Approval Status of New Drug during 1971-1981

S. No

Drug

Indication

Date of Approval

1.

Hydroxyurea USP Tablet 200 mg

Anti-neoplastic agent

Jan,1971

2.

2-thymyl-oxy-methyl glyoxalidine
hydrochloride Nasal Spray

Jan,1971

3.
4.

Jan,1971
Jan,1971

5.

Hamycin Suspension
Ferrous Sulphate Sustained
Release Tablet 150 mg
Hydroxyurea USP Capsules, 500mg

Anti-neoplastic agent

Jan,1971

6.

Ibuprofen BP Tablets, 50 mg

Anti-rheumatic

Mar,1971

7.

Hydroflumethiazide Tablet 25 mg

Mar,1971

8.

Chlorphenoxamine Hydrochloride
Tablets 12 mg
Epsilon amino caporic acid Injection
250 mg
Ibuprofen BP Tablets, 200 mg

Mar,1971

Mar,1971

Anti-rheumatic

Mar,1971

Musculotropic & Spasmolytic

Mar,1971

Apr,1971

May,1971

May,1971

Anti-T.B.
Estrogenic Steroid
Anesthetic agent
Muculo-tropic spasmolytic

Jun,1971
Jul,1971
Aug,1971
Sep,1971
Oct,1971

Oct,1971

Oct,1971
Oct,1971

Anti-diarrheal agent
Broad Spectrum Antibiotic
Bronchial Asthma
-

Oct,1971
Oct,1971
Oct,1971
Nov,1971
Nov,1971

9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.

Beverine Hydrochloride Tablets,

50mg
Panchromium Bromide Injection,
4mg/ml
Ephedrine Sulphate Sustained
Release Capsule 75 mg
L-dihydroxyphenylalanine
Tablet/Capsule 500 mg
Rifampicin USP Tablets, 450mg
Quinestral Tablets, 25mcg
Ketamine Hydrochloride
Glybenclamide Tablet 5 mg
Mebeverine Hydrochloride Tablet
100 mg
Para-aminomethylbenzoic acid
Injection 50 mg
Dihydroxyacetone Lotion
Lactobacillus Sporengenes Tablet,
50/100 million
Yeast Tannic Acid Compound
Cephalexin
Salbutamol Sulphate BP
Pheiramine Maleate Tablet
Propranolol Hydrochloride Tablet 10
mg

28.

Nov,1971

29.

Propranolol Hydrochloride Injection

1 mg/ml
Tetranicotinoyl Fructose

Nov,1971

30.
31.

Spiramycin Injection
Testolactone

Nov,1971
Nov,1971

32.

Tetranicolinoyl Fructose Tablets 250

mg
Prednisolone I.P Tablets 10 mg
3,5-Dinitro-o-toluamide
Fenfluramine Hydrochloride
Clopidal
Testolactone Tablets 50 mg

Dec,1971

Anti-obesity drug
Coccodiosis
-

Dec,1971
Jan,1972
Jan,1972
Jan,1972
Mar,1972

Apr,1972

39.

Fenfluramine Hydrochloride Tablets

20 mg
Ferric Sodium Citrate

Apr,1972

40.
41.
42.

Prothionamide B.P.
Sarcolysin I.P.
Doxepin Hydrochloride

Anti-T.B. Drug
Anti-cancer drug
Psychotic Drug

Jun,1972
Jun,1972
Jul,1972

43.

Biperiden Hydrochloride

Parkinsonism

Jul,1972

44.
45.

Anti-Helminthic
Psychotic Drug

Jul,1972
Sep,1972

46.
47.

Pyrantel Pamoate U.S.P.

Doxepin Hydrochloride
Tablets/Capsule/Dragee
2-Bromo-2-nitropropan-1,3-diol
Bupivacine Hydrochloride

Preservative
Local Anesthetic

Sep,1972
Sep,1972

48.

Fluphenazine Deconate

Antipsychotic

Sep,1972

49.

Marcaine 0.25 %/0.5% with or

without adranaline
Propranolol Hydrochloride
Chloramphenicol
Biperiden lactate Injection 5 mg

Sep,1972

Parkinsonism

Oct,1972
Oct,1972
Oct,1972

Cyclandelate
Povidone Iodine Solution 10 %
Povidone Iodine Gargle 0.5 %
Ferrous Sulphate Sustained
Release Tablet 160 mg
Lithium Carbonate Capsule 250 mg

Vasodilating Agent
-

Oct,1972
Nov,1972
Nov,1972
Nov,1972

Nov,1972

Oxyclozamide
Sodium chromoglycate
Doxycycline Hydrochloride Tablet
100 mg

Vertinary Drug
Anti-asthmatic
-

Nov,1972
Nov,1972
Dec,1972

33.
34.
35.
36.
37.
38.

50.
51.
52.
53.
54.
55.
56.
57.
58.
59.
60.

61.
62.
63.
64.
65.
66.

Isopropylthioimidazolidione Tablet 5
mg
Lincomycin Hydrochloride Capsule
500 mg
Mitomycin C Injection 2 mg

Dec,1972
Dec,1972
Dec,1972
Parkinsonism
Anti-cancer drug

67.
68.

Amantadine Hydrochloride
Daunorubicin
Cyproheptadine Hydrochloride
Tablet 4 mg
Trifluperidal Hydrochloride
Ethacrynic Acid U.S.P

69.
70.

