETATE KIT
AN-SULFUR COLLOID, TECHNETIUM TC-99M SULFUR COLLOID KIT
CIS-MDP, TECHNETIUM TC-99M MEDRONATE KIT
CIS-PYRO, TECHNETIUM TC-99M PYROPHOSPHATE KIT
HEPATOLITE, TECHNETIUM TC-99M DISOFENIN KIT

PULMOLITE, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT


PHARMASEAL
* PHARMASEAL DIV BAXTER HEALTHCARE CORP
PHARMASEAL SCRUB CARE, CHLORHEXIDINE GLUCONATE (OTC)
PIERRE FABRE
* PIERRE FABRE MEDICAMENT
NAVELBINE, VINORELBINE TARTRATE
POHL BOSKAMP
* POHL BOSKAMP
NITROLINGUAL PUMPSPRAY, NITROGLYCERIN
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 46

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** P **
POLYMEDICA
* POLYMEDICA INDUSTRIES INC
NEOPAP, ACETAMINOPHEN (OTC)
PRIMAPHARM
* PRIMAPHARM INC
HYDASE, HYALURONIDASE
PRISM PHARMS
* PRISM PHARMACEUTICALS INC
NEXTERONE, AMIODARONE HYDROCHLORIDE
PROCTER AND GAMBLE
* PROCTER AND GAMBLE CO
MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE
* PROCTER AND GAMBLE PHARMACEUTICALS INC
ASACOL HD, MESALAMINE
* PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO
ACTONEL, RISEDRONATE SODIUM
ASACOL, MESALAMINE
DIDRONEL, ETIDRONATE DISODIUM

MACROBID, NITROFURANTOIN

PROGENICS
* PROGENICS PHARMACEUTICALS INC
RELISTOR, METHYLNALTREXONE BROMIDE
PROMETHEUS LABS
* PROMETHEUS LABORATORIES INC
HELIDAC, BISMUTH SUBSALICYLATE
IMURAN, AZATHIOPRINE
LOTRONEX, ALOSETRON HYDROCHLORIDE
RIDAURA, AURANOFIN
TRANDATE, LABETALOL HYDROCHLORIDE

ZYLOPRIM, ALLOPURINOL

PROMIUS PHARMA
* PROMIUS PHARMA LLC
ISMO, ISOSORBIDE MONONITRATE
SECTRAL, ACEBUTOLOL HYDROCHLORIDE

TENEX, GUANFACINE HYDROCHLORIDE


PURDUE PHARM PRODS


* PURDUE PHARMACEUTICAL PRODUCTS LP
DILAUDID, HYDROMORPHONE HYDROCHLORIDE

DILAUDID-HP, HYDROMORPHONE HYDROCHLORIDE


PURDUE PHARMA
* PURDUE PHARMA PRODUCTS LP
RYZOLT, TRAMADOL HYDROCHLORIDE
PURDUE PHARMA LP
* PURDUE PHARMA LP
MS CONTIN, MORPHINE SULFATE

OXYCONTIN, OXYCODONE HYDROCHLORIDE


QLT
* QLT INC
VISUDYNE, VERTEPORFIN
QOL MEDCL
* QOL MEDICAL LLC
ELLIOTTS B SOLUTION, CALCIUM CHLORIDE
ETHAMOLIN, ETHANOLAMINE OLEATE

SUCRAID, SACROSIDASE

QUESTCOR PHARMS
* QUESTCOR PHARMACEUTICALS INC
DORAL, QUAZEPAM
H.P. ACTHAR GEL, CORTICOTROPIN
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 47

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** R **
R TECH UENO LTD
* R TECH UENO LTD
RESCULA, UNOPROSTONE ISOPROPYL
RANBAXY
* RANBAXY LABORATORIES INC
EURAX, CROTAMITON
EXELDERM, SULCONAZOLE NITRATE
HALOG, HALCINONIDE
ISOPTIN SR, VERAPAMIL HYDROCHLORIDE
KENALOG, TRIAMCINOLONE ACETONIDE
LAC-HYDRIN, AMMONIUM LACTATE
ULTRAVATE, HALOBETASOL PROPIONATE

WESTCORT, HYDROCORTISONE VALERATE


* RANBAXY PHARMACEUTICALS INC


AVENTYL HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

RIOMET, METFORMIN HYDROCHLORIDE


RARE DIS
* RARE DISEASE THERAPEUTICS INC
ORFADIN, NITISINONE
RARE DIS THERAP
* RARE DISEASE THERAPEUTICS INC
CYSTADANE, BETAINE HYDROCHLORIDE
RECKITT BENCKISER
* RECKITT BENCKISER
DELSYM, DEXTROMETHORPHAN POLISTIREX (OTC)
* RECKITT BENCKISER INC
MUCINEX D, GUAIFENESIN (OTC)
MUCINEX DM, DEXTROMETHORPHAN HYDROBROMIDE (OTC)

MUCINEX, GUAIFENESIN (OTC)

* RECKITT BENCKISER PHARMACEUTICALS INC


BUPRENEX, BUPRENORPHINE HYDROCHLORIDE
SUBOXONE, BUPRENORPHINE HYDROCHLORIDE

SUBUTEX, BUPRENORPHINE HYDROCHLORIDE


REGENT
* REGENT MEDICAL AMERICAS LLC
HIBICLENS, CHLORHEXIDINE GLUCONATE (OTC)

HIBISTAT, CHLORHEXIDINE GLUCONATE (OTC)


ROCHE
* HOFFMANN LA ROCHE INC
BONIVA, IBANDRONATE SODIUM
COPEGUS, RIBAVIRIN
FUZEON, ENFUVIRTIDE
INVIRASE, SAQUINAVIR MESYLATE
KLONOPIN, CLONAZEPAM
KYTRIL, GRANISETRON HYDROCHLORIDE
TAMIFLU, OSELTAMIVIR PHOSPHATE
VALIUM, DIAZEPAM

VESANOID, TRETINOIN

ROCHE PALO
* ROCHE PALO ALTO LLC
AEROBID, FLUNISOLIDE
ANAPROX DS, NAPROXEN SODIUM
ANAPROX, NAPROXEN SODIUM
CELLCEPT, MYCOPHENOLATE MOFETIL
CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE
EC-NAPROSYN, NAPROXEN
NAPROSYN, NAPROXEN

VALCYTE, VALGANCICLOVIR HYDROCHLORIDE


ROMARK
* ROMARK LABORATORIES
ALINIA, NITAZOXANIDE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 48

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** R **
ROSS LABS
* ROSS LABORATORIES DIV ABBOTT LABORATORIES INC
SURVANTA, BERACTANT
ROXANE
* ROXANE LABORATORIES INC
CODEINE SULFATE, CODEINE SULFATE
DIGOXIN, DIGOXIN
DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
FUROSEMIDE, FUROSEMIDE
LITHIUM CARBONATE, LITHIUM CARBONATE
LITHIUM CITRATE, LITHIUM CITRATE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE


SAGE PRODS
* SAGE PRODUCTS INC
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC)
SALIX PHARMS
* SALIX PHARMACEUTICALS INC
APRISO, MESALAMINE
COLAZAL, BALSALAZIDE DISODIUM
DIURIL, CHLOROTHIAZIDE
METOZOLV ODT, METOCLOPRAMIDE HYDROCHLORIDE
MOVIPREP, ASCORBIC ACID
OSMOPREP, SODIUM PHOSPHATE, DIBASIC ANHYDROUS
PEPCID, FAMOTIDINE
VISICOL, SODIUM PHOSPHATE, DIBASIC ANHYDROUS

XIFAXAN, RIFAXIMIN

SANDOZ
* SANDOZ CANADA INC
ANECTINE, SUCCINYLCHOLINE CHLORIDE
ARISTOSPAN, TRIAMCINOLONE HEXACETONIDE
COSYNTROPIN, COSYNTROPIN
INFUVITE ADULT, ALPHA-TOCOPHEROL ACETATE
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), ASCORBIC ACID
INFUVITE PEDIATRIC, ASCORBIC ACID

REGONOL, PYRIDOSTIGMINE BROMIDE


* SANDOZ INC
FUROSEMIDE, FUROSEMIDE
ISONIAZID, ISONIAZID
METRONIDAZOLE, METRONIDAZOLE
OMNITROPE, SOMATROPIN RECOMBINANT
PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE
RESERPINE, RESERPINE

SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE


SANOFI AVENTIS US
* SANOFI AVENTIS US LLC
ALLEGRA D 24 HOUR, FEXOFENADINE HYDROCHLORIDE
ALLEGRA, FEXOFENADINE HYDROCHLORIDE
ALLEGRA-D 12 HOUR, FEXOFENADINE HYDROCHLORIDE
AMARYL, GLIMEPIRIDE
AMBIEN CR, ZOLPIDEM TARTRATE
AMBIEN, ZOLPIDEM TARTRATE
ANZEMET, DOLASETRON MESYLATE
APIDRA SOLOSTAR, INSULIN GLULISINE RECOMBINANT
APIDRA, INSULIN GLULISINE RECOMBINANT
ARALEN, CHLOROQUINE PHOSPHATE
ARAVA, LEFLUNOMIDE
AVALIDE, HYDROCHLOROTHIAZIDE
AVAPRO, IRBESARTAN
BENZACLIN, BENZOYL PEROXIDE
BENZAMYCIN PAK, BENZOYL PEROXIDE

BENZAMYCIN, BENZOYL PEROXIDE


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 49

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** S **
* SANOFI AVENTIS US LLC
CANTIL, MEPENZOLATE BROMIDE
CARAC, FLUOROURACIL
CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER, CEFOTAXIME SODIUM
CLAFORAN, CEFOTAXIME SODIUM
CLOMID, CLOMIPHENE CITRATE
DDAVP (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE
DDAVP, DESMOPRESSIN ACETATE
DEMEROL, MEPERIDINE HYDROCHLORIDE
DERMATOP E EMOLLIENT, PREDNICARBATE
DERMATOP, PREDNICARBATE
DIABETA, GLYBURIDE
DRISDOL, ERGOCALCIFEROL
ELOXATIN, OXALIPLATIN
FERRLECIT, SODIUM FERRIC GLUCONATE COMPLEX
GAVISCON, ALUMINUM HYDROXIDE (OTC)
HIPREX, METHENAMINE HIPPURATE
KAYEXALATE, SODIUM POLYSTYRENE SULFONATE
KETEK, TELITHROMYCIN
KLARON, SULFACETAMIDE SODIUM
LANTUS, INSULIN GLARGINE RECOMBINANT
LASIX, FUROSEMIDE
LOVENOX (PRESERVATIVE FREE), ENOXAPARIN SODIUM
LOVENOX, ENOXAPARIN SODIUM
MULTAQ, DRONEDARONE HYDROCHLORIDE
MYTELASE, AMBENONIUM CHLORIDE
NASACORT AQ, TRIAMCINOLONE ACETONIDE
NEGGRAM, NALIDIXIC ACID
NICODERM CQ, NICOTINE (OTC)
NILANDRON, NILUTAMIDE
NORITATE, METRONIDAZOLE
NORPRAMIN, DESIPRAMINE HYDROCHLORIDE
OFORTA, FLUDARABINE PHOSPHATE
PENLAC, CICLOPIROX
PHISOHEX, HEXACHLOROPHENE
PLAQUENIL, HYDROXYCHLOROQUINE SULFATE
PLAVIX, CLOPIDOGREL BISULFATE
PRIFTIN, RIFAPENTINE
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
PRIMAQUINE, PRIMAQUINE PHOSPHATE
PSORCON, DIFLORASONE DIACETATE
RIFADIN, RIFAMPIN
RIFATER, ISONIAZID
RILUTEK, RILUZOLE
SKELID, TILUDRONATE DISODIUM
TALACEN, ACETAMINOPHEN
TALWIN NX, NALOXONE HYDROCHLORIDE
TAXOTERE, DOCETAXEL
TRENTAL, PENTOXIFYLLINE

UROXATRAL, ALFUZOSIN HYDROCHLORIDE


SANTARUS
* SANTARUS INC
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE, MAGNESIUM HYDROXIDE
ZEGERID, MAGNESIUM HYDROXIDE

ZEGERID, OMEPRAZOLE

SANTEN
* SANTEN INC
ALAMAST, PEMIROLAST POTASSIUM
IQUIX, LEVOFLOXACIN

QUIXIN, LEVOFLOXACIN

SANTEN OY
* SANTEN OY
BETIMOL, TIMOLOL
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 50

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** S **
SAVAGE LABS
* SAVAGE LABORATORIES INC DIV ALTANA INC
ETHIODOL, ETHIODIZED OIL
KAON CL-10, POTASSIUM CHLORIDE

PANDEL, HYDROCORTISONE PROBUTATE


SAVIENT PHARMS
* SAVIENT PHARMACEUTICALS INC
OXANDRIN, OXANDROLONE
SB PHARMCO
* SB PHARMCO PUERTO RICO INC
AVANDAMET, METFORMIN HYDROCHLORIDE
AVANDARYL, GLIMEPIRIDE
AVANDIA, ROSIGLITAZONE MALEATE

COREG CR, CARVEDILOL PHOSPHATE


SCHERING
* SCHERING
CLARINEX-D 12 HOUR, DESLORATADINE
* SCHERING CORP
ASMANEX TWISTHALER, MOMETASONE FUROATE
CLARINEX D 24 HOUR, DESLORATADINE
CLARINEX, DESLORATADINE
DIPROLENE AF, BETAMETHASONE DIPROPIONATE
GUANIDINE HYDROCHLORIDE, GUANIDINE HYDROCHLORIDE
INTEGRILIN, EPTIFIBATIDE
LOTRISONE, BETAMETHASONE DIPROPIONATE
NOXAFIL, POSACONAZOLE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
REBETOL, RIBAVIRIN
TEMODAR, TEMOZOLOMIDE

ZEMURON, ROCURONIUM BROMIDE


* SCHERING CORP SUB SCHERING PLOUGH CORP


CELESTONE SOLUSPAN, BETAMETHASONE ACETATE
CELESTONE, BETAMETHASONE
DIPROLENE, BETAMETHASONE DIPROPIONATE

ELOCON, MOMETASONE FUROATE


SCHERING PLOUGH
* SCHERING PLOUGH CORP
CLARINEX, DESLORATADINE
* SCHERING PLOUGH HEALTHCARE PRODUCTS INC
AFRINOL, PSEUDOEPHEDRINE SULFATE (OTC)
CHILDREN'S CLARITIN, LORATADINE (OTC)
CHLOR-TRIMETON, CHLORPHENIRAMINE MALEATE (OTC)
CLARITIN HIVES RELIEF REDITAB, LORATADINE (OTC)
CLARITIN HIVES RELIEF, LORATADINE (OTC)
CLARITIN REDITABS, LORATADINE (OTC)
CLARITIN, LORATADINE (OTC)
CLARITIN-D 24 HOUR, LORATADINE (OTC)
DISOPHROL, DEXBROMPHENIRAMINE MALEATE (OTC)
DRIXORAL PLUS, ACETAMINOPHEN (OTC)
DRIXORAL, DEXBROMPHENIRAMINE MALEATE (OTC)
GYNE-LOTRIMIN 3 COMBINATION PACK, CLOTRIMAZOLE (OTC)
GYNE-LOTRIMIN 3, CLOTRIMAZOLE (OTC)
GYNE-LOTRIMIN COMBINATION PACK, CLOTRIMAZOLE (OTC)
GYNE-LOTRIMIN, CLOTRIMAZOLE (OTC)
LOTRIMIN ULTRA, BUTENAFINE HYDROCHLORIDE (OTC)
MIRALAX, POLYETHYLENE GLYCOL 3350 (OTC)
NASONEX, MOMETASONE FUROATE MONOHYDRATE
OCUCLEAR, OXYMETAZOLINE HYDROCHLORIDE (OTC)
SHADE UVAGUARD, AVOBENZONE (OTC)

ZEGERID OTC, OMEPRAZOLE (OTC)


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 51

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** S **
SCHERING PLOUGH RES
* SCHERING PLOUGH RESEARCH INSTITUTE
LOTRISONE, BETAMETHASONE DIPROPIONATE

REBETOL, RIBAVIRIN

SCHWARZ
* SCHWARZ GMBH
MONOKET, ISOSORBIDE MONONITRATE
SCHWARZ BIOSCIENCES
* SCHWARZ BIOSCIENCES INC
VIMPAT, LACOSAMIDE
SCHWARZ PHARMA
* SCHWARZ PHARMA AG
EDEX, ALPROSTADIL
* SCHWARZ PHARMA INC
CORTIFOAM, HYDROCORTISONE ACETATE
DILATRATE-SR, ISOSORBIDE DINITRATE
FLUXID, FAMOTIDINE
KEMSTRO, BACLOFEN
LEVATOL, PENBUTOLOL SULFATE
NIRAVAM, ALPRAZOLAM
ROBAXIN, METHOCARBAMOL
ROBAXIN-750, METHOCARBAMOL
UNIRETIC, HYDROCHLOROTHIAZIDE

UNIVASC, MOEXIPRIL HYDROCHLORIDE


SCIELE PHARMA INC


* SCIELE PHARMA INC
CEDAX, CEFTIBUTEN DIHYDRATE
COGNEX, TACRINE HYDROCHLORIDE
FENOGLIDE, FENOFIBRATE
FURADANTIN, NITROFURANTOIN
JENLOGA, CLONIDINE HYDROCHLORIDE
ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE
PONSTEL, MEFENAMIC ACID
ROBINUL FORTE, GLYCOPYRROLATE
ROBINUL, GLYCOPYRROLATE
SULAR, NISOLDIPINE
TWINJECT 0.15, EPINEPHRINE
TWINJECT 0.3, EPINEPHRINE

ULESFIA, BENZYL ALCOHOL


SCIOS
* SCIOS INC
NATRECOR, NESIRITIDE RECOMBINANT
SEPRACOR
* SEPRACOR INC
BROVANA, ARFORMOTEROL TARTRATE
LUNESTA, ESZOPICLONE
XOPENEX HFA, LEVALBUTEROL TARTRATE

XOPENEX, LEVALBUTEROL HYDROCHLORIDE


SHIRE
* SHIRE DEVELOPMENT INC
ADDERALL XR 10, AMPHETAMINE ASPARTATE
ADDERALL XR 15, AMPHETAMINE ASPARTATE
ADDERALL XR 20, AMPHETAMINE ASPARTATE
ADDERALL XR 25, AMPHETAMINE ASPARTATE
ADDERALL XR 30, AMPHETAMINE ASPARTATE
ADDERALL XR 5, AMPHETAMINE ASPARTATE
AGRYLIN, ANAGRELIDE HYDROCHLORIDE
CARBATROL, CARBAMAZEPINE
DAYTRANA, METHYLPHENIDATE
FOSRENOL, LANTHANUM CARBONATE

INTUNIV, GUANFACINE HYDROCHLORIDE


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 52

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** S **
* SHIRE DEVELOPMENT INC
LIALDA, MESALAMINE
PENTASA, MESALAMINE
PROAMATINE, MIDODRINE HYDROCHLORIDE

SALURON, HYDROFLUMETHIAZIDE

SHIRE DEVELOPMENT
* SHIRE DEVELOPMENT INC
VYVANSE, LISDEXAMFETAMINE DIMESYLATE
SIGMA TAU
* SIGMA TAU PHARMACEUTICALS INC
CARNITOR SF, LEVOCARNITINE
CARNITOR, LEVOCARNITINE

MATULANE, PROCARBAZINE HYDROCHLORIDE


SIRION THERAP
* SIRION THERAPEUTICS INC
DUREZOL, DIFLUPREDNATE

ZIRGAN, GANCICLOVIR

SKINMEDICA
* SKINMEDICA INC
VANIQA, EFLORNITHINE HYDROCHLORIDE
SKYEPHARMA AG
* SKYEPHARMA AG
TRIGLIDE, FENOFIBRATE
SMITHKLINE BEECHAM
* SMITHKLINE BEECHAM
LOVAZA, OMEGA-3-ACID ETHYL ESTERS
* SMITHKLINE BEECHAM CORP
LAMICTAL XR, LAMOTRIGINE
* SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE
ARRANON, NELARABINE
AXID, NIZATIDINE
COREG, CARVEDILOL
DEXEDRINE, DEXTROAMPHETAMINE SULFATE
DYNACIRC CR, ISRADIPINE
HYCAMTIN, TOPOTECAN HYDROCHLORIDE
INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE
LAMICTAL ODT, LAMOTRIGINE
LANOXICAPS, DIGOXIN
LANOXIN, DIGOXIN
LEUKERAN, CHLORAMBUCIL
REQUIP XL, ROPINIROLE HYDROCHLORIDE
RYTHMOL SR, PROPAFENONE HYDROCHLORIDE
RYTHMOL, PROPAFENONE HYDROCHLORIDE

TYKERB, LAPATINIB DITOSYLATE


SOLUMED
* LES ENTREPRISES SOLUMED INC
CHLORASCRUB MAXI SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
CHLORASCRUB SWAB, CHLORHEXIDINE GLUCONATE (OTC)

CHLORASCRUB SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)


SOLVAY
* SOLVAY PHARMACEUTICALS
CREON, LIPASE
SOLVAY PHARMS
* SOLVAY PHARMACEUTICALS INC
ACEON, PERINDOPRIL ERBUMINE
SOMERSET
* SOMERSET PHARMACEUTICALS INC
ELDEPRYL, SELEGILINE HYDROCHLORIDE

EMSAM, SELEGILINE

30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 53

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** S **
SPECTRUM PHARMS
* SPECTRUM PHARMACEUTICALS INC
FUSILEV, LEVOLEUCOVORIN CALCIUM
STAND HOMEOPATH
* STANDARD HOMEOPATHIC CO
IVY BLOCK, BENTOQUATAM (OTC)
STAT TRADE
* STAT TRADE INC
NAPRELAN, NAPROXEN SODIUM
STEVENS J
* JEROME STEVENS PHARMACEUTICALS INC
UNITHROID, LEVOTHYROXINE SODIUM
STI PHARMA LLC
* STI PHARMA LLC
MYAMBUTOL, ETHAMBUTOL HYDROCHLORIDE
STIEFEL
* STIEFEL LABORATORIES INC
DECLOMYCIN, DEMECLOCYCLINE HYDROCHLORIDE

DUAC, BENZOYL PEROXIDE


STIEFEL LABS INC


* STIEFEL LABORATORIES INC
EVOCLIN, CLINDAMYCIN PHOSPHATE
EXTINA, KETOCONAZOLE
OLUX E, CLOBETASOL PROPIONATE
SOLAGE, MEQUINOL
SORIATANE, ACITRETIN
VERDESO, DESONIDE
VUSION, MICONAZOLE NITRATE

XOLEGEL, KETOCONAZOLE

STRAKAN
* STRAKAN INTERNATIONAL LTD
SANCUSO, GRANISETRON
SUCAMPO PHARMS
* SUCAMPO PHARMACEUTICALS INC
AMITIZA, LUBIPROSTONE
SYNCOR PHARMS
* SYNCOR PHARMACEUTICALS INC
SODIUM IODIDE I 123, SODIUM IODIDE, I-123
TAKEDA GLOBAL
* TAKEDA GLOBAL RESEARCH DEVELOPMENT CENTER INC
ACTOPLUS MET XR, METFORMIN HYDROCHLORIDE
ACTOPLUS MET, METFORMIN HYDROCHLORIDE
DUETACT, GLIMEPIRIDE

ROZEREM, RAMELTEON

TAKEDA PHARMS
* TAKEDA PHARMACEUTICALS NORTH AMERICA INC
KAPIDEX, DEXLANSOPRAZOLE

ULORIC, FEBUXOSTAT

TAKEDA PHARMS NA
* TAKEDA PHARMACEUTICALS NORTH AMERICA INC
ACTOS, PIOGLITAZONE HYDROCHLORIDE
PREVACID, LANSOPRAZOLE

PREVPAC, AMOXICILLIN

TARO
* TARO PHARMACEUTICALS USA INC
FLO-PRED, PREDNISOLONE ACETATE
FLUOCINONIDE, FLUOCINONIDE
LORATADINE, LORATADINE (OTC)

TRIVAGIZOLE 3, CLOTRIMAZOLE (OTC)


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 54

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** T **
TARO PHARMS NORTH
* TARO PHARMACEUTICALS NORTH AMERICA INC
OVIDE, MALATHION
TOPICORT LP, DESOXIMETASONE

TOPICORT, DESOXIMETASONE

TEIKOKU PHARMA USA


* TEIKOKU PHARMA USA INC
LIDODERM, LIDOCAINE
TERCICA
* TERCICA INC
INCRELEX, MECASERMIN RECOMBINANT
TEVA
* TEVA NEUROSCIENCE INC
AZILECT, RASAGILINE MESYLATE

COPAXONE, GLATIRAMER ACETATE


* TEVA PHARMACEUTICALS USA INC


BETA-VAL, BETAMETHASONE VALERATE
GALZIN, ZINC ACETATE
ORAP, PIMOZIDE
PURINETHOL, MERCAPTOPURINE

TRIMETHOPRIM, TRIMETHOPRIM

TEVA GLOBAL
* TEVA GLOBAL RESPIRATORY RESEARCH LLC
NASAREL, FLUNISOLIDE
PROAIR HFA, ALBUTEROL SULFATE
PROGLYCEM, DIAZOXIDE
QVAR 40, BECLOMETHASONE DIPROPIONATE

QVAR 80, BECLOMETHASONE DIPROPIONATE


TEVA PARENTERAL
* TEVA PARENTERAL MEDICINES INC
AZITHROMYCIN, AZITHROMYCIN
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
OXALIPLATIN, OXALIPLATIN

ZANOSAR, STREPTOZOCIN

TEVA PHARMS
* TEVA PHARMACEUTICALS USA
VANDAZOLE, METRONIDAZOLE
THERAKOS
* THERAKOS INC
UVADEX, METHOXSALEN
THERAVANCE INC
* THERAVANCE INC
VIBATIV, TELAVANCIN HYDROCHLORIDE
THREE RIVERS PHARMS
* THREE RIVERS PHARMACEUTICALS LLC
AMPHOTEC, AMPHOTERICIN B
TIBOTEC
* TIBOTEC INC
INTELENCE, ETRAVIRINE
TOLMAR
* TOLMAR INC
ATRIDOX, DOXYCYCLINE HYCLATE
TOLMAR THERAP
* TOLMAR THERAPEUTICS INC
ELIGARD, LEUPROLIDE ACETATE
TOPOTARGET
* TOPOTARGET AS
TOTECT, DEXRAZOXANE HYDROCHLORIDE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 55

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** T **
TRIAX PHARMS LLC
* TRIAX PHARMACEUTICALS LLC
LOCOID LIPOCREAM, HYDROCORTISONE BUTYRATE
LOCOID, HYDROCORTISONE BUTYRATE

MINOCIN, MINOCYCLINE HYDROCHLORIDE


TRIS PHARMA
* TRIS PHARMA INC
CLONIDINE, CLONIDINE
TYCO HLTHCARE
* TYCO HEALTHCARE GROUP LP
ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE
PAMELOR, NORTRIPTYLINE HYDROCHLORIDE
RESTORIL, TEMAZEPAM

TOFRANIL-PM, IMIPRAMINE PAMOATE


UCB INC
* UCB INC
DIPENTUM, OLSALAZINE SODIUM
KEPPRA XR, LEVETIRACETAM
KEPPRA, LEVETIRACETAM
METADATE CD, METHYLPHENIDATE HYDROCHLORIDE
PEDIAPRED, PREDNISOLONE SODIUM PHOSPHATE
SEMPREX-D, ACRIVASTINE
TUSSIONEX PENNKINETIC, CHLORPHENIRAMINE POLISTIREX
XYZAL, LEVOCETIRIZINE DIHYDROCHLORIDE

ZAROXOLYN, METOLAZONE

UCYCLYD
* UCYCLYD PHARMA INC
AMMONUL, SODIUM BENZOATE
UDL LABS
* UDL LABORATORIES
SULFAMYLON, MAFENIDE ACETATE
ULURU
* ULURU INC
APHTHASOL, AMLEXANOX
UNIMED
* UNIMED INC
MARINOL, DRONABINOL
UNIMED PHARMS
* UNIMED PHARMACEUTICALS INC
ANDROGEL, TESTOSTERONE
UNIMED PHARMS LLC
* UNIMED PHARMACEUTICALS LLC
PROMETRIUM, PROGESTERONE
UNITED GUARDIAN
* UNITED GUARDIAN INC
RENACIDIN, CITRIC ACID
UNITED THERAP
* UNITED THERAPEUTICS CORP
REMODULIN, TREPROSTINIL SODIUM

TYVASO, TREPROSTINIL SODIUM


UPSHER SMITH
* UPSHER SMITH LABORATORIES INC
DIVIGEL, ESTRADIOL
FORTICAL, CALCITONIN SALMON RECOMBINANT

KLOR-CON, POTASSIUM CHLORIDE


US SURGCL
* UNITED STATES SURGICAL DIV TYCO HEALTHCARE GROUP LP
LYMPHAZURIN, ISOSULFAN BLUE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 56

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** V **
VALEANT
* VALEANT PHARMACEUTICALS INTERNATIONAL
ANCOBON, FLUCYTOSINE
D.H.E. 45, DIHYDROERGOTAMINE MESYLATE

DIASTAT ACUDIAL, DIAZEPAM


DIASTAT, DIAZEPAM

FLUOROURACIL, FLUOROURACIL

MIGRANAL, DIHYDROERGOTAMINE MESYLATE


MOTOFEN, ATROPINE SULFATE


MYSOLINE, PRIMIDONE

VALEANT PHARM INTL


* VALEANT PHARMACEUTICALS INTERNATIONAL
8-MOP, METHOXSALEN
DALMANE, FLURAZEPAM HYDROCHLORIDE
EFUDEX, FLUOROURACIL
LEVO-DROMORAN, LEVORPHANOL TARTRATE
LIMBITROL DS, AMITRIPTYLINE HYDROCHLORIDE
LIMBITROL, AMITRIPTYLINE HYDROCHLORIDE
MESTINON, PYRIDOSTIGMINE BROMIDE
OXSORALEN, METHOXSALEN
OXSORALEN-ULTRA, METHOXSALEN
TASMAR, TOLCAPONE
TENSILON PRESERVATIVE FREE, EDROPHONIUM CHLORIDE
TENSILON, EDROPHONIUM CHLORIDE
VIRAZOLE, RIBAVIRIN

ZELAPAR, SELEGILINE HYDROCHLORIDE


VALIDUS PHARMS
* VALIDUS PHARMACEUTICALS LLC
ROCALTROL, CALCITRIOL
VALIDUS PHARMS INC
* VALIDUS PHARMACEUTICALS INC
EQUETRO, CARBAMAZEPINE

MARPLAN, ISOCARBOXAZID

VANDA PHARMS INC


* VANDA PHARMACEUTICALS INC
FANAPT, ILOPERIDONE
VATRING PHARMS
* VATRING PHARMACEUTICALS LP
UREX, METHENAMINE HIPPURATE
VEROSCIENCE
* VEROSCIENCE LLC
CYCLOSET, BROMOCRIPTINE MESYLATE
VICURON
* VICURON PHARMACEUTICALS INC
ERAXIS, ANIDULAFUNGIN
VIIV HLTHCARE
* VIIV HEALTHCARE CO
COMBIVIR, LAMIVUDINE
EPIVIR, LAMIVUDINE
EPZICOM, ABACAVIR SULFATE
LEXIVA, FOSAMPRENAVIR CALCIUM
RESCRIPTOR, DELAVIRDINE MESYLATE
RETROVIR, ZIDOVUDINE
SELZENTRY, MARAVIROC
TRIZIVIR, ABACAVIR SULFATE

ZIAGEN, ABACAVIR SULFATE


VIROPHARMA
* VIROPHARMA INC
VANCOCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 57

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** V **
VIVUS
* VIVUS INC
MUSE, ALPROSTADIL
WARNER CHILCOTT
* WARNER CHILCOTT INC
DURICEF, CEFADROXIL/CEFADROXIL HEMIHYDRATE
ESTROSTEP FE, ETHINYL ESTRADIOL
FEMCON FE, ETHINYL ESTRADIOL
FEMHRT, ETHINYL ESTRADIOL
FEMTRACE, ESTRADIOL ACETATE
LOESTRIN 21 1.5/30, ETHINYL ESTRADIOL
LOESTRIN 21 1/20, ETHINYL ESTRADIOL
LOESTRIN 24 FE, ETHINYL ESTRADIOL
LOESTRIN FE 1.5/30, ETHINYL ESTRADIOL
LOESTRIN FE 1/20, ETHINYL ESTRADIOL
OVCON-35, ETHINYL ESTRADIOL
OVCON-50, ETHINYL ESTRADIOL

SARAFEM, FLUOXETINE HYDROCHLORIDE


WATSON LABS
* WATSON LABORATORIES INC
ALLOPURINOL, ALLOPURINOL
ALORA, ESTRADIOL
ANDRODERM, TESTOSTERONE
BREVICON 28-DAY, ETHINYL ESTRADIOL
CORDRAN, FLURANDRENOLIDE
DILACOR XR, DILTIAZEM HYDROCHLORIDE
GELNIQUE, OXYBUTYNIN CHLORIDE
METRONIDAZOLE, METRONIDAZOLE
MICROZIDE, HYDROCHLOROTHIAZIDE
NORINYL 1+35 21-DAY, ETHINYL ESTRADIOL
NORINYL 1+35 28-DAY, ETHINYL ESTRADIOL
NORINYL 1+50 28-DAY, MESTRANOL
RAPAFLO, SILODOSIN
TRELSTAR DEPOT, TRIPTORELIN PAMOATE
TRELSTAR LA, TRIPTORELIN PAMOATE

TRI-NORINYL 28-DAY, ETHINYL ESTRADIOL


WATSON LABS (UTAH)


* WATSON LABORATORIES INC
INFED, IRON DEXTRAN
NOR-QD, NORETHINDRONE
OXYTROL, OXYBUTYNIN

PROGESTERONE, PROGESTERONE

WATSON PHARMS
* WATSON PHARMACEUTICALS
TENUATE DOSPAN, DIETHYLPROPION HYDROCHLORIDE

TENUATE, DIETHYLPROPION HYDROCHLORIDE


* WATSON PHARMACEUTICALS INC


ACTIGALL, URSODIOL
CONDYLOX, PODOFILOX
CORDRAN SP, FLURANDRENOLIDE
CORDRAN, FLURANDRENOLIDE
FIORICET W/ CODEINE, ACETAMINOPHEN
FIORINAL W/CODEINE, ASPIRIN
FIORINAL, ASPIRIN

MONODOX, DOXYCYCLINE

WEILL MEDCL COLL


* WEILL MEDICAL COLLEGE CORNELL UNIV
FLUDEOXYGLUCOSE F 18, FLUDEOXYGLUCOSE F-18
WELLSPRING PHARM
* WELLSPRING PHARMACEUTICAL CORP
DIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 58

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** W **
* WELLSPRING PHARMACEUTICAL CORP
DYRENIUM, TRIAMTERENE
WRASER PHARMS
* WRASER PHARMACEUTICALS LLC
CETRAXAL, CIPROFLOXACIN HYDROCHLORIDE
WYETH CONS
* WYETH CONSUMER HEALTHCARE
ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)
ADVIL COLD AND SINUS, IBUPROFEN (OTC)
ADVIL LIQUI-GELS, IBUPROFEN (OTC)
ADVIL MIGRAINE LIQUI-GELS, IBUPROFEN (OTC)
ADVIL PM, DIPHENHYDRAMINE CITRATE (OTC)
ADVIL PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)
ADVIL, IBUPROFEN (OTC)

ALAVERT, LORATADINE (OTC)

AXID AR, NIZATIDINE (OTC)

CHILDREN'S ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)

CHILDREN'S ADVIL COLD, IBUPROFEN (OTC)

CHILDREN'S ADVIL, IBUPROFEN (OTC)

CHILDREN'S ADVIL-FLAVORED, IBUPROFEN (OTC)

JUNIOR STRENGTH ADVIL, IBUPROFEN (OTC)

PEDIATRIC ADVIL, IBUPROFEN (OTC)


WYETH PHARMS INC


* WYETH PHARMACEUTICALS INC
CORDARONE, AMIODARONE HYDROCHLORIDE
EFFEXOR XR, VENLAFAXINE HYDROCHLORIDE
EFFEXOR, VENLAFAXINE HYDROCHLORIDE
LYBREL, ETHINYL ESTRADIOL
MYLOTARG, GEMTUZUMAB OZOGAMICIN
PHOSPHOLINE IODIDE, ECHOTHIOPHATE IODIDE
PREMARIN, ESTROGENS, CONJUGATED
PREMPHASE 14/14, ESTROGENS, CONJUGATED
PREMPRO, ESTROGENS, CONJUGATED
PRISTIQ, DESVENLAFAXINE SUCCINATE
PROTONIX IV, PANTOPRAZOLE SODIUM
PROTONIX, PANTOPRAZOLE SODIUM
RAPAMUNE, SIROLIMUS
TORISEL, TEMSIROLIMUS
TRECATOR, ETHIONAMIDE
TYGACIL, TIGECYCLINE
ZOSYN IN PLASTIC CONTAINER, PIPERACILLIN SODIUM

ZOSYN, PIPERACILLIN SODIUM

XANODYNE PHARM
* XANODYNE PHARMACEUTICS INC
AMICAR, AMINOCAPROIC ACID
DARVOCET-N 100, ACETAMINOPHEN
DARVOCET-N 50, ACETAMINOPHEN
DARVON, PROPOXYPHENE HYDROCHLORIDE
DARVON-N, PROPOXYPHENE NAPSYLATE
DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
DURACLON, CLONIDINE HYDROCHLORIDE
LYSTEDA, TRANEXAMIC ACID
ORAMORPH SR, MORPHINE SULFATE

ZIPSOR, DICLOFENAC POTASSIUM

XANODYNE PHARMS
* XANODYNE PHARMACEUTICALS INC
ROXICODONE, OXYCODONE HYDROCHLORIDE
XTTRIUM
* XTTRIUM LABORATORIES INC
DYNA-HEX, CHLORHEXIDINE GLUCONATE (OTC)

EXIDINE, CHLORHEXIDINE GLUCONATE (OTC)

30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST B - 59

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** Z **
ZAMBON SPA
* ZAMBON SPA ITALY
MONUROL, FOSFOMYCIN TROMETHAMINE
ZARS PHARM
* ZARS PHARMA INC
SYNERA, LIDOCAINE
ZOGENIX INC
* ZOGENIX INC
SUMAVEL DOSEPRO, SUMATRIPTAN SUCCINATE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST C-1

APPENDIX C

UNIFORM TERMS

DOSAGE FORMS

AEROSOL LOTION/SHAMPOO
AEROSOL, FOAM OIL
AEROSOL, METERED OIL/DROPS
CAPSULE OINTMENT
CAPSULE, DELAYED REL PELLETS OINTMENT, AUGMENTED
CAPSULE, DELAYED RELEASE PASTE
CAPSULE, EXTENDED RELEASE PATCH
CLOTH PELLET
CONCENTRATE POWDER
CREAM POWDER, EXTENDED RELEASE
CREAM, AUGMENTED POWDER, METERED
ELIXIR RING
EMULSION SHAMPOO
ENEMA SOLUTION
FILM SOLUTION FOR SLUSH
FILM, EXTENDED RELEASE SOLUTION, GEL FORMING/DROPS
FOR SOLUTION SOLUTION/DROPS
FOR SOLUTION; TABLET, FOR SOLUTION SPONGE
FOR SUSPENSION SPRAY
FOR SUSPENSION, DELAYED RELEASE SPRAY, METERED
FOR SUSPENSION, EXTENDED RELEASE SUPPOSITORY
GAS SUSPENSION
GEL SUSPENSION, EXTENDED RELEASE
GEL, AUGMENTED SUSPENSION/DROPS
GEL, METERED SWAB
GRANULE SYRUP
GRANULE, DELAYED RELEASE SYSTEM, EXTENDED RELEASE
GUM, CHEWING TABLET
IMPLANT TABLET, CHEWABLE
INHALANT TABLET, COATED PARTICLES
INJECTABLE TABLET, DELAYED RELEASE
INJECTABLE, LIPID COMPLEX TABLET, DELAYED RELEASE, ORALLY
INJECTABLE, LIPOSOMAL DISINTEGRATING
INSERT TABLET, EFFERVESCENT
INSERT, EXTENDED RELEASE TABLET, EXTENDED RELEASE
INTRAUTERINE DEVICE TABLET, FOR SUSPENSION
JELLY TABLET, ORALLY DISINTEGRATING
LIQUID TAPE
LOTION TROCHE/LOZENGE
LOTION, AUGMENTED

Note: Terms comprise currently marketed products


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST C-2

APPENDIX C

UNIFORM TERMS

ROUTES OF ADMINISTRATION

BUCCAL INTRAVITREAL
DENTAL IRRIGATION
ENDOCERVICAL IV (INFUSION)
EPIDURAL IV (INFUSION)-SC
FOR RX COMPOUNDING IV-SC
IM-IV N/A
IM-IV-SC NASAL
IMPLANTATION OPHTHALMIC
IM-SC ORAL
INHALATION ORAL-21
INJECTION ORAL-28
INTRA-ARTICULAR, INTRAMUSCULAR, OTIC
INTRAVITREAL PERFUSION, CARDIAC
INTRACRANIAL PERIODONTAL
INTRALYMPHATIC RECTAL
INTRAMUSCULAR SPINAL
INTRAOCULAR SUBCUTANEOUS
INTRAPERITONEAL SUBLINGUAL
INTRAPLEURAL TOPICAL
INTRATHECAL TRANSDERMAL
INTRATRACHEAL TRANSMUCOSAL
INTRAUTERINE URETHRAL
INTRAVENOUS VAGINAL
INTRAVESICAL

Note: Terms comprise currently marketed products


30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST C-3

APPENDIX C

UNIFORM TERMS

ABBREVIATIONS

AMP AMPULE
AMPICIL AMPICILLIN
APPROX APPROXIMATELY
BOT BOTTLE
CI CURIE
CSR CAROTID SINUS REFLEX
CU CLINICAL UNITS
DIPROP DIPROPIONATE
ELECT ELECTROLYTE
EQ EQUIVALENT TO
ER EXTENDED RELEASE
GM GRAM
HBR HYDROBROMIDE
HCL HYDROCHLORIDE
HR HOUR
INH INHALATION
IU INTERNATIONAL UNITS
KIU KALLIKREIN INHIBITOR UNITS
MCG MICROGRAM
MCI MILLICURIE
MEQ MILLIEQUIVALENT
MG MILLIGRAM
ML MILLILITER
N/A NOT APPLICABLE
PPM PARTS PER MILLION
REL RELEASE
SQ CM SQUARE CENTIMETER
U UNITS
UCI MICROCURIE
UMOLAR MICROMOLAR
USP UNITED STATES PHARMACOPEIA
PATENT AND EXCLUSIVITY INFORMATION ADDENDUM

This Addendum identifies drugs that qualify under the Drug Price
Competition and Patent Term Restoration Act (1984 Amendments) for periods of
exclusivity, during which abbreviated new drug applications (ANDAs) and
applications described in Section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act (the Act) for those drug products may, in some instances, not be
submitted or made effective as described below, and provides patent
information concerning the listed drug products. Those drugs that have
qualified for Orphan Drug Exclusivity pursuant to Section 527 of the Act and
those drugs that have qualified for Pediatric Exclusivity pursuant to Section
505A are also included in this Addendum. This section is arranged in
alphabetical order by active ingredient name followed the trade name. Active
ingredient headings for multiple ingredient (combination) drug products are
arranged alphabetically. For an explanation of the codes used in the
Addendum, see the Patent and Exclusivity Terms Section. Exclusivity prevents
the submission or effective approval of ANDAs or applications described in
Section 505(b)(2) of the Act. It does not prevent the submission or approval
of a second 505(b)(1) application except in the case of Orphan Drug
exclusivity. Applications qualifying for periods of exclusivity are:

(1) A new drug application approved after September 24, 1984, for a drug
product all active ingredients (including any ester or salt of the
active ingredient) of which had never been approved in any other new
drug application under Section 505 (b) of the Act. No subsequent ANDA
or application described in Section 505(b)(2) of the Act for the same
drug may be submitted for a period of five years from the date of
approval of the original application, except that such an application
may be submitted after four years if it contains a certification that a
patent claiming the drug is invalid or will not be infringed by the
product for which approval is sought.

(2) A new drug application approved after September 24, 1984, for a drug
product containing an active ingredient (including any ester or salt of
that active ingredient) that has been approved in an earlier new drug
application and that includes reports of new clinical investigations
(other than bioavailability studies). Such investigations must have
been conducted or sponsored by the applicant and must have been
essential to approval of the application. If these requirements are
met, the approval of a subsequent ANDA or an application described in
Section 505(b)(2) of the Act may not be made effective for the same drug
or use, if for a new indication, before the expiration of three years
from the date of approval of the original application. If an applicant
has exclusivity for a new application or 505(b)(2) application for the
drug product with indications or use, this does not preclude the
approval of an ANDA or 505(b)(2) application not covered by the
exclusivity.

(3) A supplement to a new drug application for a drug containing a


previously approved active ingredient including (any ester or salt of
the active ingredient) approved after September 24, 1984, that contains
reports of new clinical investigations (other than bioavailability
studies) essential to the approval of the supplement and conducted or
sponsored by the applicant. The approval of a subsequent ANDA or
505(b)(2) application for a change approved in the supplement may not be

AD 1

made effective for three years from the date of approval of the original
supplement.

The Act requires that patent information be filed with all newly
submitted Section 505(b) drug applications. No NDA may be approved after
September 24, 1984, without the submission of patent information to the
Agency. Effective August 18, 2003, this information must be filed using FDA
Form 3524a “Patent Information Submitted with the Filing of an NDA, Amendment
or Supplement”.

Effective August 18, 2003, upon approval of an application, patent


information for purposes of listing in the Orange Book must be submitted to
the agency within 30 days of approval on FDA Form 3542 “Patent Information
Submitted Upon and After Approval of an NDA or Supplement”. Patent
information on unapproved applications or on patents beyond the scope of the
Act (i.e., process or manufacturing patents) will not be published. FDA form
3542 will be the only form used for the purposes of this publication.

The patents that FDA regards as covered by the statutory provisions for
submission of patent information are: patents that claim the active
ingredient(s); drug product patents which include formulation/composition
patents; use patents for a particular approved indication or method of using
the product; and certain other patents as detailed on FDA Form 3542. This
information, as provided by the sponsor on FDA form 3542, will be published
as described above.

A requirement for submission of patent information to FDA for certain


old antibiotics became effective October 7, 2008 under section 4(b)(1) of the
Q1 Act. A guidance for industry on this subject is available at
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048345.pdf

Upon approval, patent numbers and expiration dates, in addition to


certain other information on appropriate patents claiming drug products that
are the subject of approved applications, will be published on a daily basis
in the Electronic Orange Book, http://www.fda.gov/cder/ob/default.htm. The
Addendum lists patent and exclusivity information up to January of the
Edition year. The monthly Cumulative Supplements to the annual edition list
patent and exclusivity information changes since the Annual Edition Addendum.
Since all parts of this publication are subject to changes, additions, or
deletions, the Electronic Orange Book, updated daily, should be consulted for
the most recent patent and exclusivity information.

AD 2

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PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ABACAVIR SULFATE - ZIAGEN
N020977 001 5034394 Dec 18, 2011 DS DP
5034394*PED Jun 18, 2012
5089500*PED Dec 26, 2009
6294540 May 14, 2018 DS DP U-65
6294540*PED Nov 14, 2018 U-65
ABACAVIR SULFATE - ZIAGEN
N020978 001 5034394 Dec 18, 2011 DS DP
5034394*PED Jun 18, 2012
5089500*PED Dec 26, 2009
6294540 May 14, 2018 DS DP U-65
6294540*PED Nov 14, 2018 U-65
6641843 Feb 04, 2020 DP
ABACAVIR SULFATE; LAMIVUDINE - EPZICOM
N021652 001 5034394 Dec 18, 2011 DS DP
5034394*PED Jun 18, 2012
5047407 Nov 17, 2009 DS DP U-257
5047407*PED May 17, 2010
5089500*PED Dec 26, 2009
5905082 May 18, 2016 DS DP
5905082*PED Nov 18, 2016
6294540 May 14, 2018 DS DP U-257
6294540*PED Nov 14, 2018
6417191 Mar 28, 2016 DP U-257
7119202*PED Aug 08, 2009
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE - TRIZIVIR
N021205 001 5034394 Dec 18, 2011 DS DP
5034394*PED Jun 18, 2012
5047407 Nov 17, 2009 DS DP U-248
5047407*PED May 17, 2010
5089500*PED Dec 26, 2009 U-248
5905082 May 18, 2016 DS DP U-248
5905082*PED Nov 18, 2016
6294540 May 14, 2018 DS DP U-65
6294540*PED Nov 14, 2018 U-65
6417191 Mar 28, 2016 DP U-248
7119202*PED Aug 08, 2009
ABARELIX - PLENAXIS
N021320 001 5843901 Dec 01, 2015 DS DP
5968895 Dec 11, 2016 DP
6180608 Dec 11, 2016 DP U-549
6423686 Jun 07, 2015 DS
6455499 Jun 07, 2015 U-549
6699833 Dec 11, 2016 DP
ACAMPROSATE CALCIUM - CAMPRAL
N021431 001 NCE Jul 29, 2009
ACETAMINOPHEN; ASPIRIN; CAFFEINE - EXCEDRIN (MIGRAINE)
N020802 001 5972916 Jul 14, 2017 U-296
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE - ULTRACET
N021123 001 RE39221 Aug 09, 2011 DS DP U-55
ACETYLCHOLINE CHLORIDE - MIOCHOL-E
N020213 001 6261546 Apr 29, 2019 U-506
ACETYLCYSTEINE - ACETADOTE
N021539 001 ODE Jan 23, 2011
ACYCLOVIR; HYDROCORTISONE - ACYCLOVIR AND HYDROCORTISONE
N022436 001 6514980 Jan 24, 2017 DP U-1006 NC Jul 31, 2012
7223387 Feb 28, 2021 DP U-1006
RE39264 Feb 02, 2016 DP U-1006
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PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ADAPALENE - DIFFERIN
N020338 001 4717720 May 31, 2010
RE34440 May 31, 2010 U-275
ADAPALENE - DIFFERIN
N020380 001 4717720 May 31, 2010
RE34440 May 31, 2010 U-275
ADAPALENE - DIFFERIN
N020748 001 4717720 May 31, 2010
RE34440 May 31, 2010 U-275
ADAPALENE - DIFFERIN
N021753 001 4717720 May 31, 2010 DS DP NP Jun 19, 2010
7579377 Feb 23, 2025 U-818
RE34440 May 31, 2010 U-818
ADAPALENE; BENZOYL PEROXIDE - EPIDUO
N022320 001 4717720 May 31, 2010 DS DP NC Dec 08, 2011
RE34440 May 31, 2010 U-818
ADEFOVIR DIPIVOXIL - HEPSERA
N021449 001 5663159 Sep 02, 2014 DS DP NPP Dec 19, 2010
6451340 Jul 23, 2018 DS DP U-470
ADENOSINE - ADENOSCAN
N020059 001 5731296 Mar 24, 2015 U-221
ALATROFLOXACIN MESYLATE - TROVAN PRESERVATIVE FREE
N020760 001 5164402 Nov 17, 2009 U-282
5763454 Jun 15, 2015 U-282
6080756 Jul 05, 2016
6194429 Jul 23, 2018
ALATROFLOXACIN MESYLATE - TROVAN PRESERVATIVE FREE
N020760 002 5164402 Nov 17, 2009 U-282
5763454 Jun 15, 2015 U-282
6080756 Jul 05, 2016
6194429 Jul 23, 2018
ALBUMIN HUMAN - OPTISON
N020899 001 5529766 Jun 25, 2013 U-505
5558094 Feb 28, 2012 U-505
5573751 Apr 25, 2012
6723303 Apr 20, 2021 DP
ALBUTEROL SULFATE - ACCUNEB
N020949 001 6702997 Dec 28, 2021 U-558
ALBUTEROL SULFATE - ACCUNEB
N020949 002 6702997 Dec 28, 2021 U-558
ALBUTEROL SULFATE - PROAIR HFA
N021457 001 5605674 Feb 25, 2014 DP NPP Sep 16, 2011
5695743 Jul 06, 2010 DP U-491
5766573 Nov 28, 2009 U-356
6352684 Nov 28, 2009 DP U-716
7105152 Sep 12, 2023 DP
7566445 Jun 04, 2017 DP
ALBUTEROL SULFATE - PROVENTIL-HFA
N020503 001 5225183 Jul 06, 2010
5439670 Jul 06, 2010
5605674 Feb 25, 2014
5695743 Jul 06, 2010 U-491
5766573 Jun 16, 2015
6352684 Nov 28, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 3 of 197

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PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ALBUTEROL SULFATE - VENTOLIN HFA
N020983 001 6131566 Apr 14, 2015 DP U-716
6131566 Apr 14, 2015 DP U-589
6131566*PED Oct 14, 2015
6161724 Jan 16, 2018 DP
6161724*PED Jul 16, 2018
6170717 Dec 23, 2017 DP
6170717*PED Jun 23, 2018
6315173 Dec 23, 2017 DP
6315173*PED Jun 23, 2018
6431168 Jun 08, 2018 DP
6431168*PED Dec 08, 2018
6435372 Jan 16, 2018 DP
6435372*PED Jul 16, 2018
6510969 Dec 23, 2017 DP
6510969*PED Jun 23, 2018
6532955 Apr 14, 2015 DP
6532955*PED Oct 14, 2015
6558651 Dec 19, 2016 DP U-716
6558651*PED Jun 19, 2017
6596260 Aug 10, 2014 DP
6596260*PED Feb 10, 2015
6743413 Jun 01, 2021 U-716
6743413*PED Dec 01, 2021
6938796 Jan 16, 2018 DP
6938796*PED Jul 16, 2018
6966467 Dec 23, 2017 DP
6966467*PED Jun 23, 2018
6997349 Jan 16, 2018 DP
6997349*PED Jul 16, 2018
7107986 Jun 08, 2018 DP
7107986*PED Dec 06, 2018
7143908 Jan 16, 2018 DP
7143908*PED Jul 16, 2018
7350676 Aug 24, 2018 DP
7350676*PED Feb 24, 2019
7500444 Jan 04, 2025 DP
7500444*PED Jul 04, 2025
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - COMBIVENT
N020291 001 5603918 Jun 09, 2015
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - DUONEB
N020950 001 6632842 Dec 28, 2021 U-532
ALCOHOL; CHLORHEXIDINE GLUCONATE - AVAGARD
N021074 001 5897031 Jun 21, 2016
6090395 Jun 22, 2015 DP
6534069 Jun 22, 2015 DP
6623744 Jun 23, 2015 U-1008
7081246 Aug 03, 2016 DP
7566460 Jun 22, 2015 DP U-1008
ALENDRONATE SODIUM - FOSAMAX
N020560 001 5358941 Dec 02, 2012
5358941*PED Jun 02, 2013
5681590 Dec 02, 2012
5681590*PED Jun 02, 2013
5849726 Jun 06, 2015
5849726*PED Dec 06, 2015
6008207 Jun 06, 2015 U-303
6008207*PED Dec 06, 2015 U-303
6090410 Dec 02, 2012
6090410*PED Jun 02, 2013
6194004 Dec 02, 2012
6194004*PED Jun 02, 2013
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 4 of 197

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PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ALENDRONATE SODIUM - FOSAMAX
N020560 002 5358941 Dec 02, 2012
5358941*PED Jun 02, 2013
5681590 Dec 02, 2012
5681590*PED Jun 02, 2013
5849726 Jun 06, 2015
5849726*PED Dec 06, 2015
6008207 Jun 06, 2015 U-303
6008207*PED Jun 06, 2015 U-303
6090410 Dec 02, 2012
6090410*PED Jun 02, 2013
ALENDRONATE SODIUM - FOSAMAX
N020560 003 5358941 Dec 02, 2012
5358941*PED Jun 02, 2013
5681590 Dec 02, 2012
5681590*PED Jun 02, 2013
5849726 Jun 06, 2015
5849726*PED Dec 06, 2015
6008207 Jun 06, 2015 U-303
6008207*PED Dec 06, 2015 U-303
6090410 Dec 02, 2012
6090410*PED Jun 02, 2013
ALENDRONATE SODIUM - FOSAMAX
N020560 004 5358941 Dec 02, 2012
5358941*PED Jun 02, 2013
5681590 Dec 02, 2012
5681590*PED Jun 02, 2013
5849726 Jun 06, 2015
5849726*PED Dec 06, 2015
5994329 Jul 17, 2018
5994329*PED Jan 17, 2019
6008207 Jun 06, 2015
6008207*PED Dec 06, 2015
6015801 Jul 17, 2018 U-353
6015801*PED Jan 17, 2019 U-353
6090410 Dec 02, 2012
6090410*PED Jun 02, 2013
6225294 Jul 17, 2018
6225294*PED Jan 17, 2019
ALENDRONATE SODIUM - FOSAMAX
N020560 005 5358941 Dec 02, 2012
5358941*PED Jun 02, 2013
5681590 Dec 02, 2012
5681590*PED Jun 02, 2013
5849726 Jun 06, 2015
5849726*PED Dec 06, 2015
5994329 Jul 17, 2018
5994329*PED Jan 17, 2019
6008207 Jun 06, 2015
6008207*PED Dec 06, 2015
6015801 Jul 17, 2018 U-353
6015801*PED Jan 17, 2019 U-353
6090410 Dec 02, 2012
6090410*PED Jun 02, 2013
6225294 Jul 17, 2018
6225294*PED Jan 17, 2019
ALENDRONATE SODIUM - FOSAMAX
N021575 001 5462932 May 17, 2014
5462932*PED Nov 17, 2014
5994329 Jul 17, 2018
5994329*PED Jan 17, 2019
6015801 Jul 17, 2018
6015801*PED Jan 17, 2019
6225294 Jul 17, 2018
6225294*PED Jan 17, 2019
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PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ALENDRONATE SODIUM; CHOLECALCIFEROL - FOSAMAX PLUS D
N021762 001 5358941 Dec 02, 2012 DP
5358941*PED Jun 02, 2013
5681590 Dec 02, 2012 DP
5681590*PED Jun 02, 2013
5994329 Jul 17, 2018 U-647
5994329*PED Jan 17, 2019
6090410 Dec 02, 2012 DP
6090410*PED Jun 02, 2013 DP
ALENDRONATE SODIUM; CHOLECALCIFEROL - FOSAMAX PLUS D
N021762 002 5358941 Dec 02, 2012 DP D-107 Apr 26, 2010
5358941*PED Jun 02, 2013
5681590 Dec 02, 2012 DP
5681590*PED Jun 02, 2013
6090410 Dec 02, 2012 DP
6090410*PED Jun 02, 2013 DP
ALFUZOSIN HYDROCHLORIDE - UROXATRAL
N021287 001 4661491 Jan 18, 2011 U-706
6149940 Aug 22, 2017
ALISKIREN HEMIFUMARATE - TEKTURNA
N021985 001 5559111 Jul 21, 2018 DS DP U-3 NCE Mar 05, 2012
ALISKIREN HEMIFUMARATE - TEKTURNA
N021985 002 5559111 Jul 21, 2018 DS DP U-3 NCE Mar 05, 2012
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N022107 001 5559111 Apr 04, 2015 DS DP U-3 I-600 Jul 16, 2012
NCE Mar 05, 2012
NC Jan 18, 2011
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N022107 002 5559111 Apr 04, 2015 DS DP U-3 I-600 Jul 16, 2012
NCE Mar 05, 2012
NC Jan 18, 2011
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N022107 003 5559111 Apr 04, 2015 DS DP U-3 I-600 Jul 16, 2012
NCE Mar 05, 2012
NC Jan 18, 2011
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N022107 004 5559111 Apr 04, 2015 DS DP U-3 I-600 Jul 16, 2012
NCE Mar 05, 2012
NC Jan 18, 2011
ALISKIREN HEMIFUMARATE; VALSARTAN - VALTURNA
N022217 001 5399578 Mar 21, 2012 DS DP U-3 NC Sep 16, 2012
5559111 Jul 21, 2018 DS DP U-3
ALISKIREN HEMIFUMARATE; VALSARTAN - VALTURNA
N022217 002 5399578 Mar 21, 2012 DS DP U-3 NC Sep 16, 2012
5559111 Jul 21, 2018 DS DP U-3
ALITRETINOIN - PANRETIN
N020886 001 5932622 Aug 03, 2016 U-562
ALMOTRIPTAN MALATE - AXERT
N021001 001 5565447 May 07, 2015 DS DP U-969
5565447*PED Nov 07, 2015
ALMOTRIPTAN MALATE - AXERT
N021001 002 5565447 May 07, 2015 DS DP U-969

5565447*PED Nov 07, 2015

ALOSETRON HYDROCHLORIDE - LOTRONEX


N021107 001 5360800 Jan 13, 2013 DS DP U-405 D-113 Apr 01, 2011
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PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ALOSETRON HYDROCHLORIDE - LOTRONEX
N021107 002 5360800 Jan 13, 2013 DS DP U-405 D-113 Apr 01, 2011
ALPRAZOLAM - ALPRAZOLAM
A078088 001 PC Jul 13, 2009
ALPRAZOLAM - ALPRAZOLAM
A078088 002 PC Jul 13, 2009
ALPRAZOLAM - ALPRAZOLAM
A078088 003 PC Jul 13, 2009
ALPRAZOLAM - ALPRAZOLAM
A078088 004 PC Jul 13, 2009
ALPRAZOLAM - NIRAVAM
N021726 001 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
ALPRAZOLAM - NIRAVAM
N021726 002 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
ALPRAZOLAM - NIRAVAM
N021726 003 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
ALPRAZOLAM - NIRAVAM
N021726 004 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
ALPROSTADIL - CAVERJECT
N020379 001 5741523 Apr 21, 2015
ALPROSTADIL - CAVERJECT
N020379 002 5741523 Apr 21, 2015
ALPROSTADIL - CAVERJECT
N020379 003 5741523 Apr 21, 2015
ALPROSTADIL - CAVERJECT
N020379 004 5741523 Apr 21, 2015
ALPROSTADIL - CAVERJECT IMPULSE
N021212 001 5501673 Apr 16, 2013 DP
5716338 Feb 10, 2015 DP
ALPROSTADIL - CAVERJECT IMPULSE
N021212 002 5501673 Apr 16, 2013 DP
5716338 Feb 10, 2015 DP
ALPROSTADIL - MUSE
N020700 001 5242391 Sep 07, 2010 U-155
5474535 Dec 12, 2012 U-155
5773020 Apr 25, 2010 DP
5886039 Mar 23, 2016 DP U-155
ALPROSTADIL - MUSE
N020700 002 5242391 Sep 07, 2010 U-155
5474535 Dec 12, 2012 U-155
5773020 Apr 25, 2010 DP
5886039 Mar 23, 2016 DP U-155
ALPROSTADIL - MUSE
N020700 003 5242391 Sep 07, 2010 U-155
5474535 Dec 12, 2012 U-155
5773020 Apr 25, 2010 DP
5886039 Mar 23, 2016 DP U-155
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PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ALPROSTADIL - MUSE
N020700 004 5242391 Sep 07, 2010 U-155
5474535 Dec 12, 2012 U-155
5773020 Apr 25, 2010 DP
5886039 Mar 23, 2016 DP U-155
ALVIMOPAN - ENTEREG
N021775 001 5250542 Mar 29, 2011 DS DP U-878 NCE May 20, 2013
5434171 Dec 08, 2013 DS DP U-878
6469030 Nov 29, 2020 U-879
AMBRISENTAN - LETAIRIS
N022081 001 5703017 Dec 30, 2014 DS NCE Jun 15, 2012
5840722 Nov 24, 2015 U-821 ODE Jun 15, 2014
5932730 Oct 07, 2015 DS
7109205 Oct 07, 2015 DS DP
AMBRISENTAN - LETAIRIS
N022081 002 5703017 Dec 30, 2014 DS NCE Jun 15, 2012
5840722 Nov 24, 2015 U-821 ODE Jun 15, 2014
5932730 Oct 07, 2015 DS
7109205 Oct 07, 2015 DS DP
AMIFOSTINE - ETHYOL
N020221 001 5424471 Jul 31, 2012
5591731 Jul 31, 2012
5994409 Dec 08, 2017 U-305
AMIFOSTINE - ETHYOL
N020221 002 5424471 Jul 31, 2012
5591731 Jul 31, 2012
5994409 Dec 08, 2017 U-305
AMINOLEVULINIC ACID HYDROCHLORIDE - LEVULAN
N020965 001 5079262 Sep 30, 2013 U-289
5211938 May 18, 2010 U-289
5422093 Jul 28, 2009 U-289
5954703 Oct 31, 2017 U-289
6709446 May 01, 2018 U-289
6710066 Jul 28, 2009 U-289
AMIODARONE HYDROCHLORIDE - NEXTERONE
N022325 001 5134127 Jan 23, 2010 DP
5376645 Jan 23, 2010 DP
6869939 May 04, 2022 DP
7635773 Mar 13, 2029 DP
AMLEXANOX - APHTHASOL
N020511 001 5362737 Nov 08, 2011 U-243
AMLODIPINE BESYLATE - AMLODIPINE BESYLATE
N022026 001 6828339 Nov 20, 2022 DS
AMLODIPINE BESYLATE - AMLODIPINE BESYLATE
N022026 002 6828339 Nov 20, 2022 DS
AMLODIPINE BESYLATE - AMLODIPINE BESYLATE
N022026 003 6828339 Nov 20, 2022 DS
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 8 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 001 4681893 Sep 24, 2009 DS DP U-161
4681893*PED Mar 24, 2010
5273995 Dec 28, 2010 DS DP U-162
5273995*PED Jun 28, 2011
5686104 Nov 11, 2014 DP U-213
5686104*PED May 11, 2015
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
6126971 Jan 19, 2013 DP
6126971*PED Jul 19, 2013
6455574 Aug 11, 2018 U-552
RE40667 Dec 28, 2010 DS DP U-162
RE40667*PED Jun 28, 2011
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 002 4681893 Sep 24, 2009 DS DP U-161
4681893*PED Mar 24, 2010
5273995 Dec 28, 2010 DS DP U-162
5273995*PED Jun 28, 2011
5686104 Nov 11, 2014 DP U-213
5686104*PED May 11, 2015
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
6126971 Jan 19, 2013 DP
6126971*PED Jul 19, 2013
6455574 Aug 11, 2018 U-552
RE40667 Dec 28, 2010 DS DP U-162
RE40667*PED Jun 28, 2011
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 003 4681893 Sep 24, 2009 DS DP U-161
4681893*PED Mar 24, 2010
5273995 Dec 28, 2010 DS DP U-162
5273995*PED Jun 28, 2011
5686104 Nov 11, 2014 DP U-213
5686104*PED May 11, 2015
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
6126971 Jan 19, 2013 DP
6126971*PED Jul 19, 2013
6455574 Aug 11, 2018 U-552
RE40667 Dec 28, 2010 DS DP U-162
RE40667*PED Jun 28, 2011
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 004 4681893 Sep 24, 2009 DS DP U-161
4681893*PED Mar 24, 2010
5273995 Dec 28, 2010 DS DP U-162
5273995*PED Jun 28, 2011
5686104 Nov 11, 2014 DP U-213
5686104*PED May 11, 2015
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
6126971 Jan 19, 2013 DP
6126971*PED Jul 19, 2013
6455574 Aug 11, 2018 U-552
RE40667 Dec 28, 2010 DS DP U-162
RE40667*PED Jun 28, 2011
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 9 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 005 4681893 Sep 24, 2009 DS DP U-161
4681893*PED Mar 24, 2010
5273995 Dec 28, 2010 DS DP U-162
5273995*PED Jun 28, 2011
5686104 Nov 11, 2014 DP U-213
5686104*PED May 11, 2015
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
6126971 Jan 19, 2013 DP
6126971*PED Jul 19, 2013
6455574 Aug 11, 2018 U-552
RE40667 Dec 28, 2010 DS DP U-162
RE40667*PED Jun 28, 2011
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 006 4681893 Sep 24, 2009 DS DP U-161
4681893*PED Mar 24, 2010
5273995 Dec 28, 2010 DS DP U-162
5273995*PED Jun 28, 2011
5686104 Nov 11, 2014 DP U-213
5686104*PED May 11, 2015
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
6126971 Jan 19, 2013 DP
6126971*PED Jul 19, 2013
6455574 Aug 11, 2018 U-552
RE40667 Dec 28, 2010 DS DP U-162
RE40667*PED Jun 28, 2011
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 007 4681893 Sep 24, 2009 DS DP U-161
4681893*PED Mar 24, 2010
5273995 Dec 28, 2010 DS DP U-162
5273995*PED Jun 28, 2011
5686104 Nov 11, 2014 DP U-213
5686104*PED May 11, 2015
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
6126971 Jan 19, 2013 DP
6126971*PED Jul 19, 2013
6455574 Aug 11, 2018 U-552
RE40667 Dec 28, 2010 DS DP U-162
RE40667*PED Jun 28, 2011
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 008 4681893 Sep 24, 2009 DS DP U-161
4681893*PED Mar 24, 2010
5273995 Dec 28, 2010 DS DP U-162
5273995*PED Jun 28, 2011
5686104 Nov 11, 2014 DP U-213
5686104*PED May 11, 2015
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
6126971 Jan 19, 2013 DP
6126971*PED Jul 19, 2013
6455574 Aug 11, 2018 U-552
RE40667 Dec 28, 2010 DS DP U-162
RE40667*PED Jun 28, 2011
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 10 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 009 4681893 Sep 24, 2009 DS DP U-161
4681893*PED Mar 24, 2010
5273995 Dec 28, 2010 DS DP U-162
5273995*PED Jun 28, 2011
5686104 Nov 11, 2014 DP U-213
5686104*PED May 11, 2015
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
6126971 Jan 19, 2013 DP
6126971*PED Jul 19, 2013
6455574 Aug 11, 2018 U-552
RE40667 Dec 28, 2010 DS DP U-162
RE40667*PED Jun 28, 2011
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 010 4681893 Sep 24, 2009 DS DP U-161
4681893*PED Mar 24, 2010
5273995 Dec 28, 2010 DS DP U-162
5273995*PED Jun 28, 2011
5686104 Nov 11, 2014 DP U-213
5686104*PED May 11, 2015
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
6126971 Jan 19, 2013 DP
6126971*PED Jul 19, 2013
6455574 Aug 11, 2018 U-552
RE40667 Dec 28, 2010 DS DP U-162
RE40667*PED Jun 28, 2011
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 011 4681893 Sep 24, 2009 DS DP U-161
4681893*PED Mar 24, 2010
5273995 Dec 28, 2010 DS DP U-162
5273995*PED Jun 28, 2011
5686104 Nov 11, 2014 DP U-213
5686104*PED May 11, 2015
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
6126971 Jan 19, 2013 DP
6126971*PED Jul 19, 2013
6455574 Aug 11, 2018 U-552
RE40667 Dec 28, 2010 DS DP U-162
RE40667*PED Jun 28, 2011
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N020364 002 6162802 Dec 19, 2017 U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N020364 003 6162802 Dec 19, 2017 U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N020364 004 6162802 Dec 19, 2017 U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N020364 005 6162802 Dec 19, 2017 U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N020364 006 6162802 Dec 19, 2017 DS DP U-185
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N020364 007 6162802 Dec 19, 2017 DS DP U-185
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR
N022100 001 5616599 Apr 25, 2016 DS DP U-3 NC Sep 26, 2010
5616599*PED Oct 25, 2016
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR
N022100 002 5616599 Apr 25, 2016 DS DP U-3 NC Sep 26, 2010
5616599*PED Oct 25, 2016
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 11 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR
N022100 003 5616599 Apr 25, 2016 DS DP U-3 NC Sep 26, 2010
5616599*PED Oct 25, 2016
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR
N022100 004 5616599 Apr 25, 2016 DS DP U-3 NC Sep 26, 2010
5616599*PED Oct 25, 2016
AMLODIPINE BESYLATE; TELMISARTAN - TWYNSTA
N022401 001 5591762 Jan 07, 2014 DS DP U-3 NC Oct 16, 2012
AMLODIPINE BESYLATE; TELMISARTAN - TWYNSTA
N022401 002 5591762 Jan 07, 2014 DS DP U-3 NC Oct 16, 2012
AMLODIPINE BESYLATE; TELMISARTAN - TWYNSTA
N022401 003 5591762 Jan 07, 2014 DS DP U-3 NC Oct 16, 2012
AMLODIPINE BESYLATE; TELMISARTAN - TWYNSTA
N022401 004 5591762 Jan 07, 2014 DS DP U-3 NC Oct 16, 2012
AMLODIPINE BESYLATE; VALSARTAN - EXFORGE
N021990 002 5399578 Mar 21, 2012 DS DP U-3 I-567 Jun 23, 2011
5399578*PED Sep 21, 2012 NC Jun 20, 2010
6294197 Jun 18, 2017 DP U-3
6294197*PED Dec 18, 2017
6395728 Jul 08, 2019 DP
AMLODIPINE BESYLATE; VALSARTAN - EXFORGE
N021990 003 5399578 Mar 21, 2012 DS DP U-3 I-567 Jun 23, 2011
5399578*PED Sep 21, 2012 NC Jun 20, 2010
6294197 Jun 18, 2017 DP U-3
6294197*PED Dec 18, 2017
6395728 Jul 08, 2019 DP
AMLODIPINE BESYLATE; VALSARTAN - EXFORGE
N021990 004 5399578 Mar 21, 2012 DS DP U-3 I-567 Jun 23, 2011
5399578*PED Sep 21, 2012 NC Jun 20, 2010
6294197 Jun 18, 2017 DP U-3
6294197*PED Dec 18, 2017
6395728 Jul 08, 2019 DP
AMLODIPINE BESYLATE; VALSARTAN - EXFORGE
N021990 005 5399578 Mar 21, 2012 DS DP U-3 I-567 Jun 23, 2011
5399578*PED Sep 21, 2012 NC Jun 20, 2010
6294197 Jun 18, 2017 DP U-3
6294197*PED Dec 18, 2017
6395728 Jul 08, 2019 DP
AMLODIPINE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N022314 001 5399578 Mar 21, 2012 DS DP U-3 NC Apr 30, 2012
5399578*PED Sep 21, 2012
6294197 Jun 18, 2017 DP U-3
6294197*PED Dec 18, 2017
AMLODIPINE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N022314 002 5399578 Mar 21, 2012 DS DP U-3 NC Apr 30, 2012
5399578*PED Sep 21, 2012
6294197 Jun 18, 2017 DP U-3
6294197*PED Dec 18, 2017
AMLODIPINE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N022314 003 5399578 Mar 21, 2012 DS DP U-3 NC Apr 30, 2012
5399578*PED Sep 21, 2012
6294197 Jun 18, 2017 DP U-3
6294197*PED Dec 18, 2017
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 12 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
AMLODIPINE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N022314 004 5399578 Mar 21, 2012 DS DP U-3 NC Apr 30, 2012
5399578*PED Sep 21, 2012
6294197 Jun 18, 2017 DP U-3
6294197*PED Dec 18, 2017
AMLODIPINE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N022314 005 5399578 Mar 21, 2012 DS DP U-3 NC Apr 30, 2012
5399578*PED Sep 21, 2012
6294197 Jun 18, 2017 DP U-3
6294197*PED Dec 18, 2017
AMMONIA, N-13 - AMMONIA N 13
N022119 001 NCE Aug 23, 2012
W Aug 23, 2012
AMOXICILLIN - MOXATAG
N050813 001 6544555 Oct 13, 2020 DS DP U-897
6669948 Oct 13, 2020 DS DP U-897
6723341 Oct 13, 2020 DS DP U-897
AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE - PREVPAC
N050757 001 4628098*PED Nov 10, 2009
5013743 Feb 12, 2010 U-452
5013743*PED Aug 12, 2010
AMOXICILLIN; CLAVULANATE POTASSIUM - AUGMENTIN XR
N050785 001 6746692 Apr 04, 2020 DP
6783773 Apr 04, 2020 DP
6878386 Apr 04, 2020 U-926
7217430 Apr 04, 2020 DP U-926
7250176 Apr 04, 2020 U-926
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 10
N011522 007 6384020 Jul 06, 2020
6384020*PED Jan 06, 2021
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 12.5
N011522 012 6384020 Jul 06, 2020
6384020*PED Jan 06, 2021
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 15
N011522 013 6384020 Jul 06, 2020
6384020*PED Jan 06, 2021
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 20
N011522 008 6384020 Jul 06, 2020
6384020*PED Jan 06, 2021
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 30
N011522 010 6384020 Jul 06, 2020
6384020*PED Jan 06, 2021
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 5
N011522 009 6384020 Jul 06, 2020
6384020*PED Jan 06, 2021
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 7.5
N011522 011 6384020 Jul 06, 2020

6384020*PED Jan 06, 2021

30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 13 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL XR 10
N021303 001 6322819 Oct 21, 2018

6322819*PED Apr 21, 2019

6605300 Oct 21, 2018

6605300*PED Apr 21, 2019


AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -


ADDERALL XR 15
N021303 006 6322819 Oct 21, 2018

6322819*PED Apr 21, 2019

6605300 Oct 21, 2018

6605300*PED Apr 21, 2019


AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -


ADDERALL XR 20
N021303 002 6322819 Oct 21, 2018

6322819*PED Apr 21, 2019

6605300 Oct 21, 2018

6605300*PED Apr 21, 2019


AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -


ADDERALL XR 25
N021303 004 6322819 Oct 21, 2018

6322819*PED Apr 21, 2019

6605300 Oct 21, 2018

6605300*PED Apr 21, 2019


AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -


ADDERALL XR 30
N021303 003 6322819 Oct 21, 2018

6322819*PED Apr 21, 2019

6605300 Oct 21, 2018

6605300*PED Apr 21, 2019


AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -


ADDERALL XR 5
N021303 005 6322819 Oct 21, 2018

6322819*PED Apr 21, 2019

6605300 Oct 21, 2018

6605300*PED Apr 21, 2019


AMPHOTERICIN B - AMBISOME
N050740 001 5874104 Feb 23, 2016 DP U-922
5965156 Oct 12, 2016 DP U-922
AMPRENAVIR - AGENERASE
N021007 001 5585397 Dec 17, 2013
5646180 Jul 08, 2014 U-257
5723490 Mar 03, 2015 U-257
6730679 Nov 11, 2017 DP
AMPRENAVIR - AGENERASE
N021007 002 5585397 Dec 17, 2013
5646180 Jul 08, 2014 U-257
5723490 Mar 03, 2015 U-257
6730679 Nov 11, 2017 DP
AMPRENAVIR - AGENERASE
N021039 001 5585397 Dec 17, 2013
5646180 Jul 08, 2014 U-257
5723490 Mar 03, 2015 U-257
ANASTROZOLE - ARIMIDEX
N020541 001 RE36617 Dec 27, 2009 DS DP U-946 M-61 Dec 05, 2011
RE36617*PED Jun 27, 2010 PED Jun 05, 2012
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 14 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ANIDULAFUNGIN - ERAXIS
N021632 001 5965525 Feb 17, 2020 DS DP U-540 NCE Feb 17, 2011
6384013 Mar 19, 2012 DS
6743777 Mar 19, 2012 DP U-540
6960564 Apr 12, 2021 DP U-540
7198796 Jun 13, 2022 DP
ANIDULAFUNGIN - ERAXIS
N021632 002 5965525 Feb 17, 2020 DS DP U-540 NCE Feb 17, 2011
6384013 Mar 19, 2012 DS
6743777 Mar 19, 2012 DP U-540
6960564 Apr 12, 2021 DP U-540
7198796 Jun 13, 2022 DP
APOMORPHINE HYDROCHLORIDE - APOKYN
N021264 001 ODE Apr 20, 2011
APOMORPHINE HYDROCHLORIDE - APOKYN
N021264 002 ODE Apr 20, 2011
APRACLONIDINE HYDROCHLORIDE - IOPIDINE
N019779 001 5212196 May 18, 2010 U-120
APREPITANT - EMEND
N021549 001 5145684 Jan 25, 2011 DP
5538982 Jul 23, 2013 U-745
5719147 Apr 17, 2015 DS DP U-853
6048859 Jun 29, 2012 U-745
6096742 Jul 01, 2018 DS DP U-745
6235735 Jun 29, 2012 U-747
6235735 Jun 29, 2012 U-746
7214692 Sep 18, 2012 U-853
APREPITANT - EMEND
N021549 002 5145684 Jan 25, 2011 DP
5538982 Jul 23, 2013 U-745
5719147 Jun 29, 2012 DS DP
6048859 Jun 29, 2012 U-745
6096742 Jul 01, 2018 DS DP U-745
6235735 Jun 29, 2012 U-746
6235735 Jun 29, 2012 U-747
7214692 Sep 18, 2012 U-853
APREPITANT - EMEND
N021549 003 5145684 Jan 25, 2011 DP
5538982 Jul 23, 2013 U-745
5719147 Jun 29, 2012 DS DP
6048859 Jun 29, 2012 U-745
6096742 Jul 01, 2018 DS DP U-745
6235735 Jun 29, 2012 U-747
6235735 Jun 29, 2012 U-746
7214692 Sep 18, 2012 U-853
ARBUTAMINE HYDROCHLORIDE - GENESA
N020420 001 5234404 Aug 10, 2010 U-220
5395970 Mar 07, 2012
ARFORMOTEROL TARTRATE - BROVANA
N021912 001 5795564 Apr 03, 2012 U-793 NP Oct 06, 2009
6040344 Nov 12, 2016 DS
6068833 Apr 03, 2012 U-793
6472563 Nov 09, 2021 DS
6589508 Apr 03, 2012 U-793
6720453 Nov 09, 2021 DS
6866839 Apr 03, 2012 U-793
7145036 Nov 09, 2021 DS
ARGATROBAN - ARGATROBAN
N020883 001 5214052 Jun 30, 2014 M-75 May 05, 2011
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 15 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ARIPIPRAZOLE - ABILIFY
N021436 001 5006528 Oct 20, 2014 DS DP U-761 D-115 May 06, 2011
5006528*PED Apr 20, 2015 D-110 Oct 29, 2010
I-616 Nov 19, 2012
I-559 May 06, 2011
I-555 Feb 27, 2011
I-545 Nov 16, 2010
PED Aug 27, 2011
PED Apr 29, 2011
ARIPIPRAZOLE - ABILIFY
N021436 002 5006528 Oct 20, 2014 DS DP U-761 D-115 May 06, 2011
5006528*PED Apr 20, 2015 D-110 Oct 29, 2010
I-616 Nov 19, 2012
I-559 May 06, 2011
I-555 Feb 27, 2011
I-545 Nov 16, 2010
PED Aug 27, 2011
PED Apr 29, 2011
ARIPIPRAZOLE - ABILIFY
N021436 003 5006528 Oct 20, 2014 DS DP U-761 D-115 May 06, 2011
5006528*PED Apr 20, 2015 D-110 Oct 29, 2010
I-616 Nov 19, 2012
I-559 May 06, 2011
I-555 Feb 27, 2011
I-545 Nov 16, 2010
PED Aug 27, 2011
PED Apr 29, 2011
ARIPIPRAZOLE - ABILIFY
N021436 004 5006528 Oct 20, 2014 DS DP U-761 D-115 May 06, 2011
5006528*PED Apr 20, 2015 D-110 Oct 29, 2010
I-616 Nov 19, 2012
I-559 May 06, 2011
I-555 Feb 27, 2011
I-545 Nov 16, 2010
PED Aug 27, 2011
PED Apr 29, 2011
ARIPIPRAZOLE - ABILIFY
N021436 005 5006528 Oct 20, 2014 DS DP U-761 D-115 May 06, 2011
5006528*PED Apr 20, 2015 D-110 Oct 29, 2010
I-616 Nov 19, 2012
I-559 May 06, 2011
I-555 Feb 27, 2011
I-545 Nov 16, 2010
PED Aug 27, 2011
PED Apr 29, 2011
ARIPIPRAZOLE - ABILIFY
N021436 006 5006528 Oct 20, 2014 DS DP U-761 D-115 May 06, 2011
5006528*PED Apr 20, 2015 D-110 Oct 29, 2010
I-616 Nov 19, 2012
I-559 May 06, 2011
I-555 Feb 27, 2011
I-545 Nov 16, 2010
PED Aug 27, 2011
PED Apr 29, 2011
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 16 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ARIPIPRAZOLE - ABILIFY
N021713 001 5006528 Oct 20, 2014 DS DP U-761 D-115 May 06, 2011
5006528*PED Apr 20, 2015 D-110 Oct 29, 2010
6977257 Apr 24, 2022 DS DP I-559 May 06, 2011
6977257*PED Oct 24, 2022
I-555 Feb 27, 2011
I-545 Nov 16, 2010
PED Aug 27, 2011
PED Apr 29, 2011
ARIPIPRAZOLE - ABILIFY
N021729 002 5006528 Oct 20, 2014 DS DP U-761 D-115 May 06, 2011
5006528*PED Apr 20, 2015 D-110 Oct 29, 2010
I-559 May 06, 2011
I-555 Feb 27, 2011
I-545 Nov 16, 2010
PED Aug 27, 2011
PED Apr 29, 2011
ARIPIPRAZOLE - ABILIFY
N021729 003 5006528 Oct 20, 2014 DS DP U-761 D-115 May 06, 2011
5006528*PED Apr 20, 2015 D-110 Oct 29, 2010
I-559 May 06, 2011
I-555 Feb 27, 2011
I-545 Nov 16, 2010
PED Aug 27, 2011
PED Apr 29, 2011
ARIPIPRAZOLE - ABILIFY
N021729 004 5006528 Oct 20, 2014 DS DP U-761 D-115 May 06, 2011
5006528*PED Apr 20, 2015 D-110 Oct 29, 2010
I-559 May 06, 2011
I-555 Feb 27, 2011
I-545 Nov 16, 2010
PED Aug 27, 2011
PED Apr 29, 2011
ARIPIPRAZOLE - ABILIFY
N021729 005 5006528 Oct 20, 2014 DS DP U-761 D-115 May 06, 2011
5006528*PED Apr 20, 2015 D-110 Oct 29, 2010
I-559 May 06, 2011
I-555 Feb 27, 2011
I-545 Nov 16, 2010
PED Aug 27, 2011
PED Apr 29, 2011
ARIPIPRAZOLE - ABILIFY
N021866 001 5006528 Oct 20, 2014 DS DP U-763 D-115 May 06, 2011
5006528*PED Apr 20, 2015 D-110 Oct 29, 2010
7115587 Jul 21, 2024 DS DP U-764 I-559 May 06, 2011
7115587*PED Jan 21, 2025
7550445 Jul 21, 2024 DP I-555 Feb 27, 2011
7550445*PED Jan 21, 2025 I-545 Nov 16, 2010
NDF Sep 20, 2009
PED Aug 27, 2011
PED Apr 29, 2011
PED Mar 20, 2010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 17 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY

EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

APPL/PROD DATE REQUESTED DATE

NO PATENT NO CODES CODE(S)


ARMODAFINIL - NUVIGIL
N021875 001 4927855 Apr 22, 2010 DS DP U-820 NP Jun 15, 2010
4927855*PED Oct 22, 2010
7132570 Dec 18, 2023 DS DP
7132570*PED Jun 18, 2024
7297346 Nov 29, 2023 DP
7297346*PED May 29, 2024
RE37516 Oct 06, 2014 DP U-820
RE37516*PED Apr 06, 2015
ARMODAFINIL - NUVIGIL
N021875 002 4927855 Apr 22, 2010 DS DP U-820 NP Jun 15, 2010
4927855*PED Oct 22, 2010
7132570 Dec 18, 2023 DS DP
7132570*PED Jun 18, 2024
7297346 Nov 29, 2023 DP
7297346*PED May 29, 2024
RE37516 Oct 06, 2014 DP U-820
RE37516*PED Apr 06, 2015
ARMODAFINIL - NUVIGIL
N021875 003 4927855 Apr 22, 2010 DS DP U-820 NP Jun 15, 2010
4927855*PED Oct 22, 2010
7132570 Dec 18, 2023 DS DP
7132570*PED Jun 18, 2024
7297346 Nov 29, 2023 DP
7297346*PED May 29, 2024
RE37516 Oct 06, 2014 DP U-820
RE37516*PED Apr 06, 2015
ARMODAFINIL - NUVIGIL
N021875 004 4927855 Apr 22, 2010 DS DP U-820 NP Jun 15, 2010
4927855*PED Oct 22, 2010
7132570 Dec 18, 2023 DS DP
7132570*PED Jun 18, 2024
7297346 Nov 29, 2023 DP
7297346*PED May 29, 2024
RE37516 Oct 06, 2014 DP U-820
RE37516*PED Apr 06, 2015
ARMODAFINIL - NUVIGIL
N021875 005 4927855 Apr 22, 2010 DS DP U-820 NP Jun 15, 2010
4927855*PED Oct 22, 2010
7132570 Dec 18, 2023 DS DP
7132570*PED Jun 18, 2024
7297346 Nov 29, 2023 DP
7297346*PED May 29, 2024
RE37516 Oct 06, 2014 DP U-820
RE37516*PED Apr 06, 2015
ARSENIC TRIOXIDE - TRISENOX
N021248 001 6723351 Nov 10, 2018 U-573
6855339 Nov 10, 2018 U-617
6861076 Nov 10, 2018 U-617
6884439 Nov 10, 2018 U-651
6982096 Nov 10, 2018 U-651
ARTEMETHER; LUMEFANTRINE - COARTEM
N022268 001 5677331 Oct 14, 2014 DP U-977 NCE Apr 07, 2014

ODE Apr 07, 2016

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE
HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E - M.V.I.-12
(WITHOUT VITAMIN K)
N008809 006 ODE Sep 09, 2011
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM
SULFATE - MOVIPREP
N021881 001 7169381 Sep 01, 2024 DS DP NP Aug 02, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 18 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ASENAPINE MALEATE - SAPHRIS
N022117 001 5763476 Jun 09, 2015 DP U-326 NCE Aug 13, 2014
ASENAPINE MALEATE - SAPHRIS
N022117 002 5763476 Jun 09, 2015 DP U-326 NCE Aug 13, 2014
ASPIRIN; DIPYRIDAMOLE - AGGRENOX
N020884 001 6015577 Jan 18, 2017 U-302
ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED)
N021387 001 5622985 Apr 22, 2014 U-335
5622985*PED Oct 22, 2014 U-335
ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED)
N021387 002 5622985 Apr 22, 2014 U-335

5622985*PED Oct 22, 2014 U-335

ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED)


N021387 003 5622985 Apr 22, 2014 U-335

5622985*PED Oct 22, 2014 U-335

ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED)


N021387 004 5622985 Apr 22, 2014 U-335
5622985*PED Oct 22, 2014 U-335
ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED)
N021387 005 5622985 Apr 22, 2014 U-335
5622985*PED Oct 22, 2014 U-335
ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED)
N021387 006 5622985 Apr 22, 2014 U-335
5622985*PED Oct 22, 2014 U-335
ATAZANAVIR SULFATE - REYATAZ
N021567 001 5849911 Jun 20, 2017 DS DP U-167 D-116 Sep 30, 2011
6087383 Dec 21, 2018 DS DP NPP Mar 25, 2011
ATAZANAVIR SULFATE - REYATAZ
N021567 002 5849911 Jun 20, 2017 DS DP U-167 D-116 Sep 30, 2011
6087383 Dec 21, 2018 DS DP NPP Mar 25, 2011
ATAZANAVIR SULFATE - REYATAZ
N021567 003 5849911 Jun 20, 2017 DS DP U-167 D-116 Sep 30, 2011
6087383 Dec 21, 2018 DS DP NPP Mar 25, 2011
ATAZANAVIR SULFATE - REYATAZ
N021567 004 5849911 Jun 20, 2017 DS DP U-167 D-116 Sep 30, 2011
6087383 Dec 21, 2018 DS DP NPP Mar 25, 2011
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N021411 001 5658590 Nov 26, 2016 U-494 I-562 May 07, 2011
5658590*PED May 26, 2017 U-494 M-78 Jul 23, 2011
M-66 Sep 28, 2010
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N021411 002 5658590 Nov 26, 2016 U-494 I-562 May 07, 2011
5658590*PED May 26, 2017 U-494 M-78 Jul 23, 2011
M-66 Sep 28, 2010
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N021411 003 5658590 Nov 26, 2016 U-494 I-562 May 07, 2011
5658590*PED May 26, 2017 U-494 M-78 Jul 23, 2011
M-66 Sep 28, 2010
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N021411 004 5658590 Nov 26, 2016 U-494 I-562 May 07, 2011
5658590*PED May 26, 2017 U-494 M-78 Jul 23, 2011
M-66 Sep 28, 2010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 19 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N021411 005 5658590 Nov 26, 2016 U-494 I-562 May 07, 2011
5658590*PED May 26, 2017 U-494 M-78 Jul 23, 2011
M-66 Sep 28, 2010
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N021411 006 5658590 Nov 26, 2016 U-494 I-562 May 07, 2011
5658590*PED May 26, 2017 U-494 M-78 Jul 23, 2011
M-66 Sep 28, 2010
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N021411 007 5658590 Nov 26, 2016 U-494 I-562 May 07, 2011
5658590*PED May 26, 2017 U-494 M-78 Jul 23, 2011
M-66 Sep 28, 2010
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N021411 008 5658590 Nov 26, 2016 U-494 I-562 May 07, 2011
5658590*PED May 26, 2017 U-494 M-78 Jul 23, 2011
M-66 Sep 28, 2010
ATORVASTATIN CALCIUM - LIPITOR
N020702 001 4681893 Sep 24, 2009 DS DP U-161 I-523 Mar 02, 2010
4681893*PED Mar 24, 2010 U-161
5273995 Dec 28, 2010 DS DP U-162
5273995*PED Jun 28, 2011 U-162
5686104 Nov 11, 2014 DP U-213
5686104*PED May 11, 2015 U-213
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
6126971 Jan 19, 2013 DP
6126971*PED Jul 19, 2013
RE40667 Dec 28, 2010 DS DP U-162
RE40667*PED Jun 28, 2011
ATORVASTATIN CALCIUM - LIPITOR
N020702 002 4681893 Sep 24, 2009 DS DP U-161 I-523 Mar 02, 2010
4681893*PED Mar 24, 2010 U-161
5273995 Dec 28, 2010 DS DP U-162
5273995*PED Jun 28, 2011 U-162
5686104 Nov 11, 2014 DP U-213
5686104*PED May 11, 2015 U-213
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
6126971 Jan 19, 2013 DP
6126971*PED Jul 19, 2013
RE40667 Dec 28, 2010 DS DP U-162
RE40667*PED Jun 28, 2011
ATORVASTATIN CALCIUM - LIPITOR
N020702 003 4681893 Sep 24, 2009 DS DP U-161 I-523 Mar 02, 2010
4681893*PED Mar 24, 2010 U-161
5273995 Dec 28, 2010 DS DP U-162
5273995*PED Jun 28, 2011 U-162
5686104 Nov 11, 2014 DP U-213
5686104*PED May 11, 2015 U-213
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
6126971 Jan 19, 2013 DP
6126971*PED Jul 19, 2013
RE40667 Dec 28, 2010 DS DP U-162
RE40667*PED Jun 28, 2011
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 20 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ATORVASTATIN CALCIUM - LIPITOR
N020702 004 4681893 Sep 24, 2009 DS DP U-161 I-523 Mar 02, 2010
4681893*PED Mar 24, 2010 U-161
5273995 Dec 28, 2010 DS DP U-162
5273995*PED Jun 28, 2011 U-162
5686104 Nov 11, 2014 DP U-213
5686104*PED May 11, 2015 U-213
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
6126971 Jan 19, 2013 DP
6126971*PED Jul 19, 2013
RE40667 Dec 28, 2010 DS DP U-162
RE40667*PED Jun 28, 2011
ATOVAQUONE - MEPRON
N020259 001 4981874 Aug 15, 2009 U-69
4981874*PED Feb 15, 2010 U-69
ATOVAQUONE - MEPRON
N020500 001 4981874 Aug 15, 2009 U-69
4981874*PED Feb 15, 2010 U-69
6649659 Jul 10, 2016 DS DP U-69
6649659*PED Jan 10, 2017
ATOVAQUONE; PROGUANIL HYDROCHLORIDE - MALARONE
N021078 001 5998449 Nov 25, 2013 U-990
5998449*PED May 25, 2014
6166046 Nov 25, 2013 U-406
6166046*PED May 25, 2014
6291488 Nov 25, 2013 U-406
6291488*PED May 25, 2014
ATOVAQUONE; PROGUANIL HYDROCHLORIDE - MALARONE PEDIATRIC
N021078 002 5998449 Nov 25, 2013 U-990
5998449*PED May 25, 2014
6166046 Nov 25, 2013
6166046*PED May 25, 2014
6291488 Nov 25, 2013 U-406
6291488*PED May 25, 2014
ATROPINE; PRALIDOXIME CHLORIDE - DUODOTE
N021983 001 5092843 Apr 12, 2010 DP
AVOBENZONE; ECAMSULE; OCTOCRYLENE - ANTHELIOS SX
N021502 001 5587150 Dec 24, 2013 DP U-752 NC Jul 21, 2009
AVOBENZONE; ECAMSULE; OCTOCRYLENE - CAPITAL SOLEIL 15
N021501 001 NC Jul 21, 2009
NP Oct 02, 2009
AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE - ANTHELIOS 20
N021471 001 NC Oct 05, 2009
AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE - ANTHELIOS 40
N022009 001 NP Mar 31, 2011
NC Oct 05, 2009
AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE - ANTHELIOS 40
N022009 002 NP Oct 29, 2012
AZACITIDINE - VIDAZA
N050794 001 ODE May 19, 2011
AZELAIC ACID - FINACEA
N021470 001 6534070 Nov 18, 2018
AZELASTINE HYDROCHLORIDE - ASTELIN
N020114 001 5164194 Nov 01, 2010 U-730
5164194 Nov 01, 2010 U-207
5164194*PED May 01, 2011
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 21 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
AZELASTINE HYDROCHLORIDE - ASTEPRO
N022203 001 NP Oct 15, 2011
AZELASTINE HYDROCHLORIDE - ASTEPRO
N022371 001 NP Aug 31, 2012
AZELASTINE HYDROCHLORIDE - AZELASTINE HYDROCHLORIDE
A078621 001 PC May 30, 2010
AZELASTINE HYDROCHLORIDE - OPTIVAR
N021127 001 5164194 Nov 01, 2010
5164194*PED May 01, 2011
AZITHROMYCIN - AZASITE
N050810 001 5192535 Mar 09, 2010 DP U-709
6159458 Nov 04, 2017 DP U-709
6239113 Mar 31, 2019 U-709
6569443 Mar 31, 2019 DP U-709
6861411 Nov 25, 2018 U-709
7056893 Mar 31, 2019 DP U-709
AZITHROMYCIN - AZITHROMYCIN
A065500 001 PC Nov 07, 2009
AZITHROMYCIN - AZITHROMYCIN
A065506 001 PC Nov 07, 2009
AZITHROMYCIN - ZITHROMAX
N050693 001 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZITHROMAX
N050710 001 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZITHROMAX
N050710 002 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZITHROMAX
N050711 001 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZITHROMAX
N050730 001 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZITHROMAX
N050733 001 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZITHROMAX
N050784 001 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZMAX
N050797 001 6068859 May 30, 2017 DP
6268489 Jul 31, 2018 DS
6984403 Feb 14, 2024 DP U-282
BACLOFEN - KEMSTRO
N021589 001 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
BACLOFEN - KEMSTRO
N021589 002 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
BALSALAZIDE DISODIUM - COLAZAL
N020610 001 NPP Dec 20, 2009
ODE Dec 20, 2013
PED Jun 20, 2014
PED Jun 20, 2010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 22 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
BECLOMETHASONE DIPROPIONATE - QVAR 40
N020911 002 5605674 Feb 25, 2014
5683677 Nov 04, 2014
5695743 Jul 06, 2010
5766573 Nov 28, 2009 U-356
5776432 Jul 07, 2015
6352684 Nov 28, 2009
BECLOMETHASONE DIPROPIONATE - QVAR 80
N020911 001 5605674 Feb 25, 2014
5683677 Nov 04, 2014
5695743 Jul 06, 2010
5766573 Nov 28, 2009 U-356
5776432 Jul 07, 2015
6352684 Nov 28, 2009
BENDAMUSTINE HYDROCHLORIDE - TREANDA
N022249 001 I-580 Oct 31, 2011
NCE Mar 20, 2013
ODE Mar 20, 2015
BENDAMUSTINE HYDROCHLORIDE - TREANDA
N022249 002 I-580 Oct 31, 2011
NCE Mar 20, 2013
ODE Mar 20, 2015
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - ACANYA
N050819 001 5733886 Mar 31, 2015 DP U-124
6117843 Feb 18, 2012 DP
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - DUAC
N050741 001 5466446 Feb 16, 2014 DS DP
BENZYL ALCOHOL - ULESFIA
N022129 001 5858383 Aug 11, 2017 U-970 NCE Apr 09, 2014
6139859 Aug 11, 2017 U-970
6793931 Jul 11, 2022 DP U-970
7294342 May 19, 2024 U-970
BEPOTASTINE BESILATE - BEPREVE
N022288 001 NCE Sep 08, 2014
BESIFLOXACIN HYDROCHLORIDE - BESIVANCE
N022308 001 5447926 Sep 05, 2012 DS DP U-80 NCE May 28, 2014
6685958 Jun 29, 2021 DP U-80
6699492 Mar 31, 2019 DP U-80
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE - TACLONEX
N021852 001 5763426 Jun 09, 2015 DS DP
6753013 Jan 27, 2020 DP U-193
6753013 Jan 27, 2020 DP U-88
RE39706 Jun 09, 2015 DS DP
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE - TACLONEX SCALP
N022185 001 6753013 Jan 27, 2020 DP U-88 NDF May 09, 2011
6753013 Jan 27, 2020 DP U-193
6787529 Jan 27, 2020 DP U-88
6787529 Jan 27, 2020 DP U-193
RE39706 Jun 09, 2015 DS DP
BETAMETHASONE VALERATE - LUXIQ
N020934 001 6126920 Mar 01, 2016 U-484
7078058 May 24, 2017 DP
BETAXOLOL HYDROCHLORIDE - BETOPTIC S
N019845 001 M-14 Jun 08, 2010
PED Dec 08, 2010
BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE - BETOPTIC PILO
N020619 001 5635172 Jun 03, 2014 U-191
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 23 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
BEXAROTENE - TARGRETIN
N021055 001 5780676 Jul 14, 2015 U-509
5962731 Oct 05, 2016 U-475
6043279 Apr 22, 2012 U-509
6320074 Apr 22, 2012 DS U-509
BEXAROTENE - TARGRETIN
N021056 001 5780676 Jul 14, 2015 U-510
5962731 Oct 05, 2016
6043279 Apr 22, 2012 U-510
6320074 Apr 22, 2012 DS U-510
BICALUTAMIDE - CASODEX
N020498 001 M-81 Dec 19, 2011
PED Jun 19, 2012
BIMATOPROST - LATISSE
N022369 001 6403649 Sep 21, 2012 DS NP Dec 24, 2011
7351404 May 25, 2024 U-939
7388029 Jan 21, 2022 U-938
BIMATOPROST - LUMIGAN
N021275 001 5688819 Aug 19, 2014 U-446
6403649 Sep 21, 2012 DS DP U-446
BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - HALFLYTELY
N021551 001 7291324 Oct 22, 2022 U-837
BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - HALFLYTELY
N021551 002 7291324 Oct 22, 2022 U-837 NP Sep 24, 2010
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE - PYLERA
N050786 001 5196205 Mar 23, 2010 U-933
5476669 Mar 23, 2010 U-933
6350468 Dec 14, 2018 U-932
6350468 Dec 14, 2018 U-956
BIVALIRUDIN - ANGIOMAX
N020873 001 5196404 Mar 23, 2010
5196404*PED Sep 23, 2010
7582727 Jul 27, 2028 DP
7582727*PED Jan 27, 2029
7598343 Jul 27, 2028 DP
7598343*PED Jan 27, 2029
BORTEZOMIB - VELCADE
N021602 001 5780454 May 03, 2017 DP I-564 Jun 20, 2011
6083903 Oct 28, 2014 DP U-515 I-521 Dec 08, 2009
6297217 Oct 28, 2014 U-515 ODE Mar 25, 2012
6297217 Oct 28, 2014 U-884
6297217 Oct 28, 2014 U-885