Beclomethasone Dipropionate
Xantinol Nicotinate Tablet 500 mg

Topical corticosteroid

Feb,1973
Feb,1973

71.

Bronchial Asthma

Feb,1973

Vasodilating Agent
Non-thiazide saluretic diuretic

Feb,1973
Feb,1973

74.
75.
76.
77.

Salbutamol Sulphate BP Tablet 4

mg
Cyclandelate Tablet 200 mg
Ethacrynic Acid U.S.P Tablet 25mg/
50 mg
Parbendazole
Ethacridine Lactate
Stanozolol Tablet 2 mg
Oxyfedrine

Treatment of Helminthiasis
Anti-diarrheal
Coronary Vasodilator

Feb,1973
Feb,1973
Mar,1973
Apr,1973

78.

L-Asparginase

Anti-cancer drug

May,1973

79.
80.

Sutures

May,1973
May,1973

83.

Polyglycalic acid sutures

Trifluperidal Hydrochloride Injection
1 mg/ml
Trifluperidal Hydrochloride Tablet
0.25mg/0.5mg
Trifluperidal Hydrochloride Oral
liquid, 5mg/5ml
Nitrazepam

84.
85.
86.
87.
88.
89.
90.

Oxyprenolol Hydrochloride
Fluraltadone
Oxprenolol Hydrochloride
Furaltadone
Carbencillin Sodium
Lincomycin Syrup 250 mg/5ml
Prenylamine lactate Tablet 60 mg

Beta-blocker

91.

Oxyfedrine Tablet 8 mg

Coronary Vasodilator, for angina

pectoris, myocardial infarction &
coronary insufficiency.

72.
73.

81.
82.

Non-thiazide saluretic diuretic

Dec,1972
Dec,1972
Jan,1973
Feb,1973
Feb,1973

May,1973
Neuroleptic agent

May,1973
Jun, 1973

Blocker
Antibiotic

Jun,1973
Jun,1973
Jun,1973
Jun,1973
Jun,1973
Jun,1973
Jun,1973
Jul,1973

92.

Oxyfedrine Solution 10 mg

Coronary Vasodilator, for angina

pectoris, myocardial infarction &
coronary insufficiency.

Jul,1973

93.

Oxyfedrine Injection 2 mg/ml

Coronary Vasodilator, for angina

pectoris, myocardial infarction &
coronary insufficiency.

Jul,1973

94.

Tetramisole Hydrochloride 30% w/w

95.
96.

Furaltadone powder 20 % w/w

Alphachymotrypsin injection
5mg/vial
97.
Pentazocine Tablet 50 mg
98.
Morantel tartrate
99.
Carbencillin Sodium Injection 1 g
vial
100. Lorazepam
101. Fluphenazine Deconate Injection
2mg/ml
102. Nitrazepam Tablet 5 mg
103. Lyndiol Injection
104. Pindolol
105. Nitroxazepine Hydrochloride
Injection 25 mg/2ml
106. Nitroxazepine HydrochlorideTablet
25 mg
107. Pindolol Tablet 5 mg
108. Aprotonin
109. Bleomycin
110. Carbenoxolone sodium

Jul,1973
poultry disease only

Aug,1973
Aug,1973

Antibiotic

Aug,1973
Aug,1973
Aug,1973

Psychiatric drug
Antipsychotic

Sep,1973
Sep,1973

Anti-epileptic

Sep,1973

Beta-blocking agent

Sep,1973
Sep,1973
Sep,1973
Oct,1973

Beta-blocking agent
Acute Pancreatitis
Anti-cancer drug
Gastric Ulcer

Nov, 1973
Nov,1973
Dec,1973
Dec,1973

Psychiatric drug
Topical anti-inflammatory steroid

Dec,1973
Dec,1973
Dec,1973

111.
112.
113.

Malathion dusting powder 1%

Lorazepam Tablet 1mg, 2 mg
Betamethasone-17-benzoate

114.
115.

Thiophanate
Carbenoxolone sodium Tablet 50
mg
Aprotonin Injection 100000 KIU/5ml,
200000KIU/10ml

Vertinary Anti-Helminthic
Gastric Ulcer

Dec,1973
Jan,1974

Acute Pancreatitis

Jan,1974

117.
118.

Meglumine Locarbate
Tinidazole Tablets, 150 mg

X-ray contrast media

For treatment of trichomoniasis and
intestinal ameobisis

Feb,1974
Feb,1974

119.

Clomiphene Citrate B.P. Tablet,

50mg

Induction of ovulation in patients with

persistent ovulatory dysfunction who
desire pregnancy

Feb,1974

116.

120. Nitrofurantoin BP sensitivity disk

100 mcg/200 mcg
121. D-Norgestrol Tablet 0.03 mg

Mar,1974
Oral contraceptive

Apr,1974

122. Beclomethasone Dipropionate

0.025% cream & ointment
123. Lidoflazine Tablets, 60mg

Topical corticosteroid

Apr,1974

Indicated in treatment of ischemic

heart disease and prophylaxis and
after treatment of myocardial
infarction

May,1974

124. Sodium Fusidate Ointment,

20mg/gm

For treatment of staphylococcal

infections such as abscesses,
varicose ulcer.

May,1974

125. 6 aminopenicillanic acid Capsule,

250 & 500 mg

For treatment of respiratory track, GI

tract & Genital Urinary Tract
infections.