ODE May 13, 2010
6617317 Oct 28, 2014 DS DP

6713446 Jan 25, 2022 DP


6747150 Oct 28, 2014 DP


6958319 Jan 25, 2022 DP


7119080 Oct 28, 2014 DP


BOSENTAN - TRACLEER
N021290 001 5292740 Nov 20, 2015 I-607 Aug 07, 2012
M-64 Feb 15, 2010
BOSENTAN - TRACLEER
N021290 002 5292740 Nov 20, 2015 I-607 Aug 07, 2012
M-64 Feb 15, 2010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 24 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
BRIMONIDINE TARTRATE - ALPHAGAN P
N021262 001 5424078 Jun 13, 2012
5424078*PED Dec 13, 2012
6562873 Jul 10, 2021
6562873*PED Jan 10, 2022
6627210 Jul 18, 2021 DP
6627210*PED Jan 18, 2022
6641834 Jul 28, 2021 DP
6641834*PED Jan 28, 2022
6673337 Jul 26, 2021 DP
6673337*PED Jan 26, 2022
BRIMONIDINE TARTRATE - ALPHAGAN P
N021770 001 5424078 Jun 13, 2012 DP
5424078*PED Dec 13, 2012
6562873 Jul 10, 2021 DP
6562873*PED Jan 10, 2022
6627210 Jul 18, 2021 DP
6627210*PED Jan 18, 2022
6641834 Jul 28, 2021 DP
6641834*PED Jan 28, 2022
6673337 Jul 26, 2021 DP
6673337*PED Jan 26, 2022
BRIMONIDINE TARTRATE - BRIMONIDINE TARTRATE
N021764 001 7265117 Aug 19, 2025 DP
BRIMONIDINE TARTRATE; TIMOLOL MALEATE - COMBIGAN
N021398 001 7030149 Apr 19, 2022 U-849 NC Oct 30, 2010
7320976 Apr 19, 2022 U-849
7323463 Jan 19, 2023 DP
7642258 Apr 19, 2022 DS DP U-1024
BRINZOLAMIDE - AZOPT
N020816 001 5240923 Aug 31, 2010 DS DP U-224 M-54 Sep 28, 2009
5240923*PED Mar 01, 2011 PED Mar 28, 2010
5378703 Apr 01, 2012 DS DP U-224
5378703*PED Oct 01, 2012
5461081 Oct 24, 2012 DP U-225
5461081*PED Apr 24, 2013
BROMOCRIPTINE MESYLATE - CYCLOSET
N020866 001 5468755 Nov 21, 2012 U-976 NP May 05, 2012
5679685 Oct 21, 2014 DP
5716957 Feb 10, 2015 U-976
5756513 Nov 21, 2012 U-976
5866584 Nov 21, 2012 U-976
BUDESONIDE - ENTOCORT EC
N021324 001 5643602 Jul 01, 2014 U-655
5643602*PED Jan 01, 2015 DP
6423340 Nov 15, 2010
6423340*PED May 15, 2011
BUDESONIDE - PULMICORT FLEXHALER
N021949 001 6027714 Jan 09, 2018 DP U-787 NP Jul 12, 2009
6142145 May 08, 2018 DP
6287540 Jan 09, 2018 DP
7143764 Mar 13, 2018 DP
BUDESONIDE - PULMICORT FLEXHALER
N021949 002 6027714 Jan 09, 2018 DP U-787 NP Jul 12, 2009
6142145 May 08, 2018 DP
6287540 Jan 09, 2018 DP
7143764 Mar 13, 2018 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 25 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
BUDESONIDE - PULMICORT RESPULES
N020929 001 6598603 Dec 23, 2018 U-529
6598603*PED Jun 23, 2019
6899099 Dec 23, 2018 U-529
6899099*PED Jun 23, 2019
7524834 Nov 11, 2018 DP U-966
7524834*PED May 11, 2019
BUDESONIDE - PULMICORT RESPULES
N020929 002 6598603 Dec 23, 2018 U-529
6598603*PED Jun 23, 2019
6899099 Dec 23, 2018 U-529
6899099*PED Jun 23, 2019
7524834 Nov 11, 2018 DP U-966
7524834*PED May 11, 2019
BUDESONIDE - PULMICORT RESPULES
N020929 003 6598603 Dec 23, 2018 U-529
6598603*PED Jun 23, 2019
6899099 Dec 23, 2018 U-529
6899099*PED Jun 23, 2019
7524834 Nov 11, 2018 DP U-966
7524834*PED May 11, 2019
BUDESONIDE - RHINOCORT
N020746 001 6291445 Apr 29, 2017 Y
6291445*PED Oct 29, 2017
6686346 Apr 29, 2017 DP U-557 Y
6986904 Apr 29, 2017 DP U-699 Y
BUDESONIDE - RHINOCORT
N020746 002 6291445 Apr 29, 2017
6291445*PED Oct 29, 2017
6686346 Apr 29, 2017 DP U-557
6986904 Apr 29, 2017 DP U-699
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - SYMBICORT
N021929 001 5349945 Sep 27, 2011 DP I-582 Feb 27, 2012
5674860 Oct 07, 2014 DP U-754 NC Jul 21, 2009
5972919 Dec 17, 2012 DP U-754
6123924 Sep 26, 2017 DP
6641800 Sep 23, 2012 DP
7367333 Nov 11, 2018 DP
7587988 Apr 10, 2026 DP
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - SYMBICORT
N021929 002 5349945 Sep 27, 2011 DP I-582 Feb 27, 2012
5674860 Oct 07, 2014 DP U-754 NC Jul 21, 2009
5972919 Dec 17, 2012 DP U-754
6123924 Sep 26, 2017 DP
6641800 Sep 23, 2012 DP
7367333 Nov 11, 2018 DP
7587988 Apr 10, 2026 DP
BUPRENORPHINE HYDROCHLORIDE - SUBUTEX
N020732 002 ODE Oct 08, 2009
BUPRENORPHINE HYDROCHLORIDE - SUBUTEX
N020732 003 ODE Oct 08, 2009
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE
N020733 001 ODE Oct 08, 2009
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE
N020733 002 ODE Oct 08, 2009
BUPROPION HYDROBROMIDE - APLENZIN
N022108 001 7241805 Jun 27, 2026 DP
7569610 Jun 27, 2026 U-997
7572935 Jun 27, 2026 DP
7585897 Jun 27, 2026 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 26 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
BUPROPION HYDROBROMIDE - APLENZIN
N022108 002 7241805 Jun 27, 2026 DP
7569610 Jun 27, 2026 U-997
7572935 Jun 27, 2026 DP
7585897 Jun 27, 2026 DP
BUPROPION HYDROBROMIDE - APLENZIN
N022108 003 7241805 Jun 27, 2026 DP
7569610 Jun 27, 2026 U-997
7572935 Jun 27, 2026 DP
7585897 Jun 27, 2026 DP
BUPROPION HYDROCHLORIDE - WELLBUTRIN SR
N020358 001 5358970 Aug 12, 2013
5427798 Aug 12, 2013
5731000 Aug 12, 2013
5763493 Aug 12, 2013
BUPROPION HYDROCHLORIDE - WELLBUTRIN SR
N020358 002 5358970 Aug 12, 2013
5427798 Aug 12, 2013
5731000 Aug 12, 2013
5763493 Aug 12, 2013
BUPROPION HYDROCHLORIDE - WELLBUTRIN SR
N020358 003 5358970 Aug 12, 2013
5427798 Aug 12, 2013
5731000 Aug 12, 2013
5763493 Aug 12, 2013
BUPROPION HYDROCHLORIDE - WELLBUTRIN SR
N020358 004 5358970 Aug 12, 2013
5427798 Aug 12, 2013
5731000 Aug 12, 2013
5763493 Aug 12, 2013
BUPROPION HYDROCHLORIDE - WELLBUTRIN XL
N021515 001 6096341 Oct 30, 2018
BUPROPION HYDROCHLORIDE - WELLBUTRIN XL
N021515 002 6096341 Oct 30, 2018
BUPROPION HYDROCHLORIDE - ZYBAN
N020711 002 5358970 Aug 12, 2013
5427798 Aug 12, 2013
5731000 Aug 12, 2013
5763493 Aug 12, 2013
BUPROPION HYDROCHLORIDE - ZYBAN
N020711 003 5358970 Aug 12, 2013
5427798 Aug 12, 2013
5731000 Aug 12, 2013
5763493 Aug 12, 2013
BUSULFAN - BUSULFEX
N020954 001 5430057 Sep 30, 2013 U-263
5430057*PED Mar 30, 2014 U-263
5559148 Sep 30, 2013 U-264
5559148*PED Mar 30, 2014 U-264
BUTENAFINE HYDROCHLORIDE - MENTAX
N020524 001 5021458 Oct 18, 2010 U-177
BUTOCONAZOLE NITRATE - GYNAZOLE-1
N019881 001 5266329 Nov 30, 2010 U-457
5993856 Nov 17, 2017 DP U-457
CALCIPOTRIENE - DOVONEX
N020554 001 5763426 Jun 09, 2015 DS DP
RE39706 Jun 09, 2015 DS DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 27 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
CALCIPOTRIENE - DOVONEX
N020611 001 5763426 Jun 09, 2015 DS DP
RE39706 Jun 09, 2015 DS DP
CALCITONIN SALMON RECOMBINANT - FORTICAL
N021406 001 6440392 Feb 02, 2021 DP U-227
RE40812 Feb 02, 2021 DP
CALCITONIN, SALMON - MIACALCIN
N020313 002 5733569 Mar 31, 2015 U-227
5759565 Mar 31, 2015
CALCITRIOL - CALCIJEX
N018874 001 6051567 Aug 02, 2019
6051567*PED Feb 02, 2020
6265392 Aug 02, 2019
6265392*PED Feb 02, 2020
6274169 Aug 02, 2019
6274169*PED Feb 02, 2020
CALCITRIOL - CALCIJEX
N018874 002 6051567 Aug 02, 2019
6051567*PED Feb 02, 2020
6265392 Aug 02, 2019
6265392*PED Feb 02, 2020
6274169 Aug 02, 2019
6274169*PED Feb 02, 2020
CALCITRIOL - VECTICAL
N022087 001 NDF Jan 23, 2012
CALCIUM ACETATE - PHOSLO
N021160 002 6576665 Apr 03, 2021
CALCIUM ACETATE - PHOSLO GELCAPS
N021160 003 6576665 Apr 03, 2021
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE - PEPCID COMPLETE
N020958 001 5075114 May 23, 2010 DP
5075114*PED Nov 23, 2010
5229137 May 16, 2012 U-349
5229137*PED Nov 16, 2012
5989588 Sep 30, 2015 U-349
5989588*PED Mar 30, 2016 U-349
6814978 Aug 26, 2021 DP
6814978*PED Feb 26, 2022
CALCIUM CARBONATE; RISEDRONATE SODIUM - ACTONEL WITH CALCIUM (COPACKAGED)
N021823 001 5583122 Dec 10, 2013 DS DP U-353
5583122*PED Jun 10, 2014
5994329 Jul 17, 2018 U-353
5994329*PED Jan 17, 2019
6015801 Jul 17, 2018 U-353
6015801*PED Jan 17, 2019
6096342 Nov 21, 2011 DP
6096342*PED May 21, 2012
6165513 Jun 10, 2018 DP
6165513*PED Dec 10, 2018
6432932 Jul 17, 2018 U-595
6432932*PED Jan 17, 2019
6465443 Aug 14, 2018 DP
6465443*PED Feb 14, 2019
CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM
BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE - NAVSTEL
N022193 001 5409904 Apr 25, 2012 DP U-891 NP Jul 24, 2011
5578578 Apr 25, 2012 DP
7084130 Nov 29, 2021 DP U-891
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 28 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
CANDESARTAN CILEXETIL - ATACAND
N020838 001 5196444 Jun 04, 2012 DS DP U-3
5196444 Jun 04, 2012 DS DP U-660
5196444*PED Dec 04, 2012
5534534 Jul 09, 2013 DP
5534534*PED Jan 09, 2014
5705517 Apr 18, 2011 DS DP U-660
5705517*PED Oct 18, 2011
7538133 Apr 18, 2011 DS
7538133*PED Oct 18, 2011
CANDESARTAN CILEXETIL - ATACAND
N020838 002 5196444 Jun 04, 2012 DS DP U-3
5196444 Jun 04, 2012 DS DP U-660
5196444*PED Dec 04, 2012
5534534 Jul 09, 2013 DP
5534534*PED Jan 09, 2014
5705517 Apr 18, 2011 DS DP U-660
5705517*PED Oct 18, 2011
7538133 Apr 18, 2011 DS
7538133*PED Oct 18, 2011
CANDESARTAN CILEXETIL - ATACAND
N020838 003 5196444 Jun 04, 2012 DS DP U-660
5196444 Jun 04, 2012 DS DP U-3
5196444*PED Dec 04, 2012
5534534 Jul 09, 2013 DP
5534534*PED Jan 09, 2014
5705517 Apr 18, 2011 DS DP U-660
5705517*PED Oct 18, 2011
7538133 Apr 18, 2011 DS
7538133*PED Oct 18, 2011
CANDESARTAN CILEXETIL - ATACAND
N020838 004 5196444 Jun 04, 2012 DS DP U-660
5196444 Jun 04, 2012 DS DP U-3
5196444*PED Dec 04, 2012
5534534 Jul 09, 2013 DP
5534534*PED Jan 09, 2014
5705517 Apr 18, 2011 DS DP U-660
5705517*PED Oct 18, 2011
7538133 Apr 18, 2011 DS
7538133*PED Oct 18, 2011
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - ATACAND HCT
N021093 001 5196444 Jun 04, 2012 DS DP U-3
5196444*PED Dec 04, 2012
5534534 Jul 09, 2013 DP
5534534*PED Jan 09, 2014
5705517 Apr 18, 2011 DS DP U-3
5705517*PED Oct 18, 2011
5721263 Feb 24, 2015 DP U-3
5958961 Jun 06, 2014 DP U-3
7538133 Apr 18, 2011 DS
7538133*PED Oct 18, 2011
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - ATACAND HCT
N021093 002 5196444 Jun 04, 2012 DS DP U-3
5196444*PED Dec 04, 2012
5534534 Jul 09, 2013 DP
5534534*PED Jan 09, 2014
5705517 Apr 18, 2011 DS DP U-3
5705517*PED Oct 18, 2011
5721263 Feb 24, 2015 DP U-3
5958961 Jun 06, 2014 DP U-3
7538133 Apr 18, 2011 DS
7538133*PED Oct 18, 2011
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 29 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - ATACAND HCT
N021093 003 5196444 Jun 04, 2012 DS DP U-3
5196444*PED Dec 04, 2012
5534534 Jul 09, 2013 DP
5534534*PED Jan 09, 2014
5705517 Apr 18, 2011 DS DP U-3
5705517*PED Oct 18, 2011
5721263 Feb 24, 2015 DP U-3
5958961 Jun 06, 2014 DP U-3
7538133 Apr 18, 2011 DS
7538133*PED Oct 18, 2011
CAPECITABINE - XELODA
N020896 001 4966891 Jan 13, 2011 U-272
5472949 Dec 14, 2013 U-271
CAPECITABINE - XELODA
N020896 002 4966891 Jan 13, 2011 U-272
5472949 Dec 14, 2013 U-271
CAPSAICIN - QUTENZA
N022395 001 6239180 Nov 06, 2016 DP NCE Nov 16, 2014
CAPTOPRIL - CAPOTEN
N018343 001 5238924 Aug 24, 2010 U-92
CAPTOPRIL - CAPOTEN
N018343 002 5238924 Aug 24, 2010 U-92
CAPTOPRIL - CAPOTEN
N018343 003 5238924 Aug 24, 2010 U-92
CAPTOPRIL - CAPOTEN
N018343 004 5238924 Aug 24, 2010 U-92
CAPTOPRIL - CAPOTEN
N018343 005 5238924 Aug 24, 2010 U-92
CAPTOPRIL - CAPOTEN
N018343 006 5238924 Aug 24, 2010 U-92
CAPTOPRIL - CAPOTEN
N018343 007 5238924 Aug 24, 2010 U-92
CARBAMAZEPINE - CARBATROL
N020712 001 5326570 Jul 05, 2011 U-215
5912013 Jun 15, 2016 U-277
CARBAMAZEPINE - CARBATROL
N020712 002 5326570 Jul 05, 2011 U-215
5912013 Jun 15, 2016 U-277
CARBAMAZEPINE - CARBATROL
N020712 003 5326570 Jul 05, 2011 U-215
5912013 Jun 15, 2016 U-277
CARBAMAZEPINE - EQUETRO
N021710 001 5326570 Jul 23, 2011 DP U-627
5912013 Jun 15, 2016 DP
6977253 May 19, 2024 U-693
CARBAMAZEPINE - EQUETRO
N021710 002 5326570 Jul 23, 2011 DP U-627
5912013 Jun 15, 2016 DP
6977253 May 19, 2024 U-693
CARBAMAZEPINE - EQUETRO
N021710 003 5326570 Jul 23, 2011 DP U-627
5912013 Jun 15, 2016 DP
6977253 May 19, 2024 U-693
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 30 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
CARBAMAZEPINE - TEGRETOL-XR
N020234 001 5284662 Feb 08, 2011
CARBAMAZEPINE - TEGRETOL-XR
N020234 002 5284662 Feb 08, 2011
CARBAMAZEPINE - TEGRETOL-XR
N020234 003 5284662 Feb 08, 2011
CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 100
N021485 002 5135950 Oct 31, 2010 DS DP U-219
5446194 Oct 19, 2013 DS
6500867 Jun 29, 2020 DP U-219
6797732 Jun 29, 2020 DP
CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 125
N021485 006 5135950 Oct 31, 2010 DS DP U-219
5446194 Oct 19, 2013 DS
6500867 Jun 29, 2020 DP U-219
6797732 Jun 29, 2020 DP
CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 150
N021485 003 5135950 Oct 31, 2010 DS DP U-219
5446194 Oct 19, 2013 DS
6500867 Jun 29, 2020 DP U-219
6797732 Jun 29, 2020 DP
CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 200
N021485 004 5135950 Oct 31, 2010 DS DP U-219
5446194 Oct 19, 2013 DS
6500867 Jun 29, 2020 DP U-219
6797732 Jun 29, 2020 DP
CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 50
N021485 001 5135950 Oct 31, 2010 DS DP U-219
5446194 Oct 19, 2013 DS
6500867 Jun 29, 2020 DP U-219
6797732 Jun 29, 2020 DP
CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 75
N021485 005 5135950 Oct 31, 2010 DS DP U-219
5446194 Oct 19, 2013 DS
6500867 Jun 29, 2020 DP U-219
6797732 Jun 29, 2020 DP
CARISOPRODOL - SOMA
N011792 004 NP Sep 13, 2010
CARMUSTINE - GLIADEL
N020637 001 ODE Feb 25, 2010
CARVEDILOL - COREG
N020297 001 RE40000 Jun 07, 2015 U-233 M-61 Feb 23, 2010
RE40000*PED Dec 07, 2015 M-56 Aug 28, 2009
PED Aug 23, 2010
PED Feb 28, 2010
CARVEDILOL - COREG
N020297 002 RE40000 Jun 07, 2015 U-233 M-61 Feb 23, 2010
RE40000*PED Dec 07, 2015 M-56 Aug 28, 2009
PED Aug 23, 2010
PED Feb 28, 2010
CARVEDILOL - COREG
N020297 003 RE40000 Jun 07, 2015 U-233 M-61 Feb 23, 2010
RE40000*PED Dec 07, 2015 M-56 Aug 28, 2009
PED Aug 23, 2010
PED Feb 28, 2010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 31 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
CARVEDILOL - COREG
N020297 004 RE40000 Jun 07, 2015 U-233 M-61 Feb 23, 2010
RE40000*PED Dec 07, 2015 M-56 Aug 28, 2009
PED Aug 23, 2010
PED Feb 28, 2010
CARVEDILOL PHOSPHATE - COREG CR
N022012 001 5902821 Feb 07, 2016 U-313 M-56 Aug 28, 2009
5902821 Feb 07, 2016 U-777 NDF Oct 20, 2009
5902821*PED Aug 07, 2016 PED Feb 28, 2010
6022562 Oct 17, 2015 DP
6022562*PED Apr 17, 2016
PED Apr 20, 2010
7268156 Jun 27, 2023 DS DP U-313

7268156 Jun 27, 2023 DS DP U-3


7268156*PED Dec 27, 2023

RE40000 Jun 07, 2015 U-777


RE40000*PED Dec 07, 2015


CARVEDILOL PHOSPHATE - COREG CR


N022012 002 5902821 Feb 07, 2016 U-313 M-56 Aug 28, 2009
5902821 Feb 07, 2016 U-777 NDF Oct 20, 2009
5902821*PED Aug 07, 2016 PED Feb 28, 2010
6022562 Oct 17, 2015 DP
6022562*PED Apr 17, 2016
PED Apr 20, 2010
7268156 Jun 27, 2023 DS DP U-313

7268156 Jun 27, 2023 DS DP U-3


7268156*PED Dec 27, 2023

RE40000 Jun 07, 2015 U-777


RE40000*PED Dec 07, 2015


CARVEDILOL PHOSPHATE - COREG CR


N022012 003 5902821 Feb 07, 2016 U-777 M-56 Aug 28, 2009
5902821 Feb 07, 2016 U-313 NDF Oct 20, 2009
5902821*PED Aug 07, 2016 PED Feb 28, 2010
6022562 Oct 17, 2015 DP
6022562*PED Apr 17, 2016
PED Apr 20, 2010
7268156 Jun 27, 2023 DS DP U-313

7268156 Jun 27, 2023 DS DP U-3


7268156*PED Dec 27, 2023

RE40000 Jun 07, 2015 U-777


RE40000*PED Dec 07, 2015


CARVEDILOL PHOSPHATE - COREG CR


N022012 004 5902821 Feb 07, 2016 U-777 M-56 Aug 28, 2009
5902821 Feb 07, 2016 U-313 NDF Oct 20, 2009
5902821*PED Aug 07, 2016 PED Feb 28, 2010
6022562 Oct 17, 2015 DP
6022562*PED Apr 17, 2016
PED Apr 20, 2010
7268156 Jun 27, 2023 DS DP U-313

7268156 Jun 27, 2023 DS DP U-3


7268156*PED Dec 27, 2023

RE40000 Jun 07, 2015 U-777


RE40000*PED Dec 07, 2015


CASPOFUNGIN ACETATE - CANCIDAS


N021227 001 5378804 Mar 16, 2013 DS
5378804*PED Sep 16, 2013
5514650 Jan 26, 2015 DP U-607
5514650*PED Jul 26, 2015
5792746 Mar 16, 2013 DS DP U-607
5792746*PED Sep 16, 2013
5952300 Mar 28, 2017 DP
5952300*PED Sep 28, 2017
6136783 Mar 28, 2017 U-607
6136783*PED Sep 28, 2017
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 32 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
CASPOFUNGIN ACETATE - CANCIDAS
N021227 002 5378804 Mar 16, 2013 DS
5378804*PED Sep 16, 2013
5514650 Jan 26, 2015 DP U-607
5514650*PED Jul 26, 2015
5792746 Mar 16, 2013 DS DP U-607
5792746*PED Sep 16, 2013
5952300 Mar 28, 2017 DP
5952300*PED Sep 28, 2017
6136783 Mar 28, 2017 U-607
6136783*PED Sep 28, 2017
CEFDINIR - OMNICEF
N050739 001 4935507 Dec 04, 2011 DS
CEFDINIR - OMNICEF
N050749 001 4935507 Dec 04, 2011 DS
CEFDINIR - OMNICEF
N050749 002 4935507 Dec 04, 2011 DS
CEFDITOREN PIVOXIL - SPECTRACEF
N021222 001 5958915 Oct 14, 2016
CEFDITOREN PIVOXIL - SPECTRACEF
N021222 002 5958915 Oct 14, 2016 DP
CEFTIBUTEN DIHYDRATE - CEDAX
N050685 002 4634697 Oct 01, 2009 DS DP U-578
4634697 Oct 01, 2009 DS DP U-282
4812561 Dec 20, 2009 DS
5599557 Apr 30, 2013 DP
CEFTIBUTEN DIHYDRATE - CEDAX
N050686 001 4634697 Oct 01, 2009 DS DP U-282
4634697 Oct 01, 2009 DS DP U-578
4812561 Dec 20, 2009 DS
5599557 Apr 30, 2013 DP U-282
5599557 Apr 30, 2013 DP U-578
CEFTIBUTEN DIHYDRATE - CEDAX
N050686 002 4634697 Oct 01, 2009 DS DP U-282
4634697 Oct 01, 2009 DS DP U-578
4812561 Dec 20, 2009 DS
5599557 Apr 30, 2013 DP U-578
5599557 Apr 30, 2013 DP U-282
CELECOXIB - CELEBREX
N020998 001 5466823 Nov 30, 2013 DS NPP Dec 15, 2009
5466823*PED May 30, 2014 PED Jun 15, 2010
5563165 Nov 30, 2013 DP
5563165*PED May 30, 2014
5760068 Jun 02, 2015 U-672
5760068 Jun 02, 2015 U-299
5760068*PED Dec 02, 2015
5972986 Oct 14, 2017 U-299
5972986*PED Apr 14, 2018
CELECOXIB - CELEBREX
N020998 002 5466823 Nov 30, 2013 DS NPP Dec 15, 2009
5466823*PED May 30, 2014 PED Jun 15, 2010
5563165 Nov 30, 2013 DP
5563165*PED May 30, 2014
5760068 Jun 02, 2015 U-672
5760068 Jun 02, 2015 U-299
5760068*PED Dec 02, 2015
5972986 Oct 14, 2017 U-299
5972986*PED Apr 14, 2018
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 33 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
CELECOXIB - CELEBREX
N020998 003 5466823 Nov 30, 2013 DS NPP Dec 15, 2009
5466823*PED May 30, 2014 PED Jun 15, 2010
5563165 Nov 30, 2013 DP
5563165*PED May 30, 2014
5760068 Jun 02, 2015 U-672
5760068 Jun 02, 2015 U-299
5760068*PED Dec 02, 2015
5972986 Oct 14, 2017 U-299
5972986*PED Apr 14, 2018
CELECOXIB - CELEBREX
N020998 004 5466823 Nov 30, 2013 DS NPP Dec 15, 2009
5466823*PED May 30, 2014 PED Jun 15, 2010
5563165 Nov 30, 2013 DP
5563165*PED May 30, 2014
5760068 Jun 02, 2015 U-672
5760068*PED Dec 02, 2015
CERIVASTATIN SODIUM - BAYCOL
N020740 001 5006530 Jun 26, 2011
5177080 Nov 26, 2011
CERIVASTATIN SODIUM - BAYCOL
N020740 002 5006530 Jun 26, 2011
5177080 Nov 26, 2011
CERIVASTATIN SODIUM - BAYCOL
N020740 003 5006530 Jun 26, 2011
5177080 Nov 26, 2011
CERIVASTATIN SODIUM - BAYCOL
N020740 004 5006530 Jun 26, 2011
5177080 Nov 26, 2011
CERIVASTATIN SODIUM - BAYCOL
N020740 005 5006530 Jun 26, 2011
5177080 Nov 26, 2011
CERIVASTATIN SODIUM - BAYCOL
N020740 006 5006530 Jun 26, 2011
5177080 Jan 26, 2011
CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC ALLERGY
N021621 003 6455533 Jul 02, 2018 DP U-295
CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC ALLERGY
N021621 004 6455533 Jul 02, 2018 DP U-295
CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC HIVES RELIEF
N021621 005 6455533 Jul 02, 2018 DP U-295
CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC HIVES RELIEF
N021621 006 6455533 Jul 02, 2018 DP U-295
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - ZYRTEC-D 12 HOUR
N021150 002 6469009 Jul 13, 2019 DP U-295
6489329 Apr 08, 2016 DP
7014867 Jun 10, 2022 DP
7226614 Jun 10, 2022 U-295
CETRORELIX - CETROTIDE
N021197 001 5198533 Oct 24, 2010 DS DP
6319192 Apr 23, 2018 U-426
6863891 Feb 22, 2014 U-426
7605121 Feb 22, 2014 DS DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 34 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
CETRORELIX - CETROTIDE
N021197 002 5198533 Oct 24, 2010 DS DP
6319192 Apr 23, 2018 U-426
6863891 Feb 22, 2014 U-426
7605121 Feb 22, 2014 DS DP
CEVIMELINE HYDROCHLORIDE - EVOXAC
N020989 002 4855290 Aug 30, 2009
5340821 Jul 07, 2013 U-309
CHLORHEXIDINE GLUCONATE - CHLORHEXIDINE GLUCONATE
N021669 001 7066916 Feb 17, 2024 U-737
7427574 Apr 25, 2026 DP
7595021 May 12, 2023 DP U-1022
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP
N020832 001 5690958 Sep 30, 2016 DP
6536975 Nov 10, 2020 DP
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP
N020832 004 5690958 Sep 30, 2016 DP
6536975 Nov 10, 2020 DP
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP
N020832 006 5690958 Sep 30, 2016 DP
6991394 Jan 31, 2024 DP
7182536 Dec 30, 2023 DP
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP FREPP
N020832 003 5538353 Aug 25, 2015 DP
5690958 Sep 30, 2016 DP
5752363 Apr 22, 2017 DP
5772346 Apr 22, 2017 DP
D386849 Nov 25, 2011 DP
D396911 Aug 11, 2012 DP
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP SEPP
N021555 001 5690958 Sep 30, 2016 DP
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT
N020832 002 5690958 Sep 30, 2016 DP
6729786 Mar 14, 2023 DP
6991393 Mar 14, 2023 DP
6991394 Jan 31, 2024 DP
7182536 Dec 30, 2023 DP
7241065 Mar 14, 2023 DP
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT
N020832 005 5690958 Sep 30, 2016 DP
6536975 Nov 10, 2020 DP
6729786 Mar 14, 2023 DP
6991393 Jan 31, 2024 DP
7241065 Mar 14, 2023 DP
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT
N020832 007 5690958 Sep 30, 2016 DP
6536975 Nov 10, 2020 DP
6729786 Mar 14, 2023 DP
6991393 Mar 14, 2023 DP
7241065 Mar 14, 2023 DP
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORASCRUB MAXI SWABSTICK
N021524 003 D468424 Jan 07, 2017
CHOLINE FENOFIBRATE - TRILIPIX
N022224 001 7259186 Jan 07, 2025 DS NP Dec 15, 2011
CHOLINE FENOFIBRATE - TRILIPIX
N022224 002 7259186 Jan 07, 2025 DS NP Dec 15, 2011
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 35 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
CHORIOGONADOTROPIN ALFA - OVIDREL
N021149 001 5767251 Jun 16, 2015
CHORIOGONADOTROPIN ALFA - OVIDREL
N021149 002 5767251 Jun 16, 2015 DS
6706681 Mar 16, 2021 DP
CICLESONIDE - ALVESCO
N021658 002 5482934 Oct 24, 2017 DS DP U-1002 NDF Jan 10, 2011
5605674 Feb 25, 2014 DP NCE Oct 20, 2011
5683677 Nov 04, 2014 DP
5695743 Jul 06, 2010 DP U-1001
5775321 Jul 07, 2015 DP
6006745 Dec 28, 2016 DP
6036942 Apr 30, 2013 DP
6120752 May 13, 2018 DP
6264923 May 13, 2013 DP
CICLESONIDE - ALVESCO
N021658 003 5482934 Oct 24, 2017 DS DP U-1002 NDF Jan 10, 2011
5605674 Feb 25, 2014 DP NCE Oct 20, 2011
5683677 Nov 04, 2014 DP
5695743 Jul 06, 2010 DP U-1001
5775321 Jul 07, 2015 DP
6006745 Dec 28, 2016 DP
6036942 Apr 30, 2013 DP
6120752 May 13, 2018 DP
6264923 May 13, 2013 DP
CICLESONIDE - OMNARIS
N022004 001 5482934 Oct 24, 2017 DS DP U-557 I-548 Nov 21, 2010
6767901 Oct 21, 2020 DP NCE Oct 20, 2011
6939559 Apr 21, 2019 DP
7235247 Apr 21, 2019 DP
CICLOPIROX - LOPROX
N020519 001 7018656 Sep 05, 2018 DP
7026337 Apr 02, 2018 U-714
CIDOFOVIR - VISTIDE
N020638 001 5142051 Jun 26, 2010
CILASTATIN SODIUM; IMIPENEM - PRIMAXIN
N050587 001 5147868 Sep 15, 2009 DS DP U-928
CILASTATIN SODIUM; IMIPENEM - PRIMAXIN
N050587 002 5147868 Sep 15, 2009 DS DP U-928
CILASTATIN SODIUM; IMIPENEM - PRIMAXIN
N050630 001 5147868 Sep 15, 2009 DS DP U-928
CILASTATIN SODIUM; IMIPENEM - PRIMAXIN
N050630 002 5147868 Sep 15, 2009 DS DP U-928
CINACALCET HYDROCHLORIDE - SENSIPAR
N021688 001 6011068 Dec 14, 2016 DS DP ODE Mar 08, 2011
6031003 Dec 14, 2016 U-559
6211244 Oct 23, 2015 DS DP U-560
6313146 Dec 14, 2016 DS DP
CINACALCET HYDROCHLORIDE - SENSIPAR
N021688 002 6011068 Dec 14, 2016 DS DP ODE Mar 08, 2011
6031003 Dec 14, 2016
6211244 Oct 23, 2015 DS DP U-560
6313146 Dec 14, 2016 DS DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 36 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
CINACALCET HYDROCHLORIDE - SENSIPAR
N021688 003 6011068 Dec 14, 2016 DS DP ODE Mar 08, 2011
6031003 Dec 14, 2016 U-559
6211244 Oct 23, 2015 DS DP U-560
6313146 Dec 14, 2016 DS DP
CIPROFLOXACIN - CIPRO
N020780 001 5695784 Dec 09, 2014
5695784*PED Jun 09, 2015
6136347 Jan 06, 2013 U-362
6136347*PED Jul 06, 2013
CIPROFLOXACIN - CIPRO
N020780 002 5695784 Dec 09, 2014
5695784*PED Jun 09, 2015
6136347 Jan 06, 2013 U-362
6136347*PED Jul 06, 2013
CIPROFLOXACIN HYDROCHLORIDE - CETRAXAL
N021918 001 NDF May 01, 2012
CIPROFLOXACIN HYDROCHLORIDE - CIPRO
N019537 001 5286754 Feb 15, 2011
5286754*PED Aug 15, 2011
CIPROFLOXACIN HYDROCHLORIDE - CIPRO
N019537 002 5286754 Feb 15, 2011
5286754*PED Aug 15, 2011
CIPROFLOXACIN HYDROCHLORIDE - CIPRO
N019537 003 5286754 Feb 15, 2011
5286754*PED Aug 15, 2011
CIPROFLOXACIN HYDROCHLORIDE - CIPRO
N019537 004 5286754 Feb 15, 2011
5286754*PED Aug 15, 2011
CIPROFLOXACIN HYDROCHLORIDE - PROQUIN XR
N021744 001 5972389 Sep 19, 2016 DP U-663
6340475 Sep 19, 2016 DP U-663
6488962 Jun 20, 2020 DP
6635280 Sep 19, 2016 DP U-663
CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE - CIPRO HC
N020805 001 5843930 Jun 06, 2015 U-646
5965549 Jun 06, 2015 DP
CIPROFLOXACIN; DEXAMETHASONE - CIPRODEX
N021537 001 6284804 Aug 10, 2020
6359016 Aug 10, 2020
CISAPRIDE MONOHYDRATE - PROPULSID QUICKSOLV
N020767 001 5648093 Jul 15, 2014
CISATRACURIUM BESYLATE - NIMBEX
N020551 001 5453510 Sep 26, 2012 U-127
CISATRACURIUM BESYLATE - NIMBEX PRESERVATIVE FREE
N020551 002 5453510 Sep 26, 2012 U-127
CISATRACURIUM BESYLATE - NIMBEX PRESERVATIVE FREE
N020551 003 5453510 Sep 26, 2012 U-127
CLARITHROMYCIN - BIAXIN XL
N050775 001 6010718 Apr 11, 2017 DP U-924
6551616 Jul 15, 2017 U-924
CLEVIDIPINE BUTYRATE - CLEVIPREX
N022156 001 5739152 Apr 14, 2015 DP U-893 NCE Aug 01, 2013
5856346 Jan 05, 2016 DS DP U-893
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 37 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
CLEVIDIPINE BUTYRATE - CLEVIPREX
N022156 002 5739152 Apr 14, 2015 DP U-893 NCE Aug 01, 2013
5856346 Jan 05, 2016 DS DP U-893
CLINDAMYCIN PHOSPHATE - CLEOCIN
N050767 001 6495157 Jul 20, 2020 DP
CLINDAMYCIN PHOSPHATE - CLINDAGEL
N050782 001 6387383 Aug 03, 2020 DP U-818
CLINDAMYCIN PHOSPHATE - CLINDESSE
N050793 001 5266329 Nov 30, 2010 DP
5993856 Nov 17, 2017 DP U-137
6899890 Apr 27, 2023 DP U-137
CLINDAMYCIN PHOSPHATE - EVOCLIN
N050801 001 7141237 Jan 23, 2024 DS DP
7374747 Aug 09, 2026 DS DP U-921
CLINDAMYCIN PHOSPHATE; TRETINOIN - ZIANA
N050802 001 5721275 Feb 24, 2015 DP
6387383 Aug 03, 2020 DP U-916
CLOBETASOL PROPIONATE - CLOBEX
N021535 001 6106848 Sep 22, 2017
CLOBETASOL PROPIONATE - CLOBEX
N021644 001 7316810 Jun 17, 2019 DP
CLOBETASOL PROPIONATE - CLOBEX
N021835 001 5972920 Feb 12, 2018 DP
5990100 Mar 24, 2018 DP U-742
CLOBETASOL PROPIONATE - OLUX
N021142 001 6126920 Mar 01, 2016 U-484
CLOBETASOL PROPIONATE - OLUX E
N022013 001 6730288 Sep 08, 2019 DP NP Jan 12, 2010
7029659 Sep 08, 2019 DP
CLOFARABINE - CLOLAR
N021673 001 5661136 Jan 14, 2018 U-626 NCE Dec 28, 2009
ODE Dec 28, 2011
PED Jun 28, 2012
PED Jun 28, 2010
CLONIDINE HYDROCHLORIDE - JENLOGA
N022331 001 NP Sep 29, 2012
CLOPIDOGREL BISULFATE - PLAVIX
N020839 001 4847265 Nov 17, 2011 DS DP I-502 Aug 17, 2009
5576328 Jan 31, 2014 U-432 Y
6429210 Jun 10, 2019 DS DP
6504030 Jun 10, 2019 DS
CLOPIDOGREL BISULFATE - PLAVIX
N020839 002 4847265 Nov 17, 2011 DS DP I-502 Aug 17, 2009
6429210 Jun 10, 2019 DS DP
6504030 Jun 10, 2019 DS
CLOZAPINE - FAZACLO ODT
N021590 001 5178878 Jan 12, 2010 DP
6024981 Apr 09, 2018 DP
6106861 Dec 05, 2017 DP
6221392 Apr 09, 2018 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 38 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
CLOZAPINE - FAZACLO ODT
N021590 002 5178878 Jan 12, 2010 DP
6024981 Apr 09, 2018 DP
6106861 Dec 05, 2017 DP
6221392 Apr 09, 2018 DP
CLOZAPINE - FAZACLO ODT
N021590 003 5178878 Jan 12, 2010 DP
6024981 Apr 09, 2018 DP
6106861 Dec 05, 2017 DP
6221392 Apr 09, 2018 DP
CLOZAPINE - FAZACLO ODT
N021590 004 5178878 Jan 12, 2010 DP
6024981 Apr 09, 2018 DP
6106861 Dec 05, 2017 DP
6221392 Apr 09, 2018 DP
COLCHICINE - COLCRYS
N022352 001 7601758 Feb 10, 2029 U-1007 I-603 Jul 30, 2012
7619004 Dec 03, 2028 U-1020 ODE Jul 29, 2016
COLESEVELAM HYDROCHLORIDE - WELCHOL
N021141 001 5607669 Jun 10, 2014 U-323
5607669*PED Dec 10, 2014
5679717 Apr 29, 2014 U-323
5679717*PED Oct 29, 2014
5693675 Dec 02, 2014
5693675*PED Jun 02, 2015
5917007 Apr 29, 2014 U-323
5917007*PED Oct 29, 2014
5919832 Jun 10, 2014
5919832*PED Dec 10, 2014
6066678 Jun 10, 2014 U-323
6066678*PED Dec 10, 2014
6433026 Jun 10, 2014
6433026*PED Dec 10, 2014
COLESEVELAM HYDROCHLORIDE - WELCHOL
N021176 001 5607669 Jun 10, 2014 U-323 I-608 Oct 02, 2012
5607669*PED Dec 10, 2014 I-553 Jan 18, 2011
5679717 Apr 29, 2014 U-323 PED Apr 02, 2013
5679717*PED Oct 29, 2014
5693675 Dec 02, 2014 DS PED Jul 18, 2011
5693675*PED Jun 02, 2015
5917007 Apr 29, 2014 DS U-323
5917007*PED Oct 29, 2014
5919832 Apr 29, 2014 DS
5919832*PED Oct 29, 2014
6066678 Apr 29, 2014 DS U-323
6066678*PED Oct 29, 2014
6433026 Apr 29, 2014 DS
6433026*PED Oct 29, 2014
6784254 Apr 29, 2014 DS DP
6784254*PED Oct 29, 2014
7101960 Apr 29, 2014 DS DP U-757
7101960*PED Oct 29, 2014
7229613 Apr 17, 2022 U-851
7229613*PED Oct 17, 2022
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 39 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
COLESEVELAM HYDROCHLORIDE - WELCHOL
N022362 001 5607669 Jun 10, 2014 U-757 I-608 Oct 02, 2012
5679717 Apr 29, 2014 U-757 I-553 Jan 18, 2011
5693675 Dec 02, 2014 DS PED Apr 02, 2013
5917007 Apr 29, 2014 DS U-757
5919832 Apr 29, 2014 DS
PED Jul 18, 2011
6066678 Apr 29, 2014 DS U-757

6433026 Apr 29, 2014 DS

6784254 Apr 29, 2014 DS DP

7101960 Apr 29, 2014 DS DP U-757

7229613 Apr 17, 2022 U-493

COLESEVELAM HYDROCHLORIDE - WELCHOL


N022362 002 5607669 Jun 10, 2014 U-757 I-608 Oct 02, 2012
5679717 Apr 29, 2014 U-757 I-553 Jan 18, 2011
5693675 Dec 02, 2014 DS PED Apr 02, 2013
5917007 Apr 29, 2014 DS U-757
5919832 Apr 29, 2014 DS
PED Jul 18, 2011
6066678 Apr 29, 2014 DS U-757

6433026 Apr 29, 2014 DS

6784254 Apr 29, 2014 DS DP

7101960 Apr 29, 2014 DS DP U-757

7229613 Apr 17, 2022 U-493

COLESTIPOL HYDROCHLORIDE - COLESTID


N020222 001 5490987 Feb 13, 2013 DP
CONIVAPTAN HYDROCHLORIDE - VAPRISOL
N021697 001 5723606 Dec 15, 2019 DS DP U-698 I-526 Feb 28, 2010
5723606 Dec 15, 2019 DS DP U-868 NCE Dec 29, 2010
CONIVAPTAN HYDROCHLORIDE - VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER
N021697 002 5723606 Dec 15, 2019 DS DP U-698 I-526 Feb 28, 2010
5723606 Dec 15, 2019 DS DP U-868 NCE Dec 29, 2010
CYANOCOBALAMIN - CALOMIST
N022102 001 NP Jul 22, 2010
CYANOCOBALAMIN - NASCOBAL
N021642 001 7229636 Jun 11, 2024 DP U-817
7404489 Mar 12, 2024 DP
CYCLOBENZAPRINE HYDROCHLORIDE - AMRIX
N021777 001 7387793 Feb 26, 2025 DP NDF Feb 01, 2010
7544372 Nov 14, 2023 U-979
CYCLOBENZAPRINE HYDROCHLORIDE - AMRIX
N021777 002 7387793 Feb 26, 2025 DP NDF Feb 01, 2010
7544372 Nov 14, 2023 U-979
CYCLOSPORINE - NEORAL
N050715 001 5342625 Aug 30, 2011 DP
5741512 Aug 30, 2011 DP U-906
5866159 Sep 13, 2009 DP U-906
5916589 Sep 13, 2009 DP U-906
5962014 Sep 13, 2009 DP U-906
5962017 Sep 13, 2009 DP U-906
5985321 Sep 26, 2014 DP
6007840 Sep 13, 2009 DP U-906
6024978 Sep 13, 2009 DP U-906
6258808 Jun 25, 2012 DP
6262022 Jun 25, 2012 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 40 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
CYCLOSPORINE - NEORAL
N050715 002 5342625 Aug 30, 2011 DP
5741512 Aug 30, 2011 DP U-906
5866159 Sep 13, 2009 DP U-906
5916589 Sep 13, 2009 DP U-906
5962014 Sep 13, 2009 DP U-906
5962017 Sep 13, 2009 DP U-906
5985321 Sep 26, 2014 DP
6007840 Sep 13, 2009 DP U-906
6024978 Sep 13, 2009 DP U-906
6258808 Jun 25, 2012 DP
6262022 Jun 25, 2012 DP
CYCLOSPORINE - NEORAL
N050715 003 5342625 Aug 30, 2011 DP
5741512 Aug 30, 2011 DP U-906
5866159 Sep 13, 2009 DP U-906
5916589 Sep 13, 2009 DP U-906
5962014 Sep 13, 2009 DP U-906
5962017 Sep 13, 2009 DP U-906
5985321 Sep 26, 2014 DP
6007840 Sep 13, 2009 DP U-906
6024978 Sep 13, 2009 DP U-906
6258808 Jun 25, 2012 DP
6262022 Jun 25, 2012 DP
CYCLOSPORINE - NEORAL
N050716 001 5342625 Aug 30, 2011 DP
5741512 Aug 30, 2011 DP U-906
5866159 Sep 13, 2009 DP U-906
5916589 Sep 13, 2009 DP U-906
5962014 Sep 13, 2009 DP U-906
5962017 Sep 13, 2009 DP U-906
5985321 Sep 26, 2014 DP
6007840 Sep 13, 2009 DP U-906
6024978 Sep 13, 2009 DP U-906
6258808 Jun 25, 2012 DP
6262022 Jun 25, 2012 DP
CYCLOSPORINE - RESTASIS
N050790 001 4839342 Aug 02, 2009 U-927
5474979 May 17, 2014 DP
CYCLOSPORINE - SANDIMMUNE
N050625 001 7511014 Feb 16, 2010 DP
CYCLOSPORINE - SANDIMMUNE
N050625 002 7511014 Feb 16, 2010 DP
CYCLOSPORINE - SANDIMMUNE
N050625 003 7511014 Feb 16, 2010 DP
CYTARABINE - DEPOCYT
N021041 001 5455044 May 14, 2013 U-806
5723147 Mar 03, 2015 DP U-806
DALTEPARIN SODIUM - FRAGMIN
N020287 001 I-534 May 01, 2010
DALTEPARIN SODIUM - FRAGMIN
N020287 002 I-534 May 01, 2010
DALTEPARIN SODIUM - FRAGMIN
N020287 003 I-534 May 01, 2010
DALTEPARIN SODIUM - FRAGMIN
N020287 004 I-534 May 01, 2010
DALTEPARIN SODIUM - FRAGMIN
N020287 005 I-534 May 01, 2010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 41 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
DALTEPARIN SODIUM - FRAGMIN
N020287 006 I-534 May 01, 2010
DALTEPARIN SODIUM - FRAGMIN
N020287 007 I-534 May 01, 2010
DANAPAROID SODIUM - ORGARAN
N020430 001 5164377 Oct 03, 2010
DAPSONE - ACZONE
N021794 001 5863560 Sep 11, 2016 DP M-76 Mar 14, 2011
6060085 Sep 11, 2016 U-124
6620435 Sep 11, 2016 DP
DAPTOMYCIN - CUBICIN
N021572 001 6468967 Sep 24, 2019 U-282
6852689 Sep 24, 2019 U-282
DAPTOMYCIN - CUBICIN
N021572 002 6468967 Sep 24, 2019 U-282
6852689 Sep 24, 2019 U-282
RE39071 Jun 15, 2016 DS DP U-728
DARIFENACIN HYDROBROMIDE - ENABLEX
N021513 001 5096890 Mar 13, 2015 DS DP U-631 NCE Dec 22, 2009
6106864 Aug 21, 2016 DP U-630
DARIFENACIN HYDROBROMIDE - ENABLEX
N021513 002 5096890 Mar 13, 2015 DS DP U-631 NCE Dec 22, 2009
6106864 Aug 21, 2016 DP U-630
DARUNAVIR ETHANOLATE - PREZISTA
N021976 001 5843946 Dec 01, 2015 DP U-903 D-119 Dec 18, 2011
5843946 Dec 01, 2015 DP U-935 I-578 Oct 21, 2011
5843946 Dec 01, 2015 DP U-744 NCE Jun 23, 2011
6248775 Aug 13, 2014 DS
6335460 Aug 25, 2012 DS DP U-903
6335460 Aug 25, 2012 DS DP U-935
6335460 Aug 25, 2012 DS DP U-744
DARUNAVIR ETHANOLATE - PREZISTA
N021976 002 5843946 Dec 01, 2015 DP U-935 D-119 Dec 18, 2011
5843946 Dec 01, 2015 DP U-903 I-578 Oct 21, 2011
5843946 Dec 01, 2015 DP U-744 NCE Jun 23, 2011
6248775 Aug 13, 2014 DS
6335460 Aug 25, 2012 DS DP U-935
6335460 Aug 25, 2012 DS DP U-903
6335460 Aug 25, 2012 DS DP U-744
DARUNAVIR ETHANOLATE - PREZISTA
N021976 003 5843946 Dec 01, 2015 DP U-744 D-119 Dec 18, 2011
5843946 Dec 01, 2015 DP U-935 D-118 Oct 21, 2011
5843946 Dec 01, 2015 DP U-903 I-578 Oct 21, 2011
6248775 Aug 13, 2014 DS
6335460 Aug 25, 2012 DS DP U-903 NCE Jun 23, 2011
6335460 Aug 25, 2012 DS DP U-935
DARUNAVIR ETHANOLATE - PREZISTA
N021976 004 5843946 Dec 01, 2015 DP U-935 D-119 Dec 18, 2011
6248775 Aug 13, 2014 DS NS Dec 18, 2011
6335460 Aug 25, 2012 DS DP U-935
DARUNAVIR ETHANOLATE - PREZISTA
N021976 005 5843946 Dec 01, 2015 DP U-935 D-119 Dec 18, 2011
6248775 Aug 13, 2014 DS NS Dec 18, 2011
6335460 Aug 25, 2012 DS DP U-935
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 42 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
DASATINIB - SPRYCEL
N021986 001 6596746 Jun 28, 2020 DS DP U-780 D-120 May 21, 2012
6596746 Jun 28, 2020 DS DP U-748 D-109 Nov 06, 2010
7125875 Apr 13, 2020 U-780 M-70 Nov 06, 2010
7125875 Apr 13, 2020 U-779
7153856 Apr 28, 2020 U-780 NCE Jun 28, 2011
7491725 Sep 05, 2025 DS DP ODE Jun 28, 2013
ODE Jun 28, 2013
DASATINIB - SPRYCEL
N021986 002 6596746 Jun 28, 2020 DS DP U-748 D-120 May 21, 2012
6596746 Jun 28, 2020 DS DP U-780 D-109 Nov 06, 2010
7125875 Apr 13, 2020 U-780 M-70 Nov 06, 2010
7125875 Apr 13, 2020 U-779
7153856 Apr 28, 2020 U-780 NCE Jun 28, 2011
7491725 Oct 13, 2025 DS DP ODE Jun 28, 2013
ODE Jun 28, 2013
DASATINIB - SPRYCEL
N021986 003 6596746 Jun 28, 2020 DS DP U-748 D-120 May 21, 2012
6596746 Jun 28, 2020 DS DP U-780 D-109 Nov 06, 2010
7125875 Apr 13, 2020 U-780 M-70 Nov 06, 2010
7125875 Apr 13, 2020 U-779
7153856 Apr 28, 2020 U-780 NCE Jun 28, 2011
7491725 Oct 13, 2025 DS DP ODE Jun 28, 2013
ODE Jun 28, 2013
DASATINIB - SPRYCEL
N021986 004 6596746 Jun 28, 2020 DS DP U-780 D-120 May 21, 2012
6596746 Jun 28, 2020 DS DP U-748 D-109 Nov 06, 2010
7125875 Apr 13, 2020 U-780 M-70 Nov 06, 2010
7125875 Apr 13, 2020 U-779
7153856 Apr 28, 2020 U-780 NCE Jun 28, 2011
7491725 Oct 13, 2025 DS DP ODE Jun 28, 2013
ODE Jun 28, 2013
DECITABINE - DACOGEN
N021790 001 NCE May 02, 2011
ODE May 02, 2013
DEFERASIROX - EXJADE
N021882 001 6465504 Apr 05, 2019 DS DP NCE Nov 02, 2010
6596750 Jun 24, 2017 DS U-735 ODE Nov 02, 2012
DEFERASIROX - EXJADE
N021882 002 6465504 Apr 05, 2019 DS DP NCE Nov 02, 2010
6596750 Jun 24, 2017 DS U-735 ODE Nov 02, 2012
DEFERASIROX - EXJADE
N021882 003 6465504 Apr 05, 2019 DS DP NCE Nov 02, 2010
6596750 Jun 24, 2017 DS U-735 ODE Nov 02, 2012
DEGARELIX ACETATE - FIRMAGON
N022201 001 5925730 Apr 11, 2017 DS DP U-943 NCE Dec 24, 2013
DEGARELIX ACETATE - FIRMAGON
N022201 002 5925730 Apr 11, 2017 DS DP U-943 NCE Dec 24, 2013
DELAVIRDINE MESYLATE - RESCRIPTOR
N020705 001 5563142 Oct 08, 2013
DELAVIRDINE MESYLATE - RESCRIPTOR
N020705 002 5563142 Oct 08, 2013
6177101 Jun 07, 2019
DESFLURANE - SUPRANE
N020118 001 5617906 Apr 08, 2014 DP
5617906*PED Oct 08, 2014
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 43 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
DESIRUDIN RECOMBINANT - IPRIVASK
N021271 001 4745177 May 17, 2010 DS DP
5733874 Mar 31, 2015
DESLORATADINE - CLARINEX
N021165 001 6100274 Jul 07, 2019
6100274*PED Jan 07, 2020
7211582 Dec 30, 2014 U-809
7211582*PED Jun 30, 2015
7214683 Dec 30, 2014 DP
7214683*PED Jun 30, 2015
7214684 Dec 30, 2014 U-138
7214684*PED Jun 30, 2015
7405223 Jul 07, 2019 U-886
7405223*PED Jan 07, 2020
DESLORATADINE - CLARINEX
N021300 001 6514520 Jun 01, 2018 DP
6514520*PED Dec 01, 2018
7211582 Dec 30, 2014 U-809
7211582*PED Jun 30, 2015
7214683 Dec 30, 2014 DP
7214683*PED Jun 30, 2015
7214684 Dec 30, 2014 U-138
7214684*PED Jun 30, 2015
DESLORATADINE - CLARINEX
N021312 001 5178878 Jan 12, 2010 DP
5178878*PED Jul 12, 2010
5607697 Jun 07, 2015 DP
5607697*PED Dec 07, 2015
6100274 Jul 07, 2019 DP
6100274*PED Jan 07, 2020
7211582 Dec 30, 2014 U-809
7211582*PED Jun 30, 2015
7214683 Dec 30, 2014 DP
7214683*PED Jun 30, 2015
7214684 Dec 30, 2014 U-138
7214684*PED Jun 30, 2015
7618649 Dec 19, 2020 DP U-1017
7618649*PED Jun 19, 2021
DESLORATADINE - CLARINEX
N021312 002 5178878 Jan 12, 2010 DP
5178878*PED Jul 12, 2010
5607697 Jun 07, 2015 DP
5607697*PED Dec 07, 2015
6100274 Jul 07, 2019 DP
6100274*PED Jan 07, 2020
7211582 Dec 30, 2014 U-809
7211582*PED Jun 30, 2015
7214683 Dec 30, 2014 DP
7214683*PED Jun 30, 2015
7214684 Dec 30, 2014 U-138
7214684*PED Jun 30, 2015
7618649 Dec 19, 2020 DP U-1017
7618649*PED Jun 19, 2021
DESLORATADINE; PSEUDOEPHEDRINE SULFATE - CLARINEX D 24 HOUR
N021605 001 6100274 Jul 07, 2019 DP
6100274*PED Jan 07, 2020
6979463 Mar 28, 2022 DP
7214683 Dec 30, 2014 DP
7214683*PED Jun 30, 2015
7214684 Dec 30, 2014 U-138
7214684*PED Jun 30, 2015
7618649 Dec 19, 2020 DP U-1017
7618649*PED Jun 19, 2021
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 44 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
DESLORATADINE; PSEUDOEPHEDRINE SULFATE - CLARINEX-D 12 HOUR
N021313 001 6100274 Jul 07, 2019 DP
6100274*PED Jan 07, 2020
6709676 Feb 18, 2021 DP U-707
7214683 Dec 30, 2014 DP
7214683*PED Jun 30, 2015
7214684 Dec 30, 2014 U-138
7214684*PED Jun 30, 2015
7618649 Dec 19, 2020 DP U-1017
7618649*PED Jun 19, 2021
DESMOPRESSIN ACETATE - DDAVP
N017922 001 5500413 Jun 29, 2013
5674850 Dec 23, 2013
5763407 Jun 29, 2013
DESMOPRESSIN ACETATE - DDAVP
N017922 002 5500413 Jun 29, 2013
5674850 Dec 23, 2013
5763407 Jun 29, 2013
DESMOPRESSIN ACETATE - DDAVP
N018938 001 5500413 Jun 29, 2013
5763407 Jun 29, 2013
DESMOPRESSIN ACETATE - DDAVP
N018938 002 5500413 Jun 29, 2013
5763407 Jun 29, 2013
DESMOPRESSIN ACETATE - DDAVP
N019955 001 5500413 Jun 29, 2013
5674850 Dec 23, 2013
5763407 Jun 29, 2013
7022340 Apr 30, 2023 DP
DESMOPRESSIN ACETATE - DDAVP
N019955 002 5500413 Jun 29, 2013
5674850 Dec 23, 2013
5763407 Jun 29, 2013
7022340 Apr 30, 2023 DP
DESMOPRESSIN ACETATE - DDAVP (NEEDS NO REFRIGERATION)
N017922 003 5482931 Jun 29, 2013
5500413 Jun 29, 2013
5674850 Dec 23, 2013
5763407 Jun 29, 2013
DESMOPRESSIN ACETATE - DESMOPRESSIN ACETATE
N021795 001 7022340 Apr 30, 2023 DP NP May 08, 2011
DESMOPRESSIN ACETATE - DESMOPRESSIN ACETATE
N021795 002 7022340 Apr 30, 2023 DP NP May 08, 2011
DESONIDE - DESONATE
N021844 001 6387383 Aug 03, 2020 DS DP U-783 NDF Oct 20, 2009
DESONIDE - VERDESO
N021978 001 6730288 Sep 08, 2019 DP NDF Sep 19, 2009
7029659 Sep 08, 2019 DP
DESVENLAFAXINE SUCCINATE - PRISTIQ
N021992 001 6673838 Feb 11, 2022 DS DP U-860 NCE Mar 01, 2013
7291347 Feb 11, 2022 DP
DESVENLAFAXINE SUCCINATE - PRISTIQ
N021992 002 6673838 Feb 11, 2022 DS DP U-860 NCE Mar 01, 2013
7291347 Feb 11, 2022 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 45 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
DEXAMETHASONE - OZURDEX
N022315 001 6726918 Oct 20, 2020 DP U-985 NDF Jun 17, 2012
6899717 Nov 01, 2023 U-985
7033605 Oct 20, 2020 DP
7625582 Nov 28, 2021 U-985
DEXAMETHASONE; TOBRAMYCIN - TOBRADEX
N050592 001 5149694 Sep 22, 2009 U-923
DEXAMETHASONE; TOBRAMYCIN - TOBRADEX
N050616 001 5149694 Sep 22, 2009 U-923
DEXAMETHASONE; TOBRAMYCIN - TOBRADEX ST
N050818 001 5149694 Sep 22, 2009 U-953
DEXLANSOPRAZOLE - KAPIDEX
N022287 001 6462058 Jun 15, 2020 DS DP U-949 NP Jan 30, 2012
6462058 Jun 15, 2020 DS DP U-951 PED Jul 30, 2012
6462058 Jun 15, 2020 DS DP U-950
6462058*PED Dec 15, 2020
6664276 Jun 15, 2020 DS DP U-949
6664276 Jun 15, 2020 DS DP U-951
6664276 Jun 15, 2020 DS DP U-950
6664276*PED Dec 15, 2020
6939971 Jun 15, 2020 U-951
6939971 Jun 15, 2020 U-950
6939971 Jun 15, 2020 U-949
6939971*PED Dec 15, 2020
7285668 Jun 15, 2020 DS
7285668*PED Dec 15, 2020
DEXLANSOPRAZOLE - KAPIDEX
N022287 002 6462058 Jun 15, 2020 DS DP U-951 NP Jan 30, 2012
6462058 Jun 15, 2020 DS DP U-950 PED Jul 30, 2012
6462058 Jun 15, 2020 DS DP U-949
6462058*PED Dec 15, 2020
6664276 Jun 15, 2020 DS DP U-951
6664276 Jun 15, 2020 DS DP U-950
6664276 Jun 15, 2020 DS DP U-949
6664276*PED Dec 15, 2020
6939971 Jun 15, 2020 U-951
6939971 Jun 15, 2020 U-950
6939971 Jun 15, 2020 U-949
6939971*PED Dec 15, 2020
7285668 Jun 15, 2020 DS
7285668*PED Dec 15, 2020
DEXMEDETOMIDINE - PRECEDEX
N021038 001 4910214 Jul 15, 2013 DS DP U-421 I-577 Oct 17, 2011
5344840 Sep 06, 2011 U-912
6716867 Mar 31, 2019 U-572
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN
N021278 001 5908850 Dec 04, 2015 U-422
6355656 Dec 04, 2015
6528530 Dec 04, 2015 DS DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN
N021278 002 5908850 Dec 04, 2015 U-422
6355656 Dec 04, 2015
6528530 Dec 04, 2015 DS DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN
N021278 003 5908850 Dec 04, 2015 U-422
6355656 Dec 04, 2015
6528530 Dec 04, 2015 DS DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 46 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N021802 001 5837284 Dec 04, 2015 DP D-121 Oct 23, 2012
5908850 Dec 04, 2015 U-678 M-80 Oct 17, 2011
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N021802 002 5837284 Dec 04, 2015 DP D-121 Oct 23, 2012
5908850 Dec 04, 2015 U-678 M-80 Oct 17, 2011
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N021802 003 5837284 Dec 04, 2015 DP D-121 Oct 23, 2012
5908850 Dec 04, 2015 U-678 M-80 Oct 17, 2011
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N021802 004 5837284 Dec 04, 2015 DP D-121 Oct 23, 2012
5908850 Dec 04, 2015 U-678 M-80 Oct 17, 2011
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N021802 005 D-121 Oct 23, 2012
M-80 Oct 17, 2011
DEXRAZOXANE HYDROCHLORIDE - TOTECT
N022025 001 6727253 Mar 13, 2020 U-829 NP Sep 06, 2010
ODE Sep 06, 2014
DEXRAZOXANE HYDROCHLORIDE - ZINECARD
N020212 001 5242901 Sep 07, 2010 U-339
DEXRAZOXANE HYDROCHLORIDE - ZINECARD
N020212 002 5242901 Sep 07, 2010 U-339
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN - MUCINEX DM
N021620 001 6372252 Apr 28, 2020 DP
6955821 Apr 28, 2020 DP U-685
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN - MUCINEX DM
N021620 002 6372252 Apr 28, 2020 DP
6955821 Apr 28, 2020 DP U-685
DEXTROMETHORPHAN POLISTIREX - DELSYM
N018658 001 5980882 Apr 16, 2017 DP
DIAZEPAM - DIASTAT
N020648 001 5462740 Sep 17, 2013 DP
DIAZEPAM - DIASTAT
N020648 002 5462740 Sep 17, 2013 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 47 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
DIAZEPAM - DIASTAT
N020648 003 5462740 Sep 17, 2013 DP
DIAZEPAM - DIASTAT
N020648 004 5462740 Sep 17, 2013 DP
DIAZEPAM - DIASTAT
N020648 005 5462740 Sep 17, 2013 DP
DIAZEPAM - DIASTAT ACUDIAL
N020648 006 5462740 Sep 17, 2013 DP
DIAZEPAM - DIASTAT ACUDIAL
N020648 007 5462740 Sep 17, 2013 DP
DICLOFENAC EPOLAMINE - FLECTOR
N021234 001 5607690 Apr 13, 2014 DP NE Jan 31, 2010
NDF Jan 31, 2010
DICLOFENAC POTASSIUM - CAMBIA
N022165 001 6974595 May 15, 2017 U-436
DICLOFENAC POTASSIUM - ZIPSOR
N022202 001 6365180 Jul 16, 2019 DP U-980 NDF Jun 16, 2012
DICLOFENAC SODIUM - DICLOFENAC SODIUM
N020809 001 5603929 Nov 16, 2014 U-239
5653972 Nov 16, 2014 U-239
DICLOFENAC SODIUM - PENNSAID
N020947 001 NDF Nov 04, 2012
DICLOFENAC SODIUM - SOLARAZE
N021005 001 5639738 Jun 17, 2014 U-402
5792753 Aug 11, 2015
5852002 Jun 17, 2014 U-402
5914322 Aug 11, 2015
5929048 Jul 27, 2016 U-402
5985850 Nov 16, 2016
DICLOFENAC SODIUM - VOLTAREN
N022122 001 NP Oct 17, 2010
DICLOFENAC SODIUM; MISOPROSTOL - ARTHROTEC
N020607 001 5601843 Feb 11, 2014
5698225 May 03, 2010 U-392
DICLOFENAC SODIUM; MISOPROSTOL - ARTHROTEC
N020607 002 5601843 Feb 11, 2014
5698225 May 03, 2010 U-392
DIDANOSINE - VIDEX
N020154 002 5880106 Jul 22, 2011
5880106*PED Jan 22, 2012
DIDANOSINE - VIDEX
N020154 003 5880106 Jul 22, 2011
5880106*PED Jan 22, 2012
DIDANOSINE - VIDEX
N020154 004 5880106 Jul 22, 2011
5880106*PED Jan 22, 2012
DIDANOSINE - VIDEX
N020154 005 5880106 Jul 22, 2011
5880106*PED Jan 22, 2012
DIDANOSINE - VIDEX
N020154 006 5880106 Jul 22, 2011
5880106*PED Jan 22, 2012
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 48 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
DIFLUPREDNATE - DUREZOL
N022212 001 6114319 May 12, 2018 DP NCE Jun 23, 2013
DIHYDROERGOTAMINE MESYLATE - MIGRANAL
N020148 001 5169849 Dec 08, 2009 U-227
DILTIAZEM HYDROCHLORIDE - CARDIZEM CD
N020062 001 5286497 May 20, 2011
5364620 Nov 14, 2011 U-3
5439689 Aug 08, 2012 U-107
5470584 May 20, 2011
DILTIAZEM HYDROCHLORIDE - CARDIZEM CD
N020062 002 5286497 May 20, 2011
5364620 Nov 14, 2011 U-3
5439689 Aug 08, 2012 U-107
5470584 May 20, 2011
DILTIAZEM HYDROCHLORIDE - CARDIZEM CD
N020062 003 5286497 May 20, 2011
5364620 Nov 14, 2011 U-3
5439689 Aug 08, 2012 U-107
5470584 May 20, 2011
DILTIAZEM HYDROCHLORIDE - CARDIZEM CD
N020062 004 5286497 May 20, 2011
5364620 Nov 14, 2011 U-3
5439689 Aug 08, 2012 U-107
5470584 May 20, 2011
DILTIAZEM HYDROCHLORIDE - CARDIZEM CD
N020062 005 5286497 May 20, 2011 DP
5439689 Aug 08, 2012 DP U-107
5470584 May 20, 2011 DP
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N021392 001 5288505 Jun 26, 2011
5529791 Jun 25, 2013
6923984 Feb 25, 2021 DP
7108866 Dec 17, 2019 DP U-107
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N021392 002 5288505 Jun 26, 2011
5529791 Jun 25, 2013
6923984 Feb 25, 2021 DP
7108866 Dec 17, 2019 DP U-107
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N021392 003 5288505 Jun 26, 2011
5529791 Jun 25, 2013
6923984 Feb 25, 2021 DP
7108866 Dec 17, 2019 DP U-107
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N021392 004 5288505 Jun 26, 2011
5529791 Jun 25, 2013
6923984 Feb 25, 2021 DP
7108866 Dec 17, 2019 DP U-107
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N021392 005 5288505 Jun 26, 2011
5529791 Jun 25, 2013
6923984 Feb 25, 2021 DP
7108866 Dec 17, 2019 DP U-107
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N021392 006 5288505 Jun 26, 2011
5529791 Jun 25, 2013
6923984 Feb 25, 2021 DP
7108866 Dec 17, 2019 DP U-107
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 49 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
DILTIAZEM HYDROCHLORIDE - DILACOR XR
N020092 001 5422123 Jun 06, 2012
DILTIAZEM HYDROCHLORIDE - DILACOR XR
N020092 002 5422123 Jun 06, 2012
DILTIAZEM HYDROCHLORIDE - DILACOR XR
N020092 003 5422123 Jun 06, 2012
DILTIAZEM HYDROCHLORIDE - DILTIAZEM HYDROCHLORIDE
N020939 001 5288505 Jun 26, 2011
5529791 Jun 25, 2013
DILTIAZEM HYDROCHLORIDE - DILTIAZEM HYDROCHLORIDE
N020939 002 5288505 Jun 26, 2011
5529791 Jun 25, 2013
DILTIAZEM HYDROCHLORIDE - DILTIAZEM HYDROCHLORIDE
N020939 003 5288505 Jun 26, 2011
5529791 Jun 25, 2013
DILTIAZEM HYDROCHLORIDE - DILTIAZEM HYDROCHLORIDE
N020939 004 5288505 Jun 26, 2011
5529791 Jun 25, 2013
DILTIAZEM HYDROCHLORIDE - TIAZAC
N020401 001 5529791 Jun 25, 2013
DILTIAZEM HYDROCHLORIDE - TIAZAC
N020401 002 5529791 Jun 25, 2013
DILTIAZEM HYDROCHLORIDE - TIAZAC
N020401 003 5529791 Jun 25, 2013
DILTIAZEM HYDROCHLORIDE - TIAZAC
N020401 004 5529791 Jun 25, 2013
DILTIAZEM HYDROCHLORIDE - TIAZAC
N020401 005 5529791 Jun 25, 2013
DILTIAZEM HYDROCHLORIDE - TIAZAC
N020401 006 5529791 Jun 25, 2013
DIMYRISTOYL LECITHIN; PERFLEXANE - IMAGENT
N021191 001 5605673
Feb 25, 2014
5626833
May 16, 2014 U-458
5639443
Jun 17, 2014
5695741
Dec 09, 2014 U-458
5720938
Feb 24, 2015
5798091
Aug 25, 2015 U-458
6280704
Jul 30, 2013
6280705
Jul 30, 2013
6287539
Jul 30, 2013
DINOPROSTONE - CERVIDIL
N020411 001 5269321 Jul 14, 2012 DP U-110
DIVALPROEX SODIUM - DEPAKOTE
N019680 001 M-34 Mar 24, 2011
PED Sep 24, 2011
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 50 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
DIVALPROEX SODIUM - DEPAKOTE ER
N021168 001 6419953 Dec 18, 2018 M-34 Mar 24, 2011
6419953*PED Jun 18, 2019 PED Sep 24, 2011
6511678 Dec 18, 2018
6511678*PED Jun 18, 2019
6528090 Dec 18, 2018 DP
6528090*PED Jun 18, 2019
6528091 Dec 18, 2018 U-106
6528091*PED Jun 18, 2019
6713086 Dec 18, 2018 DP U-579
6713086*PED Jun 18, 2019
6720004 Dec 18, 2018 DP
6720004*PED Jun 18, 2019
DIVALPROEX SODIUM - DEPAKOTE ER
N021168 002 6511678 Dec 18, 2018 M-34 Mar 24, 2011
6511678*PED Jun 18, 2019 PED Sep 24, 2011
6528090 Dec 18, 2018 DP
6528090*PED Jun 18, 2019
6713086 Dec 18, 2018 DP U-579
6713086*PED Jun 18, 2019
6720004 Dec 18, 2018 DP
6720004*PED Jun 18, 2019
DIVALPROEX SODIUM - DIVALPROEX SODIUM
A077567 002 PC Aug 01, 2009
DOCETAXEL - TAXOTERE
N020449 001 4814470 May 14, 2010 DS DP I-543 Sep 28, 2010
5438072 Nov 22, 2013 DP I-542 Sep 28, 2010
5698582 Jul 03, 2012 DP I-519 Oct 17, 2009
5714512 Jul 03, 2012 DP
5750561 Jul 03, 2012 DP
DOCOSANOL - ABREVA
N020941 001 4874794 Apr 28, 2014 U-815
5534554 Dec 13, 2013 DP U-815
DOFETILIDE - TIKOSYN
N020931 001 4959366 Sep 25, 2012 DS DP U-652
6124363 Oct 09, 2018
DOFETILIDE - TIKOSYN
N020931 002 4959366 Sep 25, 2012 DS DP U-652
6124363 Oct 09, 2018
DOFETILIDE - TIKOSYN
N020931 003 4959366 Sep 25, 2012 DS DP U-652
6124363 Oct 09, 2018
DOLASETRON MESYLATE - ANZEMET
N020623 001 4906755 Jul 02, 2011
DOLASETRON MESYLATE - ANZEMET
N020623 002 4906755 Jul 02, 2011
DOLASETRON MESYLATE - ANZEMET
N020624 001 4906755 Jul 02, 2011
DOLASETRON MESYLATE - ANZEMET
N020624 002 4906755 Jul 02, 2011
DOLASETRON MESYLATE - ANZEMET
N020624 003 4906755 Jul 02, 2011
DONEPEZIL HYDROCHLORIDE - ARICEPT
N020690 001 4895841 Nov 25, 2010 I-529 Oct 13, 2009
5985864 Dec 30, 2016
6140321 Dec 30, 2016
6245911 Dec 01, 2018
6372760 Mar 31, 2019 Y
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 51 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
DONEPEZIL HYDROCHLORIDE - ARICEPT
N020690 002 4895841 Nov 25, 2010 I-529 Oct 13, 2009
5985864 Dec 30, 2016
6140321 Dec 30, 2016
6245911 Dec 01, 2018
6372760 Mar 31, 2019 Y
DONEPEZIL HYDROCHLORIDE - ARICEPT
N021719 001 I-529 Oct 13, 2009
DONEPEZIL HYDROCHLORIDE - ARICEPT ODT
N021720 001 4895841 Nov 25, 2010 DS DP U-713 I-529 Oct 13, 2009
DONEPEZIL HYDROCHLORIDE - ARICEPT ODT
N021720 002 4895841 Nov 25, 2010 DS DP U-713 I-529 Oct 13, 2009
DORIPENEM - DORIBAX
N022106 001 5317016 Aug 14, 2012 DS DP U-282 NCE Oct 12, 2012
DOXERCALCIFEROL - HECTOROL
N020862 001 5602116 Feb 11, 2014 U-278
5602116 Feb 11, 2014 U-987
6903083 Jul 18, 2021 DS DP Y
DOXERCALCIFEROL - HECTOROL
N020862 002 5602116 Feb 11, 2014 U-278
5602116 Feb 11, 2014 U-987
6903083 Jul 18, 2021 DS DP Y
DOXERCALCIFEROL - HECTOROL
N020862 003 5602116 Feb 11, 2014 U-987
DOXERCALCIFEROL - HECTOROL
N021027 001 5602116 Feb 11, 2014 U-321
5707980 Aug 17, 2010 U-321 Y
6903083 Jul 18, 2021 DS DP Y
7148211 Sep 14, 2023 DP
DOXORUBICIN HYDROCHLORIDE - DOXIL
N050718 001 5013556 Oct 20, 2009 DP U-942 ODE May 17, 2014
5013556 Oct 20, 2009 DP U-941
5013556 Oct 20, 2009 DP U-940
5213804 Oct 20, 2009 DP U-940
5213804 Oct 20, 2009 DP U-941
DOXORUBICIN HYDROCHLORIDE - DOXIL
N050718 002 5013556 Oct 20, 2009 DP U-942 ODE May 17, 2014
5013556 Oct 20, 2009 DP U-941
5013556 Oct 20, 2009 DP U-940
5213804 Oct 20, 2009 DP U-941
5213804 Oct 20, 2009 DP U-940
DOXYCYCLINE - ORACEA
N050805 001 5789395 Aug 30, 2016 U-925
5919775 Aug 30, 2016 U-925
7211267 Apr 05, 2022 U-925
7232572 Apr 05, 2022 U-925
DOXYCYCLINE HYCLATE - DORYX
N050795 001 6958161 Dec 15, 2022 DP U-918
DOXYCYCLINE HYCLATE - DORYX
N050795 002 6958161 Dec 15, 2022 DP U-918
DOXYCYCLINE HYCLATE - DORYX
N050795 003 6958161 Dec 15, 2022 DP U-918
DRONABINOL - MARINOL
N018651 001 6703418 Feb 26, 2011 U-563
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 52 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
DRONABINOL - MARINOL
N018651 002 6703418 Feb 26, 2011 U-563
DRONABINOL - MARINOL
N018651 003 6703418 Feb 26, 2011 U-563
DRONEDARONE HYDROCHLORIDE - MULTAQ
N022425 001 5223510 Jul 26, 2011 DS DP U-992 NCE Jul 01, 2014
7323493 Jun 19, 2018 DP
DROSPIRENONE; ESTRADIOL - ANGELIQ
N021355 002 6933395 Aug 11, 2017 DS
DROSPIRENONE; ETHINYL ESTRADIOL - YASMIN
N021098 001 5569652 Oct 29, 2013 U-1
6787531 Aug 31, 2020 DP
6933395 Aug 11, 2017 DS
DROSPIRENONE; ETHINYL ESTRADIOL - YAZ
N021676 001 5569652 Oct 29, 2013 U-1 I-522 Jan 26, 2010
5798338 Jul 10, 2015 DP I-508 Oct 04, 2009
6787531 Aug 31, 2020 DP
6933395 Aug 11, 2017 DP
6958326 Dec 20, 2021 DP
6987101 Dec 22, 2017 U-758
7163931 Dec 20, 2021 U-1
RE37564 Jun 30, 2014 DP
RE37838 Jun 30, 2014 DP
RE38253 Jun 30, 2014 DP
DULOXETINE HYDROCHLORIDE - CYMBALTA
N021427 001 5023269 Jun 11, 2013 DS DP U-605 I-617 Nov 19, 2012
5023269 Jun 11, 2013 DS DP U-795 I-566 Jun 13, 2011
5023269 Jun 11, 2013 DS DP U-796 I-524 Feb 23, 2010
5023269 Jun 11, 2013 DS DP U-797
5023269 Jun 11, 2013 DS DP U-398 M-71 Nov 28, 2010
5023269 Jun 11, 2013 DS DP U-839 NCE Aug 03, 2009
5023269 Jun 11, 2013 DS DP U-799
5023269 Jun 11, 2013 DS DP U-882
5508276 Jul 18, 2014 DP
6596756 Sep 10, 2019 U-882
DULOXETINE HYDROCHLORIDE - CYMBALTA
N021427 002 5023269 Jun 11, 2013 DS DP U-605 I-617 Nov 19, 2012
5023269 Jun 11, 2013 DS DP U-882 I-566 Jun 13, 2011
5023269 Jun 11, 2013 DS DP U-799 I-524 Feb 23, 2010
5023269 Jun 11, 2013 DS DP U-795
5023269 Jun 11, 2013 DS DP U-796 M-71 Nov 28, 2010
5023269 Jun 11, 2013 DS DP U-797 NCE Aug 03, 2009
5023269 Jun 11, 2013 DS DP U-839
5023269 Jun 11, 2013 DS DP U-398
5508276 Jul 18, 2014 DP
6596756 Sep 10, 2019 U-882
DULOXETINE HYDROCHLORIDE - CYMBALTA
N021427 003 I-617 Nov 19, 2012
DULOXETINE HYDROCHLORIDE - CYMBALTA
N021427 004 5023269 Jun 11, 2013 DS DP U-839 I-617 Nov 19, 2012
5023269 Jun 11, 2013 DS DP U-797 I-566 Jun 13, 2011
5023269 Jun 11, 2013 DS DP U-796 I-524 Feb 23, 2010
5023269 Jun 11, 2013 DS DP U-795
5023269 Jun 11, 2013 DS DP U-398 M-71 Nov 28, 2010
5023269 Jun 11, 2013 DS DP U-799 NCE Aug 03, 2009
5023269 Jun 11, 2013 DS DP U-605
5023269 Jun 11, 2013 DS DP U-882
5508276 Jul 18, 2014 DP
6596756 Sep 10, 2019 U-882
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 53 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
DUTASTERIDE - AVODART
N021319 001 5565467 Nov 20, 2015 DS DP I-565 Jun 19, 2011
5846976 Sep 17, 2013 U-476
5998427 Sep 17, 2013 DS DP U-477
EFAVIRENZ - SUSTIVA
N020972 001 5519021 May 21, 2013 DS DP
5663169 Sep 02, 2014 U-257
5811423 Aug 07, 2012 DS DP U-256
6238695 Apr 06, 2019 DP
6555133 Apr 06, 2019 U-248
6639071 Feb 14, 2018 DS
6939964 Jan 20, 2018 DS
EFAVIRENZ - SUSTIVA
N020972 002 5519021 May 21, 2013 DS DP
5663169 Sep 02, 2014 U-257
5811423 Aug 07, 2012 DS DP U-256
6238695 Apr 06, 2019 DP
6555133 Apr 06, 2019 U-248
6639071 Feb 14, 2018 DS
6939964 Jan 20, 2018 DS
EFAVIRENZ - SUSTIVA
N020972 003 5519021 May 21, 2013 DS DP
5663169 Sep 02, 2014 U-257
5811423 Aug 07, 2012 DS DP U-256
6238695 Apr 06, 2019 DP
6555133 Apr 06, 2019 U-248
6639071 Feb 14, 2018 DS
6939964 Jan 20, 2018 DS
EFAVIRENZ - SUSTIVA
N021360 001 5519021 May 21, 2013
5663169 Sep 02, 2014
5811423 Aug 07, 2012 U-256
6639071 Feb 14, 2018 DS
6939964 Jan 20, 2018 DS
EFAVIRENZ - SUSTIVA
N021360 002 5519021 May 21, 2013 DS DP
5663169 Sep 02, 2014 U-248
5811423 Aug 07, 2012 U-256
6639071 Feb 14, 2018 DS
6939964 Jan 20, 2018 DS
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - ATRIPLA
N021937 001 5210085 May 11, 2010 U-750
5210085*PED Nov 11, 2010
5519021 May 21, 2013 DS DP
5663169 Sep 02, 2014 U-750
5811423 Aug 07, 2012 U-750
5814639 Sep 29, 2015 DS DP
5814639*PED Mar 29, 2016
5914331 Jul 02, 2017 DS
5914331*PED Jan 02, 2018
5922695 Jul 25, 2017 DS U-750
5935946 Jul 25, 2017 DS DP U-750
5977089 Jul 25, 2017 DS DP U-750
6043230 Jul 25, 2017 U-750
6639071 Feb 14, 2018 DS
6642245 Nov 04, 2020 U-750
6642245*PED May 04, 2021
6703396 Mar 09, 2021 DS DP
6703396*PED Sep 09, 2021
6939964 Jan 20, 2018 DS
7402588 Feb 01, 2010 DP U-257
7402588*PED Aug 01, 2010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 54 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
EFLORNITHINE HYDROCHLORIDE - VANIQA
N021145 001 5648394 Jul 15, 2014 U-334
ELETRIPTAN HYDROBROMIDE - RELPAX
N021016 001 5545644 Dec 26, 2016 DS DP U-876
6110940 Aug 29, 2017
ELETRIPTAN HYDROBROMIDE - RELPAX
N021016 002 5545644 Dec 26, 2016 DS DP U-876
6110940 Aug 29, 2017
ELTROMBOPAG OLAMINE - PROMACTA
N022291 001 6280959 Oct 30, 2018 DS DP U-930 NCE Nov 20, 2013
7160870 Dec 08, 2021 DS DP U-930 ODE Nov 20, 2015
7332481 May 24, 2021 U-930
7452874 May 24, 2021 DS DP
7473686 May 24, 2021 DS DP U-930
7547719 Mar 04, 2024 DS DP U-930
ELTROMBOPAG OLAMINE - PROMACTA
N022291 002 6280959 Oct 30, 2018 DS DP U-930 NCE Nov 20, 2013
7160870 Dec 08, 2021 DS DP U-930 ODE Nov 20, 2015
7332481 May 24, 2021 U-930
7452874 May 24, 2021 DS DP
7473686 May 24, 2021 DS DP U-930
7547719 Mar 04, 2024 DS DP U-930
EMEDASTINE DIFUMARATE - EMADINE
N020706 001 5441958 Dec 08, 2013 U-404
EMTRICITABINE - EMTRIVA
N021500 001 5210085 May 11, 2010 U-257
5210085*PED Nov 11, 2010
5814639 Sep 29, 2015 DS DP
5814639*PED Mar 29, 2016
5914331 Jul 02, 2017 DS
5914331*PED Jan 02, 2018
6642245 Nov 04, 2020 U-257
6642245 Nov 04, 2020 U-541
6642245*PED May 04, 2021
6703396 Mar 09, 2021 DS DP
6703396*PED Sep 09, 2021
7402588 Feb 01, 2010 DP U-257
7402588*PED Aug 01, 2010
EMTRICITABINE - EMTRIVA
N021896 001 5210085 May 11, 2010 U-257 NPP Dec 22, 2009
5210085*PED Nov 11, 2010 PED Jun 22, 2010
5814639 Sep 29, 2015 DS DP
5814639*PED Mar 29, 2016
5914331 Jul 02, 2017 DS
5914331*PED Jan 02, 2018
6642245 Nov 04, 2020 U-257
6642245*PED May 04, 2021
6703396 Mar 09, 2021 DS DP
6703396*PED Sep 09, 2021
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 55 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - TRUVADA
N021752 001 5210085 May 11, 2010 U-248
5210085 May 11, 2010 U-541
5210085*PED Nov 11, 2010
5814639 Sep 29, 2015 DS DP
5814639*PED Mar 29, 2016
5914331 Jul 02, 2017 DS DP U-248
5914331*PED Jan 02, 2018 DS
5922695 Jul 25, 2017 DS U-541
5922695 Jul 25, 2017 DS U-248
5935946 Jul 25, 2017 DS DP U-541
5935946 Jul 25, 2017 DS DP U-248
5977089 Jul 25, 2017 DS DP U-248
5977089 Jul 25, 2017 DS DP U-541
6043230 Jul 25, 2017 DP U-541
6043230 Jul 25, 2017 DP U-248
6642245 Nov 04, 2020 U-248
6642245 Nov 04, 2020 U-541
6642245*PED May 04, 2021
6703396 Mar 09, 2021 DS DP
6703396*PED Sep 09, 2021
7402588 Feb 01, 2010 DP U-257
7402588*PED Aug 01, 2010
ENFUVIRTIDE - FUZEON
N021481 001 5464933 Jun 07, 2013 M-59 Sep 29, 2009
6133418 Nov 17, 2014 DS DP
6475491 Jun 07, 2015 U-248
ENOXAPARIN SODIUM - LOVENOX
N020164 009 5389618 Feb 14, 2012 DS DP U-545 I-533 May 16, 2010
RE38743 Feb 14, 2012 DS DP U-545
ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE)
N020164 001 5389618 Feb 14, 2012 DS DP U-545 I-533 May 16, 2010
RE38743 Feb 14, 2012 DS DP U-545
ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE)
N020164 002 5389618 Feb 14, 2012 DS DP U-545 I-533 May 16, 2010
RE38743 Feb 14, 2012 DS DP U-545
ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE)
N020164 003 5389618 Feb 14, 2012 DS DP U-545 I-533 May 16, 2010
RE38743 Feb 14, 2012 DS DP U-545
ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE)
N020164 004 5389618 Feb 14, 2012 DS DP U-545 I-533 May 16, 2010
RE38743 Feb 14, 2012 DS DP U-545
ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE)
N020164 005 5389618 Feb 14, 2012 DS DP U-545 I-533 May 16, 2010
RE38743 Feb 14, 2012 DS DP U-545
ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE)
N020164 006 5389618 Feb 14, 2012 DS DP U-545 I-533 May 16, 2010
RE38743 Feb 14, 2012 DS DP U-545
ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE)
N020164 007 5389618 Feb 14, 2012 DS DP U-545 I-533 May 16, 2010
RE38743 Feb 14, 2012 DS DP U-545
ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE)
N020164 008 5389618 Feb 14, 2012 DS DP U-545 I-533 May 16, 2010
RE38743 Feb 14, 2012 DS DP U-545
ENTACAPONE - COMTAN
N020796 001 5135950 Oct 31, 2010 DS DP U-219
5446194 Oct 19, 2013 DS
6599530 Sep 14, 2018 DP U-219
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 56 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ENTECAVIR - BARACLUDE
N021797 001 5206244 Feb 21, 2015 DS NCE Mar 29, 2010
ENTECAVIR - BARACLUDE
N021797 002 5206244 Feb 21, 2015 DS NCE Mar 29, 2010
ENTECAVIR - BARACLUDE
N021798 001 5206244 Feb 21, 2015 DS NCE Mar 29, 2010
EPINASTINE HYDROCHLORIDE - ELESTAT
N021565 001 7429602 Nov 29, 2020 U-765 Y
EPINEPHRINE - EPIPEN
N019430 001 7449012 Sep 11, 2025 DP
EPINEPHRINE - EPIPEN JR.
N019430 002 7449012 Sep 11, 2025 DP
EPINEPHRINE - TWINJECT 0.15
N020800 002 7297136 Jan 18, 2025 DP
7621891 Feb 04, 2025 DP
EPINEPHRINE - TWINJECT 0.3
N020800 001 7297136 Jan 18, 2025 DP
7621891 Feb 04, 2025 DP
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE - LIDOSITE TOPICAL SYSTEM KIT
N021504 001 5246418 Sep 30, 2013 DS DP
5873850 Sep 30, 2013 DS DP
6377847 Sep 30, 2013 DS DP
6385488 Sep 30, 2013 DS DP
6629968 Jun 30, 2020 DS DP
6635045 Jun 29, 2021 DS DP
6862473 Sep 30, 2013 DP
EPLERENONE - INSPRA
N021437 001 6410054 Dec 08, 2019 U-3 M-72 Jan 31, 2011
6410054 Dec 08, 2019 U-537 PED Jul 31, 2011
6410054*PED Jun 08, 2020
6410524 Nov 05, 2019 U-467
6410524*PED May 05, 2020
6495165 Dec 08, 2019 U-3
6495165 Dec 08, 2019 U-537
6495165*PED Jun 08, 2020
6534093 Dec 08, 2019 U-3
6534093 Dec 08, 2019 U-537
6534093*PED Jun 08, 2020
6558707 Dec 08, 2019 DP U-537
6558707*PED Jun 08, 2020
6747020 Nov 05, 2019 U-587
6747020*PED May 05, 2020
6863902 Apr 10, 2020 DP U-664
6863902*PED Oct 10, 2020
7157101 Dec 08, 2019 DP U-664
7157101*PED Jun 08, 2020
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 57 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
EPLERENONE - INSPRA
N021437 002 6410054 Dec 08, 2019 U-3 M-72 Jan 31, 2011
6410054 Dec 08, 2019 U-537 PED Jul 31, 2011
6410054*PED Jun 08, 2020
6410524 Nov 05, 2019 U-467
6410524*PED May 05, 2020
6495165 Dec 08, 2019 U-537
6495165 Dec 08, 2019 U-3
6495165*PED Jun 08, 2020
6534093 Dec 08, 2019 U-3
6534093 Dec 08, 2019 U-537
6534093*PED Jun 08, 2020
6558707 Dec 08, 2019 DP U-537
6558707*PED Jun 08, 2020
6747020 Nov 05, 2019 U-587
6747020*PED May 05, 2020
6863902 Apr 10, 2020 DP U-664
6863902*PED Oct 10, 2020
7157101 Dec 08, 2019 DP U-664
7157101*PED Jun 08, 2020
EPLERENONE - INSPRA
N021437 003 6410054 Dec 08, 2019 U-537
6410054 Dec 08, 2019 U-3
6410054*PED Jun 08, 2020
6410524 Nov 05, 2019 U-467
6410524*PED May 05, 2020
6495165 Dec 08, 2019 U-537
6495165 Dec 08, 2019 U-3
6495165*PED Jun 08, 2020
6534093 Dec 08, 2019 U-537
6534093 Dec 08, 2019 U-3
6534093*PED Jun 08, 2020
6558707 Dec 08, 2019 DP U-537
6558707*PED Jun 08, 2020
6747020 Nov 05, 2019 U-587
6747020*PED May 05, 2020
6863902 Apr 10, 2020 DP U-664
6863902*PED Oct 10, 2020
7157101 Dec 08, 2019 DP U-664
7157101*PED Jun 08, 2020
EPROSARTAN MESYLATE - TEVETEN
N020738 004 5185351 Feb 09, 2010 U-3
5656650 Aug 12, 2014 U-3
EPROSARTAN MESYLATE - TEVETEN
N020738 005 5185351 Feb 09, 2010 U-3
5656650 Aug 12, 2014 U-3
EPROSARTAN MESYLATE - TEVETEN
N020738 006 5185351 Feb 09, 2010 U-3
5656650 Aug 12, 2014 U-3
EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE - TEVETEN HCT
N021268 001 5185351 Feb 09, 2010 U-3
5656650 Aug 12, 2014 U-3
EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE - TEVETEN HCT
N021268 002 5185351 Feb 09, 2010 U-3
5656650 Aug 12, 2014 U-3
EPTIFIBATIDE - INTEGRILIN
N020718 001 5686570 Nov 11, 2014
5747447 May 05, 2015
5756451 Nov 11, 2014
5807825 Sep 15, 2015 U-244
5968902 Jun 02, 2015 U-453
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 58 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
EPTIFIBATIDE - INTEGRILIN
N020718 002 5686570 Nov 11, 2014
5747447 May 05, 2015
5756451 Nov 11, 2014
5807825 Sep 15, 2015 U-244
5968902 Jun 02, 2015 U-453
ERLOTINIB HYDROCHLORIDE - TARCEVA
N021743 001 5747498 Nov 08, 2018 DS DP U-659 M-79 Sep 19, 2011
6900221 Nov 09, 2020 DS DP U-875 NCE Nov 18, 2009
6900221 Nov 09, 2020 DS DP U-659
7087613 Nov 09, 2020 U-659
RE41065 Nov 08, 2018 DS DP
ERLOTINIB HYDROCHLORIDE - TARCEVA
N021743 002 5747498 Nov 08, 2018 DS DP U-659 M-79 Sep 19, 2011
6900221 Nov 09, 2020 DS DP U-875 NCE Nov 18, 2009
6900221 Nov 09, 2020 DS DP U-659
7087613 Nov 09, 2020 U-659
RE41065 Nov 08, 2018 DS DP
ERLOTINIB HYDROCHLORIDE - TARCEVA
N021743 003 5747498 Nov 08, 2018 DS DP U-659 M-79 Sep 19, 2011
6900221 Nov 09, 2020 DS DP U-659 NCE Nov 18, 2009
6900221 Nov 09, 2020 DS DP U-875
7087613 Nov 09, 2020 U-659
RE41065 Nov 08, 2018 DS DP
ERTAPENEM SODIUM - INVANZ
N021337 001 5478820 Nov 21, 2015 DS DP U-160 I-515 Aug 10, 2009
5478820*PED May 21, 2016
5652233 Feb 02, 2013 DS DP U-160
5652233*PED Aug 02, 2013
5952323 May 15, 2017 DP
5952323*PED Nov 15, 2017
7342005 Feb 02, 2013 DP
7342005*PED Aug 02, 2013
ESCITALOPRAM OXALATE - LEXAPRO
N021323 001 6916941 Aug 12, 2022 DS DP NPP Mar 19, 2012
6916941*PED Feb 12, 2023 DS DP
7420069 Aug 12, 2022 DP
7420069*PED Feb 12, 2023
RE34712 Sep 14, 2011 DS DP
RE34712*PED Mar 14, 2012
ESCITALOPRAM OXALATE - LEXAPRO
N021323 002 6916941 Aug 12, 2022 DS DP NPP Mar 19, 2012
6916941*PED Feb 12, 2023 DS DP
7420069 Aug 12, 2022 DP
7420069*PED Feb 12, 2023
RE34712 Sep 14, 2011 DS DP
RE34712*PED Mar 14, 2012
ESCITALOPRAM OXALATE - LEXAPRO
N021323 003 6916941 Aug 12, 2022 DS DP NPP Mar 19, 2012
6916941*PED Feb 12, 2023 DS DP
7420069 Aug 12, 2022 DP
7420069*PED Feb 12, 2023
RE34712 Sep 14, 2011 DS DP
RE34712*PED Mar 14, 2012
ESCITALOPRAM OXALATE - LEXAPRO
N021365 001 RE34712 Sep 14, 2011 DS DP NPP Mar 19, 2012
RE34712*PED Mar 14, 2012
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 59 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ESMOLOL HYDROCHLORIDE - BREVIBLOC
N019386 006 6310094 Jan 12, 2021
6310094*PED Jul 12, 2021
6528540 Jan 12, 2021
6528540*PED Jul 12, 2021
ESMOLOL HYDROCHLORIDE - BREVIBLOC
N019386 007 6310094 Jan 12, 2021
6310094*PED Jul 12, 2021
6528540 Jan 12, 2021
6528540*PED Jul 12, 2021
ESMOLOL HYDROCHLORIDE - BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
N019386 005 6310094 Jan 12, 2021
6310094*PED Jul 12, 2021
6528540 Jan 12, 2021
6528540*PED Jul 12, 2021
ESMOLOL HYDROCHLORIDE - BREVIBLOC IN PLASTIC CONTAINER
N019386 004 6310094 Jan 12, 2021
6310094*PED Jul 12, 2021
6528540 Jan 12, 2021
6528540*PED Jul 12, 2021
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N021153 001 5690960 Nov 25, 2014 DP U-729 I-504 Oct 11, 2009
5690960 Nov 25, 2014 DP U-373 PED Oct 28, 2009
5690960 Nov 25, 2014 DP U-770
5690960*PED May 25, 2015 U-373
5714504 Feb 03, 2015 DP U-770
5714504 Feb 03, 2015 DP U-729
5714504 Feb 03, 2015 DP U-373
5714504*PED Aug 03, 2015 U-373
5877192 May 27, 2014 DP U-770
5877192 May 27, 2014 DP U-373
5877192 May 27, 2014 DP U-729
5877192*PED Nov 27, 2014 U-373
5900424 May 04, 2016 DS U-373
5900424 May 04, 2016 DS U-729
5900424 May 04, 2016 DS U-770
5900424*PED Nov 04, 2016 U-373
6147103 Oct 09, 2018
6147103*PED Apr 09, 2019
6166213 Oct 09, 2018
6166213*PED Apr 09, 2019
6191148 Oct 09, 2018
6191148*PED Apr 09, 2019
6369085 May 25, 2018 DS DP U-729
6369085 May 25, 2018 DS DP U-770
6369085*PED Nov 25, 2018
6428810 Nov 03, 2019 DP U-770
6428810 Nov 03, 2019 DP U-729
6428810 Nov 03, 2019 DP U-469
6428810*PED May 03, 2020 U-469
6875872 May 27, 2014 DS
6875872*PED Nov 27, 2014
7411070 May 25, 2018 DS
7411070*PED Nov 25, 2018
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 60 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N021153 002 5690960 Nov 25, 2014 DP U-770 I-504 Oct 11, 2009
5690960 Nov 25, 2014 DP U-373 PED Oct 28, 2009
5690960 Nov 25, 2014 DP U-729
5690960*PED May 25, 2015 U-373
5714504 Feb 03, 2015 DP U-373
5714504 Feb 03, 2015 DP U-770
5714504 Feb 03, 2015 DP U-729
5714504*PED Aug 03, 2015 U-373
5877192 May 27, 2014 DP U-770
5877192 May 27, 2014 DP U-729
5877192 May 27, 2014 DP U-373
5877192*PED Nov 27, 2014 U-373
5900424 May 04, 2016 DS U-729
5900424 May 04, 2016 DS U-770
5900424 May 04, 2016 DS U-373
5900424*PED Nov 04, 2016 U-373
6147103 Oct 09, 2018
6147103*PED Apr 09, 2019
6166213 Oct 09, 2018
6166213*PED Apr 09, 2019
6191148 Oct 09, 2018
6191148*PED Apr 09, 2019
6369085 May 25, 2018 DS DP U-770
6369085 May 25, 2018 DS DP U-729
6369085*PED Nov 25, 2018
6428810 Nov 03, 2019 DP U-469
6428810 Nov 03, 2019 DP U-770
6428810 Nov 03, 2019 DP U-729
6428810*PED May 03, 2020 U-469
6875872 May 27, 2014 DS
6875872*PED Nov 27, 2014
7411070 May 25, 2018 DS
7411070*PED Nov 25, 2018
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N021957 001 5690960 Nov 25, 2014 DP U-729 I-504 Oct 11, 2009
5690960 Nov 25, 2014 DP U-773 M-86 Jun 18, 2012
5690960*PED May 25, 2015 PED Dec 18, 2012
5714504 Feb 03, 2015 DP U-773
5714504 Feb 03, 2015 DP U-729 PED Oct 28, 2009
5714504*PED Aug 03, 2015
5877192 May 27, 2014 U-729
5877192 May 27, 2014 U-773
5877192*PED Nov 27, 2014
5900424 May 04, 2016 DS U-773
5900424 May 04, 2016 DS U-729
5900424*PED Nov 04, 2016
6369085 May 25, 2018 DS DP U-729
6369085 May 25, 2018 DS DP U-773
6369085*PED Nov 25, 2018
6428810 Nov 03, 2019 DP U-773
6428810 Nov 03, 2019 DP U-729
6428810*PED May 03, 2020
6875872 May 27, 2014 DS
6875872*PED Nov 27, 2014
7411070 May 25, 2018 DS
7411070*PED Nov 25, 2018
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 61 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N021957 002 5690960 Nov 25, 2014 DP U-729 I-504 Oct 11, 2009
5690960 Nov 25, 2014 DP U-773 M-86 Jun 18, 2012
5690960*PED May 25, 2015 PED Dec 18, 2012
5714504 Feb 03, 2015 DP U-729
5714504 Feb 03, 2015 DP U-773 PED Oct 28, 2009
5714504*PED Aug 03, 2015
5877192 May 27, 2014 U-773
5877192 May 27, 2014 U-729
5877192*PED Nov 27, 2014
5900424 May 04, 2016 DS U-729
5900424 May 04, 2016 DS U-773
5900424*PED Nov 04, 2016
6369085 May 25, 2018 DS DP U-773
6369085 May 25, 2018 DS DP U-729
6369085*PED Nov 25, 2018
6428810 Nov 03, 2019 DP U-773
6428810 Nov 03, 2019 DP U-729
6428810*PED May 03, 2020
6875872 May 27, 2014 DS
6875872*PED Nov 27, 2014
7411070 May 25, 2018 DS
7411070*PED Nov 25, 2018
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N022101 001 5690960 Nov 25, 2014 DP U-858 I-504 Oct 11, 2009
5690960*PED May 25, 2015 NPP Feb 27, 2011
5714504 Feb 03, 2015 DP U-858 PED Aug 27, 2011
5714504*PED Aug 03, 2015
5877192 May 27, 2014 U-858
5877192*PED Nov 27, 2014
5900424 May 04, 2016 DS U-858
5900424*PED Nov 04, 2016
6369085 May 25, 2018 DS DP U-858
6369085*PED Nov 25, 2018
6428810 Nov 03, 2019 DP U-858
6428810*PED May 03, 2020
6875872 May 27, 2014 DS
6875872*PED Nov 27, 2014
7411070 May 25, 2018 DS
7411070*PED Nov 25, 2018
ESOMEPRAZOLE SODIUM - NEXIUM IV
N021689 001 5877192 May 27, 2014 U-643
5877192*PED Nov 27, 2014
6143771 May 27, 2014 DP U-643
ESOMEPRAZOLE SODIUM - NEXIUM IV
N021689 002 5877192 May 27, 2014 U-643
5877192*PED Nov 27, 2014
6143771 May 27, 2014 DP U-643
ESTRADIOL - ALORA
N020655 001 5122383 May 17, 2011
5164190 Dec 11, 2010
5212199 May 17, 2011
5227169 May 17, 2011
ESTRADIOL - ALORA
N020655 002 5122383 May 17, 2011
5164190 Dec 11, 2010
5212199 May 17, 2011
5227169 May 17, 2011
ESTRADIOL - ALORA
N020655 003 5122383 May 17, 2011
5164190 Dec 11, 2010
5212199 May 17, 2011
5227169 May 17, 2011
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 62 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ESTRADIOL - ALORA
N020655 004 5122383 May 17, 2011
5164190 Dec 11, 2010
5212199 May 17, 2011
5227169 May 17, 2011
ESTRADIOL - CLIMARA
N020375 001 5223261 Jun 29, 2010
ESTRADIOL - CLIMARA
N020375 002 5223261 Jun 29, 2010
ESTRADIOL - CLIMARA
N020375 003 5223261 Jun 29, 2010
ESTRADIOL - CLIMARA
N020375 004 5223261 Jun 29, 2010
ESTRADIOL - CLIMARA
N020375 005 5223261 Jun 29, 2010
ESTRADIOL - CLIMARA
N020375 006 5223261 Jun 29, 2010
ESTRADIOL - DIVIGEL
N022038 003 NP Jun 04, 2010
ESTRADIOL - ELESTRIN
N021813 001 7198801 Jun 25, 2022 DP NP Dec 15, 2009
7470433 Aug 03, 2021 DP
ESTRADIOL - EVAMIST
N022014 001 6299900 Feb 19, 2017 DP U-889 NDF Jul 27, 2010
6299900 Feb 19, 2017 DP U-888
6818226 Feb 19, 2017 DP U-888
6818226 Feb 19, 2017 DP U-889
6923983 Feb 19, 2017 DP U-889
6923983 Feb 19, 2017 DP U-888
6978945 Nov 30, 2021 DP
ESTRADIOL - MENOSTAR
N021674 001 5223261 Jun 29, 2010 DP U-594
5891868 Nov 21, 2017 DP U-594
6692763 Nov 21, 2017 DP U-594
ESTRADIOL - VAGIFEM
N020908 002 7018992 Sep 17, 2022 U-1023 D-122 Nov 25, 2012
ESTRADIOL - VIVELLE
N020323 001 5300291 Apr 05, 2011
ESTRADIOL - VIVELLE
N020323 002 5300291 Apr 05, 2011
ESTRADIOL - VIVELLE
N020323 003 5300291 Apr 05, 2011
ESTRADIOL - VIVELLE
N020323 004 5300291 Apr 05, 2011
ESTRADIOL - VIVELLE
N020323 005 5300291 Apr 05, 2011
ESTRADIOL - VIVELLE-DOT
N020538 005 5474783 Dec 12, 2012
5656286 Aug 12, 2014
5958446 Dec 12, 2012
6024976 Jan 07, 2014
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 63 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ESTRADIOL - VIVELLE-DOT
N020538 006 5474783 Dec 12, 2012
5656286 Aug 12, 2014
5958446 Dec 12, 2012
6024976 Jan 07, 2014
ESTRADIOL - VIVELLE-DOT
N020538 007 5474783 Dec 12, 2012
5656286 Aug 12, 2014
5958446 Dec 12, 2012
6024976 Jan 07, 2014
ESTRADIOL - VIVELLE-DOT
N020538 008 5474783 Dec 12, 2012
5656286 Aug 12, 2014
5958446 Dec 12, 2012
6024976 Jan 07, 2014
ESTRADIOL - VIVELLE-DOT
N020538 009 5474783 Dec 12, 2012 DP
5656286 Aug 12, 2014 DP
5958446 Dec 12, 2012 DP
6024976 Jan 07, 2014 DP
ESTRADIOL ACETATE - FEMRING
N021367 001 5855906 Dec 19, 2015 U-508
ESTRADIOL ACETATE - FEMRING
N021367 002 5855906 Dec 19, 2015 U-508
ESTRADIOL ACETATE - FEMTRACE
N021633 001 6962908 Dec 21, 2021 DP
ESTRADIOL ACETATE - FEMTRACE
N021633 002 6962908 Dec 21, 2021 DP
ESTRADIOL ACETATE - FEMTRACE
N021633 003 6962908 Dec 21, 2021 DP
ESTRADIOL HEMIHYDRATE - ESTRASORB
N021371 001 5629021 Jan 31, 2015 DP
ESTRADIOL; LEVONORGESTREL - CLIMARA PRO
N021258 001 5252334 Oct 12, 2010 DP
5393529 Feb 28, 2012 DP
5676968 Oct 14, 2014 DP
5770219 Oct 12, 2010 DP
ESTRADIOL; NORETHINDRONE ACETATE - ACTIVELLA
N020907 002 D-104 Dec 28, 2009
I-525 Dec 29, 2009
NS Dec 28, 2009
ESTRADIOL; NORETHINDRONE ACETATE - COMBIPATCH
N020870 001 5474783 Dec 12, 2012
5656286 Aug 12, 2014
5958446 Dec 12, 2012
6024976 Jan 07, 2014
ESTRADIOL; NORETHINDRONE ACETATE - COMBIPATCH
N020870 002 5474783 Dec 12, 2012
5656286 Aug 12, 2014
5958446 Dec 12, 2012
6024976 Jan 07, 2014
ESTRADIOL; NORGESTIMATE - PREFEST
N021040 001 5382573 Jan 17, 2012
6747019 Mar 20, 2020 U-311
7320970 Mar 30, 2020 DP U-844
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 64 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ESTROGENS, CONJUGATED - PREMARIN
N020216 001 I-579 Nov 07, 2011
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N020992 001 5908638 Jul 26, 2015 DP
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N020992 002 5908638 Jul 26, 2015
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N020992 003 5908638 Jul 26, 2015
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N020992 004 5908638 Jul 26, 2015
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N020992 005 5908638 Jul 26, 2015
ESTROGENS, CONJUGATED SYNTHETIC A - SYNTHETIC CONJUGATED ESTROGENS A
N021788 001 NP Nov 28, 2011
ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA
N021443 001 6660726 Mar 08, 2021 DS DP U-905 I-528 Apr 23, 2010
6660726 Mar 08, 2021 DS DP U-904
6855703 Feb 12, 2021 DS DP U-905
6855703 Feb 12, 2021 DS DP U-904
ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA
N021443 002 6660726 Mar 08, 2021 DS DP U-905
6660726 Mar 08, 2021 DS DP U-904
6855703 Feb 12, 2021 DS DP U-904
6855703 Feb 12, 2021 DS DP U-905
ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA
N021443 003 6660726 Mar 08, 2021 DS DP U-904
6660726 Mar 08, 2021 DS DP U-905
6855703 Feb 12, 2021 DS DP U-905
6855703 Feb 12, 2021 DS DP U-904
ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA
N021443 004 6660726 Mar 08, 2021 DS DP U-904
6660726 Mar 08, 2021 DS DP U-905
6855703 Feb 12, 2021 DS DP U-905
6855703 Feb 12, 2021 DS DP U-904
ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA
N021443 005 6660726 Mar 08, 2021 DS DP U-904
6660726 Mar 08, 2021 DS DP U-905
6855703 Feb 12, 2021 DS DP U-904
6855703 Feb 12, 2021 DS DP U-905
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPHASE (PREMARIN;CYCRIN 14/14)
N020303 002 5210081 Feb 26, 2012
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPHASE 14/14
N020527 002 5547948 Jan 17, 2015
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPRO
N020527 001 5547948 Jan 17, 2015
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPRO
N020527 003 5547948 Jan 17, 2015
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPRO
N020527 004 5547948 Jan 17, 2015
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPRO
N020527 005 5547948 Jan 17, 2015
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPRO (PREMARIN;CYCRIN)
N020303 001 5210081 Feb 26, 2012
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 65 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ESTROGENS, CONJUGATED; MEPROBAMATE - PMB 200
N010971 005 5210081 Feb 26, 2012
ESTROGENS, CONJUGATED; MEPROBAMATE - PMB 400
N010971 003 5210081 Feb 26, 2012
ESZOPICLONE - LUNESTA
N021476 001 6319926 Jan 16, 2012 U-620 NCE Dec 15, 2009
6444673 Jan 16, 2012 DS DP
6864257 Aug 30, 2012 U-629
7381724 Jan 16, 2012 DS DP U-629
ESZOPICLONE - LUNESTA
N021476 002 6319926 Jan 16, 2012 U-620 NCE Dec 15, 2009
6444673 Jan 16, 2012 DS DP
6864257 Aug 30, 2012 U-629
7381724 Jan 16, 2012 DS DP U-629
ESZOPICLONE - LUNESTA
N021476 003 6319926 Jan 16, 2012 U-620 NCE Dec 15, 2009
6444673 Jan 16, 2012 DS DP
6864257 Aug 30, 2012 U-629
7381724 Jan 16, 2012 DS DP U-629
ETHINYL ESTRADIOL; ETONOGESTREL - NUVARING
N021187 001 5989581 Apr 08, 2018
ETHINYL ESTRADIOL; LEVONORGESTREL - LOSEASONIQUE
N022262 001 7615545 Jun 15, 2023 U-1 NP Oct 24, 2011
ETHINYL ESTRADIOL; LEVONORGESTREL - LYBREL
N021864 001 6500814 Sep 03, 2018 U-1 NP May 22, 2010
ETHINYL ESTRADIOL; LEVONORGESTREL - PREVEN EMERGENCY CONTRACEPTIVE KIT
N020946 001 6156742 Dec 05, 2020 U-374
ETHINYL ESTRADIOL; LEVONORGESTREL - SEASONALE
N021544 001 5898032 Jun 23, 2017 U-1
RE39861 Jun 23, 2017 U-828
ETHINYL ESTRADIOL; LEVONORGESTREL - SEASONIQUE
N021840 001 7320969 Jan 30, 2024 U-828
ETHINYL ESTRADIOL; NORELGESTROMIN - ORTHO EVRA
N021180 001 5876746 Nov 20, 2015 DP U-514
5972377 Jun 07, 2015 U-514
ETHINYL ESTRADIOL; NORETHINDRONE - FEMCON FE
N021490 001 6667050 Apr 06, 2019 DP U-1
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - FEMHRT
N021065 001 5208225 May 04, 2010 U-283
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - FEMHRT
N021065 002 5208225 May 04, 2010 U-283
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - LOESTRIN 24 FE
N021871 001 5552394 Jul 22, 2014 U-1
ETHINYL ESTRADIOL; NORGESTIMATE - ORTHO TRI-CYCLEN LO
N021241 001 6214815 Jun 09, 2019 U-112
6214815*PED Dec 09, 2019
ETHINYL ESTRADIOL; NORGESTIMATE - TRI LO SPRINTEC
A076784 001 PC Dec 29, 2009
ETONOGESTREL - IMPLANON
N021529 001 5150718 Sep 29, 2009 U-749 NDF Jul 17, 2009
ETOPOSIDE PHOSPHATE - ETOPOPHOS PRESERVATIVE FREE
N020457 001 RE35524 May 17, 2010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 66 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ETOPOSIDE PHOSPHATE - ETOPOPHOS PRESERVATIVE FREE
N020906 001 RE35524 May 17, 2010
ETOPOSIDE PHOSPHATE - ETOPOPHOS PRESERVATIVE FREE
N020906 002 RE35524 May 17, 2010
ETRAVIRINE - INTELENCE
N022187 001 6878717 Nov 05, 2019 U-256 NCE Jan 18, 2013
6878717 Nov 05, 2019 U-1016
7037917 Nov 05, 2019 DS DP U-1016
7037917 Nov 05, 2019 DS DP U-256
EVEROLIMUS - AFINITOR
N022334 001 5665772 Sep 09, 2014 DS DP NCE Mar 30, 2014
6004973 Jul 12, 2016 DP
7297703 Dec 06, 2019 DP
EVEROLIMUS - AFINITOR
N022334 002 5665772 Sep 09, 2014 DS DP NCE Mar 30, 2014
6004973 Jul 12, 2016 DP
7297703 Dec 06, 2019 DP
EXEMESTANE - AROMASIN
N020753 001 4808616 Apr 01, 2011 DS DP U-658
EXENATIDE SYNTHETIC - BYETTA
N021773 001 5424286 Dec 01, 2016 U-653 I-520 Dec 22, 2009
6858576 Jan 06, 2017 U-656 NCE Apr 28, 2010
6872700 Jan 14, 2020 U-654
6902744 Jan 14, 2020 DP
6956026 Jan 07, 2018 U-687
7297761 Oct 15, 2017 DP
7521423 Oct 15, 2017 DP
EXENATIDE SYNTHETIC - BYETTA
N021773 002 5424286 May 24, 2013 U-653 I-520 Dec 22, 2009
6858576 Jan 06, 2017 U-656 NCE Apr 28, 2010
6872700 Jan 14, 2020 U-654
6902744 Jan 14, 2020 DP
6956026 Jan 07, 2018 U-687
7297761 Oct 15, 2017 DP
7521423 Oct 15, 2017 DP
EZETIMIBE - ZETIA
N021445 001 5846966 Sep 21, 2013 U-474 M-54 Jun 05, 2011
5846966 Sep 21, 2013 U-473 PED Dec 05, 2011
5846966*PED Mar 21, 2014 PED Nov 23, 2009
7030106 Jan 25, 2022 DP