May,1974

126. Tretinoin 0.05% Vanishing cream

Jul, 1974

127. Tretinoin 0.05% lotion

128. Tretinoin 0.05% sewab
129. D-pencillamine Tablets, 300mg

Jul, 1974
Jul, 1974
Jul, 1974

130. Mesterolone Tablet 10 mg

131. Pimozide

In the treatment of Metallic poisoning

Wilsons diseases
In the treatment of potency
disturbances, infertility & hypogonadism

Jul,1974

In the treatment of chronic

schizophrenia
For treatment of acute and chronic
UTI
-

Aug, 1974

For treatment of onychomycosis,

dermatophytosis and vulvovaginitis.

Oct,1974

135. Salbutamol Sulphate Elixir 2mg/5ml

Oct,1974

136. Mebendazole Tablets, 100mg

For treatment of enterobiasis

ascarissis trichuriasis
ancylostomiasis strongyloidiasis
large round worm whipworm
hookworm & threadworm

Nov,1974

137. Bupivacaine Hydrochloride

Hyperbaric solution 10mg/ml
138. Pimozide Tablet 1mg, 4 mg

Anesthetic

Dec,1974

Neuroleptic agent & anti-psychotic

agent
Topical anti-fungal & anti-bacterial
agent

Dec,1974

132. Oxolinic acid

133. Isoptin Hydrochloride Injection 5 mg/
2ml
134. Miconazole

139. Miconazole Cream 2%

Sep, 1974
Sep,1974

Dec,1974

140. Desamino-oxytocin

Indicated in the treatment of

induction of labor for various reasons
and for adequate uterine actions

Dec,1974

141. Virginiamycin

Indicated for growth proportion in

poultry pigs and for prevention and
treatment for swine dysentery.

Feb,1975

142. Extract of centella asiatica

Indicated in treatment of ulcers,

burns, strain grafts, bed sores etc.

Feb,1975

143. Niflumic acid

Indicated in rheumatoid arthritis,

osteo arthritis
Indicated in treatment of
hypertension
-

Feb,1975

Mar,1975

Indicated in the treatment of various

types of neoplasia both acute and
chronic leukemia lymphomata. Soft
tissue sarcomata breast and lung
cancer.

Mar,1975
Apr,1975

149. Betahistine Dihyrochloride

Indicated in the Treatment of meniers

syndrome characterized by uni- & bilateral tinnitus, vertigo usually
accompanied by sensorineural
hearing loss

Apr,1975

150. Clotrimazole

Indicated against certain bacteria,

protozoa and against certain
organisms which are sensitive to
metronidazole

May,1975

151. Inj. Of a mixture of sod. Salt &

methyl glucamine salt of 3,5diacetamido-2,4,6-triiodobenzoic
acid

X-ray contrast media

May,1975

152. Clotrimazole Vaginal Tablets 0.1 gm

Anti-fungal & Local anti-trichomanial

agent
Anti-fungal & Local anti-trichomanial
agent
Anti-fungal & Local anti-trichomanial
agent
Antibiotic
Antihypertensive

Jun,1975

144. Clonidine
145. Testolactone Injection 100 mg/ml
146. Nitroglycerine Sustained Release
tablet 2.6 mg
147. lynestrenol BP Tablet 2.5 mg
148. Doxorubicin hydrochloride Injection
10 mg/vial

153. Clotrimazole 1gm/100gm cream

154. Clotrimazole 1gm/100ml Solution
155. Virginiamycin 2% premix
156. Clonidine Hcl Tablet /Capsule 100
mcg

Feb,1975
Mar,1975

Jun,1975
Jun,1975
Jul,1975
Jul,1975

157. Clonidine Hcl Tablet 150 mcg

Antihypertensive

Jul,1975

158. Carbadox

Indicated in the treatment of swine

dysentery and bacterial enteritis.

Jul,1975

159. Desoximetasone

Indicated in management of various

acute and chronic dermatitis viz
eczema, nummular eczema infantile
eczema, atopic dermatitis.

Jul,1975

160. Alphachymotrypsin Tablet 25 chg

units
161. Dimetridazole
162. Sodium Fluaride BP Tablet 20 mg

Jul,1975

Growth promotant in poultry

-

Aug,1975
Aug,1975

Aug,1975

Topical anti-fungal & anti-bacterial

agent
Topical corticosteroid

Aug,1975

163. Urea 30 % solution for Intraamniotic use

164. Miconazole Nitrate Powder 20
mg/gm
165. Malathion lotion 0.5 %
166. Desoximetasone Ointment
2.5mg/gm
167. Pentoxifylline

Sep, 1975
Sep,1975

Indicated in the treatment of arteril

and aterio venous circulatory
disorders

Sep,1975

168. Sodium Chloride 20% Hypertonic

saline for Intra-amniotic use

Oct,1975

169. Trofosfamide

Indicated in treatment of
lymphogranulomatosis,
lymphosarcoma reticulosacrcimo
ovarian carcinoma, and carcinoma of
breast.

Nov, 1975

170. Pentoxifylline Dragee 100 mg

171. Pentoxifylline Injection 100mg/5ml

Vasodilating Agent
Vasodilating Agent

Nov, 1975
Nov, 1975

172. Beclomethasone Dipropionate MDI

50 mcg
173. Cephradine

Dec,1975

Indicated in treatment of infections of

GI, Gentio urinary, respiratory and
soft tissue.

Jan,1976

174. Mefenamic acid

Indicated in treatment of acute and

chronic pain, post-operative and
post-partum pain, headache,
traumatic pain, muscular pain.

Jan,1976

175. Catalin (Sodium 1-hydroxy-5-oxo5H-Pyrido(3.2-a) phenoxazine-3carboxylate)

Indicated in the treatment of cataract

Jan,1976

176. Glydiazinamide

Indicated in treatment of diabetes

Feb,1976

177. Cephradine Capsule 250/500 mg

Antibiotic

Mar,1976

178. Cephradine Injection

250mg/500mg/1g/vial
179. Cephradine Suspension 250/5ml

Antibiotic

Mar,1976

Antibiotic

Mar, 1976

180. Metronidazole Suspension 125

mg/5ml
181. Extract of centella asiatica 2%
injection
182. Extract of centella asiatica 200 mg
Tablet
183. Extract of centella asiatica Ointment
1%
184. Extract of centella asiatica Powder
2%
185. Oxibendazole premix 1.33% w/w

Apr,1976

Treatment of ulcers, strain grafts, bed

sores
Treatment of ulcers, strain grafts, bed
sores
Treatment of ulcers, strain grafts, bed
sores
Treatment of ulcers, strain grafts, bed
sores
Indicated in the treatment of gastrointestinal mematodes, infection of
cattle, sheep, horses and other
domestic animals.

May, 1976

186. Aminosidine Sulphate Inj. Vial,

500mg

Indicated in the treatment of styphylo

coccus sepsis, infection of
respiratory tract due to styphylo
coccus and pneumo coccus infection
of the urinary tract due to E coli, P
vulgaris, gonococcus infections.
Resistant to other antibiotics.

May, 1976

187. Clonidine Hcl Injection 150mcg/ml

Antihypertensive

Jun, 1976

188. Halcinomide

Indicated in the treatment of various

common dermatosis
-

189. Dexchloropheniramine maleate

Tablet 2 mg
190. Trofosfamide Tablet 50 mg
191. Metronidazole Suspension 200
mg/5ml
192. Disodium chromoglycate Nasal
drops 2%
193. Valethamate bromide
194. Asiaticoside
195. Loperamide

196. Tetramisole Hydrochloride Syrup

50mg/5ml
197. Metclopramide

May, 1976
May, 1976
May, 1976
May, 1976

Jul,1976
Jul,1976

Anti-cancer drug
-

Aug, 1976
Aug,1976

Sep,1976

Indicated in acute diarrhea due to

food poisoning and viral infections.

Nov,1976
Nov,1976
Dec,1976

Dec,1976

Anti-emetic

Dec,1976

198. Fusafungin

Indicated in the treatment of sinusitis,

pharyngitis, sour throat, laryngitis,
bronchitis, prevention of respiratory
complication

Jan,1977

199. Flupenthixol

Indicated in psychiatric or
schizophrenic cases where sedative
and hypnotics effects are contra
indicated

Jan,1977

200. Isometanidium Chloride

Indicated in treatment of cardiac

arrhythmias including atrial
fibrillation, ventricular tachycardia,
arrhythmia

Jan,1977

201. Iron Polymaltose eq to Elemental

Iron Drops 50 mg/ml
202. Flupentixol Hydrochloride Tablet 0.5
mg
203. Fusafungin aerosol 25 mg
204. Loxitalmic Acid

Feb,1977

Feb,1977

Fungal Antibiotic
cerebral angiography and urography
(X-ray contrast media)

Mar,1977
Apr, 1977

205. Dothiepin Hydrochloride

Indicated in treatment of psychotic

depression neurotic depression,
anxiety depression

May, 1977

206. Norethisterone BP Tablet 0.35 mg

May,1977

207. Disopyramide Capsule 100 mg

Jun, 1977

208. 1-(2-tetrahydrofuryl)-5-flourouracil

Indicated in treatment of cancer of

stomach, colon, rectum, breast &
lung.

Jun, 1977

209. Fluphenazine Deconate Depot

Injection 20 mg/ml
210. Cyclandelate Capsule 200 mg
211. Nimorazole

Antipsychotic

Jul,1977
Jul,1977
Sep, 1977

212. Suramin Inj.

213. Doxapram Hydrochloride

Vasodilating Agent
Indicated for treatment of
trichomoniasis
veterinary Drug
For treatment of post-operative
respiratory depression and
respiratory depression due to
poisoning

214. Sulfinpyrazone Tablet 100 mg

Sep,1977

215. Sulfinpyrazone Capsule 200 mg

Sep,1977

216. Ethacridine lactate Injection 1mg/ml

Oct, 1977

217. Nimorazole Tablet 250 mg

Indicated for treatment of

trichomoniasis

Oct, 1977

Sep, 1977
Sep,1977

218. Pentazocine Lactate Injection 30

mg/ml
219. 5-Fluorouracil Capsule 250 mg
220. Orphenedrine Citrate Injection
60mg/2ml
221. Fluprednylidine 21-Acetate