7030106*PED Jul 25, 2022

RE37721 Oct 25, 2016 DS DP U-473


RE37721*PED Apr 25, 2017


EZETIMIBE; SIMVASTATIN - VYTORIN


N021687 001 5846966 Sep 21, 2013 DP U-593 M-54 Jun 05, 2011
5846966 Sep 21, 2013 DP U-473 M-60 Oct 03, 2009
5846966*PED Mar 21, 2014 PED Dec 05, 2011
RE37721 Oct 25, 2016 DS DP U-473
RE37721*PED Apr 25, 2017 PED Sep 16, 2009
PED Apr 03, 2010
EZETIMIBE; SIMVASTATIN - VYTORIN
N021687 002 5846966 Sep 21, 2013 DP U-473 M-54 Jun 05, 2011
5846966 Sep 21, 2013 DP U-593 M-60 Oct 03, 2009
5846966*PED Mar 21, 2014 PED Dec 05, 2011
RE37721 Oct 25, 2016 DS DP U-473
RE37721*PED Apr 25, 2017 PED Sep 16, 2009
PED Apr 03, 2010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 67 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
EZETIMIBE; SIMVASTATIN - VYTORIN
N021687 003 5846966 Sep 21, 2013 DP U-473 M-54 Jun 05, 2011
5846966 Sep 21, 2013 DP U-593 M-60 Oct 03, 2009
5846966*PED Mar 21, 2014 PED Sep 16, 2009
RE37721 Oct 25, 2016 DS DP U-473
RE37721*PED Apr 25, 2017 PED Apr 03, 2010

EZETIMIBE; SIMVASTATIN - VYTORIN


N021687 004 5846966 Sep 21, 2013 DP U-473 M-54 Jun 05, 2011
5846966 Sep 21, 2013 DP U-593 M-60 Oct 03, 2009
5846966*PED Mar 21, 2014 PED Dec 05, 2011
RE37721 Oct 25, 2016 DS DP U-473
RE37721*PED Apr 25, 2017 PED Sep 16, 2009
PED Apr 03, 2010
FAMCICLOVIR - FAMVIR
N020363 001 5246937 Sep 21, 2010 U-96 D-103 Jul 28, 2009
5246937*PED Mar 21, 2011 I-501 Jul 28, 2009
5840763 Sep 01, 2015 U-96 M-54 Dec 24, 2012
5840763*PED Mar 01, 2016
5866581 Oct 04, 2014 U-96 PED Jun 24, 2013
5866581*PED Apr 04, 2015 PED Jan 28, 2010
5916893 Sep 01, 2015 U-96 PED Jan 28, 2010
5916893*PED Mar 01, 2016
6124304 Oct 04, 2014 U-96
6124304*PED Apr 04, 2015
FAMCICLOVIR - FAMVIR
N020363 002 5246937 Sep 21, 2010 U-96 D-103 Jul 28, 2009
5246937*PED Mar 21, 2011 I-501 Jul 28, 2009
5840763 Sep 01, 2015 U-96 M-54 Dec 24, 2012
5840763*PED Mar 01, 2016
5866581 Oct 04, 2014 U-96 PED Jun 24, 2013
5866581*PED Apr 04, 2015 PED Jan 28, 2010
5916893 Sep 01, 2015 U-96 PED Jan 28, 2010
5916893*PED Mar 01, 2016
6124304 Oct 04, 2014 U-96
6124304*PED Apr 04, 2015
FAMCICLOVIR - FAMVIR
N020363 003 5246937 Sep 21, 2010 U-96 D-103 Jul 28, 2009
5246937*PED Mar 21, 2011 I-501 Jul 28, 2009
5840763 Sep 01, 2015 U-96 M-54 Dec 24, 2012
5840763*PED Mar 01, 2016
5866581 Oct 04, 2014 U-96 PED Jun 24, 2013
5866581*PED Apr 04, 2015 PED Jan 28, 2010
5916893 Sep 01, 2015 U-96 PED Jan 28, 2010
5916893*PED Mar 01, 2016
6124304 Oct 04, 2014 U-96
6124304*PED Apr 04, 2015
FAMOTIDINE - FLUXID
N021712 001 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
FAMOTIDINE - FLUXID
N021712 002 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
FAMOTIDINE - PEPCID AC
N020325 001 5854267 Dec 29, 2015 U-267
5854267*PED Jun 29, 2016 U-267
FAMOTIDINE - PEPCID AC
N020801 001 5075114 Oct 23, 2010
5075114*PED Nov 23, 2010
5667794 May 02, 2015 Y
5667794*PED Nov 02, 2015
5854267 Dec 29, 2015 U-267
5854267*PED Jun 29, 2016
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 68 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
FAMOTIDINE - PEPCID AC
N020801 002 5075114 May 23, 2010 DP
5075114*PED Nov 23, 2010
6814978 Aug 26, 2021 DP
6814978*PED Feb 26, 2022
FAMOTIDINE - PEPCID AC (GELTAB)
N020902 001 5854267 Dec 29, 2015 U-368
5854267*PED Jun 29, 2016 U-368
FEBUXOSTAT - ULORIC
N021856 001 5614520 Mar 25, 2014 DS DP U-954 NCE Feb 13, 2014
6225474 Jun 18, 2019 DS
7361676 Mar 08, 2024 DP
FEBUXOSTAT - ULORIC
N021856 002 5614520 Mar 25, 2014 DS DP U-954 NCE Feb 13, 2014
6225474 Jun 18, 2019 DS
7361676 Mar 08, 2024 DP
FELBAMATE - FELBATOL
N020189 001 4978680 Sep 26, 2009 U-83
5082861 Sep 26, 2009 U-83
FELBAMATE - FELBATOL
N020189 002 4978680 Sep 26, 2009 U-83
5082861 Sep 26, 2009 U-83
FELBAMATE - FELBATOL
N020189 003 4978680 Sep 26, 2009 U-83
5082861 Sep 26, 2009 U-83
FENOFIBRATE - ANTARA (MICRONIZED)
N021695 001 7101574 Aug 20, 2020 DS DP
FENOFIBRATE - ANTARA (MICRONIZED)
N021695 003 7101574 Aug 20, 2020 DS DP
FENOFIBRATE - LIPOFEN
N021612 001 5545628 Jan 10, 2015 DP U-701
FENOFIBRATE - LIPOFEN
N021612 002 5545628 Jan 10, 2015 DP U-701
FENOFIBRATE - LIPOFEN
N021612 003 5545628 Jan 10, 2015 DP U-701
FENOFIBRATE - TRICOR
N021203 001 6074670 Jan 09, 2018
6277405 Jan 09, 2018
6589552 Jan 09, 2018
6652881 Jan 09, 2018 DP
7037529 Jan 09, 2018 DP
7041319 Jan 09, 2018 DP
FENOFIBRATE - TRICOR
N021203 003 6074670 Jan 09, 2018
6277405 Jan 09, 2018
6589552 Jan 09, 2018
6652881 Jan 09, 2018 DP
7037529 Jan 09, 2018 DP
7041319 Jan 09, 2018 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 69 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
FENOFIBRATE - TRICOR
N021656 001 5145684 Jan 25, 2011 DP U-615
6277405 Jan 09, 2018 DS
6375986 Sep 21, 2020 DP U-615
6652881 Jan 09, 2018 DS
7037529 Jan 09, 2018 DP
7041319 Jan 09, 2018 DP
7276249 Feb 21, 2023 DP
7320802 Feb 21, 2023 U-847
FENOFIBRATE - TRICOR
N021656 002 5145684 Jan 25, 2011 DP U-615
6277405 Jan 09, 2018 DS
6375986 Sep 21, 2020 DP U-615
6652881 Jan 09, 2018 DS
7037529 Jan 09, 2018 DP
7041319 Jan 09, 2018 DP
7276249 Feb 21, 2023 DP
7320802 Feb 21, 2023 U-847
FENOFIBRATE - TRIGLIDE
N021350 001 6696084 Sep 11, 2021 DS DP U-680
FENOFIBRATE - TRIGLIDE
N021350 002 6696084 Sep 11, 2021 DS DP U-680
FENOFIBRIC ACID - FIBRICOR
N022418 001 7569612 Aug 20, 2027 U-1000
FENOFIBRIC ACID - FIBRICOR
N022418 002 7569612 Aug 20, 2027 U-1000
FENTANYL CITRATE - ACTIQ
N020747 001 M-63 Feb 07, 2010
FENTANYL CITRATE - ACTIQ
N020747 002 M-63 Feb 07, 2010
FENTANYL CITRATE - ACTIQ
N020747 003 M-63 Feb 07, 2010
FENTANYL CITRATE - ACTIQ
N020747 004 M-63 Feb 07, 2010
FENTANYL CITRATE - ACTIQ
N020747 005 M-63 Feb 07, 2010
FENTANYL CITRATE - ACTIQ
N020747 006 M-63 Feb 07, 2010
FENTANYL CITRATE - FENTORA
N021947 001 6200604 Mar 26, 2019 U-767 NDF Sep 25, 2009
6974590 Mar 26, 2019 U-767
FENTANYL CITRATE - FENTORA
N021947 002 6200604 Mar 26, 2019 U-767 NDF Sep 25, 2009
6974590 Mar 26, 2019 U-767
FENTANYL CITRATE - FENTORA
N021947 003 6200604 Mar 26, 2019 U-767 NDF Sep 25, 2009
6974590 Mar 26, 2019 U-767
FENTANYL CITRATE - FENTORA
N021947 004 6200604 Mar 26, 2019 U-767 NDF Sep 25, 2009
6974590 Mar 26, 2019 U-767
FENTANYL CITRATE - FENTORA
N021947 005 6200604 Mar 26, 2019 U-767 NDF Sep 25, 2009
6974590 Mar 26, 2019 U-767
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 70 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
FENTANYL CITRATE - FENTORA
N021947 006 6200604 Mar 26, 2019 U-767 NDF Sep 25, 2009
6974590 Mar 26, 2019 U-767
FENTANYL CITRATE - ONSOLIS
N022266 001 6159498 Oct 18, 2016 DP NP Jul 16, 2012
FENTANYL CITRATE - ONSOLIS
N022266 002 6159498 Oct 18, 2016 DP NP Jul 16, 2012
FENTANYL CITRATE - ONSOLIS
N022266 003 6159498 Oct 18, 2016 DP NP Jul 16, 2012
FENTANYL CITRATE - ONSOLIS
N022266 004 6159498 Oct 18, 2016 DP NP Jul 16, 2012
FENTANYL CITRATE - ONSOLIS
N022266 005 6159498 Oct 18, 2016 DP NP Jul 16, 2012
FENTANYL HYDROCHLORIDE - IONSYS
N021338 001 5697896 Dec 16, 2014 DP
5843014 Dec 01, 2015 DP
6169920 Jan 02, 2018 DP
6171294 Jun 05, 2015 U-736
6181963 Nov 02, 2019 DP
6195582 Jan 28, 2019 DP U-736
6216033 Jun 05, 2015 DP
6317629 Jun 02, 2012 DP
6425892 Jun 05, 2015 U-736
6842640 Jun 02, 2015 DP
6881208 Apr 19, 2022 U-736
6975902 Apr 01, 2024 DP
7018370 Jun 05, 2015 U-736
7027859 Sep 26, 2014 DP
7302293 Jun 05, 2015 DP
FERRIC HEXACYANOFERRATE(II) - RADIOGARDASE (PRUSSIAN BLUE)
N021626 001 ODE Oct 02, 2010
FERUMOXIDES - FERIDEX I.V.
N020416 001 5219554 Jun 15, 2010
5248492 Sep 28, 2010
FERUMOXSIL - GASTROMARK
N020410 001 5219554 Jun 15, 2010
FERUMOXYTOL - FERAHEME
N022180 001 6599498 Mar 08, 2020 DS DP NP Jun 30, 2012
7553479 Mar 08, 2020 DS DP
FESOTERODINE FUMARATE - TOVIAZ
N022030 001 6858650 May 11, 2019 DS U-913 NCE Oct 31, 2013
7384980 Oct 14, 2019 DS DP U-913
FESOTERODINE FUMARATE - TOVIAZ
N022030 002 6858650 May 11, 2019 DS U-913 NCE Oct 31, 2013
7384980 Oct 14, 2019 DS DP U-913
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 71 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
FEXOFENADINE HYDROCHLORIDE - ALLEGRA
N020625 001 5578610 Nov 26, 2013 U-192
5578610*PED May 26, 2014 U-192
5738872 Feb 28, 2015
5738872*PED Aug 28, 2015
5855912 Feb 28, 2015
5855912*PED Aug 28, 2015
5932247 Feb 28, 2015
5932247*PED Aug 28, 2015
6037353 Mar 14, 2017 U-138
6037353*PED Sep 14, 2017 U-138
6113942 Feb 28, 2015
6113942*PED Aug 28, 2015
6187791 May 11, 2012 U-138
6187791*PED Nov 11, 2012 U-138
6399632 May 11, 2012 U-468
6399632*PED Nov 11, 2012 U-468
7135571 May 18, 2014 DS
7135571*PED Nov 18, 2014
7138524 May 18, 2014 DS
7138524*PED Nov 18, 2014
FEXOFENADINE HYDROCHLORIDE - ALLEGRA
N020872 001 5578610 Nov 26, 2013 DS DP U-684
5578610 Nov 26, 2013 DS DP U-139
5578610*PED May 26, 2014 U-139
5855912 Feb 28, 2015 DP
5855912*PED Aug 28, 2015
5932247 Feb 28, 2015 DP
5932247*PED Aug 28, 2015
6037353 Mar 14, 2017 U-138
6037353 Mar 14, 2017 U-684
6037353*PED Sep 14, 2017 U-138
6113942 Feb 28, 2015 DP
6113942*PED Aug 28, 2015
6187791 May 11, 2012 U-138
6187791 May 11, 2012 U-684
6187791*PED Nov 11, 2012 U-138
6399632 May 11, 2012 U-468
6399632 May 11, 2012 U-684
6399632*PED Nov 11, 2012 U-468
7135571 May 18, 2014 DS
7135571*PED Nov 18, 2014
7138524 May 18, 2014 DS
7138524*PED Nov 18, 2014
FEXOFENADINE HYDROCHLORIDE - ALLEGRA
N020872 002 5578610 Nov 26, 2013 DS DP U-139
5578610 Nov 26, 2013 DS DP U-684
5578610*PED May 26, 2014 U-139
5855912 Feb 28, 2015 DP
5855912*PED Aug 28, 2015
5932247 Feb 28, 2015 DP
5932247*PED Aug 28, 2015
6037353 Mar 14, 2017 U-684
6037353 Mar 14, 2017 U-138
6037353*PED Sep 14, 2017 U-138
6113942 Feb 28, 2015 DP
6113942*PED Aug 28, 2015
6187791 May 11, 2012 U-138
6187791 May 11, 2012 U-684
6187791*PED Nov 11, 2012 U-138
6399632 May 11, 2012 U-468
6399632 May 11, 2012 U-684
6399632*PED Nov 11, 2012 U-468
7135571 May 18, 2014 DS
7135571*PED Nov 18, 2014
7138524 May 18, 2014 DS
7138524*PED Nov 18, 2014
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 72 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
FEXOFENADINE HYDROCHLORIDE - ALLEGRA
N020872 004 5578610 Nov 26, 2013 DS DP U-684
5578610 Nov 26, 2013 DS DP U-139
5578610*PED May 26, 2014 U-139
5855912 Feb 28, 2015 DP
5855912*PED Aug 28, 2015
5932247 Feb 28, 2015 DP
5932247*PED Aug 28, 2015
6037353 Mar 14, 2017 U-684
6037353 Mar 14, 2017 U-138
6037353*PED Sep 14, 2017 U-138
6113942 Feb 28, 2015 DP
6113942*PED Aug 28, 2015
6187791 May 11, 2012 U-684
6187791 May 11, 2012 U-138
6187791*PED Nov 11, 2012 U-138
6399632 May 11, 2012 U-468
6399632 May 11, 2012 U-684
6399632*PED Nov 11, 2012 U-468
7135571 May 18, 2014 DS
7135571*PED Nov 18, 2014
7138524 May 18, 2014 DS
7138524*PED Nov 18, 2014
FEXOFENADINE HYDROCHLORIDE - ALLEGRA
N021909 001 5178878 Jan 12, 2010 DP U-823
5578610 Nov 26, 2013 DS DP U-823
5738872 Feb 28, 2015 DP
6037353 Mar 14, 2017 U-823
6187791 May 11, 2012 U-823
6399632 May 11, 2012 U-823
7138524 May 18, 2014 DS
FEXOFENADINE HYDROCHLORIDE - ALLEGRA
N021963 001 5578610 Nov 26, 2013 DS DP U-772
6037353 Mar 14, 2017 U-772
6187791 May 11, 2012 U-772
6399632 May 11, 2012 U-772
7138524 May 18, 2014 DS
7138524*PED Nov 18, 2014
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - ALLEGRA D 24 HOUR
N021704 001 5578610 Nov 26, 2013 DS DP U-612
5578610*PED May 26, 2014
6004582 May 29, 2018 DP
6037353 Mar 17, 2017 U-612
6037353*PED Sep 14, 2017
6187791 May 11, 2012 U-612
6187791*PED Nov 11, 2012
6399632 May 11, 2012 U-612
6399632*PED Nov 11, 2012
6613357 Dec 25, 2020 DP U-612
7138524 May 18, 2014 DS
7138524*PED Nov 18, 2014
RE39069 May 29, 2018 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 73 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - ALLEGRA-D 12 HOUR
N020786 001 5578610 Nov 26, 2013
5578610*PED May 26, 2014
5855912 Feb 28, 2015
5855912*PED Aug 28, 2015
6037353 Mar 14, 2017 U-138
6037353*PED Sep 14, 2017 U-138
6039974 Jul 31, 2018
6113942 Feb 28, 2015
6113942*PED Aug 28, 2015
6187791 May 11, 2012 U-138
6187791*PED Nov 11, 2012 U-138
6399632 May 11, 2012 U-468
6399632*PED Nov 11, 2012 U-468
7135571 May 18, 2014 DS
7135571*PED Nov 18, 2014
7138524 May 18, 2014 DS
7138524*PED Nov 18, 2014
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE
HYDROCHLORIDE
A076236 001 PC May 02, 2010
FINASTERIDE - PROPECIA
N020788 001 5547957 Oct 15, 2013 U-236
5571817 Nov 05, 2013 U-259
5886184 Nov 19, 2012
FINASTERIDE - PROSCAR
N020180 001 5886184 Nov 19, 2012 DS
5942519 Oct 23, 2018 U-280
6046183 Mar 20, 2011 DP U-577
FLUDARABINE PHOSPHATE - OFORTA
N022273 001 7148207 Dec 20, 2022 DP U-944 NDF Dec 18, 2011
7547776 Dec 10, 2018 DS ODE Dec 18, 2015
FLUOCINOLONE ACETONIDE - DERMA-SMOOTHE/FS
N019452 001 NPP Dec 12, 2010
FLUOCINOLONE ACETONIDE - RETISERT
N021737 001 6217895 Mar 22, 2019 DP U-708 ODE Apr 08, 2012
6548078 Mar 22, 2019 DP U-708
FLUOCINONIDE - VANOS
N021758 001 6765001 Dec 21, 2021 DP
7220424 Jan 07, 2023 U-861
FLUOROMETHOLONE ACETATE; TOBRAMYCIN - TOBRASONE
N050628 001 5149693 Sep 22, 2009 U-923
FLUOROURACIL - CARAC
N020985 001 6670335 Jun 02, 2021 DP U-68
FLUOXETINE HYDROCHLORIDE - PROZAC
N018936 001 6960577 Nov 01, 2017 U-963 I-589 Mar 19, 2012
FLUOXETINE HYDROCHLORIDE - PROZAC
N018936 003 6960577 Nov 01, 2017 U-963 I-589 Mar 19, 2012
FLUOXETINE HYDROCHLORIDE - PROZAC
N018936 006 6960577 Nov 01, 2017 U-963 I-589 Mar 19, 2012
FLUOXETINE HYDROCHLORIDE - PROZAC WEEKLY
N021235 001 5910319 May 29, 2017 U-396
5985322 May 29, 2017 U-397
RE39030 May 29, 2017 DP U-396
RE39030 May 29, 2017 DP U-397
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 74 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N021520 001 5229382 Apr 23, 2011 DS DP I-593 Mar 19, 2012
5229382*PED Oct 23, 2011
6960577 Nov 01, 2017 U-962
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N021520 002 5229382 Apr 23, 2011 DS DP I-593 Mar 19, 2012
5229382*PED Oct 23, 2011
5945416 Mar 24, 2017 DS DP Y
6960577 Nov 01, 2017 U-962
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N021520 003 5229382 Apr 23, 2011 DS DP I-593 Mar 19, 2012
5229382*PED Oct 23, 2011
5945416 Mar 24, 2017 DS DP Y
6960577 Nov 01, 2017 U-962
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N021520 004 5229382 Apr 23, 2011 DS DP I-593 Mar 19, 2012
5229382*PED Oct 23, 2011
5945416 Mar 24, 2017 DS DP Y
6960577 Nov 01, 2017 U-962
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N021520 005 5229382 Apr 23, 2011 DS DP I-593 Mar 19, 2012
5229382*PED Oct 23, 2011
5945416 Mar 24, 2017 DS DP Y
6960577 Nov 01, 2017 U-962
FLUTICASONE FUROATE - VERAMYST
N022051 001 6858596 Aug 03, 2021 DP U-808
7101866 Aug 03, 2021 DS DP U-808
7541350 Aug 03, 2021 DP U-988
FLUTICASONE PROPIONATE - CUTIVATE
N021152 001 7300669 Oct 20, 2019 DP U-835
FLUTICASONE PROPIONATE - FLOVENT DISKUS 100
N020833 002 5590645 Mar 01, 2011 DP
5590645*PED Sep 01, 2011
5860419 Mar 01, 2011 DP
5860419*PED Sep 01, 2011
5873360 Feb 23, 2016 DP
5873360*PED Aug 23, 2016
6032666 Mar 01, 2011 DP
6032666*PED Sep 01, 2011
6378519 Mar 01, 2011 DP
6378519*PED Sep 01, 2011
6536427 Mar 01, 2011 DP
6536427*PED Sep 01, 2011
6792945 Mar 01, 2011 DP
6792945*PED Sep 01, 2011
7225808 Mar 01, 2011 DP
7225808*PED Sep 01, 2011
7389775 Mar 01, 2011 DP
7389775*PED Sep 01, 2011
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 75 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
FLUTICASONE PROPIONATE - FLOVENT DISKUS 250
N020833 003 5590645 Mar 01, 2011 DP
5590645*PED Sep 01, 2011
5860419 Mar 01, 2011 DP
5860419*PED Sep 01, 2011
5873360 Feb 23, 2016 DP
5873360*PED Aug 23, 2016
6032666 Mar 01, 2011 DP
6032666*PED Sep 01, 2011
6378519 Mar 01, 2011 DP
6378519*PED Sep 01, 2011
6536427 Mar 01, 2011 DP
6536427*PED Sep 01, 2011
6792945 Mar 01, 2011 DP
6792945*PED Sep 01, 2011
7225808 Mar 01, 2011 DP
7225808*PED Sep 01, 2011
7389775 Mar 01, 2011 DP
7389775*PED Sep 01, 2011
FLUTICASONE PROPIONATE - FLOVENT DISKUS 50
N020833 001 5590645 Mar 01, 2011 DP
5590645*PED Sep 01, 2011
5860419 Mar 01, 2011 DP
5860419*PED Sep 01, 2011
5873360 Feb 23, 2016 DP
5873360*PED Aug 23, 2016
6032666 Mar 01, 2011 DP
6032666*PED Sep 01, 2011
6378519 Mar 01, 2011 DP
6378519*PED Sep 01, 2011
6536427 Mar 01, 2011 DP
6536427*PED Sep 01, 2011
6792945 Mar 01, 2011 DP
6792945*PED Sep 01, 2011
7225808 Mar 01, 2011 DP
7225808*PED Sep 01, 2011
7389775 Mar 01, 2011 DP
7389775*PED Sep 01, 2011
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 76 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
FLUTICASONE PROPIONATE - FLOVENT HFA
N021433 001 5658549 Aug 19, 2014 DP U-710
5658549*PED Feb 19, 2015
5674472 Oct 07, 2014 DP
5674472*PED Apr 07, 2015
6161724 Jan 16, 2018 DP
6161724*PED Jul 16, 2018
6170717 Dec 23, 2017 DP
6170717*PED Jun 23, 2018
6251368 Dec 04, 2012 DP
6251368*PED Jun 04, 2013
6253762 Apr 14, 2015 DP U-582
6253762*PED Oct 14, 2015
6315173 Jun 23, 2017 DP
6315173*PED Jun 23, 2018
6431168 Jun 08, 2018 DP
6431168*PED Dec 08, 2018
6435372 Jan 16, 2018 DP
6435372*PED Jul 16, 2018
6510969 Dec 23, 2017 DP
6510969*PED Jun 23, 2018
6546928 Apr 14, 2015 DP U-583
6546928*PED Oct 14, 2015
6596260 Aug 10, 2014 DP
6596260*PED Feb 10, 2015
6743413 Jun 01, 2021 U-581
6743413*PED Dec 01, 2021
6938796 Jan 16, 2018 DP
6938796*PED Jul 16, 2018
6966467 Dec 23, 2017 DP
6966467*PED Jun 23, 2018
6997349 Jan 16, 2018 DP
6997349*PED Jul 16, 2018
7107986 Jun 08, 2018 DP
7107986*PED Dec 08, 2019
7143908 Jan 16, 2018 DP
7143908*PED Jul 16, 2018
7350676 Aug 24, 2018 DP
7350676*PED Feb 24, 2019
7500444 Jan 04, 2025 DP
7500444*PED Jul 04, 2025
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 77 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
FLUTICASONE PROPIONATE - FLOVENT HFA
N021433 002 5658549 Aug 19, 2014 DP U-710
5658549*PED Feb 19, 2015
5674472 Oct 07, 2014 DP
5674472*PED Apr 07, 2015
6161724 Jan 16, 2018 DP
6161724*PED Jul 16, 2018
6170717 Dec 23, 2017 DP
6170717*PED Jun 23, 2018
6251368 Dec 04, 2012 DP
6251368*PED Jun 04, 2013
6253762 Apr 14, 2015 DP U-582
6253762*PED Oct 14, 2015
6315173 Dec 23, 2017 DP
6315173*PED Jun 23, 2018
6431168 Jun 08, 2018 DP
6431168*PED Dec 08, 2018
6435372 Jan 16, 2018 DP
6435372*PED Jul 16, 2018
6510969 Dec 23, 2017 DP
6510969*PED Jun 23, 2018
6546928 Apr 14, 2015 DP U-583
6546928*PED Oct 14, 2015
6596260 Aug 10, 2014 DP
6596260*PED Feb 10, 2015
6743413 Jun 01, 2021 U-581
6743413*PED Dec 01, 2021
6938796 Jan 16, 2018 DP
6938796*PED Jul 16, 2018
6966467 Dec 23, 2017 DP
6966467*PED Jun 23, 2018
6997349 Jan 16, 2018 DP
6997349*PED Jul 16, 2018
7107986 Jun 08, 2018 DP
7107986*PED Dec 08, 2019
7143908 Jan 16, 2018 DP
7143908*PED Jul 16, 2018
7350676 Aug 24, 2018 DP
7350676*PED Feb 24, 2019
7500444 Jan 04, 2025 DP
7500444*PED Jul 04, 2025
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 78 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
FLUTICASONE PROPIONATE - FLOVENT HFA
N021433 003 5658549 Aug 19, 2014 DP U-710
5658549*PED Feb 19, 2015 U-710
5674472 Oct 07, 2014 DP
5674472*PED Apr 07, 2015
6161724 Jan 16, 2018 DP
6161724*PED Jul 16, 2018
6170717 Dec 23, 2017 DP
6170717*PED Jun 23, 2018
6251368 Dec 04, 2012 DP
6251368*PED Jun 04, 2013
6253762 Apr 14, 2015 DP U-582
6253762*PED Oct 14, 2015 U-582
6315173 Dec 23, 2017 DP
6315173*PED Jun 23, 2018 DP
6431168 Jun 08, 2018 DP
6431168*PED Dec 08, 2018
6435372 Jan 16, 2018 DP
6435372*PED Jul 16, 2018
6510969 Dec 23, 2017 DP
6510969*PED Jun 23, 2018 DP
6546928 Apr 14, 2015 DP U-583
6546928*PED Oct 14, 2015 U-583
6596260 Aug 10, 2014 DP
6596260*PED Feb 10, 2015
6743413 Jun 01, 2021 U-581
6743413*PED Dec 01, 2021 U-581
6938796 Jan 16, 2018 DP
6938796*PED Jul 16, 2018
6966467 Dec 23, 2017 DP
6966467*PED Jun 23, 2018
6997349 Jan 16, 2018 DP
6997349*PED Jul 16, 2018
7107986 Jun 08, 2018 DP
7107986*PED Dec 08, 2019
7143908 Jan 16, 2018 DP
7143908*PED Jul 16, 2018
7350676 Aug 24, 2018 DP
7350676*PED Feb 24, 2019
7500444 Jan 04, 2025 DP
7500444*PED Jul 04, 2025
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR DISKUS 100/50
N021077 001 5590645 Mar 01, 2011 DP I-558 Apr 30, 2011
5590645*PED Sep 01, 2011 M-84 Mar 31, 2012
5860419 Mar 01, 2011 DP
5860419*PED Sep 01, 2011
5873360 Feb 23, 2016 DP
5873360*PED Aug 23, 2016
6032666 Mar 01, 2011 DP
6032666*PED Sep 01, 2011
6378519 Mar 01, 2011 DP
6378519*PED Sep 01, 2011
6536427 Mar 01, 2011 DP
6536427*PED Sep 01, 2011
6792945 Mar 01, 2011 DP
6792945*PED Sep 01, 2011
7225808 Mar 01, 2011 DP
7225808*PED Sep 01, 2011
7389775 Mar 01, 2011 DP
7389775*PED Sep 01, 2011
RE40045 Sep 07, 2010 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 79 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR DISKUS 250/50
N021077 002 5590645 Mar 01, 2011 DP I-558 Apr 30, 2011
5590645*PED Sep 01, 2011 M-84 Mar 31, 2012
5860419 Mar 01, 2011 DP
5860419*PED Sep 01, 2011
5873360 Feb 23, 2016 DP
5873360*PED Aug 23, 2016
6032666 Mar 01, 2011 DP
6032666*PED Sep 01, 2011
6378519 Mar 01, 2011 DP
6378519*PED Sep 01, 2011
6536427 Mar 01, 2011 DP
6536427*PED Sep 01, 2011
6792945 Mar 01, 2011 DP
6792945*PED Sep 01, 2011
7225808 Mar 01, 2011 DP
7225808*PED Sep 01, 2011
7389775 Mar 01, 2011 DP
7389775*PED Sep 01, 2011
RE40045 Sep 07, 2010 DP
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR DISKUS 500/50
N021077 003 5590645 Mar 01, 2011 DP I-558 Apr 30, 2011
5590645*PED Sep 01, 2011 M-84 Mar 31, 2012
5860419 Mar 01, 2011 DP
5860419*PED Sep 01, 2011
5873360 Feb 23, 2016 DP
5873360*PED Aug 23, 2016
6032666 Mar 01, 2011 DP
6032666*PED Sep 01, 2011
6378519 Mar 01, 2011 DP
6378519*PED Sep 01, 2011
6536427 Mar 01, 2011 DP
6536427*PED Sep 01, 2011
6792945 Mar 01, 2011 DP
6792945*PED Sep 01, 2011
7225808 Mar 01, 2011 DP
7225808*PED Sep 01, 2011
7389775 Mar 01, 2011 DP
7389775*PED Sep 01, 2011
RE40045 Sep 07, 2010 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 80 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA
N021254 001 5658549 Aug 19, 2014 DP U-738
5658549*PED Feb 19, 2015 U-738
5674472 Oct 07, 2014 DP
5674472*PED Apr 07, 2015
6143277 Apr 14, 2015 DP U-738
6161724 Jan 16, 2018 DP
6161724*PED Jul 16, 2018
6170717 Dec 23, 2017 DP
6170717*PED Jun 23, 2018
6251368 Dec 04, 2012 DP
6251368*PED Jun 04, 2013
6253762 Apr 14, 2015 DP U-738
6253762*PED Oct 14, 2015 U-738
6315173 Dec 23, 2017 DP
6315173*PED Jun 23, 2018
6431168 Jun 08, 2018 DP
6431168*PED Dec 08, 2018
6435372 Jan 16, 2018 DP
6435372*PED Jul 16, 2018
6510969 Dec 23, 2017
6510969*PED Jun 23, 2018
6524555 Apr 14, 2015 DP
6546928 Apr 14, 2015 DP
6546928*PED Oct 14, 2015
6596260 Aug 10, 2014 DP
6596260*PED Feb 10, 2015
6743413 Jun 01, 2021 U-841
6743413*PED Dec 01, 2021 U-841
6938796 Jan 16, 2018 DP
6938796*PED Jul 16, 2018
6966467 Dec 23, 2017 DP
6966467*PED Jun 23, 2018
6997349 Jan 16, 2018 DP
6997349*PED Jul 16, 2018
7107986 Jun 08, 2018 DP
7107986*PED Dec 08, 2018
7143908 Jan 16, 2018 DP
7143908*PED Jul 16, 2018
7350676 Aug 24, 2018 DP
7350676*PED Feb 24, 2019
7500444 Jan 04, 2025 DP
7500444*PED Jul 04, 2025
RE40045 Sep 07, 2010 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 81 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA
N021254 002 5658549 Aug 19, 2014 DP U-738
5658549*PED Feb 19, 2015 DP U-738
5674472 Oct 07, 2014 DP
5674472*PED Apr 07, 2015 DP
6143277 Apr 14, 2015 DP U-738
6161724 Jan 16, 2018 DP
6161724*PED Jul 16, 2018
6170717 Dec 23, 2017 DP
6170717*PED Jun 23, 2018
6251368 Dec 04, 2012 DP
6251368*PED Jun 04, 2013 DP
6253762 Apr 14, 2015 DP U-738
6253762*PED Oct 14, 2015 DP U-738
6315173 Dec 23, 2017 DP
6315173*PED Jun 23, 2018 DP
6431168 Jun 08, 2018 DP
6431168*PED Dec 08, 2018
6435372 Jan 16, 2018 DP
6435372*PED Jul 16, 2018
6510969 Dec 23, 2017 DP
6510969*PED Jun 23, 2018 DP
6524555 Apr 14, 2015 DP
6546928 Apr 14, 2015 DP
6546928*PED Oct 14, 2015 DP
6596260 Aug 10, 2014 DP
6596260*PED Feb 10, 2015
6743413 Jun 01, 2021 U-841
6743413*PED Dec 01, 2021 U-841
6938796 Jan 16, 2018 DP
6938796*PED Jul 16, 2018
6966467 Dec 23, 2017 DP
6966467*PED Jun 23, 2018
6997349 Jan 16, 2018 DP
6997349*PED Jul 16, 2018
7107986 Jun 08, 2018 DP
7107986*PED Dec 08, 2018
7143908 Jan 16, 2018 DP
7143908*PED Jul 16, 2018
7350676 Aug 24, 2018 DP
7350676*PED Feb 24, 2019
7500444 Jan 04, 2025 DP
7500444*PED Jul 04, 2025
RE40045 Sep 07, 2010 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 82 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA
N021254 003 5658549 Aug 19, 2014 DP U-738
5658549*PED Feb 19, 2015 DP U-738
5674472 Oct 07, 2014 DP
5674472*PED Apr 07, 2015 DP
6143277 Apr 14, 2015 DP U-738
6161724 Jan 16, 2018 DP
6161724*PED Jul 16, 2018
6170717 Dec 23, 2017 DP
6170717*PED Jun 23, 2018
6251368 Dec 04, 2012 DP
6251368*PED Jun 04, 2013 DP
6253762 Apr 14, 2015 DP U-738
6253762*PED Oct 14, 2015 DP U-738
6315173 Dec 23, 2017 DP
6315173*PED Jun 23, 2018 DP
6431168 Jun 08, 2018 DP
6431168*PED Dec 08, 2018
6435372 Jan 16, 2018 DP
6435372*PED Jul 16, 2018
6510969 Dec 23, 2017 DP
6510969*PED Jun 23, 2018 DP
6524555 Apr 14, 2015 DP
6546928 Apr 14, 2015 DP
6546928*PED Oct 14, 2015 DP
6596260 Aug 10, 2014 DP
6596260*PED Feb 10, 2015
6743413 Jun 01, 2021 U-841
6743413*PED Dec 01, 2021 U-841
6938796 Jan 16, 2018 DP
6938796*PED Jul 16, 2018
6966467 Dec 23, 2017 DP
6966467*PED Jun 23, 2018
6997349 Jan 16, 2018 DP
6997349*PED Jul 16, 2018
7107986 Jun 08, 2018 DP
7107986*PED Dec 08, 2018
7143908 Jan 16, 2018 DP
7143908*PED Jul 16, 2018
7350676 Aug 24, 2018 DP
7350676*PED Feb 24, 2019
7500444 Jan 04, 2025 DP
7500444*PED Jul 04, 2025
RE40045 Sep 07, 2010 DP
FLUVASTATIN SODIUM - LESCOL
N020261 001 5354772 Oct 11, 2011 U-109 PED Oct 10, 2009
5354772 Oct 11, 2011 U-413
5354772*PED Apr 11, 2012
5356896 Dec 12, 2011
5356896*PED Jun 12, 2012
FLUVASTATIN SODIUM - LESCOL
N020261 002 5354772 Oct 11, 2011 U-413 PED Oct 10, 2009
5354772 Oct 11, 2011 U-109
5354772*PED Apr 11, 2012
5356896 Dec 12, 2011
5356896*PED Jun 12, 2012
FLUVASTATIN SODIUM - LESCOL XL
N021192 001 5354772 Oct 11, 2011 U-109 PED Oct 10, 2009
5354772 Oct 11, 2011 U-413
5354772*PED Apr 11, 2012
5356896 Dec 12, 2011
5356896*PED Jun 12, 2012
6242003 Apr 13, 2020
6242003*PED Oct 13, 2020
FLUVOXAMINE MALEATE - LUVOX
N021519 001 M-83 Apr 14, 2011
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 83 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
FLUVOXAMINE MALEATE - LUVOX
N021519 002 M-83 Apr 14, 2011
FLUVOXAMINE MALEATE - LUVOX
N021519 003 M-83 Apr 14, 2011
FLUVOXAMINE MALEATE - LUVOX CR
N022033 001 7465462 May 10, 2020 DP U-929 NDF Feb 28, 2011
FLUVOXAMINE MALEATE - LUVOX CR
N022033 002 7465462 May 10, 2020 DP U-929 NDF Feb 28, 2011
FOLLITROPIN ALFA/BETA - FOLLISTIM
N020582 001 5270057 Mar 20, 2011
5767251 Jun 16, 2015
FOLLITROPIN ALFA/BETA - FOLLISTIM
N020582 002 5270057 Mar 20, 2011
5767251 Jun 16, 2015
FOLLITROPIN ALFA/BETA - FOLLISTIM AQ
N021211 001 5767251 Jun 16, 2015 DS
5929028 Jan 14, 2018 DP U-567
7563763 Aug 23, 2019 U-993
FOLLITROPIN ALFA/BETA - FOLLISTIM AQ
N021211 002 5767251 Jun 16, 2015 DS
5929028 Jan 14, 2018 DP U-567
7563763 Aug 23, 2019 U-993
FOLLITROPIN ALFA/BETA - FOLLISTIM AQ
N021211 003 7563763 Aug 23, 2019 U-993
FOLLITROPIN ALFA/BETA - FOLLISTIM AQ
N021211 004 7563763 Aug 23, 2019 U-993
FOLLITROPIN ALFA/BETA - GONAL-F
N020378 001 5767251 Jun 16, 2015 DS
FOLLITROPIN ALFA/BETA - GONAL-F
N020378 002 5767251 Jun 16, 2015 DS
FOLLITROPIN ALFA/BETA - GONAL-F
N020378 003 5767251 Jun 16, 2015 DS
FOLLITROPIN ALFA/BETA - GONAL-F
N020378 004 5767067 Jun 16, 2015 DS
5767251 Jun 16, 2015 DS
7563763 Aug 23, 2019 DP
FOLLITROPIN ALFA/BETA - GONAL-F
N020378 005 5767067 Jun 16, 2015 DS
5767251 Jun 16, 2015 DS
7563763 Aug 23, 2019 DP
FOLLITROPIN ALFA/BETA - GONAL-F
N021765 001 5767251 Jun 16, 2015 DS
FOLLITROPIN ALFA/BETA - GONAL-F
N021765 003 5767251 Jun 16, 2015 DS
FOLLITROPIN ALFA/BETA - GONAL-F RFF
N021765 002 5767067 Jun 16, 2015 DS
5767251 Jun 16, 2015 DS
FOLLITROPIN ALFA/BETA - GONAL-F RFF PEN
N021684 001 5767067 Jun 16, 2015 DS
5767251 Jun 16, 2015 DS
7446090 Aug 23, 2019 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 84 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
FOLLITROPIN ALFA/BETA - GONAL-F RFF PEN
N021684 002 5767067 Jun 16, 2015 DS
5767251 Jun 16, 2015 DS
7446090 Aug 23, 2019 DP
FOLLITROPIN ALFA/BETA - GONAL-F RFF PEN
N021684 003 5767067 Jun 16, 2015 DS
5767251 Jun 16, 2015 DS
7446090 Aug 23, 2019 DP
FOMEPIZOLE - ANTIZOL
N020696 001 7553863 Jun 30, 2027 DS DP
FOMIVIRSEN SODIUM - VITRAVENE PRESERVATIVE FREE
N020961 001 5264423 Nov 23, 2010 U-522
5276019 Jan 04, 2011 U-522
5442049 Aug 15, 2012
5595978 Aug 15, 2012 U-522
FORMOTEROL FUMARATE - FORADIL
N020831 001 6488027 Mar 08, 2019
6887459 Nov 28, 2020 U-762
FORMOTEROL FUMARATE - FORADIL CERTIHALER
N021592 001 6182655 Dec 05, 2016 DP NP Dec 15, 2009
6645466 Nov 10, 2019 DP
FORMOTEROL FUMARATE - PERFOROMIST
N022007 001 6667344 Jun 22, 2021 DP NP May 11, 2010
6814953 Jun 22, 2021 DP U-813
7348362 Jun 22, 2021 DP
7462645 Jun 22, 2021 DP U-813
FOSAMPRENAVIR CALCIUM - LEXIVA
N021548 001 6436989 Dec 24, 2017 DS DP U-257
6514953 Jul 15, 2019 DS DP U-257
FOSAMPRENAVIR CALCIUM - LEXIVA
N022116 001 6436989 Dec 24, 2017 DS DP U-257 NDF Jun 14, 2010
FOSAPREPITANT DIMEGLUMINE - EMEND
N022023 001 5512570 Mar 04, 2014 U-850 NCE Jan 25, 2013
5538982 Jul 23, 2013 U-850
5691336 Mar 04, 2014 DS DP
5716942 Feb 10, 2015 U-850
7214692 Sep 18, 2012 U-850
FOSINOPRIL SODIUM - MONOPRIL
N019915 002 5006344 Jul 10, 2009
5006344*PED Jan 10, 2010
FOSINOPRIL SODIUM - MONOPRIL
N019915 003 5006344 Jul 10, 2009
5006344*PED Jan 10, 2010
FOSINOPRIL SODIUM - MONOPRIL
N019915 004 5006344 Jul 10, 2009
5006344*PED Jan 10, 2010
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE - MONOPRIL-HCT
N020286 001 5006344 Jul 10, 2009
5006344*PED Jan 10, 2010
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE - MONOPRIL-HCT
N020286 002 5006344 Jul 10, 2009
5006344*PED Jan 10, 2010
FOSPROPOFOL DISODIUM - LUSEDRA
N022244 001 6204257 Jun 07, 2018 DS DP U-945 NCE Dec 12, 2013
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 85 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
FROVATRIPTAN SUCCINATE - FROVA
N021006 001 5464864 Nov 07, 2015 U-436
5616603 Apr 01, 2014 U-436
5637611 Jun 10, 2014 U-436
5827871 Oct 27, 2015 U-436
5962501 Dec 16, 2013 U-436
FULVESTRANT - FASLODEX
N021344 001 6774122 Jan 09, 2021 U-596
7456160 Jan 09, 2021 U-596
GABAPENTIN - NEURONTIN
N020235 001 6054482 Apr 25, 2017
6054482*PED Oct 25, 2017
GABAPENTIN - NEURONTIN
N020235 002 6054482 Apr 25, 2017
6054482*PED Oct 25, 2017
GABAPENTIN - NEURONTIN
N020235 003 6054482 Apr 25, 2017
6054482*PED Oct 25, 2017
GABAPENTIN - NEURONTIN
N020882 001 6054482 Apr 25, 2017
6054482*PED Oct 25, 2017
GABAPENTIN - NEURONTIN
N020882 002 6054482 Apr 25, 2017
6054482*PED Oct 25, 2017
GABAPENTIN - NEURONTIN
N021129 001 6054482 Apr 25, 2017
6054482*PED Oct 25, 2017
7256216 May 28, 2022 DP
7256216*PED Nov 28, 2022
GADOBENATE DIMEGLUMINE - MULTIHANCE
N021357 001 4916246 Apr 10, 2012 DS NCE Nov 23, 2009
GADOBENATE DIMEGLUMINE - MULTIHANCE
N021357 002 4916246 Apr 10, 2012 DS NCE Nov 23, 2009
GADOBENATE DIMEGLUMINE - MULTIHANCE
N021357 003 4916246 Apr 10, 2012 DS NCE Nov 23, 2009
GADOBENATE DIMEGLUMINE - MULTIHANCE
N021357 004 4916246 Apr 10, 2012 DS NCE Nov 23, 2009
GADOBENATE DIMEGLUMINE - MULTIHANCE MULTIPACK
N021358 001 4916246 Apr 10, 2012 DS NCE Nov 23, 2009
GADOBENATE DIMEGLUMINE - MULTIHANCE MULTIPACK
N021358 002 4916246 Apr 10, 2012 DS NCE Nov 23, 2009
GADODIAMIDE - OMNISCAN
N020123 001 5362475 Nov 08, 2011 DS
5560903 Oct 01, 2013 DP
GADODIAMIDE - OMNISCAN
N022066 001 5560903 Oct 01, 2013 DP
GADODIAMIDE - OMNISCAN
N022066 002 5362475 Nov 08, 2011 DS
5560903 Oct 01, 2013 DP
GADOFOSVESET TRISODIUM - ABLAVAR
N021711 001 NCE Dec 22, 2013
GADOFOSVESET TRISODIUM - ABLAVAR
N021711 002 NCE Dec 22, 2013
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 86 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
GADOPENTETATE DIMEGLUMINE - MAGNEVIST
N019596 001 5362475 Nov 08, 2011
5560903 Oct 01, 2013
GADOPENTETATE DIMEGLUMINE - MAGNEVIST
N021037 001 5362475 Nov 08, 2011
5560903 Oct 01, 2013
GADOTERIDOL - PROHANCE
N020131 001 5474756 Dec 12, 2012 U-480
5846519 Dec 08, 2015
6143274 Dec 12, 2012 U-480
GADOTERIDOL - PROHANCE MULTIPACK
N021489 001 5474756 Dec 12, 2012 U-536
5846519 Dec 08, 2015
6143274 Dec 12, 2012 U-536
GADOVERSETAMIDE - OPTIMARK
N020937 001 5130120 Jul 14, 2009
5137711 Jul 14, 2009
GADOVERSETAMIDE - OPTIMARK
N020937 002 5130120 Jul 14, 2009
5137711 Jul 14, 2009
GADOVERSETAMIDE - OPTIMARK
N020937 003 5130120 Jul 14, 2009
5137711 Jul 14, 2009
GADOVERSETAMIDE - OPTIMARK
N020937 004 5130120 Jul 14, 2009
5137711 Jul 14, 2009
GADOVERSETAMIDE - OPTIMARK
N020975 001 5130120 Jul 14, 2009
5137711 Jul 14, 2009
GADOVERSETAMIDE - OPTIMARK IN PLASTIC CONTAINER
N020976 001 5130120 Jul 14, 2009
5137711 Jul 14, 2009
GADOXETATE DISODIUM - EOVIST
N022090 001 NCE Jul 03, 2013
GALANTAMINE HYDROBROMIDE - RAZADYNE
N021169 001 6099863 Jun 06, 2017
6358527 Jun 06, 2017 DP U-322
GALANTAMINE HYDROBROMIDE - RAZADYNE
N021169 002 6099863 Jun 06, 2017
6358527 Jun 06, 2017 DP U-322
GALANTAMINE HYDROBROMIDE - RAZADYNE
N021169 003 6099863 Jun 06, 2017
6358527 Jun 06, 2017 DP U-322
GALANTAMINE HYDROBROMIDE - RAZADYNE ER
N021615 001 7160559 Dec 20, 2019 DP
GALANTAMINE HYDROBROMIDE - RAZADYNE ER
N021615 002 7160559 Dec 20, 2019 DP
GALANTAMINE HYDROBROMIDE - RAZADYNE ER
N021615 003 7160559 Dec 20, 2019 DP
GANCICLOVIR - VITRASERT
N020569 001 5378475 Jan 03, 2012
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 87 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
GANCICLOVIR - ZIRGAN
N022211 001 NDF Sep 15, 2012
ODE Sep 15, 2016
GANIRELIX ACETATE - GANIRELIX ACETATE INJECTION
N021057 001 4801577 Feb 05, 2012 DS DP
5767082 Jun 16, 2015
GATIFLOXACIN - ZYMAR
N021493 001 4980470 Dec 15, 2009 DS DP
4980470*PED Jun 15, 2010
5880283 Dec 05, 2015
5880283*PED Jun 05, 2016
6333045 Aug 20, 2019 DP
6333045*PED Feb 20, 2020
GEFITINIB - IRESSA
N021399 001 5457105 Jan 19, 2013
5616582 Jan 19, 2013
5770599 May 05, 2017 DS DP U-881
GEMCITABINE HYDROCHLORIDE - GEMZAR
N020509 001 4808614 May 15, 2010 DS I-499 Jul 14, 2009
4808614*PED Nov 15, 2010
5464826 Nov 07, 2012 U-146
5464826*PED May 07, 2013
GEMCITABINE HYDROCHLORIDE - GEMZAR
N020509 002 4808614 May 15, 2010 DS I-499 Jul 14, 2009
4808614*PED Nov 15, 2010
5464826 Nov 07, 2012 U-146
5464826*PED May 07, 2013
GEMIFLOXACIN MESYLATE - FACTIVE
N021158 001 5633262 Jun 15, 2015 D-106 May 01, 2010
5776944 Apr 04, 2017 DS DP
5962468 Jun 15, 2015 U-282
6262071 Sep 21, 2019 U-513
6331550 Sep 21, 2019 U-511
6340689 Sep 14, 2019 U-512
6455540 Sep 21, 2019 U-511
6723734 Mar 20, 2018 DS DP
6803376 Sep 21, 2019 DS DP U-609
6803376 Sep 21, 2019 DS DP U-608
GEMTUZUMAB OZOGAMICIN - MYLOTARG
N021174 001 5585089 Dec 17, 2013
5606040 Feb 25, 2014
5693762 Dec 02, 2014
5739116 Apr 14, 2015
5767285 Jun 16, 2015
5773001 Jun 30, 2015 U-320
GLATIRAMER ACETATE - COPAXONE
N020622 001 5981589 May 24, 2014 I-594 Feb 27, 2012
6054430 May 24, 2014
6342476 May 24, 2014 U-441
6362161 May 24, 2014 U-441
6620847 May 24, 2014 DS
6939539 May 24, 2014 DS
7199098 May 24, 2014 DS
GLATIRAMER ACETATE - COPAXONE
N020622 002 5981589 May 24, 2014 I-594 Feb 27, 2012
6054430 May 24, 2014
6342476 May 24, 2014 U-441
6362161 May 24, 2014 U-441
6620847 May 24, 2014 DS
6939539 May 24, 2014 DS
7199098 May 24, 2014 DS
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 88 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE - DUETACT
N021925 001 4687777 Jan 17, 2011 DS
6150383 Jun 19, 2016 U-753
6211205 Jun 19, 2016 U-753
6303640 Aug 09, 2016 U-753
6329404 Jun 19, 2016 DP U-753
7538125 Jun 19, 2016 DP
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE - DUETACT
N021925 002 4687777 Jan 17, 2011 DS
6150383 Jun 19, 2016 U-753
6211205 Jun 19, 2016 U-753
6303640 Aug 09, 2016 U-753
6329404 Jun 19, 2016 DP U-753
7538125 Jun 19, 2016 DP
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N021700 001 5002953 Sep 17, 2011 DS DP U-690
5002953 Sep 17, 2011 DS DP U-781
5002953*PED Mar 17, 2012 U-781
5741803 Apr 21, 2015 DS DP U-690
5741803 Apr 21, 2015 DS DP U-781
5741803*PED Oct 21, 2015
7358366 Apr 19, 2020 DS
7358366*PED Oct 19, 2020
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N021700 002 5002953 Sep 17, 2011 DS DP U-781
5002953 Sep 17, 2011 DS DP U-690
5002953*PED Mar 17, 2012
5741803 Apr 21, 2015 DS DP U-781
5741803 Apr 21, 2015 DS DP U-690
5741803*PED Oct 21, 2015
7358366 Apr 19, 2020 DS
7358366*PED Oct 19, 2020
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N021700 003 5002953 Sep 17, 2011 DS DP U-690
5002953 Sep 17, 2011 DS DP U-781
5002953*PED Mar 17, 2012
5741803 Apr 21, 2015 DS DP U-690
5741803 Apr 21, 2015 DS DP U-781
5741803*PED Oct 21, 2015
7358366 Apr 19, 2020 DS
7358366*PED Oct 19, 2020
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N021700 004 5002953 Sep 17, 2011 DS DP U-840
5002953*PED Mar 17, 2012
7358366 Apr 19, 2020 DS
7358366*PED Oct 19, 2020
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N021700 005 5002953 Sep 17, 2011 DS DP U-840
5002953*PED Mar 17, 2012
7358366 Apr 19, 2020 DS
7358366*PED Oct 19, 2020
GLIPIZIDE - GLUCOTROL XL
N020329 001 5024843 Sep 05, 2009
5091190 Sep 05, 2009 U-111
5591454 Jan 07, 2014 U-150
GLIPIZIDE - GLUCOTROL XL
N020329 002 5024843 Sep 05, 2009
5091190 Sep 05, 2009 U-111
5591454 Jan 07, 2014 U-150
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 89 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
GLIPIZIDE - GLUCOTROL XL
N020329 003 5024843 Sep 05, 2009
5091190 Sep 05, 2009 U-111
5591454 Jan 07, 2014 U-111
GLUTAMINE - NUTRESTORE
N021667 001 5288703 Oct 07, 2011 U-898 ODE Jun 10, 2011
GLYBURIDE; METFORMIN HYDROCHLORIDE - GLUCOVANCE
N021178 001 6303146 Jul 14, 2019 U-412
6303146*PED Jan 14, 2020 U-412
GLYBURIDE; METFORMIN HYDROCHLORIDE - GLUCOVANCE
N021178 002 6303146 Jul 14, 2019 U-412
6303146*PED Jan 14, 2020 U-412
GLYBURIDE; METFORMIN HYDROCHLORIDE - GLUCOVANCE
N021178 003 6303146 Jul 14, 2019 U-412
6303146*PED Jan 14, 2020 U-412
GLYCOPYRROLATE - ROBINUL
N012827 001 7091236 Apr 24, 2024 U-877
GLYCOPYRROLATE - ROBINUL FORTE
N012827 002 7091236 Apr 24, 2024 U-877
GOSERELIN ACETATE - ZOLADEX
N019726 001 7118552 Apr 13, 2022 DP
7220247 Apr 09, 2022 DP
7500964 Feb 26, 2021 DP
GOSERELIN ACETATE - ZOLADEX
N020578 001 7118552 Apr 13, 2022 DP
7220247 Apr 09, 2022 DP
7500964 Feb 26, 2021 DP
GRANISETRON - SANCUSO
N022198 001 7608282 Oct 22, 2024 DP U-1011 NE Sep 12, 2011
NDF Sep 12, 2011
GRANISETRON HYDROCHLORIDE - KYTRIL
N020239 001 5952340 Sep 14, 2016 U-519
6294548 May 04, 2019
GRANISETRON HYDROCHLORIDE - KYTRIL
N020239 002 5952340 Sep 14, 2016 U-519
6294548 May 04, 2019
GRANISETRON HYDROCHLORIDE - KYTRIL
N020239 004 5952340 Sep 14, 2016 U-519
6294548 May 04, 2019
GREPAFLOXACIN HYDROCHLORIDE - RAXAR
N020695 001 5563138 Oct 08, 2013
GUAIFENESIN - MUCINEX
N021282 001 6372252 Apr 28, 2020 U-489
6955821 Apr 28, 2020 DP U-489
GUAIFENESIN - MUCINEX
N021282 002 6372252 Apr 28, 2020 U-489
6955821 Apr 28, 2020 DP U-489
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE - MUCINEX D
N021585 001 6372252 Apr 28, 2020 DP
6955821 Apr 28, 2020 DP U-686
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE - MUCINEX D
N021585 002 6372252 Apr 28, 2020 DP
6955821 Apr 28, 2020 DP U-686
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 90 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
GUANFACINE HYDROCHLORIDE - INTUNIV
N022037 001 5854290 Sep 21, 2015 U-494 NP Sep 02, 2012
6287599 Dec 20, 2020 DP
6811794 Jul 04, 2022 DP U-494
GUANFACINE HYDROCHLORIDE - INTUNIV
N022037 002 5854290 Sep 21, 2015 U-494 NP Sep 02, 2012
6287599 Dec 20, 2020 DP
6811794 Jul 04, 2022 DP U-494
GUANFACINE HYDROCHLORIDE - INTUNIV
N022037 003 5854290 Sep 21, 2015 U-494 NP Sep 02, 2012
6287599 Dec 20, 2020 DP
6811794 Jul 04, 2022 DP U-494
GUANFACINE HYDROCHLORIDE - INTUNIV
N022037 004 5854290 Sep 21, 2015 U-494 NP Sep 02, 2012
6287599 Dec 20, 2020 DP
6811794 Jul 04, 2022 DP U-494
HISTRELIN ACETATE - SUPPRELIN LA
N022058 001 5266325 Nov 30, 2010 DP NP May 03, 2010
5292515 Mar 08, 2011 DP ODE May 03, 2014
HISTRELIN ACETATE - VANTAS
N021732 001 5266325 Nov 30, 2010 DP
5292515 Mar 08, 2011 DP
HYALURONIDASE - AMPHADASE
N021665 001 NCE Oct 26, 2009
HYALURONIDASE - HYDASE
N021716 001 NCE Oct 25, 2010
HYALURONIDASE RECOMBINANT HUMAN - HYLENEX RECOMBINANT
N021859 001 NCE Dec 02, 2010
HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE - BIDIL
N020727 001 6465463 Sep 08, 2020 U-71
6784177 Sep 08, 2020 U-71
HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE
N020758 001 5270317 Sep 30, 2011 I-549 Nov 16, 2010
5270317*PED Mar 30, 2012
5994348 Jun 07, 2015
5994348*PED Dec 07, 2015
HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE
N020758 002 5270317 Sep 30, 2011 I-549 Nov 16, 2010
5270317*PED Mar 30, 2012
5994348 Jun 07, 2015
5994348*PED Dec 07, 2015
HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE
N020758 003 5270317 Sep 30, 2011 I-549 Nov 16, 2010
5270317*PED Mar 30, 2012
5994348 Jun 07, 2015
5994348*PED Dec 07, 2015
HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE
N020758 004 5270317 Sep 30, 2011 DS DP I-549 Nov 16, 2010
5270317*PED Mar 30, 2012
5994348 Jun 07, 2015 DP
5994348*PED Dec 07, 2015
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 91 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM - HYZAAR
N020387 001 5138069 Aug 11, 2009 DS
5138069*PED Feb 11, 2010
5153197 Oct 06, 2009 DP U-3
5153197 Oct 06, 2009 DP U-538
5153197*PED Apr 06, 2010 U-3
5153197*PED Apr 06, 2010 U-538
5608075 Mar 04, 2014 Y
5608075*PED Sep 04, 2014
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM - HYZAAR
N020387 002 5138069 Aug 11, 2009 DS
5138069*PED Feb 11, 2010
5153197 Oct 06, 2009 DP U-3
5153197 Oct 06, 2009 DP U-538
5153197*PED Apr 06, 2010 U-3
5153197*PED Apr 06, 2010 U-538
5608075 Mar 04, 2014 Y
5608075*PED Sep 04, 2014
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM - HYZAAR
N020387 003 5138069 Aug 11, 2009 DS
5138069*PED Feb 11, 2010
5153197 Oct 08, 2009 DP U-538
5153197 Oct 08, 2009 DP U-3
5153197*PED Apr 06, 2010
HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE - DUTOPROL
N021956 001 NC Aug 28, 2009
HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE - DUTOPROL
N021956 002 NC Aug 28, 2009
HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE - DUTOPROL
N021956 003 NC Aug 28, 2009
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - BENICAR HCT
N021532 002 5616599 Apr 25, 2016 DS DP U-500
5616599*PED Oct 25, 2016
6878703 Nov 19, 2021 U-3
6878703*PED May 19, 2022
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - BENICAR HCT
N021532 003 5616599 Apr 25, 2016 DS DP U-500
5616599*PED Oct 25, 2016
6878703 Nov 19, 2021 U-3
6878703*PED May 19, 2022
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - BENICAR HCT
N021532 005 5616599 Apr 25, 2016 DS DP U-500
5616599*PED Oct 25, 2016
6878703 Nov 19, 2021 U-3
6878703*PED May 19, 2022
HYDROCHLOROTHIAZIDE; TELMISARTAN - MICARDIS HCT
N021162 001 5591762 Jan 07, 2014 DS DP U-3
6358986 Jan 10, 2020
HYDROCHLOROTHIAZIDE; TELMISARTAN - MICARDIS HCT
N021162 002 5591762 Jan 07, 2014 DS DP U-3
6358986 Jan 10, 2020
HYDROCHLOROTHIAZIDE; TELMISARTAN - MICARDIS HCT
N021162 003 5591762 Jan 07, 2014 DS DP U-3
HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT
N020818 001 5399578 Mar 21, 2012 U-3 I-567 Jul 31, 2011
5399578*PED Sep 21, 2012
6294197 Jun 18, 2017 U-3
6294197*PED Dec 18, 2017
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 92 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT
N020818 002 5399578 Mar 21, 2012 U-3 I-567 Jul 31, 2011
5399578*PED Sep 21, 2012
6294197 Jun 18, 2017 U-3
6294197*PED Dec 18, 2017
HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT
N020818 003 5399578 Mar 21, 2012 U-3 I-567 Jul 31, 2011
5399578*PED Sep 21, 2012
6294197 Jun 18, 2017 U-3
6294197*PED Dec 18, 2017
HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT
N020818 004 5399578 Mar 21, 2012 U-3 I-567 Jul 31, 2011
5399578*PED Sep 21, 2012
6294197 Jun 18, 2017 U-3
6294197*PED Dec 18, 2017
HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT
N020818 005 5399578 Mar 21, 2012 U-3 I-567 Jul 31, 2011
5399578*PED Sep 21, 2012
6294197 Jun 18, 2017 U-3
6294197*PED Dec 18, 2017
HYDROCODONE BITARTRATE; IBUPROFEN - VICOPROFEN
N020716 001 6348216 Jun 10, 2017
6599531 Jun 10, 2017
HYDROCORTISONE BUTYRATE - LOCOID
N022076 001 7378405 Dec 19, 2026 DP NDF May 18, 2010
HYDROCORTISONE BUTYRATE - LOCOID LIPOCREAM
N020769 001 5635497 Jun 03, 2014 I-613 Oct 19, 2012
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N019891 001 6589960 Nov 09, 2020 DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N019892 001 6589960 Nov 09, 2020 DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N019892 002 6589960 Nov 09, 2020 DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N019892 003 6589960 Nov 09, 2020 DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID-HP
N019034 001 6589960 Nov 09, 2020 DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID-HP
N019034 002 6589960 Nov 09, 2020 DP
HYDROMORPHONE HYDROCHLORIDE - PALLADONE
N021044 001 5958452 Nov 04, 2014 DP
5965161 Nov 04, 2014 DP U-616
5968551 Dec 24, 2011 DP
6294195 Dec 24, 2011 DP
6335033 Nov 04, 2014 DP U-616
6589960 Nov 09, 2020 DP
6706281 Nov 04, 2014 DP U-616
6743442 Nov 04, 2014 DP
HYDROMORPHONE HYDROCHLORIDE - PALLADONE
N021044 002 5958452 Nov 04, 2014 DP
5965161 Nov 04, 2014 DP U-616
5968551 Dec 24, 2011 DP
6294195 Dec 24, 2011 DP
6335033 Nov 04, 2014 DP U-616
6589960 Nov 09, 2020 DP
6706281 Nov 04, 2014 DP U-616
6743442 Nov 04, 2014 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 93 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
HYDROMORPHONE HYDROCHLORIDE - PALLADONE
N021044 003 5958452 Nov 04, 2014 DP
5965161 Nov 04, 2014 DP U-616
5968551 Dec 24, 2011 DP
6294195 Dec 24, 2011 DP
6335033 Nov 04, 2014 DP U-616
6589960 Nov 09, 2020 DP
6706281 Nov 04, 2014 DP U-616
6743442 Nov 04, 2014 DP
HYDROMORPHONE HYDROCHLORIDE - PALLADONE
N021044 004 5958452 Nov 04, 2014 DP
5965161 Nov 04, 2014 DP U-616
5968551 Dec 24, 2011 DP
6294195 Dec 24, 2011 DP
6335033 Nov 04, 2014 DP U-616
6589960 Nov 09, 2020 DP
6706281 Nov 04, 2014 DP U-616
6743442 Nov 04, 2014 DP
HYDROXOCOBALAMIN - CYANOKIT
N022041 002 5834448 Nov 14, 2016 DP U-789 NP Dec 15, 2009
ODE Dec 15, 2013
IBANDRONATE SODIUM - BONIVA
N021455 001 4927814 Mar 17, 2012 DS DP U-642
4927814 Mar 17, 2012 DS DP U-700
6143326 Apr 21, 2017 U-642
6294196 Oct 07, 2019 DP
IBANDRONATE SODIUM - BONIVA
N021455 002 4927814 Mar 17, 2012 DS DP U-700
4927814 Mar 17, 2012 DS DP U-642
6294196 Oct 07, 2019 DP
7192938 May 06, 2023 U-798
7410957 May 06, 2023 U-887
IBANDRONATE SODIUM - BONIVA
N021858 001 4927814 Mar 17, 2012 DS DP U-700
5662918 Sep 02, 2014 DP
IBUPROFEN - CALDOLOR
N022348 001 6727286 Nov 27, 2021 DP U-981 NP Jun 11, 2012
IBUPROFEN - CALDOLOR
N022348 002 6727286 Nov 27, 2021 DP U-981 NP Jun 11, 2012
IBUPROFEN - CHILDREN'S MOTRIN
N020516 001 5374659 Dec 20, 2011
5374659*PED Jun 20, 2012
IBUPROFEN - CHILDREN'S MOTRIN
N020601 001 5215755 Jun 01, 2010
5215755*PED Dec 01, 2010
IBUPROFEN - CHILDREN'S MOTRIN
N020603 001 5374659 Dec 20, 2011
5374659*PED Jun 20, 2012
IBUPROFEN - JUNIOR STRENGTH MOTRIN
N020601 003 5215755 Jun 01, 2010
5215755*PED Dec 01, 2010
IBUPROFEN - MIDOL LIQUID GELS
N021472 001 6251426 Jun 25, 2018
IBUPROFEN - MOTRIN
N019842 001 5374659 Dec 20, 2011
5374659*PED Jun 20, 2012
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 94 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
IBUPROFEN - MOTRIN
N020135 001 5215755 Jun 01, 2010
5215755*PED Dec 01, 2010
5320855 Jun 14, 2011
5320855*PED Dec 14, 2011
IBUPROFEN - MOTRIN
N020135 002 5215755 Jun 01, 2010
5215755*PED Dec 01, 2010
5320855 Jun 14, 2011
5320855*PED Dec 14, 2011
IBUPROFEN LYSINE - NEOPROFEN
N021903 001 6342530 Nov 14, 2020 DS DP U-794 ODE Apr 13, 2013
6344479 Mar 20, 2021 DS DP U-794
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE - CHILDREN'S MOTRIN COLD
N021128 001 6211246 Jun 10, 2019
IBUTILIDE FUMARATE - CORVERT
N020491 001 5155268 Dec 28, 2009
ICODEXTRIN - EXTRANEAL
N021321 001 4761237 Aug 09, 2009 U-495 ODE Dec 20, 2009
6077836 Jun 20, 2017 U-495
6248726 Jun 19, 2018 U-495
ILOPERIDONE - FANAPT
N022192 001 RE39198 Nov 15, 2011 DS DP U-971 NCE May 06, 2014
ILOPERIDONE - FANAPT
N022192 002 RE39198 Nov 15, 2011 DS DP U-971 NCE May 06, 2014
ILOPERIDONE - FANAPT
N022192 003 RE39198 Nov 15, 2011 DS DP U-971 NCE May 06, 2014
ILOPERIDONE - FANAPT
N022192 004 RE39198 Nov 15, 2011 DS DP U-971 NCE May 06, 2014
ILOPERIDONE - FANAPT
N022192 005 RE39198 Nov 15, 2011 DS DP U-971 NCE May 06, 2014
ILOPERIDONE - FANAPT
N022192 006 RE39198 Nov 15, 2011 DS DP U-971 NCE May 06, 2014
ILOPERIDONE - FANAPT
N022192 007 RE39198 Nov 15, 2011 DS DP U-971 NCE May 06, 2014
ILOPROST - VENTAVIS
N021779 001 NCE Dec 29, 2009
ODE Dec 29, 2011
IMATINIB MESYLATE - GLEEVEC
N021335 001 5521184 Jan 04, 2015 DS DP PED Aug 01, 2009
5521184*PED Jul 04, 2015
6894051 May 23, 2019 DS DP U-649
6894051*PED Nov 23, 2019
6958335 Dec 19, 2021 U-791
6958335*PED Jun 19, 2022
IMATINIB MESYLATE - GLEEVEC
N021335 002 5521184 Jan 04, 2015 DS DP U-649 PED Aug 01, 2009
5521184*PED Jul 04, 2015
6894051 May 23, 2019 DS DP U-649
6894051*PED Nov 23, 2019
6958335 Dec 19, 2021 U-791
6958335*PED Jun 19, 2022
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 95 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
IMATINIB MESYLATE - GLEEVEC
N021588 001 5521184 Jan 04, 2015 DS DP I-583 Dec 19, 2011
5521184*PED Jul 04, 2015 I-510 Oct 19, 2009
6894051 May 23, 2019 DS DP U-649 I-511 Oct 19, 2009
6894051*PED Nov 23, 2019
6958335 Dec 19, 2021 U-791 I-513 Oct 19, 2009
6958335*PED Jun 19, 2022 I-512 Oct 19, 2009
7544799 Jan 16, 2019 DS DP I-514 Oct 19, 2009
7544799*PED Jul 16, 2019 ODE Oct 19, 2013
ODE Oct 19, 2013
ODE Oct 19, 2013
ODE Oct 19, 2013
ODE Oct 19, 2013
PED Aug 01, 2009
IMATINIB MESYLATE - GLEEVEC
N021588 002 5521184 Jan 04, 2015 I-583 Dec 19, 2011
5521184*PED Jul 04, 2015 I-512 Oct 19, 2009
6894051 May 23, 2019 DS DP U-649 I-513 Oct 19, 2009
6894051*PED Nov 23, 2019
6958335 Dec 19, 2021 U-791 I-511 Oct 19, 2009
6958335*PED Jun 19, 2022 I-510 Oct 19, 2009
7544799 Jan 16, 2019 DS DP I-514 Oct 19, 2009
7544799*PED Jul 16, 2019 ODE Oct 19, 2013
ODE Oct 19, 2013
ODE Oct 19, 2013
ODE Oct 19, 2013
ODE Oct 19, 2013
PED Aug 01, 2009
IMIGLUCERASE - CEREZYME
N020367 001 5549892 Aug 27, 2013 U-252
IMIGLUCERASE - CEREZYME
N020367 002 5549892 Aug 27, 2013 U-252
IMIQUIMOD - ALDARA
N020723 001 4689338 Aug 25, 2009 U-172
4689338*PED Feb 25, 2010
5238944 Aug 24, 2010
5238944*PED Feb 24, 2011
INDINAVIR SULFATE - CRIXIVAN
N020685 001 5413999 May 09, 2012 U-132
6645961 Mar 04, 2018 DP
6689761 Feb 10, 2021 U-554
INDINAVIR SULFATE - CRIXIVAN
N020685 003 5413999 May 09, 2012 U-132
6645961 Mar 04, 2018 DP
6689761 Feb 10, 2021 U-554
INDINAVIR SULFATE - CRIXIVAN
N020685 005 5413999 May 09, 2012 U-132
6645961 Mar 04, 2018 DP
6689761 Feb 10, 2021 U-554
INDINAVIR SULFATE - CRIXIVAN
N020685 006 5413999 May 09, 2012 U-132
6645961 Mar 04, 2018 DP
6689761 Feb 10, 2021 U-554
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 96 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 50/50
N021810 001 5547930 Sep 28, 2013 DS DP
5618913 Jun 07, 2014 DS DP
5618913*PED Dec 07, 2014
5834422 Sep 28, 2013 DP U-471
5840680 Sep 28, 2013 DS DP U-471
5866538 Jun 20, 2017 DP
5866538*PED Dec 20, 2017
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30
N021172 001 5547930 Sep 28, 2013
5618913 Jun 07, 2014 DS DP
5618913*PED Dec 07, 2014
5834422 Sep 28, 2013 U-471
5840680 Sep 28, 2013 U-471
5866538 Jun 19, 2017 DP
INSULIN ASPART RECOMBINANT - NOVOLOG
N020986 001 5618913 Jun 07, 2014 DS DP D-112 Mar 14, 2011
5618913*PED Dec 07, 2014
5866538 Jun 20, 2017
5866538*PED Dec 20, 2017
INSULIN DETEMIR RECOMBINANT - LEVEMIR
N021536 001 5750497 May 16, 2019 DS DP U-668 NCE Jun 16, 2010
5866538 Jun 20, 2017 DP
6011007 Feb 02, 2014 DS DP U-668
6869930 Feb 02, 2014 DS DP U-668
INSULIN GLARGINE RECOMBINANT - LANTUS
N021081 001 5656722 Aug 12, 2014 DS DP U-948
5656722*PED Feb 12, 2015
6100376 Nov 06, 2009 DS DP U-771
6100376*PED May 06, 2010
7476652 Jul 23, 2023 DP
7476652*PED Jan 23, 2024
INSULIN GLULISINE RECOMBINANT - APIDRA
N021629 001 6221633 Jun 18, 2018 DS DP U-471 NPP Oct 24, 2011
6960561 Jan 25, 2023 DP U-471
7452860 Mar 22, 2022 DP
INSULIN GLULISINE RECOMBINANT - APIDRA
N021629 002 6221633 Jun 18, 2018 DS DP U-471 NPP Oct 24, 2011
6960561 Jan 25, 2023 DP U-471
7452860 Mar 22, 2022 DP
INSULIN GLULISINE RECOMBINANT - APIDRA SOLOSTAR
N021629 003 NPP Oct 24, 2011
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT - HUMALOG MIX 50/50
N021018 001 5461031 Jun 26, 2014
5474978 Jun 16, 2014
5514646 May 07, 2013
5747642 Jun 16, 2014
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT - HUMALOG MIX 75/25
N021017 001 5461031 Jun 16, 2014
5474978 Jun 16, 2014
5514646 May 07, 2013
5747642 Jun 16, 2014
INSULIN LISPRO RECOMBINANT - HUMALOG
N020563 001 5474978 Jun 16, 2014 U-534
5514646 May 07, 2013 U-534
INSULIN LISPRO RECOMBINANT - HUMALOG PEN
N020563 002 5474978 Jun 16, 2014 U-534
5514646 May 07, 2013 U-534
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 97 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
INSULIN RECOMBINANT HUMAN - EXUBERA
N021868 001 5740794 Apr 21, 2015 DP
5997848 Mar 07, 2014 U-704
6051256 Mar 07, 2014 DP
6257233 May 14, 2019 U-704
6423344 Mar 07, 2014 DP
6543448 Sep 21, 2014 DP
6546929 May 14, 2019 U-704
6582728 Jun 24, 2020 DP
6592904 Mar 07, 2014 DP
6685967 Sep 11, 2018 DP
6737045 Mar 07, 2014 U-704
RE37872 Feb 12, 2010 DP
RE38385 Feb 12, 2010 DP
INSULIN RECOMBINANT HUMAN - EXUBERA
N021868 002 5740794 Apr 21, 2015 DP
5997848 Mar 07, 2014 U-704
6051256 Mar 07, 2014 DP
6257233 May 14, 2019 U-704
6423344 Mar 07, 2014 DP
6543448 Sep 21, 2014 DP
6546929 May 14, 2019 U-704
6582728 Jun 24, 2020 DP
6592904 Mar 07, 2014 DP
6685967 Sep 11, 2018 DP
6737045 Mar 07, 2014 U-704
RE37872 Feb 12, 2010 DP
RE38385 Feb 12, 2010 DP
IOBENGUANE SULFATE I 123 - ADREVIEW
N022290 001 NCE Sep 19, 2013
ODE Sep 19, 2015
IODINE POVACRYLEX; ISOPROPYL ALCOHOL - DURAPREP
N021586 001 NC Sep 29, 2009
IODINE POVACRYLEX; ISOPROPYL ALCOHOL - DURAPREP
N021586 002 NC Sep 29, 2009
IODIXANOL - VISIPAQUE 270
N020351 001 5349085 Sep 20, 2011
5366722 Nov 22, 2011 DP
RE36418 Jul 12, 2011 DP
IODIXANOL - VISIPAQUE 270
N020808 001 5349085 Sep 20, 2011
5366722 Nov 22, 2011 DP
RE36418 Jul 12, 2011 DP
IODIXANOL - VISIPAQUE 320
N020351 002 5349085 Sep 20, 2011
RE36418 Jul 12, 2011 DP
IODIXANOL - VISIPAQUE 320
N020808 002 5349085 Sep 20, 2011
RE36418 Jul 12, 2011 DP
IOPROMIDE - ULTRAVIST (PHARMACY BULK)
N021425 002 I-619 Dec 30, 2012
IOPROMIDE - ULTRAVIST 370
N020220 001 I-619 Dec 30, 2012
IOXILAN - OXILAN-300
N020316 001 4954348 Dec 21, 2009
IOXILAN - OXILAN-350
N020316 002 4954348 Dec 21, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 98 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
IPRATROPIUM BROMIDE - ATROVENT HFA
N021527 001 5676930 Oct 14, 2014 DP
5683677 Nov 04, 2014 DP
5695743 Jul 06, 2010 DP U-610
5766573 Nov 28, 2009 U-610
6739333 May 26, 2020 DP
6983743 May 26, 2020 DP
IRBESARTAN - AVAPRO
N020757 001 5270317 Sep 30, 2011
5270317*PED Mar 30, 2012
6342247 Jun 07, 2015
6342247*PED Dec 07, 2015
IRBESARTAN - AVAPRO
N020757 002 5270317 Sep 30, 2011
5270317*PED Mar 30, 2012
6342247 Jun 07, 2015
6342247*PED Dec 07, 2015
IRBESARTAN - AVAPRO
N020757 003 5270317 Sep 30, 2011
5270317*PED Mar 30, 2012
6342247 Jun 07, 2015
6342247*PED Dec 07, 2015
IRINOTECAN HYDROCHLORIDE - CAMPTOSAR
N020571 001 6403569 Apr 28, 2020 U-449
6403569*PED Oct 28, 2020
6794370 May 01, 2020 U-606
6794370*PED Nov 01, 2020
IRINOTECAN HYDROCHLORIDE - CAMPTOSAR
N020571 002 6403569 Apr 28, 2020 U-449
6403569*PED Oct 28, 2020
6794370 May 01, 2020 U-606
6794370*PED Nov 01, 2020
IRON DEXTRAN - DEXFERRUM
A040024 001 5624668 Sep 29, 2015
ITRACONAZOLE - SPORANOX
N020083 001 5633015 May 27, 2014
ITRACONAZOLE - SPORANOX
N020657 001 5707975 Jan 13, 2015
6407079 Jun 18, 2019
ITRACONAZOLE - SPORANOX
N020966 001 6407079 Jun 18, 2019
IXABEPILONE - IXEMPRA KIT
N022065 001 6605599 May 26, 2018 DS DP U-961 NCE Oct 16, 2012
6670384 Jan 23, 2022 DP U-959
6670384 Jan 23, 2022 DP U-960
7022330 Jan 23, 2022 DP U-958
7125899 May 26, 2018 DS DP U-957
7312237 Aug 21, 2024 U-965
IXABEPILONE - IXEMPRA KIT
N022065 002 6605599 May 26, 2018 DS DP U-961 NCE Oct 16, 2012
6670384 Jan 23, 2022 DP U-960
6670384 Jan 23, 2022 DP U-959
7022330 Jan 23, 2022 DP U-958
7125899 May 26, 2018 DS DP U-957
7312237 Aug 21, 2024 U-965
KETOCONAZOLE - EXTINA
N021738 001 7553835 Oct 19, 2018 DP U-245 NDF Jun 12, 2010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 99 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
KETOCONAZOLE - NIZORAL A-D
N020310 001 5456851 Apr 07, 2014
KETOCONAZOLE - XOLEGEL
N021946 001 7179475 Dec 04, 2018 DP U-792 NDF Jul 28, 2009
KETOROLAC TROMETHAMINE - ACULAR
N019700 001 5110493*PED Nov 05, 2009 U-75
KETOROLAC TROMETHAMINE - ACULAR LS
N021528 001 5110493*PED Nov 05, 2009
KETOROLAC TROMETHAMINE - ACUVAIL
N022427 001 NP Jul 22, 2012
LACOSAMIDE - VIMPAT
N022253 001 5654301 Aug 05, 2014 DS DP U-914 NCE Oct 28, 2013
RE38551 Mar 17, 2017 DS DP U-914
LACOSAMIDE - VIMPAT
N022253 002 5654301 Aug 05, 2014 DS DP U-914 NCE Oct 28, 2013
RE38551 Mar 17, 2017 DS DP U-914
LACOSAMIDE - VIMPAT
N022253 003 5654301 Aug 05, 2014 DS DP U-914 NCE Oct 28, 2013
RE38551 Mar 17, 2017 DS DP U-914
LACOSAMIDE - VIMPAT
N022253 004 5654301 Aug 05, 2014 DS DP U-914 NCE Oct 28, 2013
RE38551 Mar 17, 2017 DS DP U-914
LACOSAMIDE - VIMPAT
N022254 001 5654301 Aug 05, 2014 DS DP U-911 NCE Oct 28, 2013
RE38551 Mar 17, 2017 DS DP U-911
LAMIVUDINE - EPIVIR
N020564 001 5047407 Nov 17, 2009 DS DP U-257
5047407*PED May 17, 2010
5905082 May 18, 2016 DS DP U-248
5905082*PED Nov 18, 2016
7119202*PED Aug 08, 2009
LAMIVUDINE - EPIVIR
N020564 003 5047407 Nov 17, 2009
5047407*PED May 17, 2010
5905082 May 18, 2016
5905082*PED Nov 18, 2016
7119202*PED Aug 08, 2009
LAMIVUDINE - EPIVIR
N020596 001 5047407 Nov 17, 2009
5047407*PED May 17, 2010
6004968 Mar 20, 2018
6004968*PED Sep 20, 2018
7119202*PED Aug 08, 2009
LAMIVUDINE - EPIVIR-HBV
N021003 001 5047407 Nov 17, 2009
5047407*PED May 17, 2010
5905082 May 18, 2016
5905082*PED Nov 18, 2016
7119202*PED Aug 08, 2009
RE39155 Jul 02, 2013 U-250
RE39155*PED Jan 02, 2014
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 100 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
LAMIVUDINE - EPIVIR-HBV
N021004 001 5047407 Nov 17, 2009
5047407*PED May 17, 2010
6004968 Mar 20, 2018
6004968*PED Sep 20, 2018
7119202*PED Aug 08, 2009
RE39155 Jul 02, 2013 U-250
RE39155*PED Jan 02, 2014
LAMIVUDINE; ZIDOVUDINE - COMBIVIR
N020857 001 5047407 Nov 17, 2009 DS DP U-248
5047407*PED May 17, 2010
5859021 May 15, 2012 DS DP U-248
5905082 May 18, 2016 DS DP U-248
5905082*PED Nov 18, 2016 U-248
7119202*PED Aug 08, 2009
LAMOTRIGINE - LAMICTAL
N020241 001 I-516 Sep 22, 2009
PED Mar 22, 2010
LAMOTRIGINE - LAMICTAL
N020241 002 I-516 Sep 22, 2009
PED Mar 22, 2010
LAMOTRIGINE - LAMICTAL
N020241 003 I-516 Sep 22, 2009
PED Mar 22, 2010
LAMOTRIGINE - LAMICTAL
N020241 004 I-516 Sep 22, 2009
PED Mar 22, 2010
LAMOTRIGINE - LAMICTAL
N020241 005 I-516 Sep 22, 2009
PED Mar 22, 2010
LAMOTRIGINE - LAMICTAL
N020241 006 I-516 Sep 22, 2009
PED Mar 22, 2010
LAMOTRIGINE - LAMICTAL CD
N020764 001 5698226 Jan 29, 2012 I-516 Sep 22, 2009
5698226*PED Jul 29, 2012 PED Mar 22, 2010
LAMOTRIGINE - LAMICTAL CD
N020764 002 5698226 Jan 29, 2012 I-516 Sep 22, 2009
5698226*PED Jul 29, 2012 PED Mar 22, 2010
LAMOTRIGINE - LAMICTAL CD
N020764 003 5698226 Jan 29, 2012 I-516 Sep 22, 2009
5698226*PED Jul 29, 2012 PED Mar 22, 2010
LAMOTRIGINE - LAMICTAL CD
N020764 004 5698226 Jan 29, 2012 I-516 Sep 22, 2009
5698226*PED Jul 29, 2012 PED Mar 22, 2010
LAMOTRIGINE - LAMICTAL XR
N022115 001 NDF May 29, 2012
LAMOTRIGINE - LAMICTAL XR
N022115 002 NDF May 29, 2012
LAMOTRIGINE - LAMICTAL XR
N022115 003 NDF May 29, 2012
LAMOTRIGINE - LAMICTAL XR
N022115 004 NDF May 29, 2012
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 101 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
LANREOTIDE ACETATE - SOMATULINE DEPOT
N022074 001 5595760 Mar 08, 2015 DP U-831 NCE Aug 30, 2012
ODE Aug 30, 2014
LANREOTIDE ACETATE - SOMATULINE DEPOT
N022074 002 5595760 Mar 08, 2015 DP U-831 NCE Aug 30, 2012
ODE Aug 30, 2014
LANREOTIDE ACETATE - SOMATULINE DEPOT
N022074 003 5595760 Mar 08, 2015 DP U-831 NCE Aug 30, 2012
ODE Aug 30, 2014
LANSOPRAZOLE - PREVACID
N020406 001 4628098*PED Nov 10, 2009 M-85 Oct 28, 2011
5013743 Feb 12, 2010 U-452 PED Apr 28, 2012
5013743*PED Aug 12, 2010
LANSOPRAZOLE - PREVACID
N020406 002 4628098*PED Nov 10, 2009 M-85 Oct 28, 2011
5013743 Feb 12, 2010 U-452 PED Apr 28, 2012
5013743*PED Aug 12, 2010
LANSOPRAZOLE - PREVACID
N021281 001 4628098*PED Nov 10, 2009 M-85 Oct 28, 2011
5013743 Feb 12, 2010 U-452 PED Apr 28, 2012
5013743*PED Aug 12, 2010
LANSOPRAZOLE - PREVACID
N021281 002 4628098*PED Nov 10, 2009 M-85 Oct 28, 2011
5013743 Feb 12, 2010 U-452 PED Apr 28, 2012
5013743*PED Aug 12, 2010
LANSOPRAZOLE - PREVACID
N021428 001 4628098*PED Nov 10, 2009 M-85 Oct 28, 2011
5013743 Feb 12, 2010 U-452 PED Apr 28, 2012
5013743*PED Aug 12, 2010
5464632 Nov 07, 2012
5464632*PED May 07, 2013
6328994 May 17, 2019
6328994*PED Nov 17, 2019
7399485 May 26, 2018 DP
7399485*PED Nov 26, 2018
7431942 May 17, 2019 DP
7431942*PED Nov 17, 2019
LANSOPRAZOLE - PREVACID
N021428 002 4628098*PED Nov 10, 2009 M-85 Oct 28, 2011
5013743 Feb 12, 2010 U-452 PED Apr 28, 2012
5013743*PED Aug 12, 2010
5464632 Nov 07, 2012
5464632*PED May 07, 2013
6328994 May 17, 2019
6328994*PED Nov 17, 2019
7399485 May 26, 2018 DP
7399485*PED Nov 26, 2018
7431942 May 17, 2019 DP
7431942*PED Nov 17, 2019
LANSOPRAZOLE - PREVACID 24 HR
N022327 001 NP May 18, 2012
LANSOPRAZOLE - PREVACID IV
N021566 001 4628098*PED Nov 10, 2009
7396841 Aug 17, 2021 DP U-947
7396841*PED Feb 17, 2022
LANSOPRAZOLE; NAPROXEN - PREVACID NAPRAPAC 500 (COPACKAGED)
N021507 004 4628098*PED Nov 10, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 102 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
LANTHANUM CARBONATE - FOSRENOL
N021468 001 5968976 Oct 26, 2018 DP U-613 NCE Oct 26, 2009
7381428 Aug 26, 2024 U-890
7465465 Aug 26, 2024 DP
LANTHANUM CARBONATE - FOSRENOL
N021468 002 5968976 Oct 26, 2018 DP U-613 NCE Oct 26, 2009
7381428 Aug 26, 2024 U-890
7465465 Aug 26, 2024 DP
LANTHANUM CARBONATE - FOSRENOL
N021468 003 5968976 Oct 26, 2018 DP U-613 NCE Oct 26, 2009
7381428 Aug 26, 2024 U-890
7465465 Aug 26, 2024 DP
LANTHANUM CARBONATE - FOSRENOL
N021468 004 5968976 Oct 26, 2018 DP U-613 NCE Oct 26, 2009
7381428 Aug 26, 2024 U-890
7465465 Aug 26, 2024 DP
LAPATINIB DITOSYLATE - TYKERB
N022059 001 6391874 Jul 11, 2017 DS DP U-800 NCE Mar 13, 2012
6713485 Jan 08, 2019 DS DP U-800
6727256 Jan 08, 2019 DS DP U-800
6828320 Jul 11, 2017 U-800
7157466 Nov 19, 2021 DS DP
LATANOPROST - XALATAN
N020597 001 5296504 Mar 22, 2011 DP U-778
5422368 Mar 22, 2011 DP U-778 Y
6429226 Sep 06, 2009 DP U-778
7163959 Jun 19, 2010 DS
LENALIDOMIDE - REVLIMID
N021880 001 5635517 Oct 04, 2019 DS U-866 NCE Dec 27, 2010
6045501 Aug 28, 2018 U-694 ODE Jun 29, 2013
6281230 Jul 24, 2016 U-769 ODE Dec 27, 2012
6315720 Oct 23, 2020 U-694
6555554 Jul 24, 2016 DP
6561976 Aug 28, 2018 U-694
6561977 Oct 23, 2020 U-694
6755784 Oct 23, 2020 U-694
6908432 Aug 28, 2018 U-694
7119106 Jul 24, 2016 DP
7189740 Apr 11, 2023 U-769
7465800 Apr 22, 2026 DS DP
LENALIDOMIDE - REVLIMID
N021880 002 5635517 Oct 04, 2019 DS U-866 NCE Dec 27, 2010
6045501 Aug 28, 2018 U-694 ODE Jun 29, 2013
6281230 Jul 24, 2016 U-769 ODE Dec 27, 2012
6315720 Oct 23, 2020 U-694
6555554 Jul 24, 2016 DP
6561976 Aug 28, 2018 U-694
6561977 Oct 23, 2020 U-694
6755784 Oct 23, 2020 U-694
6908432 Aug 28, 2018 U-694
7119106 Jul 24, 2016 DP
7189740 Apr 11, 2023 U-769
7465800 Apr 22, 2026 DS DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 103 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
LENALIDOMIDE - REVLIMID
N021880 003 5635517 Oct 04, 2019 DS U-866 NCE Dec 27, 2010
6045501 Aug 28, 2018 U-694 ODE Jun 29, 2013
6281230 Jul 24, 2016 U-769
6315720 Oct 23, 2020 U-694
6555554 Jul 24, 2016 DP
6561976 Aug 28, 2018 U-694
6561977 Oct 23, 2020 U-694
6755784 Oct 23, 2020 U-694
6908432 Aug 28, 2018 U-694
7119106 Jul 24, 2016 DP
7189740 Apr 11, 2023 U-769
7465800 Apr 22, 2026 DS DP
LENALIDOMIDE - REVLIMID
N021880 004 5635517 Oct 04, 2019 DS U-866 NCE Dec 27, 2010
6045501 Aug 28, 2018 U-694 ODE Jun 29, 2013
6281230 Jul 24, 2016 U-769
6315720 Oct 23, 2020 U-694
6555554 Jul 24, 2016 DP
6561976 Aug 28, 2018 U-694
6561977 Oct 23, 2020 U-694
6755784 Oct 23, 2020 U-694
6908432 Aug 28, 2018 U-694
7119106 Jul 24, 2016 DP
7189740 Apr 11, 2023 U-769
7465800 Apr 22, 2026 DS DP
LEPIRUDIN RECOMBINANT - REFLUDAN
N020807 001 5180668 Jan 19, 2010
LETROZOLE - FEMARA
N020726 001 4978672 Jun 03, 2011 U-203
LEUPROLIDE ACETATE - ELIGARD
N021343 001 5278201 Jan 11, 2011
5324519 Oct 20, 2011
5599552 Feb 04, 2014
6395293 Sep 28, 2013 DP U-801
6565874 Oct 28, 2018 DP U-801
6626870 Mar 27, 2020 DP
6773714 Oct 28, 2018 DP U-801
LEUPROLIDE ACETATE - ELIGARD
N021379 001 5278201 Jan 11, 2011
5324519 Oct 20, 2011
5599552 Feb 04, 2014
6395293 Sep 28, 2013 DP
6565874 Oct 28, 2018 DP U-801
6626870 Mar 27, 2020 DP
6773714 Oct 28, 2018 DP U-801
LEUPROLIDE ACETATE - ELIGARD
N021488 001 5278201 Jan 11, 2011
5324519 Oct 20, 2011
5599552 Feb 04, 2014
6395293 Sep 28, 2013 DP
6565874 Oct 28, 2018 DP U-801
6626870 Mar 27, 2020 DP
6773714 Oct 28, 2018 DP U-801
LEUPROLIDE ACETATE - ELIGARD
N021731 001 5278201 Jan 11, 2011 DP
5324519 Jun 28, 2011 DP
5599552 Feb 04, 2014 DP U-621
6395293 Sep 28, 2013 DP
6565874 Oct 28, 2018 DP U-621
6626870 Mar 27, 2020 DP
6773714 Oct 28, 2018 U-621
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 104 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
LEUPROLIDE ACETATE - LUPRON DEPOT
N019732 001 5575987 Sep 02, 2013
5631020 May 20, 2014
5716640 Sep 02, 2013
6036976 Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT
N020011 001 5575987 Sep 02, 2013
5631021 May 20, 2014
5716640 Sep 02, 2013
LEUPROLIDE ACETATE - LUPRON DEPOT
N020517 001 5480656 Jan 02, 2013
5575987 Sep 02, 2013
5631020 May 20, 2014
5643607 Jan 02, 2013
5716640 Sep 02, 2013
5814342 Feb 01, 2011
6036976 Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT-3
N020708 001 5480656 Jan 02, 2013
5575987 Sep 02, 2013
5631020 May 20, 2014
5643607 Jan 02, 2013
5716640 Sep 02, 2013
5814342 Feb 01, 2011
6036976 Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT-4
N020517 002 5480656 Jan 02, 2013
5575987 Sep 02, 2013
5631020 May 20, 2014
5643607 Jan 02, 2013
5716640 Sep 02, 2013
5814342 Feb 01, 2011
6036976 Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
N020263 002 5575987 Sep 02, 2013
5631020 May 20, 2014
5716640 Sep 02, 2013
6036976 Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
N020263 003 5575987 Sep 02, 2013
5631020 May 20, 2014
5716640 Sep 02, 2013
6036976 Dec 13, 2013
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
N020263 004 5575987 Sep 02, 2013
5631020 May 20, 2014
5716640 Sep 02, 2013
6036976 Dec 13, 2013
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
N020263 005 5575987 Sep 02, 2013
5631020 May 20, 2014
5716640 Sep 02, 2013
6036976 Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
N020263 006 5575987 Sep 02, 2013
5631020 May 20, 2014
5716640 Sep 02, 2013
6036976 Dec 13, 2016
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 105 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
LEUPROLIDE ACETATE - VIADUR
N021088 001 5728396 Jan 30, 2017 U-316
5932547 Jun 13, 2017
5985305 Jan 30, 2017
6113938 Jul 24, 2018
6124261 Jun 13, 2017
6132420 Jan 30, 2017
6156331 Jan 30, 2017
6235712 Jun 13, 2017
6375978 Dec 17, 2018
6395292 Jan 30, 2017
LEVALBUTEROL HYDROCHLORIDE - XOPENEX
N020837 001 5362755 Mar 25, 2013 U-332
5547994 Aug 20, 2013 U-332
5760090 Jan 05, 2010 U-332
5844002 Jan 05, 2010 U-332
6083993 Jan 05, 2010 U-332
6451289 Mar 21, 2021
LEVALBUTEROL HYDROCHLORIDE - XOPENEX
N020837 002 5362755 Mar 25, 2013 U-332
5547994 Aug 20, 2013 U-332
5760090 Jan 05, 2010 U-332
5844002 Jan 05, 2010 U-332
6083993 Jan 05, 2010 U-332
6451289 Mar 21, 2021
LEVALBUTEROL HYDROCHLORIDE - XOPENEX
N020837 003 5362755 Mar 25, 2013 U-332
5547994 Aug 20, 2013 U-332
5760090 Jan 05, 2010 U-332
5844002 Jan 05, 2010 U-332
6083993 Jan 05, 2010 U-332
6451289 Mar 21, 2021
LEVALBUTEROL HYDROCHLORIDE - XOPENEX
N020837 004 5362755 Mar 25, 2013 U-332
5547994 Aug 20, 2013 U-332
5760090 Jan 05, 2010 U-332
5844002 Jan 05, 2010 U-5
6083993 Jan 05, 2010 U-332
6451289 Mar 21, 2021 DP
LEVALBUTEROL TARTRATE - XOPENEX HFA
N021730 001 5225183 Jul 06, 2010 DP
5362755 Mar 25, 2013 U-636
5439670 Jul 06, 2010 DP
5547994 Aug 20, 2013 U-636
5605674 Feb 25, 2014 DP
5695743 Jul 06, 2010 DP U-636
5760090 Jan 05, 2010 U-636
5836299 Nov 17, 2017 DP
5844002 Jan 05, 2010 U-636
6083993 Jan 05, 2010 U-636
6352684 Nov 28, 2009 DP
7256310 Oct 08, 2024 DS DP U-636
LEVETIRACETAM - KEPPRA
N021035 001 I-527 Mar 19, 2010
I-506 Aug 15, 2009
PED Feb 15, 2010
PED Sep 19, 2010
LEVETIRACETAM - KEPPRA
N021035 002 I-527 Mar 19, 2010
I-506 Aug 15, 2009
PED Feb 15, 2010
PED Sep 19, 2010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 106 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
LEVETIRACETAM - KEPPRA
N021035 003 I-527 Mar 19, 2010
I-506 Aug 15, 2009
PED Feb 15, 2010
PED Sep 19, 2010
LEVETIRACETAM - KEPPRA
N021035 004 I-527 Mar 19, 2010
I-506 Aug 15, 2009
PED Feb 15, 2010
PED Sep 19, 2010
LEVETIRACETAM - KEPPRA
N021505 001 I-527 Mar 19, 2010
I-506 Aug 15, 2009
PED Feb 15, 2010
PED Sep 19, 2010
LEVETIRACETAM - KEPPRA
N021872 001 I-563 Mar 19, 2010
I-544 Aug 15, 2009
NDF Jul 31, 2009
PED Feb 15, 2010
PED Jan 31, 2010
LEVETIRACETAM - KEPPRA XR
N022285 001 NDF Sep 12, 2011
LEVETIRACETAM - KEPPRA XR
N022285 002 NDF Sep 12, 2011
LEVOBETAXOLOL HYDROCHLORIDE - BETAXON
N021114 001 5540918 Jul 30, 2013 DP M-54 Sep 28, 2009
5540918*PED Jan 30, 2014 PED Mar 28, 2010
LEVOBUPIVACAINE HYDROCHLORIDE - CHIROCAINE
N020997 001 5708011 Oct 13, 2014 U-276
LEVOBUPIVACAINE HYDROCHLORIDE - CHIROCAINE
N020997 002 5708011 Oct 13, 2014 U-276
LEVOBUPIVACAINE HYDROCHLORIDE - CHIROCAINE
N020997 003 5708011 Oct 13, 2014 U-276
LEVOCARNITINE - CARNITOR
N020182 001 6335369 Jan 18, 2021 U-433
6429230 Jan 18, 2021 U-433
6696493 Jan 18, 2021 U-433
LEVOCETIRIZINE DIHYDROCHLORIDE - XYZAL
N022064 001 5698558 Sep 24, 2012 U-812 NPP Aug 21, 2012
5698558*PED Mar 24, 2013 NP May 25, 2010
PED Nov 25, 2010
PED Feb 21, 2013
LEVOCETIRIZINE DIHYDROCHLORIDE - XYZAL
N022157 001 5698558 Sep 24, 2012 U-852 NPP Aug 21, 2012
5698558*PED Mar 24, 2013 NP May 25, 2010
PED Nov 25, 2010
PED Feb 21, 2013
LEVOFLOXACIN - IQUIX
N021571 001 5053407 Dec 20, 2010 DS DP U-600
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 107 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
LEVOFLOXACIN - LEVAQUIN
N020634 001 5053407 Dec 20, 2010 D-108 Sep 14, 2010
5053407*PED Jun 20, 2011 M-61 Sep 10, 2010
PED Mar 10, 2011
LEVOFLOXACIN - LEVAQUIN
N020634 002 5053407 Dec 20, 2010 D-108 Sep 14, 2010
5053407*PED Jun 20, 2011 M-61 Sep 10, 2010
PED Mar 10, 2011
LEVOFLOXACIN - LEVAQUIN
N020634 003 5053407 Dec 20, 2010 D-108 Sep 14, 2010
5053407*PED Jun 20, 2011 M-61 Sep 10, 2010
PED Mar 10, 2011
LEVOFLOXACIN - LEVAQUIN
N020635 001 5053407 Dec 20, 2010 D-108 Sep 14, 2010
5053407*PED Jun 20, 2011 M-61 Sep 10, 2010
PED Mar 10, 2011
LEVOFLOXACIN - LEVAQUIN
N020635 004 5053407 Dec 20, 2010 D-108 Sep 14, 2010
5053407*PED Jun 20, 2011 M-61 Sep 10, 2010
PED Mar 10, 2011
LEVOFLOXACIN - LEVAQUIN
N021721 001 5053407 Dec 20, 2010 DS U-36 D-108 Sep 14, 2010
5053407*PED Jun 20, 2011 M-61 Sep 10, 2010
6806256 Feb 26, 2022 DP PED Mar 10, 2011
6806256*PED Aug 26, 2022
LEVOFLOXACIN - LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
N020635 002 5053407 Dec 20, 2010 D-108 Sep 14, 2010
5053407*PED Jun 20, 2011 M-61 Sep 10, 2010
PED Mar 10, 2011
LEVOFLOXACIN - LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
N020635 003 5053407 Dec 20, 2010 D-108 Sep 14, 2010
5053407*PED Jun 20, 2011 M-61 Sep 10, 2010
PED Mar 10, 2011
LEVOFLOXACIN - LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
N020635 005 5053407 Dec 20, 2010 D-108 Sep 14, 2010
5053407*PED Jun 20, 2011 M-61 Sep 10, 2010
PED Mar 10, 2011
LEVOFLOXACIN - QUIXIN
N021199 001 5053407 Dec 20, 2010
LEVOLEUCOVORIN CALCIUM - FUSILEV
N020140 001 6500829 Dec 31, 2019 DS DP NP Mar 07, 2011
ODE Mar 07, 2015
LEVONORGESTREL - MIRENA
N021225 001 5785053 Dec 05, 2015 DP I-610 Oct 01, 2012
LEVONORGESTREL - PLAN B
N021045 002 NP Aug 24, 2009
LEVONORGESTREL - PLAN B ONE-STEP
N021998 001 NP Jul 10, 2012
LEVOTHYROXINE SODIUM - LEVO-T
N021342 001 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N021342 002 6399101 Mar 30, 2020
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 108 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
LEVOTHYROXINE SODIUM - LEVO-T
N021342 003 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N021342 004 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N021342 005 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N021342 006 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N021342 007 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N021342 008 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N021342 009 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N021342 010 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N021342 011 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVOXYL
N021301 001 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Aug 14, 2022 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N021301 002 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Aug 14, 2022 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N021301 003 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Aug 14, 2022 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N021301 004 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Aug 14, 2022 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N021301 005 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Aug 14, 2022 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N021301 006 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Aug 14, 2022 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N021301 007 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Aug 14, 2022 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N021301 008 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Aug 14, 2022 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N021301 009 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Aug 14, 2022 U-759
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 109 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
LEVOTHYROXINE SODIUM - LEVOXYL
N021301 010 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Aug 14, 2022 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N021301 011 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Aug 14, 2022 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N021301 012 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Aug 14, 2022 U-759
LIDOCAINE - DENTIPATCH
N020575 001 5234957 Feb 27, 2011
5332576 Jul 26, 2011
5446070 Feb 27, 2011
LIDOCAINE - DENTIPATCH
N020575 002 5234957 Feb 27, 2011
5332576 Jul 26, 2011
5446070 Feb 27, 2011
LIDOCAINE - LIDODERM
N020612 001 5411738 May 02, 2012
5601838 May 02, 2012 U-488
5827529 Oct 27, 2015 U-486
LIDOCAINE HYDROCHLORIDE - AKTEN
N022221 001 NDF Oct 07, 2011
LIDOCAINE HYDROCHLORIDE - ZINGO
N022114 001 5630796 May 20, 2014 NPP Jan 08, 2012
5899880 May 04, 2016 DP
6004286 Mar 17, 2017 DP
6881200 Jun 11, 2016 DP
LIDOCAINE; PRILOCAINE - ORAQIX
N021451 001 6031007 Apr 01, 2017 DP U-553
LIDOCAINE; TETRACAINE - LIDOCAINE AND TETRACAINE
N021717 001 5919479 Jul 28, 2015 DP
6528086 Sep 28, 2019 DP
LIDOCAINE; TETRACAINE - SYNERA
N021623 001 5658583 Jul 28, 2015 DP
5919479 Jul 28, 2015 DP
6306431 Jul 28, 2015 DP
6465006 Jul 28, 2015 DP
6546281 Jul 28, 2015 DP
6780426 Jul 28, 2015 DP
LINEZOLID - ZYVOX
N021130 001 5688792 Nov 18, 2014 DS U-319
5688792*PED May 18, 2015
6514529 Mar 15, 2021 DP
6514529*PED Sep 15, 2021
6559305 Jan 29, 2021 DS
6559305*PED Jul 29, 2021
LINEZOLID - ZYVOX
N021130 002 5688792 Nov 18, 2014 DS U-319
5688792*PED May 18, 2015
6514529 Mar 15, 2021 DP
6514529*PED Sep 15, 2021
6559305 Jan 29, 2021 DS
6559305*PED Jul 29, 2021
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 110 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
LINEZOLID - ZYVOX
N021131 001 5688792 Nov 18, 2014 U-319
5688792*PED May 18, 2015
6559305 Jan 29, 2021 DS
6559305*PED Jul 29, 2021
LINEZOLID - ZYVOX
N021132 001 5688792 Nov 18, 2014 DS U-319
5688792*PED May 18, 2015
6559305 Jan 29, 2021 DS
6559305*PED Jul 29, 2021
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N021977 001 7105486 Jun 29, 2023 U-727 NPP Apr 23, 2011
7223735 Jun 29, 2023 DP NCE Feb 23, 2012
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N021977 002 7105486 Jun 29, 2023 U-727 NPP Apr 23, 2011
7223735 Jun 29, 2023 DP NCE Feb 23, 2012
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N021977 003 7105486 Jun 29, 2023 U-727 NPP Apr 23, 2011
7223735 Jun 29, 2023 DP NCE Feb 23, 2012
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N021977 004 7105486 Jun 29, 2023 U-842 NPP Apr 23, 2011
7223735 Jun 29, 2023 DP NCE Feb 23, 2012
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N021977 005 7105486 Jun 29, 2023 U-842 NPP Apr 23, 2011
7223735 Jun 29, 2023 DP NCE Feb 23, 2012
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N021977 006 7105486 Jun 29, 2023 U-842 NPP Apr 23, 2011
7223735 Jun 29, 2023 DP NCE Feb 23, 2012
LODOXAMIDE TROMETHAMINE - ALOMIDE
N020191 001 5457126 Oct 10, 2012 U-117
LOPERAMIDE HYDROCHLORIDE - IMODIUM A-D EZ CHEWS
N020448 001 5489436 Feb 06, 2013 DP
6814978 Aug 26, 2021 DP
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE - IMODIUM MULTI-SYMPTOM RELIEF
N020606 001 5248505 Jul 28, 2010 Y
5489436 Feb 06, 2013
5612054 Sep 28, 2010 Y
5679376 Oct 21, 2014 Y
5716641 May 21, 2012 U-226 Y
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE - IMODIUM MULTI-SYMPTOM RELIEF
N021140 001 6103260 Jul 17, 2017 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 111 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
LOPINAVIR; RITONAVIR - KALETRA
N021226 001 5541206 Jul 30, 2013 U-348
5541206*PED Jan 30, 2014
5635523 Jun 03, 2014 U-352
5635523*PED Dec 03, 2014
5648497 Jul 15, 2014
5648497*PED Jan 15, 2015
5674882 Oct 07, 2014 U-344
5674882*PED Apr 07, 2015
5846987 Dec 29, 2012 U-350
5846987*PED Jun 29, 2013
5886036 Nov 19, 2013 DS DP
5886036*PED May 19, 2014
5914332 Dec 13, 2015 U-351
5914332*PED Jun 13, 2016
5948436 Sep 13, 2013 DP
5948436*PED Mar 13, 2014
6037157 Jun 26, 2016 U-346
6037157*PED Dec 26, 2016
6232333 Nov 07, 2017
6232333*PED May 07, 2018
6284767 Feb 15, 2016 DP U-688
6284767 Feb 15, 2016 DP U-401
6284767*PED Aug 15, 2016
6458818 Nov 07, 2017
6458818*PED May 07, 2018
6521651 Nov 07, 2017 DP
6521651*PED May 07, 2018
6703403 Jun 26, 2016 U-257
6703403*PED Dec 26, 2016
7141593 May 22, 2020 DP
7141593*PED Nov 22, 2020
7432294 May 22, 2020 DP
7432294*PED Nov 22, 2020
LOPINAVIR; RITONAVIR - KALETRA
N021251 001 5484801 Jan 28, 2014 DP
5484801*PED Jul 28, 2014
5541206 Jul 30, 2013 U-348
5541206*PED Jan 30, 2014
5635523 Jun 03, 2014 U-352
5635523*PED Dec 03, 2014
5648497 Jul 15, 2014
5648497*PED Jan 15, 2015
5674882 Oct 07, 2014 U-344
5674882*PED Apr 07, 2015
5846987 Dec 29, 2012 U-350
5846987*PED Jun 29, 2013
5886036 Nov 19, 2013 DS DP
5886036*PED May 19, 2014
5914332 Dec 13, 2015 U-351
5914332*PED Jun 13, 2016
5948436 Sep 13, 2013 DP
5948436*PED Mar 13, 2014
6037157 Jun 26, 2016 U-346
6037157*PED Dec 26, 2016
6284767 Feb 15, 2016 DP U-401
6284767 Feb 15, 2016 DP U-895
6284767*PED Aug 15, 2016
6703403 Jun 26, 2016 U-257
6703403*PED Dec 26, 2016
6911214 Nov 28, 2021 DP
6911214*PED May 28, 2022
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 112 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
LOPINAVIR; RITONAVIR - KALETRA
N021906 001 5541206 Jul 30, 2013 DS DP U-688
5541206*PED Jan 30, 2014
5635523 Jun 03, 2014 U-688
5635523*PED Dec 03, 2014
5648497 Jul 15, 2014 DS DP
5648497*PED Jan 15, 2015
5674882 Oct 07, 2014 U-688
5674882*PED Apr 07, 2015
5886036 Nov 19, 2013 DS DP
5886036*PED May 19, 2014
5914332 Dec 13, 2015 DS DP U-688
5914332*PED Jun 13, 2016
6037157 Jun 26, 2016 U-688
6037157*PED Dec 26, 2016
6284767 Feb 15, 2016 DP U-688
6284767*PED Aug 15, 2016
6703403 Jun 26, 2016 U-688
6703403*PED Dec 26, 2016
7148359 Jul 19, 2019 DP
7148359*PED Jan 19, 2020
7364752 Nov 10, 2020 DP U-688
7364752*PED May 10, 2021
LOPINAVIR; RITONAVIR - KALETRA
N021906 002 5541206 Jul 30, 2013 DS DP U-688
5541206*PED Jan 30, 2014
5635523 Jun 03, 2014 U-688
5635523*PED Dec 03, 2014
5648497 Jul 15, 2014 DS DP
5648497*PED Jan 15, 2015
5674882 Oct 07, 2014 U-688
5674882*PED Apr 07, 2015
5886036 Nov 19, 2013 DS DP
5886036*PED May 19, 2014
5914332 Dec 13, 2015 DS DP U-688
5914332*PED Jun 13, 2016
6037157 Jun 26, 2016 U-688
6037157*PED Dec 26, 2016
6284767 Feb 15, 2016 DP U-688
6284767*PED Aug 15, 2016
6703403 Jun 26, 2016 U-688
6703403*PED Dec 26, 2016
7148359 Jul 19, 2019 DP
7148359*PED Jan 19, 2020
7364752 Nov 10, 2020 DP U-688
7364752*PED May 10, 2021
LORATADINE - CLARITIN
N020641 002 6132758 Jun 01, 2018
LORATADINE; PSEUDOEPHEDRINE SULFATE - CLARITIN-D 24 HOUR
N020470 002 5314697 Oct 23, 2012
LOSARTAN POTASSIUM - COZAAR
N020386 001 5138069 Aug 11, 2009
5138069*PED Feb 11, 2010
5153197 Oct 06, 2009 U-3
5153197*PED Apr 06, 2010 U-3
5210079 May 11, 2010 U-496
5210079*PED Nov 11, 2010 U-496
5608075 Mar 04, 2014 Y
5608075*PED Sep 04, 2014
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 113 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
LOSARTAN POTASSIUM - COZAAR
N020386 002 5138069 Aug 11, 2009
5138069*PED Feb 11, 2010
5153197 Oct 06, 2009 U-3
5153197*PED Apr 06, 2010 U-3
5210079 May 11, 2010 U-496
5210079*PED Nov 11, 2010 U-496
5608075 Mar 04, 2014 Y
5608075*PED Sep 04, 2014
LOSARTAN POTASSIUM - COZAAR
N020386 003 5138069 Aug 11, 2009
5138069*PED Feb 11, 2010
5153197 Oct 06, 2009 U-3
5153197*PED Apr 06, 2010 U-3
5210079 May 11, 2010 U-496
5210079*PED Nov 11, 2010 U-496
5608075 Mar 04, 2014 Y
5608075*PED Sep 04, 2014
LOTEPREDNOL ETABONATE - ALREX
N020803 001 4996335 Mar 09, 2012
5540930 Oct 25, 2013
5747061 Oct 25, 2013 DP U-576
LOTEPREDNOL ETABONATE - LOTEMAX
N020583 001 4996335 Mar 09, 2012
5540930 Oct 25, 2013
5747061 Oct 25, 2013 DP U-575
LOTEPREDNOL ETABONATE - LOTEMAX
N020841 001 5540930 Oct 25, 2013
LOTEPREDNOL ETABONATE; TOBRAMYCIN - ZYLET
N050804 001 4996335 Mar 09, 2012 DS DP U-920
5540930 Oct 25, 2013 DP
5747061 Oct 25, 2013 DP U-920
LOVASTATIN - ALTOPREV
N021316 001 5916595 Dec 12, 2017
6080778 Mar 23, 2018 U-456
6485748 Dec 12, 2017 DP
LOVASTATIN - ALTOPREV
N021316 002 5916595 Dec 12, 2017
6080778 Mar 23, 2018 U-456
6485748 Dec 12, 2017 DP
LOVASTATIN - ALTOPREV
N021316 003 5916595 Dec 12, 2017
6080778 Mar 23, 2018 U-456
6485748 Dec 12, 2017 DP
LOVASTATIN - ALTOPREV
N021316 004 5916595 Dec 12, 2017
6080778 Mar 23, 2018 U-456
6485748 Dec 12, 2017 DP
LOVASTATIN; NIACIN - ADVICOR
N021249 001 6080428 May 27, 2017 U-447
6129930 Sep 20, 2013 U-448
6406715 Sep 20, 2013 DP U-450
6469035 Mar 15, 2018 U-768
6676967 Sep 20, 2013 U-548
6746691 Sep 20, 2013 U-586
6818229 Feb 15, 2014 DP
7011848 Sep 20, 2013 U-712
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 114 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
LOVASTATIN; NIACIN - ADVICOR
N021249 002 6080428 May 27, 2017 U-447
6129930 Sep 20, 2013 U-448
6406715 Sep 20, 2013 DP U-450
6469035 Mar 15, 2018 U-768
6676967 Sep 20, 2013 U-548
6746691 Sep 20, 2013 U-586
6818229 Feb 15, 2014 DP
7011848 Sep 20, 2013 U-712
LOVASTATIN; NIACIN - ADVICOR
N021249 003 6080428 May 27, 2017 U-447
6129930 Sep 20, 2013 U-448
6406715 Sep 20, 2013 DP U-450
6469035 Mar 15, 2018 U-768
6676967 Sep 20, 2013 U-548
6746691 Sep 20, 2013 U-586
7011848 Sep 20, 2013 U-712
LOVASTATIN; NIACIN - ADVICOR
N021249 004 6406715 Sep 20, 2013 DP
6469035 Mar 15, 2018 U-768
LUBIPROSTONE - AMITIZA
N021908 001 5284858 Jul 14, 2014 DS DP NCE Jan 31, 2011
5317032 May 31, 2011 DS DP U-717
6414016 Sep 05, 2020 DS DP U-717
6583174 Oct 16, 2020 DS DP
7064148 Aug 30, 2022 DS DP U-739
7417067 Oct 16, 2020 DS DP
LUBIPROSTONE - AMITIZA
N021908 002 5284858 Jul 14, 2014 DS DP I-557 Apr 28, 2011
5317032 May 31, 2011 DS DP U-874 NS Apr 28, 2011
6414016 Sep 05, 2020 DS DP U-874 NCE Jan 31, 2011
6583174 Oct 16, 2020 DS DP