Oct,1977

Nov,1977
Nov,1977

Indicated in treatment of allergic

pruritus and inflammatory dermatosis

Dec,1977

222. Beta-methyl Digoxin

Dec,1977

223. 2-Pyrrolidone Acetamide

Indicated in treatment for behavior

and psychotic problems in old age
and mental retardation in children

Dec,1977

224. Diazepam Injection 5mg/ml

225. Gentamycin Injection 2 mg/ml
226. Fluprednylidine 21-Acetate Cream
0.1%
227. 2-Pyrrolidone Acetamide Capsule
400 mg
228. 2-Pyrrolidone Acetamide Injection
200mg/ml
229. Diethylamine Salicylate Cream 10%
w/w
230. Beta-methyl Digoxin Tablet 0.1 mg &
0.05 mg
231. Beta-methyl Digoxin Liquid 0.6 mg

Topical Corticosteroid

Dec,1977
Jan,1978
Jan,1978

Psychotic Drug

Jan,1978

Psychotic Drug

Jan,1978

Mar,1978

Cardiac glycoside

Mar,1978

Cardiac glycoside

Mar,1978

232. Beta-methyl Digoxin Injection 0.1

mg
233. Methyl predinsolone

Cardiac glycoside

Mar,1978

Indicated for conditions requiring

glucocorticoid activity including
collagen diseases allergic diseases,
hyper sensitivity reactions

Mar,1978

234. N-phenylethylanthranilic acid

Capsule 300 mg
235. Chlorpheniramine maleate USP
Sustained Release Tablet 8 mg
236. Sulphametopyrazine

Apr,1978

Apr,1978

The drug in combination with

pyrimethamine for the treatment of
cases of malaria which are resistant
to chloroquine

Jun, 1978

237. Flavonoids Extracted from Rutacea

(Aurantiaceae) containing standard
amount of Diosmin

Indicated in the treatment of

Hemorrhoids

Jun, 1978

238. Miconazole Nitrate Vaginal Passary

100 mg

Jun,1978

239. Soyabean Protein 33.2 g/150 g

240. Salcatonin
241. Dicloxacillin Sodium

Polypeptide hormone
Indicated in infection of respiratory
tract, skin & mucosa, bone infection.

Jun,1978
Jul, 1978
Jul, 1978

242. Sotalol

Indicated in treatment of angina

pectoris. Hyper tension cardiac
arrhythmias

Aug, 1978

243. Diazoxide

Indicated for reduction of blood

pressure in malignant hypertension

Aug, 1978

244. Povidone Iodine USP Scrub 4%

Sep, 1978

245. Povidone Iodine USP Solution 5%

Sep, 1978

246. Povidone Iodine USP Ointment 5%

Sep, 1978

247. Ifosfamide

Indicated in the treatment of ovarian

breast testicular carcinoma
hypernaphroma, pancreatic
carcinoma and malignant lymphoma

Sep,1978

248. Zinc Sulphate IP Capsule 220 mg

Sep,1978

249. Human Placental Extract Injection

Sep,1978

250. Indapamide Hemihydrate Tablets,

2.5mg
251. Glucagon Injection

For mild to moderate hypertension

Oct, 1978

Indicated in the treatment of severe

hypoglycemic reactions in diabetic
patients

Oct, 1978

252. Amitryptylline Hydrochloride Tablet

75 mg
253. Oxymetazoline Hydrochloride 0.25%
(Paediatric)
254. Bleomycin Injection 5 mg
255. Metronidazole Injection IV 2mg/ml

Oct,1978

Anti-cancer drug
-

Oct,1978
Nov,1978

256. Choline Salicylate solution 8.7%

Nov,1978

257. Doxapram Hydrochloride Injection

20mg/vial
258. Amoxycillin

Nov,1978

Indicated in treatment of UTI,

Respiratory, Genito Urinary, ENT &
soft tissue infections

Dec,1978

Treatment of headache, body ache,

fever, rhinitis sinusitis

Dec,1978

259. Benorylate

Oct,1978

260. Mebendazole Suspension 100

mg/5ml
261. Trichlormethiazide Tablets, 2mg

Broad Spectrum Antibiotic

Dec,1978

In the treatment of hepatic cirrhosis,

edema hypertension.

Dec,1978

262. Cralanthamine Hydrobromide Tablet

& Injection

Treatment of neuritis, poliomyelitis &

infantile cerebral palsies

Dec,1978

263. Benorylate Tablet 250 mg

264. Benorylate Suspension 2g/5ml
265. 5-Fluorouracil Oral Solution
250mg/5ml
266. Salbutamol Sulphate Injection
50mg/5ml
267. Amoxycillin Capsule 250mg &
500mg

Analgesic & Anti-pyretic

Analgesic & Anti-pyretic
-

Dec,1978
Dec,1978
Jan,1979

Bronchial Asthma

Jan,1979

Antibiotic

Jan,1979

268. Amoxycillin Syrup 125mg/5ml &

250mg/5ml

Antibiotic

Jan,1979

269. Amoxycillin Paediatric Suspension

125mg/1.25 ml

Antibiotic

Jan,1979

270. Imipramine Pamoate Capsule 75

mg/ 150 mg
271. Naproxen Tablets 250 mg

Indicated in the treatment of all forms

of depression
Indicated in treatment of rheumatoid
arthritis

Jan,1979

272. Allergen extracts

273. Fenbendazole

274. Chlorphenoxamine Embonate Syrup

17.5mg/5ml
275. Carboprost Tromethamine Sterile
Solution 250 mcg/ml
276. Miconazole Nitrate Solution 2%
277. Ifosfamide Injection
200mg/500mg/1g/vial
278. Clemastine