7064148 Aug 30, 2022 DS DP U-873


7417067 Oct 16, 2020 DS DP


LUTROPIN ALFA - LUVERIS


N021322 001 5767251 Jun 16, 2015 DS ODE Oct 08, 2011
MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - NORMOCARB HF 25
N021910 001 5945449 Oct 31, 2017 DP U-785 ODE Jul 26, 2013
7300674 Mar 04, 2023 DP U-785
MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - NORMOCARB HF 35
N021910 002 5945449 Oct 31, 2017 DP U-785 ODE Jul 26, 2013
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE - MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM
BICARBONATE
N022456 001 6489346 Jul 16, 2016 DP U-1021

6489346 Jul 16, 2016 DP U-588

6645988 Jul 16, 2016 DP

6699885 Jul 16, 2016 DP U-588

6699885 Jul 16, 2016 DP U-1021

7399772 Jul 16, 2016 DP U-1021

7399772 Jul 16, 2016 DP U-588

MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE - MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM
BICARBONATE
N022456 002 6489346 Jul 16, 2016 DP U-588

6489346 Jul 16, 2016 DP U-1021

6645988 Jul 16, 2016 DP

6699885 Jul 16, 2016 DP U-1021

6699885 Jul 16, 2016 DP U-588

7399772 Jul 16, 2016 DP U-588

7399772 Jul 16, 2016 DP U-1021

30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 115 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID
N021850 001 6489346 Jul 16, 2016 DS DP U-588
6645988 Jul 16, 2016 DS DP U-588
6699885 Jul 16, 2016 U-588
7399772 Jul 16, 2016 U-588
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID
N021850 002 6489346 Jul 16, 2016 DS DP U-623
6645988 Jul 16, 2016 DS DP U-623
6699885 Jul 16, 2016 U-623
7399772 Jul 16, 2016 U-623
MALATHION - OVIDE
N018613 001 7560445 Feb 01, 2027 DS DP U-986
MANGAFODIPIR TRISODIUM - TESLASCAN
N020652 001 4933456 Nov 27, 2011
5223243 Jun 29, 2010 U-237
MARAVIROC - SELZENTRY
N022128 001 6586430 Dec 01, 2019 DS DP U-824 NCE Aug 06, 2012
6667314 May 25, 2021 DS DP U-824
7368460 Nov 25, 2022 U-824
7576097 May 25, 2021 DS
MARAVIROC - SELZENTRY
N022128 002 6586430 Dec 01, 2019 DS DP U-824 NCE Aug 06, 2012
6667314 May 25, 2021 DS DP U-824
7368460 Nov 25, 2022 U-824
7576097 May 25, 2021 DS
MECASERMIN RECOMBINANT - INCRELEX
N021839 001 5681814 Sep 18, 2017 DP NCE Aug 30, 2010
5824642 Jul 08, 2014 U-681 ODE Aug 30, 2012
6207640 Apr 07, 2014 U-681
MECASERMIN RINFABATE RECOMBINANT - IPLEX
N021884 001 5200509 Apr 06, 2010 DS ODE Dec 12, 2012
5681818 Oct 28, 2014 U-697
MEDROXYPROGESTERONE ACETATE - DEPO-SUBQ PROVERA 104
N021583 001 6495534 May 15, 2020 DP
MEGESTROL ACETATE - MEGACE
N020264 001 5338732 Aug 16, 2011
MEGESTROL ACETATE - MEGACE ES
N021778 001 5145684 Jan 25, 2011 DP U-673
6592903 Sep 21, 2020 DP
7101576 Apr 22, 2024 U-755
MELOXICAM - MOBIC
N020938 001 ODE Aug 11, 2012
PED Feb 11, 2013
MELOXICAM - MOBIC
N020938 002 ODE Aug 11, 2012
PED Feb 11, 2013
MELOXICAM - MOBIC
N021530 001 6184220 Mar 25, 2019 DP ODE Aug 11, 2012
6184220*PED Sep 25, 2019 PED Feb 11, 2013
MEMANTINE HYDROCHLORIDE - NAMENDA
N021487 001 5061703 Apr 11, 2015 U-539
MEMANTINE HYDROCHLORIDE - NAMENDA
N021487 002 5061703 Apr 11, 2015 U-539
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 116 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
MEMANTINE HYDROCHLORIDE - NAMENDA
N021627 001 5061703 Apr 11, 2015 U-539
MENTHOL; METHYL SALICYLATE - SALONPAS
N022029 001 NDF Feb 20, 2011
NC Feb 20, 2011
MEQUINOL; TRETINOIN - SOLAGE
N020922 001 5194247 Dec 10, 2013 DP U-294
5470567 Mar 19, 2010 U-294
6353029 Aug 24, 2020
MEROPENEM - MERREM I.V.
N050706 001 4943569 Jun 21, 2010 DS DP U-282
MEROPENEM - MERREM I.V.
N050706 003 4943569 Jun 21, 2010 DS DP U-282
MESALAMINE - APRISO
N022301 001 6551620 Apr 20, 2018 DS DP U-907 NP Oct 31, 2011
MESALAMINE - ASACOL
N019651 001 5541170 Jul 30, 2013 U-141
5541171 Jul 30, 2013 U-141
MESALAMINE - ASACOL HD
N021830 001 5541170 Jul 30, 2013 DP U-141 NP May 29, 2011
5541171 Jul 30, 2013 DP U-141
6893662 Nov 15, 2021 DP U-141
MESALAMINE - LIALDA
N022000 001 6773720 Jun 08, 2020 DP NP Jan 16, 2010
MESNA - MESNEX
N020855 001 5252341 Jul 16, 2011
5262169 Jul 16, 2011
METAXALONE - SKELAXIN
N013217 001 6407128 Dec 03, 2021 U-189
6683102 Dec 03, 2021 U-189
METAXALONE - SKELAXIN
N013217 003 6407128 Dec 03, 2021 U-189
6683102 Dec 03, 2021 U-189
7122566 Feb 06, 2026 U-915
METFORMIN HYDROCHLORIDE - FORTAMET
N021574 001 6099859 Mar 20, 2018 DP
6495162 Mar 20, 2018 DP
6790459 Mar 17, 2021 U-604
6866866 Mar 17, 2021 DP
METFORMIN HYDROCHLORIDE - FORTAMET
N021574 002 6099859 Mar 20, 2018 DP
6495162 Mar 20, 2018 DP
6790459 Mar 17, 2021 U-604
6866866 Mar 17, 2021 DP
METFORMIN HYDROCHLORIDE - GLUCOPHAGE XR
N021202 001 6475521 Mar 19, 2018
6660300 Mar 19, 2018 U-542
METFORMIN HYDROCHLORIDE - GLUCOPHAGE XR
N021202 004 6475521 Mar 19, 2018
6660300 Mar 19, 2018 U-542
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 117 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
METFORMIN HYDROCHLORIDE - GLUMETZA
N021748 001 6340475 Sep 19, 2016 DS DP U-669
6488962 Jun 20, 2020 DS DP
6635280 Sep 19, 2016 DS DP
6723340 Oct 25, 2021 DS DP
METFORMIN HYDROCHLORIDE - GLUMETZA
N021748 002 6488962 Jun 20, 2020 DS DP
METFORMIN HYDROCHLORIDE - RIOMET
N021591 001 6890957 Sep 14, 2023 DP
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET
N021842 001 4687777 Jan 17, 2011 DS
5965584 Jun 19, 2016 DP U-679
6166042 Jun 19, 2016 U-679
6166043 Jun 19, 2016 U-679
6172090 Jun 19, 2016 U-679
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET
N021842 002 4687777 Jan 17, 2011 DS
5965584 Jun 19, 2016 DP U-679
6166042 Jun 19, 2016 U-679
6166043 Jun 19, 2016 U-679
6172090 Jun 19, 2016 U-679
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET XR
N022024 001 4687777 Jan 17, 2011 DS
5965584 Jun 19, 2016 DP U-973
6099859 Mar 20, 2018 DP
6166042 Jun 19, 2016 U-973
6166043 Jun 19, 2016 U-973
6172090 Jun 19, 2016 U-973
6495162 Mar 20, 2018 DP
6790459 Mar 17, 2021 U-974
6866866 Mar 17, 2021 DP
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET XR
N022024 002 4687777 Jan 17, 2011 DS
5965584 Jun 19, 2016 DP U-973
6099859 Mar 20, 2018 DP
6166042 Jun 19, 2016 U-973
6166043 Jun 19, 2016 U-973
6172090 Jun 19, 2016 U-973
6495162 Mar 20, 2018 DP
6790459 Mar 17, 2021 U-974
6866866 Mar 17, 2021 DP
METFORMIN HYDROCHLORIDE; REPAGLINIDE - PRANDIMET
N022386 001 6677358 Jun 12, 2018 DP U-546
METFORMIN HYDROCHLORIDE; REPAGLINIDE - PRANDIMET
N022386 002 6677358 Jun 12, 2018 DP U-546
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N021410 001 5002953 Sep 17, 2011 DS DP U-690 M-62 Jan 31, 2010
5002953 Sep 17, 2011 DS DP U-734
5002953 Sep 17, 2011 DS DP U-691
5002953 Sep 17, 2011 DS DP U-493
5002953*PED Mar 17, 2012
5741803 Apr 21, 2015 DS DP U-734 Y
5741803 Apr 21, 2015 DS DP U-493 Y
5741803*PED Oct 21, 2015
5965584 Jun 19, 2016 U-493 Y
6166042 Jun 19, 2016 U-493 Y
6288095 Feb 11, 2017 U-493 Y
6288095*PED Aug 11, 2017
7358366 Apr 19, 2020 DS
7358366*PED Oct 19, 2020
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 118 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N021410 002 5002953 Sep 17, 2011 DS DP U-493 M-62 Jan 31, 2010
5002953 Sep 17, 2011 DS DP U-691
5002953 Sep 17, 2011 DS DP U-690
5002953 Sep 17, 2011 DS DP U-734
5002953*PED Mar 17, 2012
5741803 Apr 21, 2015 DS DP U-734 Y
5741803 Apr 21, 2015 DS DP U-493 Y
5741803*PED Oct 21, 2015
5965584 Jun 19, 2016 U-493 Y
6166042 Jun 19, 2016 U-493 Y
6288095 Feb 11, 2017 U-493 Y
6288095*PED Aug 11, 2017
7358366 Apr 19, 2020 DS
7358366*PED Oct 19, 2020
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N021410 003 5002953 Sep 17, 2011 DS DP U-690 M-62 Jan 31, 2010
5002953 Sep 17, 2011 DS DP U-493
5002953 Sep 17, 2011 DS DP U-691
5002953 Sep 17, 2011 DS DP U-734
5002953*PED Mar 17, 2012
5741803 Apr 21, 2015 DS DP U-493 Y
5741803 Apr 21, 2015 DS DP U-734 Y
5741803*PED Oct 21, 2015
5965584 Jun 19, 2016 U-493 Y
6166042 Jun 19, 2016 U-493 Y
6288095 Feb 11, 2017 U-493 Y
6288095*PED Aug 11, 2017
7358366 Apr 19, 2020 DS
7358366*PED Oct 19, 2020
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N021410 004 5002953 Sep 17, 2011 DS DP U-734 M-62 Jan 31, 2010
5002953 Sep 17, 2011 DS DP U-493
5002953 Sep 17, 2011 DS DP U-691
5002953 Sep 17, 2011 DS DP U-690
5002953*PED Mar 17, 2012
5741803 Apr 21, 2015 DS DP U-734 Y
5741803 Apr 21, 2015 DS DP U-493 Y
5741803*PED Oct 21, 2015
7358366 Apr 19, 2020 DS
7358366*PED Oct 19, 2020
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N021410 005 5002953 Sep 17, 2011 DS DP U-493 M-62 Jan 31, 2010
5002953 Sep 17, 2011 DS DP U-690
5002953 Sep 17, 2011 DS DP U-734
5002953 Sep 17, 2011 DS DP U-691
5002953*PED Mar 17, 2012
5741803 Apr 21, 2015 DS DP U-734 Y
5741803 Apr 21, 2015 DS DP U-493 Y
5741803*PED Oct 21, 2015
7358366 Apr 19, 2020 DS
7358366*PED Oct 19, 2020
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET
N022044 001 6303661 Apr 24, 2017 U-802 M-69 Oct 12, 2010
6699871 Jul 26, 2022 DS DP U-802 M-68 Oct 12, 2010
6890898 Feb 02, 2019 U-803 NC Mar 30, 2010
7078381 Feb 02, 2019 U-803
7125873 Jul 26, 2022 DP U-803 NCE Oct 16, 2011
7326708 Apr 11, 2026 DS DP U-802
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 119 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET
N022044 002 6303661 Apr 24, 2017 U-802 M-69 Oct 12, 2010
6699871 Jul 26, 2022 DS DP U-802 M-68 Oct 12, 2010
6890898 Feb 02, 2019 U-803 NC Mar 30, 2010
7078381 Feb 02, 2019 U-803
7125873 Jul 26, 2022 DP U-803 NCE Oct 16, 2011
7326708 Apr 11, 2026 DS DP U-802
METHYL AMINOLEVULINATE HYDROCHLORIDE - METVIXIA
N021415 001 6034267 Mar 08, 2016 U-804 M-77 Jun 26, 2011
METHYLNALTREXONE BROMIDE - RELISTOR
N021964 001 NCE Apr 24, 2013
METHYLPHENIDATE - DAYTRANA
N021514 001 5958446 Dec 12, 2012 DP
6210705 Sep 30, 2018 DP U-727
6348211 Sep 30, 2018 DP U-727
METHYLPHENIDATE - DAYTRANA
N021514 002 5958446 Dec 12, 2012 DP
6210705 Sep 30, 2018 DP U-727
6348211 Sep 30, 2018 DP U-727
METHYLPHENIDATE - DAYTRANA
N021514 003 5958446 Dec 12, 2012 DP
6210705 Sep 30, 2018 DP U-727
6348211 Sep 30, 2018 DP U-727
METHYLPHENIDATE - DAYTRANA
N021514 004 5958446 Dec 12, 2012 DP
6210705 Sep 30, 2018 DP U-727
6348211 Sep 30, 2018 DP U-727
METHYLPHENIDATE HYDROCHLORIDE - CONCERTA
N021121 001 6919373 Jul 31, 2017 U-666 M-88 Nov 04, 2012
6919373*PED Jan 31, 2018 NPP Jun 27, 2011
6930129 Jul 31, 2017 U-666
6930129*PED Jan 31, 2018
METHYLPHENIDATE HYDROCHLORIDE - CONCERTA
N021121 002 6919373 Jul 31, 2017 U-666 M-88 Nov 04, 2012
6919373*PED Jan 31, 2018 NPP Jun 27, 2011
6930129 Jul 31, 2017 U-666
6930129*PED Jan 31, 2018
METHYLPHENIDATE HYDROCHLORIDE - CONCERTA
N021121 003 6919373 Jul 31, 2017 U-666 M-88 Nov 04, 2012
6919373*PED Jan 31, 2018 NPP Jun 27, 2011
6930129 Jul 31, 2017 U-666
6930129*PED Jan 31, 2018
METHYLPHENIDATE HYDROCHLORIDE - CONCERTA
N021121 004 6919373 Jul 31, 2017 U-666 M-88 Nov 04, 2012
6919373*PED Jan 31, 2018 NPP Jun 27, 2011
6930129 Jul 31, 2017 U-666
6930129*PED Jan 31, 2018
METHYLPHENIDATE HYDROCHLORIDE - METADATE CD
N021259 001 6344215 Oct 27, 2020 DP
METHYLPHENIDATE HYDROCHLORIDE - METADATE CD
N021259 002 6344215 Oct 27, 2020 DP
METHYLPHENIDATE HYDROCHLORIDE - METADATE CD
N021259 003 6344215 Oct 27, 2020 DP
METHYLPHENIDATE HYDROCHLORIDE - METADATE CD
N021259 004 6344215 Oct 27, 2020 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 120 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
METHYLPHENIDATE HYDROCHLORIDE - RITALIN LA
N021284 001 5837284 Dec 04, 2015 DP
6228398 Nov 01, 2019 DP U-472
6635284 Dec 04, 2015 DP U-591
7431944 Dec 04, 2015 DP
METHYLPHENIDATE HYDROCHLORIDE - RITALIN LA
N021284 002 5837284 Dec 04, 2015 DP
6228398 Nov 01, 2019 DP U-472
6635284 Dec 04, 2015 DP U-591
7431944 Dec 04, 2015 DP
METHYLPHENIDATE HYDROCHLORIDE - RITALIN LA
N021284 003 5837284 Dec 04, 2015 DP
6228398 Nov 01, 2019 DP U-472
6635284 Dec 04, 2015 DP U-591
7431944 Dec 04, 2015 DP
METHYLPHENIDATE HYDROCHLORIDE - RITALIN LA
N021284 004 5837284 Dec 04, 2015 DP
6228398 Nov 01, 2019 DP
6635284 Dec 04, 2015 DP U-591
7431944 Dec 04, 2015 DP
METOCLOPRAMIDE HYDROCHLORIDE - METOZOLV ODT
N022246 001 6413549 Jul 11, 2017 DP
METOCLOPRAMIDE HYDROCHLORIDE - METOZOLV ODT
N022246 002 6413549 Jul 11, 2017 DP
METOCLOPRAMIDE HYDROCHLORIDE - REGLAN ODT
N021793 001 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
METOCLOPRAMIDE HYDROCHLORIDE - REGLAN ODT
N021793 002 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
METOPROLOL SUCCINATE - TOPROL-XL
N019962 001 M-61 Jul 18, 2010
PED Jan 18, 2011
METOPROLOL SUCCINATE - TOPROL-XL
N019962 002 M-61 Jul 18, 2010
PED Jan 18, 2011
METOPROLOL SUCCINATE - TOPROL-XL
N019962 003 M-61 Jul 18, 2010
PED Jan 18, 2011
METOPROLOL SUCCINATE - TOPROL-XL
N019962 004 M-61 Jul 18, 2010
PED Jan 18, 2011
METRONIDAZOLE - FLAGYL ER
N020868 001 6103262 Aug 15, 2017 DP U-137
METRONIDAZOLE - METROGEL
N021789 001 6881726 Feb 21, 2022 DP U-743
7348317 Feb 21, 2022 DP U-743
METRONIDAZOLE - METROGEL-VAGINAL
N020208 001 5536743 Jul 16, 2013 U-137
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 121 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
MICAFUNGIN SODIUM - MYCAMINE
N021506 002 5376634 Dec 27, 2011 DS DP I-554 Jan 22, 2011
6107458 Mar 16, 2019 DS DP U-650 NCE Mar 16, 2010
6107458 Mar 16, 2019 DS DP U-845
6265536 Sep 29, 2015 DS DP U-650
6265536 Sep 29, 2015 DS DP U-845
6774104 Jan 08, 2021 DP U-845
6774104 Jan 08, 2021 DP U-650
MICAFUNGIN SODIUM - MYCAMINE
N021506 003 5376634 Dec 27, 2011 DS DP I-554 Jan 22, 2011
6107458 Mar 16, 2019 DS DP U-650 NCE Mar 16, 2010
6107458 Mar 16, 2019 DS DP U-845
6265536 Sep 29, 2015 DS DP U-845
6265536 Sep 29, 2015 DS DP U-650
6774104 Jan 08, 2021 DP U-845
6774104 Jan 08, 2021 DP U-650
MICONAZOLE NITRATE - MONISTAT 1 COMBINATION PACK
N021308 001 5514698 Mar 21, 2014 Y
6153635 Nov 28, 2020 Y
MIGLUSTAT - ZAVESCA
N021348 001 5472969 May 13, 2013 ODE Jul 31, 2010
5525616 Jun 11, 2013
MILNACIPRAN HYDROCHLORIDE - SAVELLA
N022256 001 6602911 Nov 05, 2021 U-882 NCE Jan 14, 2014
6992110 Nov 05, 2021 U-882
MILNACIPRAN HYDROCHLORIDE - SAVELLA
N022256 002 6602911 Nov 05, 2021 U-882 NCE Jan 14, 2014
6992110 Nov 05, 2021 U-882
MILNACIPRAN HYDROCHLORIDE - SAVELLA
N022256 003 6602911 Nov 05, 2021 U-882 NCE Jan 14, 2014
6992110 Nov 05, 2021 U-882
MILNACIPRAN HYDROCHLORIDE - SAVELLA
N022256 004 6602911 Nov 05, 2021 U-882 NCE Jan 14, 2014
6992110 Nov 05, 2021 U-882
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N050808 001 5908838 Feb 19, 2018 U-917
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N050808 002 5908838 Feb 19, 2018 U-917
7541347 Apr 02, 2027 U-917
7544373 Apr 02, 2027 DP
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N050808 003 5908838 Feb 19, 2018 U-917
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N050808 004 5908838 Feb 19, 2018 U-917
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N050808 005 5908838 Feb 19, 2018 U-917
MINOXIDIL - MEN'S ROGAINE
N021812 001 6946120 Apr 20, 2019 DP U-702
MIRTAZAPINE - REMERON SOLTAB
N021208 001 5178878 Jan 12, 2010
MIRTAZAPINE - REMERON SOLTAB
N021208 002 5178878 Jan 12, 2010
MIRTAZAPINE - REMERON SOLTAB
N021208 003 5178878 Jan 12, 2010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 122 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
MODAFINIL - PROVIGIL
N020717 001 7297346 Nov 29, 2023 DP
7297346*PED May 29, 2024
RE37516 Oct 06, 2014 U-255
RE37516*PED Apr 06, 2015
MODAFINIL - PROVIGIL
N020717 002 7297346 Nov 29, 2023 DP
7297346*PED May 29, 2024
RE37516 Oct 06, 2014 U-255
RE37516*PED Apr 06, 2015
MOMETASONE FUROATE - ASMANEX TWISTHALER
N021067 001 5394868 Jun 25, 2012 DP NPP Feb 01, 2011
5394868*PED Dec 25, 2012
5687710 Nov 18, 2014 DP
5687710*PED May 18, 2015
5829434 Nov 03, 2015 DP
5829434*PED May 03, 2016
5889015 Jan 27, 2014 U-645
5889015*PED Jul 27, 2014
6057307 Jan 27, 2014 DP U-645
6057307*PED Jul 27, 2014
6240918 Feb 20, 2017 DP
6240918*PED Aug 20, 2017
6365581 Jan 27, 2014 U-645
6365581*PED Jul 27, 2014
6503537 Mar 17, 2018 DP
6503537*PED Sep 17, 2018
6677322 Jan 27, 2014 U-645
6677322*PED Jul 27, 2014
6949532 Jan 27, 2014 U-645
6949532*PED Jul 27, 2014
MOMETASONE FUROATE - ASMANEX TWISTHALER
N021067 002 5394868 Jun 25, 2012 DP NPP Feb 01, 2011
5394868*PED Dec 25, 2012
5687710 Nov 18, 2014 DP
5687710*PED May 18, 2015
5829434 Nov 03, 2015 DP
5829434*PED May 03, 2016
5889015 Jan 27, 2014 U-645
5889015*PED Jul 27, 2014
6057307 Jan 27, 2014 DP U-645
6057307*PED Jul 27, 2014
6240918 Feb 20, 2017 DP
6240918*PED Aug 20, 2017
6365581 Jan 27, 2014 U-645
6365581*PED Jul 27, 2014
6503537 Mar 17, 2018 DP
6503537*PED Sep 17, 2018
6677322 Jan 27, 2014 U-645
6677322*PED Jul 27, 2014
6949532 Jan 27, 2014 U-645
6949532*PED Jul 27, 2014
MOMETASONE FUROATE MONOHYDRATE - NASONEX
N020762 001 5837699 Jan 27, 2014 DP U-625
5837699*PED Jul 27, 2014
6127353 Oct 03, 2017 DS DP
6127353*PED Apr 03, 2018
6723713 Jan 27, 2014 U-625
6723713*PED Jul 27, 2014
MONTELUKAST SODIUM - SINGULAIR
N020829 002 5565473 Feb 03, 2012 DS DP U-228 I-530 Apr 13, 2010
5565473 Feb 03, 2012 DS DP U-807
5565473 Feb 03, 2012 DS DP U-675
5565473*PED Aug 03, 2012 U-228
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 123 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
MONTELUKAST SODIUM - SINGULAIR
N020830 001 5565473 Feb 03, 2012 DS DP U-807 I-530 Apr 13, 2010
5565473 Feb 03, 2012 DS DP U-228
5565473 Feb 03, 2012 DS DP U-675
5565473*PED Aug 03, 2012 U-228
MONTELUKAST SODIUM - SINGULAIR
N020830 002 5565473 Feb 03, 2012 DS DP U-807 I-530 Apr 13, 2010
5565473 Feb 03, 2012 DS DP U-675
5565473 Feb 03, 2012 DS DP U-228
5565473*PED Aug 03, 2012 U-228
MONTELUKAST SODIUM - SINGULAIR
N021409 001 5565473 Feb 03, 2012 DS DP U-675 I-530 Apr 13, 2010
5565473 Feb 03, 2012 DS DP U-807
5565473*PED Aug 03, 2012
MORPHINE SULFATE - AVINZA
N021260 001 6066339 Nov 25, 2017
MORPHINE SULFATE - AVINZA
N021260 002 6066339 Nov 25, 2017
MORPHINE SULFATE - AVINZA
N021260 003 6066339 Nov 25, 2017
MORPHINE SULFATE - AVINZA
N021260 004 6066339 Nov 25, 2017
MORPHINE SULFATE - AVINZA
N021260 005 6066339 Nov 25, 2017 DP
MORPHINE SULFATE - AVINZA
N021260 006 6066339 Nov 25, 2017 DP
MORPHINE SULFATE - DEPODUR
N021671 001 5723147 Mar 03, 2015 DP U-584
5807572 Sep 15, 2015 DP
5891467 Jan 31, 2017 DP
5931089 Jul 14, 2015 U-584
5962016 Jan 31, 2017 DP U-584
5997899 Sep 01, 2016 DP
6171613 Oct 01, 2016 DP
6193998 Sep 01, 2016 DP
6241999 Sep 01, 2016 DP
MORPHINE SULFATE - DEPODUR
N021671 002 5723147 Mar 03, 2015 DP U-584
5807572 Sep 15, 2015 DP
5891467 Jan 31, 2017 DP
5931089 Jul 14, 2015 U-584
5962016 Jan 31, 2017 DP U-584
5997899 Sep 01, 2016 DP
6171613 Oct 01, 2016 DP
6193998 Sep 01, 2016 DP
6241999 Sep 01, 2016 DP
MORPHINE SULFATE - DEPODUR
N021671 003 5723147 Mar 03, 2015 DP U-584
5807572 Sep 15, 2015 DP
5891467 Jan 31, 2017 DP
5931089 Jul 14, 2015 U-584
5962016 Jan 31, 2017 DP U-584
5997899 Sep 01, 2016 DP
6171613 Oct 01, 2016 DP
6193998 Sep 01, 2016 DP
6241999 Sep 01, 2016 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 124 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
MORPHINE SULFATE - KADIAN
N020616 001 5202128 Apr 13, 2010
5378474 Mar 23, 2010
MORPHINE SULFATE - KADIAN
N020616 002 5202128 Apr 13, 2010
5378474 Mar 23, 2010
MORPHINE SULFATE - KADIAN
N020616 003 5202128 Apr 13, 2010
5378474 Mar 23, 2010
MORPHINE SULFATE - KADIAN
N020616 004 5202128 Apr 13, 2010
5378474 Mar 23, 2010
MORPHINE SULFATE - KADIAN
N020616 005 5202128 Apr 13, 2010
5378474 Mar 23, 2010
MORPHINE SULFATE - KADIAN
N020616 006 5202128 Apr 13, 2010 DP
5378474 Mar 23, 2010 DP
MORPHINE SULFATE - KADIAN
N020616 007 5202128 Apr 13, 2010 DP
5378474 Mar 23, 2010 DP
MORPHINE SULFATE - KADIAN
N020616 008 5202128 Apr 13, 2010
5378474 Mar 23, 2010 DP
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N022321 001 5202128 Apr 13, 2010 DP U-43 NC Aug 13, 2012
5378474 Mar 23, 2010 DP
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N022321 002 5202128 Apr 13, 2010 DP U-43 NC Aug 13, 2012
5378474 Mar 23, 2010 DP
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N022321 003 5202128 Apr 13, 2010 DP U-43 NC Aug 13, 2012
5378474 Mar 23, 2010 DP
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N022321 004 5202128 Apr 13, 2010 DP U-43 NC Aug 13, 2012
5378474 Mar 23, 2010 DP
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N022321 005 5202128 Apr 13, 2010 DP U-43 NC Aug 13, 2012
5378474 Mar 23, 2010 DP
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N022321 006 5202128 Apr 13, 2010 DP U-43 NC Aug 13, 2012
5378474 Mar 23, 2010 DP
MOXIFLOXACIN HYDROCHLORIDE - AVELOX
N021085 001 4990517 Dec 08, 2011 DS DP U-298
5607942 Mar 04, 2014 U-298
5849752 Dec 05, 2016 U-298
6610327 Oct 29, 2019 DP U-298
MOXIFLOXACIN HYDROCHLORIDE - AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
N021277 001 4990517 Dec 08, 2011 DS DP U-298
5607942 Mar 04, 2014 U-298
5849752 Dec 05, 2016 U-298
6548079 Jul 25, 2020 DP U-298
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 125 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
MOXIFLOXACIN HYDROCHLORIDE - VIGAMOX
N021598 001 4990517 Dec 08, 2011 DS DP U-709
4990517*PED Jun 08, 2012
5607942 Mar 04, 2014 DS DP U-709
5607942*PED Sep 04, 2014
6716830 Sep 29, 2019 DP
6716830*PED Mar 29, 2020
MUPIROCIN - CENTANY
N050788 001 6013657 Jul 08, 2018 DP
MYCOPHENOLATE MOFETIL - CELLCEPT
N050759 001 5688529 Nov 18, 2014 DP
MYCOPHENOLATE MOFETIL HYDROCHLORIDE - CELLCEPT
N050758 001 5543408 Sep 15, 2013 DP
MYCOPHENOLIC ACID - MYFORTIC
N050791 001 6025391 Apr 10, 2017 DP U-908
6172107 Apr 10, 2017 DP U-908
6306900 Apr 10, 2017 DP
MYCOPHENOLIC ACID - MYFORTIC
N050791 002 6025391 Apr 10, 2017 DP U-908
6172107 Apr 10, 2017 DP U-908
6306900 Apr 10, 2017 DP
NALTREXONE - VIVITROL
N021897 001 5792477 May 02, 2017 DP
5916598 May 02, 2017 DP
6110503 May 02, 2017 DP
6194006 Dec 30, 2018 DP
6264987 May 19, 2020 DP
6331317 Nov 12, 2019 DP
6379703 Dec 30, 2018 DP
6379704 May 19, 2020 DP
6395304 Nov 12, 2019 DP
6403114 May 02, 2017 DP
6495164 May 25, 2020 DP
6495166 Nov 12, 2019 DP
6534092 May 19, 2020 DP
6537586 Nov 12, 2019 DP
6596316 Dec 30, 2018 DP
6667061 May 25, 2020 DP
6713090 Nov 12, 2019 DP
6939033 Nov 12, 2019 DP
NAPROXEN SODIUM - NAPRELAN
N020353 001 5637320 Jun 10, 2014
NAPROXEN SODIUM - NAPRELAN
N020353 002 5637320 Jun 10, 2014
NAPROXEN SODIUM - NAPRELAN
N020353 003 5637320 Jun 10, 2014
NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE - TREXIMET
N021926 001 6060499 Aug 14, 2017 DP U-867 NC Apr 15, 2011
6586458 Aug 14, 2017 DP U-867
7332183 Oct 02, 2025 DP U-867
NARATRIPTAN HYDROCHLORIDE - AMERGE
N020763 001 4997841 Jul 07, 2010 U-232
NARATRIPTAN HYDROCHLORIDE - AMERGE
N020763 002 4997841 Jul 07, 2010 U-232
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 126 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
NATEGLINIDE - STARLIX
N021204 001 5463116 Oct 21, 2012
5488150 Jan 30, 2013
6559188 Sep 15, 2020 DP U-827
6641841 Nov 14, 2017 DP U-214
6844008 Nov 14, 2017 DP U-214
6878749 Sep 15, 2020 DP
RE34878 Sep 08, 2009
NATEGLINIDE - STARLIX
N021204 002 5463116 Oct 21, 2012
5488150 Jan 30, 2013
6559188 Sep 15, 2020 DP U-827
6641841 Nov 14, 2017 DP U-214
6844008 Nov 14, 2017 DP U-214
6878749 Sep 15, 2020 DP
RE34878 Sep 08, 2009
NEBIVOLOL HYDROCHLORIDE - BYSTOLIC
N021742 002 5759580 Jun 02, 2015 DP NCE Dec 17, 2012
6545040 Apr 08, 2020 DP U-3
NEBIVOLOL HYDROCHLORIDE - BYSTOLIC
N021742 003 5759580 Jun 02, 2015 DP NCE Dec 17, 2012
6545040 Apr 08, 2020 DP U-3
NEBIVOLOL HYDROCHLORIDE - BYSTOLIC
N021742 004 5759580 Jun 02, 2015 DP NCE Dec 17, 2012
6545040 Apr 08, 2020 DP U-3
NEBIVOLOL HYDROCHLORIDE - BYSTOLIC
N021742 005 NCE Dec 17, 2012
NEDOCROMIL SODIUM - ALOCRIL
N021009 001 RE38628 Aug 22, 2012 U-304
NELARABINE - ARRANON
N021877 001 5424295 Jun 13, 2012 DS DP NCE Oct 28, 2010
5492897 Feb 20, 2013 U-689 ODE Oct 28, 2012
5747472 Feb 20, 2013 U-696
5747472 Feb 20, 2013 U-689
5747472 Feb 20, 2013 U-695
5821236 Feb 20, 2013 U-695
NELFINAVIR MESYLATE - VIRACEPT
N020778 001 5484926 Oct 07, 2013
5484926*PED Apr 07, 2014
5952343 Oct 07, 2013 U-257
5952343*PED Apr 07, 2014 U-257
6162812 Oct 07, 2013 U-248
6162812*PED Apr 07, 2014 U-248
NELFINAVIR MESYLATE - VIRACEPT
N020779 001 5484926 Oct 07, 2013
5484926*PED Apr 07, 2014
5952343 Oct 07, 2013 U-257
5952343*PED Apr 07, 2014 U-257
6162812 Oct 07, 2013 U-248
6162812*PED Apr 07, 2014 U-248
NELFINAVIR MESYLATE - VIRACEPT
N021503 001 5484926 Oct 07, 2013
5484926*PED Apr 07, 2014
5952343 Oct 07, 2013 U-257
5952343*PED Apr 07, 2014 U-257
6162812 Oct 07, 2013 U-248
6162812*PED Apr 07, 2014 U-248
NEPAFENAC - NEVANAC
N021862 001 5475034 Jun 06, 2014 U-100 NCE Aug 19, 2010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 127 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
NESIRITIDE RECOMBINANT - NATRECOR
N020920 001 5114923 May 19, 2014 DS DP U-855
NEVIRAPINE - VIRAMUNE
N020636 001 5366972 Nov 22, 2011 U-167
5366972*PED May 22, 2012
NEVIRAPINE - VIRAMUNE
N020933 001 5366972 Nov 22, 2011
5366972*PED May 22, 2012
NIACIN - NIASPAN
N020381 001 6080428 May 27, 2017 U-331
6129930 Sep 20, 2013 U-354
6406715 Sep 20, 2013 U-450
6746691 Sep 20, 2013 U-586
6818229 Feb 15, 2014 DP
7011848 Sep 20, 2013 U-712
NIACIN - NIASPAN
N020381 002 6080428 May 27, 2017 U-331
6129930 Sep 20, 2013 U-354
6406715 Sep 20, 2013 U-450
6469035 Mar 15, 2018 U-768
6676967 Sep 20, 2013 U-548
6746691 Sep 20, 2013 U-586
6818229 Feb 15, 2014 DP
7011848 Sep 20, 2013 U-712
NIACIN - NIASPAN
N020381 003 6080428 May 27, 2017 U-331
6129930 Sep 20, 2013 U-354
6406715 Sep 20, 2013 U-450
6469035 Mar 15, 2018 U-768
6676967 Sep 20, 2013 U-548
6746691 Sep 20, 2013 U-586
6818229 Feb 15, 2014 DP
7011848 Sep 20, 2013 U-712
NIACIN - NIASPAN
N020381 004 6080428 May 27, 2017 U-331
6129930 Sep 20, 2013 U-354
6406715 Sep 20, 2013 U-450
6469035 Mar 15, 2018 U-768
6676967 Sep 20, 2013 U-548
6746691 Sep 20, 2013 U-586
6818229 Feb 15, 2014 DP
7011848 Sep 20, 2013 U-712
NIACIN - NIASPAN TITRATION STARTER PACK
N020381 005 6080428 May 27, 2017 U-331
6129930 Sep 20, 2013 U-354
6406715 Sep 20, 2013 U-450
6746691 Sep 20, 2013 U-586
7011848 Sep 20, 2013 U-712
NIACIN; SIMVASTATIN - SIMCOR
N022078 001 6080428 May 27, 2017 U-862 NC Feb 15, 2011
6129930 Sep 20, 2013 DP U-862
6406715 Sep 20, 2013 DP
6469035 Mar 15, 2018 U-863
6676967 Sep 20, 2013 U-862
6746691 Sep 20, 2013 DP
6818229 Feb 15, 2014 DP
7011848 Sep 20, 2013 U-862
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 128 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
NIACIN; SIMVASTATIN - SIMCOR
N022078 002 6080428 May 27, 2017 U-862 NC Feb 15, 2011
6129930 Sep 20, 2013 DP U-862
6406715 Sep 20, 2013 DP
6469035 Mar 15, 2018 U-863
6676967 Sep 20, 2013 U-862
6746691 Sep 20, 2013 DP
6818229 Feb 15, 2014 DP
7011848 Sep 20, 2013 U-862
NIACIN; SIMVASTATIN - SIMCOR
N022078 003 6080428 May 27, 2017 U-862 NC Feb 15, 2011
6129930 Sep 20, 2013 DP U-862
6406715 Sep 20, 2013 DP
6469035 Mar 15, 2018 U-863
6676967 Sep 20, 2013 U-862
6746691 Sep 20, 2013 DP
6818229 Feb 15, 2014 DP
7011848 Sep 20, 2013 U-862
NICARDIPINE HYDROCHLORIDE - CARDENE
N019734 001 5164405 Nov 17, 2009
NICARDIPINE HYDROCHLORIDE - CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
N019734 004 7612102 Dec 26, 2027 DP
NICARDIPINE HYDROCHLORIDE - CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
N019734 003 7612102 Dec 26, 2027 DP
NICARDIPINE HYDROCHLORIDE - CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
N019734 002 7612102 Dec 26, 2027 DP
NICARDIPINE HYDROCHLORIDE - CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
N019734 005 7612102 Dec 26, 2027 DP
NICARDIPINE HYDROCHLORIDE - CARDENE SR
N020005 001 5198226 Mar 30, 2010
NICARDIPINE HYDROCHLORIDE - CARDENE SR
N020005 002 5198226 Mar 30, 2010
NICARDIPINE HYDROCHLORIDE - CARDENE SR
N020005 003 5198226 Mar 30, 2010
NICOTINE - NICODERM CQ
N020165 004 5508038 Apr 16, 2013
NICOTINE - NICODERM CQ
N020165 005 5508038 Apr 16, 2013
NICOTINE - NICODERM CQ
N020165 006 5508038 Apr 16, 2013
NICOTINE - NICOTROL
N020385 001 5656255 Aug 12, 2014
NICOTINE - NICOTROL
N020536 001 5501236 Jun 08, 2010
6098632 Jun 08, 2010
NICOTINE - NICOTROL
N020714 001 5167242 Jun 08, 2010
5400808 Jun 08, 2010
5501236 Jun 08, 2010
6098632 Jun 08, 2010
NICOTINE POLACRILEX - COMMIT
N021330 001 5110605 Aug 21, 2010
NICOTINE POLACRILEX - COMMIT
N021330 002 5110605 Aug 21, 2010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 129 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
NICOTINE POLACRILEX - NICORETTE
N022360 001 5110605 Aug 21, 2010 DP
NICOTINE POLACRILEX - NICORETTE
N022360 002 5110605 Aug 21, 2010 DP
NIFEDIPINE - ADALAT CC
N020198 001 5264446 Nov 23, 2010
NIFEDIPINE - ADALAT CC
N020198 002 5264446 Nov 23, 2010
NIFEDIPINE - ADALAT CC
N020198 003 5264446 Nov 23, 2010
NIFEDIPINE - PROCARDIA XL
N019684 001 5264446 Nov 23, 2010
NIFEDIPINE - PROCARDIA XL
N019684 002 5264446 Nov 23, 2010
NIFEDIPINE - PROCARDIA XL
N019684 003 5264446 Nov 23, 2010
NILOTINIB HYDROCHLORIDE MONOHYDRATE - TASIGNA
N022068 001 7169791 Jul 04, 2023 DS DP U-836 NCE Oct 29, 2012
ODE Oct 29, 2014
NISOLDIPINE - SULAR
N020356 005 5422123 Jun 06, 2012 DP
5626874 Nov 30, 2014 DP
NISOLDIPINE - SULAR
N020356 006 5422123 Jun 06, 2012 DP
5626874 Nov 30, 2014 DP
NISOLDIPINE - SULAR
N020356 007 5422123 Jun 06, 2012 DP
5626874 Nov 30, 2014 DP
NISOLDIPINE - SULAR
N020356 008 5422123 Jun 06, 2012 DP
5626874 Nov 30, 2014 DP
NITAZOXANIDE - ALINIA
N021497 001 5387598 Feb 07, 2012 DP U-524 ODE Nov 22, 2009
5578621 Nov 26, 2013 DP U-525
5968961 May 07, 2017 DP
6020353 Sep 18, 2014 DS DP
NITAZOXANIDE - ALINIA
N021498 001 5387598 Feb 07, 2012 U-524 ODE Nov 22, 2009
5578621 Sep 08, 2014 U-525 ODE Nov 22, 2009
5965590 Jul 03, 2017 U-523
5968961 May 07, 2017
6020353 Sep 08, 2014
6117894 May 07, 2017
NITISINONE - ORFADIN
N021232 001 5550165 Aug 27, 2013
NITISINONE - ORFADIN
N021232 002 5550165 Aug 27, 2013
NITISINONE - ORFADIN
N021232 003 5550165 Aug 27, 2013
NITRIC OXIDE - INOMAX
N020845 002 5485827 Jan 23, 2013 U-297
5873359 Jan 23, 2013 U-297
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 130 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
NITRIC OXIDE - INOMAX
N020845 003 5485827 Jan 23, 2013 U-297
5873359 Jan 23, 2013 U-297
NITROGLYCERIN - NITRO-DUR
N020145 001 5186938 Feb 16, 2010
NITROGLYCERIN - NITRO-DUR
N020145 002 5186938 Feb 16, 2010
NITROGLYCERIN - NITRO-DUR
N020145 003 5186938 Feb 16, 2010
NITROGLYCERIN - NITRO-DUR
N020145 004 5186938 Feb 16, 2010
NITROGLYCERIN - NITRO-DUR
N020145 005 5186938 Feb 16, 2010
NITROGLYCERIN - NITRO-DUR
N020145 006 5186938 Feb 16, 2010
NITROGLYCERIN - NITROLINGUAL PUMPSPRAY
N018705 002 5186925 Mar 06, 2011 DP
NITROGLYCERIN - NITROMIST
N021780 001 5869082 Apr 16, 2016 DP NP Nov 02, 2009
NITROGLYCERIN - NITROSTAT
N021134 001 6500456 Sep 16, 2018
NITROGLYCERIN - NITROSTAT
N021134 002 6500456 Sep 16, 2018
NITROGLYCERIN - NITROSTAT
N021134 003 6500456 Sep 16, 2018
NIZATIDINE - AXID
N021494 001 6930119 Jul 17, 2022 DP
OCTREOTIDE ACETATE - SANDOSTATIN
N019667 001 5753618 May 19, 2015
5753618*PED Nov 19, 2015
OCTREOTIDE ACETATE - SANDOSTATIN
N019667 002 5753618 May 19, 2015
5753618*PED Nov 19, 2015
OCTREOTIDE ACETATE - SANDOSTATIN
N019667 003 5753618 May 19, 2015
5753618*PED Nov 19, 2015
OCTREOTIDE ACETATE - SANDOSTATIN
N019667 004 5753618 May 19, 2015
5753618*PED Nov 19, 2015
OCTREOTIDE ACETATE - SANDOSTATIN
N019667 005 5753618 May 19, 2015
5753618*PED Nov 19, 2015
OCTREOTIDE ACETATE - SANDOSTATIN LAR
N021008 001 5538739 Jul 23, 2013 DP M-73 Mar 03, 2011
5538739*PED Jan 23, 2014 PED Nov 10, 2009
5639480 Jun 17, 2014 DP
5639480*PED Dec 17, 2014
5688530 Nov 18, 2014 U-268
5688530*PED May 18, 2015
5922338 Jul 13, 2016 DP
5922338*PED Jan 13, 2017
5922682 Jul 13, 2016 DP
5922682*PED Jan 13, 2017
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 131 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
OCTREOTIDE ACETATE - SANDOSTATIN LAR
N021008 002 5538739 Jul 23, 2013 M-73 Mar 03, 2011
5538739*PED Jan 23, 2014 PED Nov 10, 2009
5639480 Jun 17, 2014 DP
5639480*PED Dec 17, 2014
5688530 Nov 18, 2014 U-268
5688530*PED May 18, 2015
5922338 Jul 13, 2016 DP
5922338*PED Jan 13, 2017
5922682 Jul 13, 2016 DP
5922682*PED Jan 13, 2017
OCTREOTIDE ACETATE - SANDOSTATIN LAR
N021008 003 5538739 Jul 23, 2013 M-73 Mar 03, 2011
5538739*PED Jan 23, 2014 PED Nov 25, 2009
5639480 Jun 17, 2014 DP
5639480*PED Dec 17, 2014
5688530 Nov 18, 2014 U-268
5688530*PED May 18, 2015
5922338 Jul 13, 2016 DP
5922338*PED Jan 13, 2017
5922682 Jul 13, 2016 DP
5922682*PED Jan 13, 2017
OFLOXACIN - FLOXIN OTIC
N020799 001 5401741 Mar 27, 2012 U-407
OLANZAPINE - ZYPREXA
N020592 001 5229382 Apr 23, 2011 DS DP U-149 I-591 Mar 19, 2012
5229382 Apr 23, 2011 DS DP U-547 NPP Dec 04, 2012
5229382*PED Oct 23, 2011 NPP Dec 04, 2012
5605897 Feb 25, 2014 U-176
5605897*PED Aug 25, 2014 PED Jun 04, 2013
5627178 Apr 23, 2011 U-364 PED Jun 04, 2013
5627178*PED Oct 23, 2011
5736541 Mar 24, 2015 U-307
5736541*PED Sep 24, 2015
5817655 Apr 23, 2011 U-364
5817655*PED Oct 23, 2011
5817656 Apr 23, 2011 U-360
5817656*PED Oct 23, 2011
5817657 Apr 23, 2011 U-363
5817657*PED Oct 23, 2011
5919485 Mar 24, 2015 U-308
5919485*PED Sep 24, 2015
6251895 Sep 23, 2017
6251895*PED Mar 23, 2018
6960577 Nov 01, 2017 U-963
OLANZAPINE - ZYPREXA
N020592 002 5229382 Apr 23, 2011 DS DP U-547 I-591 Mar 19, 2012
5229382 Apr 23, 2011 DS DP U-149 NPP Dec 04, 2012
5229382*PED Oct 23, 2011 NPP Dec 04, 2012
5605897 Feb 25, 2014 U-176
5605897*PED Aug 25, 2014 PED Jun 04, 2013
5627178 Apr 23, 2011 U-364 PED Jun 04, 2013
5627178*PED Oct 23, 2011
5736541 Mar 24, 2015 U-307
5736541*PED Sep 24, 2015
5817655 Apr 23, 2011 U-364
5817655*PED Oct 23, 2011
5817656 Apr 23, 2011 U-360
5817656*PED Oct 23, 2011
5817657 Apr 23, 2011 U-363
5817657*PED Oct 23, 2011
5919485 Mar 24, 2015 U-308
5919485*PED Sep 24, 2015
6251895 Sep 23, 2017
6251895*PED Mar 23, 2018
6960577 Nov 01, 2017 U-963
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 132 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
OLANZAPINE - ZYPREXA
N020592 003 5229382 Apr 23, 2011 DS DP U-149 I-591 Mar 19, 2012
5229382 Apr 23, 2011 DS DP U-547 NPP Dec 04, 2012
5229382*PED Oct 23, 2011 NPP Dec 04, 2012
5605897 Feb 25, 2014 U-176
5605897*PED Aug 25, 2014 PED Jun 04, 2013
5627178 Apr 23, 2011 U-364 PED Jun 04, 2013
5627178*PED Oct 23, 2011
5736541 Mar 24, 2015 U-307
5736541*PED Sep 24, 2015
5817655 Apr 23, 2011 U-364
5817655*PED Oct 23, 2011
5817656 Apr 23, 2011 U-360
5817656*PED Oct 23, 2011
5817657 Apr 23, 2011 U-363
5817657*PED Oct 23, 2011
5919485 Mar 24, 2015 U-308
5919485*PED Sep 24, 2015
6251895 Sep 23, 2017
6251895*PED Mar 23, 2018
6960577 Nov 01, 2017 U-963
OLANZAPINE - ZYPREXA
N020592 004 5229382 Apr 23, 2011 DS DP U-547 I-591 Mar 19, 2012
5229382 Apr 23, 2011 DS DP U-149 NPP Dec 04, 2012
5229382*PED Oct 23, 2011 NPP Dec 04, 2012
5605897 Feb 25, 2014 U-176
5605897*PED Aug 25, 2014 PED Jun 04, 2013
5627178 Apr 23, 2011 U-364 PED Jun 04, 2013
5627178*PED Oct 23, 2011
5736541 Mar 24, 2015 U-307
5736541*PED Sep 24, 2015
5817655 Apr 23, 2011 U-364
5817655*PED Oct 23, 2011
5817656 Apr 23, 2011 U-360
5817656*PED Oct 23, 2011
5817657 Apr 23, 2011 U-363
5817657*PED Oct 23, 2011
5919485 Mar 24, 2015 U-308
5919485*PED Sep 24, 2015
6251895 Sep 23, 2017
6251895*PED Mar 23, 2018
6960577 Nov 01, 2017 U-963
OLANZAPINE - ZYPREXA
N020592 005 5229382 Apr 23, 2011 DS DP U-547 I-591 Mar 19, 2012
5229382 Apr 23, 2011 DS DP U-149 NPP Dec 04, 2012
5229382*PED Oct 23, 2011 NPP Dec 04, 2012
5605897 Feb 25, 2014 U-176
5605897*PED Aug 25, 2014 PED Jun 04, 2013
5627178 Apr 23, 2011 U-364 PED Jun 04, 2013
5627178*PED Oct 23, 2011
5736541 Mar 24, 2015 U-307
5736541*PED Sep 24, 2015
5817655 Apr 23, 2011 U-364
5817655*PED Oct 23, 2011
5817656 Apr 23, 2011 U-360
5817656*PED Oct 23, 2011
5817657 Apr 23, 2011 U-363
5817657*PED Oct 23, 2011
5919485 Mar 24, 2015 U-308
5919485*PED Sep 24, 2015
6251895 Sep 23, 2017
6251895*PED Mar 23, 2018
6960577 Nov 01, 2017 U-963
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 133 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
OLANZAPINE - ZYPREXA
N020592 006 5229382 Apr 23, 2011 DS DP U-149 I-591 Mar 19, 2012
5229382 Apr 23, 2011 DS DP U-547 NPP Dec 04, 2012
5229382*PED Oct 23, 2011 NPP Dec 04, 2012
5605897 Feb 25, 2014 U-176
5605897*PED Aug 25, 2014 PED Jun 04, 2013
5627178 Apr 23, 2011 U-364 PED Jun 04, 2013
5627178*PED Oct 23, 2011
5736541 Mar 24, 2015 U-307
5736541*PED Sep 24, 2015
5817655 Apr 23, 2011 U-364
5817655*PED Oct 23, 2011
5817656 Apr 23, 2011 U-360
5817656*PED Oct 23, 2011
5817657 Apr 23, 2011 U-363
5817657*PED Oct 23, 2011
5919485 Mar 24, 2015 U-308
5919485*PED Sep 24, 2015
6251895 Sep 23, 2017
6251895*PED Mar 23, 2018
6960577 Nov 01, 2017 U-963
OLANZAPINE - ZYPREXA
N021253 001 5229382 Apr 23, 2011 DS DP U-571
5229382*PED Oct 23, 2011
OLANZAPINE - ZYPREXA ZYDIS
N021086 001 5229382 Apr 23, 2011 U-324 I-591 Mar 19, 2012
5229382*PED Oct 23, 2011
6960577 Nov 01, 2017 U-964
OLANZAPINE - ZYPREXA ZYDIS
N021086 002 5229382 Apr 23, 2011 U-324 I-591 Mar 19, 2012
5229382*PED Oct 23, 2011
6960577 Nov 01, 2017 U-964
OLANZAPINE - ZYPREXA ZYDIS
N021086 003 5229382 Apr 23, 2011 U-324 I-591 Mar 19, 2012
5229382*PED Oct 23, 2011
6960577 Nov 01, 2017 U-964
OLANZAPINE - ZYPREXA ZYDIS
N021086 004 5229382 Apr 23, 2011 U-324 I-591 Mar 19, 2012
5229382*PED Oct 23, 2011
6960577 Nov 01, 2017 U-964
OLANZAPINE PAMOATE - ZYPREXA RELPREVV
N022173 001 5229382 Apr 23, 2011 DS DP U-1026 NP Dec 11, 2012
5229382 Apr 23, 2011 DS DP U-543
5229382*PED Oct 23, 2011
6169084 Sep 30, 2018 DP U-1026
OLANZAPINE PAMOATE - ZYPREXA RELPREVV
N022173 002 5229382 Apr 23, 2011 DS DP U-1026 NP Dec 11, 2012
5229382 Apr 23, 2011 DS DP U-543
5229382*PED Oct 23, 2011
6169084 Sep 30, 2018 DP U-1026
OLANZAPINE PAMOATE - ZYPREXA RELPREVV
N022173 003 5229382 Apr 23, 2011 DS DP U-543 NP Dec 11, 2012
5229382 Apr 23, 2011 DS DP U-1026
5229382*PED Oct 23, 2011
6169084 Sep 30, 2018 DP U-1026
OLMESARTAN MEDOXOMIL - BENICAR
N021286 001 5616599 Apr 25, 2016 DS DP U-500
5616599*PED Oct 25, 2016
6878703 Nov 19, 2021 U-3 Y
6878703*PED May 19, 2022
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 134 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
OLMESARTAN MEDOXOMIL - BENICAR
N021286 003 5616599 Apr 25, 2016 DS DP U-500
5616599*PED Oct 25, 2016
6878703 Nov 19, 2021 U-3 Y
6878703*PED May 19, 2022
OLMESARTAN MEDOXOMIL - BENICAR
N021286 004 5616599 Apr 25, 2016 DS DP U-500
5616599*PED Oct 25, 2016
6878703 Nov 19, 2021 U-3 Y
6878703*PED May 19, 2022
OLOPATADINE HYDROCHLORIDE - PATADAY
N021545 001 5116863 Dec 18, 2010 DS DP
5116863*PED Jun 18, 2011
5641805 Jun 06, 2015 U-765
5641805*PED Dec 06, 2015
6995186 Nov 12, 2023 DP U-765
6995186*PED May 12, 2024
7402609 Jun 19, 2022 DP
7402609*PED Dec 19, 2022
OLOPATADINE HYDROCHLORIDE - PATANASE
N021861 001 5116863 Dec 18, 2010 DS DP NPP Dec 01, 2012
5116863*PED Jun 18, 2011 NDF Apr 15, 2011
PED Jun 01, 2013
PED Oct 15, 2011
OLOPATADINE HYDROCHLORIDE - PATANOL
N020688 001 5116863 Dec 18, 2010
5116863*PED Jun 18, 2011
5641805 Jun 06, 2015 U-184
5641805*PED Dec 06, 2015
OMEGA-3-ACID ETHYL ESTERS - LOVAZA
N021654 001 5502077 Mar 26, 2013 DS U-822 M-87 Sep 16, 2012
5656667 Apr 10, 2017 DS DP U-822 M-64 Jun 12, 2010
5698594 Aug 04, 2009 DS U-822 NCE Nov 10, 2009
OMEPRAZOLE - PRILOSEC
N019810 001 6147103 Oct 09, 2018
6147103*PED Apr 09, 2019
6150380 Nov 10, 2018
6150380*PED May 10, 2019
6166213 Oct 09, 2018
6166213*PED Apr 09, 2019
6191148 Oct 09, 2018
6191148*PED Apr 09, 2019
OMEPRAZOLE - PRILOSEC
N019810 002 6147103 Oct 09, 2018
6147103*PED Apr 09, 2019
6150380 Nov 10, 2018
6150380*PED May 10, 2019
6166213 Oct 09, 2018
6166213*PED Apr 09, 2019
6191148 Oct 09, 2018
6191148*PED Apr 09, 2019
OMEPRAZOLE - PRILOSEC
N019810 003 6147103 Oct 09, 2018
6147103*PED Apr 09, 2019
6150380 Nov 10, 2018
6150380*PED May 10, 2019
6166213 Oct 09, 2018
6166213*PED Apr 09, 2019
6191148 Oct 09, 2018
6191148*PED Apr 09, 2019
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 135 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
OMEPRAZOLE MAGNESIUM - OMEPRAZOLE MAGNESIUM
A078878 001 PC Jun 07, 2010
OMEPRAZOLE MAGNESIUM - PRILOSEC
N022056 001 5690960 Nov 25, 2014 DP U-864 NPP Mar 20, 2011
5900424 May 04, 2016 DS U-864 PED Sep 20, 2011
6428810 Nov 03, 2019 DP U-864
OMEPRAZOLE MAGNESIUM - PRILOSEC
N022056 002 5690960 Nov 25, 2014 DP U-864 NPP Mar 20, 2011
5900424 May 04, 2016 DS U-864 PED Sep 20, 2011
6428810 Nov 03, 2019 DP U-864
OMEPRAZOLE MAGNESIUM - PRILOSEC OTC
N021229 001 5690960 Nov 25, 2014
5753265 Jun 07, 2015
5817338 Oct 06, 2015
5900424 May 04, 2016
6403616 Nov 15, 2019
6428810 Nov 03, 2019
OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID
N021636 001 5840737 Jul 16, 2016 U-588
6489346 Jul 16, 2016 DS DP U-588
6645988 Jul 16, 2016 DS DP
6699885 Jul 16, 2016 U-588
6780882 Jul 16, 2016 DS DP
7399772 Jul 16, 2016 U-588
OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID
N021636 002 5840737 Jul 16, 2016 U-623
5840737 Jul 16, 2016 U-624
6489346 Jul 16, 2016 DS DP U-624
6489346 Jul 16, 2016 DS DP U-623
6645988 Jul 16, 2016 DS DP
6699885 Jul 16, 2016 U-623
6699885 Jul 16, 2016 U-624
6780882 Jul 16, 2016 DS DP
7399772 Jul 16, 2016 U-623
7399772 Jul 16, 2016 U-624
OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID
N021849 001 6489346 Jul 16, 2016 DS DP U-588
6645988 Jul 16, 2016 DS DP
6699885 Jul 16, 2016 U-588
7399772 Jul 16, 2016 U-588
OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID
N021849 002 6489346 Jul 16, 2016 DS DP U-623
6645988 Jul 16, 2016 DS DP
6699885 Jul 16, 2016 U-623
7399772 Jul 16, 2016 U-623
OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID OTC
N022281 001 6489346 Jul 15, 2016 DP U-1025
6645988 Jul 15, 2016 DP
6699885 Jul 15, 2016 DP
7399772 Jul 15, 2016 U-1025
ONDANSETRON - ZOFRAN ODT
N020781 001 5955488 Nov 14, 2015
5955488*PED May 14, 2016
6063802 Nov 14, 2015
6063802*PED May 14, 2016
ONDANSETRON - ZOFRAN ODT
N020781 002 5955488 Nov 14, 2015
5955488*PED May 14, 2016
6063802 Nov 14, 2015
6063802*PED May 14, 2016
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 136 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ONDANSETRON HYDROCHLORIDE - ZOFRAN
N020103 001 5344658 Sep 06, 2011
5344658*PED Mar 06, 2012
ONDANSETRON HYDROCHLORIDE - ZOFRAN
N020103 002 5344658 Sep 06, 2011
5344658*PED Mar 06, 2012
ONDANSETRON HYDROCHLORIDE - ZOFRAN
N020103 003 5344658 Sep 06, 2011
5344658*PED Mar 06, 2012
ONDANSETRON HYDROCHLORIDE - ZOFRAN
N020605 001 5854270 Nov 20, 2015 DP U-44
5854270*PED May 20, 2016
ORLISTAT - ALLI
N021887 001 6004996 Jan 06, 2018 DP NP Feb 07, 2010
ORLISTAT - XENICAL
N020766 001 4598089*PED Dec 18, 2009
6004996 Jan 06, 2018
6004996*PED Jul 06, 2018
OSELTAMIVIR PHOSPHATE - TAMIFLU
N021087 001 5763483 Dec 27, 2016
5763483*PED Jun 27, 2017
5866601 Feb 02, 2016
5866601*PED Aug 02, 2016
5952375 Feb 02, 2016
5952375*PED Aug 02, 2016
OSELTAMIVIR PHOSPHATE - TAMIFLU
N021246 001 5763483 Dec 27, 2016 U-376
5763483*PED Jun 27, 2017
5866601 Feb 02, 2016
5866601*PED Aug 02, 2016
5952375 Feb 02, 2016
5952375*PED Aug 02, 2016
OXALIPLATIN - ELOXATIN
N021492 001 5290961 Jan 12, 2013 DS M-61 Jan 10, 2010
5290961*PED Jul 12, 2013 PED Jul 10, 2010
5338874 Apr 07, 2013 DS
5338874*PED Oct 07, 2013
5420319 Aug 09, 2016 DS
5420319*PED Feb 09, 2017
OXALIPLATIN - ELOXATIN
N021492 002 5290961 Jan 12, 2013 DS M-61 Jan 10, 2010
5290961*PED Jul 12, 2013 PED Jul 10, 2010
5338874 Apr 07, 2013 DS
5338874*PED Oct 07, 2013
5420319 Aug 09, 2016 DS
5420319*PED Feb 09, 2017
OXALIPLATIN - ELOXATIN
N021759 001 5290961 Jan 12, 2013 DS
5290961*PED Jul 12, 2013
5338874 Apr 07, 2013 DS
5338874*PED Oct 07, 2013
5420319 Aug 09, 2016 DS
5420319*PED Feb 09, 2017
5716988 Aug 07, 2015 DP
5716988*PED Feb 07, 2016
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 137 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
OXALIPLATIN - ELOXATIN
N021759 002 5290961 Jan 12, 2013 DS
5290961*PED Jul 12, 2013
5338874 Apr 07, 2013 DS
5338874*PED Oct 07, 2013
5420319 Aug 09, 2016 DS
5420319*PED Feb 09, 2017
5716988 Aug 07, 2015 DP
5716988*PED Feb 07, 2016
OXALIPLATIN - ELOXATIN
N021759 003 5290961 Jan 12, 2013 DS
5290961*PED Jul 12, 2013
5338874 Apr 07, 2013 DS
5338874*PED Oct 07, 2013
5420319 Aug 09, 2016 DS
5420319*PED Feb 09, 2017
5716988 Aug 07, 2015 DP
5716988*PED Feb 07, 2016
OXANDROLONE - OXANDRIN
N013718 001 5872147 Dec 05, 2017 U-585
6090799 Jul 18, 2017 U-585
6576659 Dec 05, 2017 U-585
6670351 Oct 20, 2012 U-585
6828313 Dec 05, 2017 U-585
OXANDROLONE - OXANDRIN
N013718 002 5872147 Dec 05, 2017 U-585
6090799 Jul 18, 2017 U-585
6576659 Dec 05, 2017 U-585
6670351 Oct 20, 2012 U-585
6828313 Dec 05, 2017 U-585
OXAPROZIN POTASSIUM - DAYPRO ALTA
N020776 001 6030643 May 16, 2017 U-497
OXCARBAZEPINE - TRILEPTAL
N021014 001 7037525 Feb 12, 2018 U-724
7037525*PED Aug 12, 2018
OXCARBAZEPINE - TRILEPTAL
N021014 002 7037525 Feb 12, 2018 U-724
7037525*PED Aug 12, 2018
OXCARBAZEPINE - TRILEPTAL
N021014 003 7037525 Feb 12, 2018 U-724