Indicated in treatment of
gastrointestinal nematodes infections
of live stocks

Jan,1979
Jan,1979
Jan,1979

Mar, 1979
For treatment of second trimester
abortions only

Mar, 1979
Mar,1979
Mar,1979

Treatment of rhinitis urticaria, pruritus

itching dermatoses

Apr, 1979

279. Isoxuprine Hydrochloride Sustained

Release Tablet 40 mg

Apr,1979

280. Ibuprofen Suspension 100mg/5ml

Apr,1979

281. Oxyfedrine Tablet 24 mg

Apr,1979

282. Niflumic acid Capsule 250 mg

283. Diosmin Tablet/Capsule 150 mg

Indicated in treatment of
hemorrhoids
Antibiotic

May,1979
Jun,1979

Indicated in rheumatoid arthritis,

osteoarthritis and allied disorders

Jul, 1979

286. Clopamide Tablet 20 mg

Indicated in the treatment of edema

of cardiac, hepatic or renal region
and hypertension only.

Jul, 1979

287. Sodium Nitroprusside USP Injection

50mg/vial
288. Desoximetasone Ointment 0.05%

Jul,1979

Topical corticosteroid

Jul,1979

Aug,1979

Antibiotic

Aug,1979

Antibiotic

Aug,1979

Aug,1979

Indicated in treatment of vaginal

irritation and discharge due to
monilial, trichomonial infection

Sep, 1979

294. Betamethasone Dipropionate

Ointment 0.5mg/g

Indicated of treatment of Psoriasis

contact dermatitis, atopic dermatitis,
neuro dermatitis senile pruritus

Sep, 1979

295. Silver Sulphadiazine Cream 1% w/w

Indicated in treatment of burns and

wound infections
Indicated in treatment of bronchitis
and other conditions where sputum is
troublesome

Sep, 1979

297. Bromhexine Hydrochloride Elixir

4mg/5ml

Indicated in treatment of bronchitis

and other conditions where sputum is
troublesome

Sep, 1979

298. Amiloride HCl Tablet 5 mg

Indicated in treatment of edema and

hypertension
-

Sep, 1979

Sep,1979

284. Amoxycillin Injection

250mg/500mg/1g/vial
285. Flurbiprofen Tablet 50 mg & 100 mg

289. Tetracycline Sustained Release

Capsule 250 mg
290. 6 aminopenicillanic acid Injection
250 & 500 mg
291. 6 aminopenicillanic acid Oral
Suspension 125mg/5ml, 250mg/5ml
292. Dicloxacillin Sodium Capsule 125
mg & 250 mg
293. Natamycin cream 2%

296. Bromhexine Hydrochloride Tablet 8

mg

299. Dioctyl Sodium Sulfosuccinate USP

Ear Drop 5%
300. Dicloxacillin Sodium Oral Solution
62.5 mg

Jun,1979

Sep, 1979

Sep,1979

301. Natamycin Vaginal Tablets 25 mg

Oct, 1979

302. Albendazole Suspension 2.5 % w/v

& 10% w/v

Indicated in control of Gastro

Intestinal round warm, tap warm,
lung warm and adult liver flukes in
cattle and sheeps.

Oct, 1979

303. Terbutamine Sulphate Tablet 5 mg

Indicated in treatment of asthma

Nov, 1979

304. Terbutamine Sulphate Syrup 0.3

mg/ml
305. Dilazep Tablets 50 mg

Indicated in treatment of asthma

Nov, 1979

Indicated in treatment of coronary

insufficiency, coronary sclerosis,
angina pectoris as well as for
prophylaxis and follow up treatment
of myocardial infarction.

Nov,1979

306. Terbutaline Sulphate Tablet 2.5 mg

& 5 mg
307. Terbutaline Sulphate Syrup
0.3mg/ml
308. Glycopyrrolate Injection 0.2 mg/ml

Nov,1979

--

Nov,1979

Anesthetic agent

Dec,1979

309. Dopamine HCl Injection 200 mg/5ml

Indicated for treatment of

hemodynamic imbalances present in
the shock syndrome due to
myocardial infraction, trauma
endotoxic septicemia, open heart
surgery and renal failure.

Jan,1980

310. Estriol Succinate Tablet 2 mg

Indicated in treatment of local and

general complaints arising from
diminished estrogen production after
menopause and after surgical
removal of ovary.

Mar, 1980

311.

Mar,1980

Bronchial Asthma

Mar,1980

Aid in treatment of chronic

respiratory disease in chicken and for
maintaining weight gain feed
efficiency.

May, 1980

Indicated for treatment of benign

gastric duodenal recurrent and
stomal ulceration, reflux esophagitis

May,1980

Amoxicillin Dispersible Tablet 125

mg
312. Salbutamol Sulphate Sustained
Release Tablet 8 mg
313. Tylvalosin Tartarate

314. Cimetidine Injection 100mg/ml

315. Cimetidine Tablet/Capsule 200 mg

Indicated for treatment of benign

gastric duodenal recurrent and
stomal ulceration, reflux esophagitis

May,1980

316. Cimetidine Syrup 200mg/5ml

Indicated for treatment of benign

gastric duodenal recurrent and
stomal ulceration, reflux esophagitis

May,1980

317. Trimetazidine Dihydrochloride Tablet

3 mg

Indicated in treatment of angina

pectoris and intermittent claudication

Jun, 1980

318. Cytrabine Injection

Indicated in treatment of acute

myeloid leukemia
Indicated in treatment of breast
cancer in pre and post-menopausal
women

Jun, 1980

319. Tamoxifen Citrate

320. Xipamid Tablet 40 mg

321. Halofuginone
322. Methicillin Sodium

323. Terbutaline Sulphate Injection 0.5

mg/ml
324. Levamisole Hydrochloride Injection
15% & 30% w/v
325. Levamisole Injection 18.2% w/v
326. Medrysone Ophthalmic Suspension
1.0%
327. Bumetionide Tablet 1 mg

Jun,1980

Jul, 1980
For prevention and treatment of
poultry coccidiosis
indicated in treatment of infections
due to penicillinase producing
staphylococci

Jul, 1980

Jul,1980

Jul,1980

Jul,1980
Jul,1980

Jul, 1980

Indicated in treatment of edema

associate with congestive heart
failure, coronary edema, hepatic
ascites and renal disease including
nephortic syndrome

Aug, 1980

328. Bumetionide Injection 0.25 mg/ml

Indicated in treatment of edema

associate with congestive heart
failure, coronary edema, hepatic
ascites and renal disease including
nephritic syndrome

Aug, 1980

329. Lomustine Capsule 10 mg, 40 mg &

100 mg
330. Quinpramine Sulphate
331. Quinpramine Chloride

Aug, 1980

Aug,1980
Aug,1980

332. Fenpipramide Methobromide and

para-piperdinoethoxy ocarboxymethoxy benzophenol
hydrochloride

Oct,1980

333. Azatidine Maleate Tablet 1 mg

334. Flavoxate HCl Tablet 100 mg

Anti-allergic
For relief of dysuria urgency,
nocturia, suprapubic pain, frequency,
Incontinence prostatitis, urethritis,
urethrotrigenitis, vaso urethral
spasms.

Nov, 1980
Nov,1980

335. Econazole Nitrate Cream 1%

Topical Antifungal

Dec,1980

336. Econazole Nitrate Vaginal Tablets

150 mg
337. Cephalothin Sodium

Topical Antifungal

Dec,1980

In the treatment of Infections of soft

tissue, respiratory and urinary tract,
meningitis, other infections due to
susceptible organisms and in the
treatment of infection due to penicillin
resistant strains of staphylococci.

Dec,1980

338. Plantago Ovata (Isapgol) seed husk

(I.P)
339. Mesterolone Tablet 25 mg

Mar,1981

Mar,1981

340. Ketoprofen Tablets/Capsule 50mg

Indicated in the treatment of

rheumatoid arthritis osteoarthritis,
ankylosing spondylitis, gout.

Apr, 1981

341. Sulphadoxine

Indicated for the treatment of cases

of malaria which are resistant to
chloroquine

Apr, 1981

342. Procarbazine

For treatment of Hodgkins disease

Apr, 1981

343. Inactivated rabies vaccine (Human

Diploid cell)
344. Sisomicin Sulphate

For the treatment of rabies.

Apr, 1981

Indicated in treatment of and

systemic and local infections of
kidney, genito urinary tract, LRTI,
septicemia, soft tissue infections, GIT
infections, infection of CNS peritonitis
or pelvic

Apr, 1981

345. Tamoxifen Citrate Capsule 10 mg

346. Terizidone

Apr,1981
Indicated in treatment of
Tuberculosis

Jun, 1981

347. Azabiperidol

Indicated in treatment of acute and

chronic schizophrenia anxiety,
neurosis, manic depressive
psychosis & hyper kinetic children.

Sep,1981

348. Clindamycin

Indicated in treatment of gram

positive organism pathogen,
staphylococci and streptococci,
pneumococci etc.

Oct,1981

349. Sodium Valporate

Indicated in treatment of all forms of

epilepsies
Indicated in lumber thoracic cervical
& total columnar myelography, direct
ventriculography etc.

Oct,1981

350. Metrizamide

351. Sodium-2-mercepto-ethane
sulphonate

Indicated for prevention of urotoxic

side effects associated with
treatment of malignant tumors by
oxazaphosphorines

Nov, 1981

Dec,1981

Approval Status of New Drug during 1982-1992

S
No

Drug

Nitroglycerin ointment

Danazol capsule
100mg/200mg

Metoprolol Tartrate tablet 50

mg/100mg
Cisplatin injection 10 mg/ 50
mg per vial
Urokinase for Injection

Rosoxacin Capsules 150 mg

7
8
9

Magaldrate tab 400 mg

Fenbendazole
Measles Mumps Rubella
Vaccine
Ethacridine lactate 100 mg/
200 mg
Rifampicin syrup
Trimethoprim tablet 100 mg
Disopyramide inj. 100 mg/5 ml
& 150 mg/7.5 ml
Tinidazole suspension 75 mg/5
ml
Ponderax SR tab.60 mg
Nifedipine capsules 5 mg/ 10
mg
Septopal Beads and Chains