7037525*PED Aug 12, 2018

OXCARBAZEPINE - TRILEPTAL
N021285 001 7037525 Feb 12, 2018 U-724
7037525*PED Aug 12, 2018
OXYBUTYNIN - OXYTROL
N021351 002 5164190 Dec 11, 2010
5601839 Apr 26, 2015
5834010 Apr 26, 2015
6743441 Apr 26, 2020 DP U-318
7081249 Apr 26, 2020 DP U-318
7081250 Apr 26, 2020 DP U-318
7081251 Apr 26, 2020 DP U-318
7081252 Apr 26, 2020 DP U-318
7179483 Apr 26, 2020 DS DP U-318
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 138 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
OXYBUTYNIN CHLORIDE - DITROPAN XL
N020897 001 5674895 May 22, 2015
5674895*PED Nov 22, 2015
5840754 May 22, 2015
5840754*PED Nov 22, 2015
5912268 May 22, 2015
5912268*PED Nov 22, 2015
6262115 May 22, 2015 U-393
6262115*PED Nov 22, 2015 U-393
6919092 May 22, 2015 DP U-667
6919092*PED Nov 22, 2015
OXYBUTYNIN CHLORIDE - DITROPAN XL
N020897 002 5674895 May 22, 2015
5674895*PED Nov 22, 2015
5840754 May 22, 2015
5840754*PED Nov 22, 2015
5912268 May 22, 2015
5912268*PED Nov 22, 2015
6262115 May 22, 2015 U-393
6262115*PED Nov 22, 2015 U-393
6919092 May 22, 2015 DP U-667
6919092*PED Nov 22, 2015
OXYBUTYNIN CHLORIDE - DITROPAN XL
N020897 003 5674895 May 22, 2015
5674895*PED Nov 22, 2015
5840754 May 22, 2015
5840754*PED Nov 22, 2015
5912268 May 22, 2015
5912268*PED Nov 22, 2015
6262115 May 22, 2015 U-393
6262115*PED Nov 22, 2015 U-393
6919092 May 22, 2015 DP U-667
6919092*PED Nov 22, 2015
OXYBUTYNIN CHLORIDE - GELNIQUE
N022204 001 7029694 Apr 26, 2020 DP U-318 NDF Jan 27, 2012
7179483 Apr 26, 2020 U-318
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N020553 001 5508042 Apr 16, 2013 U-443
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N020553 002 5508042 Apr 16, 2013 U-443
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N020553 003 5508042 Apr 16, 2013 U-443
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N020553 004 5508042 Apr 16, 2013 U-443
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N020553 005 5508042 Apr 16, 2013 U-443
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N020553 006 5508042 Apr 16, 2013 U-443
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N020553 007 5508042 Apr 16, 2013 U-443
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N020553 008 5508042 Apr 16, 2013 U-443
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N021610 001 5662933 Sep 09, 2013 DP
5958456 Sep 09, 2013 DP
7276250 Jul 03, 2022 DP U-826
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 139 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N021610 002 5662933 Sep 09, 2013 DP
5958456 Sep 09, 2013 DP
7276250 Jul 03, 2022 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N021610 003 5662933 Sep 09, 2013 DP
5958456 Sep 09, 2013 DP
7276250 Jul 03, 2022 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N021610 004 5662933 Sep 09, 2013 DP
5958456 Sep 09, 2013 DP
7276250 Jul 03, 2022 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N021610 005 5662933 Sep 09, 2013 DP
5958456 Sep 09, 2013 DP
7276250 Jul 03, 2022 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N021610 006 5662933 Sep 09, 2013 DP
5958456 Sep 09, 2013 DP
7276250 Jul 03, 2022 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N021610 007 5662933 Sep 09, 2013 DP
5958456 Sep 09, 2013 DP
7276250 Jul 03, 2022 DP U-826
PACLITAXEL - ABRAXANE
N021660 001 5439686 Feb 22, 2013 DP
5498421 Mar 12, 2013 DP U-634
6096331 Feb 22, 2013 DP U-633
6506405 Feb 22, 2013 DP U-633
6537579 Feb 22, 2013 U-632
6749868 Feb 22, 2013 DP
6753006 Feb 22, 2013 DP
PALIPERIDONE - INVEGA
N021999 001 5158952 Apr 09, 2012 DP U-90 I-605 Jul 31, 2012
I-606 Jul 31, 2012
I-531 Apr 27, 2010
NCE Dec 19, 2011
PALIPERIDONE - INVEGA
N021999 002 5158952 Apr 09, 2012 DP U-90 I-605 Jul 31, 2012
I-606 Jul 31, 2012
I-531 Apr 27, 2010
NCE Dec 19, 2011
PALIPERIDONE - INVEGA
N021999 003 5158952 Apr 09, 2012 DP U-90 I-605 Jul 31, 2012
I-606 Jul 31, 2012
I-531 Apr 27, 2010
NCE Dec 19, 2011
PALIPERIDONE - INVEGA
N021999 004 5158952 Apr 09, 2012 DP U-90 I-531 Apr 27, 2010
NCE Dec 19, 2011
PALIPERIDONE - INVEGA
N021999 006 5158952 Apr 09, 2012 DP U-90 I-605 Jul 31, 2012
I-606 Jul 31, 2012
I-531 Apr 27, 2010
NCE Dec 19, 2011
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 140 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
PALIPERIDONE PALMITATE - INVEGA SUSTENNA
N022264 001 5254556 Oct 27, 2010 DS DP U-543 NDF Jul 31, 2012
5352459 Dec 16, 2012 DP NCE Dec 19, 2011
6077843 May 12, 2017 DP U-543
6555544 Nov 10, 2018 DP U-543
PALIPERIDONE PALMITATE - INVEGA SUSTENNA
N022264 002 5254556 Oct 27, 2010 DS DP U-543 NDF Jul 31, 2012
5352459 Dec 16, 2012 DP NCE Dec 19, 2011
6077843 May 12, 2017 DP U-543
6555544 Nov 10, 2018 DP U-543
PALIPERIDONE PALMITATE - INVEGA SUSTENNA
N022264 003 5254556 Oct 27, 2010 DS DP U-543 NDF Jul 31, 2012
5352459 Dec 16, 2012 DP NCE Dec 19, 2011
6077843 May 12, 2017 DP U-543
6555544 Nov 10, 2018 DP U-543
PALIPERIDONE PALMITATE - INVEGA SUSTENNA
N022264 004 5254556 Oct 27, 2010 DS DP U-543 NDF Jul 31, 2012
5352459 Dec 16, 2012 DP NCE Dec 19, 2011
6077843 May 12, 2017 DP U-543
6555544 Nov 10, 2018 DP U-543
PALIPERIDONE PALMITATE - INVEGA SUSTENNA
N022264 005 5254556 Oct 27, 2010 DS DP U-543 NDF Jul 31, 2012
5352459 Dec 16, 2012 DP NCE Dec 19, 2011
6077843 May 12, 2017 DP U-543
6555544 Nov 10, 2018 DP U-543
PALONOSETRON HYDROCHLORIDE - ALOXI
N021372 001 5202333 Apr 13, 2015 DS DP U-528
PALONOSETRON HYDROCHLORIDE - ALOXI
N021372 002 5202333 Apr 13, 2015 DS DP U-901 I-556 Mar 01, 2011
NS Mar 01, 2011
PALONOSETRON HYDROCHLORIDE - ALOXI
N022233 001 5202333 Apr 13, 2015 DS DP U-528 NDF Aug 22, 2011
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - CREON
N020725 001 NCE Apr 30, 2014
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - CREON
N020725 002 NCE Apr 30, 2014
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - CREON
N020725 003 NCE Apr 30, 2014
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP
N022210 001 NCE Aug 27, 2014
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP
N022210 002 NCE Aug 27, 2014
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP
N022210 003 NCE Aug 27, 2014
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP
N022210 004 NCE Aug 27, 2014
PANTOPRAZOLE SODIUM - PROTONIX
N020987 001 4758579 Jul 19, 2010 I-614 Nov 12, 2012
4758579*PED Jan 19, 2011 M-54 Nov 12, 2012
5997903 Dec 07, 2016 PED May 12, 2013
5997903*PED Jun 07, 2017
PED May 12, 2013
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 141 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
PANTOPRAZOLE SODIUM - PROTONIX
N020987 002 4758579 Jul 19, 2010 I-614 Nov 12, 2012
4758579*PED Jan 19, 2011 M-54 Nov 12, 2012
5997903 Dec 07, 2016 PED May 12, 2013
5997903*PED Jun 07, 2017
PED May 12, 2013
PANTOPRAZOLE SODIUM - PROTONIX
N022020 001 4758579 Jul 19, 2010 DS DP U-859 I-614 Nov 12, 2012
4758579*PED Jan 19, 2011 M-54 Nov 12, 2012
7544370 Feb 07, 2026 DP PED May 12, 2013
7544370*PED Aug 07, 2026
7550153 Sep 30, 2024 U-859 PED May 12, 2013
7550153*PED Mar 30, 2025
7553498 Sep 30, 2024 U-859
7553498*PED Mar 30, 2025
PANTOPRAZOLE SODIUM - PROTONIX IV
N020988 001 4758579 Jul 19, 2010
4758579*PED Jan 19, 2011
6780881 Nov 17, 2021 DP
6780881*PED May 17, 2022
7351723 Nov 17, 2021 DP
7351723*PED May 17, 2022
PARICALCITOL - ZEMPLAR
N020819 001 5246925 Apr 17, 2012 U-314
5246925*PED Oct 17, 2012
5587497 Dec 24, 2013
5587497*PED Jun 24, 2014
6136799 Apr 08, 2018
6136799*PED Oct 08, 2018
6361758 Apr 08, 2018 DP
6361758*PED Oct 08, 2018
PARICALCITOL - ZEMPLAR
N020819 002 5246925 Apr 17, 2012 U-314
5246925*PED Oct 17, 2012
5587497 Dec 24, 2013
5587497*PED Jun 24, 2014
6136799 Apr 08, 2018
6136799*PED Oct 08, 2018
6361758 Apr 08, 2018 DP
6361758*PED Oct 08, 2018
PARICALCITOL - ZEMPLAR
N021606 001 5246925 Apr 17, 2012 U-671 I-599 Jun 29, 2012
5246925*PED Oct 17, 2012
5587497 Dec 24, 2013 DS
5587497*PED Jun 24, 2014
PARICALCITOL - ZEMPLAR
N021606 002 5246925 Apr 17, 2012 U-671 I-599 Jun 29, 2012
5246925*PED Oct 17, 2012
5587497 Dec 24, 2013 DS
5587497*PED Jun 24, 2014
PARICALCITOL - ZEMPLAR
N021606 003 5246925 Apr 17, 2012 U-671 I-599 Jun 29, 2012
5246925*PED Oct 17, 2012
5587497 Dec 24, 2013 DS
5587497*PED Jun 24, 2014
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 142 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
PAROXETINE HYDROCHLORIDE - PAXIL
N020031 001 5872132 May 19, 2015
5872132*PED Nov 19, 2015
5900423 May 19, 2015
5900423*PED Nov 19, 2015
6113944 Dec 14, 2014
6113944*PED Jun 14, 2015
6121291 Mar 17, 2017 U-431
6121291 Mar 17, 2017 U-286
6121291*PED Sep 17, 2017 U-431
6121291*PED Sep 17, 2017 U-286
6133289 May 19, 2015 U-358
6133289*PED Nov 19, 2015 U-358
PAROXETINE HYDROCHLORIDE - PAXIL
N020031 002 5872132 May 19, 2015
5872132*PED Nov 19, 2015
5900423 May 19, 2015
5900423*PED Nov 19, 2015
6113944 Dec 14, 2014
6113944*PED Jun 14, 2015
6121291 Mar 17, 2017 U-431
6121291 Mar 17, 2017 U-286
6121291*PED Sep 17, 2017 U-286
6121291*PED Sep 17, 2017 U-431
6133289 May 19, 2015 U-358
6133289*PED Nov 19, 2015 U-358
PAROXETINE HYDROCHLORIDE - PAXIL
N020031 003 5872132 May 19, 2015
5872132*PED Nov 19, 2015
5900423 May 19, 2015
5900423*PED Nov 19, 2015
6113944 Dec 14, 2014
6113944*PED Jun 14, 2015
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6121291*PED Sep 17, 2017 U-286
6121291*PED Sep 17, 2017 U-431
6133289 May 19, 2015 U-358
6133289*PED Nov 19, 2015 U-358
PAROXETINE HYDROCHLORIDE - PAXIL
N020031 004 5872132 May 19, 2015
5872132*PED Nov 19, 2015
5900423 May 19, 2015
5900423*PED Nov 19, 2015
6113944 Dec 14, 2014
6113944*PED Jun 14, 2015
6121291 Mar 17, 2017 U-431
6121291 Mar 17, 2017 U-286
6121291*PED Sep 17, 2017 U-431
6121291*PED Sep 17, 2017 U-286
6133289 May 19, 2015 U-358
6133289*PED Nov 19, 2015 U-358
PAROXETINE HYDROCHLORIDE - PAXIL
N020031 005 5872132 May 19, 2015
5872132*PED Nov 19, 2015
5900423 May 19, 2015
5900423*PED Nov 19, 2015
6113944 Dec 14, 2014
6113944*PED Jun 14, 2015
6121291 Mar 17, 2017 U-431
6121291 Mar 17, 2017 U-286
6121291*PED Sep 17, 2017 U-286
6121291*PED Sep 17, 2017 U-431
6133289 May 19, 2015 U-358
6133289*PED Nov 19, 2015 U-358
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 143 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
PAROXETINE HYDROCHLORIDE - PAXIL
N020710 001 5811436 Sep 22, 2015
5811436*PED Mar 22, 2016
5872132 May 19, 2015
5872132*PED Nov 19, 2015
5900423 May 19, 2015
5900423*PED Nov 19, 2015
6121291 Mar 17, 2017 U-431
6121291 Mar 17, 2017 U-286
6121291*PED Sep 17, 2017 U-431
6121291*PED Sep 17, 2017 U-286
6133289 May 19, 2015 U-358
6133289*PED Nov 19, 2015 U-358
PAROXETINE HYDROCHLORIDE - PAXIL
N020885 001 5872132 May 19, 2015
5872132*PED Nov 19, 2015
5900423 May 19, 2015
5900423*PED Nov 19, 2015
6063927 Apr 23, 2019
6063927*PED Oct 23, 2019
6080759 May 19, 2015
6080759*PED Nov 19, 2015
6121291 Mar 17, 2017 U-431
6121291 Mar 17, 2017 U-286
6121291*PED Sep 17, 2017 U-286
6121291*PED Sep 17, 2017 U-431
6133289 May 19, 2015 U-358
6133289*PED Nov 19, 2015 U-358
6172233 Jan 15, 2018
6172233*PED Jul 15, 2018
PAROXETINE HYDROCHLORIDE - PAXIL
N020885 002 5872132 May 19, 2015
5872132*PED Nov 19, 2015
5900423 May 19, 2015
5900423*PED Nov 19, 2015
6063927 Apr 23, 2019
6063927*PED Oct 23, 2019
6080759 May 19, 2015
6080759*PED Nov 19, 2015
6121291 Mar 17, 2017 U-431
6121291 Mar 17, 2017 U-286
6121291*PED Sep 17, 2017 U-286
6121291*PED Sep 17, 2017 U-431
6133289 May 19, 2015 U-358
6133289*PED Nov 19, 2015 U-358
6172233 Jan 15, 2018
6172233*PED Jul 15, 2018
PAROXETINE HYDROCHLORIDE - PAXIL
N020885 003 5872132 May 19, 2015
5872132*PED Nov 19, 2015
5900423 May 19, 2015
5900423*PED Nov 19, 2015
6063927 Apr 23, 2019
6063927*PED Oct 23, 2019
6080759 May 19, 2015
6080759*PED Nov 19, 2015
6121291 Mar 17, 2017 U-431
6121291 Mar 17, 2017 U-286
6121291*PED Sep 17, 2017 U-431
6121291*PED Sep 17, 2017 U-286
6133289 May 19, 2015 U-358
6133289*PED Nov 19, 2015 U-358
6172233 Jan 15, 2018
6172233*PED Jul 15, 2018
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 144 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
PAROXETINE HYDROCHLORIDE - PAXIL
N020885 004 5872132 May 19, 2015
5872132*PED Nov 19, 2015
5900423 May 19, 2015
5900423*PED Nov 19, 2015
6062927 Apr 23, 2019
6063927*PED Oct 23, 2019
6080759 May 19, 2015
6080759*PED Nov 19, 2015
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6121291*PED Sep 17, 2017 U-286
6121291*PED Sep 17, 2017 U-431
6133289 May 19, 2015 U-358
6133289*PED Nov 19, 2015 U-358
6172233 Jan 15, 2018
6172233*PED Jul 15, 2018
PAROXETINE HYDROCHLORIDE - PAXIL CR
N020936 001 5422123 Jun 06, 2012
5422123*PED Dec 06, 2012
5789449*PED Jul 06, 2009
5872132 May 19, 2015
5872132*PED Nov 19, 2015
5900423 May 19, 2015
5900423*PED Nov 19, 2015
6121291 Mar 17, 2017 U-286
6121291*PED Sep 17, 2017 U-286
6133289 May 19, 2015 U-286
6133289*PED Nov 19, 2015 U-286
6548084 Jul 19, 2016
6548084*PED Jan 19, 2017
7229640 Jul 19, 2016 DP U-816
PAROXETINE HYDROCHLORIDE - PAXIL CR
N020936 002 5422123 Jun 06, 2012
5422123*PED Dec 06, 2012
5789449*PED Jul 06, 2009
5872132 May 19, 2015
5872132*PED Nov 19, 2015
5900423 May 19, 2015
5900423*PED Nov 19, 2015
6121291 Mar 17, 2017 U-286
6121291*PED Sep 17, 2017 U-286
6133289 May 19, 2015 U-286
6133289*PED Nov 19, 2015 U-286
6548084 Jul 19, 2016
6548084*PED Jan 19, 2017
7229640 Jul 19, 2016 DP U-816
PAROXETINE HYDROCHLORIDE - PAXIL CR
N020936 003 5422123 Jun 06, 2012
5422123*PED Dec 06, 2012
5789449*PED Jul 06, 2009
5872132 May 19, 2015
5872132*PED Nov 19, 2015
5900423 May 19, 2015
5900423*PED Nov 19, 2015
6121291 Mar 17, 2017 U-286
6121291*PED Sep 17, 2017 U-286
6133289 May 19, 2015 U-286
6133289*PED Nov 19, 2015 U-286
6548084 Jul 19, 2016
6548084*PED Jan 19, 2017
7229640 Jul 19, 2016 DP U-816
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 145 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
PAROXETINE MESYLATE - PEXEVA
N021299 001 5874447 Jun 10, 2017 U-46
5874447 Jun 10, 2017 U-518
5874447 Jun 10, 2017 U-286
6703408 Oct 21, 2022 DP
PAROXETINE MESYLATE - PEXEVA
N021299 002 5874447 Jun 10, 2017 U-286
5874447 Jun 10, 2017 U-46
5874447 Jun 10, 2017 U-518
6703408 Oct 21, 2022 DP
PAROXETINE MESYLATE - PEXEVA
N021299 003 5874447 Jun 10, 2017 U-286
5874447 Jun 10, 2017 U-46
5874447 Jun 10, 2017 U-518
6703408 Oct 21, 2022 DP
PAROXETINE MESYLATE - PEXEVA
N021299 004 5874447 Jun 10, 2017 U-286
5874447 Jun 10, 2017 U-46
5874447 Jun 10, 2017 U-518
6703408 Oct 21, 2022 DP
PAZOPANIB HYDROCHLORIDE - VOTRIENT
N022465 001 7105530 Dec 19, 2021 DS DP NCE Oct 19, 2014
7262203 Dec 19, 2021 DS DP
PAZOPANIB HYDROCHLORIDE - VOTRIENT
N022465 002 7105530 Dec 19, 2021 DS DP NCE Oct 19, 2014
7262203 Dec 19, 2021 DS DP
PEGAPTANIB SODIUM - MACUGEN
N021756 001 5919455 Oct 27, 2013 DS NCE Dec 17, 2009
5932462 Aug 03, 2016 DS
6011020 Jan 04, 2017 DS
6051698 May 19, 2015 DS U-622
6113906 Oct 27, 2013 DS
6147204 Jun 11, 2010 DS
6426335 Jun 11, 2010 U-622
PEGVISOMANT - SOMAVERT
N021106 001 5350836 Sep 27, 2011 U-507 ODE Mar 25, 2010
5681809 Sep 27, 2011 U-507
5849535 Mar 25, 2017 DS
5958879 Sep 27, 2011 U-507
6057292 Sep 21, 2015 U-507
6583115 Sep 27, 2011 U-507
PEGVISOMANT - SOMAVERT
N021106 002 5350836 Sep 27, 2011 U-507 ODE Mar 25, 2010
5681809 Sep 27, 2011 U-507
5849535 Mar 25, 2017 DS
5958879 Sep 27, 2011 U-507
6057292 Sep 21, 2015 U-507
6583115 Sep 27, 2011 U-507
PEGVISOMANT - SOMAVERT
N021106 003 5350836 Sep 27, 2011 U-507 ODE Mar 25, 2010
5681809 Sep 27, 2011 U-507
5849535 Mar 25, 2017 DS
5958879 Sep 27, 2011 U-507
6057292 Sep 21, 2015 U-507
6583115 Sep 27, 2011 U-507
PEMETREXED DISODIUM - ALIMTA
N021462 001 5217974 Mar 29, 2011 U-551 I-601 Jul 02, 2012
5344932 Jul 24, 2016 DS DP I-571 Sep 26, 2011
ODE Feb 04, 2011
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 146 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
PEMETREXED DISODIUM - ALIMTA
N021462 002 5217974 Mar 29, 2011 U-551 I-601 Jul 02, 2012
5344932 Jul 24, 2016 DS DP I-571 Sep 26, 2011
ODE Feb 04, 2011
PEMIROLAST POTASSIUM - ALAMAST
N021079 001 5034230 Jan 02, 2011 DP U-184
5034230*PED Jul 02, 2011 U-184
PENCICLOVIR SODIUM - DENAVIR
N020629 001 5075445 Sep 24, 2010
5840763 Sep 01, 2015 U-501
5866581 Sep 04, 2014 U-501
5916893 Sep 01, 2015 U-501
6124304 Sep 04, 2014 U-501
6469015 Oct 22, 2019 U-501
6573378 Sep 24, 2010
6579981 Jun 17, 2020 U-501
PENTETATE CALCIUM TRISODIUM - PENTETATE CALCIUM TRISODIUM
N021749 001 NCE Aug 11, 2009
ODE Aug 11, 2011
PENTETATE ZINC TRISODIUM - PENTETATE ZINC TRISODIUM
N021751 001 NCE Aug 11, 2009
ODE Aug 11, 2011
PENTOSAN POLYSULFATE SODIUM - ELMIRON
N020193 001 5180715 Jan 19, 2010 U-159
PERFLUOROPOLYMETHYLISOPROPYL ETHER; POLYTETRAFLUOROETHYLENE - SKIN EXPOSURE REDUCTION PASTE AGAINST
CHEMICAL WARFARE AGENTS
N021084 001 5607979 May 30, 2015
PERFLUTREN - DEFINITY
N021064 001 5547656 Apr 05, 2011
5769080 Jul 20, 2010
6033645 Jun 19, 2016 U-665
6146657 Dec 22, 2009 DS
6528039 Apr 05, 2011 DS
6773696 Apr 05, 2011 DS
PERGOLIDE MESYLATE - PERMAX
N019385 001 5114948 Oct 19, 2009
PERGOLIDE MESYLATE - PERMAX
N019385 002 5114948 Oct 19, 2009
PERGOLIDE MESYLATE - PERMAX
N019385 003 5114948 Oct 19, 2009
PERINDOPRIL ERBUMINE - ACEON
N020184 001 5162362 Nov 10, 2009 DS DP U-531
PERINDOPRIL ERBUMINE - ACEON
N020184 002 5162362 Nov 10, 2009 DS DP U-531
PERINDOPRIL ERBUMINE - ACEON
N020184 003 5162362 Nov 10, 2009 DS DP U-531
PHENTOLAMINE MESYLATE - ORAVERSE
N022159 001 6764678 May 11, 2021 U-967 NP May 09, 2011
6872390 May 11, 2021 DP
7229630 Jun 20, 2023 DP
7569230 Oct 17, 2023 U-967
7575757 Apr 21, 2025 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 147 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
PIMECROLIMUS - ELIDEL
N021302 001 5912238 Jun 15, 2016
5912238*PED Dec 15, 2016
6352998 Oct 26, 2015
6352998*PED Apr 26, 2016
6423722 Jun 26, 2018
6423722*PED Dec 26, 2018
PIOGLITAZONE HYDROCHLORIDE - ACTOS
N021073 001 4687777 Jan 17, 2011
5965584 Jun 19, 2016 U-417
6150383 Jun 19, 2016 U-418
6150384 Jun 19, 2016 U-419
6166042 Jun 19, 2016 U-414
6166043 Jun 19, 2016 U-415
6172090 Jun 19, 2016 U-416
6211205 Jun 19, 2016 U-410
6271243 Jun 19, 2016 U-411
6303640 Aug 09, 2016 U-425
6329404 Jun 19, 2016 U-430
PIOGLITAZONE HYDROCHLORIDE - ACTOS
N021073 002 4687777 Jan 17, 2011
5965584 Jun 19, 2016 U-417
6150383 Jun 19, 2016 U-418
6150384 Jun 19, 2016 U-419
6166042 Jun 19, 2016 U-414
6166043 Jun 19, 2016 U-415
6172090 Jun 19, 2016 U-416
6211205 Jun 19, 2016 U-410
6271243 Jun 19, 2016 U-411
6303640 Aug 09, 2016 U-425
6329404 Jun 19, 2016 U-430
PIOGLITAZONE HYDROCHLORIDE - ACTOS
N021073 003 4687777 Jan 17, 2011
5965584 Jun 19, 2016 U-417
6150383 Jun 19, 2016 U-418
6150384 Jun 19, 2016 U-419
6166042 Jun 19, 2016 U-414
6166043 Jun 19, 2016 U-415
6172090 Jun 19, 2016 U-416
6211205 Jun 19, 2016 U-410
6271243 Jun 19, 2016 U-411
6303640 Aug 09, 2016 U-425
6329404 Jun 19, 2016 U-430
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - PIPERACILLIN AND TAZOBACTAM
A065386 001 PC Mar 30, 2010
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - PIPERACILLIN AND TAZOBACTAM
A065386 002 PC Mar 28, 2010
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - PIPERACILLIN AND TAZOBACTAM
A065386 003 PC Mar 21, 2010
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - PIPERACILLIN AND TAZOBACTAM
A065446 001 PC Apr 27, 2010
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN
N050684 001 6900184 Apr 14, 2023 DS DP U-282
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN
N050684 002 6900184 Apr 14, 2023 DS DP U-282
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN
N050684 003 6900184 Apr 14, 2023 DS DP U-282
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN
N050684 004 6900184 Apr 14, 2023 DS DP U-282
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 148 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN IN PLASTIC CONTAINER
N050750 001 6207661 Feb 22, 2019 DS DP
6900184 Apr 14, 2023 DS DP U-282
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN IN PLASTIC CONTAINER
N050750 002 6207661 Feb 22, 2019 DS DP
6900184 Apr 14, 2023 DS DP U-282
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN IN PLASTIC CONTAINER
N050750 003 6207661 Feb 22, 2019 DS DP

6900184 Apr 14, 2023 DS DP U-282

PITAVASTATIN CALCIUM - LIVALO


N022363 001 5753675 May 19, 2015 DS DP U-998 NCE Aug 03, 2014
5854259 Dec 29, 2015 DP
5856336 Jan 05, 2016 DS U-998
6465477 Dec 20, 2016 DP
7022713 Feb 19, 2024 U-998
PITAVASTATIN CALCIUM - LIVALO
N022363 002 5753675 May 19, 2015 DS DP U-998 NCE Aug 03, 2014
5854259 Dec 29, 2015 DP
5856336 Jan 05, 2016 DS U-998
6465477 Dec 20, 2016 DP
7022713 Feb 19, 2024 U-998
PITAVASTATIN CALCIUM - LIVALO
N022363 003 5753675 May 19, 2015 DS DP U-998 NCE Aug 03, 2014
5854259 Dec 29, 2015 DP
5856336 Jan 05, 2016 DS U-998
6465477 Dec 20, 2016 DP
7022713 Feb 19, 2024 U-998
PLERIXAFOR - MOZOBIL
N022311 001 5583131 Dec 10, 2013 DP NCE Dec 15, 2013
6987102 Jul 22, 2023 U-936 ODE Dec 15, 2015
POLYETHYLENE GLYCOL 3350 - MIRALAX
N022015 001 NP Oct 06, 2009
PORFIMER SODIUM - PHOTOFRIN
N020451 001 5145863 Dec 15, 2009 U-129 ODE Aug 01, 2010
5438071 Aug 01, 2012
POSACONAZOLE - NOXAFIL
N022003 001 5661151 Jul 19, 2019 DS DP U-760 NCE Sep 15, 2011
5703079 Aug 26, 2014 DS DP U-760
6958337 Oct 05, 2018 DS DP U-760
PRALATREXATE - FOLOTYN
N022468 001 6028071 Jul 16, 2017 DS DP U-1004 NCE Sep 24, 2014
7622470 May 31, 2025 U-1015 ODE Sep 24, 2016
PRALATREXATE - FOLOTYN
N022468 002 6028071 Jul 16, 2017 DS DP U-1004 NCE Sep 24, 2014
7622470 May 31, 2025 U-1015 ODE Sep 24, 2016
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N020667 001 4886812 Oct 08, 2010 DS DP I-517 Nov 07, 2009
6001861 Jan 16, 2018 U-784
6194445 Jan 16, 2018 U-784
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N020667 002 4886812 Oct 08, 2010 DS DP I-517 Nov 07, 2009
6001861 Jan 16, 2018 U-784
6194445 Jan 16, 2018 U-784
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 149 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N020667 003 4886812 Oct 08, 2010 DS DP I-517 Nov 07, 2009
6001861 Jan 16, 2018 U-784
6194445 Jan 16, 2018 U-784
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N020667 004 4886812 Oct 08, 2010 DS DP
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N020667 005 4886812 Oct 08, 2010 DS DP I-517 Nov 07, 2009
6001861 Jan 16, 2018 U-784
6194445 Jan 16, 2018 U-784
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N020667 006 4886812 Oct 08, 2010 DS DP I-517 Nov 07, 2009
6001861 Jan 16, 2018 U-784
6194445 Jan 16, 2018 U-784
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N020667 007 4886812 Oct 08, 2010 DS DP I-517 Nov 07, 2009
6001861 Jan 16, 2018 U-784
6194445 Jan 16, 2018 U-784
PRAMLINTIDE ACETATE - SYMLIN
N021332 001 5686411 Mar 16, 2019 DS DP U-638 NCE Mar 16, 2010
5814600 Sep 29, 2015 U-639
5998367 Mar 08, 2011 DS DP
6114304 Sep 05, 2017 U-640
6608029 Sep 07, 2013 U-641
6610824 Mar 08, 2011 DS
7271238 Mar 08, 2011 DS U-637
7271238 Mar 08, 2011 DS U-638
7407934 Mar 08, 2011 U-640
PRAMLINTIDE ACETATE - SYMLIN
N021332 002 5686411 Mar 16, 2019 DS DP U-638 NCE Mar 16, 2010
5814600 Sep 29, 2015 U-639
5814600 Sep 29, 2015 U-638
5814600 Sep 29, 2015 U-637
5998367 Mar 08, 2011 DS DP
6114304 Sep 05, 2017 U-640
6114304 Sep 05, 2017 U-637
6608029 Sep 07, 2013 U-641
6608029 Sep 07, 2013 U-640
6608029 Sep 07, 2013 U-637
6610824 Mar 03, 2011 DS
7271238 Mar 08, 2011 DS U-637
7271238 Mar 08, 2011 DS U-638
7407934 Mar 08, 2011 U-640
7407934 Mar 08, 2011 U-637
PRAMLINTIDE ACETATE - SYMLIN
N021332 003 5686411 Mar 16, 2019 DS DP U-638 NCE Mar 16, 2010
5814600 Sep 29, 2015 U-639
5814600 Sep 29, 2015 U-638
5814600 Sep 29, 2015 U-637
5998367 Mar 08, 2011 DS DP
6114304 Sep 05, 2017 U-640
6114304 Sep 05, 2017 U-637
6608029 Sep 07, 2013 U-641
6608029 Sep 07, 2013 U-640
6608029 Sep 07, 2013 U-637
6610824 Mar 03, 2011 DS
7271238 Mar 08, 2011 DS U-638
7271238 Mar 08, 2011 DS U-637
7407934 Mar 08, 2011 U-640
7407934 Mar 08, 2011 U-637
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 150 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
PRASUGREL HYDROCHLORIDE - EFFIENT
N022307 001 5288726 Sep 08, 2012 DS DP U-991 NCE Jul 10, 2014
6693115 Jul 03, 2021 DS DP U-991
PRASUGREL HYDROCHLORIDE - EFFIENT
N022307 002 5288726 Sep 08, 2012 DS DP U-991 NCE Jul 10, 2014
6693115 Jul 03, 2021 DS DP U-991
PRAVASTATIN SODIUM - PRAVACHOL
N019898 002 5622985 Apr 22, 2014 U-335
5622985*PED Oct 22, 2014 U-335
PRAVASTATIN SODIUM - PRAVACHOL
N019898 003 5622985 Apr 22, 2014 U-335
5622985*PED Oct 22, 2014 U-335
PRAVASTATIN SODIUM - PRAVACHOL
N019898 004 5622985 Apr 22, 2014 U-335
5622985*PED Oct 22, 2014 U-335
PRAVASTATIN SODIUM - PRAVACHOL
N019898 008 5622985 Apr 22, 2014 U-335
5622985*PED Oct 22, 2014 U-335
PREDNISOLONE ACETATE - FLO-PRED
N022067 001 5881926 Mar 16, 2016 DP
6071523 Jun 03, 2018 DP
6102254 Mar 11, 2013 DP
6399079 Jun 03, 2018 DP
6656482 Jun 03, 2018 DP
PREDNISOLONE ACETATE - FLO-PRED
N022067 002 5881926 Mar 16, 2016 DP
6071523 Jun 03, 2018 DP
6102254 Mar 11, 2013 DP
6399079 Jun 03, 2018 DP
6656482 Jun 03, 2018 DP
PREDNISOLONE SODIUM PHOSPHATE - ORAPRED ODT
N021959 001 5178878 Jan 12, 2010 DP
6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
PREDNISOLONE SODIUM PHOSPHATE - ORAPRED ODT
N021959 002 5178878 Jan 12, 2010 DP
6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
PREDNISOLONE SODIUM PHOSPHATE - ORAPRED ODT
N021959 003 5178878 Jan 12, 2010 DP
6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
PREGABALIN - LYRICA
N021446 001 5563175 Oct 08, 2013 U-661 I-535 Jun 21, 2010
6001876 Dec 30, 2018 U-55 NCE Dec 30, 2009
6001876 Dec 30, 2018 U-819
6197819 Dec 30, 2018 DS DP
PREGABALIN - LYRICA
N021446 002 5563175 Oct 08, 2013 U-661 I-535 Jun 21, 2010
6001876 Dec 30, 2018 U-55 NCE Dec 30, 2009
6001876 Dec 30, 2018 U-819
6197819 Dec 30, 2018 DS DP
PREGABALIN - LYRICA
N021446 003 5563175 Oct 08, 2013 U-661 I-535 Jun 21, 2010
6001876 Dec 30, 2018 U-55 NCE Dec 30, 2009
6001876 Dec 30, 2018 U-819
6197819 Dec 30, 2018 DS DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 151 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
PREGABALIN - LYRICA
N021446 004 5563175 Oct 08, 2013 U-661 I-535 Jun 21, 2010
6001876 Dec 30, 2018 U-55 NCE Dec 30, 2009
6001876 Dec 30, 2018 U-819
6197819 Dec 30, 2018 DS DP
PREGABALIN - LYRICA
N021446 005 5563175 Oct 08, 2013 U-661 I-535 Jun 21, 2010
6001876 Dec 30, 2018 U-819 NCE Dec 30, 2009
6001876 Dec 30, 2018 U-55
6197819 Dec 30, 2018 DS DP
PREGABALIN - LYRICA
N021446 006 5563175 Oct 08, 2013 U-661 I-535 Jun 21, 2010
6001876 Dec 30, 2018 U-55 NCE Dec 30, 2009
6001876 Dec 30, 2018 U-819
6197819 Dec 30, 2018 DS DP
PREGABALIN - LYRICA
N021446 007 5563175 Oct 08, 2013 U-661 I-535 Jun 21, 2010
6001876 Dec 30, 2018 U-55 NCE Dec 30, 2009
6001876 Dec 30, 2018 U-819
6197819 Dec 30, 2018 DS DP
PREGABALIN - LYRICA
N021446 008 5563175 Oct 08, 2013 U-661 I-535 Jun 21, 2010
6001876 Dec 30, 2018 U-819 NCE Dec 30, 2009
6001876 Dec 30, 2018 U-55
6197819 Dec 30, 2018 DS DP
PROCAINAMIDE HYDROCHLORIDE - PROCANBID
N020545 001 5656296 Aug 12, 2014
PROCAINAMIDE HYDROCHLORIDE - PROCANBID
N020545 002 5656296 Aug 12, 2014
PROGESTERONE - CRINONE
N020701 001 5543150 Sep 15, 2013 U-209
PROGESTERONE - CRINONE
N020701 002 5543150 Sep 15, 2013 U-209
PROGESTERONE - ENDOMETRIN
N022057 001 7300664 Nov 17, 2019 U-856 NP Jun 21, 2010
7320800 Nov 17, 2019 U-856
7393543 Nov 17, 2019 DP U-880
PROPAFENONE HYDROCHLORIDE - RYTHMOL SR
N021416 001 5681588 Oct 28, 2014
PROPAFENONE HYDROCHLORIDE - RYTHMOL SR
N021416 002 5681588 Oct 28, 2014
PROPAFENONE HYDROCHLORIDE - RYTHMOL SR
N021416 003 5681588 Oct 28, 2014
PROPOFOL - DIPRIVAN
N019627 002 5714520 Mar 22, 2015
5714520*PED Sep 22, 2015
5731355 Mar 22, 2015 U-217
5731355*PED Sep 22, 2015 U-217
5731356 Mar 22, 2015 U-218
5731356*PED Sep 22, 2015 U-218
5908869 Mar 22, 2015 U-270
5908869*PED Sep 22, 2015 U-270
PROPRANOLOL HYDROCHLORIDE - INNOPRAN XL
N021438 001 6500454 Dec 31, 2022
PROPRANOLOL HYDROCHLORIDE - INNOPRAN XL
N021438 002 6500454 Dec 31, 2022
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 152 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
QUAZEPAM - DORAL
N018708 001 7608616 Jun 03, 2028 U-1012
QUAZEPAM - DORAL
N018708 003 7608616 Jun 03, 2028 U-1012
QUETIAPINE FUMARATE - SEROQUEL
N020639 001 4879288 Sep 26, 2011 DS DP U-550 I-560 May 13, 2011
4879288*PED Mar 26, 2012 I-503 Oct 20, 2009
NPP Dec 02, 2012
NPP Dec 02, 2012
PED Jun 02, 2013
PED Jun 02, 2013
PED Nov 13, 2011
PED Apr 20, 2010
QUETIAPINE FUMARATE - SEROQUEL
N020639 002 4879288 Sep 26, 2011 DS DP U-550 I-560 May 13, 2011
4879288*PED Mar 26, 2012 I-503 Oct 20, 2009
NPP Dec 02, 2012
NPP Dec 02, 2012
PED Jun 02, 2013
PED Jun 02, 2013
PED Nov 13, 2011
PED Apr 20, 2010
QUETIAPINE FUMARATE - SEROQUEL
N020639 003 4879288 Sep 26, 2011 DS DP U-550 I-560 May 13, 2011
4879288*PED Mar 26, 2012 I-503 Oct 20, 2009
NPP Dec 02, 2012
NPP Dec 02, 2012
PED Jun 02, 2013
PED Jun 02, 2013
PED Nov 13, 2011
PED Apr 20, 2010
QUETIAPINE FUMARATE - SEROQUEL
N020639 004 4879288 Sep 26, 2011 DS DP U-550 I-560 May 13, 2011
4879288*PED Mar 26, 2012 I-503 Oct 20, 2009
NPP Dec 02, 2012
NPP Dec 02, 2012
PED Jun 02, 2013
PED Jun 02, 2013
PED Nov 13, 2011
PED Apr 20, 2010
QUETIAPINE FUMARATE - SEROQUEL
N020639 005 4879288 Sep 26, 2011 DS DP U-550 I-560 May 13, 2011
4879288*PED Mar 26, 2012 I-503 Oct 20, 2009
NPP Dec 02, 2012
NPP Dec 02, 2012
PED Jun 02, 2013
PED Jun 02, 2013
PED Nov 13, 2011
PED Apr 20, 2010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 153 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
QUETIAPINE FUMARATE - SEROQUEL
N020639 006 4879288 Sep 26, 2011 DS DP U-550 I-560 May 13, 2011
4879288*PED Mar 26, 2012 I-503 Oct 20, 2009
NPP Dec 02, 2012
NPP Dec 02, 2012
PED Jun 02, 2013
PED Jun 02, 2013
PED Nov 13, 2011
PED Apr 20, 2010
QUETIAPINE FUMARATE - SEROQUEL
N020639 007 4879288 Sep 26, 2011 DS DP U-550 I-560 May 13, 2011
4879288*PED Mar 26, 2012 I-503 Oct 20, 2009
NPP Dec 02, 2012
NPP Dec 02, 2012
PED Jun 02, 2013
PED Jun 02, 2013
PED Nov 13, 2011
PED Apr 20, 2010
QUETIAPINE FUMARATE - SEROQUEL XR
N022047 001 4879288 Sep 26, 2011 DS DP U-839 D-117 Oct 08, 2011
4879288 Sep 26, 2011 DS DP U-814 I-618 Dec 02, 2012
4879288 Sep 26, 2011 DS DP U-601 I-576 Oct 08, 2011
4879288*PED Mar 26, 2012
5948437 May 28, 2017 DP U-839 I-575 Oct 08, 2011
5948437 May 28, 2017 DP U-814 I-574 Oct 08, 2011
5948437 May 28, 2017 DP U-601 NDF May 17, 2010
5948437*PED Nov 28, 2017 PED Nov 17, 2010
PED Apr 08, 2012
PED Apr 08, 2012
PED Apr 08, 2012
PED Apr 08, 2012
QUETIAPINE FUMARATE - SEROQUEL XR
N022047 002 4879288 Sep 26, 2011 DS DP U-839 D-117 Oct 08, 2011
4879288 Sep 26, 2011 DS DP U-814 I-618 Dec 02, 2012
4879288 Sep 26, 2011 DS DP U-601 I-576 Oct 08, 2011
4879288*PED Mar 26, 2012
5948437 May 28, 2017 DP U-814 I-575 Oct 08, 2011
5948437 May 28, 2017 DP U-839 I-574 Oct 08, 2011
5948437 May 28, 2017 DP U-601 NDF May 17, 2010
5948437*PED Nov 28, 2017 PED Nov 17, 2010
PED Apr 08, 2012
PED Apr 08, 2012
PED Apr 08, 2012
PED Apr 08, 2012
QUETIAPINE FUMARATE - SEROQUEL XR
N022047 003 4879288 Sep 26, 2011 DS DP U-601 D-117 Oct 08, 2011
4879288 Sep 26, 2011 DS DP U-814 I-618 Dec 02, 2012
4879288 Sep 26, 2011 DS DP U-839 I-576 Oct 08, 2011
4879288*PED Mar 26, 2012
5948437 May 28, 2017 DP U-839 I-575 Oct 08, 2011
5948437 May 28, 2017 DP U-601 I-574 Oct 08, 2011
5948437 May 28, 2017 DP U-814 NDF May 17, 2010
5948437*PED Nov 28, 2017 PED Nov 17, 2010
PED Apr 08, 2012
PED Apr 08, 2012
PED Apr 08, 2012
PED Apr 08, 2012
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 154 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
QUETIAPINE FUMARATE - SEROQUEL XR
N022047 004 4879288 Sep 26, 2011 DS DP U-839 D-117 Oct 08, 2011
4879288 Sep 26, 2011 DS DP U-601 I-618 Dec 02, 2012
4879288 Sep 26, 2011 DS DP U-814 I-576 Oct 08, 2011
4879288*PED Mar 26, 2012
5948437 May 28, 2017 DP U-601 I-575 Oct 08, 2011
5948437 May 28, 2017 DP U-839 I-574 Oct 08, 2011
5948437 May 28, 2017 DP U-814 NDF May 17, 2010
5948437*PED Nov 28, 2017 PED Nov 17, 2010
PED Apr 08, 2012
PED Apr 08, 2012
PED Apr 08, 2012
PED Apr 08, 2012
QUETIAPINE FUMARATE - SEROQUEL XR
N022047 005 4879288 Sep 26, 2011 DS DP U-839 D-117 Oct 08, 2011
4879288 Sep 26, 2011 DS DP U-601 I-618 Dec 02, 2012
4879288 Sep 26, 2011 DS DP U-814 I-576 Oct 08, 2011
4879288*PED Mar 26, 2012
5948437 May 28, 2017 DP U-839 I-575 Oct 08, 2011
5948437 May 28, 2017 DP U-601 I-574 Oct 08, 2011
5948437 May 28, 2017 DP U-814 NDF May 17, 2010
5948437*PED Nov 28, 2017 PED Nov 17, 2010
PED Apr 08, 2012
PED Apr 08, 2012
PED Apr 08, 2012
PED Apr 08, 2012
QUINAPRIL HYDROCHLORIDE - ACCUPRIL
N019885 001 5684016 Nov 04, 2014 U-210
5684016*PED May 04, 2015 U-210
QUINAPRIL HYDROCHLORIDE - ACCUPRIL
N019885 002 5684016 Nov 04, 2014 U-210
5684016*PED May 04, 2015 U-210
QUINAPRIL HYDROCHLORIDE - ACCUPRIL
N019885 003 5684016 Nov 04, 2014 U-210
5684016*PED May 04, 2015 U-210
QUINAPRIL HYDROCHLORIDE - ACCUPRIL
N019885 004 5684016 Nov 04, 2014 U-210
5684016*PED May 04, 2015 U-210
QUININE SULFATE - QUALAQUIN
N021799 001 ODE Aug 12, 2012
RABEPRAZOLE SODIUM - ACIPHEX
N020973 001 5045552 May 08, 2013 U-385
RABEPRAZOLE SODIUM - ACIPHEX
N020973 002 5045552 May 08, 2013 U-385 NPP Jun 30, 2011
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 155 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
RALOXIFENE HYDROCHLORIDE - EVISTA
N020815 001 5393763 Jul 28, 2012 U-114 Y I-539 Sep 13, 2010
5457117 Jul 28, 2012 U-114 Y ODE Sep 13, 2014
5478847 Mar 02, 2014 U-114 Y
5811120 Mar 02, 2014
5972383 Mar 02, 2014 U-287
6458811 Mar 10, 2017 DS DP U-825
6797719 Mar 10, 2017 DP
6894064 Mar 10, 2017 DP U-657
6906086 Jul 28, 2012 U-657
6906086 Jul 28, 2012 U-662
RE38968 Jul 28, 2012 U-662
RE38968 Jul 28, 2012 U-657
RE39049 Jul 28, 2012 U-657
RE39049 Jul 28, 2012 U-662
RE39050 Mar 02, 2014 U-657
RE39050 Mar 02, 2014 U-662
RALTEGRAVIR POTASSIUM - ISENTRESS
N022145 001 7169780 Oct 09, 2023 DS DP NCE Oct 12, 2012
7217713 Oct 21, 2022 U-257
7435734 Oct 21, 2022 U-900
RAMELTEON - ROZEREM
N021782 001 6034239 Mar 06, 2017 DS DP U-674 M-82 Oct 27, 2011
NCE Jul 22, 2010
RAMIPRIL - ALTACE
N019901 001 5403856 Apr 04, 2012 U-71
7368469 Aug 30, 2020 U-871
RAMIPRIL - ALTACE
N019901 002 5403856 Apr 04, 2012 U-71
7368469 Aug 30, 2020 U-871
RAMIPRIL - ALTACE
N019901 003 5403856 Apr 04, 2012 U-71
7368469 Aug 30, 2020 U-871
RAMIPRIL - ALTACE
N019901 004 5403856 Apr 04, 2012 U-71
7368469 Aug 30, 2020 U-871
RAMIPRIL - ALTACE
N022021 001 5403856 Apr 04, 2012 U-71
7368469 Aug 30, 2020 U-871
RAMIPRIL - ALTACE
N022021 002 5403856 Apr 04, 2012 U-71
7368469 Aug 30, 2020 U-871
RAMIPRIL - ALTACE
N022021 003 5403856 Apr 04, 2012 U-71
7368469 Aug 30, 2020 U-871
RAMIPRIL - ALTACE
N022021 004 5403856 Apr 04, 2012 U-71
7368469 Aug 30, 2020 U-871
RANITIDINE BISMUTH CITRATE - TRITEC
N020559 001 5008256 Jul 17, 2009
5256684 Oct 26, 2010 U-199
5403830 Apr 04, 2012 U-200
5407688 Apr 04, 2012 U-201
5456925 Oct 10, 2012
5601848 Feb 11, 2014 U-202
5629297 May 13, 2014 U-186
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 156 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
RANITIDINE HYDROCHLORIDE - ZANTAC 150
N020095 001 5028432 Feb 22, 2010
5028432*PED Aug 22, 2010
RANITIDINE HYDROCHLORIDE - ZANTAC 150
N020251 001 5102665*PED Dec 23, 2009
RANITIDINE HYDROCHLORIDE - ZANTAC 150
N020251 002 5102665*PED Dec 23, 2009
RANITIDINE HYDROCHLORIDE - ZANTAC 150
N021698 002 5098715 Dec 20, 2010 DP
RANITIDINE HYDROCHLORIDE - ZANTAC 300
N020095 002 5028432 Feb 22, 2010
5028432*PED Aug 22, 2010
RANOLAZINE - RANEXA
N021526 001 6303607 May 27, 2019 U-705 NCE Jan 27, 2011
6369062 May 27, 2019 DP
6479496 May 27, 2019 U-705
6503911 May 27, 2019 DP
6525057 May 27, 2019 U-705
6562826 May 27, 2019 U-705
6617328 May 27, 2019 DP
6620814 May 27, 2019 U-705
6852724 May 27, 2019 U-705
6864258 May 27, 2019 U-705
RANOLAZINE - RANEXA
N021526 002 6303607 May 27, 2019 U-705 NCE Jan 27, 2011
6369062 May 27, 2019 DP
6479496 May 27, 2019 U-705
6503911 May 27, 2019 DP
6525057 May 27, 2019 U-705
6562826 May 27, 2019 U-705
6617328 May 27, 2019 DP
6620814 May 27, 2019 U-705
6852724 May 27, 2019 U-705
6864258 May 27, 2019 U-705
RAPACURONIUM BROMIDE - RAPLON
N020984 001 5418226 Apr 14, 2013
RAPACURONIUM BROMIDE - RAPLON
N020984 002 5418226 Apr 14, 2013
RASAGILINE MESYLATE - AZILECT
N021641 001 5387612 Feb 07, 2012 U-219 NCE May 16, 2011
5453446 Feb 07, 2017 U-219
5457133 Feb 07, 2012 DS DP
5532415 Jul 02, 2013 DS
5786390 Feb 07, 2012 DP
6126968 Sep 18, 2016 DP
7572834 Dec 05, 2026 DP
RASAGILINE MESYLATE - AZILECT
N021641 002 5387612 Feb 07, 2012 U-219 NCE May 16, 2011
5453446 Feb 07, 2017 U-219
5457133 Feb 07, 2012 DS DP
5532415 Jul 02, 2013 DS
5786390 Feb 07, 2012 DP
6126968 Sep 18, 2016 DP
7572834 Dec 05, 2026 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 157 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
REGADENOSON - LEXISCAN
N022161 001 6403567 Jun 22, 2019 DS DP U-869 NCE Apr 10, 2013
6642210 Jun 22, 2019 DS DP U-869
7144872 Jun 22, 2019 DS DP U-869
7144872 Jun 22, 2019 DS DP U-870
7144872 Jun 22, 2019 DS DP U-116
7183264 Jun 22, 2019 DP U-116
7183264 Jun 22, 2019 DP U-870
7183264 Jun 22, 2019 DP U-869
7582617 Jun 22, 2019 U-1003
REMIFENTANIL HYDROCHLORIDE - ULTIVA
N020630 001 5019583 Jul 12, 2010 DS DP U-952
5019583*PED Jan 12, 2011
5466700 Aug 30, 2013 U-156
5466700*PED Mar 01, 2014 U-156
5866591 Sep 10, 2017 DP
5866591*PED Mar 10, 2018
REMIFENTANIL HYDROCHLORIDE - ULTIVA
N020630 002 5019583 Jul 12, 2010 DS DP U-952
5019583*PED Jan 12, 2011
5466700 Aug 30, 2013 U-156
5466700*PED Mar 01, 2014
5866591 Sep 10, 2017 DP
5866591*PED Mar 10, 2018
REMIFENTANIL HYDROCHLORIDE - ULTIVA
N020630 003 5019583 Jul 12, 2010 DS DP U-952
5019583*PED Jan 12, 2011
5466700 Aug 30, 2013 U-156
5466700*PED Mar 01, 2014 U-156
5866591 Sep 10, 2017 DP
5866591*PED Mar 10, 2018
REPAGLINIDE - PRANDIN
N020741 001 6677358 Jun 12, 2018 DS DP U-968
REPAGLINIDE - PRANDIN
N020741 002 6677358 Jun 12, 2018 DS DP U-968
REPAGLINIDE - PRANDIN
N020741 003 6677358 Jun 12, 2018 DS DP U-968
RETAPAMULIN - ALTABAX
N022055 001 RE39128 Oct 27, 2018 DS DP U-805 NCE Apr 12, 2012
RIBAVIRIN - REBETOL
N020903 001 6172046 Sep 21, 2017 U-377 ODE Jul 29, 2010
6172046 Sep 21, 2017 U-1014 PED Jan 29, 2011
6172046*PED Mar 21, 2018 U-377
6177074 Nov 01, 2016 U-1013
6177074 Nov 01, 2016 U-454
6177074*PED May 01, 2017 U-454
6461605 Nov 01, 2016 U-1013
6461605 Nov 01, 2016 U-478
6461605*PED May 01, 2017 U-478
6472373 Sep 21, 2017 U-1014
6472373 Sep 21, 2017 U-479
6472373*PED Mar 21, 2018 U-479
6524570 Nov 01, 2016 U-499
6524570 Nov 01, 2016 U-1013
6524570*PED May 01, 2017 U-499
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 158 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
RIBAVIRIN - REBETOL
N020903 002 6172046 Sep 21, 2017 U-377 ODE Jul 29, 2010
6172046 Sep 21, 2017 U-1014 PED Jan 29, 2011
6172046*PED Mar 21, 2018 U-377
6177074 Nov 01, 2016 U-1013
6177074 Nov 01, 2016 U-454
6177074*PED May 01, 2017 U-454
6461605 Nov 01, 2016 U-478
6461605 Nov 01, 2016 U-1013
6461605*PED May 01, 2017 U-478
6472373 Sep 21, 2017 U-479
6472373 Sep 21, 2017 U-1014
6472373*PED Mar 21, 2018 U-479
6524570 Nov 01, 2016 U-499
6524570 Nov 01, 2016 U-1013
6524570*PED May 01, 2017 U-499
RIBAVIRIN - REBETOL
N021546 001 6172046 Sep 21, 2017 U-1014 ODE Jul 29, 2010
6172046 Sep 21, 2017 U-521 PED Jan 29, 2011
6172046*PED Mar 21, 2018 U-521
6177074 Nov 01, 2016 U-1013
6177074*PED May 01, 2017
6461605 Nov 01, 2016 U-521
6461605 Nov 01, 2016 U-1013
6461605*PED May 01, 2017 U-521
6472373 Sep 21, 2017 U-521
6472373*PED Mar 21, 2018 U-521
6524570 Nov 01, 2016 U-1013
6524570*PED May 01, 2017
6790837 Apr 05, 2023 DP
6790837*PED Oct 05, 2023 U-1014
RIBAVIRIN - VIRAZOLE
N018859 001 6150337 Nov 21, 2017 U-400
RIFAXIMIN - XIFAXAN
N021361 001 7045620 Jun 19, 2024 DS DP
7612199 Jun 19, 2024 DS DP
RILUZOLE - RILUTEK
N020599 001 5527814 Jun 18, 2013
RISEDRONATE SODIUM - ACTONEL
N020835 001 5583122 Dec 10, 2013 U-222 M-61 Jul 23, 2012
5583122*PED Jun 10, 2014 PED Jan 23, 2013
6096342 Nov 22, 2011
6096342*PED May 22, 2012
6165513 Jun 10, 2018
6165513*PED Dec 10, 2018
RISEDRONATE SODIUM - ACTONEL
N020835 002 5583122 Dec 10, 2013 U-222 M-61 Jul 23, 2012
5583122*PED Jun 10, 2014 PED Jan 23, 2013
6096342 Nov 22, 2011
6096342*PED May 22, 2012
6165513 Jun 10, 2018
6165513*PED Dec 10, 2018
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 159 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
RISEDRONATE SODIUM - ACTONEL
N020835 003 5583122 Dec 10, 2013 DS DP U-222 I-309 Aug 11, 2009
5583122 Dec 10, 2013 DS DP U-756 M-61 Jul 23, 2012
5583122*PED Jun 10, 2014 PED Jan 23, 2013
5994329 Jul 17, 2018 U-353
5994329*PED Jan 17, 2019 PED Feb 11, 2010
6015801 Jul 17, 2018 U-353
6015801*PED Jan 17, 2019
6096342 Nov 22, 2011 DP
6096342*PED May 22, 2012
6165513 Jun 10, 2018 DP
6165513*PED Dec 10, 2018
6432932 Jul 17, 2018 U-595
6432932*PED Jan 17, 2019
6465443 Aug 14, 2018 DP
6465443*PED Feb 14, 2019
RISEDRONATE SODIUM - ACTONEL
N020835 004 5583122 Dec 10, 2013 DS DP U-353 D-105 Apr 16, 2010
5583122*PED Jun 10, 2014 M-61 Jul 23, 2012
6096342 Nov 22, 2011 DP U-353 PED Jan 23, 2013
6096342*PED May 22, 2012
6165513 Jun 10, 2018 DP PED Oct 16, 2010
6165513*PED Dec 10, 2018
RISEDRONATE SODIUM - ACTONEL
N020835 005 5583122 Dec 10, 2013 DS DP U-353 M-61 Jul 23, 2012
5583122*PED Jun 10, 2014 NS Apr 22, 2011
6165513 Jun 10, 2018 DP PED Jan 23, 2013
6165513*PED Dec 10, 2018
7192938 May 06, 2023 U-353 PED Oct 22, 2011
7192938*PED Nov 06, 2023
RISPERIDONE - RISPERDAL
N020272 001 I-540 Aug 22, 2010
I-541 Aug 22, 2010
I-509 Oct 06, 2009
PED Feb 22, 2011
PED Feb 22, 2011
PED Apr 06, 2010
RISPERIDONE - RISPERDAL
N020272 002 I-540 Aug 22, 2010
I-541 Aug 22, 2010
I-509 Oct 06, 2009
PED Feb 22, 2011
PED Feb 22, 2011
PED Apr 06, 2010
RISPERIDONE - RISPERDAL
N020272 003 I-540 Aug 22, 2010
I-541 Aug 22, 2010
I-509 Oct 06, 2009
PED Feb 22, 2011
PED Feb 22, 2011
PED Apr 06, 2010
RISPERIDONE - RISPERDAL
N020272 004 I-540 Aug 22, 2010
I-541 Aug 22, 2010
I-509 Oct 06, 2009
PED Feb 22, 2011
PED Feb 22, 2011
PED Apr 06, 2010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 160 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
RISPERIDONE - RISPERDAL
N020272 005 I-540 Aug 22, 2010
I-541 Aug 22, 2010
PED Feb 22, 2011
PED Feb 22, 2011
RISPERIDONE - RISPERDAL
N020272 007 I-540 Aug 22, 2010
I-541 Aug 22, 2010
I-509 Oct 06, 2009
PED Feb 22, 2011
PED Feb 22, 2011
PED Apr 06, 2010
RISPERIDONE - RISPERDAL
N020272 008 I-540 Aug 22, 2010
I-541 Aug 22, 2010
I-509 Oct 06, 2009
PED Feb 22, 2011
PED Feb 22, 2011
PED Apr 06, 2010
RISPERIDONE - RISPERDAL
N020588 001 5453425 Jul 11, 2014 DP I-541 Aug 22, 2010
5453425*PED Jan 11, 2015 I-540 Aug 22, 2010
5616587 Jul 11, 2014 Y I-509 Oct 06, 2009
5616587*PED Jan 11, 2015
RE39181 Jul 11, 2014 DP PED Feb 22, 2011
RE39181*PED Jan 11, 2015 PED Feb 22, 2011
PED Apr 06, 2010
RISPERIDONE - RISPERDAL
N021444 001 5648093 Jul 15, 2014 DP I-541 Aug 22, 2010
5648093*PED Jan 15, 2015 I-540 Aug 22, 2010
6224905 Jun 10, 2017 DP I-509 Oct 06, 2009
6224905*PED Dec 10, 2017
PED Feb 22, 2011
PED Feb 22, 2011
PED Apr 06, 2010
RISPERIDONE - RISPERDAL
N021444 002 5648093 Jul 15, 2014 DP I-541 Aug 22, 2010
5648093*PED Jan 15, 2015 I-540 Aug 22, 2010
6224905 Jun 10, 2017 DP I-509 Oct 06, 2009
6224905*PED Dec 10, 2017
PED Feb 22, 2011
PED Feb 22, 2011
PED Apr 06, 2010
RISPERIDONE - RISPERDAL
N021444 003 5648093 Jul 15, 2014 DP I-541 Aug 22, 2010
5648093*PED Jan 15, 2015 I-540 Aug 22, 2010
6224905 Jun 10, 2017 DP I-509 Oct 06, 2009
6224905*PED Dec 10, 2017
PED Feb 22, 2011
PED Feb 22, 2011
PED Apr 06, 2010
RISPERIDONE - RISPERDAL
N021444 004 5648093 Jul 15, 2014 DP I-541 Aug 22, 2010
5648093*PED Jan 15, 2015 I-540 Aug 22, 2010
6224905 Jun 10, 2017 DP I-509 Oct 06, 2009
6224905*PED Dec 10, 2017
PED Feb 22, 2011
PED Feb 22, 2011
PED Apr 06, 2010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 161 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
RISPERIDONE - RISPERDAL
N021444 005 5648093 Jul 15, 2014 DP I-541 Aug 22, 2010
5648093*PED Jan 15, 2015 I-540 Aug 22, 2010
6224905 Jun 10, 2017 DP I-509 Oct 06, 2009
6224905*PED Dec 10, 2017
PED Feb 22, 2011
PED Feb 22, 2011
PED Apr 06, 2010
RISPERIDONE - RISPERDAL CONSTA
N021346 001 5688801 Nov 18, 2014 U-543 I-597 May 15, 2012
5688801 Nov 18, 2014 U-972 I-596 May 15, 2012
5688801*PED May 18, 2015
5792477 May 02, 2017 DP
5792477*PED Nov 02, 2017
5916598 May 02, 2017 DP
5916598*PED Nov 02, 2017
5965168 Nov 19, 2013 DP
5965168*PED May 19, 2014
6110921 Nov 19, 2013 U-543
6110921*PED May 19, 2014
6194006 Dec 30, 2018 DP
6194006*PED Jun 30, 2019
6368632 Nov 19, 2013 U-543
6368632*PED May 19, 2014
6379703 Dec 30, 2018 DP
6379703*PED Jun 30, 2019
6403114 May 02, 2017 DP
6403114*PED Nov 02, 2017
6596316 Dec 30, 2018 DP
6596316*PED Jun 30, 2019
6667061 May 25, 2020 DP
6667061*PED Nov 25, 2020
7547452 Nov 19, 2013 DP
7547452*PED May 19, 2014
RISPERIDONE - RISPERDAL CONSTA
N021346 002 5688801 Nov 18, 2014 U-543 I-597 May 15, 2012
5688801 Nov 18, 2014 U-972 I-596 May 15, 2012
5688801*PED May 18, 2015
5792477 May 02, 2017 DP
5792477*PED Nov 02, 2017
5916598 May 02, 2017 DP
5916598*PED Nov 02, 2017
5965168 Nov 19, 2013 DP
5965168*PED May 19, 2014
6110921 Nov 19, 2013 U-543
6110921*PED May 19, 2014
6194006 Dec 30, 2018 DP
6194006*PED Jun 30, 2019
6368632 Nov 19, 2013 U-543
6368632*PED May 19, 2014
6379703 Dec 30, 2018 DP
6379703*PED Jun 30, 2019
6403114 May 02, 2017 DP
6403114*PED Nov 02, 2017
6596316 Dec 30, 2018 DP
6596316*PED Jun 30, 2019
6667061 May 25, 2020 DP
6667061*PED Nov 25, 2020
7547452 Nov 19, 2013 DP
7547452*PED May 19, 2014
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 162 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
RISPERIDONE - RISPERDAL CONSTA
N021346 003 5688801 Nov 18, 2014 U-543 I-597 May 15, 2012
5688801 Nov 18, 2014 U-972 I-596 May 15, 2012
5688801*PED May 18, 2015
5792477 May 02, 2017 DP
5792477*PED Nov 02, 2017
5916598 May 02, 2017 DP
5916598*PED Nov 02, 2017
5965168 Nov 19, 2013 DP
5965168*PED May 19, 2014
6110921 Nov 19, 2013 U-543
6110921*PED May 19, 2014
6194006 Dec 30, 2018 DP
6194006*PED Jun 30, 2019
6368632 Nov 19, 2013 U-543
6368632*PED May 19, 2014
6379703 Dec 30, 2018 DP
6379703*PED Jun 30, 2019
6403114 May 02, 2017 DP
6403114*PED Nov 02, 2017
6596316 Dec 30, 2018 DP
6596316*PED Jun 30, 2019
6667061 May 25, 2020 DP
6667061*PED Nov 25, 2020
7547452 Nov 19, 2013 DP
7547452*PED May 19, 2014
RISPERIDONE - RISPERDAL CONSTA
N021346 004 5688801 Nov 18, 2014 U-972 I-597 May 15, 2012
5688801 Nov 18, 2014 U-543 I-596 May 15, 2012
5688801*PED May 18, 2015
5792477 May 02, 2017 DP
5792477*PED Nov 02, 2017
5916598 May 02, 2017 DP
5916598*PED Nov 02, 2017
5965168 Nov 19, 2013 DP
5965168*PED May 19, 2014
6110503 May 02, 2017 DP
6110503*PED Nov 02, 2017
6110921 Nov 19, 2013 U-543
6110921*PED May 19, 2014
6194006 Dec 30, 2018 DP
6194006*PED Jun 30, 2019
6368632 Nov 19, 2013 U-543
6368632*PED May 19, 2014
6379703 Dec 30, 2018 DP
6379703*PED Jun 30, 2019
6403114 May 02, 2017 DP
6403114*PED Nov 02, 2017
6596316 Dec 30, 2018 DP
6596316*PED Jun 30, 2019
6667061 May 25, 2020 DP
6667061*PED Nov 25, 2020
7547452 Nov 19, 2013 DP
7547452*PED May 19, 2014
RISPERIDONE - RISPERIDONE
A076440 001 PC Jul 29, 2009
RISPERIDONE - RISPERIDONE
A077494 001 PC Nov 28, 2009
RISPERIDONE - RISPERIDONE
A077494 005 PC Nov 28, 2009
RISPERIDONE - RISPERIDONE
A077494 006 PC Nov 28, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 163 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
RITONAVIR - NORVIR
N020659 001 5484801 Jan 28, 2014
5484801*PED Jul 28, 2014
5541206 Jul 30, 2013 U-140
5541206*PED Jan 30, 2014
5635523 Jun 03, 2014 U-190
5635523*PED Dec 03, 2014
5648497 Jul 15, 2014
5648497*PED Jan 15, 2015
5674882 Oct 07, 2014
5674882*PED Apr 07, 2015
5846987 Dec 29, 2012 U-190
5846987*PED Jun 29, 2013
5948436 Sep 13, 2013 DP
5948436*PED Mar 13, 2014
6037157 Jun 26, 2016
6037157*PED Dec 26, 2016
6703403 Jun 26, 2016 U-564
6703403*PED Dec 26, 2016
RITONAVIR - NORVIR
N020680 001 5541206 Jul 30, 2013 U-140
5541206*PED Jan 30, 2014
5635523 Jun 03, 2014 U-190
5635523*PED Dec 03, 2014
5648497 Jul 15, 2014
5648497*PED Jan 15, 2015
5846987 Dec 29, 2012 U-190
5846987*PED Jun 29, 2013
5948436 Sep 13, 2013
5948436*PED Mar 13, 2014
RITONAVIR - NORVIR
N020945 001 5541206 Jul 30, 2013 U-348
5541206*PED Jan 30, 2014
5635523 Jun 03, 2014 U-347
5635523*PED Dec 03, 2014
5648497 Jul 15, 2014
5648497*PED Jan 15, 2015
5674882 Oct 07, 2014 U-895
5674882*PED Apr 07, 2015
5846987 Dec 29, 2012 U-347
5846987*PED Jun 29, 2013
5948436 Sep 13, 2013 DP
5948436*PED Mar 13, 2014
6037157 Jun 26, 2016 U-895
6037157*PED Dec 26, 2016
6232333 Nov 07, 2017
6232333*PED May 07, 2018
6703403 Jun 26, 2016 U-564
6703403*PED Dec 26, 2016
7141593 May 22, 2020 DP
7141593*PED Nov 22, 2020
7432294 May 22, 2020 DP
7432294*PED Nov 22, 2020
RIVASTIGMINE - EXELON
N022083 001 4948807 Aug 14, 2012 DS U-322 NDF Jul 06, 2010
5602176 Feb 11, 2014 DS DP U-322
6316023 Jan 08, 2019 DP
6335031 Jan 08, 2019 DP
RIVASTIGMINE - EXELON
N022083 002 4948807 Aug 14, 2012 DS U-322 NDF Jul 06, 2010
5602176 Feb 11, 2014 DS DP U-322
6316023 Jan 08, 2019 DP
6335031 Jan 08, 2019 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 164 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
RIVASTIGMINE TARTRATE - EXELON
N020823 003 4948807 Aug 14, 2012 DS U-322
5602176 Feb 11, 2014 U-322
RIVASTIGMINE TARTRATE - EXELON
N020823 004 4948807 Aug 14, 2012 DS U-322
5602176 Feb 11, 2014 U-322
RIVASTIGMINE TARTRATE - EXELON
N020823 005 4948807 Aug 14, 2012 DS U-322
5602176 Feb 11, 2014 U-322
RIVASTIGMINE TARTRATE - EXELON
N020823 006 4948807 Aug 14, 2012 DS U-322
5602176 Feb 11, 2014 U-322
RIVASTIGMINE TARTRATE - EXELON
N021025 001 4948807 Aug 14, 2012 DS U-322
5602176 Feb 11, 2014 U-322
RIZATRIPTAN BENZOATE - MAXALT
N020864 001 5298520 Jun 29, 2012 U-240
5602162 Feb 11, 2014
RIZATRIPTAN BENZOATE - MAXALT
N020864 002 5298520 Jun 29, 2012 U-240
5602162 Feb 11, 2014
RIZATRIPTAN BENZOATE - MAXALT-MLT
N020865 001 5298520 Jun 29, 2012 U-240
5457895 Oct 01, 2013
5602162 Feb 11, 2014 U-240
RIZATRIPTAN BENZOATE - MAXALT-MLT
N020865 002 5298520 Jun 29, 2012 U-240
5457895 Oct 01, 2013
5602162 Feb 11, 2014 U-240
ROCURONIUM BROMIDE - ZEMURON
N020214 001 NPP Aug 28, 2011
PED Feb 28, 2012
ROCURONIUM BROMIDE - ZEMURON
N020214 002 NPP Aug 28, 2011
PED Feb 28, 2012
ROCURONIUM BROMIDE - ZEMURON
N020214 003 NPP Aug 28, 2011
PED Feb 28, 2012
ROFECOXIB - VIOXX
N021042 001 5474995 Jun 24, 2013 DS DP U-602
5474995*PED Dec 24, 2013
5691374 May 18, 2015
5691374*PED Nov 18, 2015
6063811 May 06, 2017 U-602
6063811*PED Nov 06, 2017
6239173 Jun 24, 2013 DS DP U-602
6239173*PED Dec 24, 2013
ROFECOXIB - VIOXX
N021042 002 5474995 Jun 24, 2013 DS DP U-602
5474995*PED Dec 24, 2013
5691374 May 18, 2015
5691374*PED Nov 18, 2015
6063811 May 06, 2017 U-602
6063811*PED Nov 06, 2017
6239173 Jun 24, 2013 DS DP U-602
6239173*PED Dec 24, 2013
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 165 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ROFECOXIB - VIOXX
N021042 003 5474995 Jun 24, 2013 DS DP U-602
5474995*PED Dec 24, 2013
5691374 May 18, 2015
5691374*PED Nov 18, 2015
6063811 May 06, 2017 U-602
6063811*PED Nov 06, 2017
6239173 Jun 24, 2013 DS DP U-602
6239173*PED Dec 24, 2013
ROFECOXIB - VIOXX
N021052 001 5474995 Jun 24, 2013 U-266
5474995*PED Dec 24, 2013
5691374 May 18, 2015
5691374*PED Nov 18, 2015
6063811 May 06, 2017 U-266
6063811*PED Nov 06, 2017
6239173 Jun 24, 2013
6239173*PED Dec 24, 2013
ROFECOXIB - VIOXX
N021052 002 5474995 Jun 24, 2013 U-266
5474995*PED Dec 24, 2013
5691374 May 18, 2015
5691374*PED Nov 18, 2015
6063811 May 06, 2017 U-266
6063811*PED Nov 06, 2017
6239173 Jun 24, 2013
6239173*PED Dec 24, 2013
ROMIDEPSIN - ISTODAX
N022393 001 4977138 Jul 06, 2010 DS DP NCE Nov 05, 2014
7608280 Aug 22, 2021 DS
7611724 Aug 22, 2021 DS
ROPINIROLE HYDROCHLORIDE - REQUIP XL
N022008 001 5422123 Jun 06, 2012 DP NDF Jun 13, 2011
ROPINIROLE HYDROCHLORIDE - REQUIP XL
N022008 002 5422123 Jun 06, 2012 DP NDF Jun 13, 2011
ROPINIROLE HYDROCHLORIDE - REQUIP XL
N022008 003 5422123 Jun 06, 2012 DP NDF Jun 13, 2011
ROPINIROLE HYDROCHLORIDE - REQUIP XL
N022008 004 5422123 Jun 06, 2012 DP NDF Jun 13, 2011
ROPINIROLE HYDROCHLORIDE - REQUIP XL
N022008 005 5422123 Jun 06, 2012 DP NDF Jun 13, 2011
ROPINIROLE HYDROCHLORIDE - REQUIP XL
N022008 006 5422123 Jun 06, 2012 DP NDF Jun 13, 2011
ROPIVACAINE HYDROCHLORIDE MONOHYDRATE - NAROPIN
N020533 001 4870086 Sep 24, 2010
5670524 May 26, 2014 DS DP U-833
5834489 May 26, 2014 DS DP U-838
ROPIVACAINE HYDROCHLORIDE MONOHYDRATE - NAROPIN
N020533 003 4870086 Sep 24, 2010
5670524 May 26, 2014 DS DP U-833
5834489 May 26, 2014 DS DP U-838
ROPIVACAINE HYDROCHLORIDE MONOHYDRATE - NAROPIN
N020533 004 4870086 Sep 24, 2010
5670524 May 26, 2014 DS DP U-833
5834489 May 26, 2014 DS DP U-838
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 166 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ROPIVACAINE HYDROCHLORIDE MONOHYDRATE - NAROPIN
N020533 005 4870086 Sep 24, 2010
5670524 May 26, 2014 DS DP U-833
5834489 May 26, 2014 DS DP U-838
ROSIGLITAZONE MALEATE - AVANDIA
N021071 002 5002953 Sep 17, 2011 DS DP U-628
5002953 Sep 17, 2011 DS DP U-840
5002953 Sep 17, 2011 DS DP U-329
5002953*PED Mar 17, 2012
5741803 Apr 21, 2015 DS DP U-628 Y
5741803 Apr 21, 2015 DS DP U-329 Y
5741803*PED Oct 21, 2015
6288095 Feb 11, 2017 U-420 Y
6288095*PED Aug 11, 2017
7358366 Apr 19, 2020 DS
7358366*PED Oct 19, 2020
ROSIGLITAZONE MALEATE - AVANDIA
N021071 003 5002953 Sep 17, 2011 DS DP U-628
5002953 Sep 17, 2011 DS DP U-840
5002953 Sep 17, 2011 DS DP U-329
5002953*PED Mar 17, 2012
5741803 Apr 21, 2015 DS DP U-329 Y
5741803 Apr 21, 2015 DS DP U-628 Y
5741803*PED Oct 21, 2015
6288095 Feb 11, 2017 U-420 Y
6288095*PED Aug 11, 2017
7358366 Apr 19, 2020 DS
7358366*PED Oct 19, 2020
ROSIGLITAZONE MALEATE - AVANDIA
N021071 004 5002953 Sep 17, 2011 DS DP U-628
5002953 Sep 17, 2011 DS DP U-329
5002953 Sep 17, 2011 DS DP U-840
5002953*PED Mar 17, 2012
5741803 Apr 21, 2015 DS DP U-628 Y
5741803 Apr 21, 2015 DS DP U-329 Y
5741803*PED Oct 21, 2015
6288095 Feb 11, 2017 U-420 Y
6288095*PED Aug 11, 2017
7358366 Apr 19, 2020 DS
7358366*PED Oct 19, 2020
ROSUVASTATIN CALCIUM - CRESTOR
N021366 002 6316460 Aug 04, 2020 DP I-611 Oct 16, 2012
6316460*PED Feb 04, 2021 I-573 Nov 06, 2011
6858618 Dec 17, 2021 U-618 I-547 Nov 08, 2010
6858618*PED Jun 17, 2022
RE37314 Jan 08, 2016 DS PED Apr 16, 2013
RE37314*PED Jul 08, 2016 PED May 08, 2011
PED May 06, 2012
ROSUVASTATIN CALCIUM - CRESTOR
N021366 003 6316460 Aug 04, 2020 DP I-611 Oct 16, 2012
6316460*PED Feb 04, 2021 I-573 Nov 06, 2011
6858618 Dec 17, 2021 U-618 I-547 Nov 08, 2010
6858618*PED Jun 17, 2022
RE37314 Jan 08, 2016 DS PED Apr 16, 2013
RE37314*PED Jul 08, 2016 PED May 08, 2011
PED May 06, 2012
ROSUVASTATIN CALCIUM - CRESTOR
N021366 004 6316460 Aug 04, 2020 DP I-611 Oct 16, 2012
6316460*PED Feb 04, 2021 I-573 Nov 06, 2011
6858618 Dec 17, 2021 U-618 I-547 Nov 08, 2010
6858618*PED Jun 17, 2022
RE37314 Jan 08, 2016 DS PED Apr 16, 2013
RE37314*PED Jul 08, 2016 PED May 08, 2011
PED May 06, 2012
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 167 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ROSUVASTATIN CALCIUM - CRESTOR
N021366 005 6316460 Aug 04, 2020 DP I-611 Oct 16, 2012
6316460*PED Feb 04, 2021 I-573 Nov 06, 2011
6858618 Dec 17, 2021 U-618 I-547 Nov 08, 2010
6858618*PED Jun 17, 2022
RE37314 Jan 08, 2016 DS PED Apr 16, 2013
RE37314*PED Jul 08, 2016 PED May 08, 2011
PED May 06, 2012
ROTIGOTINE - NEUPRO
N021829 001 6884434 Mar 18, 2019 DP NCE May 09, 2012
7413747 Mar 18, 2019 DP
ROTIGOTINE - NEUPRO
N021829 002 6884434 Mar 18, 2019 DP NCE May 09, 2012
7413747 Mar 18, 2019 DP
ROTIGOTINE - NEUPRO
N021829 003 6884434 Mar 18, 2019 DP NCE May 09, 2012
7413747 Mar 18, 2019 DP
RUFINAMIDE - BANZEL
N021911 001 NCE Nov 14, 2013
ODE Nov 14, 2015
RUFINAMIDE - BANZEL
N021911 002 NCE Nov 14, 2013
ODE Nov 14, 2015
RUFINAMIDE - BANZEL
N021911 003 NCE Nov 14, 2013
ODE Nov 14, 2015
SALMETEROL XINAFOATE - SEREVENT
N020692 001 5590645 Mar 01, 2011 DP
5590645*PED Sep 01, 2011
5860419 Mar 01, 2011 DP
5860419*PED Sep 01, 2011
5873360 Feb 23, 2016 DP
5873360*PED Aug 23, 2016
6032666 Mar 01, 2011 DP
6032666*PED Sep 01, 2011
6378519 Mar 01, 2011 DP
6378519*PED Sep 01, 2011
6536427 Mar 01, 2011 DP
6536427*PED Sep 01, 2011
6792945 Mar 01, 2011 DP
6792945*PED Sep 01, 2011
7225808 Mar 01, 2011 DP
7225808*PED Sep 01, 2011
7389775 Mar 01, 2011 DP
7389775*PED Sep 01, 2011
SAPROPTERIN DIHYDROCHLORIDE - KUVAN
N022181 001 7566462 Nov 16, 2025 DP NCE Dec 13, 2012
7566714 Nov 17, 2024 U-989 ODE Dec 13, 2014
7612073 Nov 17, 2024 U-1010
SAQUINAVIR - FORTOVASE
N020828 001 5196438 Nov 19, 2010
6008228 Jun 06, 2015
6352717 Nov 16, 2019
SAQUINAVIR MESYLATE - INVIRASE
N020628 001 5196438 Nov 19, 2010
SAQUINAVIR MESYLATE - INVIRASE
N021785 001 5196438 Nov 19, 2010 DS DP U-834
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 168 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
SAXAGLIPTIN HYDROCHLORIDE - ONGLYZA
N022350 001 6395767 Feb 16, 2021 DS DP U-995 NCE Jul 31, 2014
SAXAGLIPTIN HYDROCHLORIDE - ONGLYZA
N022350 002 6395767 Feb 16, 2021 DS DP U-995 NCE Jul 31, 2014
SELEGILINE - EMSAM
N021336 001 7070808 May 10, 2018 DS DP
7150881 Jun 12, 2018 DS DP
SELEGILINE - EMSAM
N021336 002 7150881 Jun 12, 2018 DS DP
SELEGILINE - EMSAM
N021336 003 7150881 Jun 12, 2018 DS DP
SELEGILINE HYDROCHLORIDE - ZELAPAR
N021479 001 5648093 Jul 15, 2014 DP
6423342 Mar 01, 2016 DP
SERTACONAZOLE NITRATE - ERTACZO
N021385 001 5135943 May 31, 2014 DS DP U-786
SERTRALINE HYDROCHLORIDE - ZOLOFT
N019839 001 4962128 Nov 02, 2009 U-152
4962128*PED May 02, 2010 U-152
5248699 Aug 13, 2012
5248699*PED Feb 13, 2013
SERTRALINE HYDROCHLORIDE - ZOLOFT
N019839 002 4962128 Nov 02, 2009 U-152
4962128*PED May 02, 2010 U-152
5248699 Aug 13, 2012
5248699*PED Feb 13, 2013
SERTRALINE HYDROCHLORIDE - ZOLOFT
N019839 003 4962128 Nov 02, 2009 U-152
4962128*PED May 02, 2010 U-152
5248699 Aug 13, 2012
5248699*PED Feb 13, 2013
SERTRALINE HYDROCHLORIDE - ZOLOFT
N019839 004 4962128 Nov 02, 2009 U-152
4962128*PED May 02, 2010 U-152
5248699 Aug 13, 2012
5248699*PED Feb 13, 2013
SERTRALINE HYDROCHLORIDE - ZOLOFT
N019839 005 4962128 Nov 02, 2009 U-152
4962128*PED May 02, 2010 U-152
5248699 Aug 13, 2012
5248699*PED Feb 13, 2013
SERTRALINE HYDROCHLORIDE - ZOLOFT
N020990 001 5248699 Aug 13, 2012
5248699*PED Feb 13, 2013
6727283 Oct 11, 2019 DP U-580
6727283*PED Apr 11, 2020
7067555 Nov 10, 2019 DP
7067555*PED May 10, 2020
SEVELAMER CARBONATE - RENVELA
N022127 001 5496545 Aug 11, 2013 DP U-246 NE Oct 19, 2010
5667775 Sep 16, 2014 U-246
6509013 Aug 11, 2013 DP
6858203 Aug 11, 2013 DP U-246
7014846 Aug 11, 2013 DP U-246
7459151 Aug 11, 2013 U-246
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 169 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
SEVELAMER CARBONATE - RENVELA
N022318 001 5496545 Aug 11, 2013 DP U-246 NDF Aug 12, 2012
5667775 Sep 16, 2014 U-246 NE Oct 19, 2010
6509013 Aug 11, 2013 DP
6858203 Aug 11, 2013 DP U-246
7014846 Aug 11, 2013 DP U-246
7459151 Aug 11, 2013 U-246
SEVELAMER CARBONATE - RENVELA
N022318 002 5496545 Aug 11, 2013 DP U-246 NDF Aug 12, 2012
5667775 Sep 16, 2014 U-246 NE Oct 19, 2010
6509013 Aug 11, 2013 DP
6858203 Aug 11, 2013 DP U-246
7014846 Aug 11, 2013 DP U-246
7459151 Aug 11, 2013 U-246
SEVELAMER HYDROCHLORIDE - RENAGEL
N020926 001 5496545 Aug 11, 2013 U-246
5667775 Sep 16, 2014 U-246
6509013 Aug 11, 2013
SEVELAMER HYDROCHLORIDE - RENAGEL
N021179 001 5496545 Aug 11, 2013 U-246 M-67 Oct 19, 2010
5667775 Sep 16, 2014 U-246
6509013 Aug 11, 2013
6733780 Oct 18, 2020 DP
7014846 Aug 11, 2013 DP U-246
7459151 Aug 11, 2013 U-246
SEVELAMER HYDROCHLORIDE - RENAGEL
N021179 002 5496545 Aug 11, 2013 U-246 M-67 Oct 19, 2010
5667775 Sep 16, 2014 U-246
6509013 Aug 13, 2013
6733780 Oct 18, 2020 DP
7014846 Aug 11, 2013 DP U-246
7459151 Aug 11, 2013 U-246
SEVOFLURANE - ULTANE
N020478 001 5990176 Jan 27, 2017
5990176*PED Jul 27, 2017
6074668 Jan 09, 2018
6074668*PED Jul 09, 2018
6288127 Jan 27, 2017
6288127*PED Jul 27, 2017
6444859 Jan 27, 2017
6444859*PED Jul 27, 2017
SIBUTRAMINE HYDROCHLORIDE - MERIDIA
N020632 001 5436272 Jul 25, 2012 U-439
5436272*PED Jan 25, 2013
SIBUTRAMINE HYDROCHLORIDE - MERIDIA
N020632 002 5436272 Jul 25, 2012 U-439
5436272*PED Jan 25, 2013
SIBUTRAMINE HYDROCHLORIDE - MERIDIA
N020632 003 5436272 Jul 25, 2012 U-439
5436272*PED Jan 25, 2013
SILDENAFIL CITRATE - REVATIO
N021845 001 5250534 Mar 27, 2012 DS DP I-598 May 07, 2012
SILDENAFIL CITRATE - REVATIO
N022473 001 5250534 Mar 27, 2012 DS DP NDF Nov 20, 2012
SILDENAFIL CITRATE - VIAGRA
N020895 001 5250534 Mar 27, 2012
6469012 Oct 22, 2019 U-155
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 170 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
SILDENAFIL CITRATE - VIAGRA
N020895 002 5250534 Mar 27, 2012
6469012 Oct 22, 2019 U-155
SILDENAFIL CITRATE - VIAGRA
N020895 003 5250534 Mar 27, 2012
6469012 Oct 22, 2019 U-155
SILODOSIN - RAPAFLO
N022206 001 5387603 Dec 01, 2013 DS DP NCE Oct 08, 2013
5403847 Nov 13, 2012 U-902
5780485 Nov 13, 2012 U-902
6015819 Nov 13, 2012 U-902
SILODOSIN - RAPAFLO
N022206 002 5387603 Dec 01, 2013 DS DP NCE Oct 08, 2013
5403847 Nov 13, 2012 U-902
5780485 Nov 13, 2012 U-902
6015819 Nov 13, 2012 U-902
SINCALIDE - KINEVAC
N017697 001 6803046 Aug 16, 2022 DP
SINECATECHINS - VEREGEN
N021902 001 5795911 Oct 31, 2020 U-172 NP Oct 31, 2009
5968973 Apr 10, 2017 U-172
SIROLIMUS - RAPAMUNE
N021083 001 5100899 Jul 07, 2013 U-290 D-114 Jan 30, 2010
5100899*PED Jan 07, 2014
5212155 May 18, 2010 U-291
5212155*PED Nov 18, 2010
5308847 May 03, 2011 U-292
5308847*PED Nov 03, 2011
5403833 Apr 04, 2012 U-293
5403833*PED Oct 04, 2012
5536729 Sep 30, 2013 DP
5536729*PED Mar 30, 2014
SIROLIMUS - RAPAMUNE
N021110 001 5100899 Jul 07, 2013 U-290 D-114 Jan 30, 2010
5100899*PED Jan 07, 2014
5145684 Jan 25, 2011 DP U-857
5145684*PED Jul 25, 2011
5212155 May 18, 2010 U-291
5212155*PED Nov 18, 2010
5308847 May 03, 2011 U-292
5308847*PED Nov 03, 2011
5403833 Apr 04, 2012 U-293
5403833*PED Oct 04, 2012
5989591 Mar 11, 2018 DP
5989591*PED Sep 11, 2018
SIROLIMUS - RAPAMUNE
N021110 002 5100899 Jul 07, 2013 U-290 D-114 Jan 30, 2010
5100899*PED Jan 07, 2014
5145684 Jan 25, 2011 DP U-857
5145684*PED Jul 25, 2011
5212155 May 18, 2010 U-291
5212155*PED Nov 18, 2010
5308847 May 03, 2011 U-292
5308847*PED Nov 03, 2011
5403833 Apr 04, 2012 U-293
5403833*PED Oct 04, 2012
5989591 Mar 11, 2018 DP
5989591*PED Sep 11, 2018
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 171 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
SIROLIMUS - RAPAMUNE
N021110 003 5100899 Jul 07, 2013 U-290
5100899*PED Jan 07, 2014
5145684 Jan 25, 2011 DP U-857
5145684*PED Jul 25, 2011
5212155 May 18, 2010 U-291
5212155*PED Nov 18, 2010
5403833 Apr 04, 2012 U-293
5403833*PED Oct 04, 2012
5989591 Mar 11, 2018 DP
5989591*PED Sep 11, 2018
SITAGLIPTIN PHOSPHATE - JANUVIA
N021995 001 6303661 Apr 24, 2017 U-774 M-68 Oct 12, 2010
6699871 Jul 26, 2022 DS DP U-774 M-69 Oct 12, 2010
6890898 Feb 02, 2019 U-775 NCE Oct 16, 2011
7078381 Feb 02, 2019 U-775

7125873 Jul 26, 2022 U-775

7326708 Apr 11, 2026 DS DP U-802

SITAGLIPTIN PHOSPHATE - JANUVIA


N021995 002 6303661 Apr 24, 2017 U-774 M-68 Oct 12, 2010
6699871 Jul 26, 2022 DS DP U-774 M-69 Oct 12, 2010
6890898 Feb 02, 2019 U-775 NCE Oct 16, 2011
7078381 Feb 02, 2019 U-775

7125873 Jul 26, 2022 U-775

7326708 Apr 11, 2026 DS DP U-802

SITAGLIPTIN PHOSPHATE - JANUVIA


N021995 003 6303661 Apr 24, 2017 U-774 M-68 Oct 12, 2010
6699871 Jul 26, 2022 DS DP U-774 M-69 Oct 12, 2010
6890898 Feb 02, 2019 U-775 NCE Oct 16, 2011
7078381 Feb 02, 2019 U-775

7125873 Jul 26, 2022 U-775

7326708 Apr 11, 2026 DS DP U-802

SODIUM BENZOATE; SODIUM PHENYLACETATE - AMMONUL


N020645 001 ODE Feb 17, 2012
SODIUM FLUORIDE; TRICLOSAN - COLGATE TOTAL
N020231 001 5156835 Oct 20, 2009 DP
SODIUM OXYBATE - XYREM
N021196 001 6780889 Jul 04, 2020 DP ODE Nov 18, 2012
7262219 Jul 04, 2020 DP ODE Jul 17, 2009
SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE - OSMOPREP
N021892 001 5616346 May 18, 2013 DP U-715
SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE - VISICOL
N021097 001 5616346 May 18, 2013 U-359
SOLIFENACIN SUCCINATE - VESICARE
N021518 001 6017927 Nov 19, 2018 DS DP NCE Nov 19, 2009
SOLIFENACIN SUCCINATE - VESICARE
N021518 002 6017927 Nov 19, 2018 DS DP NCE Nov 19, 2009
SOMATROPIN RECOMBINANT - ACCRETROPIN
N021538 001 NP Jan 23, 2011
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N020280 001 5435076 Apr 16, 2013 DP
5501673 Apr 16, 2013 DP
5716338 Feb 10, 2015 DP
6152897 Nov 20, 2018 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 172 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N020280 002 5435076 Apr 16, 2013 DP
5501673 Apr 16, 2013 DP
5716338 Feb 10, 2015 DP
6152897 Nov 20, 2018 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N020280 003 5435076 Apr 16, 2013 DP
5501673 Apr 16, 2013 DP
5716338 Feb 10, 2015 DP
6152897 Nov 20, 2018 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N020280 005 5435076 Apr 16, 2013 DP
5501673 Apr 16, 2013 DP
5716338 Feb 10, 2015 DP
6152897 Nov 20, 2018 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N020280 008 5435076 Apr 16, 2013 DP
5501673 Apr 16, 2013 DP
5716338 Feb 10, 2015 DP
6152897 Nov 20, 2018 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N020280 009 5435076 Apr 16, 2013 DP
5501673 Apr 16, 2013 DP
5716338 Feb 10, 2015 DP
6152897 Nov 20, 2018 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N020280 010 5435076 Apr 16, 2013 DP
5501673 Apr 16, 2013 DP
5716338 Feb 10, 2015 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N020280 011 5435076 Apr 16, 2013 DP
5501673 Apr 16, 2013 DP
5716338 Feb 10, 2015 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N020280 012 5435076 Apr 16, 2013 DP
5501673 Apr 16, 2013 DP
5716338 Feb 10, 2015 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N020280 013 5435076 Apr 16, 2013 DP
5501673 Apr 16, 2013 DP
5716338 Feb 10, 2015 DP
SOMATROPIN RECOMBINANT - HUMATROPE
N019640 001 I-585 Mar 12, 2012
SOMATROPIN RECOMBINANT - HUMATROPE
N019640 004 5612315 Mar 18, 2014 DP I-585 Mar 12, 2012
I-518 Nov 01, 2009
SOMATROPIN RECOMBINANT - HUMATROPE
N019640 005 5612315 Mar 18, 2014 DP I-585 Mar 12, 2012
I-518 Nov 01, 2009
SOMATROPIN RECOMBINANT - HUMATROPE
N019640 006 5612315 Mar 18, 2014 DP I-585 Mar 12, 2012
I-518 Nov 01, 2009
SOMATROPIN RECOMBINANT - HUMATROPE
N019640 007 5612315 Mar 18, 2014 DP I-585 Mar 12, 2012
I-518 Nov 01, 2009
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 173 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
SOMATROPIN RECOMBINANT - NORDITROPIN
N021148 001 5849700 Dec 15, 2015 U-340 I-572 Oct 31, 2011
5849704 Dec 15, 2015 I-551 Sep 20, 2010
I-536 May 31, 2010
ODE May 31, 2014
SOMATROPIN RECOMBINANT - NORDITROPIN
N021148 002 5849700 Dec 15, 2015 U-340 I-572 Oct 31, 2011
5849704 Dec 15, 2015 I-551 Sep 20, 2010
I-536 May 31, 2010
ODE May 31, 2014
SOMATROPIN RECOMBINANT - NORDITROPIN
N021148 003 5633352 May 27, 2014 I-572 Oct 31, 2011
5849700 Dec 15, 2015 U-340 I-551 Sep 20, 2010
5849704 Dec 15, 2015 I-536 May 31, 2010
ODE May 31, 2014
SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX
N021148 004 5849700 Dec 15, 2015 U-340 I-572 Oct 31, 2011
5849704 Dec 15, 2015 DP U-340 I-551 Sep 20, 2010
I-536 May 31, 2010
ODE May 31, 2014
SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX
N021148 005 5849700 Dec 15, 2015 U-340 I-572 Oct 31, 2011
5849704 Dec 15, 2015 DP U-340 I-551 Sep 20, 2010
I-536 May 31, 2010
ODE May 31, 2014
SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX
N021148 006 5849700 Dec 15, 2015 U-340 I-572 Oct 31, 2011
5849704 Dec 15, 2015 DP U-340 I-551 Sep 20, 2010
I-536 May 31, 2010
ODE May 31, 2014
SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX
N021148 007 5849700 Dec 15, 2015 U-340 I-551 Sep 20, 2010
5849704 Dec 15, 2015 DP U-340 I-536 May 31, 2010
I-572 Oct 31, 2011
ODE May 31, 2014
SOMATROPIN RECOMBINANT - NUTROPIN AQ
N020522 001 5763394 Jun 09, 2015 DP
SOMATROPIN RECOMBINANT - NUTROPIN AQ PEN
N020522 002 5763394 Jun 09, 2015 DP
SOMATROPIN RECOMBINANT - NUTROPIN DEPOT
N021075 001 5654010 Aug 05, 2014
5656297 Jul 25, 2014
5912015 Mar 12, 2012
6051259 Dec 02, 2012 U-340
SOMATROPIN RECOMBINANT - NUTROPIN DEPOT
N021075 002 5654010 Aug 05, 2014
5656297 Jul 25, 2014
5912015 Mar 12, 2012
6051259 Dec 02, 2012 U-340
SOMATROPIN RECOMBINANT - NUTROPIN DEPOT
N021075 003 5654010 Aug 05, 2014
5656297 Jul 25, 2014
5912015 Mar 12, 2012
6051259 Dec 02, 2012 U-340
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 174 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
SOMATROPIN RECOMBINANT - SAIZEN
N019764 002 5898030 Apr 27, 2016 DP
SOMATROPIN RECOMBINANT - SAIZEN
N019764 003 5898030 Apr 27, 2016 DP
SOMATROPIN RECOMBINANT - SEROSTIM
N020604 001 5898030 Apr 27, 2016 DP M-65 Jul 13, 2010
SOMATROPIN RECOMBINANT - SEROSTIM
N020604 002 5898030 Apr 27, 2016 DP M-65 Jul 13, 2010
SOMATROPIN RECOMBINANT - SEROSTIM
N020604 003 5898030 Apr 27, 2016 DP M-65 Jul 13, 2010
SOMATROPIN RECOMBINANT - SEROSTIM
N020604 004 5898030 Apr 27, 2016 DP M-65 Jul 13, 2010
SOMATROPIN RECOMBINANT - SEROSTIM LQ
N020604 005 M-65 Jul 13, 2010
SOMATROPIN RECOMBINANT - VALTROPIN
N021905 001 NP Apr 19, 2010
SOMATROPIN RECOMBINANT - ZORBTIVE
N021597 001 ODE Dec 01, 2010
SOMATROPIN RECOMBINANT - ZORBTIVE
N021597 002 ODE Dec 01, 2010
SOMATROPIN RECOMBINANT - ZORBTIVE
N021597 003 ODE Dec 01, 2010
SOMATROPIN RECOMBINANT - ZORBTIVE
N021597 004 5288703 Oct 07, 2011 U-898 ODE Dec 01, 2010
5898030 Apr 27, 2016 DP
SORAFENIB TOSYLATE - NEXAVAR
N021923 001 7235576 Jan 12, 2020 DS DP I-546 Nov 16, 2010
7351834 Jan 12, 2020 DS NCE Dec 20, 2010
ODE Nov 16, 2014
ODE Dec 20, 2012
SOTALOL HYDROCHLORIDE - SOTALOL HYDROCHLORIDE
N022306 001 ODE Jul 02, 2016
SPARFLOXACIN - ZAGAM
N020677 001 4795751 Feb 04, 2010 U-160
STAVUDINE - ZERIT XR
N021453 001 7135465 Feb 18, 2023 DP U-167
7135465*PED Aug 18, 2023
STAVUDINE - ZERIT XR
N021453 002 7135465 Feb 18, 2023 DP U-167
7135465*PED Aug 18, 2023
STAVUDINE - ZERIT XR
N021453 003 7135465 Feb 18, 2023 DP U-167
7135465*PED Aug 18, 2023
STAVUDINE - ZERIT XR
N021453 004 7135465 Feb 18, 2023 DP U-167
7135465*PED Aug 18, 2023
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 175 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
SUMATRIPTAN - IMITREX
N020626 001 5307953 Dec 02, 2012
5307953*PED Jun 02, 2013
5554639 Sep 10, 2013 U-232
5554639*PED Mar 10, 2014
5705520 Dec 10, 2011 U-232
5705520*PED Jun 10, 2012
SUMATRIPTAN - IMITREX
N020626 002 5307953 Dec 02, 2012
5307953*PED Jun 02, 2013
5554639 Sep 10, 2013 U-232
5554639*PED Mar 10, 2014
5705520 Dec 10, 2011 U-232
5705520*PED Jun 10, 2012
SUMATRIPTAN - IMITREX
N020626 003 5307953 Dec 02, 2012
5307953*PED Jun 02, 2013
5554639 Sep 10, 2013 U-232
5554639*PED Mar 10, 2014
5705520 Dec 10, 2011 U-232
5705520*PED Jun 10, 2012
SUMATRIPTAN SUCCINATE - SUMATRIPTAN SUCCINATE
A076572 001 PC Aug 08, 2009
SUMATRIPTAN SUCCINATE - SUMATRIPTAN SUCCINATE
A076840 001 PC Aug 08, 2009
SUMATRIPTAN SUCCINATE - SUMATRIPTAN SUCCINATE
A076840 002 PC Aug 08, 2009
SUMATRIPTAN SUCCINATE - SUMATRIPTAN SUCCINATE
A076840 003 PC Aug 08, 2009
SUMATRIPTAN SUCCINATE - SUMAVEL DOSEPRO
N022239 001 5891086 Jul 27, 2014 DP
5957886 Mar 08, 2016 DP
6135979 Mar 21, 2017 DP
SUNITINIB MALATE - SUTENT
N021938 001 6573293 Feb 15, 2021 DS DP U-703 NCE Jan 26, 2011
7125905 Feb 15, 2021 DS DP
7211600 Dec 22, 2020 U-883
SUNITINIB MALATE - SUTENT
N021938 002 6573293 Feb 15, 2021 DS DP U-703 NCE Jan 26, 2011
7125905 Feb 15, 2021 DS DP
7211600 Dec 22, 2020 U-883
SUNITINIB MALATE - SUTENT
N021938 003 6573293 Feb 15, 2021 DS DP U-703 NCE Jan 26, 2011
7125905 Feb 15, 2021 DS DP
7211600 Dec 22, 2020 U-883
SUNITINIB MALATE - SUTENT
N021938 004 6573293 Feb 15, 2021 DS DP U-703 NCE Jan 26, 2011
7125905 Feb 15, 2021 DS DP
7211600 Dec 22, 2020 U-883
TACROLIMUS - PROGRAF
N050708 001 ODE Mar 29, 2013
TACROLIMUS - PROGRAF
N050708 002 ODE Mar 29, 2013
TACROLIMUS - PROGRAF
N050708 003 ODE Mar 29, 2013
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 176 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
TACROLIMUS - PROGRAF
N050709 001 5260301 Feb 28, 2011 DP ODE Mar 29, 2013
TACROLIMUS - PROTOPIC
N050777 001 5385907 Jan 31, 2012 DP
5665727 Sep 09, 2014 U-919
TACROLIMUS - PROTOPIC
N050777 002 5385907 Jan 31, 2012 DP
5665727 Sep 09, 2014 U-919
TADALAFIL - ADCIRCA
N022332 001 5859006 Nov 21, 2017 DS DP U-975 NP May 22, 2012
6821975 Nov 19, 2020 DS DP ODE May 22, 2016
7182958 Apr 26, 2020 DP
TADALAFIL - CIALIS
N021368 001 5859006 Nov 21, 2017 DS DP D-111 Jan 07, 2011
6140329 Jul 11, 2016 DP U-155
6821975 Nov 19, 2020 DS DP U-533
6821975 Nov 19, 2020 DS DP U-614
6943166 Apr 26, 2020 U-155
6943166 Apr 26, 2020 U-614
7182958 Apr 26, 2020 DP U-155
TADALAFIL - CIALIS
N021368 002 5859006 Nov 21, 2017 DS DP
6140329 Jul 11, 2016 DP U-155
6821975 Nov 19, 2020 DS DP U-533
6821975 Nov 19, 2020 DS DP U-614
6943166 Apr 26, 2020 U-614
6943166 Apr 26, 2020 U-155
7182958 Apr 26, 2020 DP U-155
TADALAFIL - CIALIS
N021368 003 5859006 Nov 21, 2017 DS DP
6140329 Jul 11, 2016 DP U-155
6821975 Nov 19, 2020 DS DP U-614
6821975 Nov 19, 2020 DS DP U-533
6943166 Apr 26, 2020 U-614
7182958 Apr 26, 2020 DP U-155
TADALAFIL - CIALIS
N021368 004 5859006 Nov 21, 2017 DS DP D-111 Jan 07, 2011
6140329 Jul 11, 2016 DP U-155
6821975 Nov 19, 2020 DS DP U-614
6821975 Nov 19, 2020 DS DP U-533
6943166 Apr 26, 2020 U-155
7182958 Apr 26, 2020 DP U-155
TAMOXIFEN CITRATE - SOLTAMOX
N021807 001 6127425 Jun 26, 2018 DP
TAMSULOSIN HYDROCHLORIDE - FLOMAX
N020579 001 4703063 Oct 27, 2009 M-54 Dec 22, 2012
4703063*PED Apr 27, 2010 PED Jun 22, 2013
TAPENTADOL HYDROCHLORIDE - NUCYNTA
N022304 001 6071970 Jun 06, 2017 U-931 NCE Nov 20, 2013
RE39593 Jun 18, 2018 DS DP U-931
TAPENTADOL HYDROCHLORIDE - NUCYNTA
N022304 002 6071970 Jun 06, 2017 U-931 NCE Nov 20, 2013
RE39593 Jun 18, 2018 DS DP U-931
TAPENTADOL HYDROCHLORIDE - NUCYNTA
N022304 003 6071970 Jun 06, 2017 U-931 NCE Nov 20, 2013
RE39593 Jun 18, 2018 DS DP U-931
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 177 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
TAZAROTENE - AVAGE
N021184 003 5089509 Jun 13, 2011 U-481
TAZAROTENE - TAZORAC
N020600 001 5089509 Jun 13, 2011 U-193
5089509 Jun 13, 2011 U-481
5914334 Jun 07, 2014 U-517
6258830 Jun 07, 2014 U-517
TAZAROTENE - TAZORAC
N020600 002 5089509 Jun 13, 2011 U-481
5089509 Jun 13, 2011 U-193
5914334 Jun 07, 2014 U-517
6258830 Jun 07, 2014 U-517
TAZAROTENE - TAZORAC
N021184 001 5089509 Jun 13, 2011 U-481
TAZAROTENE - TAZORAC
N021184 002 5089509 Jun 13, 2011 U-481
TECHNETIUM TC-99M APCITIDE - ACUTECT
N020887 001 5443815 Aug 22, 2012
5508020 Apr 16, 2013
5645815 Jul 08, 2014
TECHNETIUM TC-99M BICISATE KIT - NEUROLITE
N020256 001 5431900 Jul 11, 2012 U-336
TECHNETIUM TC-99M SESTAMIBI KIT - CARDIOLITE
N019785 001 M-54 Apr 30, 2011
PED Oct 30, 2011
TECHNETIUM TC-99M TEBOROXIME KIT - CARDIOTEC
N019928 001 6056941 Jul 28, 2019 DP
TECHNETIUM TC-99M TETROFOSMIN KIT - MYOVIEW
N020372 001 5045302 Feb 09, 2010
TEGASEROD MALEATE - ZELNORM
N021200 001 5510353 Apr 26, 2013 U-466
TEGASEROD MALEATE - ZELNORM
N021200 002 5510353 Apr 26, 2013 U-466
TELAVANCIN HYDROCHLORIDE - VIBATIV
N022110 001 6635618 Sep 22, 2021 DS DP U-728 NCE Sep 11, 2014
6858584 Aug 24, 2022 DP
6872701 Jun 05, 2021 DP
7008923 May 06, 2021 U-1005
7208471 May 01, 2021 DS DP
7351691 May 01, 2021 DS DP U-728
7531623 Nov 26, 2026 DS
7544364 May 01, 2021 DP
TELAVANCIN HYDROCHLORIDE - VIBATIV
N022110 002 6635618 Sep 22, 2021 DS DP U-728 NCE Sep 11, 2014
6858584 Aug 24, 2022 DP
6872701 Jun 05, 2021 DP
7008923 May 06, 2021 U-1005
7208471 May 01, 2021 DS DP
7351691 May 01, 2021 DS DP U-728
7531623 Nov 26, 2026 DS
7544364 May 01, 2021 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 178 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
TELBIVUDINE - TYZEKA
N022011 001 6395716 Aug 10, 2019 U-782 NCE Oct 25, 2011
6444652 Aug 10, 2019 U-782
6566344 Aug 10, 2019 U-782
6569837 Oct 25, 2020 U-999
6569837 Oct 25, 2020 U-782
7589079 Sep 11, 2023 DS DP U-999
TELBIVUDINE - TYZEKA
N022154 001 6395716 Aug 10, 2019 U-999 NCE Oct 25, 2011
6444652 Aug 10, 2019 U-999
6566344 Aug 10, 2019 U-999
6569837 Oct 25, 2020 U-999
TELITHROMYCIN - KETEK
N021144 001 5635485 Apr 01, 2018 DS DP U-578
D459798 Sep 24, 2015 DP
TELITHROMYCIN - KETEK
N021144 002 5635485 Apr 01, 2018 DS DP U-578
D459798 Sep 24, 2015 DP
TELMISARTAN - MICARDIS
N020850 001 5591762 Jan 07, 2014 U-3
6358986 Jan 10, 2020
TELMISARTAN - MICARDIS
N020850 002 5591762 Jan 07, 2014 DS DP U-3 I-612 Oct 16, 2012
6358986 Jan 10, 2020
TELMISARTAN - MICARDIS
N020850 003 5591762 Jan 07, 2014 U-3
6358986 Jan 10, 2020
TEMAZEPAM - RESTORIL
N018163 003 5211954 May 18, 2010
TEMOZOLOMIDE - TEMODAR
N021029 001 5260291 Aug 11, 2013 DS DP U-619 ODE Mar 15, 2012
5260291*PED Feb 11, 2014
TEMOZOLOMIDE - TEMODAR
N021029 002 5260291 Aug 11, 2013 DS DP U-619 ODE Mar 15, 2012
5260291*PED Feb 11, 2014
TEMOZOLOMIDE - TEMODAR
N021029 003 5260291 Aug 11, 2013 DS DP U-619 ODE Mar 15, 2012
5260291*PED Feb 11, 2014
TEMOZOLOMIDE - TEMODAR
N021029 004 5260291 Aug 11, 2013 DS DP U-619 ODE Mar 15, 2012
5260291*PED Feb 11, 2014
TEMOZOLOMIDE - TEMODAR
N021029 005 5260291 Aug 11, 2013 DS DP U-619 ODE Mar 15, 2012
5260291*PED Feb 11, 2014
TEMOZOLOMIDE - TEMODAR
N021029 006 5260291 Aug 11, 2013 DS DP U-619 ODE Mar 15, 2012
5260291*PED Feb 11, 2014
TEMOZOLOMIDE - TEMODAR
N022277 001 5260291 Aug 11, 2013 DS DP U-619
5260291*PED Feb 11, 2014
6987108 Sep 08, 2023 DP
TEMSIROLIMUS - TORISEL
N022088 001 5362718 Apr 18, 2014 DS DP NCE May 30, 2012
ODE May 30, 2014
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 179 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
TENOFOVIR DISOPROXIL FUMARATE - VIREAD
N021356 001 5922695 Jul 25, 2017 DS U-250 I-569 Aug 11, 2011
5922695 Jul 25, 2017 DS U-248
5922695 Jul 25, 2017 DS U-999
5922695 Jul 25, 2017 DS U-256
5935946 Jul 25, 2017 DS DP U-999
5935946 Jul 25, 2017 DS DP U-250
5935946 Jul 25, 2017 DS DP U-248
5935946 Jul 25, 2017 DS DP U-256
5977089 Jul 25, 2017 DS DP U-248
5977089 Jul 25, 2017 DS DP U-999
5977089 Jul 25, 2017 DS DP U-256
5977089 Jul 25, 2017 DS DP U-250
6043230 Jul 25, 2017 U-248
6043230 Jul 25, 2017 U-256
6043230 Jul 25, 2017 U-250
6043230 Jul 25, 2017 U-999
TERAZOSIN HYDROCHLORIDE - HYTRIN
N019057 001 5212176 Jun 29, 2010
5294615 Apr 29, 2013 U-165
5294615 Apr 29, 2013 U-3
5412095 Apr 29, 2013
TERAZOSIN HYDROCHLORIDE - HYTRIN
N019057 002 5212176 Jun 29, 2010
5294615 Apr 29, 2013 U-165
5294615 Apr 29, 2013 U-3
5412095 Apr 29, 2013
TERAZOSIN HYDROCHLORIDE - HYTRIN
N019057 003 5212176 Jun 29, 2010
5294615 Apr 29, 2013 U-165
5294615 Apr 29, 2013 U-3
5412095 Apr 29, 2013
TERAZOSIN HYDROCHLORIDE - HYTRIN
N019057 004 5212176 Jun 29, 2010
5294615 Apr 29, 2013 U-165
5294615 Apr 29, 2013 U-3
5412095 Apr 29, 2013
TERAZOSIN HYDROCHLORIDE - HYTRIN
N020347 001 5212176 Jun 29, 2010
5294615 Apr 29, 2013 U-3
5294615 Apr 29, 2013 U-165
5412095 Apr 29, 2013
TERAZOSIN HYDROCHLORIDE - HYTRIN
N020347 002 5212176 Jun 29, 2010
5294615 Apr 29, 2013 U-165
5294615 Apr 29, 2013 U-3
5412095 Apr 29, 2013
TERAZOSIN HYDROCHLORIDE - HYTRIN
N020347 003 5212176 Jun 29, 2010
5294615 Apr 29, 2013 U-3
5294615 Apr 29, 2013 U-165
5412095 Apr 29, 2013
TERAZOSIN HYDROCHLORIDE - HYTRIN
N020347 004 5212176 Jun 29, 2010
5294615 Apr 29, 2013 U-3
5294615 Apr 29, 2013 U-165
5412095 Apr 29, 2013
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 180 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
TERBINAFINE - LAMISIL
N020846 001 5681849 Oct 28, 2014 DP
5681849*PED Apr 28, 2015
5856355 May 18, 2012 DP U-502
5856355 May 18, 2012 DP U-540
5856355 May 18, 2012 DP U-504
5856355*PED Nov 18, 2012
6005001 May 18, 2012 DP U-502
6005001 May 18, 2012 DP U-540
6005001 May 18, 2012 DP U-504
6005001*PED Nov 18, 2012
6121314 May 18, 2012 DP U-504
6121314 May 18, 2012 DP U-540
6121314 May 18, 2012 DP U-502
6121314*PED Nov 18, 2012
TERBINAFINE - LAMISIL AT
N021958 001 5681849 Oct 28, 2014 DP
5856355 May 18, 2012 DP U-504
5856355 May 18, 2012 DP U-540
6121314 May 18, 2012 U-540
6121314 May 18, 2012 U-504
TERBINAFINE HYDROCHLORIDE - LAMISIL
N020749 001 6121314 May 18, 2012 U-502
6121314*PED Nov 18, 2012
TERBINAFINE HYDROCHLORIDE - LAMISIL AT
N021124 001 5681849 Oct 28, 2014
5681849*PED Apr 28, 2015
6121314 May 18, 2012 U-504
6121314*PED Nov 18, 2012
TERBINAFINE HYDROCHLORIDE - LAMISIL AT
N021124 002 5681849 Oct 28, 2014
5681849*PED Apr 28, 2015
6121314 May 18, 2012 U-504
6121314*PED Nov 18, 2012
TERIPARATIDE RECOMBINANT HUMAN - FORTEO
N021318 001 6770623 Dec 08, 2018 DP U-597 I-602 Jul 22, 2012
6977077 Aug 19, 2019 U-597
7144861 Dec 08, 2018 DP
7163684 Aug 19, 2019 U-790
7351414 Aug 19, 2019 U-865
7550434 Dec 08, 2018 DP U-982
TERIPARATIDE RECOMBINANT HUMAN - FORTEO
N021318 002 6770623 Dec 08, 2018 DP U-982 I-602 Jul 22, 2012
6977077 Aug 19, 2019 U-994
6977077 Aug 19, 2019 U-982
7144861 Dec 08, 2018 DP
7163684 Aug 19, 2019 U-983
7163684 Aug 19, 2019 U-994
7351414 Aug 19, 2019 U-994
7351414 Aug 19, 2019 U-984
7550434 Dec 08, 2018 DP U-982
TESTOSTERONE - ANDRODERM
N020489 001 5152997 Dec 11, 2010 U-490
5164190 Dec 11, 2010
TESTOSTERONE - ANDRODERM
N020489 002 5152997 Dec 11, 2010 U-490
5164190 Dec 11, 2010
TESTOSTERONE - ANDROGEL
N021015 001 6503894 Aug 30, 2020 U-490
6503894*PED Mar 01, 2021
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 181 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT

EXCLUSIVITY

EXPIRATION PATENT DELIST


EXCLUSIVITY EXPIRATION

APPL/PROD DATE REQUESTED DATE


NO PATENT NO CODES CODE(S)


TESTOSTERONE - ANDROGEL

N021015 002 6503894


Aug 30, 2020 U-490

6503894*PED
Mar 01, 2021

TESTOSTERONE - ANDROGEL

N021015 003 6503894


Aug 30, 2020 U-490

6503894*PED
Mar 01, 2021

TESTOSTERONE - STRIANT

N021543 001 6248358


Aug 23, 2019 U-527

TESTOSTERONE - TESTIM

N021454 001 7320968


Jan 18, 2025 U-843

7608605
Apr 21, 2023 U-1009

7608606
Apr 21, 2023 U-1009

7608607
Apr 21, 2023 U-1009

7608608
Apr 21, 2023 U-1009

7608609
Apr 21, 2023 U-1009

7608610
Apr 21, 2023 U-1009

TESTOSTERONE - TESTODERM

N019762 001 5840327


Aug 15, 2016
TESTOSTERONE - TESTODERM

N019762 002 5840327


Aug 15, 2016
TESTOSTERONE - TESTODERM TTS

N020791 001 6348210


Nov 10, 2019 U-440

TETRABENAZINE - XENAZINE
N021894 001 NCE Aug 15, 2013

ODE Aug 15, 2015


TETRABENAZINE - XENAZINE
N021894 002 NCE Aug 15, 2013

ODE Aug 15, 2015


THALIDOMIDE - THALOMID

N020785 001 5629327


May 13, 2014 U-731 ODE
May 25, 2013

6045501
Aug 28, 2018 U-371

6045501
Aug 28, 2018 U-731

6235756
Mar 01, 2013 U-731

6315720
Oct 23, 2020 U-731

6315720
Oct 23, 2020 U-442

6561976
Aug 28, 2018 U-731

6561976
Aug 28, 2018 U-371

6561977
Oct 23, 2020 U-731

6561977
Oct 23, 2020 U-371

6755784
Oct 23, 2020 U-371

6755784
Oct 23, 2020 U-731

6869399
Oct 23, 2020 U-732

6869399
Oct 23, 2020 U-371

6869399
Oct 23, 2020 U-731

6869399
Oct 23, 2020 U-733

6908432
Aug 28, 2018 U-371

6908432
Aug 28, 2018 U-731

7141018
Oct 23, 2020 U-732

7141018
Oct 23, 2020 U-733

7141018
Oct 23, 2020 U-731

7141018
Oct 23, 2020 U-371

7230012
Dec 09, 2023 DP

7435745
Nov 03, 2017 U-899

30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 182 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
THALIDOMIDE - THALOMID
N020785 002 5629327 May 13, 2014 U-731 ODE May 25, 2013
6045501 Aug 28, 2018 U-371
6045501 Aug 28, 2018 U-731
6235756 Mar 01, 2013 U-731
6315720 Oct 23, 2020 U-442
6315720 Oct 23, 2020 U-731
6561976 Aug 28, 2018 U-731
6561976 Aug 28, 2018 U-371
6561977 Oct 23, 2020 U-371
6561977 Oct 23, 2020 U-731
6755784 Oct 23, 2020 U-371
6755784 Oct 23, 2020 U-731
6869399 Oct 23, 2020 U-371
6869399 Oct 23, 2020 U-731
6869399 Oct 23, 2020 U-733
6869399 Oct 23, 2020 U-732
6908432 Aug 28, 2018 U-731
6908432 Aug 28, 2018 U-371
7141018 Oct 23, 2020 U-733
7141018 Oct 23, 2020 U-732
7141018 Oct 23, 2020 U-731
7141018 Oct 23, 2020 U-371
7230012 Dec 09, 2023 DP
7435745 Nov 03, 2017 U-899
THALIDOMIDE - THALOMID
N020785 003 5629327 May 13, 2014 U-731 ODE May 25, 2013
6045501 Aug 28, 2018 U-731
6045501 Aug 28, 2018 U-371
6235756 Mar 01, 2013 U-731
6315720 Oct 23, 2020 U-731
6315720 Oct 23, 2020 U-442
6561976 Aug 28, 2018 U-371
6561976 Aug 28, 2018 U-731
6561977 Oct 23, 2020 U-731
6561977 Oct 23, 2020 U-371
6755784 Oct 23, 2020 U-731
6755784 Oct 23, 2020 U-371
6869399 Oct 23, 2020 U-733
6869399 Oct 23, 2020 U-731
6869399 Oct 23, 2020 U-732
6869399 Oct 23, 2020 U-371
6908432 Aug 28, 2018 U-731
6908432 Aug 28, 2018 U-371
7141018 Oct 23, 2020 U-732
7141018 Oct 23, 2020 U-731
7141018 Oct 23, 2020 U-371
7141018 Oct 23, 2020 U-733
7230012 Dec 09, 2023 DP
7435745 Nov 03, 2017 U-899
THALIDOMIDE - THALOMID
N020785 004 5629327 May 13, 2014 U-731 ODE May 23, 2013
6045501 Aug 28, 2018 U-731
6235756 Mar 01, 2013 U-731
6315720 Oct 23, 2020 U-731
6561976 Aug 28, 2018 U-731
6561977 Oct 23, 2020 U-731
6755784 Oct 23, 2020 U-731
6869399 Oct 23, 2020 U-731
6908432 Aug 28, 2018 U-731
7141018 Oct 23, 2020 U-731
7435745 Nov 03, 2017 U-899
THYROTROPIN ALFA - THYROGEN
N020898 001 5840566 Nov 24, 2015 I-552 Dec 14, 2010
6365127 Nov 24, 2015 DS DP U-556 ODE Dec 14, 2014
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 183 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
TIAGABINE HYDROCHLORIDE - GABITRIL
N020646 001 5010090 Sep 30, 2011
5354760 Mar 24, 2012
5866590 Apr 29, 2016
5958951 Jun 10, 2017
TIAGABINE HYDROCHLORIDE - GABITRIL
N020646 002 5010090 Sep 30, 2011
5354760 Mar 24, 2012
5866590 Apr 29, 2016
5958951 Jun 10, 2017
TIAGABINE HYDROCHLORIDE - GABITRIL
N020646 003 5010090 Sep 30, 2011
5354760 Mar 24, 2012
5866590 Apr 29, 2016
5958951 Jun 10, 2017
TIAGABINE HYDROCHLORIDE - GABITRIL
N020646 004 5010090 Sep 30, 2011
5354760 Mar 24, 2012
5866590 Apr 29, 2016
5958951 Jun 10, 2017
TIAGABINE HYDROCHLORIDE - GABITRIL
N020646 005 5010090 Sep 30, 2011
5354760 Mar 24, 2012
5866590 Apr 29, 2016
5958951 Jun 10, 2017
TIGECYCLINE - TYGACIL
N021821 001 RE40086 Jun 25, 2013 U-282 I-588 Mar 20, 2012
RE40183 Apr 09, 2016 DS DP I-587 Mar 20, 2012
I-586 Mar 20, 2012
NCE Jun 15, 2010
TILUDRONATE DISODIUM - SKELID
N020707 001 4876248 Jan 30, 2010
TIMOLOL - BETIMOL
N020439 001 5231095 Jul 27, 2010
TIMOLOL - BETIMOL
N020439 002 5231095 Jul 27, 2010
TIMOLOL MALEATE - ISTALOL
N021516 001 6335335 Nov 02, 2018 DP
TIMOLOL MALEATE - TIMOLOL MALEATE
N020963 001 6174524 Mar 26, 2019 DP M-14 Jun 08, 2010
6174524*PED Sep 26, 2019 PED Dec 08, 2010
TIMOLOL MALEATE - TIMOLOL MALEATE
N020963 002 6174524 Mar 26, 2019 DP
6174524*PED Sep 26, 2019
TINIDAZOLE - TINDAMAX
N021618 001 I-532 May 21, 2010
ODE May 17, 2011
ODE May 17, 2011
TINIDAZOLE - TINDAMAX
N021618 002 I-532 May 21, 2010
ODE May 17, 2011
ODE May 17, 2011
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 184 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
TIOTROPIUM BROMIDE MONOHYDRATE - SPIRIVA
N021395 001 5478578 Dec 26, 2012 DP M-89 Dec 17, 2012
6777423 Sep 24, 2021 DS DP
6908928 Nov 25, 2022 DS DP U-566
7070800 Jan 22, 2022 DP U-566
7309707 Mar 10, 2023 DS DP
RE38912 Oct 11, 2021 DP
RE39820 Jan 30, 2018 DS DP U-566
TIPRANAVIR - APTIVUS
N021814 001 5852195 Jun 22, 2019 DS I-568 Jun 23, 2011
5852195*PED Dec 22, 2019 NCE Jun 22, 2010
6147095 Oct 29, 2019 U-670 PED Dec 23, 2011
6147095*PED Apr 29, 2020
6169181 May 06, 2014 DS PED Dec 22, 2010
6169181*PED Nov 06, 2014
6231887 Jul 27, 2018 DP
6231887*PED Jan 27, 2019
TIPRANAVIR - APTIVUS
N022292 001 5852195 Jun 22, 2019 DS I-568 Jun 23, 2011
5852195*PED Dec 22, 2019 NCE Jun 22, 2010
6147095 Oct 29, 2019 U-670 PED Dec 23, 2011
6147095*PED Apr 29, 2020
6169181 May 06, 2014 DS
PED Dec 22, 2010
6169181*PED Nov 06, 2014

TIROFIBAN HYDROCHLORIDE - AGGRASTAT


N020912 001 5292756 May 14, 2012 U-230
5658929 Sep 27, 2010
5733919 Oct 23, 2016
5880136 Sep 27, 2010 U-254
5965581 Oct 23, 2016
5972967 Oct 23, 2016
5978698 Oct 08, 2017
6136794 Jan 29, 2019
TIROFIBAN HYDROCHLORIDE - AGGRASTAT
N020913 001 5292756 May 14, 2012 U-230
5658929 Sep 27, 2010
5733919 Oct 23, 2016
5880136 Sep 27, 2010 U-254
5965581 Oct 23, 2016
5972967 Oct 23, 2016
5978698 Oct 08, 2017
6136794 Jan 29, 2019
TIROFIBAN HYDROCHLORIDE - AGGRASTAT
N020913 002 5292756 May 14, 2012 U-230
5658929 Sep 27, 2010
5733919 Oct 23, 2016
5880136 Sep 27, 2010 U-254
5965581 Oct 23, 2016
5972967 Oct 23, 2016
5978698 Oct 08, 2017
6136794 Jan 29, 2019
TIROFIBAN HYDROCHLORIDE - AGGRASTAT
N020913 003 5292756 May 14, 2012 U-230
5658929 Sep 27, 2010
5733919 Oct 23, 2016
5880136 Sep 27, 2010 U-254
5965581 Oct 23, 2016
5972967 Oct 23, 2016
5978698 Oct 08, 2017
6136794 Jan 29, 2019
TIZANIDINE HYDROCHLORIDE - ZANAFLEX
N021447 001 6455557 Nov 28, 2021
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 185 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
TIZANIDINE HYDROCHLORIDE - ZANAFLEX
N021447 002 6455557 Nov 28, 2021
TIZANIDINE HYDROCHLORIDE - ZANAFLEX
N021447 003 6455557 Nov 28, 2021
TOBRAMYCIN - TOBI
N050753 001 5508269 Oct 19, 2014 DP U-909
TOLCAPONE - TASMAR
N020697 001 5236952 Jan 29, 2012
5476875 Dec 19, 2012 U-219
TOLCAPONE - TASMAR
N020697 002 5236952 Jan 29, 2012
5476875 Dec 19, 2012 U-219
TOLTERODINE TARTRATE - DETROL
N020771 001 5382600 Mar 25, 2012
5382600*PED Sep 25, 2012
TOLTERODINE TARTRATE - DETROL
N020771 002 5382600 Mar 25, 2012
5382600*PED Sep 25, 2012
TOLTERODINE TARTRATE - DETROL LA
N021228 001 5382600 Mar 25, 2012
5382600*PED Sep 25, 2012
6630162 Nov 11, 2019 DP U-544
6630162*PED May 11, 2020
6770295 Aug 26, 2019 DP U-544
6770295*PED Feb 26, 2020
6911217 Aug 26, 2019 DP U-544
6911217*PED Feb 26, 2020 DP U-544
TOLTERODINE TARTRATE - DETROL LA
N021228 002 5382600 Mar 25, 2012
5382600*PED Sep 25, 2012
6630162 Nov 11, 2019 DP U-544
6630162*PED May 11, 2020
6770295 Aug 26, 2019 DP U-544
6770295*PED Feb 26, 2020
6911217 Aug 26, 2019 DP U-544
6911217*PED Feb 26, 2020 DP U-544
TOLVAPTAN - SAMSCA
N022275 001 5258510 Nov 02, 2010 DS NCE May 19, 2014
5753677 May 19, 2015 U-978
TOLVAPTAN - SAMSCA
N022275 002 5258510 Nov 02, 2010 DS NCE May 19, 2014
5753677 May 19, 2015 U-978
TOLVAPTAN - SAMSCA
N022275 003 5258510 Nov 02, 2010 DS NCE May 19, 2014
5753677 May 19, 2015 U-978
TOPIRAMATE - TOPAMAX
N020505 001 5998380 Oct 13, 2015 U-598 M-54 Dec 22, 2012
5998380*PED Apr 13, 2016 PED Jun 22, 2013
6503884 Oct 13, 2015 U-598
6503884*PED Apr 13, 2016
7018983 Oct 13, 2015 U-723
7018983*PED Apr 13, 2016
7498311 Oct 13, 2015 U-955
7498311*PED Apr 13, 2016
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 186 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
TOPIRAMATE - TOPAMAX
N020505 002 5998380 Oct 13, 2015 U-598 M-54 Dec 22, 2012
5998380*PED Apr 13, 2016 PED Jun 22, 2013
6503884 Oct 13, 2015 U-598
6503884*PED Apr 13, 2016
7018983 Oct 13, 2015 U-723
7018983*PED Apr 13, 2016
7498311 Oct 13, 2015 U-955
7498311*PED Apr 13, 2016
TOPIRAMATE - TOPAMAX
N020505 003 5998380 Oct 13, 2015 U-598 M-54 Dec 22, 2012
5998380*PED Apr 13, 2016 PED Jun 22, 2013
6503884 Oct 13, 2015 U-598
6503884*PED Apr 13, 2016
7018983 Oct 13, 2015 U-723
7018983*PED Apr 13, 2016
7498311 Oct 13, 2015 U-955
7498311*PED Apr 13, 2016
TOPIRAMATE - TOPAMAX
N020505 004 5998380 Oct 13, 2015 U-598 M-54 Dec 22, 2012
5998380*PED Apr 13, 2016 PED Jun 22, 2013
6503884 Oct 13, 2015 U-598
6503884*PED Apr 13, 2016
7018983 Oct 13, 2015 U-723
7018983*PED Apr 13, 2016
7498311 Oct 13, 2015 U-955
7498311*PED Apr 13, 2016
TOPIRAMATE - TOPAMAX
N020505 005 5998380 Oct 13, 2015 U-598 M-54 Dec 22, 2012
5998380*PED Apr 13, 2016 PED Jun 22, 2013
6503884 Oct 13, 2015 U-598
6503884*PED Apr 13, 2016
7018983 Oct 13, 2015 U-723
7018983*PED Apr 13, 2016
7498311 Oct 13, 2015 U-955
7498311*PED Apr 13, 2016
TOPIRAMATE - TOPAMAX
N020505 006 5998380 Oct 13, 2015 U-598 M-54 Dec 22, 2012
5998380*PED Apr 13, 2016 PED Jun 22, 2013
6503884 Oct 13, 2015 U-598
6503884*PED Apr 13, 2016
7018983 Oct 13, 2015 U-723
7018983*PED Apr 13, 2016
7498311 Oct 13, 2015 U-955
7498311*PED Apr 13, 2016
TOPIRAMATE - TOPAMAX
N020844 001 5998380 Oct 13, 2015 U-598 M-54 Dec 22, 2012
5998380*PED Apr 13, 2016 PED Jun 22, 2013
6503884 Oct 13, 2015 U-598
6503884*PED Apr 13, 2016
7018983 Oct 13, 2015 U-723
7018983*PED Apr 13, 2016
7125560 Mar 01, 2019 U-766
7125560*PED Sep 01, 2019
7498311 Oct 13, 2015 U-955
7498311*PED Apr 13, 2016
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 187 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
TOPIRAMATE - TOPAMAX
N020844 002 5998380 Oct 13, 2015 U-598 M-54 Dec 22, 2012
5998380*PED Apr 13, 2016 PED Jun 22, 2013
6503884 Oct 13, 2015 U-598
6503884*PED Apr 13, 2016
7018983 Oct 13, 2015 U-723
7018983*PED Apr 13, 2016
7125560 Mar 01, 2019 U-766
7125560*PED Sep 01, 2019
7498311 Oct 13, 2015 U-955
7498311*PED Apr 13, 2016
TOPIRAMATE - TOPAMAX SPRINKLE
N020844 003 5998380 Oct 13, 2015 U-598 M-54 Dec 22, 2012
5998380*PED Apr 13, 2016 PED Jun 22, 2013
6503884 Oct 13, 2015 U-598
6503884*PED Apr 13, 2016
7018983 Oct 13, 2015 U-723
7018983*PED Apr 13, 2016
7125560 Mar 01, 2019 U-766
7125560*PED Sep 01, 2019
7498311 Oct 13, 2015 U-955
7498311*PED Apr 13, 2016
TOPIRAMATE - TOPIRAMATE
A076448 001 PC Oct 12, 2009
TOPIRAMATE - TOPIRAMATE
A076448 002 PC Oct 12, 2009
TOPIRAMATE - TOPIRAMATE
A077868 001 PC Oct 12, 2009
TOPIRAMATE - TOPIRAMATE
A077868 002 PC Oct 12, 2009
TOPOTECAN HYDROCHLORIDE - HYCAMTIN
N020671 001 5004758 May 28, 2010 DS DP U-741
5004758*PED Nov 28, 2010
5674872 Oct 07, 2014 U-910
5674872*PED Apr 07, 2015
TOPOTECAN HYDROCHLORIDE - HYCAMTIN
N020981 001 5004758 May 28, 2010 DS DP U-830 NDF Oct 11, 2010
5004758*PED Nov 28, 2010
TOPOTECAN HYDROCHLORIDE - HYCAMTIN
N020981 002 5004758 May 28, 2010 DS DP U-830 NDF Oct 11, 2010
5004758*PED Nov 28, 2010
TOREMIFENE CITRATE - FARESTON
N020497 001 4696949 Sep 29, 2009 U-196
TRAMADOL HYDROCHLORIDE - RYZOLT
N021745 001 5591452 May 10, 2014 DP NP Dec 30, 2011
6254887 May 10, 2014 DP
6607748 Jun 29, 2020 DP
TRAMADOL HYDROCHLORIDE - RYZOLT
N021745 002 5591452 May 10, 2014 DP NP Dec 30, 2011
6254887 May 10, 2014 DP
6607748 Jun 29, 2020 DP
TRAMADOL HYDROCHLORIDE - RYZOLT
N021745 003 5591452 May 10, 2014 DP NP Dec 30, 2011
6254887 May 10, 2014 DP
6607748 Jun 29, 2020 DP
TRAMADOL HYDROCHLORIDE - TRAMADOL HYDROCHLORIDE
N021693 001 5464632 Mar 22, 2013 DP
6106861 Dec 05, 2017 DP
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 188 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
TRAMADOL HYDROCHLORIDE - ULTRAM
N020281 001 6339105 Oct 12, 2019 U-435
6339105*PED Apr 12, 2020 U-435
TRAMADOL HYDROCHLORIDE - ULTRAM
N020281 002 6339105 Oct 12, 2019 U-435
6339105*PED Apr 12, 2020 U-435
TRAMADOL HYDROCHLORIDE - ULTRAM ER
N021692 001 6254887 May 10, 2014 DP
7074430 May 10, 2014 DP
TRAMADOL HYDROCHLORIDE - ULTRAM ER
N021692 002 6254887 May 10, 2014 DP
7074430 May 10, 2014 DP
TRAMADOL HYDROCHLORIDE - ULTRAM ER
N021692 003 6254887 May 10, 2014 DP
7074430 May 10, 2014 DP
TRANDOLAPRIL - MAVIK
N020528 001 5744496 Apr 28, 2015 U-229
TRANDOLAPRIL - MAVIK
N020528 002 5744496 Apr 28, 2015 U-229
TRANDOLAPRIL - MAVIK
N020528 003 5744496 Apr 28, 2015 U-229
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA
N020591 001 5721244 Feb 24, 2015
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA
N020591 002 5721244 Feb 24, 2015
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA
N020591 003 5721244 Feb 24, 2015
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA
N020591 004 5721244 Feb 24, 2015
TRANEXAMIC ACID - LYSTEDA
N022430 001 NDF Nov 13, 2012
TRAVOPROST - TRAVATAN
N021257 001 5510383 Aug 03, 2013 DP U-383
5631287 Dec 22, 2014 U-382
5849792 Dec 22, 2014 DP U-383
5889052 Dec 02, 2014 DP U-383
6011062 Dec 22, 2014 DP
TRAVOPROST - TRAVATAN Z
N021994 001 5510383 Aug 03, 2013 DP U-383
5889052 Dec 02, 2014 DP U-383
6503497 May 06, 2012 DP
6849253 May 06, 2012 DP
TREPROSTINIL SODIUM - REMODULIN
N021272 001 5153222 Oct 06, 2014 U-455
6765117 Oct 24, 2017 DS
TREPROSTINIL SODIUM - REMODULIN
N021272 002 5153222 Oct 06, 2014 U-455
6765117 Oct 24, 2017 DS
TREPROSTINIL SODIUM - REMODULIN
N021272 003 5153222 Oct 06, 2014 U-455
6765117 Oct 24, 2017 DS
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 189 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
TREPROSTINIL SODIUM - REMODULIN
N021272 004 5153222 Oct 06, 2014 U-455
6765117 Oct 24, 2017 DS
TREPROSTINIL SODIUM - TYVASO
N022387 001 5153222 Oct 16, 2014 U-1019 NDF Jul 30, 2012
6521212 Nov 13, 2018 U-1018
6756033 Nov 13, 2018 U-1018
6765117 Oct 24, 2017 DS
TRETINOIN - ATRALIN
N022070 001 5670547 Sep 23, 2014 DP NP Jul 26, 2010
TRETINOIN - RENOVA
N021108 001 6531141 Mar 07, 2020
TRETINOIN - RETIN-A MICRO
N020475 001 5955109 Sep 21, 2016 DP U-134
TRETINOIN - RETIN-A MICRO
N020475 002 5955109 Sep 21, 2016 U-134
TRIAMCINOLONE ACETONIDE - NASACORT AQ
N020468 001 5976573 Jul 03, 2016 DP U-295 NPP Sep 19, 2011
5976573 Jul 03, 2016 DP U-896
6143329 Jul 03, 2016 DP U-896
TRIAMCINOLONE ACETONIDE - TRIESENCE
N022048 001 6395294 Jan 13, 2020 DP U-846 NP Nov 29, 2010
TRIMETHOPRIM HYDROCHLORIDE - PRIMSOL
A074973 001 5763449 Aug 07, 2016
5962461 Aug 07, 2016
TRIMETREXATE GLUCURONATE - NEUTREXIN
N020326 001 6017922 May 18, 2018
TRIMETREXATE GLUCURONATE - NEUTREXIN
N020326 002 6017922 May 18, 2018
TRIPTORELIN PAMOATE - TRELSTAR DEPOT
N020715 001 5225205 Jul 20, 2010
5776885 Jul 07, 2015
TRIPTORELIN PAMOATE - TRELSTAR LA
N021288 001 5225205 Jul 20, 2010
TROGLITAZONE - PRELAY
N020719 001 5602133 Sep 15, 2013 U-173
5859037 Nov 13, 2017 U-251
6011049 Nov 13, 2017 U-301
6046202 Sep 15, 2013 U-317
TROGLITAZONE - PRELAY
N020719 002 5602133 Sep 15, 2013 U-173
5859037 Nov 13, 2017 U-251
6011049 Nov 13, 2017 U-301
6046202 Sep 15, 2013 U-317
TROGLITAZONE - PRELAY
N020719 003 5602133 Sep 15, 2013 U-173
5859037 Nov 13, 2017 U-251
6011049 Nov 13, 2017 U-301
6046202 Sep 15, 2013 U-317
TROGLITAZONE - REZULIN
N020720 001 5602133 Sep 15, 2013 U-173
5859037 Nov 13, 2017 U-251
6011049 Nov 13, 2017 U-301
6046202 Sep 15, 2013 U-317
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 190 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
TROGLITAZONE - REZULIN
N020720 002 5602133 Sep 15, 2013 U-173
5859037 Nov 13, 2017 U-251
6011049 Nov 13, 2017 U-301
6046202 Sep 15, 2013 U-317
TROGLITAZONE - REZULIN
N020720 003 5602133 Sep 15, 2013 U-173
5859037 Nov 13, 2017 U-251
6011049 Nov 13, 2017 U-301
6046202 Sep 15, 2013 U-317
TROSPIUM CHLORIDE - SANCTURA XR
N022103 001 7410978 Feb 01, 2025 DP NDF Aug 03, 2010
TROVAFLOXACIN MESYLATE - TROVAN
N020759 001 5164402 Dec 18, 2011 U-282
5763454 Jun 15, 2015 U-282
6187341 Jan 20, 2019
TROVAFLOXACIN MESYLATE - TROVAN
N020759 002 5164402 Dec 18, 2011 U-282
5763454 Jun 15, 2015 U-282
6187341 Jan 20, 2019
TRYPAN BLUE - MEMBRANEBLUE
N022278 001 NCE Dec 16, 2009
ODE Dec 16, 2011
TRYPAN BLUE - VISIONBLUE
N021670 001 NCE Dec 16, 2009
UNOPROSTONE ISOPROPYL - RESCULA
N021214 001 5166178 Nov 24, 2009 U-333
5208256 May 21, 2011 DP U-333
5212200 May 18, 2010 U-333
5221763 Jul 15, 2012 DS
6458836 Jul 09, 2021 U-333
UREA, C-13 - BREATHTEK UBT FOR H-PYLORI
N020586 002 4830010 Oct 27, 2009 U-147
5140993 Aug 24, 2009 U-148
UREA, C-13 - MERETEK UBT KIT (W/ PRANACTIN)
N020586 001 4830010 Oct 27, 2009 U-147
5140993 Aug 24, 2009 U-148
UROFOLLITROPIN - FERTINEX
N019415 004 5767067 Jun 16, 2015
UROFOLLITROPIN - FERTINEX
N019415 005 5767067 Jun 16, 2015
VALACYCLOVIR HYDROCHLORIDE - VALACYCLOVIR HYDROCHLORIDE
A076588 001 PC May 24, 2010
VALACYCLOVIR HYDROCHLORIDE - VALACYCLOVIR HYDROCHLORIDE
A076588 002 PC May 24, 2010
VALACYCLOVIR HYDROCHLORIDE - VALTREX
N020487 001 4957924*PED Dec 23, 2009 I-570 Sep 02, 2011
5879706 Jan 19, 2016 DP U-530 NPP Sep 02, 2011
5879706 Jan 19, 2016 DP U-894 PED Mar 02, 2012
5879706*PED Jul 19, 2016
6107302 Jan 19, 2016 DS U-530 PED Mar 02, 2012
6107302 Jan 19, 2016 DS U-894
6107302*PED Jul 19, 2016
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 191 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
VALACYCLOVIR HYDROCHLORIDE - VALTREX
N020487 002 4957924*PED Dec 23, 2009 I-570 Sep 02, 2011
5879706 Jan 19, 2016 DP U-530 NPP Sep 02, 2011
5879706 Jan 19, 2016 DP U-894 PED Mar 02, 2012
5879706*PED Jul 19, 2016
6107302 Jan 19, 2016 DS U-894 PED Mar 02, 2012
6107302 Jan 19, 2016 DS U-530
6107302*PED Jul 19, 2016
VALDECOXIB - BEXTRA
N021341 002 5633272 Feb 13, 2015 U-462
7135489 Aug 12, 2017 DS DP
VALDECOXIB - BEXTRA
N021341 003 5633272 Feb 13, 2015 U-462
7135489 Aug 12, 2017 DS DP
VALGANCICLOVIR HYDROCHLORIDE - VALCYTE
N021304 001 6083953 Mar 29, 2015 DS DP U-384 I-604 Aug 28, 2012
6083953 Mar 29, 2015 DS DP U-854 PED Feb 28, 2013
6083953*PED Sep 29, 2015
VALGANCICLOVIR HYDROCHLORIDE - VALCYTE
N022257 001 6083953 Mar 29, 2015 DS DP U-384 NDF Aug 28, 2012
6083953 Mar 29, 2015 DS DP U-854 PED Feb 28, 2013
VALSARTAN - DIOVAN
N020665 001 5399578 Mar 21, 2012 U-3
5399578*PED Sep 21, 2012
VALSARTAN - DIOVAN
N020665 002 5399578 Mar 21, 2012 U-3
5399578*PED Sep 21, 2012
VALSARTAN - DIOVAN
N021283 001 5399578 Mar 21, 2012 I-550 Nov 29, 2010
5399578*PED Sep 21, 2012 PED May 29, 2011
5972990 Oct 26, 2016 U-692
5972990*PED Apr 26, 2017
6294197 Jun 18, 2017 U-3
6294197*PED Dec 18, 2017
VALSARTAN - DIOVAN
N021283 002 5399578 Mar 21, 2012 I-550 Nov 29, 2010
5399578*PED Sep 21, 2012 PED May 29, 2011
5972990 Oct 26, 2016 U-692
5972990*PED Apr 26, 2017
6294197 Jun 18, 2017 U-3
6294197*PED Dec 18, 2017
VALSARTAN - DIOVAN
N021283 003 5399578 Mar 21, 2012 I-550 Nov 29, 2010
5399578*PED Sep 21, 2012 PED May 29, 2011
5972990 Oct 26, 2016 U-692
5972990*PED Apr 26, 2017
6294197 Jun 18, 2017 U-3
6294197*PED Dec 18, 2017
VALSARTAN - DIOVAN
N021283 004 5399578 Mar 21, 2012 I-550 Nov 29, 2010
5399578*PED Sep 21, 2012 PED May 29, 2011
5972990 Oct 26, 2016 U-692
5972990*PED Apr 26, 2017
6294197 Jun 18, 2017 U-3
6294197*PED Dec 18, 2017
VARDENAFIL HYDROCHLORIDE - LEVITRA
N021400 001 6362178 Oct 31, 2018 DS DP U-533
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 192 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
VARDENAFIL HYDROCHLORIDE - LEVITRA
N021400 002 6362178 Oct 31, 2018 DS DP U-533
VARDENAFIL HYDROCHLORIDE - LEVITRA
N021400 003 6362178 Oct 31, 2018 DS DP U-533
VARDENAFIL HYDROCHLORIDE - LEVITRA
N021400 004 6362178 Oct 31, 2018 DS DP U-533
VARENICLINE TARTRATE - CHANTIX
N021928 001 6410550 May 10, 2020 DS DP U-56 NCE May 10, 2011
6890927 May 06, 2022 DS DP U-56
7265119 Aug 19, 2022 DS DP U-56
VARENICLINE TARTRATE - CHANTIX
N021928 002 6410550 May 10, 2020 DS DP U-56 NCE May 10, 2011
6890927 May 06, 2022 DS DP U-56
7265119 Aug 19, 2022 DS DP U-56
VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR
N020699 001 5916923 Jun 28, 2013 U-398 I-561 Dec 14, 2010
5916923*PED Dec 28, 2013 U-398
6274171 Mar 20, 2017
6274171*PED Sep 20, 2017
6310101 Jun 28, 2013 U-46
6403120 Mar 20, 2017 U-451
6403120 Mar 20, 2017 U-535
6403120*PED Sep 20, 2017 U-535
6403120*PED Sep 20, 2017 U-451
6419958 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-459
6419958*PED Sep 20, 2017 U-535
6419958*PED Sep 20, 2017 U-459
6444708 Jun 28, 2013 U-398
6444708*PED Dec 28, 2013 U-398
VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR
N020699 002 5916923 Jun 28, 2013 U-398 I-561 Dec 14, 2010
5916923*PED Dec 28, 2013 U-398
6274171 Mar 20, 2017
6274171*PED Sep 20, 2017
6310101 Jun 28, 2013 U-46
6403120 Mar 20, 2017 U-451
6403120 Mar 20, 2017 U-535
6403120*PED Sep 20, 2017 U-535
6403120*PED Sep 20, 2017 U-451
6419958 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-459
6419958*PED Sep 20, 2017 U-535
6419958*PED Sep 20, 2017 U-459
6444708 Jun 28, 2013 U-398
6444708*PED Dec 28, 2013 U-398
VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR
N020699 003 5916923 Jun 28, 2013 U-398 I-561 Dec 14, 2010
5916923*PED Dec 28, 2013 U-398
6274171 Mar 20, 2017
6274171*PED Sep 20, 2017
6403120 Mar 20, 2017 U-535
6403120 Mar 20, 2017 U-451
6403120*PED Sep 20, 2017 U-451
6403120*PED Sep 20, 2017 U-535
6419958 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-459
6419958*PED Sep 20, 2017 U-459
6419958*PED Sep 20, 2017 U-535
6444708 Jun 28, 2013 U-398
6444708*PED Dec 28, 2013 U-398
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 193 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR
N020699 004 5916923 Jun 28, 2013 U-398 I-561 Dec 14, 2010
5916923*PED Dec 28, 2013 U-398
6274171 Mar 20, 2017
6274171*PED Sep 20, 2017
6310101 Jun 28, 2013 U-46
6403120 Mar 20, 2017 U-451
6403120 Mar 20, 2017 U-535
6403120*PED Sep 20, 2017 U-451
6403120*PED Sep 20, 2017 U-535
6419958 Mar 20, 2017 U-459
6419958 Mar 20, 2017 U-535
6419958*PED Sep 20, 2017 U-459
6419958*PED Sep 20, 2017 U-535
6444708 Jun 28, 2013 U-398
6444708*PED Dec 28, 2013 U-398
VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE
N022104 001 6403120 Mar 20, 2017 U-535
6403120 Mar 20, 2017 U-839
6419958 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-839
VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE
N022104 002 6403120 Mar 20, 2017 U-535
6403120 Mar 20, 2017 U-839
6419958 Mar 20, 2017 U-839
6419958 Mar 20, 2017 U-535
VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE
N022104 003 6403120 Mar 20, 2017 U-839
6403120 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-839
6419958 Mar 20, 2017 U-535
VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE
N022104 004 6403120 Mar 20, 2017 U-535
6403120 Mar 20, 2017 U-839
6419958 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-839
VERAPAMIL HYDROCHLORIDE - COVERA-HS
N020552 001 5160744 Jun 27, 2011
5232705 Aug 31, 2010
5252338 Jun 27, 2011
5785994 Oct 22, 2009 U-315
6096339 Apr 04, 2017 U-365
VERAPAMIL HYDROCHLORIDE - COVERA-HS
N020552 002 5160744 Jun 27, 2011
5232705 Aug 31, 2010
5252338 Jun 27, 2011
5785994 Oct 22, 2009 U-315
6096339 Apr 04, 2017 U-365
VERTEPORFIN - VISUDYNE
N021119 001 5095030 Sep 09, 2011 DS
5214036 May 25, 2010
5707608 Aug 02, 2015
5756541 Mar 11, 2016 U-357
5770619 Jan 06, 2015 U-357
5798349 Aug 25, 2015 U-357
6074666 Feb 05, 2012
VIGABATRIN - SABRIL
N020427 001 NCE Aug 21, 2014
VIGABATRIN - SABRIL
N022006 001 NCE Aug 21, 2014
ODE Aug 21, 2016
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 194 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
VORICONAZOLE - VFEND
N021266 001 5116844 Aug 11, 2009 DP U-540
5364938 Nov 15, 2011 DS
5567817 May 24, 2016 DS DP U-540
5773443 Jan 25, 2011 DS DP U-540
VORICONAZOLE - VFEND
N021266 002 5116844 Aug 11, 2009 DP U-540
5364938 Nov 15, 2011 DS
5567817 May 24, 2016 DS DP U-540
5773443 Jan 25, 2011 DS DP U-540
VORICONAZOLE - VFEND
N021267 001 5116844 Aug 11, 2009 DP U-540
5134127 Jan 23, 2010 DP
5364938 Nov 15, 2011 DS
5376645 Jan 23, 2010 DP
5567817 May 24, 2016 DS DP U-540
5773443 Jan 25, 2011 DS DP U-540
6632803 Jun 02, 2018 DP
VORICONAZOLE - VFEND
N021630 001 5116844 Aug 11, 2009 DP U-540
5364938 Nov 15, 2011 DS
5567817 May 24, 2016 DS DP U-540
5773443 Jan 25, 2011 DS DP U-540
VORINOSTAT - ZOLINZA
N021991 001 6087367 Oct 04, 2011 U-776 NCE Oct 06, 2011
7399787 Feb 09, 2025 U-892 ODE Oct 06, 2013
7456219 Nov 14, 2026 DS
RE38506 Nov 29, 2011 DS DP
ZAFIRLUKAST - ACCOLATE
N020547 001 4859692 Sep 26, 2010
5294636 Dec 11, 2011
5319097 Dec 11, 2011
5482963 Jan 09, 2013
5583152 Sep 26, 2010
5612367 Mar 18, 2014 U-189
6143775 Dec 11, 2011
ZAFIRLUKAST - ACCOLATE
N020547 003 4859692 Sep 26, 2010
5294636 Dec 11, 2011
5319097 Dec 11, 2011
5482963 Jan 09, 2013
5583152 Sep 26, 2010
5612367 Mar 18, 2014 U-189
6143775 Dec 11, 2011
ZANAMIVIR - RELENZA
N021036 001 5360817 Jul 26, 2013 DS DP
5648379 Jul 15, 2014 U-722
5648379 Jul 15, 2014 U-274
5648379 Jul 15, 2014 U-721
6294572 Dec 15, 2014 DS DP
ZICONOTIDE - PRIALT
N021060 001 5364842 Dec 30, 2016 U-55 NCE Dec 28, 2009
5364842 Dec 30, 2016 U-48
5795864 Jun 27, 2015 DP
5859186 Dec 30, 2011 U-48
5859186 Dec 30, 2011 U-55
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 195 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ZICONOTIDE - PRIALT
N021060 002 5364842 Dec 30, 2016 U-48 NCE Dec 28, 2009
5364842 Dec 30, 2016 U-55
5795864 Jun 27, 2015 DP
5859186 Dec 30, 2011 U-48
5859186 Dec 30, 2011 U-55
ZICONOTIDE - PRIALT
N021060 003 5364842 Dec 30, 2016 U-48 NCE Dec 28, 2009
5364842 Dec 30, 2016 U-55
5795864 Jun 27, 2015 DP
5859186 Dec 30, 2011 U-48
5859186 Dec 30, 2011 U-55
ZICONOTIDE - PRIALT
N021060 004 5364842 Dec 30, 2016 U-55 NCE Dec 28, 2009
5364842 Dec 30, 2016 U-48
5795864 Jun 27, 2015 DP
5859186 Dec 30, 2011 U-48
5859186 Dec 30, 2011 U-55
ZILEUTON - ZYFLO
N020471 001 4873259 Dec 10, 2010 U-168
ZILEUTON - ZYFLO
N020471 003 4873259 Dec 10, 2010 U-168
ZILEUTON - ZYFLO CR
N022052 001 4873259 Dec 09, 2010 DS
5422123 Jun 06, 2012 DP
ZIPRASIDONE HYDROCHLORIDE - GEODON
N020825 001 4831031 Mar 02, 2012 DS DP U-720 I-615 Nov 20, 2012
5312925 Sep 01, 2012 DS DP
6150366 May 27, 2019 DP
6245766 Dec 18, 2018 U-601
ZIPRASIDONE HYDROCHLORIDE - GEODON
N020825 002 4831031 Mar 02, 2012 DS DP U-720 I-615 Nov 20, 2012
5312925 Sep 01, 2012 DS DP
6150366 May 27, 2019 DP
6245766 Dec 18, 2018 U-601
ZIPRASIDONE HYDROCHLORIDE - GEODON
N020825 003 4831031 Mar 02, 2012 DS DP U-720 I-615 Nov 20, 2012
5312925 Sep 01, 2012 DS DP
6150366 May 27, 2019 DP
6245766 Dec 18, 2018 U-601
ZIPRASIDONE HYDROCHLORIDE - GEODON
N020825 004 4831031 Mar 02, 2012 DS DP U-720 I-615 Nov 20, 2012
5312925 Sep 01, 2012 DS DP
6150366 May 27, 2019 DP
6245766 Dec 18, 2018 U-601
ZIPRASIDONE HYDROCHLORIDE - GEODON
N021483 001 4831031 Mar 02, 2012 DS DP U-720
5312925 Sep 01, 2012 DS DP U-720
6150366 May 27, 2019 DP U-719
6245766 Dec 18, 2018 U-601
7175855 May 18, 2020 DP
ZIPRASIDONE MESYLATE - GEODON
N020919 001 4831031 Mar 02, 2012 DS DP U-720
5134127 Jan 23, 2010 DP
5376645 Jan 23, 2010 DP
6110918 Mar 26, 2017
6232304 Apr 01, 2017
6399777 Apr 01, 2017
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 196 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
ZOLEDRONIC ACID - RECLAST
N021817 001 4939130 Sep 02, 2012 DS DP U-662 I-595 May 29, 2012
4939130*PED Mar 02, 2013 I-584 Mar 15, 2012
I-581 Dec 19, 2011
I-271 Aug 17, 2010
NP Apr 16, 2010
PED Feb 17, 2011
PED Oct 16, 2010
ZOLEDRONIC ACID - ZOMETA
N021223 001 4939130 Sep 02, 2012 DS DP U-53
4939130*PED Mar 02, 2013
ZOLEDRONIC ACID - ZOMETA
N021223 002 4939130 Sep 02, 2012 DS DP U-53 M-61 Mar 20, 2011
4939130*PED Mar 02, 2013 PED Sep 20, 2011
ZOLMITRIPTAN - ZOMIG
N020768 001 5466699 Nov 14, 2012
5466699*PED May 14, 2013
5863935 Nov 14, 2012
5863935*PED May 14, 2013
ZOLMITRIPTAN - ZOMIG
N020768 002 5466699 Nov 14, 2012
5466699*PED May 14, 2013
5863935 Nov 14, 2012
5863935*PED May 14, 2013
ZOLMITRIPTAN - ZOMIG
N021450 004 5466699 Nov 14, 2012 U-436
5466699*PED May 14, 2013
6750237 Nov 28, 2020 DP
6750237*PED May 28, 2021
7220767 Nov 28, 2020 DP
7220767*PED May 28, 2021
ZOLMITRIPTAN - ZOMIG-ZMT
N021231 001 5466699 Nov 14, 2012
5466699*PED May 14, 2013
ZOLMITRIPTAN - ZOMIG-ZMT
N021231 002 5466699 Nov 14, 2012
5466699*PED May 14, 2013
ZOLPIDEM TARTRATE - AMBIEN
N019908 001 M-54 Mar 29, 2010
PED Sep 29, 2010
ZOLPIDEM TARTRATE - AMBIEN
N019908 002 M-54 Mar 29, 2010
PED Sep 29, 2010
ZOLPIDEM TARTRATE - AMBIEN CR
N021774 001 6514531 Dec 01, 2019 DP
6514531*PED Jun 01, 2020
ZOLPIDEM TARTRATE - AMBIEN CR
N021774 002 6514531 Dec 01, 2019 DP
6514531*PED Jun 01, 2020
ZOLPIDEM TARTRATE - EDLUAR
N021997 001 6761910 Sep 24, 2018 DP U-674
ZOLPIDEM TARTRATE - EDLUAR
N021997 002 6761910 Sep 24, 2018 DP U-674
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 197 of 197

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST


See report footnote for information regarding report content

PATENT PATENT EXCLUSIVITY


EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)

Footnote:
1. Patents are published upon receipt by the Orange Book Staff and may not reflect the official receipt date as described in 21 CFR
314.53(d)(5).

2. Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and submitted by the sponsor.
They may not be flagged with respect to other claims which may apply.
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 1 of 1
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT


ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

PATENT PATENT EXCLUSIVITY


APPL/PROD DATE PATENT DELIST EXCLUSIVITY EXPIRATION
NO PATENT NO EXPIRATION CODES REQUESTED CODE(S) DATE
HYDROXYETHYL STARCH 130/0.4 IN 6% SODIUM CHLORIDE 0.9%; VOLUVEN
N070012 001 NP Dec 10, 2010
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 1 of 45

PATENT & EXCLUSIVITY ABBREVIATIONS


D NEW DOSING SCHEDULE (SEE INDIVIDUAL REFERENCES)
I NEW INDICATION (SEE INDIVIDUAL REFERENCES)
M MISCELLANEOUS EXCLUSIVITY CODES (SEE INDIVIDUAL REFERENCES)
NC NEW COMBINATION
NCE NEW CHEMICAL ENTITY
NDF NEW DOSAGE FORM
NE NEW ESTER OR SALT OF AN ACTIVE INGREDIENT
NP NEW PRODUCT
NP* NEW PRODUCT (MINT FLAVORED)
NPP NEW PATIENT POPULATION
NR NEW ROUTE
NS NEW STRENGTH
ODE ORPHAN DRUG EXCLUSIVITY
PC PATENT CHALLENGE
PED PEDIATRIC EXCLUSIVITY
RTO RX TO OTC SWITCH OR OTC USE
U PATENT USE CODE (SEE INDIVIDUAL REFERENCES)
W EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE
SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY

EXCLUSIVITY DOSING SCHEDULE


D-1 ONCE A DAY APPLICATION
D-2 ONCE DAILY DOSING
D-3 SEVEN DAYS/SEVEN DAYS/SEVEN DAYS DOSING SCHEDULE
D-4 SEVEN DAYS/FOURTEEN DAYS DOSING SCHEDULE
D-5 TEN DAYS/ELEVEN DAYS DOSING SCHEDULE
D-6 SEVEN DAYS/NINE DAYS/FIVE DAYS DOSING SCHEDULE
D-7 BID DOSING
D-8 INTRAVENOUS, EPIDURAL AND INTRATHECAL DOSING
D-9 NARCOTIC OVERDOSE IN ADULTS
D-10 NARCOTIC OVERDOSE IN CHILDREN
D-11 POSTOPERATIVE NARCOTIC DEPRESSION IN CHILDREN
D-12 BEDTIME DOSING OF 800MG FOR TREATMENT OF ACTIVE DUODENAL ULCER
D-13 INCREASED MAXIMUM DAILY DOSAGE RECOMMENDATION
D-14 BEDTIME DOSING OF 800MG FOR TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
D-15 SINGLE DAILY DOSE OF 25MG/37.5MG
D-16 CONTINUOUS INTRAVENOUS INFUSION
D-17 400MG EVERY 12 HOURS FOR THREE DAYS FOR UNCOMPLICATED URINARY TRACT INFECTIONS
D-18 LOWER RECOMMENDED STARTING DOSE GUIDELINES
D-19 BOLUS DOSING GUIDELINES
D-20 SINGLE 32MG DOSE
D-21 ALTERNATIVE DOSAGE OF 300MG ONCE DAILY AFTER THE EVENING MEAL
D-22 REDUCTION IN INFUSION TIME FROM 24 TO 4 HOURS FOR THE 60MG DOSE
D-23 INCREASE MAXIMUM DOSE AND VARIATIONS IN THE DOSING REGIMEN
D-24 FOR OVARIAN CANCER THE RECOMMENDED REGIMEN IS 135MG/M2 OR 175MG/M2 INTRAVENOUSLY OVER
THREE HOURS EVERY THREE WEEKS
D-25 ADDITIONAL DOSAGE REGIMEN EQUAL TO HALF THE ORIGINAL DOSING REGIMEN
D-26 ONCE WEEKLY APPLICATION
D-27 BID DOSING IN PATIENTS 12 YEARS OF AGE AND OLDER FOR PREVENTION OF NAUSEA AND VOMITING
ASSOCIATED WITH MODERATE EMETOGENIC CANCER CHEMOTHERAPY
D-28 USE OF ISOVUE-370 IN EXCRETORY UROGRAPHY AT EQUIVALENT GRAMS OF IODINE TO THE CURRENTLY
APPROVED ISOVUE-250 AND ISOVUE-300
D-29 INCREASE OF CUMULATIVE DOSE TO 0.3MMOL/KG FOR MRI OF CNS IN ADULTS
D-30 5000 IU DOSE FOR PHOPHYLAXIX AGAINST DEEP VEIN THROMBOSIS
D-31 CHANGE IN RECOMMENDED TOTAL DAILY DOSE TO 80MG (40MG BID)
D-32 REMOVAL OF THE RESTRICTIONS LIMITING TREATMENT TO TWO CONSECUTIVE WEEKS AND TO SMALL
AREAS
D-33 ONCE DAILY DOSING FOR PLAQUE PSORIASIS
D-34 EVERY FOUR MONTHS DOSAGE REGIMEN
D-35 FOR A ONE WEEK DOSING OF INTERDIGITAL TINEA PEDIS
D-36 FOR A SINGLE 2MG DOSE AS AN ALTERNATIVE TO THE 1MG DOSE GIVEN TWICE DAILY
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 2 of 45

EXCLUSIVITY DOSING SCHEDULE


D-37 DOSING REGIMEN FOR ADMINISTRATION EITHER ONCE DAILY (QD) OR TWICE DAILY (BID)
D-38 CONTINUOUS INFUSION AS AN ALTERNATE METHOD OF ADMINISTRATION
D-39 CHANGE IN TIME TO TAKE THE DRUG PRIOR TO A MEAL TO PREVENT MEAL-INDUCED HEARTBURN
SYMPTOMS FROM "..1/2 TO 1 HOUR BEFORE EATING" TO ".. RIGHT BEFORE EATING OR UP TO 60MIN
BEFORE CONSUMING..."
D-40 ONCE-A-DAY DOSING REGIMEN
D-41 DRUG MAY BE DOSED RIGHT BEFORE A MEAL OR ANY TIME UP TO 30MIN BEFORE EATING OR DRINKING
FOOD AND BEVERAGES THAT WOULD BE EXPECTED TO CAUSE SYMPTOMS
D-42 TEN DAY DOSING REGIMEN FOR TRIPLE THERAPY, PREVACID IN COMBINATION WITH CLARITHROMYCIN
AND AMOXICILLIN, FOR THE ERADICATION OF H.PYLORI IN PATIENTS WITH DUODENAL ULCER DISEASE
D-43 INITIATION OF TREATMENT WITH 900MG/DAY BY DELETION OF THE REQUIREMENT TO TITRATE TO
900MG/DAY OVER A 3-DAY PERIOD
D-44 IN A CLINICAL TRIAL, FEWER DISCONTINUATIONS DUE TO ADVERSE EVENTS, ESPECIALLY DIZZINESS
AND VERTIGO, WERE OBSERVED WHEN TITRATING THE DOSE IN INCREMENTS OF 50MG/DAY EVERY 3
DAYS UNTIL AN EFFECTIVE DOSE (NOT EXCEEDING 400MG/DAY) WAS REACHED
D-45 ONCE DAILY DOSING FOR MAINTENANCE ONLY
D-46 NEW DOSING REGIMEN OF 80MG DAILY
D-47 PREVENTION OF HEARTBURN SYMPTOMS WHEN ADMINISTERED FROM 15 MINUTES UP TO, BUT NOT
INCLUDING, 1 HOUR PRIOR TO A PROVOCATIVE MEAL
D-48 ADIMISTRATION OF CISATRICURIUM A NEUROMUSCULAR BLOCKING AGENT AT DOSES OF 3 AND 4X THE
ED95 OF CISATRICURIUM FOLLOWING INDUCTION WITH THIOPENTAL
D-49 PEDIATRIC DOSING GUIDELINES
D-50 INFORMATION FOR USE OF CORVERT IN POST-CARDIAC SURGERY PATIENTS
D-51 OPTIONAL STARTING DOSE OF 40MG/DAY
D-52 ALTERNATE DOSING REGIMEN OF 1250MG TWICE DAILY
D-53 USE IN PEDIATRIC PATIENTS FROM 1 MONTH TO 16 YEARS OF AGE
D-54 USE OF ZYBAN FOR MAINTENANCE THERAPY. TREATMENT UP TO 6 MONTHS WAS SHOWN EFFICACIOUS
D-55 ADDITION OF A HIGHER DOSE OF NUTROPIN FOR PUBERTAL PATIENTS (PUBERTAL DOSE LESS THAN OR
EQUAL TO 0.7MG/KG/WEEK)
D-56 ADDITION OF POSTPRANDIAL DOSING
D-57 3-HOUR INFUSION OF TAXOL GIVEN EVERY THREE WEEKS AT A DOSE OF 175MG/M2 FOLLOWED BY
CISPLATIN AT A DOSE OF 75MG/M2 FOR THE FIRST-LINE TREATMENT OF ADVANCED OVARIAN CANCER
D-58 CHANGE IN DOSING INTERVAL TO ONCE-DAILY ADMINISTRATION
D-59 REDUCTION OF ELEVATED LDL-C IN A NEW, HIGHER STRENGTH TABLET, 0.8MG, AND FOR EXTENSION
OF THE DOSAGE RANGE TO 0.8MG DAILY
D-60 ADDITION OF A POST-OPERATIVE DOSING REGIMEN
D-61 ONCE WEEKLY DOSING FOR THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
D-62 ONCE WEEKLY DOSING FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
D-63 TO ALLOW A TITRATION DOSING REGIMEN USING A 25MG DOSE
D-64 INCREASING DOSAGE FOR NERVE BLOCK ANESTHESIA USING NAROPIN 7.5MG/ML AND FOR EXTENDING
THE DURATION OF TREATMENT FOR POSTOPERATIVE ANALGESIA USING NAROPIN 2MG/ML
D-65 CHANGE DOSING AND ADMINISTRATION TO INDICATE MAINTENANCE OF WEIGHT LOSS OVER AN 18 MONTH
PERIOD THUS EXTENDING THE USE OF THIS DRUG FROM ONE TO TWO YEARS
D-66 DOSING RECOMMENDATIONS FOR PATIENTS UNDERGOING PCI
D-67 SHORTER TREATMENT COURSE OF THREE DAYS IN THE TREATMENT OF RECURRENT EPISODES OF GENITAL
HERPES
D-68 CHANGE OF ADMIN RATE FOR INFUSION OF AREDIA FOR TREATMENT OF MODERATE AND SEVERE
HYPERCALCEMIA OF MALIGNANCY FROM 24 HOURS TO 2 HOURS UP TO BUT NOT INCLUDING 24 HOURS
D-69 SHORTENED DOSING REGIMEN TO 5 DAYS FOR THE TREATMENT OF ACUTE EXACERBATION OF CHRONIC
BRONCHITIS
D-70 80MG ONCE DAILY DOSING REGIMEN
D-71 EIGHT WEEK DOSING REGIMEN
D-72 INFORMATION REGARDING INCREASED RATE OF INFUSION FOR DEPACON
D-73 ONCE A WEEK DOSING FOR THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
D-74 ONCE A WEEK DOSING FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
D-75 INTERMITTENT DOSING REGIMEN, STARTING DAILY DOSE 14 DAYS PRIOR TO THE ANTICIPATED ONSET
OF MENSTRUATION THROUGH THE FIRST FULL DAY OF MENSES AND REPEATING WITH EACH NEW CYCLE
D-76 FOR USE ON AN "AS NEEDED" OR PRN BASIS FOR THE MANAGEMENT OF NASAL SYMPTOMS IN PATIENTS
FOR WHOM THE DRUG IS INDICATED
D-77 ADDITION OF 20MG AND 40MG DAILY AS OPTIONAL STARTING DOSES WITH 40MG INTENDED FOR
PATIENTS WHO REQUIRE A LARGE REDUCTION IN LDL-C (MORE THAN 45%)
D-78 USE OF FLEXERIL 5MG FOR THE RELIEF OF MUSCLE SPASM ASSOCIATED WITH ACUTE, PAINFUL,
MUSCULOSKELETAL CONDITIONS
D-79 NEW LOWER STARTING DOSE FOR TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS AND/OR
MODERATE TO SEVERE SYMPTOMS OF VULVAR AND VAGINAL ATROPHY ASSOCIATED W/ THE MENOPAUSE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 3 of 45

EXCLUSIVITY DOSING SCHEDULE


D-80 CHANGE OF DOSING SCHEDULE FOR LANTUS FROM ONCE DAILY AT BEDTIME TO FLEXIBLE DAILY DOSING
D-81 NEW LOWER STARTING DOSE FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPORSIS
D-82 USE OF PREMARIN 0.3 MG AND 0.45 MG FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
D-83 750 MG, ONCE DAILY FOR 5 DAYS FOR COMMUNITY ACQUIRED PNEUMONIA (CAP)
D-84 ONCE-A-DAY DOSING OF FLOXACIN OTIC FOR THE TREATMENT OF ADULTS AND PEDIATRIC
PATIENTS(AGES 6 MO & OLDER) W/ OTITIS EXTERNA CAUSED BY SUSCEPTIBLE STRAINS OF E.COLI,
P.AERUGINOSA AND S.AUREUS
D-85 LOWER RECOMMENDED STARTING DOSE GUIDELINES FOR TREATMENT OF MODERATE TO SEVERE VASOMOTOR
SYMPTOMS ASSOCIATED WITH THE MENOPAUSE
D-86 FOR USE IN SELECT EXTERNAL INSULIN PUMPS
D-87 ADDITION OF ONCE-WEEKLY DOSING FOR THE TREATMENT TO INCREASE BONE MASS IN MEN WITH
OSTEOPOROSIS
D-88 NEW DOSING RANGE OF 200-400MG PER DAY IN TWO DIVIDED DOSES FOR ADULTS WITH PARTIAL
SEIZURES
D-89 USE OF REYATAZ 300 MG/RITONAVIR 100 MG ONCE DAILY FOR TREATMENT IN HIV-INFECTED
ANTIRETROVIRAL-EXPERIENCED PATIENTS
D-90 ADDITION OF DAYTIME ADMINISTRATION TO TREAT VULVOVAGINAL CANDIDIASIS
D-91 ALTERNATE INTERMITTENT DOSING REGIMEN
D-92 ALTERNATIVE DOSAGE OF 1000MG ONCE DAILY AT BEDTIME
D-93 ALTERNATE TWO OR THREE TIMES DAILY DOSING REGIMENS
D-94 NEW MAXIMUM DOSAGE OF 72 MG/DAY IN ADOLESCENTS 13-17 YEARS OF AGE WITH ATTENTION DEFECIT
HYPERACTIVITY DISORDER (ADHD)
D-95 BROADENED INITIAL STARTING DOSE FOR HYPERTENSION FROM 50 MG TO 100 MG TO 25 MG TO 100 MG
DOSE RANGE
D-96 ONCE-MONTHLY TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS WITH BONIVA (IBANDRONATE SODIUM)
150 MG TABLETS
D-97 PED CANCER PT POPULATION EXPANDED TO INCLUDE PTS 6 MOS UP TO BUT NOT INCLUDING 4 YRS AND
DOSING INSTRUCTIONS TO ADMIN 30 MIN BEFPRE CHEMO WITH SECOND AND THIRD DOSES 4 & 8 HOURS
AFTER FIRST DOSE
D-98 DOSING FOR PED SURGICAL PTS EXPANDED TO INCLUDE PTS 1 MONTH UP TO BUT NOT INCLUDING 2
YEARS OF AGE
D-99 ONCE DAILY ADMINISTRATION FOR THE TREATMENT OF HIV INFECTION IN THERAPY NAIVE ADULT
PATIENTS
D-100 750 MG ONCE DAILY FOR FIVE DAYS FOR THE TREATMENT OF ACUTE BACTERIAL SINUSITIS
D-101 ONCE DAILY IN CHRONIC IDIOPATHIC UTICARIA FOR ADULTS AND CHILDREN 12 YEARS OF AGE AND
OLDER
D-102 NEW DOSING REGIMEN OF ONE SPRAY TWICE DAILY FOR SEASONAL ALLERIC RHINITIS IN PATIENTS 12
YRS OF AGE AND OLDER
D-103 NEW DOSING RECOMMENDATION FOR THE TREATMENT OF RECURRENT GENITAL HERPES IN
IMMUNOCOMPETENT PATIENTS, SPECIFICALLY A REDUCTION IN COURSE OF THERAPY FROM FAMCICLOVIR
125 MG TWICE-A-DAY FOR 5 DAYS TO 1000 MG TWICE-A-DAY FOR 1 DAY.
D-104 0.5MG/0.1MG FOR THE TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH
MENOPAUSE IN WOMEN WHO HAVE A UTERUS
D-105 USE OF ACTONEL 75MG TWO CONSECUTIVE DAYS PER MONTH FOR THE PREVENTION AND TREATMENT OF
POSTMENOPAUSAL OSTEOPOROSIS
D-106 FIVE DAY TREATMENT OF SELECTED SUSCEPTIBLE STRAINS OF STREPTOCOCCUS PNEUMONIAE,
HAEMOPHILUS INFLUENZA, MYCOPLASMA PNEUMONIAE, AND CHLAMYDIA PNEUMONIAE FOR COMMUNITY-
ACQUIRED PNEUMONIA
D-107 PROVIDES FOR THE COMBINATION TABLET OF 70MG ALENDRONATE AND 5600 IU OF VITAMIN D3 FOR
THE TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN AND TO INCREASE BONE MASS IN MEN
WITH OSTEOPOROSIS
D-108 TREATMENT OF COMPLICATED URINARY TRACT INFECTION AND ACUTE PYELONEPHRITIS WITH LEVAQUIN
750MG ONCE DAILY FOR FIVE DAYS
D-109 PROVIDE FOR THE USE OF A LOWER DOSE FOR THE TREATMENT OF ADULTS WITH CHRONIC PHASE
CHRONIC MYELOID LEUKEMIA (CML) WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING
IMATINIB MESYLATE
D-110 TREATMENT OF SCHIZOPHRENIA IN ADOLESCENTS AGED 13-17
D-111 PROVIDES FOR ONCE DAILY USE OF CIALIS, 2.5 MG AND 5 MG, FOR THE TREAMTENT OF ERECTILE
DYSFUNCTION
D-112 PROVIDES FOR PEDIATRIC PUMP USE
D-113 ONCE DAILY DOSING REGIMEN FOR PATIENTS WHO BECOME CONSTIPATED ON TWICE DAILY REGIMEN
D-114 NEW DOSING RECOMMENDATIONS FOR USE OF SIROLIMUS IN COMBINATION WITH CYCLOSPORINE FOR THE
PROPHYLAXIS OF REJECTION IN HIGH-RISK RENAL TRANSPLANT RECIPIENTS
D-115 STARTING DOSE OF 15MG/DAY FOR MONOTHERAPY IN ACUTE TREATMENT OF BIPOLAR DISORDER, MANIC
OR MIXED
D-116 ALTERNATIVE DOSING REGIMEN ATAZANAVIR SULATE CO-ADMINISTERED WITH RITONAVIR FOR THE
TREATMENT OF HIV-1 INFECTION IN TREATMENT NAIVE PATIENTS
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 4 of 45

EXCLUSIVITY DOSING SCHEDULE


D-117 50 MG TABLET FOR INITIATION OF DOSE TITRATION FOR BIPOLAR DISORDER
D-118 TWO 400MG TABLETS ONCE DAILY, CO-ADMINISTERED WITH 100MG RITONAVIR
D-119 DOSING RECOMMENDATIONS FOR HIV INFECTED PEDIATRIC PATIENTS 6 TO LESS THAN 18 YEARS OF AGE
D-120 DOSING REGIMEN ADJUSTMENTS
D-121 CHANGE TO REMOVE 20 MG MAXIMUM DOSAGE RESTRICTION
D-122 USE OF VAGIFEM 10 MCG FOR THE TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE

EXCLUSIVITY INDICATION
I-1 DYSMENORRHEA
I-2 CHOLANGIOPANCREATOGRAPHY
I-3 INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY
I-4 PERIPHERAL VENOGRAPHY (PHLEBOGRAPHY)
I-5 HYSTEROSALPINGOGRAPHY
I-6 TREATMENT OF JUVENILE ARTHRITIS
I-7 BIOPSY PROVEN MINIMAL CHANGE NEPHROTIC SYNDROME IN CHILDREN
I-8 ADULT INTRAVENOUS CONTRAST-ENHANCED COMPUTED TOMOGRAPHY OF THE HEAD AND BODY
I-9 PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING
I-10 PREVENTION OF POSTOPERATIVE DEEP VENOUS THROMBOSIS AND PULMONARY EMBOLISM IN TOTAL HIP
REPLACEMENT SURGERY
I-11 RELIEF OF MILD TO MODERATE PAIN
I-12 TREATMENT OF CUTANEOUS CANDIDIASIS
I-13 URINARY TRACT INFECTION (UTI) PREVENTION FOR PERIODS UP TO FIVE MONTHS IN WOMEN WITH A
HISTORY OF RECURRENT UTI
I-14 SEBORRHEIC DERMATITIS
I-15 PHOTOPHERESIS IN THE PALLIATIVE TREATMENT OF SKIN MANIFESTATIONS OF CUTANEOUS T-CELL
LYMPHOMA IN PERSONS NOT RESPONSIVE TO OTHER TREATMENT
I-16 STIMULATE THE DEVELOPMENT OF MULTIPLE FOLLICLES/OOCYTES IN OVULATORY PATIENTS
PARTICIPATING IN AN IN VITRO FERTILIZATION PROGRAM
I-17 MANAGEMENT OF CONGESTIVE HEART FAILURE
I-18 ENDOSCOPIC RETROGRADE PANCREATOGRAPHY
I-19 HERNIOGRAPHY
I-20 KNEE ARTHROGRAPHY
I-21 HIGH DOSE METHOTREXATE WITH LEUCOVORIN RESCUE IN COMBINATION WITH OTHER CHEMOTHERAPEUTIC
AGENTS TO DELAY RECURRENCE IN PATIENTS WITH NONMETASTATIC OSTEOSARCOMA WHO HAVE
UNDERGONE SURGICAL RESECTION OR AMPUTATION FOR THE PRIMARY TUMOR
I-22 RESCUE AFTER HIGH-DOSE METHOTREXATE THERAPY IN OSTEOSARCOMA
I-23 SHORT-TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
I-24 TREATMENT OF RHEUMATOID ARTHRITIS
I-25 ADULT INTRA-ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY OF THE HEAD, NECK, ABDOMINAL, RENAL
AND PERIPHERAL VESSELS
I-26 TREATMENT OF LIVER FLUKES
I-27 ADJUNCTIVE THERAPY TO DIET TO REDUCE THE RISK OF CORONARY ARTERY DISEASE
I-28 SELECTIVE ADULT VISCERAL ARTERIOGRAPHY
I-29 METASTATIC BREAST CANCER IN PREMENOPAUSAL WOMEN AS AN ALTERNATIVE TO OOPHORECTOMY OR
OVARIAN IRRADIATION
I-30 TREATMENT OF TINEA PEDIS
I-31 CONTRAST ENHANCEMENT AGENT TO FACILITATE VISUALIZATION OF LESIONS IN THE SPINE AND
ASSOCIATED TISSUES
I-32 PEDIATRIC MYELOGRAPHY
I-33 ORAL USE OF DILUTED OMNIPAQUE INJECTION IN ADULTS FOR CONTRAST ENHANCED COMPUTED
TOMOGRAPHY OF THE ABDOMEN
I-34 ORAL USE IN ADULTS FOR PASS-THROUGH EXAMINATION OF THE GASTROINTESTINAL TRACT
I-35 PEDIATRIC CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC HEAD IMAGING
I-36 ARTHROGRAPHY OF THE SHOULDER JOINTS IN ADULTS
I-37 RADIOGRAPHY OF THE TEMPOROMANDIBULAR JOINT IN ADULTS
I-38 CONTRAST ENHANCEMENT AGENT TO FACILITATE VISUALIZATION OF LESIONS OF THE CENTRAL NERVOUS
SYSTEM IN CHILDREN (2 YEARS OF AGE AND OLDER)
I-39 TREATMENT OF ACUTE MYOCARDIAL INFARCTION
I-40 PRIMARY NOCTURNAL ENURESIS
I-41 MIGRAINE HEADACHE PROPHYLAXIS
I-42 HERPES ZOSTER
I-43 HERPES SIMPLEX ENCEPHALITIS
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 5 of 45

EXCLUSIVITY INDICATION
I-44 MAINTENANCE THERAPY IN HEALED DUODENAL ULCER PATIENTS AT DOSE OF 1 GRAM TWICE DAILY
I-45 ACUTE TREATMENT OF VARICELLA ZOSTER VIRUS
I-46 USE IN PEDIATRIC COMPUTED TOMOGRAPHIC HEAD AND BODY IMAGING
I-47 TREATMENT OF PEDIATRIC PATIENTS WITH SYMPTOMATIC HUMAN IMMUNODEFICIENCY VIRUS (HIV)
DISEASE
I-48 PEDIATRIC ANGIOCARDIOGRAPHY
I-49 TREATMENT OF TRAVELERS' DIARRHEA DUE TO SUSCEPTIBLE STRAINS OF ENTEROTOXIGENIC
ESCHERICHIA COLI
I-50 FOR USE IN WOMEN WITH AXILLARY NODE-NEGATIVE BREAST CANCER
I-51 TREATMENT OF PRIMARY DYSMENORRHEA AND FOR THE TREATMENT OF IDIOPATHIC HEAVY MENSTRUAL
BLOOD LOSS
I-52 PEDIATRIC EXCRETORY UROGRAPHY
I-53 TREATMENT OF PANIC DISORDER, WITH OR WITHOUT AGORAPHOBIA
I-54 RENAL CONCENTRATION CAPACITY TEST
I-55 HYPERTENSION
I-56 EROSIVE GASTROESOPHAGEAL REFLUX DISEASE
I-57 SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER
I-58 INITIAL TREATMENT OF ADVANCED OVARIAN CARCINOMA IN COMBINATION WITH OTHER APPROVED
CHEMOTHERAPEUTIC AGENTS
I-59 ENDOSCOPICALLY DIAGNOSED ESOPHAGITIS, INCLUDING EROSIVE AND ULCERATIVE ESOPHAGITIS, AND
ASSOCIATED HEARTBURN DUE TO GASTROESOPHAGEAL REFLUX DISEASE
I-60 SINGLE APPLICATION TREATMENT OF HEAD LICE IN CHILDREN TWO MONTHS TO TWO YEARS IN AGE
I-61 FEMALE ANDROGENETIC ALOPECIA
I-62 PREVENTION AND TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
I-63 ONCE DAILY TREATMENT AS INITIAL THERAPY IN THE TREATMENT OF HYPERTENSION
I-64 PREVENTION OF SUPRAVENTRICULAR TACHYCARDIAS
I-65 PREVENTION OF UPPER GASTROINTESTINAL BLEEDING IN CRITICALLY ILL PATIENTS
I-66 UNCOMPLICATED GONORRHEA
I-67 TREATMENT OF ACUTE ASTHMATIC ATTACKS IN CHILDREN SIX YEARS OF AGE AND OLDER
I-68 CENTRAL PRECOCIOUS PUBERTY
I-69 SHORT TERM TREATMENT OF PATIENTS WITH SYMPTOMS OF GASTROESOPHAGEAL REFLUX DISEASE
(GERD), AND FOR THE SHORT TERM TREATMENT OF ESOPHAGITIS DUE TO GERD INCLUDING ULCERATIVE
DISEASE DIAGNOSED BY ENDOSCOPY
I-70 USE IN COMBINATION WITH 5-FLUOROURACIL TO PROLONG SURVIVAL IN THE PALLIATIVE TREATMENT
OF PATIENTS WITH ADVANCED COLORECTAL CANCER
I-71 VARICELLA INFECTIONS (CHICKENPOX)
I-72 PREVENTION OF CMV DISEASE IN TRANSPLANT PATIENTS AT RISK FOR CMV DISEASE
I-73 INITIATE AND MAINTAIN MONITORED ANESTHESIA CARE (MAC) SEDATION DURING DIAGNOSTIC
PROCEDURES
I-74 INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY
I-75 TREATMENT OF ENDOSCOPICALLY DIAGNOSED EROSIVE ESOPHAGITIS
I-76 PREVENTION OF OSTEOPOROSIS
I-77 DERMAL INFECTIONS-TINEA PEDIS, TINEA CORPORIS, TINEA CRURIS DUE TO EPIDERMOPHYTON
FLOCCOSUM
I-78 CONTRAST ENHANCED COMPUTED TOMOGRAPHIC IMAGING OF THE HEAD AND BODY AND INTRAVENOUS
EXCRETORY UROGRAPHY
I-79 MANAGEMENT OF CHRONIC STABLE ANGINA AND ANGINA DUE TO CORONARY ARTERY SPASM
I-80 DIAGNOSIS AND LOCALIZATION OF ISCHEMIA AND CORONARY HEART DISEASE
I-81 PROPHYLAXIS IN DESIGNATED IMMUNOCOMPROMISED CONDITIONS TO REDUCE THE INCIDENCE OF
OROPHARYNGEAL CANDIDIASIS
I-82 TREATMENT OF TRAVELERS' DIARRHEA
I-83 ANGIOCARDIOGRAPHY, CONTRAST ENHANCED COMPUTED TOMOGRAPHIC IMAGING OF THE HEAD AND BODY,
AND INTRAVENOUS EXCRETORY UROGRAPHY IN CHILDREN
I-84 INTRAOPERATIVE AND POSTOPERATIVE TACHYCARDIA AND/OR HYPERTENSION
I-85 TREATMENT OF ANOREXIA ASSOCIATED WITH WEIGHT LOSS IN PATIENTS WITH AIDS
I-86 TREATMENT OF SECONDARY CARNITINE DEFICIENCY
I-87 RENAL IMAGING AGENT FOR USE IN CHILDREN
I-88 MANAGEMENT OF ENDOMETRIOSIS
I-89 EPIDURAL USE IN LABOR AND DELIVERY AS AN ANALGESIC ADJUNCT TO BUPIVACAINE
I-90 INTENSIVE CARE UNIT SEDATION
I-91 MONOTHERAPY USE FOR HYPERTENSION
I-92 ADJUNCTIVE THERAPY IN THE MANAGEMENT OF HEART FAILURE
I-93 PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN CHILDREN AGES 4-11 YEARS
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 6 of 45

EXCLUSIVITY INDICATION
I-94 USE WITH MRI IN ADULTS TO PROVIDE CONTRAST ENHANCEMENT AND FACILITATE VISUALIZATION OF
LESIONS IN THE BODY [EXCLUDING THE HEART]
I-95 TREATMENT OF LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL INFARCTION
I-96 TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA
I-97 ORAL OR RECTAL USE IN CHILDREN FOR THE EXAMINATION OF THE GASTROINTESTINAL TRACT
I-98 TREATMENT OF CHILDREN WHO HAVE GROWTH FAILURE ASSOCIATED WITH CHRONIC RENAL INSUFFICIENCY
I-99 PEDIATRIC ANESTHESIA IN CHILDREN 3 YEARS AND OLDER
I-100 TO DECREASE THE INCIDENCE OF CANDIDIASIS IN PATIENTS UNDERGOING BONE MARROW
TRANSPLANTATION WHO RECEIVE CYTOTOXIC CHEMOTHERAPY AND/OR RADIATION THERAPY
I-101 TREATMENT OF DIABETIC NEPHROPATHY IN PATIENTS WITH TYPE I INSULIN-DEPENDENT DIABETES
MELLITUS AND RETINOPATHY
I-102 TREATMENT OF OBSESSIVE-COMPULSIVE DISORDER
I-103 PROPHYLAXIS AGAINST PNEUMOCYSTIS CARINII PNEUMONIA IN INDIVIDUALS WHO ARE
IMMUNOCOMPROMISED AND CONSIDERED TO BE AT RISK OF DEVELOPING PNEUMOCYSTIS CARINII
PNEUMONIA
I-104 TREATMENT OF PULMONARY AND EXTRAPULMONARY ASPERGILLOSIS IN PATENTS WHO ARE INTOLERANT OF
OR WHO ARE REFRACTORY TO AMPHOTERICIN B THERAPY
I-105 TREATMENT OF METASTATIC CARCINOMA OF THE BREAST AFTER FAILURE OF FIRST-LINE OR
SUBSEQUENT CHEMOTHERAPY
I-106 TREATMENT OF ACROMEGALY
I-107 VAGINAL CANDIDIASIS
I-108 EXPANDED USE-FOR ICU PATIENTS UNDERGOING LONG-TERM INFUSION DURING MECHANICAL VENTILATION
I-109 TYPHOID FEVER
I-110 PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH RADIOTHERAPY
I-111 TREATMENT OF PAGET'S DISEASE OF BONE
I-112 MANAGEMENT OF MODERATE TO SEVERE PAIN
I-113 TREATMENT OF PROSTATITIS
I-114 USE IN CHILDREN TO VISUALIZE LESIONS WITH ABNORMAL VASCULARITY IN THE BRAIN
(INTRACRANIAL LESIONS), SPINE, AND ASSOCIATED TISSUE
I-115 USE IN MRI IN ADULTS TO VISUALIZE LESIONS IN THE HEAD AND NECK
I-116 MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
I-117 TO SLOW THE PROGRESSION FO CORONANY ATHEROSCLEROSIS IN PATIENTS WITH CORONARY HEART
DISEASE
I-118 PREVENTION OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM FOLLOWING KNEE
REPLACEMENT SURGERY
I-119 TREATMENT OF ANEMIA CAUSED BY UTERINE LEIOMYOMATA IN WOMEN WHO FAIL IRON THERAPY
I-120 MAINTENANCE THERAPY FOR GASTRIC ULCER PATIENTS AT REDUCED DOSAGE AFTER HEALING ACUTE
ULCERS
I-121 EXPANDED PATIENT POPULATION -- USE IN ICU PATIENTS
I-122 PSORIASIS OF THE SCALP
I-123 RELIEF OF MILD TO MODERATE PAIN IN PATIENTS AGED 6 MONTHS AND OLDER
I-124 LEUCOCYTE LABELED SCINTIGRAPHY AS AN ADJUNCT IN THE LOCALIZATION OF INTRA-ABDOMINAL
INFECTION AND INFLAMMATORY BOWEL DISEASE
I-125 EXPANSION OF CONSCIOUS SEDATION INDICATION TO INCLUDE SHORT THERAPEUTIC PROCEDURES
I-126 ADJUNCT TO THALLIUM- 201 MYOCARDIAL PERFUSION IN PATIENTS UNABLE TO EXERCISE ADEQUATELY
I-127 TREATMENT OF ACYCLOVIR-RESISTANT HERPES IN IMMUNOCOMPROMISED PATIENTS
I-128 IN PT W/ CH DISEASE AND HYPERCHOLESTEROLEMIA: REDUCE RISK TOTAL MORTALITY BY REDUCING
CORONARY DEATH; REDUCE RISK NON-FATAL MI; REDUCE RISK UNDERGOING MYOCARDIAL
REVASCULARIZATION PROCEDURES; REDUCTION ELEVATED TOTAL AND LDL CHOL LEVELS...
I-129 TREATMENT OF ALCOHOL DEPENDENCE
I-130 MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
I-131 PERIPHERAL ARTERIOGRAPHY
I-132 TREATMENT OF MANIC PHASE OF BIPOLAR DISORDER
I-133 MANAGEMENT OF CHRONIC STABLE ANGINA
I-134 HEART FAILURE POST MYOCARDIAL INFARCTION
I-135 BONE METASTASES ASSOCIATED WITH MULTIPLE MYELOMA
I-136 IDIOPATHIC CHRONIC URTICARIA
I-137 PREVENTION OF METAL-INDUCED HEART BURN, ACID INDIGESTION, AND SOUR STOMACH WHEN TAKEN 30
MINUTES PRIOR TO CONSUMING FOOD OR BEVERAGES
I-138 TREATMENT OF ACUTE RECURRENT GENITAL HERPES
I-139 PALLIATIVE TREATMENT OF ADVANCED BREAST CANCER IN PRE- AND PERIMENOPAUSAL WOMEN
I-140 PREVENTION OF CYTOMEGALOVIRUS (CMV) DISEASE IN INDIVIDUALS WITH HIV INFECTION AT RISK
FOR DEVELOPING CMV DISEASE
I-141 TREATMENT OF HEMODYNAMICALLY STABLE PATIENTS WITHIN 24 HOURS OF ACUTE MYOCARDIAL
INFARCTION TO IMPROVE SURVIVAL
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 7 of 45

EXCLUSIVITY INDICATION
I-142 LOCALIZE MYOCARDIAL ISCHEMIA(REVERSIBLE DEFECT) AND INFARCTION (NON-REVERSIBLE DEFECTS)
IN EVALUATING MYOCARDIAL FUNCTION
I-143 EPISODIC TREATMENT OF RECURRENT GENITAL HERPES IN IMMUNOCOMPETENT ADULTS
I-144 ENHANCEMENT OF MRI OF THE ADULT BODY INTERNAL ORGANS
I-145 0.1MMOL/KG AS A SINGLE INTRAVEOUS BOLUS FOR MRI OF THE CNS IN CHILDREN
I-146 CONTRAST ENHANCEMENT AND FACILITATION OF VISUALIZATION OF EXTRACRANIAL HEAD AND NECK
LESIONS
I-147 PREVENTION OF GALLSTONE FORMATION IN OBESE PATIENTS EXPERIENCING RAPID WEIGHT LOSS
I-148 TREATMENT OF ACUTE PNEUMOCYSTIC CARINI PNEUMONIA (PCP) IN HIV-INFECTED PATIENTS WHOSE
ALVEOLAR-ARTERIAL OXYGEN DIFFERENCE (AaDO2) IS LESS THAN OR EQUAL TO 55 TORR
I-149 TREATMENT OF PATIENTS WITH NON-SMALL CELL LUNG CANCER
I-150 TREATMENT OF OBSESSIVE COMPULSIVE DISORDER AND PANIC DISORDER
I-151 PREVENTION OF AND PREVENTION OF FURTHER POSTOPERATIVE NAUSEA AND VOMITING IN PEDIATRIC
PATIENTS RECEIVING GENERAL ANESTHESIA
I-152 SLOWING THE PROGRESSION OF CORONARY ATHEROSCLEROSIS AND REDUCING THE RISK OF ACUTE
CORONARY EVENTS
I-153 MANAGEMENT OF SEVERE SPASTICITY [ENCOMPASES SPINAL AND CEREBRAL ORIGIN]
I-154 PATIENT POPULATION ALTERED TO INCLUDE PEDIATRIC USE
I-155 TREATMENT OF ONCHOMYCOSIS DUE TO DERMATOPHYTES (TINEA UNGUIUM) OF THE TOENAIL WITH OR
WITHOUT FINGERNAIL INVOLVEMENT
I-156 ADDITIONAL DATA REGARDING THE SAFE USE OF NORVASC IN PATIENTS WITH HEART FAILURE
I-157 TREATMENT OF ACUTE UNCOMPLICATED CYSTITIS IN FEMALES
I-158 TREATMENT OF OSTEOLYTIC BONE METASTASES OF BREAST CANCER
I-159 FOR HYPERCHOLESTEROLEMIC PATIENTS WITHOUT CLINICALLY EVIDENT HEART DISEASE REDUCE THE
RISK OF MYOCARDIAL INFARCTION, REVASCULARIZATION, AND DEATH DUE TO CARDIOVASCULAR CAUSES
WITH NO INCREASE IN DEATH FROM NON-CARDIOVASCULAR CAUSES
I-160 TREATMENT OF BACTERIAL CORNEAL ULCERS
I-161 TREATMENT OF ADULT-ONSET OR CHILDHOOD-ONSET ADULT GROWTH HORMONE DEFICIENCY
I-162 FOR USE IN PATIENTS 6-11 YEARS OF AGE
I-163 TREATMENT OF PHOTOPHOBIA
I-164 CHRONIC BACTERIAL PROSTATITIS
I-165 MANAGEMENT OF ADULTS WITH ACTIVE, CLASSIC AND DEFINITIVE RHEUMATOID ARTHRITIS WHO HAVE
HAD INSUFFICIENT THERAPEUTIC RESPONSE TO OR ARE INTOLERANT OF AN ADEQUATE TRIAL OF FULL
DOSES OF ONE OR MORE NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
I-166 TREATMENT OF BULIMIA
I-167 COMPLICATED INTRA-ABDOMINAL INFECTIONS (USED IN COMBINATION WITH METRONIDAZOLE) CAUSED
BY MIXED AEROBIC/ANAEROBIC PATHOGENS
I-168 MANAGEMENT OF LOCALLY CONFINED STAGE B2-C METASTATIC CARCINOMA OF THE PROSTATE (IN
COMBINATION WITH LHRH AGONISTS)
I-169 USE IN COMBINATION WITH CORTICOSTEROIDS AS INITIAL CHEMOTHERAPY FOR THE TREATMENT OF
PATIENTS WITH PAIN RELATED TO ADVANCED HORMONE-REFRACTORY PROSTATE CANCER
I-170 PROPHYLACTIC USE DURING HEAD LICE EPIDEMICS
I-171 RELIEF OF SYMPTOMS OF THE COMMON COLD
I-172 TREATMENT OF INITIAL EPISODE OF GENITAL HERPES
I-173 PREOPERATIVELY FOR THE PREVENTION OF INFECTION IN TRANSRECTAL PROSTATE BIOPSY
I-174 PELVIC INFLAMMATORY DISEASE
I-175 TREATMENT OF TINEA CORPORIS AND TINEA CRURIS
I-176 TREATMENT OF POSTOPERATIVE INFLAMMATION IN PATIENTS WHO HAVE UNDERGONE CATARACT
EXTRACTION
I-177 TX OF MODERATE ACNE VULGARIS IN FEMALES,GREATER OR EQUAL TO 15YRS OF AGE,WHO HAVE NO
KNOWN CONTRAINDICATIONS TO ORAL CONTRACEPTIVE THERAPY,DESIRE CONTRACEPTION,HAVE ACHIEVED
MENARCHE AND ARE UNRESPONSIVE TO TOPICAL ANTI-ACNE MEDICATIONS
I-178 TREATMENT OF ONCHOMYCOSIS OF THE FINGERNAIL WITHOUT CONCOMITANT ONCHOMYCOSIS OF THE
TOENAIL WITH A PULSE DOSING REGIMEN
I-179 NOSOCOMIAL PNEUMONIA-MILD TO MODERATE AND SEVERE CAUSED BY HAEMOPHILUS INFLUENZAE OR
KLEBSIELLA PNEUMONIAE
I-180 TREATMENT OF PLANTAR TINEA PEDIS (MOCCASIN TYPE)
I-181 TREATMENT OF PATIENTS WITH COMPLEX PARTIAL SEIZURES WITH AND WITHOUT SECONDARY
GENERALIZATION
I-182 TREATMENT OF GROWTH FAILURE ASSOCIATED WITH TURNER SYNDROME
I-183 MAINTENANCE THERAPY IN THE MANAGEMENT OF MILD TO MODERATE ASTHMA IN PEDIATRIC PATIENTS
AGES 6-11
I-184 TREATMENT OF PANIC DISORDER AT A RECOMMENDED DOSE RANGE OF 1 TO 2MG/DAY (MAXIMUM OF 4MG)
I-185 PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 8 of 45

EXCLUSIVITY INDICATION
I-186 TREATMENT OF TINEA (PITYRIASIS) VERSICOLOR CAUSED BY OR PRESUMED TO BE CAUSED BY
PITYROSPORUM ORBICULARE (ALSO KNOWN AS MALASSEZIA FURFUR OR M. ORBICULARE)
I-187 PREVENTION OF FRACTURES IN THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
I-188 TREATMENT OF ACUTE SINUSITIS AND ACUTE EXACERBATION OF CHRONIC SINUSITIS
I-189 TREATMENT OF ACUTE OTITIS MEDIA IN PEDIATRIC PATIENTS
I-190 PLANAR IMAGING AS A SECOND LINE DIAGNOSTIC DRUG AFTER MAMMOGRAPHY TO ASSIST IN THE
EVALUATION OF BREAST LESIONS IN PATIENTS WITH AN ABNORMAL MAMMOGRAM OR A PALPABLE BREAST
MASS
I-191 ENDOMETRIAL THINNING AGENT PRIOR TO ENDOMETRIAL ABLATION FOR DYSFUNCTIONAL UTERINE
BLEEDING
I-192 THE PREVENTION OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM, IN
PATIENTS UNDERGOING ABDOMINAL SURGERY WHO ARE AT RISK FOR THROMBOEMBOLIC COMPLICATIONS
AND A NEW DOSAGE REGIMEN, 40MG ONCE DAILY, FOR THIS INDICATION
I-193 TREATMENT OF PANIC DISORDER IN A RECOMMENDED DOSE RANGE OF 50 TO 200MG/DAY
I-194 CONGESTIVE HEART FAILURE
I-195 FOR USE OF LANSOPRAZOLE IN COMBINATION WITH CLARITHROMYCIN AND AMOXICILLIN FOR THE
ERADICATION OF HELICOBACTER PYLORI IN PATIENTS WITH ACTIVE DUODENAL ULCER DISEASE OR A
ONE-YEAR HISTORY OF DUODENAL ULCER
I-196 ACUTE TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
I-197 MAINTENANCE OF HEALING OF DUODENAL ULCER
I-198 FOR THE USE OF LANSOPRAZOLE IN COMBINATION WITH AMOXICILLIN FOR THE ERADICATION OF
HELICOBACTER PYLORI IN PATIENTS WITH ACTIVE DUODENAL ULCER DISEASE OR A ONE-YEAR HISTORY
OF A DUODENAL ULCER
I-199 MONOTHERAPY AND COMBINATION THERAPY WITH SULFONYL UREAS IN THE TREATMENT OF TYPE II
DIABETES
I-200 TREATMENT OF TINEA (PITYRIASIS) VERSICOLOR
I-201 EMPIRICAL THERAPY FOR FEBRILE NEUTROPENIC PATIENTS
I-202 SECOND-LINE TREAMENT OF AIDS-RELATED KAPOSI'S SARCOMA
I-203 MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS
I-204 USE IN PEDIATRIC PATIENTS BETWEEN THE AGES OF 6 AND 11 FOR THE TREATMENT OF THE NASAL
SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS
I-205 INITIAL ANTICONVULSANT TREATMENT OF STATUS EPILEPTICUS
I-206 TREATMENT OF EDEMA ASSOCIATED WITH CHRONIC RENAL FAILURE
I-207 FOR THE SUPPRESSION OF RECURRENT EPISODES OF GENITAL HERPES IN IMMUNOCOMPETENT ADULTS
I-208 TREATMENT OF OBSESSIVE COMPULSIVE DISORDER IN THE PEDIATRIC POPULATION
I-209 PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT)
I-210 TO SLOW THE PROGRESSION OF CORONARY ATHEROSCLEROSIS IN PATIENTS WITH CORONARY HEART
DISEASE AS PART OF A TREATMENT STRATEGY TO LOWER TOTAL AND LDL CHOLESTEROL TO TARGET
LEVELS
I-211 FOR USE IN PEDIATRIC POPULATION
I-212 TREATMENT OF SYMPTOMS OF DRY MOUTH IN PATIENTS WITH SJOGREN'S SYNDROME
I-213 TEMPORARY RELIEF OF PAIN AND PHOTOPHOBIA IN PATIENTS UNDERGOING CORNEAL REFRACTIVE
SURGERY
I-214 TREATMENT OF OSTEOPOROSIS
I-215 PRE-PROCEDURAL APPLICATION TO ADULT MALE GENITAL SKIN PRIOR TO SITE-SPECIFIC
SUBCUTANEOUS INFILTRATION WITH LIDOCAINE FOR THE REMOVAL OF GENITAL WARTS
I-216 FOR THE LONG-TERM TWICE-DAILY (MORNING AND EVENING) ADMINISTRATION IN THE MAINTENANCE
TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD, INCLUDING CHRONIC BRONCHITIS AND
EMPHYSEMA
I-217 PREVENTION (DURING AND FOLLOWING HOSPITALIZATION) OF DEEP VEIN THROMBOSIS, WHICH MAY
LEAD TO PULMONARY EMBOLISM, IN PATIENTS UNDERGOING HIP REPLACEMENT SURGERY
I-218 USE OF LIPITOR AS AN ADJUNCTIVE THERAPY TO DIET FOR THE TREATMENT OF PATIENTS WITH
ELEVATED SERUM TRIGLYCERIDE LEVELS (FREDERICKSON TYPE IV)
I-219 USE OF LIPITOR BY PATIENTS WITH PRIMARY DYSBETALIPOPROTEINEMIA (FREDERICKSON TYPE III)
WHO DO NOT RESPOND ADEQUATELY TO DIET
I-220 TREATMENT OF EPISODIC- HEARTBURN, ACID INDIGESTION AND SOUR STOMACH
I-221 TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN WITH AN ENLARGED PROSTATE TO
IMPROVE SYMPTOMS, REDUCE THE RISK OF ACUTE URINARY RETENTION AND REDUCE THE RISK OF THE
NEED OF SURGERY
I-222 PREVENTION OF ISCHEMIC COMPLICATIONS OF UNSTABLE ANGINA AND NON-Q-WAVE MYOCARDIAL
INFARCTION, WHEN CONCURRENTLY ADMINISTERED WITH ASPIRIN
I-223 USE IN THE SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH ALLERGIC AND NONALLERGIC-
PERENNIAL RHINITIS IN CHILDREN AGE 6-11 YEARS
I-224 FOR THE USE IN PEDIATRIC PATIENTS 4 TO 11 YEARS OF AGE FOR THE MANAGEMENT OF THE NASAL
SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 9 of 45

EXCLUSIVITY INDICATION
I-225 USE IN PATIENTS WITH PREVIOUS MI AND NORMAL CHOLESTEROL LEVELS, TO REDUCE RISK OF
RECURRENT MI, MYOCARDIAL REVASCULARIZATION, AND CEREBROVASCULAR DISEASE EVENTS
I-226 FIRST-LINE THERAPY FOR THE TREATMENT OF ADVANCED CARCINOMA OF THE OVARY IN COMBINATION
WITH CISPLATIN
I-227 SHORT-TERM TREATMENT OF SYMPTOMATIC GASTROESPHAGEAL REFLUX DISEASE (GERD)
I-228 PREVENTION OF MEAL INDUCED HEARTBURN AT A DOSE OF 75MG TAKEN 30-60MIN PRIOR TO A MEAL
I-229 PRILOSEC (OMEPRAZOLE), AMOXICILLIN, AND CLARITHROMYCIN FOR THE ERADICATION OF H. PYLORI
IN PATIENTS WITH DUODENAL ULCER DISEASE
I-230 IN COMBINATION WITH CIS-PLATIN, FOR THE FIRST LINE TREATMENT OF NON-SMALL CELL LUNG
CANCER IN PATIENTS WHO ARE NOT CANDIDATES FOR POTENTIALLY CURATIVE SURGERY AND/OR
RADIATION
I-231 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC BREAST CANCER AFTER FAILURE OF
PRIOR CHEMOTHERAPY
I-232 TREATMENT OF RECURRENT MUCOCUTANEOUS HERPES SIMPLEX INFECTIONS IN HIV-AFFECTED PATIENTS
AT A DOSE OF 500MG TWICE DAILY
I-233 PROPHYLACTIC USE TO REDUCE PERIOPERATIVE BLOOD LOSS AND THE NEED FOR BLOOD TRANSUFSION
IN PATIENTS UNDERGOING CARDIOPULMONARY BYPASS IN THE COURSE OF CORONARY ARTERY BYPASS
GRAFT SURGERY
I-234 FOR USE IN COMBINATION WITH CISPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH
INOPERABLE LOCALLY ADVANCED (STAGE IIIA OR IIIB) OR METASTATIC (STAGE IV) NON-SMALL CELL
LUNG CANCER
I-235 PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN PATIENTS 12 YEARS OF AGE AND OLDER
I-236 PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN PATIENTS 4 YEARS OF AGE AND OLDER
I-237 MAINTENANCE TREATMENT OF ASTHMA AND PREVENTION OF BRONCHOSPASM IN PATIENTS 4 YEARS OF
AGE AND OLDER
I-238 ADJUNCTIVE TREATMENT OF LENNOX-GASTAUT SYNDROME IN PEDIATRIC AND ADULT PATIENTS
I-239 TREATMENT OF PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
I-240 MANAGEMENT OF SECONDARY HYPERPARATHYROIDISM AND RESULTANT METABOLIC BONE DISEASE IN
PATIENTS WITH MODERATE TO SEVERE CHRONIC RENAL FAILURE (CCR 15 TO 55ML/MIN) NOT YET ON
DIALYSIS
I-241 USE IN PHOTODYNAMIC THERAPY (PDT) FOR REDUCTION OF OBSTRUCTION AND PALLIATION OF
SYMPTOMS IN PATIENTS WITH COMPLETELY OR PARTIALLY OBSTRUCTING ENDOBRONCHIAL NONSMALL
CELL LUNG CANCER
I-242 TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH THE MENOPAUSE AND IN
THE TREATMENT OF VULVAR AND VAGINAL ATROPHY IN WOMEN WITH AN INTACT UTERUS
I-243 USE IN THE SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH THE COMMON COLD IN CHILDREN
AGE 5 TO 11 YEARS
I-244 REDUCE THE INCIDENCE OF BREAST CANCER IN WOMEN AT HIGH RISK FOR BREAST CANCER
I-245 TREATMENT OF ACUTE SINUSITIS
I-246 TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS
I-247 USE IN CONVERSION TO MONOTHERAPY IN ADULTS WITH PARTIAL SEIZURES WHO ARE RECEIVING
TREATMENT WITH A SINGLE ENZYME-INDUCING ANTIEPILEPTIC DRUG
I-248 INPATIENT TREATMENT OF ACUTE DEEP VEIN THROMBOSIS WITH/WITHOUT PULMONARY EMBOLISM WHEN
ADMIN WITH WARFARIN SODIM AND OUTPATIENT TREATMENT OF ACUTE DEEP VEIN THROMBOSIS WITHOUT
PULMONARY EMBOLISM WHEN ADMIN WITH WARFARIN SODIUM
I-249 TREATMENT OF CHRONIC HEPATITIS C IN PATIENTS WITH COMPENSATED LIVER DISEASE PREVIOUSLY
UNTREATED WITH ALPHA INTERFERON THERAPY
I-250 PRIMARY PREVENTION OF CORONARY HEART DISEASE IN PATIENTS WITHOUT SYMPATOMATIC
CARDIOVASCULAR DISEASE WHO HAVE AVERAGE TO MODERATELY ELEVATED TOTAL-C AND LDL-C AND
BELOW AVERAGE HDL-C
I-251 TREATMENT OF GENERALIZED ANXIETY DISORDER
I-252 NEW COMBINATION USE OF PRECOSE FOR PATIENTS WITH TYPE 2 DIABETES TREATED WITH DIET PLUS
METFORMIN
I-253 COMBINATION USE OF PRECOSE FOR PATIENTS WITH TYPE 2 DIABETES TREATED WITH DIET PLUS
INSULIN
I-254 PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS (LOSS OF BONE MASS)
I-255 PREVENTION OF PNEUMOCYSTIS CARINII PNEUMONIA (PCP)
I-256 USE IN TREATMENT OF SMALL CELL LUNG CANCER SENSITIVE DISEASE AFTER FAILURE OF FIRST-LINE
CHEMOTHERAPY
I-257 TREATMENT OF CHRONIC HEPATITIS B ASSOCIATED WITH EVIDENCE OF HEPATITIS B VIRAL
REPLICATION AND ACTIVE LIVER INFLAMATION
I-258 FOR PERENNIAL NONALLERGIC RHINITIS FOR AGES 4 AND ABOVE
I-259 PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT), WHICH MAY LEAD TO PULMONARY EMBOLISM, IN
PATIENTS UNDERGOING HIP REPLACEMENT SURGERY
I-260 EXPANDED PEDIATRIC USE IN CHILDREN YOUNGER THAN ONE MONTH OF AGE TO BIRTH (WITH A
GESTATIONAL AGE OF 37 WEEKS OR GREATER)
I-261 TREATMENT OF SOCIAL ANXIETY DISORDER
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 10 of 45

EXCLUSIVITY INDICATION
I-262 TREATMENT OR PREVENTION OF BRONCHOSPASM WITH REVERSIBLE OBSTRUCTIVE AIRWAY DISEASE AND
FOR THE PREVENTION OF EXERCISE INDUCED BRONCHOSPASM IN CHILDREN AGES 4-12
I-263 TREATMENT OF UNSTABLE ANGINA AND NON-Q-WAVE MYOCARDIAL INFARCTION FOR THE PREVENTION OF
ISCHEMIC COMPLICATIONS IN PATIENTS ON CONCURRENT ASPIRIN THERAPY
I-264 PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH RADIATION, INCLUDING TOTAL BODY
IRRADIATION (TBI) AND FRACTIONATED ABDOMINAL RADIATION
I-265 TREATMENT OF ATOPIC DERMATITIS IN PEDIATRIC PATIENTS 6 YEARS AND OLDER
I-266 USE OF TOPAMAX AS ADJUNCTIVE THERAPY IN PEDIATRIC PATIENTS AGES 2-16 YEARS WITH PARTIAL
ONSET SEIZURES
I-267 USE IN PEDIATRIC PATIENTS 3 MONTHS OLD AND OLDER - FOR CORTICOSTEROID-RESPONSIVE
DERMATOSES
I-268 PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA IN PATIENTS 7-11 YEARS OF AGE
I-269 PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH HIGHLY EMETOGENIC CANCER CHEMOTHERAPY,
INCLUDING CISPLATIN
I-270 ADJUVANT TREATMENT OF NODE-POSITIVE BREAST CANCER ADMINISTRERED SEQUENTIALLY TO STANDARD
DOXORUBICIN-CONTAINING COMBINATION CHEMOTHERAPY
I-271 TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
I-272 TREATMENT OF GLUCOCORTICOID-INDUCED OSTEOPOROSIS IN MEN AND WOMEN RECEIVING
GLUCOCORTICOIDS IN A DAILY DOSE EQUIVALENT TO 7.5MG OR GREATER OF PREDNISONE AND WHO
HAVE LOW BONE MINERAL DENSITY
I-273 ADJUNCT TO DIET TO INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(HETEROZYGOUS FAMILIAL AND NON FAMILIAL) AND MIXED DYSLIPIDEMIA (FREDERICKSON TYPES IIA
AND IIB)
I-274 USE OF TOPAMAX AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-
CLONIC SEIZURES
I-275 USE IN COMBINATION WITH METFORMIN AND SULFONYLUREA IN PATIENTS WITH TYPE 2 DIABETES
I-276 USE OF REZULIN IN COMBINATION WITH METFORMIN AND SULFONYLUREAS IN PATIENTS WITH TYPE 2
DIABETES
I-277 TREATMENT OF TYPE III HYPERLIPOPROTEINEMIA
I-278 TREATMENT OF PATIENTS WITH ISOLATED HYPERTRIGLYCERIDEMIA (FREDERICKSON TYPE IV)
I-279 TREATMENT OF POST-TRAUMATIC STRESS DISORDER
I-280 USE OF CARNITOR INJECTION FOR THE PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY IN
PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS
I-281 INCREASING HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA (HETEROZYGOUS FAMILIAL
AND NONFAMILIAL) AND MIXED DYSLIPIDEMIA (FREDERICKSON TYPES IIA AND IIB)
I-282 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
AFTER FAILURE OF PRIOR PLATINUM-BASED CHEMOTHERAPY
I-283 TO REDUCE THE INCIDENCE OF MODERATE TO SEVERE XEROSTOMIA IN PATIENTS UNDERGOING POST-
OPERATIVE RADIATION TREATMENT FOR HEAD AND NECK CANCER, WHERE THE RADIATION PORT
INCLUDES A SUBSTANTIAL PORTION OF THE PAROTID GLANDS
I-284 TO REDUCE THE NUMBER OF ADENOMATOUS COLORECTAL POLYPS IN FAMILIAL ADENOMATOUS POLYPOSIS
PATIENTS AS AN ADJUNCT TO USUAL CARE
I-285 TREATMENT OF NASAL SYMPTOMS OF SEASONAL AND PERENNIAL RHINITIS IN ADULTS AND CHILDREN 3
YEARS OF AGE AND OLDER
I-286 TREATMENT OF PATIENTS WITH FREDERICKSON TYPE III
I-287 USE OF PRAVASTATIN IN PATIENTS WITH EVIDENT CORONARY HEART DISEASE TO REDUCE THE RISK OF
TOTAL MORTALITY BY REDUCING CORONARY DEATH
I-288 CHANGES IN SEVERAL SECTIONS OF THE INSERT TO INCORPORATE STATEMENTS CONCERNING THE USE
OF HIGH DOSES OF LISINOPRIL TO REDUCE THE RISK OF THE COMBINED OUTCOMES OF MORTALITY AND
HOSPITALIZATION IN PATIENTS WITH CONGESTIVE HEART FAILURE
I-289 USE OF AVANDIA IN COMBINATION WITH A SULFONYLUREA IN PATIENTS WITH TYPE 2 DIABETES
MELLLITUS WHEN DIET AND EXERCISE WITH EITHER SINGLE AGENT DOES NOT ACHIEVE ADEQUATE
GLYCEMIC CONTROL
I-290 PREVENTION OF CORTICOSTEROID-INDUCED OSTEOPOROSIS
I-291 PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
I-292 TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
I-293 TREATMENT OF CORTICOSTEROID-INDUCED OSTEOPOROSIS
I-294 TREATMENT OF UNCOMPLICATED ACUTE ILLNESS DUE TO INFLUENZA A AND B IN PEDIATRIC PATIENTS
7 YEARS AND OLDER WHO HAVE BEEN SYMPTOMATIC FOR NO MORE THAN 2 DAYS
I-295 PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS FOR WOMEN WITH AN INTACT UTERUS
I-296 LONG-TERM INTRAVENOUS TREATMENT OF PULMONARY HYPERTENSION ASSOCIATED WITH THE
SCLERODERMA SPECTRUM OF DISEASE IN NYHA CLASS III AND CLASS IV PATIENTS WHO DO NOT
RESPOND TO CONVENTIONAL THERAPY
I-297 SHORT-TERM TREATMENT OF ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
I-298 TREATMENT OF PATIENTS WITH FREDERICKSON TYPE IIA AND IIB HYPERLIPOPROTEINEMIA
I-299 USE OF CAMPTOSAR AS A COMPONENT OF FIRST-LINE THERAPY IN COMBINATION WITH 5-FLUROURACIL
AND LEUCOVARIN FOR PATIENTS WITH METASTATIC CARCINOMA OF THE COLON OR RECTUM
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 11 of 45

EXCLUSIVITY INDICATION
I-300 PROPHYLAXIS FOR ASTHMA IN CHILDREN 2-5 YEARS OF AGE
I-301 TREATMENT OF SIGNS AND SYMPTOMS OF ALLERGIC CONJUNCTIVITIS
I-302 TREATMENT OF PEDIATRIC PATIENTS WITH PRADER-WILLI SYNDROME
I-303 INCREASING HDL-CHOLESTEROL IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA AND MIXED
DYSLIPIDEMIAS
I-304 TREATMENT OF PATIENTS WITH FREDERICKSON TYPE IV
I-305 TREATMENT OF LEVOFLOXACIN SUSCEPTIBLE STRAINS OF PENICILLIN-RESISTANT STREPTOCOCCUS
PNEUMONIAE IN PATIENTS WITH COMMUNITY ACQUIRED PNEUMONIA
I-306 INDUCTION OF SPERMATOGENESIS IN MEN WITH PRIMARY AND SECONDARY HYPOGONADOTROPIC
HYPOGONADISM IN WHOM THE CAUSE OF INFERTILITY IS NOT DUE TO PRIMARY TESTICULAR FAILURE
I-307 NEW COMBINATION USE OF METFORMIN AND INSULIN IN TYPE 2 DIABETES
I-308 TREATMENT OF PEDIATRIC PATIENTS WITH POLYARTICULAR COURSE JUVENILE RHEUMOTOID ARTHRITIS
WHO RESPONDED INADEQUATELY TO SALICYLATES OR OTHER NSAIDS
I-309 USE OF ACTONEL 35MG ONCE A WEEK TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
I-310 REDUCTION IN RISK OF MYOCARDIAL INFARCTION, STROKE, AND DEATH FROM CARDIOVASCULAR CAUSES
I-311 ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL SEIZURES IN PEDIATRIC PATIENTS AGE 3 TO
12 YEARS
I-312 FIRST LINE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE OR HORMONE
RECEPTOR UNKNOWN LOCALLY ADVANCED OR METASTATIC BREAST CANCER
I-313 EXTENSION OF INDICATION TO PROVIDE FOR MAINTENANCE OF RESPONSE
I-314 TOPICAL ANESTHETIC FOR SUPERFICIAL MINOR SURGERY OF GENITAL MUCOUS MEMBRANES AND AS AN
ADJUNCT FOR LOCAL INFILTRATION ANESTHESIA IN GENITAL MUCOUS MEMBRANES
I-315 THROMBOPROPHYLAXIS OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM,IN
MEDICAL PATIENTS WHO ARE AT RISK FOR THROMBOEMBOLIC COMPLICATIONS DUE TO SEVERELY
RESTRICTED MOBILITY DURING ACUTE ILLNESS
I-316 TREATMENT OF NSAID-ASSOCIATED GASTRIC ULCER PATIENTS WHO CONTINUE NSAID USE AND REDUCING
RISK OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS WITH HISTORY OF DOCUMENTED GASTRIC
ULCER WHO REQUIRE USE OF AN NSAID
I-317 PROPHYLAXIS OF INFLUENZA IN ADULTS AND ADOLESCENTS 13 YEARS AND OLDER
I-318 FIRSTLINE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE OR HORMONE
RECEPTOR UNKNOWN LOCALLY ADVANCED OR METASTATIC BREAST CANCER
I-319 USE FOR SUSPECTED OR CONFIRMED METHANOL POISONING, EITHER ALONE OR IN COMBINATION WITH
HEMODIALYSIS
I-320 TREATMENT OF TYPE 2 DIABETES IN PEDIATRIC PATIENTS (AGES 10-16 YEARS)
I-321 JUVENILE RHEUMATOID ARTHRITIS
I-322 USE OF DIPRIVAN IN PATIENTS 3 MONTHS TO 16 YEARS
I-323 COLORECTAL CANCER
I-324 REDUCING NEUROLOGIC DISABILITY AND/OR FREQUENCY OF CLINICAL RELAPSES IN PATIENTS WITH
SECONDARY (CHRONIC) PROGRESSIVE, PROGRESSIVE RELAPSING, OR WORSENING RELAPSING-REMITTING
MULTIPLE SCLEROSIS
I-325 PREVENTION OF RELAPSE AND RECURRENCE OF DEPRESSION
I-326 GENERALIZED ANXIETY DISORDER
I-327 SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN PATIENTS
5 YEARS AND OLDER
I-328 PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA IN PATIENTS 5-6 YEARS OF AGE
I-329 UNCOMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
I-330 MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND CONTROL OF DAYTIME AND NIGHTTIME
HEARTBURN SYSTOMS IN PATIENTS WITH GERD
I-331 TREATMENT OF MODERATE ACNE VULGARIS
I-332 EMPIRIC THERAPY IN FEBRILE NEUTROPENIC PATIENTS WITH SUSPECTED FUNGAL INFECTIONS (EFTN)
I-333 TOPICAL TREATMENT OF TINEA (PITYRIASIS) VERSICOLOR DUE TO MALASSEZIA FURFUR (FORMERLY
PITYROSPORUM ORBICULARE)
I-334 LONG-TERM TREATMENT OF GROWTH FAILURE IN CHILDREN BORN SMALL FOR GESTATIONAL AGE WHO
FAIL TO MANIFEST CATCH-UP GROWTH BY TWO YEARS OF AGE
I-335 ADJUNCTIVE THERAPY IN PATIENTS TWO YEARS AND OLDER WITH SEIZURES ASSOCIATED WITH LENNOX-
GASTAUT SYNDROME
I-336 EXPANSION OF INDICATION TO INCLUDE THE TREATMENT OF PATIENTS WITH PREDOMINATELY CLASSIC
SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO PATHOLOGIC MYOPIA OR PRESUMED OCULAR
HISTOPLASMOSIS
I-337 PATHOLOGICAL HYPERSECRETION ASSOCIATED WITH ZOLLINGER-ELLISON SNYDROME
I-338 MANAGEMENT OF ACUTE PAIN IN ADULTS AND TREATMENT OF PRIMARY DYSMENORRHEA
I-339 TREATMENT OF HEPATITIS B IN PEDIATRIC PATIENTS AGES 2-17 YEARS
I-340 ATOPIC DERMATITIS IN PEDIATRIC PATIENTS AGES 2-5
I-341 BREAST CANCER COMBINATION THERAPY
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 12 of 45

EXCLUSIVITY INDICATION
I-342 USE OF FORADIL FOR LONG-TERM, TWICE DAILY (MORNING AND EVENING) ADMINISTRATION IN THE
MAINTENANCE TREATMENT OF BRONCHO-CONSTRICTION IN PATIENTS WITH COPD INCLUDING CHRONIC
BRONCHITIS AND EMPHYSEMA
I-343 USE OF COREG FOR SEVERE HEART FAILURE
I-344 ACNE VULGARIS
I-345 TREATMENT OF POSTTRAUMATIC STRESS DISORDER
I-346 TREATMENT OF SYMPTOMATIC GASTRO ESOPHAGEAL REFLUX DISEASE (GERD)
I-347 TREATMENT OR PREVENTION OF BRONCHOSPASM IN CHILDREN 6 YEARS OF AGE AND OLDER WITH
OBSTRUCTIVE AIRWAY DISEASE
I-348 LONG-TERM, TWICE-DAILY (MORNING AND EVENING) ADMINISTRATION IN THE MAINTENANCE TREATMENT
OF BRONCHOSPASM ASSOCIATED WITH COPD (INCLUDING EMPHYSEMA AND CHRONIC BRONCHITIS)
I-349 ACUTE CORONARY SYNDROME
I-350 TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN ADOLESCENT BOYS AND GIRLS AT
LEAST ONE YEAR POSTMENARCHAL, AGES 10 TO 17 YEARS, WITH A RECOMMENDED DOSING RANGE OF 10
TO 40MG ONCE DAILY
I-351 PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS FOR ALL STRENGTHS
I-352 ANTICOAGULANT IN PATIENTS WITH OR AT RISK FOR HEPARIN-INDUCED THROMBOCYTOPENIA
UNDERGOING PERCUTANEOUS CORONARY INTERVENTIONS (PCI)
I-353 TREATMENT OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS
I-354 MANAGEMENT OF POST HERPETIC NEURALGIA
I-355 PREMENSTRUAL DYSPHORIC DISORDER
I-356 TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS, INCLUDING ZOLLINGER-ELLISON SYNDROME
I-357 TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
I-358 TREATMENT OF PANIC DISORDER
I-359 TREATMENT OF VULVAR AND VAGINAL ATROPHY ASSOCIATED WITH THE MENOPAUSE
I-360 TREATMENT OF NASAL SYMPTOMS OF SEASONAL AND PERENNIAL RHINITIS IN CHILDREN AGES TWO UP
TO AGE THREE
I-361 TREATMENT OF MULTIPLE MYELOMA AND DOCUMENTED BONE METASTASES FROM SOLID TUMORS, IN
CONJUNCTION WITH STANDARD ANTINEOPLASTIC THERAPY. PROSTATE CANCER SHOULD HAVE PROGRESSED
AFTER TREATMENT WITH AT LEAST ONE HORMONAL THERAPY
I-362 TREATMENT OF PANIC DISORDER, WITH OR WITHOUT AGORAPHOBIA
I-363 ADJUVANT TREATMENT OF POST MENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE EARLY BREAST
CANCER
I-364 TREATMENT OF COMMUNITY-ACQUIRED PNEUMONIA IN ADULTS
I-365 TREATMENT OF HEART FAILURE (NYHA CLASS II-IV) IN PATIENTS WHO ARE INTOLERANT TO AN ACE
INHIBITOR
I-366 PREVENTION OF RELAPSE FOLLOWING LONG-TERM TREATMENT OF MAJOR DEPRESSIVE DISORDER
I-367 COMBINATION THERAPY WITH THIAZOLIDINEDIONE TO LOWER BLOOD GLUCOSE IN PTS WHOSE
HYPERGLYCEMIA CANNOT BE CONTROLLED BY DIET/EXERCISE PLUS MONOTHERAPY WITH ANY OF THE
FOLLOWING AGENTS:METFORMIN,SULFONYLUREAS,REPAGLINIDE,OR THIAZOLIDINEDIONES
I-368 USE OF GLUCOVANCE WITH A THIAZOLIDINEDIONE WHEN GLYCEMIC CONTROL IS NOT OBTAINED WITH
GLUCOVANCE ALONE
I-369 PREVENTION AND TREATMENT OF POSTOPERATIVE NAUSEA AND VOMITING
I-370 TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN CHILDREN, AGES 8-13 YEARS,
WITH RECOMMENDED DOSE OF 20MG ONCE DAILY AND IN ADOLESCENTS, AGES 14-18 WITH A
RECOMMENDED DOSE OF 40MG ONCE DAILY
I-371 HELICOBACTER PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
I-372 NOSOCOMIAL PNEUMONIA
I-373 TREATMENT OF TYPE 2 DIABETIC NEPHROPATHY
I-374 SHORT TERM TOPICAL TREATMENT OF MILD TO MODERATE PLAQUE-TYPE PSORIASIS OF NON SCALP
REGIONS
I-375 FIRST LINE THERAPY FOR THE REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN-ANGLE
GLAUCOMA OR OCULAR HYPERTENSION
I-376 TREATMENT OF NEWLY DIAGNOSED ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE
CHRONIC MYELOID LEUKEMIA (CML)
I-377 USE OF BRAVELLE FOR MULTIPLE FOLLICULAR DEVELOPMENT (CONTROLLED OVARIAN STIMULATION)
DURING ASSISTED REPRODUCTIVE TECHNOLOGY CYCLES IN PATIENTS WHO HAVE PREVIOUSLY RECEIVED
PITUITARY SUPPRESSION
I-378 RELIEF OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS IN ADULTS AND PEDIATRIC PATIENTS 2
YEARS OF AGE AND OLDER
I-379 USE TAXOTERE IN COMBINATION WITH CISPLATIN FOR THE TREATMENT OF PATIENTS WITH
UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WHO HAVE NOT
PREVIOUSLY RECEIVED CHEMOTHERAPY FOR THIS CONDITION
I-380 TO TREAT PATIENTS WITH SCHIZOPHRENIA OR SCHIZOAFFECTIVE DISORDER AT RISK FOR EMERGENT
SUICIDAL BEHAVIOR
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 13 of 45

EXCLUSIVITY INDICATION
I-381 TREATMENT OF COLD SORES (HERPES LABIALIS) IN ADULT AND ADOLESCENT PATIENTS 12 YEARS OF
AGE AND OLDER
I-382 FOR NEWLY-DIAGNOSED HIGH GRADE MALIGNANT GLIOMA PATIENTS AS AN ADJUNCT TO SURGERY AND
RADIATION
I-383 TREATMENT OF TYPE 2 DIABETIC NEPHROPATHY
I-384 USE IN COMBINATION WITH INSULIN FOR THE TREATMENT OF PATIENTS WITH TYPE 2 DIABETES
MELLITUS
I-385 MODIFICATION OF THE INDICATION FOR COMMUNITY ACQUIRED PNEUMONIA TO ADD"INCLUDING
PENICILLIN-RESISTANT STRAINS, MIC PENICILLIN>=2MCG/ML TO STREPTOCOCCUS PNEUMONIAE
I-386 RAPAMUNE (SIROLIMUS) WITHIN AN IMMUNOSUPPRESSIVE REGIMEN THAT WOULD ALLOW FOR THE
WITHDRAWAL OF CYCLOSPORINE 2 TO 4 MONTHS AFTER RENAL TRANSPLANTATION IN PATIENTS
CONSIDERED AT LOW TO MODERATE IMMUNOLOGIC RISK FOR RENAL TRANSPLANT REJECTION
I-387 ADJUNCTIVE THERAPY OF PARTIAL SEIZURES IN PEDIATRIC PATIENTS GREATER THAT OR EQUAL TO 2
YEARS OF AGE
I-388 TREATMENT OF PATIENTS WITH LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL INFARCTION
I-389 SUPRESSION OF RECURRENT GENITAL HERPES IN HIV-INFECTED INDIVIDUALS
I-390 USE IN PTS AT HIGH RISK CORONARY EVENTS DUE TO EXISTING CORONARY HEART
DISEASE,DIABETES,PERIPHERAL VESSEL DISEASE,STROKE HISTORY,OTHER CV DISEASE TO REDUCE
RISK TOTAL MORTALITY BY REDUCING CORONARY DEATH,REDUCE NONFATAL MI & STROKE.....
I-391 ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT UNDERGO
ESOPHAGECTOMY
I-392 TX OF PED PATIENTS W/PH+ CHRONIC PHASE CML DISEASE RECUR AFTER STEM CELL TRNSPLT OR
RESIST TO INTERFERON ALPHA THERAPY.NO CONTROLLED TRIALS DEMONSTRATING A CLINICAL BENEFIT
SUCH AS IMPROVE IN DISEASE RELATED SX OR INCREASED SURVIVAL
I-393 CHRONIC BACTERIAL PROSTATITIS
I-394 USE IN PATIENTS WITH CORONARY HEART DISEASE TO REDUCE THE RISK OF UNDERGOING CORONARY
REVASCULARIZATION PROCEDURES
I-395 TO IMPROVE PHYSICAL FUNCTION
I-396 EXPANDED INDICATION TO INCLUDE THE ASSESSMENT OF VENTRICULAR FUNCTION IN SUBJECTS BEING
EVALUATED FOR HEART DISEASE AND/OR VENTRICULAR FUNCTION
I-397 EXTENDED PROPHYLAXIS IN PATIENTS UNDERGOING HIP FRACTURE SURGERY
I-398 IDIOPATHIC SHORT STATURE
I-399 TREATMENT OF CANDIDEMIA AND THE FOLLOWING CANDIDA INFECTIONS: INTRA-ABDOMINAL
ABSCESSES, PERITONITIS AND PLEURAL SPACE INFECTIONS
I-400 USE OF OLANZAPINE IN COMBINATION WITH LITHIUM OR VALPROATE FOR THE TREATMENT OF ACUTE
MANIC EPISODES ASSOCIATED WITH BIPOLAR DISORDER
I-401 LONGER-TERM EFFICACY OF ARIPIPRAZOLE IN THE TREATMENT OF SCHIZOPHRENIA
I-402 DIABETIC FOOT INFECTIONS WITHOUT CONCOMITANT OSTEOMYELITIS
I-403 USE OF VALTREX IN COMBINATION WITH SAFER SEX PRACTICES FOR THE REDUCTION OF THE RISK OF
TRANSMISSION OF GENITAL HERPES DURING SUPPRESIVE THERAPY OF THE SOURCE PARTNER IN A
HETEROSEXUAL COUPLE
I-404 MAINTENANCE TREATMENT OF BIPOLAR I DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD
EPISODES (DEPRESSION, MANIA, HYPOMANIA, MIXED EPISODES) IN PATIENTS TREATED FOR ACUTE
MOOD EPISODES WITH STANDARD THERAPY
I-405 TREATMENT OF PREMENSTRUAL DYSPHORIC DISORDER (PMDD) USING AN INTERMITTENT DOSING REGIMEN
I-406 PREVENTION OF CYTOMEGALOVIRUS DISEASE IN KIDNEY, HEART, AND KIDNEY-PANCREAS TRANSPLANT
PATIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE)
I-407 IMPROVE SURVIVAL OF STABLE PATIENTS WITH LEFT VENTRICULAR SYSTOLIC DYSFUNCTION (EJECTION
FRACTION<=40%) AND CLINICAL EVIDENCE OF CONGESTIVE HEART FAILURE AFTER AN ACUTE
MYOCARDIAL INFARCTION
I-408 STIMULATION OF PANCREATIC SECRETIONS TO FACILITATE THE INDENTIFICATION OF THE AMPULLA OF
VATER AND ACCESSORY PAPILLA DURING ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP)
I-409 ESOPHAGEAL CANDIDIASIS
I-410 USE OF ADVAIR DISKUS 250/50 FOR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) ASSOCIATED
WITH CHRONIC BRONCHITIS
I-411 EXPANDED INDICATION FOR USE IN COMBINATION WITH ANTIDIABETIC DRUGS IN THE
THIAZOLIDINEDIONE CLASS
I-412 MONOTHERAPY FOR THE SHORT TERM TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED
WITH BIPOLAR I DISORDER
I-413 ADJUNCTIVE THERAPY FOR THE SHORT TERM TREATMENT OF ACUTE MANIC OR MIXED EPISODES
ASSOCIATED WITH BIPOLAR I DISORDER
I-414 PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT), WHICH MAY LEAD TO PULMONARY EMBOLISM (PE) IN
MEDICAL PATIENTS WHO ARE AT RISK FOR THROMBOEMBOLIC COMPLICATIONS DUE TO SEVERELY
RESTRICTED MOBILITY DURING ACUTE ILLNESS
I-415 SEVERE HYPERTENSION WHEN THE VALUE OF ACHIEVING PROMPT BLOOD PRESSURE CONTROL EXCEEDS
THE RISK OF INITIATING COMBINATION THERAPY
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 14 of 45

EXCLUSIVITY INDICATION
I-416 THE USE OF CIPRO XR FOR COMPLICATED URINARY TRACT INFECTIONS AND ACUTE UNCOMPLICATED
PYELONEPHRITIS
I-417 USE IN THE LONG TERM TREATMENT OF BIPOLAR I DISORDER
I-418 ADJUNCTIVE THERAPY W/ MOOD STABILIZERS (LITHIUM OR DIVALPROEX) IN THE TREATMENT OF ACUTE
MANIC EPISODES ASSOCIATED WITH BIPOLAR I DISORDERS
I-419 MONOTHERAPY IN THE TREATMENT OF ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
I-420 TOPICAL TREATMENT OF CLINICALLY TYPICAL, NONHYPERKERATOTIC, NONHYPERTROPHIC ACTINIC
KERATOSES ON THE FACE OR SCALP IN IMMUNOCOMPETENT ADULTS
I-421 TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS AND PYELONEPHRITIS DUE TO E.COLI FOR
PED PATIENTS (1-17) NOT AS FIRST CHOICE
I-422 INDICATED FOR THE IN-HOSPITAL SHORT-TERM (UP TO 4 HOURS) REDUCTION IN BLOOD PRESSURE IN
PEDIATRIC PATIENTS
I-423 ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
I-424 MANAGEMENT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH MODERATE TO SEVERE CHRONIC
RENAL INSUFFICIENCY NOT YET ON DIALYSIS
I-425 FLOXATIN IN COMBINATION WITH INFUSIONAL 5-FLUOROURACIL (5-FU) AND LEUCOVORIN (LV) FOR
THE TREATMENT OF PATIENTS PREVIOUSLY UNTREATED FOR ADVANCED COLORECTAL CANCER
I-426 TREATMENT OF ACUTE PULMONARY EMBOLISM WHEN ADMINISTERED IN CONJUNCTION WITH WARFARIN
SODIUM
I-427 TREATMENT OF ACUTE DEEP VEIN THROMBOSIS WITHOUT PULMONARY EMBOLISM WHEN ADMINISTERED IN
CONJUNCTION WITH WARFARIN SODIUM
I-428 FOR USE IN COMBINATION WITH PACLITAXEL FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH
METASTATIC BREAST CANCER AFTER FAILURE OF PRIOR ANTHRACYCLINE CONTAINING ADJUVANT
CHEMOTHERAPY UNLESS ANTHRACYCLINES WERE CLINICALLY CONTRAINDICATED
I-429 FOR USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH ANDROGEN
INDEPENDENT (HORMONE REFRACTORY) METASTATIC PROSTATE CANCER
I-430 FOR USE IN THE RELIEF OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS IN ADULTS
I-431 NOSOCOMIAL PNEUMONIA AND COMMUNITY-ACQUIRED PNEUMONIA CAUSED BY STREPTOCOCCUS PNEUMONIAE
INDICATION EXPANDED TO INCLUDE MULTI-DRUG RESISTANT STRAINS
I-432 TREATMENT OF COMMUNITY ACQUIRED PNEUMONIA CAUSED BY MULTI-DRUG RESISTANT STREPTOCOCCUS
PNEUMONIAE
I-433 TREATMENT OF BIOPSY-CONFIRMED, PRIMARY SUPERFICIAL BASAL CELL CARCINOMA IN
IMMUNOCOMPETENT ADULTS, WITH A MAXIMUM TUMOR DIAMETER OF 2.0CM, LOCATED ON THE TRUNK
(EXCLUDING ANOGENITAL SKIN), NECK, OR EXTREMITIES (EXCLUDING HANDS AND FEET)
I-434 PREVENTION OF CARDIOVASCULAR DISEASE IN ADULT PATIENTS WITHOUT CLINICALLY EVIDENT HEART
DISEASE, BUT WITH MULTIPLE RISK FACTORS FOR CORONARY HEART DISEASE TO REDUCE RISK OF MI
AND RISK FOR REVASCULARIZATION PROCEDURES AND ANGINA
I-435 CHRONIC IDIOPATHIC CONSTIPATION
I-436 FOR USE IN COMBINATION WITH DOXORUBICIN AND CYCLOPHOSPHAMIDE FOR THE ADJUVANT TREATMENT
OF PATIENTS WITH OPERABLE NODE-POSITIVE BREAST CANCER
I-437 TREATMENT OF ACUTE MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR DISORDER
I-438 EMPIRICAL THERAPY FOR PRESUMED FUNGAL INFECTIONS IN FEBRILE, NEUTROPENIC PATIENTS
I-439 USED TO TREAT ADULTS WITH GROWTH HORMONE DEFICIENCY
I-440 FOR THE REPLACEMENT OF ENDOGENOUS GROWTH HORMONE IN ADULTS WITH GROWTH HORMONE DEFICIENCY
I-441 USE COMBINATION WITH INFUSIONAL 5-FU/LV FOR ADJUVANT TREATMENT STAGE III COLON CANCER
PTS WHO HAVE UNDERGONE COMPLETE RESECTION PRIMARY TUMOR-BASED ON IMPROVEMENT IN DISEASE
FREE SURVIVAL, NO DEMONSTRATED BENEFIT OVERALL SURVIVAL AFTER 4YRS
I-442 USED FOR CANDIDEMIA IN NONNEUTROPENIC PATIENTS AND THE FOLLOWING CANDIDA INFECTIONS:
DISSEMINATED INFECTIONS IN SKIN & INFECTIONS IN ABDOMEN, KIDNEY, BLADDER WALL, AND WOUNDS
I-443 TREATMENT OF NASAL POLYPS IN PATIENTS 18 YEARS OF AGE AND OLDER
I-444 USE OF PROTONIX IV FOR INJECTION AS STAND ALONE THERAPY FOR THE SHORT-TERM TREATMENT OF
PATIENTS HAVING GASTROESOPHAGEAL REFLUX (GERD) WITH A HISTORY OF EROSIVE ESOPHAGITIS
I-445 TO IMPROVE (COMPARED TO 4.25% DEXTROSE) LONG-DWELL ULTRAFILTRATION AND CLEARANCE OF
CREATININE AND UREA NITROGEN IN PATIENTS WITH HIGH AVERAGE OR GREATER TRANSPORT
CHARACTERISTICS, AS DEFINED USING THE PERITONEAL EQUILIBRATION TEST (PET)
I-446 EXTENDED ADJUVANT TREATMENT OF EARLY BREAST CANCER IN POSTMENOPAUSAL WOMEN WHO HAVE
RECEIVED 5 YRS ADJUVANT TAMOXIFEN THERAPY-EFFECTIVENESS BASED ON AN ANALYSIS OF DISEASE
FREE SURVIVAL IN PATIENTS TREATED FOR A MEDIAN 24 MONTHS
I-447 USE OF COPEGUS (RIBAVIRIN) FOR TREATMENT OF CHRONIC HEPATITIS C IN ADULT PATIENTS
COINFECTED WITH HIV IN COMBINATION WITH PEGASYS (PEGINTERFERON ALFA-2A)
I-448 TREATMENT OF HEART FAILURE (NYHA CLASS II-IV AND EJECTION FRACTION <=40%) TO REDUCE THE
RISK OF DEATH FROM CARDIOVASCULAR CAUSES AND TO REDUCE HOSPITALIZATIONS FOR HEART FAILURE
I-449 TO IMPROVE WAKEFULNESS IN TWO NEW PATIENT POPULATIONS WITH EXCESSIVE SLEEPINESS: THOSE
WITH OBSTRUCTIVE SLEEP APNEA/HYPOPNEA SYNDROME AND THOSE WITH SHIFT WORK SLEEP DISORDER
I-450 TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED HIGH GRADE GLIOMAS CONCOMITANTLY WITH
RADIOTHERAPY AND THEN AS ADJUVANT TREATMENT
I-451 MANAGEMENT OF ENDOMETRIOSIS ASSOCIATED PAIN
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 15 of 45

EXCLUSIVITY INDICATION
I-452 EXPANDED INDICATION TO INCLUDE TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE RECEIVED
AT LEAST 1 PRIOR THERAPY
I-453 USE IN COMBINATION WITH A SULFONYLUREA PLUS METFORMIN WHEN DIET, EXERCISE AND BOTH
AGENTS DO NOT RESULT IN ADEQUATE GLYCEMIC CONTROL (TRIPLE THERAPY)
I-454 MAINTENANCE OF CLINICAL REMISSION OF MILD TO MODERATE CHRON'S DISEASE INVOLVING THE
ILEUM AND/OR THE ASCENDING COLON FOR UP TO 3 MONTHS
I-455 MODIFIED HEART FAILURE INDICATION TO INCLUDE TREATMENT OF HEART FAILURE IN PATIENTS
WITH LEFT VENTRICULAR SYSTOLIC DYSFUNCTION (NYHA CLASS II-IV; EJECTION FRACTION LESS
THAN OR EQUAL TO 40%
I-456 TO REDUCE CARDIOVASCULAR DEATH AND TO REDUCE HEART FAILURE HOSPITALIZATIONS. INCLUDES
ADDITIONAL INFORMATION ON THE ADDED EFFECT ON THESE OUTCOMES WHEN USED WITH AN ACE
INHIBITOR
I-457 TREATMENT OF PATIENTS UNDERGOING ABDOMINAL SUREGERY WHO ARE AT RISK FOR THROMBOEMBOLIC
COMPLIATIONS
I-458 USE OF BIVALIRUDIN FOR INJECTION WITH PROVISIONAL USE OF GLYCOPROTEIN IIB/IIA INHIBITOR
(GPI) AS LISTED IN THE CLINICAL TRIALS REPLACE-2 SECTION FOR USE AS AN ANTICOAGULANT IN
PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI)
I-459 NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE (NDD-CKD) PATIENTS RECEIVING OR NOT
RECEIVING AN ERYTHROPOIETIN
I-460 TREATMENT OF DIARRHEA CAUSED BY CRYPTOSPORIDIUM PARVUM IN NON-HIV INFECTED PATIENTS 12
YEARS OF AGE AND OLDER
I-461 USE AS A SINGLE AGENT FOR ADJUVANT TREATMENT IN PATIENTS WITH DUKES' C COLON CANCER WHO
HAVE UNDERGONE COMPLETE RESECTION OF THE PRIMARY TUMOR WHEN TREATMENT WITH
FLUOROPYRIMIDINE THERAPY ALONE IS PREFERRED
I-462 LONG TERM TREATMENT OF IDIOPATHIC SHORT STATURE
I-463 TREATMENT OF PATIENTS POST MYOCARDIAL INFARCTION
I-464 TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME
I-465 PERENNIAL ALLERGIC RHINITIS IN ADULTS AND PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER
I-466 FOR RELIEF OF THE SIGNS AND SYMPTOMS OF ANKYLOSING SPONDYLITIS
I-467 USE OF TOPIRAMATE AS INITIAL MONOTHERAPY IN PATIENTS 10 YEARS OF AGE AND OLDER WITH
PARTIAL ONSET OR PRIMARY GENERALIZED TONIC CLONIC SEIZURES
I-468 USE IN PATIENTS WITH STABLE CORONARY ARTERY DISEASE TO REDUSE THE RISK OF CARDIOVASCULAR
MORTALITY OR NON-FATAL MYOCARDIAL INFECTION
I-469 RELIEF OF THE SIGNS AND SYMPTOMS OF PAUCIARTICULAR OR POLYARTICULAR COURSE JUVENILE
RHEUMATOID ARTHRITIS IN PATIENTS 2 YEARS OF AGE AND OLDER
I-470 DIABETIC PERIPHERAL NEUROPATHIC PAIN
I-471 INDICATED TO REDUCE THE RISK OF MYOCARDIAL INFARCTION AND STROKE IN PATIENTS WITH TYPE 2
DIABETES AND WITHOUT CLINICALLY EVIDENT CORONARY HEART DISEASE BUT WITH MULTIPLE RISK
FACTORS FOR CORONARY HEART DISEASE
I-472 USE IN PATIENTS WITH ANGIOGRAPHICALLY DOCUMENTED CORONARY ARTERY DISEASE
I-473 USE IN COMBINATION WITH GEMCITABINE FOR THE FIRST LINE TREATMENT OF PATIENTS WITH
LOCALLY ADVANCED UNRESECTABLE OR METASTATIC PANCREATIC CANCER
I-474 TREATMENT OF IRON DEFICIENCY ANEMIA IN PERITONEAL DIALYSIS DEPENDANT CHRONIC KIDNEY
DISEASE IN PATIENTS RECIEVING AN ERYTHROPOIETIN
I-475 PREVENTION OF NAUSEA AND VOMITTING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF
MODERATELY EMETOGENIC CANCER CHEMOTHERAPY
I-476 TREATMENT OF DIABETIC FOOT INFECTIONS WITHOUT OSTEOMYELITIS
I-477 TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY METHICILLIN
SUSCEPTIBLE STAPHYLOCOCCUS AUREUS, ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE, OR
ENTEROBACTER CLOACAE
I-478 FOR USE AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL SEIZURES IN CHILDREN WITH
EPILEPSY AGED 2-4 YEARS
I-479 TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS CAUSED BY E.COLI, B. FRAGILIS,
S.ANGINOSUS, S.CONSTELLATUS, E. FAECALIS, P. MIRABILIS, C. PERFRINGENS, B.
THETAIOTAOMICRON OR PEPTOSTREPTOCOCCUS SPECIES
I-480 PROPHYLAXIS OF INFLUENZA FOR PATIENTS BETWEEN 1-12 YEARS OF AGE
I-481 INDICATED FOR THE ADJUVANT TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR
POSITIVE EARLY BREAST CANCER
I-482 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH OR
WITHOUT PSYCHOTIC FEATURES
I-483 PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
I-484 FOR THE RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS
I-485 TREATMENT OF POSTOPERATIVE INFLAMMATION AND REDUCTION OF OCULAR PAIN IN PATIENTS WHO
HAVE UNDERGONE CATARACT EXTRACTION
I-486 ANGIOMAX IS INDICATED FOR PATIENTS WITH, OR AT RISK OF, HIT/HITTS UNDERGOING PCI
I-487 INDICATED FOR THE RELIEF OF THE INFAMMATORY AND PRURITIC MANIFESTATIONS OF
CORTICOSTEROID RESPONSIVE DERMATOSES IN PATIENTS 12 YRS OF AGE OR OLDER
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 16 of 45

EXCLUSIVITY INDICATION
I-488 MAINTENANCE THERAPY IN BIPOLAR I DISORDER
I-489 FOR USE IN PEDIATRIC PATIENTS WITH TYPE I DIABETES
I-490 FOR USE IN COMBINATION WITH CISPLATIN AND FLUOROURACIL FOR THE TREATMENT OF PATIENTS
WITH ADVANCED GASTRIC ADENOCARCINOMA, INCLUDING ADENOCARCINOMA OF GASTROESOPHAGEAL
JUNCTION, WHO HAVE NOT RECEIVED PRIOR CHEMOTHERAPY FOR ADVANCED DISEASE
I-491 INFLUENZA PROPHYLAXIS
I-492 MONOTHERAPY IN THE TREATMENT OF ACUTE MANIC OR MIXED EPISODES IN BIPOLAR I DISORDER,
WITH OR WITHOUT PSYCHOTIC FEATURES
I-493 ADMINISTERED IN COMBINATION WITH FENOFIBRATE, AS ADJUNCTIVE THERAPY TO DIET FOR THE
REDUCTION OF ELEVATED TOTAL-C, LDL-C, APO B, AND NON-HDL-C IN PATIENTS WITH MIXED
HYPERLIPIDEMIA
I-494 CLINICAL DATA IN SUPPORT OF AVANDAMET AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE
GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHEN TREATMENT WITH DUAL
ROSIGLITAZONE AND METFORMIN THERAPY IS APPROPRIATE
I-495 ADJUVANT TX OF POSTMENOPAUSAL WOMEN WITH ESTROGEN-RECEPTOR POSITIVE EARLY BREAST CANCER
WHO HAVE RECEIVED 2 TO 3 YRS OF TAMOXIFEN AND ARE SWITCHED TO AROMASIN FOR COMPLETION OF
A TOTAL OF 5 CONSECUTIVE YRS OF ADJUVANT HORMONAL THERAPY
I-496 LONG TERM TREATMENT OF GROWTH FAILURE ASSOCIATED WITH TURNER SYNDROME IN PATIENTS WHO
HAVE OPEN EPIPHYSES
I-497 PREVENTION OF SEASONAL MAJOR DEPRESSIVE EPISODES IN PATIENTS WITH SEASONAL AFFECTIVE
DISORDER
I-498 PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING
I-499 USE OF GEMZAR IN COMBINATION WITH CARBOPLATIN FOR THE TREATMENT OF PATIENTS WITH
ADVANCED OVARIAN CANCER THAT HAS RELAPSED AT LEAST 6 MONTHS AFTER COMPLETION OF PLATINUM-
BASED THERAPY
I-500 FOR USE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF MULTIPLE MYELOMA PATIENTS
WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
I-501 TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) IN IMMUNOCOMPETANT PATIENTS WITH A
SINGLE DOSE OF FAMCICLOVIR 1500 MG.
I-502 FOR PTS WITH ST-SEGMENT ELEVATION ACUTE MYOCARDIAL INFARCTION, PLAVIX TO REDUCE RATE OF
DEATH FROM ANY CAUSE AND THE RATE OF A COMBINED ENDPOINT OF DEATH, REINFARCTION OR
STROKE. NOT KNOWN TO PERTAIN TO PTS WHO RECEIVE PRIMARY ANGIOPLASTY
I-503 TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER
I-504 TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME
I-505 TREATMENT OF STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA), INCLUDING THOSE
WITH RIGHT SIDED INFECTIVE ENDOCARDITIS, CAUSED BY METHICILLIN-SUSCEPTIBLE AND
METHICILLIN-RESISTANT ISOLATES
I-506 ADJUNCTIVE THERAPY OF MYOCLONIC SEIZURES IN ADULTS AND ADOLESCENTS AGE 12 AND OVER WITH
JUVENILE MYOCLONIC EPILEPSY
I-507 ADJUNCT TO DIET TO REDUCE TOTAL-C, LDL-C AND APO B LEVELS IN ADOLESCENT BOYS AND GIRLS
WHO ARE AT LEAST ONE YEAR POST-MENARCHE, 10-16 YEARS OF AGE, WITH HETEROZYGOUS FAMILIAL
HYPERCHOLESTEROLEMIA
I-508 PREMENSTRUAL DYSPHONIC DISORDER
I-509 TREATMENT OF IRRATABILITY ASSOCIATED WITH AUTISTIC DISORDER
I-510 ADULT DERMAFIBROSARCOMA PROTUBERANS (DFSP)
I-511 ADULT MYELODYSPLASTIC SYNDROME/MYELOPROLIFERATIVE DISEASES (MDS/MDP)
I-512 ADULT PH+ ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) MONOTHERAPY
I-513 ADULT AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM)
I-514 ADULT HYPEREOSINOPHILIC SYNDROME/CHRONIC EOSINOPHILIC LEUKEMIA (HES/CEL)
I-515 PROPHYLAXIS OF SURGICAL SITE INFECTION FOLLOWING ELECTIVE COLORECTAL SURGERY
I-516 PRIMARY GENERALIZED TONIC CLONIC SEIZURES IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF
AGE AND OLDER
I-517 TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEG SYNDROME (RLS)
I-518 TREATMENT OF SHORT STATURE OR GROWTH FAILURE IN CHILDREN WITH SHOX (SHORT STATURE
HOMEOBOX CONTAINING GENE) DEFICIENCY WHOSE EPIPHYSES ARE NOT CLOSED
I-519 USE OF TAXOTERE (DOCETAXEL) INJECTION CONCENTRATE IN COMBINATION WITH CISPLATIN AND
FLUOROURACIL FOR THE INDUCTION OF PATIENTS WITH INOPERABLE LOCALLY ADVANCED SQUAMOUS
CELL CARCINOMA OF THE HEAD AND NECK (SCCHN)
I-520 USE OF EXENATIDE IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE USING A
THIAZOLIDINEDIONE ALONE OR IN COMBINATION WITH METFORMIN BUT HAVE NOT ACHIEVED ADEQUATE
GLYCEMIC CONTROL
I-521 TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST 1 YEAR PRIOR
THERAPY
I-522 TREATMENT OF MODERATE ACNE VULGARIS IN WOMEN AT LEAST 14 YRS OF AGE, WHO HAVE NO KNOWN
CONTRAINDICATIONS TO ORAL CONTRACEPTIVE THERAPY, AND HAVE ACHIEVED MENARCHE, IF THE
PATIENT DESIRES AN ORAL CONTRACEPTIVE FOR BIRTH CONTROL.
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 17 of 45

EXCLUSIVITY INDICATION
I-523 USE IN ADULT PATIENTS WITH CLINICALLY EVIDENT CORONARY HEART DISEASE TO REDUCE THE RISK
OF NONFATAL MYOCARDIAL INFARCTION, FATAL AND NONFATAL STROKE, ANGINA, REVASCULARIZATION
PROCEDURES AND HOSPITALIZATION FOR CONGESTIVE HEART FAILURE
I-524 GENERALIZED ANXIETY DISORDER (GAD)
I-525 USE OF 0.5MG/0.1MG FOR PREVENTION OF POST-MENOPAUSAL OSTEOPOROSIS
I-526 TREATMENT OF HYPONATREMIA IN HOSPITALIZED PATIENTS
I-527 ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN
ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER WITH IDIOPATHIC GENERALIZED EPILEPSY
I-528 TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF
VULVAR AND VAGINAL ATROPHY ASSOCIATED WITH MENOPAUSE
I-529 TREATMENT OF DEMENTIA OF THE ALZHEIMER'S TYPE IN PATIENTS WITH SEVERE ALZHEIMER'S DISEASE
I-530 PREVENTION OF EXERCISE-INDUCED BRONCHOCONSTRICTION IN PATIENTS 15 YEARS OF AGE AND OLDER
I-531 MAINTENANCE TREATMENT OF SCHIZOPHRENIA
I-532 TREATMENT OF BACTERIAL VAGINOSIS IN NON-PREGNANT FEMALES
I-533 ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI)
I-534 EXTENDED TREATMENT OF SYMPTOMATIC VENOUS THROMBOEMBOLISM (VTE) AND/OR PULMONARY EMBOLISM
TO REDUCE THE RECCURENCE OF VTE IN PATIENTS WITH CANCER
I-535 MANAGEMENT OF FIBROMYALGIA
I-536 FOR THE TREATMENT OF SHORT STATURE IN CHILDREN WITH NOONAN SYNDROME
I-537 LONG TERM TREATMENT OF PANIC DISORDER
I-538 SHORT TERM TREATMENT OF PANIC DISORDER
I-539 REDUCTION IN RISK OF INVASIVE BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS OR
AT HIGH RISK FOR INVASIVE BREAST CANCER
I-540 TREATMENT OF SCHIZOPHRENIA IN ADOLESCENTS AGES 13-17
I-541 TREATMENT OF BIPOLAR I DISORDER IN CHILDREN AGES 10-12 AND ADOLESCENTS AGES 13-17
I-542 EXPANSION OF PATIENT POPULATION FOR HEAD AND NECK CANCER FROM "INOPERABLE" PATIENTS TO
ALL PATIENTS
I-543 USE IN COMBINATION WITH CISPLATIN AND FLUOROURACIL FOR THE INDUCTION TREATMENT OF
PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN)
I-544 ADJUNCTIVE THERAPY OF MYOCLONIC SEIZURES IN ADULTS AND ADOLESCENTS AGE 16 AND OVER WITH
JUVENILE MYOCLONIC EPILEPSY
I-545 ADJUNCTIVE TREATMENT TO TREAT PATIENTS WITH MAJOR DEPRESSIVE DISORDER
I-546 TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA
I-547 ADJUNCTIVE THERAPY TO DIET TO SLOW THE PROGRESSION OF ARTHEROSCLEROSIS IN ADULT PATIENTS
AS PART OF A TREATMENT STRATEGY TO LOWER TOTAL-C AND LDL-C TO TARGET LEVELS
I-548 SEASONAL ALLERGIC RHINITIS IN PATIENTS 6 THROUGH LESS THAN 12 YEARS OF AGE
I-549 USE OF AVALIDE TABLETS AS INITIAL THERAPY IN PATIENTS WHO ARE LIKELY TO NEED MULTIPLE
DRUGS TO ACHIEVE THEIR BLOOD PRESSURE GOALS
I-550 TREATMENT OF HYPERTENSION IN PEDIATRIC PATIENTS 6-16 YEARS OF AGE
I-551 TREATMENT OF SHORT STATURE IN CHILDREN WITH TURNER'S SYNDROME
I-552 ADJUNCTIVE TREATMENT FOR RADIOIODINE ABLATION OF THYROID TISSUE REMNANTS IN PATIENTS WHO
HAVE UNDERGONE THYROIDECTOMY FOR WELL-DIFFERENTIATED THYROID CANCER AND WHO DO NOT HAVE
EVIDENCE OF METASTATIC THYROID CANCER
I-553 FOR USE AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH
TYPE 2 DIABETES MELLITUS
I-554 TREATMENT OF PATIENTS WITH CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, CANDIDA PERITONIS
AND ABSCESSES
I-555 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN
PEDIATRIC PATIENTS AGED 10-17 YEARS
I-556 PREVENTION OF POST OPERATIVE NAUSEA AND VOMITING FOR UP TO 24 HOURS FOLLOWING SURGERY
I-557 USE OF AMITIZA (LUBIPROSTONE) 8 MCG TWICE DAILY FOR TREATMENT OF IRRITABLE BOWEL
SYNDROME WITH CONSTIPATION IN WOMEN GREATER THAN OR EQUAL TO 18 YEARS OLD
I-558 MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION AND REDUCING EXACERATIONS IN PATIENTS WITH
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA
I-559 ADJUNCTIVE THERAPY ADDED TO LITHIUM OR VALPROATE IN SHORT TERM TREATMENT OF BIPOLAR
DISORDER, MANIC OR MIXED
I-560 MAINTENANCE TREATMENT FOR BIPOLAR I DISORDER, AS ADJUNCTIVE THERAPY TO LITHIUM OR
DIVALPROEX
I-561 LONG-TERM TREATMENT OF SOCIAL ANXIETY DISORDER
I-562 MAINTENANCE TREATMENT OF ATTENTION-DEFICIT DISORDER (ADHD) IN CHILDREN AND ADOLESCENTS
I-563 ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SIEZURES IN
ADULTS AND CHILDREN 16 YEARS OF AGE AND OLDER WITH IDIOPATHIC GENERALIZED EPILEPSY
I-564 TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA
I-565 USE OF DUTASTERIDE IN COMBINATION WITH TAMSULOSIN FOR THE TREATMENT OF SYMPTOMATIC
BENIGN PROSTATIC HYPERPLASIA (BPH)
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 18 of 45

EXCLUSIVITY INDICATION
I-566 MANAGEMENT OF FIBROMYALGIA
I-567 INITIAL THERAPY IN PATIENTS LIKELY TO NEED MULTIPLE DRUGS TO ACHIEVE THEIR BLOOD
PRESSURE GOALS
I-568 USE OF APTIVUS, CO-ADMINISTERED W/RITONAVIR, FOR COMBINATION ANTIRETROVIRAL TREATMENT OF
HIV-1 INFECTED PED (AGE 2-18 YRS) PATIENTS WHO ARE TREATMENT-EXPERIENCED AND INFECTED
W/HIV-1 STRAINS RESISTANT TO MORE THAN ONE PROTEASE INHIBITOR
I-569 TREATMENT OF CHRONIC HEPATITIS B
I-570 TREATMENT OF CHICKEN POX IN IMMUNOCOMPETENT PEDIATRIC PATIENTS 2 TO <18 YEARS OF AGE
I-571 NON-SMALL CELL LUNG CANCER IN COMBINATION WITH CISPLATIN AND AS SINGLE AGENT FOR
NONSQAUMOUS NON-SMALL CELL LUNG CANCER
I-572 TREATMENT OF GROWTH FAILURE IN CHILDREN BORN SMALL FOR GESTATIONAL AGE (SGA) WITH NO
CATCH-UP BY AGE 2-4 YRS.
I-573 TO TREAT PATIENTS WITH PRIMARY DYSBETALIPOPROTEINEMIA (FREDICKSON TYPE III
HYPERLIPOPROTEINEMIA) AS AN ADJUNCT TO DIET
I-574 MONOTHERAPY IN THE TREATMENT OF BIPOLAR DEPRESSION
I-575 MONOTHERAPY IN THE TREATMENT OF BIPOLAR MANIA
I-576 ADJUNCTIVE THERAPY IN THE TREATMENT OF BIPOLAR MANIA
I-577 SEDATION OF NON-INTUBATED PATIENTS PRIOR TO AND/OR DURING SURGICAL AND OTHER PROCUDURES
I-578 EXPANSION OF INDICATION TO INCLUDE TREATMENT OF HIV IN TREATMENT NAIVE ADULTS
I-579 TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA, A SYMPTOM OF VULVAR AND VAGINAL ATROPHY,
DUE TO MENOPAUSE AND NEW TWICE WEEKLY DOSING REGIMEN FOR THIS INDICATION
I-580 INDOLENT B-CELL NON-HODGKINS LYMPHOMA (NHL) THAT HAS PROGRESSED DURING OR WITHIN SIX
MONTHS OF TREATMENT WITH RITUXIMAB OR A RITUXIMAB CONTAINING REGIMEN
I-581 TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
I-582 TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
I-583 ADJUVANT TREATMENT OF ADULT PATIENTS FOLLOWING COMPLETE GROSS RESECTION OF KIT (CD117)
POSITIVE GASTOINTESTINAL STROMAL TUMORS (GIST)
I-584 TREATMENT AND PREVENTION OF GLUCOCORTICOID-INDUCED OSTEOPOROSIS IN PATIENTS EXPECTED TO
BE ON GLUCOCORTICOIDS FOR AT LEAST 12 MONTHS
I-585 TREATMENT OF SHORT STATURE IN PEDIATRIC PATIENTS SMALL FOR GESTATIONAL AGE WHO DO NOT
MANIFEST CATCH UP GROWTH BY AGE 2 TO 4 YEARS
I-586 COMMUNITY ACQUIRED BACTERIAL PNEUMONIA
I-587 ADDITIONAL PATHOGENS TO COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS INDICATION
I-588 ADDITIONAL PATHOGENS TO COMPLICATED INTRA-ABDOMINAL INFECTIONS INDICATION
I-589 TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD) IN COMBINATION WITH OLANZAPINE
I-590 ACUTE TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER (IN COMBINATION
WITH OLANZAPINE)
I-591 TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD) IN COMBINATION WITH FLUOXETINE
I-592 ACUTE TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER (IN COMBINATION
WITH FLUOXETINE)
I-593 TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD)
I-594 INDICATION EXPANDED TO INCLUDE PATIENTS WHO HAVE EXPERIENCED A FIRST CLINICAL EPISODE
AND HAVE MRI FEATURES CONSISTENT WITH MULTIPLE SCLEROSIS
I-595 PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
I-596 USE AS ADJUNCTIVE THERAPY WITH LITHIUM OR VALPROATE FOR THE MAINTENANCE TREATMENT OF
BIPOLAR I DISORDER
I-597 MONOTHERAPY FOR THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER
I-598 TREATMENT OF PULMONARY ARTERIAL HYPERTENSION INDICATION EXPANDED TO INCLUDE DELAY IN
CLINICAL WORSENING
I-599 PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY
DISEASE (CKD) STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS
I-600 FOR USE AS INITIAL THERAPY IN PATIENTS WHO ARE LIKELY TO NEED MULTIPLE DRUGS TO ACHIEVE
THEIR BLOOD PRESSURE GOALS
I-601 MAINTENANCE TREATMENT IN PATIENTS WITH ADVANCED OR METASTATIC NONSQUAMOUS NON-SMALL CELL
LUNG CANCER WHOSE DISEASE HAS NOT PROGRESSED AFTER FOUR CYCLES OF PLATINUM-BASED FIRST
LINE CHEMOTHERAPY
I-602 TREATMENT OF MEN AND WOMEN WITH OSTEOPOROSIS ASSOCIATED WITH SUSTAINED SYSTEMIC
GLUCOCORTICOID THERAPY AT HIGH RISK FOR FRACTURE
I-603 GOUT FLARES
I-604 PREVENTION OF CMV DISEASE IN KIDNEY AND HEART TRANSPLANT PATIENTS 4 MONTHS TO 16 YEARS
AT HIGH RISK
I-605 ADJUNCT TO MOOD STABILIZERS AND/OR ANTIDEPRESSANTS FOR SCHIZOAFFECTIVE DISORDER
I-606 TREATMENT OF SCHIZOAFFECTIVE DISORDER AS MONOTHERAPY
I-607 INDICATION EXPANDED TO INCLUDE TREATMENT OF PULMONARY ARTENAL HYPERTENSION (WHO GROUP I)
IN PATIENTS WITH CLASS II SYMPTOMS
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 19 of 45

EXCLUSIVITY INDICATION
I-608 REDUCE LDL-C LEVELS IN BOYS AND POSTMENARCHAL GIRLS, 10 TO 17 YEARS OF AGE, WITH
HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA AS MONOTHERAPY OR IN COMBINATION WITH A
STATIN AFTER FAILING AN ADEQUATE TRIAL OF DIET THERAPY
I-610 TREATMENT OF HEAVY MENSTRUAL BLEEDING FOR WOMEN WHO CHOOSE TO USE INTRAUTERINE
CONTRACEPTION AS THEIR METHOD OF CONTRACEPTION
I-611 TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN ADOLESCENT BOYS AND
POSTMENARCHAL GIRLS, AGES 10 TO 17 YEARS, WITH A RECOMMENDATION DOSING RANGE OF 5 TO 20
MG ONCE DAILY
I-612 MICARDIS 80 MG FOR REDUCTION OF THE RISK OF MYOCARDIAL INFARCTION, STROKE, OR DEATH FROM
CARDIOVASCULAR CAUSES IN PATIENTS 55 YEARS OF AGE OR OLDER AT HIGH RISK OF DEVELOPING
MAJOR CARDIOVASCULAR EVENTS WHO ARE UNABLE TO TAKE ACE INHIBITORS
I-613 MILD TO MODERATE ATOPIC DERMATITIS IN PATIENTS 3 MONTHS OF AGE TO LESS THAN 18 YEARS OF
AGE
I-614 SHORT TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD IN PEDIATRIC PATIENTS
AGES FIVE YEARS AND OLDER
I-615 MAINTENANCE TREATMENT OF BIPOLAR DISORDER AS AN ADJUNCT TO LITHIUM OR VALPROATE
I-616 TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER IN PEDIATRIC PATIENTS AGES 6-
17 YEARS OF AGE
I-617 MAINTENANCE OF GENERALIZED ANXIETY DISORDER (GAD)
I-618 ADJUNCTIVE THERAPY IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
I-619 INTRAVENOUS CONTRAST ENHANCED COMPUTER TOMOGRAPHY OF THE HEAD AND BODY

EXCLUSIVITY MISCELLANEOUS
M-1 INFORMATION REGARDING SUPERIORITY CLAIM OVER RANITIDINE FOR DAY AND NIGHT HEARTBURN
ADDED TO CLINICAL STUDIES SECTION
M-2 APPROVAL FOR ADDTION TO CLINICAL PHARMACOLOGY SECTION OF THE LABEL REGARDING (1)
IMPROVEMENT IN BONE MINERAL DENSITY IN CHILDHOOD-ONSET ADULT GROWTH HORMONE DEFICIENT
PATIENTS AND (2) INCREASES IN SERUM ALKALINE PHOSPHATASE
M-3 ADDITION OF EFFICACY AND SAFETY INFORMATION IN WHICH FOSAMAX WAS USED CONCOMITANTLY WITH
ESTROGEN ALONE OR WITH ESTROGEN PLUS PROGESTIN
M-4 CHANGES TO PEDIATRIC USE SECTION TO PROVIDE INFORMATION REGARDING SAFETY AND EFFICACY IN
PEDIATRIC PATIENTS AS YOUNG AS 2 YEARS OLD
M-5 INFORMATION REGARDING EFFECTS IN PATIENTS WITH ASTHMA ON CONCOMITANT INHALED
CORTICOSTEROIDS IN CLINICAL PHARMACOLOGY SECTION
M-6 ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES DONE WITH GLUCOPHAGE/GLYBURIDE
COMBINATION ADDED TO CLINICAL PHARMACOLOGY AND DOSING AND ADMINISTRATION
M-7 CLINICAL PHARMACOLOGY IN PEDIATRIC PATIENTS; DOSAGE AND ADMINISTRATION INFORMATION
M-8 ADDITIONAL INFORMATION FOR THE USE OF SONATA CAPSULES FOR UP TO 5 WEEKS (35 NIGHTS) OF
TREATMENT IN A CONTROLLED TRIAL SETTING
M-9 ADDITION TO THE CLINICAL STUDIES SECTION OF THE LABELING OF TEXT AND TWO TABLES
CONTAINING INFORMATION FOR THE PRESCRIBING PHYSICIAN ON BLOOD PRESSURE, HEART RATE, AND
HEART RATE VARIABILITY
M-10 INFORMATION REGARDING MAINTENANCE OF AN ANTIDEPRESSANT EFFECT UP TO 1 YEAR OF DOSING
M-11 USE FOR LONG-TERM TREATMENT OF POSTTRAUMATIC STRESS DISORDER
M-12 NEW LANGUAGE FOR PEDIATRIC USE
M-13 INFORMATION FROM PEDIATRIC STUDIES ADDED TO CLINICAL PHARMACOLOGY, PRECAUTIONS, AND
DOSAGE AND ADMINISTRATION
M-14 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
M-15 LONGER TERM EFFICACY INFORMATION FOR RISPERIDONE IN THE TREATMENT OF SCHIZOPHRENIA
M-16 CHANGE IN WORDING OF THE PEDIATRIC SECTION OF THE PACKAGE INSERT
M-17 INFORMATION REGARDING USE OF ULTANE IN PEDIATRIC PATIENTS WITH CONGENITAL HEART DISEASE
M-18 INFORMATION DENOTING THE EFFICACY OF REMERON IN MAINTAINING A RESPONSE IN PATIENTS WITH
MAJOR DEPRESSIVE DISORDER (MDD)
M-19 INFORMATION REGARDING USE IN PEDIATRIC PATIENTS TWO YEARS OF AGE AND OLDER
M-20 LABELING REVISIONS RELATED TO MCCUNE ALBRIGHT SYNDROME
M-21 COMPARISON DATA ON THE ANTIHYPERTENSIVE EFFECTS OF ATACAND AND COZAAR
M-22 CHANGE IN TIME TO ONSET OF ACTION
M-23 INFORMATION REGARDING ELIMINATION ADDED TO CLINICAL PHARMACOLOGY, STUDY RESULTS IN
PATIENTS WITH HEPATIC AND RENAL IMPAIRMENT
M-24 INFORMATION ON RESULTS OF A LONG TERM LONGITUDINAL GROWTH STUDY AND PEDIATRIC SAFETY
INFORMATION
M-25 ADDITIONAL SAFETY & PK INFORMATION IN CHILDREN 6 MONTHS TO LESS THAN 6 YEARS OF AGE
ADDED TO PKG INSERT
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 20 of 45

EXCLUSIVITY MISCELLANEOUS
M-26 INCORPORATION OF INFORMATION CONTAINED IN THE PEG-INTRON PACKAGE INSERT INTO THE REBETOL
PACKAGE INSERT AND MEDGUIDE-PEG-INTRON WAS APPROVED FOR USE IN COMBINATION WITH REBETOL
FOR TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION ON 8/7/01
M-27 INFORMATION DESCRIBING ASPIRIN ENDOSCOPY STUDY AND THE MAXIMUM RECOMMENDED DOSE FOR
PATIENTS WITH MODERATE HEPATIC INSUFFICIENCY
M-28 INFORMATION FROM A STUDY IN PEDIATRIC PATIENTS IN ASSOCIATION WITH A NEUROLOGICAL
CONDITION
M-29 LABELING CHANGES TO PROVIDE INFORMATION IN THE MANAGEMENT OF OBESITY IN ADOLESCENTS AGED
12 TO 16 YEARS
M-30 CHANGES TO CLINICAL PHARMACOLOGY, PRECAUTIONS, AND DOSAGE AND ADMINISTRATION SECTIONS OF
LABELING CONCERNING USE OF LOTENSIN IN PEDIATRIC PATIENTS WITH HYPERTENSION
M-31 INFORMATION FOR USE IN PEDIATRIC PATIENTS WITH CHRONIC KIDNEY DISEASE STAGE 5 (END-STAGE
RENAL DISEASE)
M-32 ADDITIONAL LANGUAGE TO CLINICAL PHARMACOLOGY AND CLINICAL STUDIES
M-33 INFORMATION FOR USE OF ADVAIR DISKUS 100/50 IN CHILDREN 4 TO 11 YEARS OF AGE WITH ASTHMA
M-34 EXPANDED INFORMATION TO PEDIATRIC USE SUBSECTION OF LABELING IN RESPONSE TO PEDIATRIC
WRITTEN REQUEST
M-35 ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES DONE WITH ACTOS IN COMBINATION WITH
METFORMIN, A SULFONYLUREA, OR INSULIN ADDED TO CLINICAL PHARMACOLOGY
M-36 ADDITION OF INFORMATION TO CLINICAL STUDIES REGARDING PREVENTION OF CARDIOVASCULAR
DISEASE
M-37 INFORMATION ADDED TO THE LABELING THAT DETAILS INFORMATION RELATIVE TO STUDIES DONE IN
PEDIATRIC POPULATIONS IN THE CLINICAL PHARMACOLOGY AND PEDIATRIC USE SUBSECTIONS
M-38 SAFETY AND IOP-LOWERING EFFECTS OF TRUSOPT HAVE BEEN DEMONSTRATED IN PEDIATRIC PATIENTS
IN A 3 MONTH, MULTI-CENTER DOUBLE MASKED ACTIVE-TREATMENT-CONTROLLED TRIAL
M-39 FOR LABELING CHANGES BASED ON RESULTS OF THE SPD422-202 CLINICAL STUDY REPORT (CSR)
SUBMITTED IN RESPONSE TO THE WRITTEN REQUEST
M-40 ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES PERFORMED IN PEDIATRIC PATIENTS WITH
LEUKEMIA ADDED TO PRECAUTIONS
M-41 REVISION TO THE PEDIATRIC USE PRECAUTIONS OF THE PRESCRIBING INFORMATION TO INCORPORATE
THE RESULTS FROM THE CAPPS-169 STUDY ENTITLED "THE EFFECT OF ORTHO TRICYCLEN ON BONE
MINERAL DENISTY IN PEDIATRIC SUBJECTS WITH ANOREXIA NERVOSA"
M-42 ADDITION OF A GERIATRIC USE SUBSECTION TO THE PRECAUTIONS SECTION OF THE PACKAGE INSERT
AND GERIATRIC DOSING INFORMATION
M-43 INCLUSION OF RESULTS OF STUDY-"PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY AND PILOT
EFFICACY OF ILOPROST AS ADD ON THERAPY WITH BOSENTAN IN SUBJECTS WITH PULMONARY ARTERIAL
HYPERTENSION
M-44 CLINICAL INFORMATION ADDED TO THE PEDIATRIC USE SUBSECTION OF PRECAUTIONS REGARDING THE
USE OF NOVOLOG IN ADOLESCENTS WITH TYPE I DIABETES AGE 6 TO 18
M-45 INFORMATION ADDED TO CLINICAL TRIALS SECTION OF LABELING - EFFECTS OF HUMATROPE
TREATMENT IN ADULTS WITH GROWTH HORMONE DEFICIENCY
M-46 PROVISION OF RESULTS OF STUDY AND PROPOSED REVISIONS TO PACKAGE INSERT SEE SECTION ON
CARDIAC ELECTROPHYSIOLOGY
M-47 PROVIDES FOR USE OF ANTARA WITHOUT REGARD TO MEALS
M-48 CHANGES TO THE LABELING DESCRIBING THE RESULTS OF A STUDY OF THE USE OF NOVOLOG MIX
70/30 WITH ORAL ANTIDIABETIC AGENTS IN PATIENTS WITH TYPE 2 DIABETES
M-49 CLINICAL DATA ADDED TO THE CLINICAL PHARMACOLOGY SECTION REGARDING EFFECT OF SINGULAIR
ON GROWTH RATES IN PREPUBERTAL CHILDREN
M-50 NEW INFO TO THE CLINICAL STUDIES, ADULT GROWTH HORMONE DEFICIENCY (GHD) SUBSECTION OF
THE NUTROPIN AQ PACKAGE INSERT DESCRIBING THE EFFECTS OF SOMATROPIN ON VISCERAL ADIPOSE
TISSUE IN THE ADULT GROWTH HORMONE DEFICIENT PATIENT POPULATION
M-51 INFORMATION ADDED TO LABELING REGARDING OSTEOGENESIS IMPERFECTA STUDY
M-52 INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY/CLINICAL STUDIES SECTION REGARDING THE
USE OF RISEDRONATE ADMINISTERED ONCE A WEEK IN THE PREVENTION OF OSTEOPOROSIS IN
POSTMENOPAUSAL WOMEN
M-53 FOR LABELING CHANGES TO THE QUALITY OF LIFE (QOL) STATEMENT IN THE APPROVED PACKAGE
INSERT
M-54 INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL
M-55 INFORMATION ON RESULTS OF A STUDY OF THE USE OF SANDOSTATIN LAR DEPOT IN PEDIATRIC
PATIENTS WITH HYPOTHALAMIC OBESITY.
M-56 INFORMATION ADDED TO CLINICAL TRIAL SECTION WITH INFORMATION ON "GEMINI" TRIAL
M-57 CLINICAL DATA ADDED TO THE CLINICAL PHARMACOLOGY SECTION REGARDING THE PHARMACOKINETICS
OF EZETIMIBE IN ASIAN SUBJECTS
M-58 CHANGES TO THE CLINICAL STUDIES, PRIMARY HYPERCHOLESTEROLEMIA, VYTORIN SUBSECTION OF THE
PACKAGE INSERT TO ADD EFFICACY DATA FOR THE EZETIMIBE/SIMVASTATIN COMBINATION PRODUCT
AND FOR AN ATORVASTATIN PRODUCT ON LDL-C AND OTHER LIPID PRMTRS
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 21 of 45

EXCLUSIVITY MISCELLANEOUS
M-59 RESULTS OF THE T20-310 STUDY WHICH EVALUATED THE PHARMACOKINETICS, SAFETY, AND ANTIVIRAL
ACTIVITY OF FUZEON IN TREATMENT EXPERIENCED PEDIATRIC SUBJECTS AND ADOLSCENTS WAS ADDED
TO THE PEDIATRIC SUBSECTION OF PRECAUTIONS
M-60 CHANGES TO CLINICAL STUDIES, PRIMARY HYPERCHOLESTEROLEMIA, TO ADD EFFICACY DATA FOR THE
EZETIMIBE/SIMVASTATIN COMBINATION PRODUCT AND FOR A ROSUVASTATIN PRODUCT ON LDL-C AND
OTHER LIPID PARAMETERS IN PATIENTS WTH HYPERCHOLESTEROLEMIA
M-61 REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
M-62 CLINICAL INFORMATION FROM ONE CLINICAL STUDY INVESTIGATING THE USE OF AVANDAMET PLUS
INSULIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE NOT ACHIEVED ADEQUATE
GLYCEMIC CONTROL WITH PREVIOUS ANTI-DIABETIC THERAPIES
M-63 DETAILED INFORMATION ON AN INCONCLUSIVE PEDIATRIC STUDY
M-64 CHANGES TO CLINICAL PHARMACOLOGY DETAILING STUDY RESULTS
M-65 ADDITION OF INFORMATION TO LABEL TO INCLUDE INFORMATION REGARDING USE IN PATIENTS WITH
HIV-ASSOCIATED ADIPOSE REDISTRIBUTION SYNDROME (HARS)
M-66 USE IN SPECIFIC POPULATIONS - PATIENTS WITH CONCOMITANT ILLNESS SUBSECTION OF THE
LABELING REGARDING USE OF STRATTERA IN PATIENTS WITH ADHD WHO HAVE COMORBID TIC DISORDER
M-67 INDICATION EXPANDED TO INCLUDE PATIENTS ON PERITONEAL DIALYSIS
M-68 DESCRIPTION OF RESULTS OF STUDY OF INITIAL THERAPY IN COMBINATION WITH METFORMIN WHEN
DIET AND EXERCISE DO NOT PROVIDE GLYCEMIC CONTROL
M-69 RESULTS OF STUDY OF COMBINATION THERAPY AND NON-INFERIORITY STUDY
M-70 PROVISION OF INFORMATION OF THE RESULTS OF A PHASE 2 RANDOMIZED TRIAL OF SPRYCEL 70MG
TWICE DAILY OR IMATINIB 800MG DAILY
M-71 REVISIONS TO PROVIDE FOR RESULTS OF MAINTENANCE DATA IN ADULT PATIENTS WITH MAJOR
DEPRESSIVE DISORDER
M-72 INFORMATION ABOUT USE OF INSPRA (EPLERENONE) FOR HYPERTENSION IN PEDIATRIC PATIENTS
M-73 NEW INFORMATION ADDED REGARDING THE TUMOR SHRINKING POTENTIAL OF SANDOSTATIN LAR DEPOT
INJECTION ON GH - SECRETING PITUITARY ADENOMAS
M-74 REVISIONS TO CLINICAL STUDIES - CHILDREN AND ADOLSCENTS BASED ON CLINICAL TRIAL DATA TO
SUPPORT A DURATION OF ACTION CLAIM UP TO 12 HOURS
M-75 PROVISION FOR USE OF ARGAGATROBAN IN CERTAIN PEDIATRIC PATIENTS WITH HEPARIN-INDUCED
THROMBOCYTOPENIA (HIT) OR HEPARIN-INDUCED THROMBOCYTOPENIA WITH THROMBOSIS (HITTS)
M-76 REMOVAL OF SCREEN REQUIREMENT IN PTS WITH G6PD DEFICIENCY PRIOR TO INITIATING ACZONE
TREATMENT; REMOVAL OF BLOOD COUNT & RETICULOCYTE MONITORING DURING TREATMENT IN G6PD
DEFICIENT PTS AND IN PATIENTS WITH HISTORY OF ANEMIA
M-77 USE IN COMBINATION WITH THE NEW AKTILITE CL128 LAMP FOR THE TREATMENT OF THIN AND
MODERATELY THICK, NON-HYPERKERATOTIC, NON-PIGMENTED ACTINIC KERATOSES OF THE FACE AND
SCALP IN IMMUNOCOMPETENT PATIENTS
M-78 CLINICAL TRIAL INFO ON USE OF STRATTERA IN PATIENTS WITH ATTENTION DEFICIT HYPERACTIVITY
DISORDER (ADHD) AND COMORBID ANXIETY DISORDER WITHOUT CAUSING WORSENING OF ANXIETY
M-79 LABELING REVISIONS RELATED TO SMOKING AND ERLOTIMB EXPOSURE
M-80 ADDITIONAL TIME POINT OF 30 MINUTES (0.5 HOUR) IN CHILDREN AGED 6-12 YEARS WITH A
DIAGNOSIS OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD)
M-81 ADDITIONAL INFO FOR PEDIATRIC USE FOR CASODEX (STUDIED IN COMBINATION WITH ARIMIDEX) IN
THE PEDIATRIC POPULATION, SPECIFICALLY BOYS WITH FAMILIAL MALE-LIMITED PRECOCIOUS
PUBERTY (TESTOXICOSIS)
M-82 LABELING REVISIONS RELATED TO CLINICAL STUDIES
M-83 ADDITIONAL INFORMATION ADDED TO LABELING REGARDING ESTABLISHMENT OF EFFICACY IN
ADDITIONAL CLINICAL TRIALS AND ONE MAINTENANCE TRIAL
M-84 STUDY INFORMATION ADDED TO LABEL REGARDING BONE MINERAL DENSITY
M-85 INFORMATION ADDED TO LABELING REGARDING USE OF PREVACID IN PATIENTS LESS THAN 1 YEAR
WITH SYMPTOMATIC GERD
M-86 LABELING CHANGES SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST FOR INFANTS AGES
BIRTH TO 11 MONTH INCLUSIVE REFLECTING LACK OF EFFICACY FOR GERD INDICATION FOR THIS
PATIENT POPULATION
M-87 INCLUSION OF RESULTS FROM TWO DRUG INTERACTION STUDIES WITH LIPITOR AND CRESTOR IN
CLINICAL PHARMACOLOGY SECTION
M-88 ADDITION OF INFORMATION REGARDING ABUSE POTENTIAL OF CONCERTA VERSUS IMMEDIATE-RELEASE
METHYLPHENIDATE
M-89 PROVIDES FOR REVISIONS TO MULTIPLE SECTIONS OF THE PACKAGE INSERT TO REFLECT RESULTS OF
CLINICAL TRIALS 205.235 (UPLIFT) AND 205.266 (VA STUDY) IN SUPPORT OF EXACERBATION CLAIM

PATENT USE
U-1 PREVENTION OF PREGNANCY
U-2 TREATMENT OR PROPHYLAXIS OF ANGINA PECTORIS AND ARRHYTHMIA
U-3 TREATMENT OF HYPERTENSION
U-4 PROVIDING PREVENTION AND TREATMENT OF EMESIS AND NAUSEA IN MAMMALS
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 22 of 45

PATENT USE
U-5 METHOD OF PRODUCING BRONCHODILATION
U-6 METHOD OF PRODUCING SYMPATHOMIMETIC EFFECTS
U-7 INCREASING CARDIAC CONTRACTILITY
U-8 ACUTE MYOCARDIAL INFARCTION
U-9 CONTROL OF EMESIS ASSOCIATED WITH ANY CANCER CHEMOTHERAPY AGENT
U-10 DIAGNOSTIC METHOD FOR DISTINGUISHING BETWEEN HYPOTHALMIC MALFUNCTIONS OR LESIONS IN
HUMANS
U-11 TREATMENT OR PROPHYLAXIS OF CARDIAC DISORDERS
U-12 METHOD OF TREATING [A] HUMAN SUFFERING FROM DEPRESSION
U-13 A METHOD FOR TREATING ANXIETY IN A HUMAN SUBJECT IN NEED OF SUCH TREATMENT
U-14 ADJUNCTIVE THERAPY FOR THE PREVENTION AND TREATMENT OF HYPERAMMONEMIA IN THE CHRONIC
MANAGEMENT OF PATIENTS WITH UREA CYCLE ENZYMOPATHIES
U-15 METHOD OF LOWERING INTRAOCULAR PRESSURE
U-16 USE IN LUNG SCANNING PROCEDURES
U-17 TREATMENT OF VENTRICULAR AND SUPRAVENTRICULAR ARRHYTHMIAS
U-18 METHOD FOR INHIBITING GASTRIC SECRETION IN MAMMALS
U-19 TREATMENT OF INFLAMMATION
U-20 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF
TREATMENT
U-21 TREATMENT OF HUMANS SUFFERING UNDESIRED UROTOXIC SIDE EFFECTS CAUSED BY CYTOSTATICALLY
ACTIVE ALKYLATING AGENTS
U-22 METHOD OF COMBATTING PATHOLOGICALLY REDUCED CEREBRAL FUNCTIONS AND PERFORMANCE
WEAKNESSES, CEREBRAL INSUFFICIENCY AND DISORDERS IN CEREBRAL CIRCULATION AND METABOLISM
IN WARM-BLOODED ANIMALS
U-23 METHOD FOR TREATING PROSTATIC CARCINOMA COMPRISING ADMINISTERING FLUTAMIDE
U-24 METHOD FOR TREATING PROSTATE ADENOCARCINOMA COMPRISING ADMINISTERING AN ANTIANDROGEN
INCLUDING FLUTAMIDE AND AN LHRH AGONIST
U-25 REDUCING CHOLESTEROL IN CHOLELITHIASIS PATIENTS
U-26 REDUCING CHOLESTEROL GALLSTONES AND/OR FRAGMENTS THEREOF
U-27 DISSOLVING CHOLESTEROL GALLSTONES AND/OR FRAGMENTS THEREOF
U-28 CEREBRAL, CORONARY, PERIPHERAL, VISCERAL AND RENAL ARTERIOGRAPHY, AORTOGRAPHY AND LEFT
VENTRICULOGRAPHY
U-29 CT IMAGING OF THE HEAD AND BODY, AND INTRAVENOUS EXCRETORY UROGRAPHY
U-30 CEREBRAL ANGIOGRAPHY, AND VENOGRAPHY
U-31 INTRA-ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY
U-32 PALLIATIVE TREATMENT OF PATIENTS WITH OVARIAN CARCINOMA RECURRENT AFTER PRIOR
CHEMOTHERAPY, INCLUDING PATIENTS WHO HAVE BEEN PREVIOUSLY TREATED WITH CISPLATIN
U-33 TREATING VIRAL INFECTIONS IN A MAMMAL
U-34 TREATING VIRAL INFECTIONS IN A WARM-BLOODED ANIMAL
U-35 TREATING CYTOMEGALOVIRUS IN A HUMAN WITH AN INJECTABLE COMPOSITION
U-36 METHODS OF TREATING BACTERIAL ILLNESSES
U-37 METHOD OF TREATING GASTROINTESTINAL DISEASE
U-38 TREATMENT OF PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA
U-39 ANGINA PECTORIS
U-40 METHOD OF TREATMENT OF BURNS
U-41 METHOD OF TREATING CARDIAC ARRHYTHMIAS
U-42 ADJUVANT TREATMENT IN COMBINATION WITH FLUOROURACIL AFTER SURGICAL RESECTION IN PATIENTS
WITH DUKES' STAGE C COLON CANCER
U-43 MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
U-44 RELIEF OF NAUSEA AND VOMITING
U-45 TREATMENT OF INFLAMMATION AND ANALGESIA
U-46 TREATMENT OF PANIC DISORDER
U-47 STIMULATION OF THE RELEASE OF GROWTH HORMONE
U-48 ANALGESIA
U-49 SYMPTOMATIC CANCER-RELATED HYPERCALCEMIA
U-50 USE IN TREATING INFLAMMATORY DERMATOSES
U-51 BLOOD POOL IMAGING, INCLUDING CARDIAC FIRST PASS AND GATED EQUILIBRIUM IMAGING AND FOR
DETECTION OF SITES OF GASTROINTESTINAL BLEEDING
U-52 TREATMENT OF ADULT AND PEDIATRIC PATIENTS(OVER SIX MONTHS OF AGE) WITH ADVANCED HIV
INFECTION
U-53 HYPERCALCEMIA OF MALIGNANCY
U-54 REVERSAL AGENT OR ANTAGONIST OF NONDEPOLARIZING NEUROMUSCULAR BLOCKING AGENTS
U-55 TREATMENT OF PAIN
U-56 AID TO SMOKING CESSATION
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 23 of 45

PATENT USE
U-57 OPHTHALMIC USE OF NORFLOXACIN
U-58 METHOD OF TREATING INFLAMMATORY INTESTINAL DISEASES
U-59 METHOD OF TREATING HYPERCHOLESTEROLEMIA
U-60 NASAL ADMINISTRATION OF BUTORPHANOL
U-61 CEREBRAL AND PERIPHERAL ARTERIOGRAPHY AND CT IMAGING OF THE HEAD
U-62 CORONARY ARTERIOGRAPHY, LEFT VENTRICULOGRAPHY, CT IMAGING OF THE BODY, INTRAVENOUS
EXCRETORY UROGRAPHY, INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY AND VENOGRAPHY
U-63 ISOPRENALINE ANTAGONISM ON THE HEART RATE OR BLOOD PRESSURE
U-64 TREATMENT OF VIRAL INFECTIONS
U-65 METHOD OF TREATMENT OF A PATIENT INFECTED WITH HIV
U-66 TRIPHASIC REGIMEN
U-67 METHOD OF INDUCING ANESTHESIA IN A WARM BLOODED ANIMAL
U-68 TREATMENT OF ACTINIC KERATOSIS
U-69 TREATMENT OF PNEUMOCYSTIS CARINII INFECTIONS
U-70 TREATMENT OF TRANSIENT INSOMNIA
U-71 METHOD OF TREATMENT OF HEART FAILURE
U-72 TREATMENT OF MIGRAINE
U-73 METHOD OF TREATING DISEASES OR INFECTIONS CAUSED BY MYCETES
U-74 METHOD OF PROVIDING HYPNOTIC EFFECT
U-75 RELIEF OF OCULAR ITCHING DUE TO SEASONAL ALLERGIC CONJUNCTIVITIS
U-76 USE TO IMAGE A SUBJECT WITH A MAGNETIC RESONANCE IMAGING SYSTEM
U-77 TREATMENT OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
U-78 ULCERATIVE COLITIS
U-79 SYMPTOMATIC TREATMENT OF PATIENTS WITH NOCTURNAL HEARTBURNDUE TO GERD
U-80 METHOD OF TREATING OCULAR BACTERIAL INFECTIONS
U-81 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS
U-82 TREATMENT FOR DEMENTIA IN PATIENTS WITH ALZHEIMER'S DISEASE
U-83 TREATMENT OF SEIZURES
U-84 A METHOD OF BLOCKING THE UPTAKE OF MONOAMINES BY BRAIN NEURONS IN ANIMALS
U-85 NASAL TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
U-86 METHOD OF TREATING CERTAIN FORMS OF EPILEPSY
U-87 METHOD FOR NONINVASIVE ADMINISTRATION OF SEDATIVES, ANALGESICS, AND ANESTHETICS
U-88 TREATMENT OF MODERATE PLAQUE PSORIASIS
U-89 TREATMENT OR PROPHYLAXIS OF EMESIS
U-90 TREATMENT OF PYSCHOTIC DISORDERS
U-91 ALTERNATIVE THERAPY TO TRIMETHOPRIM-SULFAMETHOXAZOLE FOR TREATMENT OF MODERATE-TO-SEVERE
PNEUMOCYSTIS CARINII PNEUMONIA IN IMMUNOCOMPROMISED AND AIDS PATIENTS
U-92 TREATMENT OF DIABETIC NEPHROPATHY IN PATIENTS WITH TYPE I INSULIN DEPENDENT DIABETES
MELLITUS AND RETINOPATY
U-93 USE AS AN ANTIHISTAMINE/DECONGESTANT
U-94 TREATMENT-ADULTS W/ ADVANCED HIV,INTOLERANT OF APPROVED THERAPIES,INTOLERANT OF APPROVED
THERAPIES W/PROVEN BENEFIT OR HAVE EXPERIENCED CLINICAL/IMMUNOLOGICAL DETERIORATION
WHILE RECEIVING..OR FOR WHOM SUCH THERAPIES-CONTRAINDICATED
U-95 SHORT TERM MANAGEMENT OF MODERATE PRURITIS IN ADULTS WITH ATOPIC DERMATITIS AND LICHEN
SIMPLEX CHRONICUS
U-96 METHOD OF TREATING VARICELLA ZOSTER (SHINGLES) INFECTIONS
U-97 A METHOD OF TREATING A PATIENT IN NEED OF MEMORY ENHANCEMENT
U-98 A METHOD OF INDUCING REGRESSION OF LEUKEMIA CELL GROWTH IN A MAMMAL
U-99 METHOD OF PROVIDING POTASSIUM TO A SUBJECT IN NEED OF POTASSIUM
U-100 METHOD OF TREATING OCULAR INFLAMMATION
U-101 ADJUNCT TO CONVENTIONAL CT OR MRI IMAGING IN THE LOCALIZATION OF STROKE IN PATIENTS IN
WHOM STROKE HAS ALREADY BEEN DIAGNOSED
U-102 METHOD OF HORMONALLY TREATING MENOPAUSAL OR POST-MENOPAUSAL DISORDERS IN WOMEN
U-103 TREATMENT OF OCULAR HYPERTENSION
U-104 TREATMENT OF AQUEOUS HUMOR FORMATION AND INTRAOCULAR PRESSURE
U-105 EMESIS
U-106 TREATMENT OF EPILEPSY
U-107 TREATMENT OF HYPERTENSION AND ANGINA PECTORIS
U-108 SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER, GASTROESOPHAGEAL REFLUX DISEASE (GERD),
SEVERE EROSIVE ESOPHAGITIS, POORLY RESPONSIVE SYMPTOMATIC GERD AND PATHOLOGIAL
HYPERSECRETORY CONDITIONS AND MAINTENANCE HEALING OF EROSIVE ESOPHAGITIS
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 24 of 45

PATENT USE
U-109 ADJUNCT DIET IN THE TX OF ELEVATED TOTAL CHOLESTEROL AND LDL-C LEVELS IN PTS W/PRIMARY
HYPERCHOLESTEROLEMIA WHOSE RESPONSE TO DIETARY RESTRICTION OF SAT FAT AND CHOLESTEROL
AND OTHER NONPHARMACOLOGICAL MEASURES HAS NOT BEEN ADEQUATE
U-110 USE AS A RETRIEVABLE PERSSARY
U-111 DIABETES
U-112 CONTRACEPTION
U-113 METHOD OF CONDUCTING RADIOLOGICAL EXAMINATION OF A PATIENT BY ADMINISTERING TO SAID
PATIENT A RADIOPAQUE AMOUNT OF IOPROMIDE
U-114 USE FOR INHIBITING BONE RESORPTION
U-115 USE OF VASODILATORS TO EFFECT AND ENHANCE AN ERECTION (AND THUS TREAT ERECTILE
DYSFUNCTION), BY INJECTION INTO THE PENIS
U-116 METHOD OF MYOCARDIAL IMAGING
U-117 TREATMENT OF OCULAR ALLERGIC RESPONSE IN HUMAN EYES
U-118 METHOD OF LOWERING BLOOD SUGAR LEVEL
U-119 TREATMENT OF NASAL HYPERSECRETION
U-120 CONTROLLING OR PREVENTING POST-OPERATIVE INTRAOCULAR PRESSURE RISES ASSOCIATED WITH
OPHTHALMIC LASER SURGICAL PROCEDURES
U-121 METHOD OF TREATING CONDITIONS MEDIATED THROUGH HISTAMINE H2-RECEPTORS
U-122 A THERAPEUTIC METHOD FOR CONTROLLING THROMBOSIS
U-123 METHOD FOR CONTROLLING THROMBOSIS AND DECREASING BLOOD HYPERCOAGULATION AND HEMORRHAGING
RISKS
U-124 TREATMENT OF ACNE
U-125 TREATMENT NEUROGENERATIVE DISEASES
U-126 TREATMENT OF GASTRITIS
U-127 METHOD OF PRODUCING NEUROMUSCULAR BLOCKADE
U-128 METHOD FOR TREATMENT OF TUMORS
U-129 METHOD TO DESTROY OR IMPAIR TARGET CELLS
U-130 MANAGEMENT OF PATIENTS WITH MASTOCYTOSIS
U-131 PHOTODAMAGED SKIN
U-132 INHIBITING HIV PROTEASE
U-133 MANAGEMENT OF OBESITY INCLUDING WEIGHT LOSS AND MAINTENANCE IN PATIENTS ON A REDUCED-
CALORIE DIET
U-134 TREATMENT OF ACNE VULGARIS
U-135 ANTITUMOR AGENT
U-136 PROCESS FOR WASTE NITROGEN REMOVAL
U-137 METHOD OF TREATING BACTERIAL VAGINOSIS
U-138 TREATMENT OF ALLERGIC RHINITIS
U-139 TREATMENT OF ALLERGIC REACTIONS
U-140 USE OF NORVIR TO INHIBIT HIV PROTEASE OR TO INHIBIT AN HIV INFECTION
U-141 TREATMENT OF ULCERATIVE COLITIS
U-142 METHOD OF TREATING ALLERGIC REACTIONS IN A MAMMAL BY USING THIS ACTIVE METABOLITE
U-143 BIODEGRADABLE SUPERPARAMAGNETIC METAL OXIDES AS CONTRAST AGENTS FOR MR IMAGING
U-144 BIOLOGICALLY DEGRADABLE SUPERPARAMAGNETIC MATERIALS FOR USE IN CLINICAL APPLICATIONS
U-145 BIOLOGICALLY DEGRADABLE SUPERPARAMAGNETIC PARTICLES FOR USE AS NUCLEAR MAGNETIC
RESONANCE IMAGING AGENTS
U-146 METHOD OF TREATING SUSCEPTIBLE NEOPLASMS IN MAMMALS
U-147 DETECTION OF GASTROINTESTINAL DISORDERS AND THE SUBSEQUENT BREATH COLLECTION AND
MEASUREMENT OF 13CO2
U-148 DEVICE FOR COLLECTING A BREATH SAMPLE
U-149 METHOD OF TREATING AN ANIMAL, INCLUDING A HUMAN SUFFERING FROM OR SUSCEPTIBLE TO
PSYCHOSIS, ACUTE MANIA OR MILD ANXIETY STATES
U-150 METHOD OF USE FOR CONTROLLING HYPERGLYCEMIA BY ADMINISTRATION OF THIS SUSTAINED RELEASE
DOSAGE FORM OF GLIPIZIDE
U-151 RELIEF OF SYMPTOMS OF THE COMMON COLD
U-152 METHOD OF TREATING ANXIETY RELATED DISORDERS INCLUDING OBSESSIVE COMPULSIVE DISORDER
U-153 TREATMENT OF INITIAL EPISODE GENITAL HERPES
U-154 METHOD OF TREATING ANIMALS SUFFERING FROM AN APPETITE DISORDER
U-155 TREATMENT OF ERECTILE DYSFUNCTION
U-156 METHOD OF PROVIDING ANESTHESIA
U-157 TREATMENT OF A HUMAN SUFFERING FROM VITAMIN B12 DEFICIENCY
U-158 ANGINA
U-159 TREATMENT OF INTERSTITIAL CYSTITIS
U-160 TREATMENT OF BACTERIAL INFECTIOUS DISEASE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 25 of 45

PATENT USE
U-161 METHOD OF INHIBITING CHOLESTEROL BIOSYNTHESIS IN A PATIENT
U-162 METHOD OF USE TO INHIBIT CHOLESTEROL SYNTHESIS IN A HUMAN SUFFERING FROM
HYPERCHOLESTEROLEMIA
U-163 METHOD OF USING TROGLITAZONE TO TREAT IMPAIRED GLUCOSE TOLERANCE TO PREVENT OR DELAY THE
ONSET OF NONINSULIN-DEPENDENT DIABETES MELLITUS
U-164 METHOD OF USING TROGLITAZONE TO PREVENT OR DELAY THE ONSET OF NONINSULIN-DEPENDENT
DIABETES MELLITUS IN A DEFINED POPULATION OF PATIENTS
U-165 TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA
U-166 TREATMENT OF H.PYLORI-ASSOCIATED DUODENAL ULCER
U-167 METHOD FOR TREATING HIV-1 INFECTION
U-168 METHOD OF INHIBITING LIPOXYGENASE ACTIVITY IN A MAMMAL WHICH IS THE MODE OF ACTION IN
THE TREATMENT OF ASTHMA
U-169 METHODS OF USING THE COMPOUND/DRUG PRODUCT AS A CONTRAST AGENT IN MAGNETIC RESONANCE
IMAGING
U-170 METHOD OF OBTAINING AN MR IMAGE USING THE COMPOSITION/DRUG PRODUCT AS A CONTRAST AGENT
U-171 METHODS OF USING THE COMPOUND/DRUG PRODUCT AS AN ORAL CONTRAST AGENT IN MAGNETIC
RESONANCE IMAGING OF THE GASTROINTESTINAL TRACT
U-172 TREATMENT OF GENITAL WARTS
U-173 ADMINISTRATION TO A HOST SUFFERING FROM GESTATIONAL DIABETES
U-174 USE AS AN ANTIHISTAMINE AGENT
U-175 METHOD OF TREATING MALIGNANT TUMORS
U-176 METHOD OF TREATING A PATIENT SUFFERING FROM LISTED CONDITIONS, INCLUDING SPECIFIC
PSYCHOSES
U-177 FUNGICIDE
U-178 FACILITATED ADHERENCE OF AGENTS TO SKIN
U-179 ENHANCED CUTANEOUS PENETRATION OF A DERMALLY-APPLIED PHARMACOLOGICALLY ACTIVE AGENT
U-180 TREATMENT OF ADULT AND PEDIATRIC PATIENTS (OVER 6 MONTHS OF AGE) WITH ADVANCED HIV
INFECTION
U-181 PRODUCING ALPHA ADRENERGIC ANTAGONISTIC ACTION IN A HOST
U-182 USE OF SALMETEROL IN PATIENTS WITH REVERSIBLE AIRWAY OBSTRUCTION
U-183 TREATMENT OF CONDITIONS CAUSED BY DISTURBANCE OF NEURONAL 5HT FUNCTION
U-184 TREATING ALLERGIC EYE DISEASES IN HUMANS
U-185 METHOD OF TREATING HYPERTENSION
U-186 METHOD FOR TREATING GI DISORDERS CAUSED BY H.RYLORI WHICH COMPRISES ADMINISTRATION OF
RANITIDINE BISMUTH CITRATE AND CLARITHROMYCIN FOR A GREATER THAN ADDITIVE EFFECT
U-187 THERAPEUTIC TREATMENT OF CALCIFIC TUMORS
U-188 TREATMENT OF H.PYLORI ASSOCIATED DUODENAL ULCER
U-189 ENHANCEMENT OF THE BIOAVAILABILITY OF THE DRUG SUBSTANCE
U-190 USE OF RITONAVIR IN COMBINATION WITH ANY REVERSE TRANSCRIPTASE INHIBITOR
U-191 METHOD OF TREATMENT FOR CONTROLLING AND LOWERING INTRAOCULAR PRESSURE IN A HUMAN
U-192 USE IN TREATING ALLERGIC REACTIONS
U-193 PSORIASIS
U-194 TREATING ANGINA PECTORIS AND HIGH BLOOD PRESSURE
U-195 METHOD FOR THE DIAGNOSIS OF GASTROINTESTINAL DISORDERS BY UREA ISOTOAC OR NITROGEN
LABELED CARBON
U-196 TREATMENT OF METASTATIC BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH ESTROGEN RECEPTOR
POSITIVE TUMORS
U-197 USE IN COMBINATION WITH CERTAIN LHRH ANALOGUES FOR THE TREATMENT OF ADVANCED PROSTATE
CANCER
U-198 TREATMENT METASTATIC CARCINOMA OF OVARY AFTER 1ST LINE FAILURE OR SUBSQUENT
CHEMOTHERAPY, TREATMENT OF BREAST CANCER AFTER FAILURE OF COMBINATION CHEMOTHERAPY FOR
METASTATIC DISEASE AND 2ND LINE TREATMENT OF AIDS RELATED KAPOSI'S SARCOMA
U-199 METHOD OF TREATING INFECTIOUS UPPER GI TRACT DISORDERS CAUSED BY CAMPYLOBACTER PYLORIDIS
INFECTION COMPRISING ADMINISTRATION OF A BISMUTH AGENT AND AN ANTIMICROBIAL AGENT
U-200 METHOD OF TREATING GI DISORDERS COMPRISING ADMINISTRATION OF A BISMUTH-CONTAINING AGENT
AND H2 RECEPTOR BLOCKING ANTI-SECRETORY AGENT
U-201 METHOD OF TREATING GI DISORDERS COMPRISING ADMINISTRATION OF CAMPYLOBACTER-INHIBITING
ANTIMICROBIAL AGENT AND H2 RECEPTOR BLOCKING ANTI-SECRETORY AGENT
U-202 METHOD OF TREATING PEPTIC ULCER DISEASE CAUSED BY CAMPYLOBACTER PYLORIDIS COMPRISING
ORAL ADMINISTRATION OF 50 TO 5,000MG BISMUTH DAILY FOR 3-56 DAYS
U-203 TREATMENT OF ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH DISEASE PROGRESSION
FOLLOWING ANTIESTROGEN THERAPY
U-204 USE OF TAXOL IN COMBINATION WITH G-CSF FOR TREATMENT OF PATIENTS WITH AIDS-RELATED
KAPOSI'S SARCOMA
U-205 METHOD FOR TREATING HEARTBURN
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 26 of 45

PATENT USE
U-206 METHOD OF USING FSH ALONE, WITHOUT THE PRESENCE OF EXOGENEOUS LH, IN IN VITRO
FERTILIZATION
U-207 USE AS NASAL SPRAY
U-208 VAGINAL ADMINISTRATION USING SPECIFIED FORMULATION
U-209 VAGINAL ADMINISTRATION OF PROGESTERONE USING SPECIFIED FORMULATION
U-210 METHOD OF TREATING CONGESTIVE HEART FAILURE
U-211 USE IN PATIENTS WITH REVERSIBLE AIRWAY OBSTRUCTION
U-212 METHOD OF TREATMENT OF PARKINSON'S DISEASE
U-213 METHOD OF INHIBITING CHOLESTEROL BIOSYNTHESIS AND TREATING HYPERCHOLESTEROLEMIA AND
METHOD FOR TREATING HYPERLIPIDEMIA
U-214 USE AS A BLOOD GLUCOSE-LOWERING AGENT
U-215 TREATMENT OF EPILEPSY TWICE DAILY. TREATING A PATIENT BY ADMINISTERING CARBAMAZEPINE IN
A DOSAGE FORM CAPABLE OF MAINTAINING BLOOD CONCENTRATION FROM 4-12MCG/ML OVER 12 HOURS
U-216 TREATMENT OF ADENOCARCINOMA, INCLUDING STAGE B2-C BY ADMINISTERING AN AGONIST OF LH-RH
AND FLUTAMIDE
U-217 METHOD OF PRODUCING ANESTHESIA
U-218 METHOD FOR LIMITING THE POTENTIAL FOR MICROBIAL GROWTH IN THE DRUG PRODUCT
U-219 TREATMENT OF PARKINSON'S DISEASE
U-220 METHOD OF DIAGNOSIS
U-221 SELECTIVE VASODILATION BY CONTINUOUS ADENOSINE INFUSION
U-222 METHOD OF TREATING PAGET'S DISEASE USING ACTONEL
U-223 TREATMENT OF BACTERIAL CONJUNCTIVITIS CAUSED BY SUSCEPTIBLE STRAINS OF MICROORGANISMS
U-224 CONTROLLING INTRAOCULAR PRESSURE
U-225 MEHTOD FOR DELIVERY
U-226 METHOD OF ENHANCING THE DISSOLUTION PROFILE OF A PHARMACEUTICAL FROM A SOLID DOSAGE FORM
CONTAINING THE PHARMACEUTICAL AND SIMETHICONE
U-227 NASAL ADMINISTRATION
U-228 ASTHMA
U-229 CARDIAC INSUFFICIENCY (CONGESTIVE HEART FAILURE)
U-230 PREVENTION OF ACUTE CARDIAC ISCHEMIC EVENTS
U-231 USE IN PARKINSON'S DISEASE
U-232 METHOD OF TREATING MIGRAINE
U-233 DECREASING MORTALITY CAUSED BY CONGESTIVE HEART FAILURE
U-234 METHOD OF USING RIBAVIRIN TO TREAT VIRAL INFECTIONS IN MAMMALS
U-235 METHOD OF MODULATING TH1 AND TH2 RESPONSE IN ACTIVATED T CELLS OF A HUMAN COMPRISING
ADMINISTERING RIBAVIRIN TO THE T CELLS IN A DOSAGE WHICH PROMOTES THE TH1 RESPONSE AND
SUPPRESSES THE TH2 RESPONSE
U-236 TREATING MALE PATTERN BALDNESS WITH 0.05 TO 3.0MG/DAY
U-237 METHOD OF PERFORMING NMR IMAGING WITH A PATIENT COMPRISING ADMINISTERING TO THE PATIENT
AN EFFECTIVE AMOUNT OF CONTRAST AGENT DISCLOSED IN THE CLAIMS
U-238 IMAGING A BODY TISSUE AND SUBJECTING TO NMR TOMOGRAPHY, ADMINISTERING AN AMOUNT OF
PHARMACEUTICAL AGENT FOR AFFECTING THE RELAXATION TIMES OF ATOMS IN BODY TISSUES
UNDERGOING NMR DIAGNOSIS, WHEREBY THE IMAGE CONTRAST IN ENHANCED....
U-239 TREATING OR CONTROLLING OCULAR INFLAMATION WHICH COMPRISES TOPICALLY ADMINISTERING TO
AFFECTED EYE A COMPOSITION COMPRISING AN NSAID, A POLYMERIC QUATERNARY AMMONIUM COMPOUND
AND BORIC ACID
U-240 TREATMENT OF ACUTE MIGRAINE ATTACKS
U-241 FOR SHORT-TERM TREATMENT ACTIVE DUODENAL ULCER, MAINTENANCE THERAPY FOR DUODENAL ULCER
PATIENTS AT REDUCED DOSAGE AFTER HEALING OF ACTIVE ULCER, SHORT-TERM TREATMENT ACTIVE
BENIGN GASTRIC ULCER & GERD, PATHOLOGICAL HYPERSECRETORY CONDITIONS
U-242 USE OF FOLLITROPIN ALPHA ALONE IN IN-VITRO FERTILIZATION
U-243 TOPICAL ADMINISTRATION
U-244 PLATELET AGGREGATION INHIBITORS
U-245 TREATMENT OF SEBORRHEA DERMATITIS IN HUMANS
U-246 PHOSPHATE BINDING
U-247 TREATMENT OF RHEUMATOID ARTHRITIS
U-248 TREATMENT OF HIV
U-249 METHOD OF TREATING ALLERGIC OR NON-ALLERGIC RHINITIS IN PATIENTS BY ADMINISTERING
AEROSOLIZED PARTICLES OF MOMETASONE FUROATE
U-250 TREATMENT OF HEPATITIS B INFECTION
U-251 USE OF TROGLITAZONE IN COMBINATION WITH SULFONYLUREAS IN THE TREATMENT OF TYPE II
DIABETES
U-252 METHOD OF TREATING A HUMAN SUBJECT HAVING GAUCHER'S DISEASE
U-253 ORAL TRANSMUCOSAL USE
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 27 of 45

PATENT USE
U-254 USE OF AGGRASTAT IN COMBINATION WITH HEPARIN
U-255 IMPROVED WAKEFULNESS IN PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH
NARCOLEPSY
U-256 TREATMENT OF HIV INFECTION IN COMBINATION WITH ONE OR MORE ADDITIONAL HIV ANTIVIRAL
AGENTS
U-257 TREATMENT OF HIV INFECTION
U-258 TREATMENT OF NEURODEGENERATIVE DISEASES
U-259 TREATMENT OF ANDROGENIC ALOPECIA BY ORAL ADMINISTRATION DRUG SUBSTANCE
U-260 REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA AND OCULAR
HYPERTENSION WHO ARE INTOLERANT OF OTHER IOP LOWERING MEDICATIONS OR INSUFFICIENTLY
RESPONSIVE TO ANOTHER IOP LOWERING MEDICATION
U-261 TREATING BENIGN PROSTATIC HYPERPLASIA WITH A GENUS OF COMPOUNDS, INCLUDING FINASTERIDE
U-262 TREATING BENIGN PROSTATIC HYPERTROPHY WITH FINASTERIDE
U-263 METHOD OF TREATING A MALIGNANT CONDITION THROUGH INTRAVASCULAR ADMINISTRATION OF
BUSULFAN. METHOD FOR TREATING LEUKEMIA OR LYMPHOMA IN A PATIENT UNDERGOING A BONE MARROW
TRANSPLANT THROUGH INTRAVENOUS ADMINISTRATION OF BUSULFAN
U-264 METHOD OF TREATING A MALIGNANT DISEASE THROUGH PARENTERAL ADMINISTRATION OF BUSULFAN.
METHOD FOR TREATING A PATIENT UNDERGOING A BONE MARROW TRANSPLANT THROUGH INTRAVASCULAR
ADMINISTRATION OF BUSULFAN
U-265 USE AS LAXATIVE
U-266 RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS; RELIEF OF THE SIGNS AND SYMPTOMS OF
RHEUMATOID ARTHRITIS IN ADULTS; MANAGEMENT OF ACUTE PAIN IN ADULTS; TREATMENT OF PRIMARY
DYSMENNORRHEA; ACUTE TREATMENT OF MIGRAINE ATTACKS IN ADULTS
U-267 PREVENTING HEARTBURN EPISODES FOLLOWING INGESTION OF HEARTBURN-INDUCING FOOD/BEVERAGE,
COMPRISING ADMIN TO PT, 30 MIN PRIOR TO CONSUMPTION BY THE PT THE FOOD/BEVERAGE, A
COMPOSITION COMPRISING 10MG FAMOTIDINE
U-268 ACROMEGALY
U-269 EXCESS GH-SECRETION OR GASTRO-INTESTINAL DISORDERS
U-270 METHOD OF IMPROVING THE TIME FOR ADMINISTRATION OR THE TIME BETWEEN CHANGES OF GIVING
SETS FOR THE DRUG PRODUCT
U-271 METHOD OF TREATING TUMORS
U-272 METHOD OF TREATING CARCINOMA
U-273 CUTANEOUS T-CELL LYMPHOMA
U-274 ZANAMIVIR FOR INHALATION
U-275 METHOD OF USE OF THE DRUG SUBSTANCE
U-276 METHOD OF USE OF LEVOBUPIVACAINE
U-277 NEUROLOGICAL AND OTHER DISORDERS (TREATMENT OF EPILEPSY, BID ORAL DOSING)
U-278 METHOD OF USE OF THE INDICATION OF THE DRUG PRODUCT
U-279 METHOD OF USE OF THE APPROVED PRODUCT
U-280 TREATING PRECIPITATED ACUTE URINARY RETENTION WITH FINASTERIDE
U-281 ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS
U-282 METHOD OF TREATING BACTERIAL INFECTIONS
U-283 METHOD FOR TREATING MENOPAUSAL SYMPTOMS IN A POSTMENOPAUSAL FEMALE
U-284 MENOPAUSAL AND POSTMENOPAUSAL DISORDERS (INCLUDING VASOMOTOR SYMPTOMS ASSOCIATED WITH
MENOPAUSE, AND VULVAR AND VAGINAL ATROPHY) AND OSTEOPOROSIS
U-285 DEPRESSION AND SOCIAL ANXIETY DISORDER/SOCIAL PHOBIA
U-286 DEPRESSION
U-287 TREATMENT OR PREVENTION OF OSTEOPOROSIS
U-288 THERAPY OF INFLUENZA
U-289 TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP
U-290 INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS)
U-291 INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH
CYCLOSPORIN
U-292 INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH
AZATHIOPRINE
U-293 INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH A
CORTICOSTEROID
U-294 TREATMENT OF HYPERPIGMENTARY DISORDERS
U-295 TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
U-296 TREATING MIGRAINE PAIN AND ONE OR MORE OF A CLUSTER OF SYMPTOMS CHARACTERISTIC OF A
MIGRAINE ATTACK SYMPTOMS BEING SELECTED FROM PHOTOPHOBIA, PHONOPHOBIA NAUSEA AND
FUNCTIONAL DISABILITY
U-297 PREVENTION OR TREATMENT OF REVERSIBLE VASOCONSTRICTION BY THE INHALATION OF NITRIC OXIDE
WITH AN OXYGEN CONTAINING GAS
U-298 METHOD OF COMBATING BACTERIA IN A PATIENT
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 28 of 45

PATENT USE
U-299 TREATMENT OF ADENOMATOUS POLYPS
U-300 INDICATED FOR THE REDUCTION OF ELEVATED TOTAL AND LDL CHOLESTEROL LEVELS IN PATIENTS
WITH PRIMARY HYPERCHOLESTEROLEMIA
U-301 USE OF TROGLITAZONE IN COMBINATION WITH SULFONYLUREAS AND BIGUANIDES IN THE TREATMENT OF
TYPE II DIABETES
U-302 TO REDUCE THE RISK OF STROKE IN PATIENTS WHO HAVE HAD TRANSIENT ISCHEMIA OF THE BRAIN OR
COMPLETED ISCHEMIC STROKE DUE TO THROMBOSIS
U-303 METHOD OF USE PATENT-PRODUCT APPROVED FOR TREATMENT OF OSTEOPOROSIS, PAGET'S DISEASE,
PREVENTION AND TREATMENT OF GLUCOCORTICOID INDUCED OSTEOPOROSIS
U-304 A METHOD OF TREATMENT OF A CONDITION INVOLVING AN ANTIBODY ANTIGEN REACTION
U-305 METHODS FOR USING THE DRUG PRODUCT
U-306 TREATMENT OF POST-MENOPAUSAL UROGENITAL SYMPTOMS ASSOCIATED WITH ESTROGEN DEFICIENCY
U-307 CLAIMS AN OLANZAPINE POLYMORPH USEFUL FOR TREATING ANY NUMBER OF LISTED CONDITIONS,
INCLUDING SPECIFIC PSYCHOSES,EMPLOYING OLANZAPINE AS PER THE INDICATION OF THIS NDA
U-308 CLAIMS A SOLID ORAL FORMULATION INCLUDING TABLETS AND GRANULES OF OLANZAPINE USEFUL FOR
TREATING ANY NUMBER OF LISTED CONDITIONS, INCLUDING SPECIFIC PSYCHOLES, EMPLOYING
OLANZAPINE AS PER THE INDICATIONS OF THIS NDA
U-309 TREATING SJOEGREN SYNDROME
U-310 TREATMENT OF XEROSTOMIA
U-311 HORMONE REPLACEMENT
U-312 PANIC DISORDER, OBSESSIVE-COMPULSIVE DISORDER, POSTTRAUMATIC STRESS DISORDER
U-313 TREATMENT OF CONGESTIVE HEART FAILURE
U-314 METHOD FOR TREATING HYPERPARATHYROIDISM WHICH COMPRISES SUPPRESSING PARATHYROID ACTIVITY
U-315 METHOD FOR ADMINISTERING DRUG TO GASTROINTESTINAL TRACT
U-316 METHOD OF TREATING A SUBJECT SUFFERING FROM PROSTATE CANCER
U-317 METHOD OF USING TROGLITAZONE TO TREAT PATIENTS HAVING INSULIN RESISTANCE
U-318 TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY,
URGENCY, OR URGE INCONTINENCE
U-319 TREATMENT OF MICROBIAL INFECTIONS
U-320 INHIBITING OR ELIMINATING ACUTE MYELOID LEUKEMIA
U-321 REDUCTION OF ELEVATED IPTH LEVELS IN THE MGT OF SECONDARY HYPERPARATHYROIDISM IN
PATIENTS UNDERGONG CHRONIC RENAL DIALYSIS
U-322 TREATMENT OF ALZHEIMER'S DEMENTIA
U-323 USE AS A BILE ACID SEQUESTRANT
U-324 METHOD OF TREATING AN ANIMAL, INCLUDING A HUMAN, SUFFERING FROM OR SUSCEPTIBLE TO
PSYCHOSIS OR ACUTE MANIA EMPLOYING OLANZAPINE
U-325 METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF LISTED CONDITIONS,
INCLUDING "BIPOLAR DISORDER NOS" EMPLOYING OLANZAPINE
U-326 METHOD OF TREATING SCHIZOPHRENIA AND BIPOLAR DISORDER
U-327 METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF LISTED PSYCHOTIC
CONDITONS EMPLOYING OLANZAPINE
U-328 METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF LISTED CONDITIONS
INCLUDING "A PSYCHOTIC CONDITION" EMPLOYING AN OLANZAPINE POLYMORPH
U-329 USE OF AVANDIA AS MONOTHERAPY, IN COMBINATION WITH METFORMIN, AND IN COMBINATION WITH
SULFONYLUREAS TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
U-330 TREATMENT OF NAUSEA AND VOMITING
U-331 METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID BY DOSING ONCE PER DAY IN THE
EVENING OR AT NIGHT
U-332 TREATMENT OR PREVENTION OF BRONCHOSPASM
U-333 METHOD OF TREATING OCULAR HYPERTENSION
U-334 TREATMENT OF EXCESSIVE FEMALE FACIAL HAIR
U-335 USE OF PRAVASTATIN SODIUM FOR SECONDARY PREVENTION OF CORONARY EVENTS IN MEN AND WOMEN
WHO HAVE HAD A MYOCARDIAL INFARCTION AND HAVE NORMAL CHOLESTEROL LEVELS
U-336 DIAGNOSTIC RADIOIMAGING
U-337 USE OF CARDIOLITE/MIRALUMA KIT FOR THE PREPARATION OF TC99M SESTAMIBI
U-338 METHODS FOR TREATING DISTURBANCES OF MOOD, DISTURBANCES OF APPETITE, DEPRESSED MOOD, OR
CARBOHYDRATE CRAVING ALL ASSOCIATED WITH PREMENSTRUAL SYNDROME
U-339 PREVENTION OF CARDIO-TOXICITY CAUSED BY THE ADMINISTRATION OF DOXORUBICIN
U-340 THE LONG TERM TREATMENT OF GROWTH FAILURE DUE TO LACK OF ADEQUATE ENDOGENOUS GROWTH
HORMONE SECRETION IN CHILDREN
U-341 METHOD FOR ENHANCING THE TREATMENT OF ... LATE LUTEAL PHASE DYSPHORIC DISORDER
U-342 METHOD FOR TREATMENT OF LATE LUTEAL PHASE DYSPHORIC DISORDER
U-343 REDUCTION OF INTESTINAL GAS, CRAMPING AND ANORECTAL IRRITATION
U-344 METHOD FOR INHIBITING HIV INFECTION BY ADMINISTERING RITONAVIR IN COMBINATION WITH
ANOTHER HIV PROTEASE INHIBITOR
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 29 of 45

PATENT USE
U-345 RITONAVIR AND ANOTHER HIV PROTEASE INHIBITOR FOR CONCOMITANT ADMINISTRATION FOR THE
TREATMENT OF AN HIV INFECTION
U-346 METHOD FOR INHIBITING CYTOCHROME P450 MONOOXYGENASE WITH RITONAVIR AND A METHOD FOR
IMPROVING THE PHARMCOKINETICS OF A DRUG THAT IS MTABOLIZED BY CYTOCHROME P450
MONOOXYGENASE BY ADMIN THE DRUG AND RITONAVIR
U-347 METHOD OF USE IN COMBINATION WITH REVERSE TRANSCRIPTASE INHIBITORS
U-348 METHOD OF USE FOR INHIBITING HIV INFECTION
U-349 METHOD OF USE WHICH IS SUBJECT OF THE APPLICATION
U-350 PREPARATION OF A PHARMACEUTICAL COMPOSITION FOR CONCOMITANT ADMIN WITH A REVERSE
TRANSCRIPTASE INHIBITOR
U-351 INHIBITING PROTEASE WITH LOPINAVIR AND INHIBITING AN HIV INFECTION WITH LOPINAVIIR
U-352 INHIBITING HIV INFECTION BY ADMINISTERING RITONAVIR IN COMBINATION WITH A REVERSE
TRANSCRIPTASE INHIBITOR
U-353 PREVENTION AND TREATMENT OF OSTEOPOROSIS
U-354 METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID WITHOUT CAUSING TREATMENT-LIMITING
ELEVATIONS IN URIC ACID OR GLUCOSE LEVELS OR CAUSING LIVER DAMAGE, BY DOSING ONCE PER
DAY IN THE EVENING OR AT NIGHT
U-355 METHOD OF ASSISTING PERSON TO QUIT SMOKING...TRANSDERMALLY ADMIN NICOTINE VIA..PATCH
ADHERED TO SKIN AT DOSING RATE APPROX SAME AS ABSORBED FROM SMOKING
U-356 DELIVERING A MEDICINAL AEROSOL FORMULATION USING CFC-FREE PROPELLANT 134A.
U-357 USE OF THE DRUG PRODUCT IN PHOTODYNAMIC THERAPEUTIC PROTOCOLS FOR THE TREATMENT OF AGE-
RELATED MACULAR DEGENERATION AND RELATED CONDITIONS INVOLVING UNWANTED NEOVASCULATURE IN
THE EYE
U-358 DEPRESSION, OBSESSIVE COMPULSIVE DISORDER, PANIC DISORDER AND SOCIAL ANXIETY DISORDER
U-359 METHOD OF USE OF VISICOL
U-360 METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF PATHOLOGICAL
PSYCHOLOGICAL CONDITIONS INCLUDING MENTAL DISORDERS EMPLOYING OLANZAPINE AS PER THE
INDICATION WHICH IS THE SUBJECT MATTER OF THIS SNDA-011
U-361 MANAGEMENT OF ANXIETY DISORDERS AND THE SHORT-TERM RELIEF OF THE SYMPTOMS OF ANXIETY
U-362 USE OF APPROVED FORMULATIONS TO TREAT ALL APPROVED DISEASE INDICATIONS
U-363 METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF PATHOLOGICAL
PSYCHOLOGICAL CONDITIONS THAT RELATE TO THE USE OF A PSYCHOACTIVE SUBSTANCE EMPLOYING
OLANZAPINE AS PER THE INDICATION THE SUBJECT MATTER OF SUPPLEMENT 011
U-364 TREATING A PATIENT SUFFERING FROM OR SUSCEPTIBLE TO ANY NUMBER OF LISTED CONDITIONS
INCLUDING PSYCHOSIS, EMPLOYING OLANZAPINE AS PER THE INDICATION WHICH IS THE SUBJECT
MATTER OF THIS SNDA-011
U-365 METHOD FOR THE TREATMENT OF CARDIOVASCULAR DISEASE THROUGH THE ADMINISTRATION OF A
CALCIUM BLOCKING VASODILATOR IN OUR EXTENDED, CONTROLLED RELEASE FORMULATION
U-366 METHOD FOR THE TREATMENT OF CARDIOVASCULAR DISEASE THROUGH THE ADMINISTRATION OF A
CALCIUM BLOCKING VASODILATOR IN A DELAYED RELEASE FORMULATION
U-367 TREATMENT OF CARDIOVASCULAR DISORDERS
U-368 HEARTBURN
U-369 METHOD OF CONTROLLING AND LOWERING INTRAOCULAR PRESSURE
U-370 INTRAVAGINAL TREATMENT OF VAGINAL INFECTIONS WITH BUFFERED METRONIDAZOLE COMPOSITIONS
U-371 APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED
"SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY" (S.T.E.P.S.)
U-372 METHOD FOR ADMINISTERING A BENEFICIAL DRUG TO THE GI TRACT OF AN ANIMAL, WHICH METHOD
COMPRISES ADMITTING AN OSMOTIC DEVICE ORALLY INTO THE ANIMAL...
U-373 GENERAL USE CLAIM SUBMITTED FOR 12 NEXIUM PATIENTS STATING "PERTINENT TO THE CAPSULE
FORMULATION FOR NEXIUM AND ITS INDICATIONS FOR THE TREATMENT OF GERD AND ERADICATION OF
H.PYLORI TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
U-374 KIT ADAPTED AND DESIGNED TO PROVIDE BOTH DATA ON THE CURRENT REPRODUCTIVE STATUS OF A
PATIENT AND CONTRACEPTION FOR THOSE WHO ARE NOT PREGNANT, BUT RECENTLY ENGAGED IN
UNPROTECTED SEX
U-375 METHOD OF USING RIBAVIRIN FOR TREATING A DISEASE RESPONSIVE TO RIBAVIRIN, E.G. HEPATITIS
C
U-376 TREATMENT OF INFLUENZA
U-377 METHOD OF TREATING PT WITH CHRONIC HEPATITIS C HAVING HCV GENOTYPE 1 AND VIRAL LOAD
GREATER THAN 2 MILLION COPIES/ML TO ERADICATE DETECTABLE HCV-RNA BY ADMIN COMBINATION OF
RIBAVIRIN AND INTERFERON ALFA-2B FOR A LEAST 24 WEEKS
U-378 METHOD FOR TREATING INCONTINENCE
U-379 METHOD OF TREATING ONYCHROMYCOSIS
U-380 COMBINATIONS OF TAXOL (PACLITAXEL) AND CISPLATIN WHICH ARE SUITABLE FOR THE TREATMENT OF
OVARIAN AND NON-SMALL CELL LUNG CARCINOMAS
U-381 TREATMENT OF HYPERPHOSPHATEMIA
U-382 METHOD OF STABLIZING PROSTAGLANDIN
U-383 METHOD FOR TREATING GLAUCOMA AND OCULAR HYPERTENSION
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 30 of 45

PATENT USE
U-384 TREATMENT OF CMV RETINITIS
U-385 TREATMENT OF PEPTIC ULCERS
U-386 TREATMENT OF PATIENTS SUFFERING FROM A LATE ASTHMATIC REACTION OR LATE PHASE ASTHMA
U-387 TREATMENT OF PATIENTS WITH RESPIRATORY DISORDERS
U-388 SMOKING CESSATION AID APPLIED TO THE SKIN
U-389 SMOKING CESSATION AID APPLIED TO THE SKIN ON WAKING AND REMOVED PRIOR TO SLEEP AFTER
ABOUT 16 HOURS
U-390 METHOD OF USING THE DRUG TO TREAT NEUROIMMUNOLOGIC DISEASES (INCLUDING MULTIPLE
SCLEROSIS)
U-391 USE OF CASODEX IN COMBINATION WITH LHRH AGONISTS FOR THE TREATMENT OF PROSTATE CANCER
U-392 TREATMENT OF PATIENTS FOR INFLAMMATION
U-393 MANAGEMENT OF INCONTINENCE, MGT OF HORMONE REPLACEMENT THERAPY, TREATMENT OF INVOLUNTARY
INCONTINENCE, MGT OVERACTIVE BLADDER AND INCREASING COMPLIANCE IN SUCH PT
U-394 METHOD OF USE OF ALPHAGAN
U-395 METHOD OF USE OF ALPHAGAN P
U-396 METHOD OF TREATING PEOPLE SUFFERING FROM DEPRESSION
U-397 METHOD OF TREATING PEOPLE SUFFERING FROM DEPRESSION WITHOUT AN INCREASE IN NAUSEA
U-398 TREATMENT OF GENERALIZED ANXIETY DISORDER
U-399 IN-THE-EYE USE OF CHLORINE DIOXIDE CONTAINING COMPOSITIONS
U-400 USE OF RIBAVIRIN TO INCREASE TYPE 1 CYTOKINE RESPONSE AND SUPPRESS TYPE 2 CYTOKINE
RESP0NSE TO LYMPHOCYTES, INCLUDING METHODS THAT TAKE ADVANTAGE OF SUCH MODULATION TO
TREAT INFECTIONS AND INFESTATIONS
U-401 USE OF LOPINAVIR IN COMBINATION WITH REVERSE TRANSCRIPTASE INHIBITORS FOR TREATING HIV
INFECTION AND IN COMBO WITH OTHER HIV PROTEASE INHIBITORS
U-402 TREATMENT OF ACTINIC KERATOSES
U-403 ANTI-ALLERGIC FOR VARIOUS ALLERGIC DISEASES
U-404 TREATMENT OF ALLERGIC CONJUNCTIVITIS
U-405 FOR WOMEN WITH SEVERE DIARRHEA-PREDOMINANT IRRITABLE BOWEL SYNDROME (IBS)
U-406 METHOD OF USE OF ATOVAQUONE AND PROGUANIL
U-407 METHOD OF TREATING OTOPATHY
U-408 FOR INDUCING OVULATION IN CONJUNCTION WITH A GONADOTROPIN RELEASING FACTOR ANTAGONIST
AND RECRUITING OOCYTES FOR IN-VITRO FERTILIZATION
U-409 METHOD OF TREATING INFLAMMATION USING DRUG SUBSTANCE
U-410 METHOD OF REDUCING AMOUNT OF RESPECTIVE ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC
PATIENT BY ADMINISTERING A CHEMICAL COMPOUND HAVING A PARTICULAR FORMULA (INCLUDING
PIOGLITAZONE) IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
U-411 METHOD OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC
PATIENT BY ADMINISTERING A CHEMICAL COMPOUND HAVING A PARTICULAR FORMULA (WHICH INCLUDES
PIOGLITAZONE) IN COMBINATION WITH AN INSULIN PREPARATION
U-412 TREATMENT OF TYPE 2 DIABETES
U-413 USE OF THE ACTIVE INGREDIENT FOR INHIBITING THE BIOSYNTHESIS OF CHOLESTEROL AND
TREATMENT OF ATHEROSCLEROSIS
U-414 A METHOD OF TREATING GLYCOMETABOLISM DISORDERS BY ADMINISTERING AN INSULIN SENSITIVITY
ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE
U-415 A METHOD FOR REDUCING THE AMOUNT OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC PATIENT
BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION
WITH A BIGUANIDE AS SAID ACTIVE COMPONENTS
U-416 A METHOD FOR REDUCING SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC
PATIENT BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN
COMBINATION WITH A BIGUANIDE AS SAID ACTIVE COMPONENTS
U-417 COMBINATION USE OF AD-4833 WITH A BIGUANIDE
U-418 A METHOD OF TREATING LIPID METABOLISM DISORDERS BY ADMINISTERING A CHEMICAL COMPOUND
HAVING A PARTICULAR FORMULA (WHICH INCLUDES PIOGLITAZONE) IN COMBINATION WITH AN INSULIN
SECRETION ENHANCER
U-419 A METHOD OF TREATING LIPID METABOLISM DISORDERS BY ADMINISTERING AN INSULIN SENSITIVITY
ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE
U-420 METHOD OF TREATMENT OF TYPE II DIABETES
U-421 USE FOR SEDATION
U-422 METHOD OF TREATING AT LEAST ONE OF ATTENTION DEFICIT DISORDER AND ATTENTION DEFICIT
HYPERACTIVITY DISORDER
U-423 METHOD OF TREATING AT LEAST ONE OF ATTENTION DEFICIT DISORDER, ATTENTION DEFICIT
HYPERACTIVITY DISORDER, OR AIDS RELATED DEMENTIA
U-424 FOR ONCE DAILY, BOLUS ADMINISTRATION TO A PATIENT IN ORDER TO ENGENDER TREATMENT FOR A
NERVOUS DISORDER FOR SUBSTANTIALLY AN ENTIRE DAY ON A CHRONIC BASIS
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PATENT AND EXCLUSIVITY TERMS ADB 31 of 45

PATENT USE
U-425 METHOD OF REDUCING SIDE EFFECTS OF ACTIVE COMPONENTS ADMIN TO A DIABETIC BY ADMIN A
CHEMICAL COMPOUND HAVING FORMULA (INCL PIOGLITAZONE) IN COMBINATION WITH AN INSULIN
SECRETION ENHANCER
U-426 PREVENTION OF PREMATURE LH SURGES IN WOMEN UNDERGOING CONTROLLED OVARIAN STIMULATION
U-427 METHOD OF TREATING ALLERGIC REACTIONS IN MAMMALS
U-428 METHOD OF TREATING ALLERGY IN A MAMMAL USING THIS ACTIVE METABOLITE
U-429 METHOD OF USING DESLORATADINE TO TREAT ALLERGIC RHINITIS
U-430 METHOD OF TREATING A DIABETIC BY ADMINISTERING AN INSULIN SENSITIZER IN COMBINATION WITH
AN INSULIN SECRETION ENHANCER, AND A DRUG PRODUCT C0MPRISING AN INSULIN SENSITIZER AND
AN INSULIN SECRETION ENHANCER
U-431 POSTTRAUMATIC STRESS DISORDER
U-432 REDUCTION OF ATHEROSCLEROTIC EVENTS (MYOCARDIAL INFARCTION, STROKE, AND VASCULAR DEATH)
IN PATIENTS WITH ATHEROSCLEROSIS DOCUMENTED BY RECENT STROKE, RECENT MYOCARDIAL
INFARCTION OR ESTABLISHED PERIPHERAL ARTERIAL DISEASE
U-433 USE OF LEVOCARITINE IN PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY IN PATIENTS WITH
END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS
U-434 CONTROLLED SYMPTOMS OF DIARRHEA, BLOATING PRESSURE AND CRAMPS, COMMONLY REFERRED TO AS
GAS
U-435 A TITRATION DOSING REGIMEN FOR THE TREATMENT OF PAIN USING AN INITIAL DOSE OF ABOUT 25MG
U-436 ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
U-437 METHOD OF USE EQUAL TO PROCESS OF PREPARATION
U-438 TREATMENT/PREVENTION OF NEURODEGENERATIVE DISEASE
U-439 TREATMENT OF OBESITY
U-440 METHOD FOR TRANSDERMAL ADMINISTRATION OF A DRUG THROUGH NON-SCROTAL SKIN USING A
TRANSDERMAL DRUG DELIVERY DEVICE CONTAINING THE DRUG AND HAVING AN ADHESIVE SURFACE
U-441 METHOD OF TREATING MS BY ADMINISTERING COPAXONE
U-442 METHOD FOR DELIVERING A DRUG TO A PATIENT IN NEED OF THE DRUG, WHILE AVOIDING THE
OCCURENCE OF AN ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY SAID DRUG
U-443 MANAGEMENT OF MODERATE TO SEVERE PAIN WHEN A CONTINUOUS, AROUND-THE-CLOCK ANALGESIC IS
NEEDED FOR AN EXTENDED PERIOD OF TIME
U-444 TREATMENT OF MIGRAINE
U-445 USE AS AN ANTIMYCOTIC AGENT
U-446 TOPICAL TREATMENT OF OCULAR HYPERTENSION AND GLAUCOMA
U-447 METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID BY DOSING ONCE PER DAY IN THE
EVENING OR AT NIGHT
U-448 METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID WITHOUT CAUSING TREATMENT-LIMITING
ELEVATIONS IN URIC ACID OR GLUCOSE LEVELS OR CAUSING LIVER DAMAGE, BY DOSING ONCE PER
DAY IN THE EVENING OR AT NIGHT
U-449 USE IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN FOR THE TREATMENT OF METASTATIC
COLORECTAL CANCER WHERE THE DOSE OF LEUCOVORIN IS AT LEAST 200MG PER SQUARE METER
U-450 INTERMEDIATE REL NICOTINIC ACID FORMULATIONS HAVING UNIQUE URINARY METAB PROFILES
RESULTING FROM ABSORPTION PROFILES OF NICOTINIC ACID FROM THE INTERMEDIATE NICOTINIC
ACID FORMULATIONS,SUITABLE FOR TX HYPERLIPIDEMIA FOLLOWING QD DOSING
U-451 TREATMENT OF DEPRESSION AND GENERALIZED ANXIETY DISORDER
U-452 USE OF LANSOPRAZOLE FOR COMBATTING DISEASES CAUSED BY THE GENUS CAMPYLOBACTER
(C.PYLORI=H.PYLORI)
U-453 TREATMENT OF PLATELET ASSOCIATED ISCHEMIC DISORDERS
U-454 METHOD OF TX A PT SUSPECTED OF HAVING HEPATITIS C BY ADMIN, IN COMBINATION, A CONJUGATE
COMPRISING PEG 12000 & INTERFERON ALFA-2B IN AN AMT OF FROM 0.5MCG/KG TO 2MCG/KG, ONCE
WEEKLY, AND RIBAVIRIN
U-455 TREATMENT OF PULMONARY HYPERTENSION WITH UT-15
U-456 METHOD OF DECREASING THE PRODUCTION OF A-BETA USING A COMPOSITION WHICH DECREASES BLOOD
CHOLESTEROL IN PATIENTS AT RISK OF OR EXHIBITING SYMPTOMS OF ALZHEIMER'S DISEASE
U-457 METHOD OF TREATING A VAGINAL FUNGAL INFECTION IN A FEMALE HUMAN
U-458 METHOD OF USE OF IMAGENT
U-459 TREATMENT OF DEPRESSION AND GENERALIZED ANXIETY DISORDER
U-460 METHOD OF TREATING PSYCHIATRIC SYMPTOMS ASSOCIATED WITH PREMENSTRUAL DISORDERS USING
SERTRALINE
U-461 METHOD OF TREATMENT OF LATE LUTEAL PHASE DYSPHORIC DISORDER (PMDD) USING SERTRALINE
U-462 SIGNS AND SYMPTOMS OF OSTEOARTHRITIS AND ADULT RHEUMATOID ARTHRITIS AND TREATMENT OF
PRIMARY DYSMENORRHEA
U-463 VENOGRAPHY
U-464 PERIPHERAL ARTERIOGRAPHY
U-465 CT IMAGING OF THE HEAD
U-466 TREATMENT OF IRRITABLE BOWEL SYNDROME
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PATENT AND EXCLUSIVITY TERMS ADB 32 of 45

PATENT USE
U-467 USE OF EPLERENONE IN COMBINATION WITH AN ANGIOTENSIN CONVERTING ENZYME (ACE) INHIBITOR
FOR TREATING HYPERTENSION
U-468 METHOD OF USING FEXOFENADINE HCL IN TREATING ALLERGIC RHINITIS
U-469 TREATMENT OF GASTROESOPHAGEAL REFLEX DISEASE (GERD) AND ERADICATION OF H.PYLORI TO
REDUCE RISK OF DUODENAL ULCER RECURRENCE
U-470 THERAPY IN CHRONIC HEPATITIS B VIRUS INFECTION
U-471 METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS
U-472 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING METHYLPHENIDATE BI-MODAL
RELEASE PROFILE EXTENDED-RELEASE CAPSULES
U-473 TO REDUCE PLASMA CHOLESTEROL LEVELS IN A MAMMAL
U-474 TO REDUCE PLASMA CHOLESTEROL LEVELS BY ADMIN EZETIMIBE IN COMBO WITH CHOLESTEROL
BIOSYNTHESIS INHIB SELECTED FROM GROUP CONSISTING OF HMG COA REDUCTASE INHIBITORS INCL
SIMVASTATIN
U-475 TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO ARE
REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY
U-476 METHOD OF TREATING ANDROGEN RESPONSIVE/MEDIATED CONDITION IN MAMMAL BY ADMIN A SAFE,
EFFECTIVE AMOUNT OF DUTASTERIDE OR PHARMACEUTICALLY ACCEPTABLE DERIVATIVE
THEREOF..CONDITIONS INCLUDE BENIGN PROSTATIC HYPERTROPHY
U-477 METHOD OF INHIBITING 5 ALPHA TESTOSTERONE REDUCTASE ENZYME WITH DUTASTERIDE OR ITS
DERIVATIVE AND TREATING ANDROGEN RESPONSIVE/MEDIATED DISEASE INCLUDING BENIGN PROSTATIC
HYPERPLASIA
U-478 METHOD OF TREATING HEPATITIS C VIRAL INFECTION BY CONTINUOUS PARENTERAL ADMIN INTERFERON
ALPHA 2-10 MILLION IU WEEKLY, SUBCUTANEOUSLY, INJECTION OF POLYMER-INTERFERON ALPHA
CONJUGATE-POLYMER IS PEG-INTERFERON IS ALPHA 2B
U-479 METHOD OF USING PEG-INTRON/REBETOL COMBINATION THERAPY AND INTRON/REBETOL COMBINATION
THERAPY
U-480 CONTRAST AGENT FOR MRI
U-481 DISUBSTITUTED ACETYLENES BEARING HETEROAROMATIC AND HETEROBICYCLIC GROUPS HAVING
RETINOID-LIKE ACTIVITY
U-482 METHOD OF IN VITRO FERTILIZATION THERAPY INCLUDING MEANS FOR INDUCING OVULATION....
U-483 METHOD FOR THE ADMINISTRATION OF DRUGS USING THAT COMPOUND
U-484 METHOD OF TREATING A SKIN DISEASE WITH A CORTICOSTEROID-CONTAINING PHARMACEUTICAL
COMPOSITION
U-485 METHOD AND COMPOSITION FOR REDUCING NERVE INJURY PAIN ASSOCIATED WITH SHINGLES (HERPES
ZOSTER AND POST-HERPETIC NEURALGIA)
U-486 EXTERNAL PREPARATION FOR APPLICATION TO THE SKIN CONTAINING LIDOCAINE-DRUG RETAINING
LAYER PLACED ON SUPPORT AND COMPRISES ADHESIVE GEL BASE 1-10% BY WEIGHT OF LIDOCAINE
U-487 METHOD AND COMPOSITION FOR REDUCING NERVE INJURY PAIN ASSOCIATED WITH SHINGLES (HERPES
ZOSTER AND POST-HERPETIC NEURALGIA)
U-488 METHOD FOR REDUCING THE PAIN ASSOCIATED WITH HERPES-ZOSTER AND POST-HERPETIC NEURALGIA
U-489 EXPECTORANT
U-490 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR
ABSENCE OF ENDOGENOUS TESTOSTERONE
U-491 METHOD OF DELIVERING A DRUG TO THE LUNG
U-492 METHOD FOR THE TREATMENT OF SKIN, SUFFERING FROM A CONDITION SELECTED FROM A GROUP
CONSISTING OF NONACNE INFLAMMATORY DERMATOSES... COMPRISING APPLYING TO AFFECTED AREA. A
THERAPEUTICALLY EFFECTIVE AMT AZELAIC ACID
U-493 TREATMENT OF TYPE 2 DIABETES MELLITUS
U-494 TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER
U-495 PERITONEAL DIALYSIS SOLUTION
U-496 METHOD FOR TREATING CHRONIC RENAL FAILURE
U-497 RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS AND RHEUMATOID ARTHRITIS
U-498 INTRA-ARTERIAL AND INTRAVENOUS USES OF ULTRAVIST
U-499 METHOD OF USING REBETOL CAPSULES IN COMBINATION WITH A CONJUGATE COMPRISING POLYETHYLENE
GLYCOL(PEG) AND AN ALPHA INTERFERON, INCLUDING, FOR EXAMPLE, PEG-INTRON POWDER FOR
INJECTION
U-500 USE AS AN ANTIHYPERTENSIVE AGENT
U-501 TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) IN ADULTS
U-502 PITYRIASIS VERSICOLOR
U-503 GENERATOR MUST BE USED WITH INFUSION SYSTEM SPECIFICALLY LABELED FOR USE WITH GENERATOR
U-504 TINEA PEDIS, TINEA CRURIS, TINEA CORPORIS
U-505 ULTRASOUND CONTRAST AGENT
U-506 PHARM PRODUCT CONTAINER 1ST CHAMBER IS DISPOSED AQUEOUS DILUENT SOL 2ND CHAMBER PHARM
ACTIVE AGENT COMPRISING ACETYLCHOLINE,BUFFER IN 1ST CHAM IS SUFFICIENT TO BUFFER PH OF
MIXED SOL RESULTING MIXTURE OF AQUEOUS DILUENT SOL & PHARM ACTIVE..
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PATENT AND EXCLUSIVITY TERMS ADB 33 of 45

PATENT USE
U-507 ACROMEGALY IN PATIENTS W/INADEQUATE RESPONSE TO SURGERY AND/OR RADIATION THERAPY AND/OR
MEDICAL THERAPIES, OR FOR WHOM THESE THERAPIES ARE NOT APPROPRIATE
U-508 METHOD OF RELEASING 17-BETA OESTRADIOL PRECURSOR IN A SUBSTANTIALLY ZERO ORDER PATTERN
FOR AT LEAST THREE WEEKS
U-509 TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO ARE
REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY
U-510 TOPICAL TREATMENT OF CUTANEOUS LESIONS IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA (STAGE
IA AND IB) WHO HAVE REFRACTORY OR PERSISTENT DISEASE AFTER OTHER THERAPIES OR WHO HAVE
NOT TOLERATED OTHER THERAPIES
U-511 USE OF QUINOLONE COMPOUNDS AGAINST ANAEROBIC PATHOGENIC BACTERIA
U-512 USE OF QUINOLONE COMPOUNDS AGAINST ATYPICAL UPPER RESPIRATORY PATHOGENIC BACTERIA
U-513 METHODS OF USE OF ANTIMICROBIAL COMPOUNDS AGAINST PATHOGENIC AMYCOPLASMA BACTERIA
U-514 PREVENTION OF OVULATION IN A WOMAN
U-515 TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES
AND HAVE DEMONSTRATED DISEASE PROGRESSION ON THE LAST THERAPY
U-516 METHOD OF TREATING A PSYCHOTIC DISEASE
U-517 STABLE GEL FORMULATION FOR TOPICAL TREATMENT OF SKIN CONDITIONS
U-518 OBSESSIVE COMPULSIVE DISORDER
U-519 POST OPERATIVE NAUSEA AND VOMITING
U-520 PREMENOPAUSAL OSTEOPOROSIS
U-521 METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTRON A (INTERFERON ALPHA-2 B
RECOMBINANT) INJECTION TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
U-522 TREATMENT OF CMV RETINITIS BY INTRAVITREAL ADMIN OF A PHOSPHOROTHIOATE OLIGONUCLEOTIDE
CAPABLE OF HYBRIDIZING WITH CMV MRNA
U-523 METHOD OF TREATING INFECTION BY CRYPTOSPORIDIUM PARVUM IN AN IMMUNOCOMPROMISED MAMMAL
U-524 METHOD OF TREATING DIARRHEA
U-525 METHOD OF TREATING PARASITIC INFECTIONS
U-526 METHOD OF PROVIDING CONTROLLED RELEASE OF A TREATING AGENT USING A CONTROLLED RELEASE
COMPOSITION
U-527 METHOD OF DELIVERING AN ACTIVE INGREDIENT USING A PROGRESSIVE HYDRATION BIOADHESIVE
U-528 PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING
U-529 ONCE DAILY TREATMENT OF ASTHMA WITH NEBULIZED BUDESONIDE
U-530 TREATMENT OF HERPES ZOSTER, TREATMENT OF GENITAL HERPES, TREATMENT OF COLD SORES,
SUPPRESSION OF GENITAL HERPES IN IMMUNOCOPETENT AND HIV-INFECTED INDIVIDUALS, REDUCTION
OF RISK OF HETEROSEXUAL TRANSMISSION OF GENITAL HERPES
U-531 TREATMENT OF PATIENTS WITH ESSENTIAL HYPERTENSION. MAY BE USED ALONE OR GIVEN WITH
OTHER CLASSES OF ANTIHYPERTENSIVES, ESPECIALLY THIAZIDE DERIVATIVES
U-532 TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD IN PATIENTS REQUIRING MORE THAN ONE
BRONCHO DILATOR
U-533 ERECTILE DYSFUNCTION
U-534 HUMALOG IS AN INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT OF PATIENTS WITH
DIABETES MELLITUS FOR THE CONTROL OF HYPERGLYCEMIA
U-535 TREATMENT OF SOCIAL ANXIETY DISORDER
U-536 CONTRAST AGENT FOR MAGNETIC RESONACE IMAGING
U-537 TREATMENT OF CONDITIONS RELATED TO HYPERALDOSTERONISM SUCH AS HYPERTENSION AND CARDIAC
INSUFFICIENCY, WITH EPLERENONE
U-538 FIRST LINE TREATMENT OF SEVERE HYPERTENSION, IN PATIENTS WITH HYPERTENSION SEVERE ENOUGH
THAT THE VALUE OF ACHIEVING PROMPT BLOOD PRESSURE CONTROL EXCEEDS THE RISK OF INITIATING
COMBINATION THERAPY IN THESE PATIENTS
U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
U-540 TREATMENT OF FUNGAL INFECTIONS
U-541 METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1
U-542 METHOD OF TREATING PATIENT WITH TYPE 2 DIABETES BY ONCE DAILY ADMINISTRATION
U-543 TREATMENT OF SCHIZOPHRENIA
U-544 TREATMENT OF OVERACTIVE BLADDER. TREATMENT OF URINARY INCONTINENCE.
U-545 METHOD FOR THE PREVENTION AND/OR TREATMENT OF THROMBOTIC EPISODES, SUCH AS MYOCARDIAL
INFARCTION, IN A HUMAN PATIENT AND METHOD FOR THE PREVENTION OF VENOUS THROMBOSIS IN A
POSTOPERATIVE HUMAN PATIENT
U-546 USE OF REPAGLINIDE IN COMBINATION WITH METFORMIN TO LOWER BLOOD GLUCOSE
U-547 MAINTENANCE MONOTHERAPY FOR BIPOLAR DISORDER
U-548 A METHOD OF REDUCING FLUSH IN AN INDIVIDUAL BEING TREATED FOR A LIPIDEMIC DISORDER AND
EFFECTIVELY TREATING THE LIPIDEMIC DISORDER
U-549 USE IN THE TREATMENT OF MEN WITH ADVANCED SYMPTOMATIC PROSTATE CANCER
U-550 TREATMENT OF BIPOLAR DISORDER AND SCHIZOPHRENIA
U-551 METHOD FOR REDUCING TOXICITY OF ALIMTA TREATED PATIENTS BY ADMINISTERING FOLIC ACID
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 34 of 45

PATENT USE
U-552 TREATMENT OF HYPERTENSION AND HYPERLIPIDEMIA WITH A SINGLE COMPOSITION
U-553 MANAGEMENT OF PAIN AND DISCOMFORT ASSOCIATED WITH PERIDONTAL SCALING AND ROOT PLANNING
PROCEDURES BY APPLICATION OF AN EUTECTIC MIXTURE OF LOCAL ANESTHETICS TO PERIDONTAL
POCKETS
U-554 TREATING HIV INFECTION WITH INDINAVIR SULFATE IN COMBINATION WITH ANTIRETROVIRAL AGENTS
U-555 TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS AND ACUTE UNCOMPLICATED PYELONEPHRITIS
U-556 USE AS ADJUNCT DIAGNOSTIC FOR SERUM THYROGLOBULIN (TG) TESTING
U-557 NASAL TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
U-558 INDICATED FOR THE RELIEF OF BRONCHOSPASM IN PATIENTS 2-12 YEARS OF AGE WITH ASTHMA
(REVERSIBLE OBSTRUCTIVE AIRWAY DISEASE)
U-559 METHOD OF DECREASING OR REDUCING PARATHYROID HORMONE LEVEL; METHOD OF MODULATING
PARATHYROID HORMONE SECRETION;METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF REDUCING
SERUM IONIZED CALCIUM LEVEL
U-560 METHOD OF DECREASING PARATHYROID HORMONE LEVEL;METHOD OF TREATING HYPERPARATHYROIDISM
U-561 COSOPT IS INDICATED FOR THE REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH
OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION WHO ARE INSUFFICIENTLY RESPONSIVE TO BETA
BLOCKERS
U-562 TOPICAL TREATMENT OF CUTANEOUS LESIONS IN PATIENTS WITH AIDS-RELATED KAPOSI'S SARCOMA
U-563 MARINOL IS INDICATED FOR, INTER ALIA, ANOREXIA ASSOCIATED WITH WEIGHT LOSS IN PATIENTS
WITH AIDS
U-564 TREATMENT OF HIV IN CONCOMITANT THERAPY
U-565 TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS, AND CHRONIC URTICARIA
U-566 FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA
U-567 METHOD OF TREATING INFERTILITY
U-568 METHOD OF USING FSH ALONE (WITHOUT EXOGENOUS LH) IN IN VITRO FERTILIZATION
U-569 METHOD OF USING FSH ALONE (WITHOUT EXOGENOUS LH) IN IN VITRO FERTILIZATION AND WHEREIN
THEREAFTER AN OVULATORY INDUCING AMOUNT OF HCG IS ADMINISTERED
U-570 METHOD OF USING FSH ALONE (WITHOUT EXOGENOUS LH) IN IN VITRO FERTILIZATION AND WHEREIN
THE DAILY AMOUNT OF FSH IS ABOUT 5-10 IU/KG
U-571 TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA AND BIPOLAR I MANIA
U-572 INTENSIVE CARE UNIT SEDATION
U-573 TREATMENT OF ACUTE PROMYELOGENOUS LEUKEMIA (APL)
U-574 PROPHYLAXIS AND TREATMENT OF THE NASAL SYMPTOMS OF SEASONAL ALLERGIC RHINITIS AND
TREATMENT OF THE NASAL SYMPTOMS OF PERENNIAL ALLERGIC RHINITIS IN ADULTS AND PEDIATRIC
PATIENTS 12 YEARS OF AGE AND OLDER
U-575 LOTEMAX OPTHALMIC SUSPENSION IS INDICATED FOR THE TREATMENT OF STEROID RESPONSIVE
CONDITIONS OF THE PALPEBRAL BULBAR CONJUNCTIVA, CORNEA AND ANTERIOR SEGMENT OF THE GLOBE.
U-576 ALREX OPTHALMIC SUSPENSION IS INDICATED FOR THE TEMPORARY RELIEF OF THE SIGNS AND
SYMPTOMS OF SEASONAL ALLERGIC CONJUNCTIVITIS.
U-577 TREATMENT OF BENIGN PROSTATIC HYPERPLASIA WITH FINASTERIDE IN COMBINATION WITH DOXAZOSIN
U-578 TREATMENT OF COMMUNITY ACQUIRED PNEUMONIA, ACUTE EXACERBATION OF CHRONIC BRONCHITIS, AND
ACUTE BACTERIAL SINUSITIS CAUSED BY SUSCEPTIBLE STRAINS OF DESIGNATED MICROORGANISMS IN
PATIENTS 18 YEARS AND OLDER.
U-579 TREATMENT OF EPILEPSY AND/OR MIGRAINE.
U-580 TREATMENT OF DISORDERS OF THE SEROTONERGIC SYSTEM SUCH AS DEPRESSION AND ANXIETY-RELATED
DISORDERS
U-581 METHOD OF TREATING A CONDITION CAPABLE OF TREATMENT BY INHALATION, E.G. ASTHMA,
COMPRISING ADMINISTRATION OF A FORMULATION CLAIMED IN US PATENT NO. 6743413
U-582 METHOD FOR THE TREATMENT OF A RESPIRATORY DISORDER, E.G. ASTHMA, COMPRISING
ADMINISTERING AN EFFECTIVE AMOUNT OF AN AEROSOL COMPOSITION TO A PATIENT FROM A METERED
DOSE INHALER SYSTEM AS CLAIMED IN US PATENT NO. 6253762
U-583 METHOD FOR THE TREATMENT OF A RESPIRATORY DISORDER, E.G. ASTHMA, COMPRISING
ADMINISTERING TO A PATIENT BY INHALATION, A METERED AEROSOL DOSE OF A DRUG FORMULATION
FROM THE METERED DOSE INHALER SYSTEM CLAIMED IN US 6546928
U-584 SINGLE-DOSE ADMINISTRATION BY THE EPIDURAL ROUTE, AT THE LUMBAR LEVEL, FOR THE TREATMENT
OF PAIN FOLLOWING MAJOR SURGERY
U-585 TO PROMOTE WEIGHT GAIN AFTER WEIGHT LOSS IN CERTAIN TYPES OF PATIENTS
U-586 AN INTERMEDIATE RELEASE NICOTINIC ACID FORMULATION SUITABLE FOR ORAL ADMINISTRATION ONCE-
A-DAY AS A SINGLE DOSE FOR TREATING HYPERLIPIDEMIA WITHOUT CAUSING DRUG-INDUCED
HEPATOTOXICITY OR ELEVATIONS IN URIC ACID OR GLUCOSE OR BOTH
U-587 USE OF EPLERENONE IN COMBINATION WITH AN ANGIOTENSIN CONVERTING ENZYME (ACE) INHIBITOR
(AND OPTIONALLY A DIURETIC) FOR TREATING CONGESTIVE HEART FAILURE AND HYPERTENSION
U-588 SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER; TREATMENT OF HEARTBURN AND OTHER SYMPTOMS
ASSOCIATED WITH GERD; SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS; MAINTENANCE OF
HEALING OF EROSIVE ESOPHAGITIS
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 35 of 45

PATENT USE
U-589 METHOD FOR TREATMENT OF A RESPIRATORY DISORDER, E.G., BRONCHOSPASM, COMPRISING
ADMINISTERING AN EFFECTIVE AMOUNT OF AN AEROSOL COMPOSITION TO A PATIENT FROM A METERED
DOSE INHALER SYSTEM AS CLAIMED IN U.S. PATENT NO. 6131966
U-590 METHOD FOR TREATMENT OF A RESPIRATORY DISORDER,E.G.,BRONCHOSPASM,COMPRISING
ADMINISTERING TO A PATIENT BY ORAL OR NASAL INHALATION A DRUG FORMULATION BY USING THE
METERED DOSE INHALER SYSTEM AS CLAIMED IN US PATENT NO.6532955
U-591 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING A DOSAGE FORM WHICH PROVIDES
ONCE-DAILY ORAL ADMINISTRATION OF A PHENIDATE DRUG
U-592 TREATMENT OF PRIMARY HYPERCHOLESTEROLEMIA, MIXED HYPERLIPIDEMIA AND/OR HOMOZYGOUS
FAMILIAL HYPERCHOLESTEROLEMIA (HOFH)
U-593 TREATMENT OF PRIMARY HYPERCHOLESTEROLEMIA, MIXED HYPERLIPIDEMIA AND/OR HOMOZYGOUS
FAMILIAL HYPERCHOLESTEROLEMIA (HOFH)
U-594 PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
U-595 35 MG ORALLY ONCE A WEEK FOR PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN; 35 MG
ORALLY ONCE A WEEK FOR TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
U-596 TREATMENT OF HORMONE RECEPTOR POSITIVE METASTATIC BREAST CANCER IN POSTMENOPAUSAL WOMEN
WITH DISEASE PROGRESSION FOLLOWING ANTIESTROGEN THERAPY
U-597 FORTEO IS INDICATED FOR THE TREATMENT OF POST MENOPAUSAL WOMEN WITH OSTEOPOROSIS WHO ARE
AT HIGH RISK FOR FRACTURE
U-598 PROPHYLACTIC TREATMENT OF MIGRAINE
U-599 METHOD FOR TREATING ALLERGIC CONJUNCTIVITIS
U-600 A METHOD OF TREATING A PATIENT IN NEED OF OPHTHALMIC ANTIMICROBIAL THERAPY WITH
LEVOFLOXACIN
U-601 TREATMENT OF BIPOLAR DISORDER
U-602 SIGNS AND SYMPTOMS OF OSTEOARTHRITIS, RHEUMATOID ARTHRITIS IN ADULTS, AND/OR
PAUCIARTICULAR OR POLYARTICULAR COURSE JUVENILE RHEUMATOID ARTHRITIS, ACUTE PAIN IN
ADULTS; PRIMARY DYSMENORRHEA; AND/OR ACUTE MIGRAINE ATTACKS IN ADULTS
U-603 METHOD OF TREATING INFECTIONS COMPRISING ORALLY ADMINISTERING AN EFFECTIVE AMOUNT OF THE
FDA APPROVED ORAL SUSPENSION
U-604 METHOD OF LOWERING BLOOD GLUCOSE BY ONCE DAILY ADMINISTRATION
U-605 TREATMENT OF MAJOR DEPRESSIVE DISORDER(MDD);ALTHOUGH THE MEHCHANISM OF THE
ANTIDEPRESSANT ACTION OF DULOXETINE IN HUMANS IS UNKNOWN, IT IS BELIEVED TO BE RELATED
TO ITS POTENTIATION OF SERATONERGIC AND NORADRENERGIC ACTIVITY IN THE CNS
U-606 USE OF IRINOTECAN IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN FOR THE TREATMENT OF
METASTATIC COLRECTAL CANCER
U-607 CANCIDAS IS INDICATED FOR EMPIRICAL THERAPY FOR PRESUMED FUNGAL INFECTIONS IN FEBRILE,
NEUTROPENIC PATIENTS.
U-608 USE OF QUINOLONE COMPOUNDS AGAINST PNEUMOCOCCAL PATHOGENIC BACTERIA
U-609 USE OF QUINOLONE COMPOUNDS AGAINST QUINOLONE-RESISTANT PNEUMOCOCCAL PATHOGENIC BACTERIA
U-610 ATROVENT HFA (IPRATROPIUM BROMIDE HFA) INHALATION AEROSOL IS INDICATED AS A
BRONCHODILATOR FOR MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH CHRONIC
OBSTRUCTIVE PULMONARY DISEASE, INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA.
U-611 METHOD OF USING DESLORATADINE TO TREAT SEASONAL AND PERENNIAL ALLERGIC RHINITIS,
PRURITIS, AND CHRONIC IDIOPATHIC URTICARIA IN PATIENTS 2 YEARS OF AGE AND OLDER
U-612 TREATMENT OF SEASONAL ALLERGY SYMPTOMS WITH NASAL CONGESTION IN ADULTS AND CHILDREN 12
YEARS OF AGE AND OLDER
U-613 REDUCTION OF SERUM PHOSPHATE
U-614 TREATMENT OF SEXUAL DYSFUNCTION
U-615 ADJUNCTIVE THERAPY TO DIET IN ADULTS TO REDUCE LDL-C, TOTAL-C, TRIGLYCERIDES AND APO B,
AND INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED DYSLIPIDEMIA
(TYPES IIA, IIB) AND TO TREAT HYPERTRIGLYCERIDEMIA (TYPES IV, V)
U-616 MANAGEMENT OF PERSISTENT, MODERATE TO SEVERE PAIN IN PATIENTS REQUIRING CONTINUOUS,
AROUND-THE-CLOCK ANALGESIA WITH A HIGH POTENCY OPIOID FOR AN EXTENDED PERIOD OF TIME
GENERALLY WEEKS TO MONTHS OR LONGER
U-617 TREATMENT OF ACUTE PROMYELOGENOUS LEUKEMIA (APL)
U-618 USE OF ROSUVASTATIN CALCIUM TO REDUCE ELEVATED TOTAL-C, LDL-C, APOB, NONHDL-C OR TG
LEVELS; TO INCREASE HDL-C IN ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED
DYSLIPIDEMIA; AND TO SLOW THE PROGRESSION OF ATHEROSCLEROSIS.
U-619 TREATMENT OF MALIGNANT NEOPLASM
U-620 TREATMENT OF INSOMNIA
U-621 METHOD OF TREATING CANCER
U-622 TREATMENT OF VEGF MEDIATED OCULAR DISEASE.
U-623 SHORT TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
U-624 REDUCTION OF RISK OF UPPER GASTROINTESTINAL BLEEDING IN CRITICALLY ILL PATIENTS
U-625 ALLERGIC RHINITIS OR NASAL POLYPS
U-626 CLOLAR IS INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 TO 21 YEARS OLD WITH
RELAPSED OR REFRACTORY ACUTE LYMPHOBLASTIC LEUKEMIA AFTER AT LEAST TWO PRIOR REGIMENS
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 36 of 45

PATENT USE
U-627 TREATMENT OF PATIENTS USING EXTENDED-RELEASE CARBAMAZEPINE
U-628 USE OF AVANDIA IN COMBINATION WITH A SULFONYLUREA, AND IN COMBINATION WITH METFORMIN AND
A SULFONYLUREA TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
U-629 METHOD OF INDUCING A HYPNOTIC OR SEDATIVE EFFECT IN A HUMAN BY ADMINISTERING ESZOPICLONE
U-630 TREATING URINARY INCONTINENCE BY ADMINISTERING AN EXTENDED-RELEASE FORM OF DARIFENACIN
U-631 TREATING A DISEASE OF ALTERED MOTILITY OR TONE OF SMOOTH MUSCLE BY ADMINISTERING A
MUSCARINIC RECEPTOR ANTAGONIZING AMOUNT OF DARIFENACIN
U-632 METHOD OF TREATMENT OF CANCER BY ADMINISTERING PARTICLES OF PACLITAXEL THAT HAVE A
PROTEIN COATING
U-633 METHOD FOR TREATMENT OF TUMORS BY ADMINISTERING PACLITAXEL AT A DOSE IN THE RANGE OF
ABOUT 30MG/METER SQUARE TO ABOUT 100MG/METER SQUARE IN A PHARMACEUTICALLY ACCEPTABLE
FORMULATION THAT DOES NOT CONTAIN CREMOPHOR
U-634 METHOD FOR DELIVERY OF A BIOLOGIC (INCLUDING ANTINEOPLASTIC AGENTS) BY ADMINISTERING TO
A PATIENT AN EFFECTIVE AMOUNT OF A BIOLOGIC AS A SOLID OR LIQUID WITH A POLYMERIC
BIOCOMPATIBLE MATERIAL
U-635 TREATMENT OF GERD, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND RISK REDUCTION OF
NSAID ASSOCIATED GASTRIC ULCERS
U-636 TREATMENT OR PREVENTION OF BRONCHOSPASM OR ASTHMATIC SYMPTOMS
U-637 TREATMENT OF DIABETES WITH AN AMYLIN AGONIST
U-638 TREATMENT OF DIABETES WITH AN AMYLIN AGONIST, INCLUDING WITH INSULIN
U-639 TREATMENT OF A MAMMAL HAVING A NEED OF OR REDUCED ABILITY TO PRODUCE INSULIN WITH AN
INSULIN AND AN AMYLIN SUCH AS PRAMLINTIDE
U-640 USE OF AN AMYLIN AGONIST TO REDUCE GASTRIC MOTILITY AND TREAT POST PRANDIAL HYPERGYLCEMIA
U-641 USE OF AN AMYLIN AGONIST HAVING SPECIFIED BINDING ACTIVITY TO REDUCE GASTRIC MOTILITY,
INCLUDING USE THROUGH PARENTERAL ADMINISTRATION
U-642 TREATMENT AND PREVENTION OF OSTEOPOROSIS
U-643 THE SHORT TERM TREATMENT (UP TO 10 DAYS) IN PTS HAVING GASTROESOPHAGEAL REFLUX DISEASE
(GERD) AS AN ALTERNATIVE TO ORAL THERAPY IN PTS WHEN THERAPY WITH NEXIUM CAPSULES IS NOT
POSSIBLE OR APPROPRIATE
U-644 TREATMENT OF SEASONAL ALLERGIC RHINITIS
U-645 TREATMENT OF ASTHMA
U-646 METHOD OF TREATING OTITIS
U-647 TREATMENT OF OSTEOPOROSIS IN POST MENOPAUSAL WOMEN AND/OR THE TREATMENT TO INCREASE BONE
MASS IN MEN WITH OSTEOPOROSIS
U-648 THE TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN AND/OR THE TREATMENT TO INCREASE
BONE MASS IN MEN
U-649 A METHOD FOR TREATING A TUMOR DISEASE
U-650 TREATMENT OF ESOPHAGEAL CANDIDIASIS AND PROPHYLAXIS OF CANDIDA INFECTIONS IN HSCT
PATIENTS
U-651 TREATMENT OF ACUTE PROMYELOCYTIC LEUKEMIA (APL)
U-652 TREATMENT OF CARDIAC ARRHYTHMIA
U-653 STIMULATING INSULIN RELEASE BY ADMINISTERING EXENATIDE
U-654 LOWERING PLASMA GLUCAGON IN A SUBJECT IN NEED THEREOF, INCLUDING ONE WITH TYPE 2
DIABETES, BY ADMINISTERING AN EXEDIN OR ANALOG, SUCH AS EXENDIN-4
U-655 TREATMENT OF MILD TO MODERATE ACTIVE CHROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE
ASCENDING COLON AND THE MAINTENANCE OF CLINICAL REMISSION OF MILD TO MODERATE CROHN'S
DISEASE INVOLVING THE ILEUM AND/OR ASCENDING COLON FOR UP TO 3 MONTHS
U-656 REDUCING GASTRIC MOTILITY OR DELAYING GASTRIC EMPTYING BY ADMINISTERING AN EXENDIN, SUCH
AS EXENDIN-4
U-657 PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
U-658 TREATMENT OF ADVANCED HORMONE-DEPENDENT BREAST CANCER
U-659 TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON SMALL-CELL LUNG CANCER (NSCLC) AFTER
FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN
U-660 TREATMENT OF HYPERTENSION AND TREATMENT OF HEART FAILURE
U-661 TREATMENT OF SEIZURE DISORDER
U-662 TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
U-663 THE TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS
U-664 TREATMENT OF CONDITIONS FOR WHICH AN ALDOSTERONE RECEPTOR BLOCKER IS INDICATED, SUCH AS
HYPERTENSION, HEART FAILURE, AND POST-MYOCARDIAL INFARCTION
U-665 METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING
U-666 METHOD OF TREATING ADHD
U-667 MANAGEMENT OF INCONTINENCE; METHOD FOR TREATING INCONTINENCE
U-668 LEVEMIR IS A LONG-ACTING BASAL INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT OF
PATIENTS WITH DIABETES MELLITUS
U-669 INDICATION OF TYPE II DIABETES
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 37 of 45

PATENT USE
U-670 TREATMENT OF HIV-1 INFECTION BY THE CO-ADMINISTRATION OF TIPRANAVIR AND RITONAVIR.
U-671 PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY
DISEASE (CKD) STAGE 3 AND 4
U-672 TREATMENT OF INFLAMMATION OR AN INFLAMMATION-ASSOCIATED DISORDER
U-673 METHOD OF TREATMENT WITH ONCE-DAILY DOSES OF 625MG/5ML
U-674 METHOD OF TREATING INSOMNIA CHARACHTERIZED BY DIFFICULTY WITH SLEEP ONSET
U-675 PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA; RELIEF OF SYMPTOMS OF ALLERGIC RHINITIS
U-676 METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR
PULSATILE RELEASE COMPOSITION
U-677 A METHOD OF TREATING DISEASE AMENABLE TO TREATMENT WITH A PHENIDATE DRUG BY ONCE DAILY
ORAL ADMINISTRATION OF AN EXTENDED RELEASE DOSAGE FORM
U-678 METHOD OF TREATING ATTENTION DEFICIT DISORDER AND/OR ATTENTION DEFICIT HYPERACTIVITY
DISORDER
U-679 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2
DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN
U-680 A METHOD OF TREATING DYSLIPIDEMIA AND DYSLIPOPROTEINEMIA USING A DOSAGE FORM THAT CAN
PROVIDE AN EFFECTIVE AMOUNT OF FENOFIBRATE TO A PATIENT IN A FASTED STATE WHICH IS AT
LEAST 90% OF THE AUC AMOUNT PROVIDED BY THE DOSAGE FORM
U-681 TREATMENT OF PRIMARY IGF-1 DEFICIENCY
U-682 NON-BENZODIAZEPINE HYPNOTIC AGENT INDICATED FOR TREATMENT OF INSOMNIA, CHARACTERIZED BY
DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE
U-683 PREVENTION OR TREATMENT OF ISCHEMIC HEART DISEASE
U-684 TREATMENT OF UNCOMPLICATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA IN ADULTS
AND CHILDREN 6 YEARS OF AGE AND OLDER
U-685 EXPECTORANT AND COUGH SUPPRESSANT
U-686 EXPECTORANT AND NASAL DECONGESTANT
U-687 REDUCING FOOD INTAKE IN A SUBJECT WITH TYPE 2 DIABETES BY ADMINISTERING AN EXENDIN, SUCH
AS EXENDIN-4
U-688 TREATMENT OF HIV-INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
U-689 TREATMENT OF PATIENTS WITH T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA WHOSE DISEASE HAS NOT
RESPONDED TO OR HAS RELAPSED FOLLOWING TREATMENT WITH AT LEAST TWO CHEMOTHERAPY REGIMENS
U-690 TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
U-691 USE AS A MONOTHERAPY, IN COMBINATION WITH A SULFONYLUREA, METFORMIN OR INSULIN OR IN
COMBINATION WITH A SULFONYLUREA PLUS METFORMIN TO IMPROVE GLYCEMIC CONTROL IN PATIENTS
WITH TYPE 2 DIABETES MELLITUS
U-692 USE OF VALSARTAN TO REDUCE CARDIOVASCULAR MORTALITY IN CLINICALLY STABLE PATIENTS WITH
LEFT VENTRICULAR FAILURE OR LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL INFARCTION
U-693 THE RECOMMENDED INITIAL DOSE OF EQUETRO IS 400MG/DAY GIVEN IN DIVIDED DOSES, TWICE
DAILY. THE DOSE SHOULD BE ADJUSTED IN 200MG DAILY INCREMENTS TO ACHIEVE OPTIMAL CLINICAL
RESPONSE.
U-694 LENALIDOMIDE IS AN ANALOGUE OF THALIDOMIDE. THALIDOMIDE IS A KNOWN HUMAN TERATOGEN THAT
CAUSES SEVERE LIFE-THREATENING HUMAN BIRTH DEFECTS. IF LENALIDOMIDE IS TAKEN DURING
PREGNANCY, IT MAY CAUSE BIRTH DEFECTS OR DEATH TO AN UNBORN BABY.
U-695 TREATMENT OF PATIENTS WITH T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA AND T-CELL LYMPHOBLASTIC
LYMPHOMA WHOSE DISEASE HAS NOT RESPONDED TO OR HAS RELAPSED FOLLOWING TREATMENT WITH AT
LEAST TWO CHEMOTHERAPY REGIMENS
U-696 TREATMENT OF PATIENTS WITH T-CELL LYMPHOBLASTIC LYMPHOMA WHOSE DISEASE HAS NOT RESPONDED
TO OR HAS RELAPSED FOLLOWING TREATMENT WITH AT LEAST TWO CHEMOTHERAPY REGIMENS
U-697 A METHOD OF USING RINFABATE RECOMBINANT (RHIGFBP-3) WITH MECASERMIN RECOMBINANT (RHIGF-
1) TO PROMOTE LINEAR GROWTH IN THE TRATMENT OF PRIMARY IGF-1 DEFICIENCY
U-698 METHOD OF USING ANTAGONIST OF ARGININE VASOPRESSIN (AVA) V1A AND V2 RECEPTORS FOR
INTRAVENOUS TREATMENT OF PATEINTS WITH EUVOLEMIC HYPONATREMIA
U-699 NASAL TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
U-700 TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
U-701 TREATMENT OF HYPERCHOLESTEROLEMIA AND/OR HYPERTRIGLYCERIDEMIA
U-702 TOPICAL AEROSOL HAIR REGROWTH TREATMENT
U-703 TREATMENT OF PROTEIN KINASE RELATED DISORDERS, SUCH AS GASTROINTESTINAL STROMAL TUMOR
AND RENAL CELL CARCINOMA WITH SUNITINIB
U-704 METHOD OF ADMINISTERING INSULIN VIA INHALATION
U-705 TREATING CHRONIC ANGINA BY ADMINISTERING AN EXTENDED RELEASE FORM OF RANOLAZINE
U-706 TREATMENT OF BENIGN PROSTATIC HYPERPLASIA
U-707 ALLERGIC RHINITIS
U-708 TREATMENT OF CHRONIC NON-INFECTIOUS UVEITIS AFFECTING THE POSTERIOR SEGMENT OF THE EYE
U-709 METHOD OF COMBATING BACTERIA IN A PATIENT
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 38 of 45

PATENT USE
U-710 A METHOD OF TREATING RESPIRATORY DISORDERS, E.G., ASTHMA, WHICH COMPRISES ADMINISTRATION
BY INHALATION OF AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL FORMULATION AS CLAIMED IN US
PATENT NO. 5658549
U-711 ACUTE AND LONGER-TERM TREATMENT OF MAJOR DEPRESSIVE DISORDER
U-712 A METHOD OF USING A NICOTINIC ACID FORMULATION TO REDUCE ELEVATED TC, LDL-C AND TG
LEVELS, AND RAISE HDL-C LEVELS IN PATIENTS WITH HYPERLIPIDEMIA
U-713 TREATMENT OF MILD TO MODERATE DEMENTIA OF THE ALZHEIMER'S TYPE
U-714 TOPICAL TREATMENT OF INTERDIGITAL TINEA PEDIS AND TINEA CORPORIS DUE TO TRICHOPHYTON
RUBRUM, TRICHOPHYTON MENTAGROPHYTES OR EPIDERMOPHYTON FLOCCOSUM
U-715 FOR CLEANSING THE BOWEL IN PREPARATION FOR COLONOSCOPY, IN ADULTS 18 YEARS OF AGE OR
OLDER
U-716 THE TREATMENT OR PREVENTION OF BRONCHOSPASM IN ADULTS AND CHILDREN 4 YEARS OF AGE AND
OLDER WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE AND THE PREVENTION OF EXERCISED-
INDUCED BRONCHOSPASM IN PATIENTS 4 YEARS OF AGE AND OLDER
U-717 METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT
U-718 TREATMENT OF FUNGAL INFECTIONS
U-719 TREATENT OF PSYCHOSIS
U-720 TREATMENT OF NEUROLEPTIC DISEASES
U-721 TREATMENT OF INFLUENZA
U-722 PROPHYLAXIS OF INFLUENZA
U-723 PROPHYLACTIC TREATMENT OF MIGRAINE
U-724 METHOD OF TREATING SEIZURES
U-725 ALLERGIC RHINITIS AND URTICARIA
U-726 ALLERGIC RHINITIS
U-727 FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
U-728 METHOD FOR TREATING BACTERIAL INFECTION
U-729 TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD), RISK-REDUCTION OF NSAID-ASSOCIATED
GASTRIC ULCER, H. PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
U-730 USE AS A NASAL SPRAY FOR TREATMENT OF THE SYMPTOMS OF SEASONAL ALLERGIC RHINITIS AND
VASOMOTOR RHINITIS
U-731 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH
NEWLY DIAGNOSED MULTIPLE MYELOMA
U-732 ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA NODOSUM
LEPROSUM (ENL)
U-733 MAINTENANCE THERAPY FOR PREVENTION AND SUPRESSION OF THE CUTANEOUS MANIFESTATIONS OF ENL
RECURRENCE
U-734 FIRST LINE THERAPY FOR TYPE 2 DIABETES MELLITUS
U-735 METHOD OF TREATING CHRONIC IRON OVERLOAD
U-736 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
U-737 DISINFECTION OF PATIENT SKIN PRIOR TO AN INVASIVE PROCEDURE
U-738 INDICATED FOR THE LONG-TERM, TWICE-DAILY MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12
YEARS OF AGE OR OLDER
U-739 METHOD FOR TREATING CONSTIPATION BY OPENING CIC CHANNELS IN A MAMALIAN SUBJECT
U-740 FOR THE TREATMENT OF PATIENTS WITH PRIMARY BILIARY CIRRHOSIS
U-741 COMBINATION THERAPY WITH CISPLATIN FOR THE TREATMENT OF LATE STAGE CERVICAL CANCER
U-742 TWICE DAILY TOPICAL TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS.
U-743 ONCE A DAY TOPICAL TREATMENT OF THE INFLAMMATORY LESIONS OF ROSACEA
U-744 TREATMENT OF HIV INFECTION IN ANTIRETROVIRAL TREATMENT-EXPERIENCED ADULT PATIENTS
U-745 TREATMENT OR PREVENTION OF EMESIS
U-746 PREVENTION OR TREATMENT OF NAUSEA OR EMESIS INDUCED BY A CANCER CHEMOTHERAPEUTIC AGENT
U-747 PREVENTION OR TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING
U-748 A METHOD FOR THE TREATMENT OF A PROTEIN TYROSINE KINASE-ASSOCIATED DISORDER
U-749 METHOD OF CONTRACEPTION
U-750 TREATMENT OF HIV-1 INFECTION IN ADULTS
U-751 ONCE DAILY DOSING OF BUDESONIDE VIA NEBULIZER FOR THE TREATMENT OF ASTHMA
U-752 SUNSCREEN
U-753 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2
DIABETES
U-754 USE FOR THE LONG-TERM MAINTENANCE TREATMENT OF ASTHMA
U-755 TREATMENT OF ANOREXIA, CACHEXIA, OR AN UNEXPLAINED, SIGNIFICANT WEIGHT LOSS IN PATIENTS
WITH A DIAGNOSIS OF ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)
U-756 ADDITION OF ONCE-WEEKLY DOSING FOR THE TREATMENT TO INCREASE BONE MASS IN MEN WITH
OSTEOPOROSIS
U-757 USE AS A BILE ACID SEQUESTRANT FOR LOWERING CHOLESTEROL
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 39 of 45

PATENT USE
U-758 TREATMENT OF SYMPTOMS OF PREMENSTRUAL DYSPHORIC DISORDER
U-759 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
U-760 PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS AND TREATMENT OF
OROPHARYNGEAL CANDIDAIASIS
U-761 TREATMENT OF SCHIZOPHRENIA INCLUDING MAINTAINING STABILITY IN PATIENTS WITH SCHIZOPHRENIA
U-762 TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
U-763 ADMINISTRATION OF ARIPIPRAZOLE BY INJECTION
U-764 TREATMENT OF SCHIZOPHRENIA
U-765 METHOD OF TREATING ALLERGIC CONJUNCTIVITIS
U-766 TREATMENT OF SEIZURES
U-767 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
U-768 A METHOD OF REDUCING THE CAPACITY OF EXTENDED RELEASE NICOTINIC ACID TO PROVOKE A
FLUSHING REACTION BY PRETREATING AN INDIVIDUAL WITH A FLUSH INHIBITING AGENT PRIOR TO
THE ADMINISTRATION OF THE EXTENDED RELEASE NICOTINIC ACID
U-769 REVLIMID (LENALIDOMIDE) IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT
OF MULTIPLE MYELOMA PATIENTS WHO HAVE RECEIVED AT LEASET ONE PRIOR THERAPY
U-770 LONG-TERM TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS
U-771 METHOD FOR THE TREATMENT OF DIABETES MELLITUS, SUCH AS TYPE 1 DIABETES MELLITUS OR TYPE
2 DIABETES MELITUS, IN A HUMAN PATIENT
U-772 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN CHILDREN 2 TO 11 YEARS
AND FOR THE RELIEF OF SYMPTOMS ASSOCIATED WITH UNCOMPLICATED SKIN MANIFESTATIONS OF
CHRONIC IDIOPATHIC URTICARIA IN CHILDREN 6 MONTHS TO 11 YEARS
U-773 PATHOLOGICAL HYPERSECRETORY CONDITIONS
U-774 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASTE-IV
INHIBITOR
U-775 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV
INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
U-776 TREATMENT OF CUTANEOUS MANIFESTATION IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA (CTCL)
WHO HAVE PROGRESSIVE, PERSISTENT OR RECURRENT DISEASE ON OR FOLLOWING TWO SYSTEMIC
THERAPIES.
U-777 DECREASING MORTALITY CAUSED BY CONGESTIVE HEART FAILURE
U-778 REDUCTION OF ELEVATED INTRAOCULAR PRESSUE IN PATEINTS WITH OPEN ANGLE GLAUCOME OR OCULAR
HYPERTENSION
U-779 A METHOD FOR TREATMENT OF A CANCER, WHEREIN THE CANCER IS CHRONIC MYELOGENOUS LEUKEMIA
U-780 A METHOD FOR THE TREATMENT OF CANCER
U-781 FOR TREATMENT OF ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE NAIVE TO
PHARMACOLOGIC THERAPY
U-782 TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS WITH EVIDENCE OF VIRAL REPLICATION
AND EITHER EVIDENCE OF PERSISTANT ELEVATIONS IN SERUM AMINOTRANSFERASES (ALT OR AST) OR
HISTOLOGICALLY ACTIVE DISEASE
U-783 DESONATE GEL IS INDICATED FOR THE TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS IN
PATIENTS 3 MONTHS OF AGE AND OLDER
U-784 TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS)
U-785 USE AS REPLACEMENT SOLUTION, HEMOFILTRATION SOLUTION OR HEMODIAFILTRATION SOLUTION IN
CONTINUOUS RENAL REPLACEMENT THERAPY
U-786 PRODUCT IS APPROVED FOR THE TOPICAL TREATMENT OF TINEA PEDIS
U-787 MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN ADULT AND PEDIATRIC PATIENTS
SIX YEARS OF AGE OR OLDER, INCLUDING PATIENTS REQUIRING ORAL CORTICOSTEROID THERAPY FOR
ASTHMA
U-788 METHOD OF TREATING PSYCHIATRIC SYMPTOMS ASSOCIATED WITH PREMENSTRUAL DISORDERS USING
PAROXETINE
U-789 TREATMENT OF KNOWN OR SUSPECTED CYANIDE POISONING
U-790 FORTEO IS INDICATED FOR THE TREATMENT OF POST MENOPAUSAL WOMEN WITH OSTEOPOROSIS WHO ARE
AT RISK FOR FRACTURE. FORTEO CAN BE USED BY PEOPLE WHO HAVE HAD A FRACTURE RELATED TO
OSTEOPOROSIS
U-791 GLEEVEC IS ALSO INDICATED FOR THE TREATMENT OF PATIENTS WITH KIT (CD117) POSITIVE
UNRESECTABLE AND/OR METASTATIC MALIGNANT GASTROINTESTINAL STROMAL TUMORS (GIST)
U-792 TREATMENT OF SEBORRHEA DERMATITIS IN HUMANS
U-793 FOR THE LONG TERM TREATMENT, TWICE DAILY (MORNING AND EVENING) MAINTENANCE TREATMENT OF
BRONCHOCONSTRICTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD),
INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA
U-794 CLOSURE OF A CLNICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS
WEIGHING BETWEEN 500 AND 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN USUAL
MEDICAL MANAGEMENT IS INEFFECTIVE
U-795 METHOD FOR INHIBITING NOREPINEPHRINE UPTAKE
U-796 METHOD OF TREATING DEPRESSION
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 40 of 45

PATENT USE
U-797 METHOD OF TREATING ANXIETY
U-798 TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN BY ONCE-MONTHLY ORAL
ADMINISTRATION OF IBANDRONATE SODIUM MONOHYDRATE EQUIVALENT TO 150MG OF IBANDRONIC ACID
U-799 METHOD FOR INHIBITING SEROTONIN UPTAKE
U-800 TREATMENT OF PATIENTS WITH ADVANCED OR METASTATIC BREAST CANCER WHOSE TUMORS OVEREXPRESS
HER2 AND WHO HAVE RECEIVED PRIOR THERAPY INCLUDING ANTHRACYCLINE, A TAXANE AND
TRASTUZUMAB
U-801 METHOD OF TREATING CANCER
U-802 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV
INHIBITOR
U-803 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV
INHIBITOR IN COMBINATION WITH METFORMIN
U-804 TREATMENT OF ACTINIC KERATOSES BY PHOTODYNAMIC THERAPY
U-805 TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES
U-806 INTRATHECAL TREATMENT OF LYMPHOMATOUS MENINGITIS
U-807 PREVENTION OF EXERCISE-INDUCED BRONCHOCONSTRICTION
U-808 THE TREATMENT OF THE SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN PATIENTS 2
YEARS OF AGE AND OLDER
U-809 TREATMENT OF CHRONIC IDIOPATHIC URTICARIA
U-810 METHOD OF TREATMENT TO ALLEVIATE INFLAMMATION OF THE EYE
U-811 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS AND
TREATMENT OF THE UNCOMPLICATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA
U-812 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS
U-813 MAINTENANCE TREATMENT OF BRONCHOCONSTRICTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE
PULMONARY DISEASE (COPD)
U-814 TREATMENT OF SCHIZOPHRENIA
U-815 TREATS COLD SORES/FEVER BLISTERS ON THE FACE OR LIPS. SHORTENS HEALING TIME AND DURATION
OF SYMPTOMS: TINGLING, PAIN, BURNING AND/OR ITCHING
U-816 DEPRESSION, PANIC DISORDER, PREMENSTRUAL DISORDERS AND SOCIAL ANXIETY DISORDER
U-817 NASAL ADMINISTRATION OF CYANOCOBALAMIN
U-818 TOPICAL TREATMENT OF ACNE VULGARIS
U-819 MANAGEMENT OF FIBROMYALGIA
U-820 IMPROVED WAKEFULNESS IN PATIENTS WITH EXCESSIVE SLEEPINESS ASSOCIATED WITH NARCOLEPSY,
OBSTRUCTIVE SLEEP APNEA/HYPOPNEA SYNDROME, AND SHIFT WORK SLEEP DISORDER
U-821 METHOD OF INHIBITING ENTHOTHELIN RECEPTORS BY ADMINISTERING AMBRISENTAN TO A PATIENT TO
TREAT PULMONARY ARTERIAL HYPERTENSION.
U-822 USE IN LIPID MANAGEMENT
U-823 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS AND FOR THE TREATMENT OF
UNCOMPLCATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA IN CHILDREN 6 TO 11
YEARS OF AGE
U-824 METHOD OF TREATING PATIENTS INFECTED WITH CCR5-TROPIC HIV-1
U-825 USE FOR PREVENTION OF BREAST CANCER
U-826 RELIEF OF MODERATE TO SEVERE PAIN
U-827 USE FOR TREATMENT OF DIABETES, PARTICULARLY TYPE 2 DIABETES
U-828 PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD OF
CONTRACEPTION
U-829 TREATMENT OF EXTRAVASATION RESULTING FROM IV ANTHRACYCLINE CHEMOTHERAPY
U-830 TREATMENT OF RELAPSED SMALL CELL LUNG CANCER
U-831 METHOD OF ADMINISTERING LANREOTIDE ACETATE
U-832 ZINGO IS INDICATED FOR THE USE ON INTACT SKIN TO PROVIDE LOCAL ANALGESIA PRIOR TO
VENIPUNCTURE OR INTRAVENOUS CANNULATION.
U-833 METHOD OF TREATING PAIN USING A PHARMACEUTICALLY ACCEPTABLE SALT OF ROPIVACAINE AND
ADMINISTERING A COMPOSITION CONTAINING LESS THAN 0.25% BY WEIGHT OF ROPIVACAINE
U-834 INVIRASE IN COMBINATION WITH RITONAVIR AND OTHER ANTIRETROVIRAL AGENTS IS INDICATED FOR
THE TREATMENT OF HIV INFECTION
U-835 RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF ATOPIC DERMATITIS IN PATIENTS
ONE YEAR OF AGE OR OLDER
U-836 A METHOD FOR THE TREATMENT OF LEUKEMIAS
U-837 GASTROINTESTINAL LAVAGE INDICATED FOR CLEANSING OF THE COLON AS A PREPARATION FOR
COLONOSCOPY IN ADULTS
U-838 METHOD OF TREATING PAIN USING A PHARMACEUTICALLY ACCEPTABLE SALT OF ROPIVACAINE AND
ADMINISTERING A COMPOSITION CONTAINING LESS THAN 0.5% BY WEIGHT OF ROPIVACAINE
U-839 TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
U-840 TREATMENT FOR TYPE 2 DIABETES MELLITUS
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 41 of 45

PATENT USE
U-841 INDICATED FOR THE LONG-TERM, MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE
AND OLDER
U-842 INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
U-843 METHOD FOR ADMINISTRATION OF TESTOSTERONE
U-844 PREFEST IS INDICATED IN WOMEN WHO HAVE A UTERUS FOR THE TREATMENT OF MODERATE TO SEVERE
VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE; TREATMENT OF VULVAR AND VAGINAL ATROPHY;
PREVENTION OF OSTEOPOROSIS
U-845 TREATMENT OF PATIENTS WITH CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, CANDIDA
PERITONITIS AND ABCESSES
U-846 USE FOR DELINEATION (VISUALIZATION) DURING A VITRECTOMY SURGICAL PROCEDURE
U-847 ADJUNCTIVE THERAPY TO DIET IN ADULTS TO REDUCE LDL-C, TRIGLYCERIDES AND APO B, AND
INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED DYSLIPIDEMIA
(TYPES IIA, IIB) AND TO TREAT HYPERTRIGLYCERIDEMIA (TYPES IV, V)
U-848 ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA
U-849 REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR OCULAR
HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO INADEQUATELY
CONTROLLED IOP. DOSE IS ONE DROP OF COMBIGAN IN THE AFFECTED EYE TWICE DAILY
U-850 PREVENTION OR TREATMENT OF NAUSEA OR EMESIS INDUCED BY A CANCER CHEMOTHERAPEUTIC AGENT
U-851 TREATMENT OF TYPE 2 DIABETES MELLITUS
U-852 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS
U-853 TREATMENT OR PREVENTION OF EMESIS
U-854 PREVENTION OF CMV DISEASE IN KIDNEY, HEART, AND KIDNEY-PANCREAS TRANSPLANT PATIENTS AT
HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE)
U-855 METHOD TO INDUCE NATRIURESIS, DIURESIS AND/OR VASODILATION
U-856 SUPPORT EMBRYO IMPLANTATION AND EARLY PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL
FUNCTION AS PART OF AN ASSISTED REPORDUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR
INFERTILE WOMEN
U-857 INHIBITION OF TRANSPLANT REJECTION
U-858 PEDIATRIC USE AGED 1-11 YEARS, GERD AND EROSIVE ESOPHAGITIS
U-859 EROSIVE ESOPHAGITIS, HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME,
MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND REDUCTION OF SYMPTOMS IN PATIENTS WITH
GERD
U-860 FOR THE APPROVED USES AND CONDITIONS OF USE, INCLUDING DEPRESSION
U-861 RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF CORTICOSTEROID RESPONSIVE
DERMATOSES IN PATIENTS 12 YEARS OF AGE OR OLDER
U-862 ADJUNCT TO DIET TO REDUCE ELEVATED TOTAL-C, LDL-C, NON-HDL-C, APO B, TG, AND LP(A)
LEVELS AND TO INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA, MIXED
DYSLIPIDEMIA, AND HYPERTRIGLYCERIDEMIA
U-863 TAKING ASPIRIN OR NON-STEROIDAL ANTI-INFLAMMATORY MEDICATIONS APPROXIMATELY 30 MINUTES
BEFORE DOSING CAN MINIMIZE FLUSHING, A COMMON SIDE EFFECT OF NIACIN THERAPY
U-864 PEDIATRIC USE AGES 1-2 YEARS, GERD AND EROSIVE ESOPHAGITIS
U-865 TREATMENT OF A WOMAN WITH OSTEOPOROSIS AND A HIGH RISK FOR BONE FRACTURE BY REDUCING THE
RISK OF VERTEBRAL AND NONVERTEBRAL BONE FRACTURE
U-866 THE LABEL REFERENCES THE EFFECTS OF THE ACTIVE INGREDIENT OF REVLIMID UPON CYTOKINES
U-867 TREATMENT OF MIGRAINE
U-868 METHOD OF USING ANTAGONIST OF ARGININE VASOPRESSIN (AVA) V1A AND V2 RECEPTORS FOR
INTRAVENOUS TREATMENT OF PATIENTS WITH HYPERVOLEMIC HYPONATREMIA
U-869 METHOD FOR STIMULATING CORONOARY VASODILATION FOR PURPOSES OF IMAGING THE HEART
U-870 METHOD OF PRODUCING CORONARY VASODILATION WITHOUT PERIPHERAL VASODILATION
U-871 METHOD OF REDUCING RISK OF MYOCARDIAL INFARCTION, STROKE AND DEATH
U-872 TWICE DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC
OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA. TO
REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS
U-873 METHOD OF TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME BY OPENING
CHLORIDE CHANNELS (CIC)
U-874 METHOD OF TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME
U-875 FIRST-LINE TREATMENT OF LOCALLY ADVANCED UNRESECTABLE OR METASTATIC PANCREATIC CANCER
U-876 TREATMENT OF MIGRAINE WITH OR WITHOUT AURA
U-877 FOR USE AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PEPTIC ULCER
U-878 A METHOD FOR BINDING A PERIPHERAL OPIOID RECEPTOR
U-879 A METHOD OF TREATING OR PREVENTING ILEUS
U-880 ENDOMETRIN IS A PROGESTERONE INDICATED TO SUPPORT EMBRYO IMPLANTATION AND EARLY
PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL FUNCTION AS PART OF AN ASSISTED
REPRODUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR INFERTILE WOMEN
U-881 TREATMENT OF NON-SMALL CELL LUNG CANCER
U-882 MANAGEMENT OF FIBROMYALGIA (FM)
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 42 of 45

PATENT USE
U-883 TREATMENT OF GASTROINTESTINAL STROMAL TUMOR WITH SUNITINIB
U-884 TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA
U-885 TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR
THERAPY
U-886 ADMINISTERING DESLORATADINE TO TREAT THE SYMPTOMS OF PERENNIAL ALLERGIC RHINITIS,
SEASONAL ALLERGIC RHINITIS, OR CHRONIC IDIOPATHIC URTICARIA
U-887 TREATMENT AND PREVENTION OF OSTEOPOROSIS
U-888 FEMALE HORMONE REPLACEMENT THERAPY FOR POSTMENOPAUSAL WOMEN
U-889 MENOPAUSAL AND POSTMENOPAUSAL DISORDERS (INCLUDING VASOMOTOR SYMPTOMS ASSOCCIATED WITH
MENOPAUSE)
U-890 REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE
U-891 USE AS AN INTRAOCULAR IRRIGATING SOLUTION DURING SURGICAL PROCEDURES INVOLVING PERFUSION
OF THE EYE
U-892 TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WTIH CUTANEOUS T-CELL LYMPHOMA (CTCL)
U-893 CLEVIPREX IS A DIHYDROPYRIDINE CALCIUM CHANNEL BLOCKER INDICATED FOR THE REDUCTION OF
BLOOD PRESSURE WHEN ORAL THERAPY IS NOT FEASIBLE OR NOT DESIRABLE
U-894 TREATMENT OF COLD SORES IN PEDIATRIC PATIENTS TWELVE YEARS OF AGE AND OLDER
U-895 TREATMENT OF HIV INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
U-896 TREATMENT OF NASAL SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN ADULTS AND
CHILDREN TWO YEARS OF AGE AND OLDER
U-897 METHOD OF TREATING TONSILLITIS AND/OR PHARYNGITIS SECONDARY TO STREPTOCOCCUS PYOGENES IN
A ONCE-A-DAY AMOXICILLIN PRODUCT
U-898 USE OF GLUTAMINE TOGETHER WITH GROWTH HORMONE FOR THE TREATMENT OF PATIENTS WITH SHORT
BOWEL SYNDROME
U-899 USE OF THALIDOMIDE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH
NEWLY DIAGNOSED MULTIPLE MYELOMA
U-900 INTEGRASE INHIBITION FOR THE TREATMENT OF HIV INFECTION
U-901 PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING
U-902 USE IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA (BPH)
U-903 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN ADULT PATIENTS
U-904 TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
U-905 TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF
VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE
U-906 PROPHYLAXIS OF ORGAN REJECTION IN KIDNEY, LIVER AND HEART ALLOGENIC TRANSPLANTS;
TREATMENT OF PATIENTS WITH SEVERE ACTIVE, RHEUMATOID ARTHRITIS; TREATMENT OF ADULT,
NONIMMUNOCOMPROMISED PATIENTS WITH SEVERE, RECALCITRANT, PLAQUE PSORIASIS
U-907 FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS IN SUBJECTS 18 YEARS OF AGE AND
OLDER
U-908 PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS RECEIVING ALLOGENEIC RENAL TRANSPLANTS
U-909 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
U-910 TREATMENT OF METASTATIC CARCINOMA OF THE OVARY AFTER FAILURE OF INITIAL OR SUBSEQUENT
CHEMOTHERAPY
U-911 METHOD OF TREATING, AS ADJUNCTIVE THERAPY, PARTIAL-ONSET SEIZURES IN A PATIENT WITH
EPILEPSY AGED 17 YEARS AND OLDER WHEN ORAL TREATMENT IS TEMPORARILY NOT FEASIBLE
U-912 SEDATION OF NON-INTUBATED PATIENTS PRIOR TO AND/OR DURING SURGICAL AND OTHER PROCEDURES
U-913 TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND
FREQUENCY
U-914 METHOD OF TREATING, AS ADJUNCTIVE THERAPY, PARTIAL-ONSET SEIZURES IN A PATIENT WITH
EPILEPSY AGED 17 YEARS AND OLDER
U-915 TREATMENT OF MUSCULOSKELETAL CONDITIONS
U-916 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
U-917 TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
U-918 TO TREAT OR PREVENT INFECTIONS CAUSED BY SUSCEPTIBLE BACTERIA USING DELAYED-RELEASE
TABLETS CONSISTING OF DOXYCYCLINE HYCLATE COATED PELLETS IN A TABLET
U-919 FOR THE TREATMENT OF DERMATITIS
U-920 STEROID-RESPONSIVE INFLAMMATORY OCULAR CONDITIONS FOR WHICH A CORTICOSTEROID IS
INDICATED AND WHERE SUPERFICIAL BACTERIAL OCULAR INFECTION OR A RISK OF BACTERIAL OCULAR
INFECTION EXISTS
U-921 TREATMENT OF ACNE VULGARIS
U-922 FOR THE TREATMENT OF FUNGAL INFECTIONS
U-923 METHOD OF TREATING OPHTHALMIC INFLAMMATION AND INFECTION
U-924 TREATMENT OF MILD TO MODERATE INFECTION CAUSED ABY SUSCEPTIBLE STRAINS
U-925 TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTILES) OF ROSACEA
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 43 of 45

PATENT USE
U-926 MGT SPECIFIC BACTERIAL INFECTIONS. TREATMENT PTS W/ COMMUNITY ACQUIRED PNEUMONIA OR
BACTERIAL SINUSITIS DUE TO CONFIRMED, OR SUSPECTED B-LACTAMASE PRODUCING PATHOGENS & S.
PNEUMONIAE WITH REDUCED SUSCEPTIBILITY TO PENICILLIN (MIC=2MC/ML)
U-927 METHOD FOR INCREASING TEAR PRODUCTION
U-928 TREATMENT OF BACTERIAL INFECTIOUS DISEASE
U-929 TREATMENT OF OBSESSIVE COMPULSIVE DISORDER TREATABLE WITH AN SSRI
U-930 TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
U-931 RELIEF OF MODERATE TO SEVERE ACUTE PAIN
U-932 PYLERA CAPSULES, IN COMBINATION WITH OMEPRAZOLE ARE INDICATED FOR THE TREATMENT OF
PATIENTS WITH HELICOBACTER PYLORI INFECTION AND DUODENAL ULCER DISEASE TO ERADICATE H.
PYLORI
U-933 FOR THE TREATMENT OF PATIENTS WITH HELICOBACTER PYLORI INFECTION AND DUODENAL ULCER
DISEASE TO ERADICATE H. PYLORI. THE ERADICATION OF HELICOBACTER PYLORI HAS BEEN SHOWN TO
REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
U-934 IN COMBINATION WITH GRANULOCYTE-COLONY STIMULATING FACTOR (G-CSF) TO MOBILIZE
HEMATOPOIETIC STEM CELL TO THE PERIPHERAL BLOOD FOR COLLECTION AND SUBSEQUENT AUTOLOGOUS
TRANSPLANTATION WITH NON-HODGKINS LYMPHOMA AND MULTIPLE MYELOMA
U-935 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND
TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND
OLDER
U-936 USE IN COMBINATION WITH GRANULOCYTE-COLONY STIMULATING FACTOR (G-CSF) TO MOBILIZE
HEMATOPOIETIC STEM CELLS TO PERIPHERAL BLOOD FOR COLLECTION & SUBSEQUENT AUTOLOGOUS
TRANSPLANTATION IN PATIENTS WITH NON-HODGKIN'S LYMPHOMA & MULTIPLE MYELOMA
U-937 TREATMENT OF PROSTATE CANCER
U-938 TREATMENT OF HAIR LOSS AND HYPOTRICHOSIS OF THE EYELASHES BY INCREASING THEIR GROWTH
INCLUDING LENGTH, THICKNESS AND DARKNESS
U-939 TREATMENT OF HYPOTRICHOSIS OF THE EYELASHES BY INCREASING AND STIMULATING THEIR GROWTH
INCLUDING LENGTH, THICKNESS AND DARKNESS
U-940 METHOD TO TREAT AIDS-RELATED KAPOSI'S SARCOMA
U-941 METHOD TO TREAT OVARIAN CANCER
U-942 METHOD TO TREAT MULTIPLE MYELOMA
U-943 GNRH ANTAGONIST INDICATED FOR TREATMENT OF PATIENTS WITH ADVANCED PROSTATE CANCER
U-944 TREATMENT OF PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
U-945 SEDATIVE-HYPNOTIC AGENT INDICATED FOR MONITORED ANESTHESIA CARE (MAC) SEDATION
U-946 TREATMENT OF BREAST CANCER
U-947 WHEN PATIENTS ARE UNABLE TO TAKE THE ORAL FORMULATIONS, PREVACID IV, FOR INJECTION IS
INDICATED AS AN ALTERNATIVE FOR THE SHORT-TERM TREATMENT (UP TO 7 DAYS) OF ALL GRADES OF
EROSIVE ESOPHAGITIS
U-948 TREATMENT OF DIABETES MELLITUS
U-949 HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
U-950 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
U-951 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE
(GERD) FOR 4 WEEKS
U-952 USE AS AN ANALGESIC
U-953 METHOD OF TREATING OPHTHALMIC INFLAMMATION AND INFECTION
U-954 CHRONIC MANAGEMENT OF HYPERURICEMIA IN PATIENTS WITH GOUT. NOT RECOMMENDED FOR THE
TREATMENT OF ASYMPTOMATIC HYPERURICEMIA
U-955 PROPHYLACTIC TREATMENT OF MIGRAINE
U-956 TREATMENT OF PATIENTS WITH H. PYLORI INFECTION AND DUODENAL ULCER DISEASE
U-957 A METHOD OF TREATING CANCER IN A PATIENT COMPRISING ADMINISTERING IXABEPILONE OR
PHARMACEUTICAL COMPOSITIONS COMPRISING IXABEPILONE
U-958 METHOD OF TREATING PATIENT COMPRISING MIXING FIRST AND SECOND VIALS OF PRODUCT
COMPRISING LYOPHILIZED IXABEPILONE TO PROVIDE AN EPOTHILONE ANALOG SOLUTION, DILUTING
SOLUTION WITH A SUITABLE DILUENT TO PREPARE INTRAVENOUS FORMULATION FOR PT
U-959 METHOD OF TREATING CANCER, IV ADMIN, LYOPHYLIZED IXABEPILONE DILUTED, EVERY WEEK OR 3
WEEKS; LYOPHILIZED IXABEPILONE WITH SOLVENT(DEHYDRATED ETHANOL) DILUTED TO
CONCENTRATION OF 0.1MG/ML TO 0.9MG/ML
U-960 METHOD OF TREATING CANCER IN A PATIENT COMPRISING INTRAVENOUSLY ADMINISTERING TO THE
PATIENT IXABEPILONE DILUTED IN A PARENTERAL DILUENT
U-961 METHOD OF TREATING BREAST CANCER BY ADMINISTERING IXABEPILONE; A METHOD OF TREATING A
CANCER RESPONSIBLE TO MICROTUBULE STABILIZATION BY ADMINISTERING IXABEPILONE
U-962 SYMBYAX IS INDICATED FOR THE ACUTE TREATMENT OF TREATMENT RESISTANT DEPRESSION IN ADULTS
U-963 PROZAC AND OLANZAPINE IN COMBINATION FOR THE ACUTE TREATMENT OF TREATMENT RESISTANT
DEPRESSION IN ADULTS
U-964 ZYPREXA ZYDIS AND FLUOXETINE IN COMBINATION FOR THE ACUTE TREATMENT OF TREATMENT
RESISTANT DEPRESSION IN ADULTS
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 44 of 45

PATENT USE
U-965 USE OF IXABEPILONE IN COMBINATION WITH CAPECITABINE IN TREATMENT OF METASTASIS BREAST
CANCER
U-966 TREATMENT OF ASTHMA (MAINTENANCE AND PROPHYLACTIC THERAPY)
U-967 A METHOD OF REVERSING SOFT-TISSUE ANESTHESIA I.E. ANESTHESIA OF THE LIP AND TONGUE, AND
THE ASSOCIATED FUNCTIONAL DEFICITS RESULTING FROM AN INTRAORAL SUBMUCOSAL INJECTION OF A
LOCAL ANESTHETIC
U-968 A METHOD FOR IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
U-969 TREATMENT OF MIGRAINE
U-970 TOPICAL TREATMENT OF LICE INFESTATIONS
U-971 INDICATED FOR THE ACUTE TREATMENT OF ADULTS WITH SCHIZOPHRENIA
U-972 MONOTHERAPY OR AS ADJUNCTIVE THERAPY TO LITHIUM OR VALPROATE FOR THE MAINTENANCE
TREATMENT OF BIPOLAR I DISORDER
U-973 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
MELLITUS WHO ARE ALREADY TREATED WITH PIOGLITAZONE AND METFORMIN OR WHO HAVE INADEQUATE
GLYCEMIC CONTROL ON PIOGLITAZONE OR METFORMIN ALONE
U-974 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2
DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN
U-975 TREATMENT OF PULMONARY HYPERTENSION
U-976 IMPROVEMENT OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES
U-977 TREATMENT OF ACUTE, UNCOMPLICATED MALARIA INFECTION DUE TO PLASMODIUM FALCIPARUM IN
PATIENTS OF 5KG BODYWEIGHT AND ABOVE
U-978 METHOD OF TREATING HYPONATREMIA
U-979 RELIEF OF MUSCLE SPASM
U-980 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
U-981 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT
TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND
ANTIPYRETIC ACTIVITY
U-982 A METHOD OF TREATING OSTEOPOROSIS
U-983 METHOD OF TREATING OSTEOPOROSIS IN A POST-MENOPAUSAL WOMAN AT RISK FOR FRACTURE
U-984 METHOD FOR THE TREATMENT OF A WOMAN WITH OSTEOPOROSIS AND AT RISK FOR BONE FRACTURE
U-985 TREATMENT OF MACULAR EDEMA FOLLOWING BRANCH RETINAL VEIN OCCLUSION (BRVO) OR CENTRAL
RETINAL VEIN OCCLUSION (CRVO)
U-986 TREATMENT OF PATIENTS INFECTED WITH PEDICULUS HUMANUS CAPITIS (HEAD LICE AND THEIR OVA)
OF THE SCALP HAIR
U-987 TREATMENT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH CHRONIC KIDNEY DISEASE ON
DIALYSIS
U-988 TREATMENT OF RHINITIS COMPRISING THE NASAL APPLICATION OF A PHARMACEUTICAL FORMULATION
AS CLAIMED IN US PATENT 7541350
U-989 FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
U-990 TREATMENT OF PROTOZOAL INFECTION
U-991 TREATMENT OR PROPHYLAXIS OF THROMBOSIS OR EMBOLISMS
U-992 REDUCTION OF THE RISK OF CARDIOVASCULAR HOSPITALIZATION
U-993 METHOD OF TREATING INFERTILITY
U-994 METHOD OF TREATMENT OF OSTEOPOROSIS WHEREIN THE OSTEOPOROSIS IS STEROID-INDUCED
U-995 METHOD FOR TREATING TYPE II DIABETES BY ADMINISTERING SAXAGLIPTIN
U-996 AN ADJUNCTIVE THERAPY TO DIET TO REDUCT ELEVATED TOTAL CHLORESTEROL (TC), LOW-DENSITY
LIPOPROTEIN CHOLESTEROL, APOLIPOPROTEIN B, TRIGLYCERIDES, AND TO INCREASE HDL-C IN ADULT
PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIX DYSLIPIDEMIA
U-997 TREATMENT OF MAJOR DEPRESSIVE DISORDER BY DOSING AT INTERVALS OF 24 HOURS
U-998 ADJUNCITVE THERAPY TO DIET TO REDUCE ELEVATED TOTAL CHOLESTEROL, LOW-DENSITY LIPOPROTEIN
CHOLESTEROL, APOLIPOPRTEIN B, TRIGLYCERIDES AND TO INCREASE HDL-C IN ADULT PATIENTS WITH
PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA
U-999 TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS
U-1000 ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS
U-1001 METHOD FOR DELIVERING DRUG TO LUNG OF MAMMAL, COMPRISING ADMINISTERING DRUG PRODUCT BY
INHALATION. TREATING A MAMMAL HAVING A CONDITION CAPABLE OF TREATMENT BY INHALATION,
COMPRISING ADMINISTERING TO THE LUNG THE DRUG PRODUCT BY INHALATION
U-1002 METHOD OF TREATING INFLAMMATORY CONDITIONS
U-1003 A METHOD OF MYOCARDIAL PERFUSION IMAGING AND INCREASING CORONARY BLOOD FLOW
U-1004 TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
U-1005 METHOD OF TREATING A STAPHYLOCOCCAL INFECTION
U-1006 NEW COMBINATION PRODUCT FOR THE EARLY TREATMENT OF RECURRENT HERPES LABIALIS (COLD
SORES) TO REDUCE THE LIKELIHOOD OF ULCERATIVE COLD SORES AND TO SHORTEN THE LESION
HEALING TIME IN ADULTS AND ADOLESCENTS (12 YEARS OF AGE AND OLDER)
U-1007 METHOD OF TREATING GOUT FLARES
30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS ADB 45 of 45

PATENT USE
U-1008 APPLICATION OF ANTISEPTIC WITH MOISTURIZERS FOR SURGICAL AND HEALTHCARE PERSONNEL SKIN
DISINFECTION
U-1009 METHOD FOR ADMINISTRATION OF TESTOSTERONE
U-1010 TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA DUE TO TETRA
HYDROBIOPTERIN RESPONSIVE PHENYLKETONURIA. KUVAN SHOULD BE TAKEN ORALLY WITH FOOD TO
INCREASE ABSORPTION
U-1011 USE OF GRANISETRON TRANSDERMAL SYSTEM TO TREAT/PREVENT CHEMOTHERAPY INDUCED NAUSEA AND
VOMITING
U-1012 METHOD FOR TREATING INSOMNIA WHILE REDUCING THE RISK OF AN ADVERSE DRUG INTERACTION
U-1013 METHOD OF USING RIBAVIRIN IN COMBINATION WITH PEGYLATED INTERFERON ALPHA-2B TO TRAT
PATIENTS WITH CHRONIC HEPATITIS C
U-1014 METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTERFERON 2B(PEGYLATED AND NONPEGYLATED)
TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
U-1015 TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
U-1016 IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION IN
TREATMENT-EXPERIENCED ADULT PATIENTS, WHO HAVE EVIDENCE OF VIRAL REPLICATION AND HIV-1
STRAINS RESISTANT TO AN NNRTI AND OTHER ANTIRETROVIRAL AGENTS
U-1017 A METHOD OF TREATING NASAL AND NON-NASAL SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
U-1018 TREATMENT OF PULMONARY HYPERTENSION BY INHALATION
U-1019 TREATMENT OF PULMONARY HYPERTENSION
U-1020 METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
U-1021 SHORT-TERM TREATMENT (4-8 WEEKS) OF ACTIVE BENIGN GASTRIC ULCER
U-1022 FOR THE PREPARATIO NOF SKIN PRIOR TO SURGERY; HELPS REDUCE BACTERIA THAT CAN POTENTIALLY
CAUSE SKIN INFECTION
U-1023 TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE
U-1024 REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH GLAUCOMA OR OCULAR
HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO INADEQUATELY
CONTROLLED IOP
U-1025 TREATING FREQUENT HEARTBURN
U-1026 A METHOD OF TREATING HUMAN SUFFERING FROM OR SUSCEPTIBLE TO PSYCHOSIS.

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