10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29

Timolol Maleate oph. Solution

2.5 mg/ml
Flurazepam capsules 15 mg/
30 mg
Tonazoline HCl nasal drop
0.08% sol.
Metoprolol inj. 1 mg/ml
Praziquantel tablet 600 mg
Nimustine HCl inj. 25 mg/ 50
mg per vial
Carboquone tablet 0.25 mg/
0.5 mg
Carboquone inj. 1 mg/ vial
Centbucridine inj. 0.5 %
Etomidate inj.2 mg/ ml
Cinnarizine tablet 25 mg/15
mg

Indication

Date of
Approval

For treatment of Angina Pectoris due to

coronary artery disease
Indicated in the treatment of endometriosis,
gynaecomastia, fibrocystic mastitis,
precocious puberty and pubertal breast
hypertrophy
Indicated in treatment of hypertension

Jan-82

Indicated in the treatment of metastatic

testicular and ovarian cancer
Indicated in treatment of pulmonary
embolism and thromboembolic disorders
involving deep veins
Indicated in treatment of gonorrhoeal
Urethritis
----

Mar-82

Mar-82
Apr-82
May-82
Jul-82
Nov-82
Jan-83
Feb-83

--

Jun-83

----

Jun-83
Jun-83
Aug-83

--

Dec-83

---

Sep-84
Dec-84

For treatment of Bones and Soft Tissue

infections
For treatment of Chronic Open angle
Glaucoma , Ocular Hypertension
--

Jan-85

Aug-85

Nasal Decongestant

Aug-85

Jul-85

----

Aug-85
Aug-85
Aug-85

--

Aug-85

----

Aug-85
Aug-85
Aug-85
Aug-85

--

Aug-85

anaesthetic

Mianserin HCl tablet 10/20/30

mg

S
No

Drug

Indication

Date of
Approval

30

Netilmicin sulphate inj. 10 mg/

25 mg/ 100 mg per ml

Aug-85

31
32

---

Aug-85

38

Spectinomycin hydrochloride

39

Tobramycin inj. 10/40 mg per

ml

40

Monensin Sodium premix

41

Cefazolin Sodium inj. 250 mg,

500 mg & 1 gm. per vial

42

Diclofenac Sodium tablet

25/50 mg

43

Nadolol

44

Testosterone Undecanoate
capsules 40 mg

45

Dextranomer sachet 4 gm. & 6

gm. per sachet

46

Serratio peptidase tablet 5 mg

47

Cimetidine inj. 100 mg/ ml

Indicated in the treatment of CHD and

anti-anginal
-In the treatment of hypertension angina
pectoris cardiac arrhythmias
Indicated in the treatment of acute
gonorrhoeal urethritis & proctitis in male
and acute gonorrhoeal cervicitis & proctitis
in female
In the treatment of serious bacterial
infections such as sceptical lower
respiratory tract infections , serious central
nervous system infections, abdominal l
infections complicated and recurrent
urinary tract infections & skin and bone
infections
In the treatment of Coccidiosis in chicken
and hens
In the treatment of serious infections due &
susceptible organisms, respiratory tract
infections urinary biliary tract infections.
In the treatment of
rheumatoid arthritis ,osteoarthritis
ankylosing spondylitis gout, painful post
operatic pain following dental surgery etc.
In the treatment
angina pectoris, cardiac arrhythmias and
essential hypertension
Indicated for
replacement therapy in cases of
hypogonadism and male climacteric in the
treatment of gynaecomastia
In cleansing secreting
wounds like venous stasis ulcers,
decubitus ,ulcers infected traumatic ulcers
& infected tumours
Indication for the
remission of various inflammatory
disorders including post-operative
inflammation and traumatic injury.
--

Aug-85

36
37

Ranitidine tablet 150 mg

Hydrocortisone Butyrate
cream/ ointment 0.10 %
Mexiletine inj. 250 mg/ 10 ml
Mexiletine capsules 50/150
mg
Isosorbide Mononitrate tablet
20/40/60 mg
Aminoglutethimide
Atenolol tablet 50 mg/ 100 mg

Indicated in the treatment of Septicaemia

including neonatal sepsis and other severe
systemic infections.
---

48

Econazole ophthalmic
ointment 1%
Propranolol HCl SR tablets

in treatment of fungal infection of the eye

Sep-85

33
34
35

49

--

Aug-85
Aug-85

Aug-85
Sep-85
Sep-85

Sep-85

Sep-85
Sep-85
Sep-85

Sep-85
Sep-85

Sep-85

Sep-85

Sep-85

Sep-85

80/160 mg

S
No
50
51

Drug
Bleomycin Oil Suspension
injection.
Ciclopirox Olamine solution/
cream 10 mg/ ml

52

Bacampicillin tablet 400 mg

53

Captopril tablet 25/50 mg

54

Ivermectin solution 10 % w/v

and 1% w/v injection

55

Nicergoline sugar coated

tablet,5 mg/ 30 mg

56

Amoxapine tablet 25/ 50/ 100

mg

57

Purified chick Embryo

58

amoseanate tablet 250 mg.

59

Satranidazole tablet 150 mg

60

Benserazide Hydrochloride

61

Acebutolol Hydrochloride
capsule 100 mg/ 200 mg/ 400
mg

62

Acebutolol Hydrochloride
injection 5 mg

63

Atracurium Dibesylate
Injection

64

Sulprostone injection

65

Praziquantel tablet

Indication

Date of
Approval

Indicated in the
treatment of cancer
Indicated in the
treatment of fungal infections of the skin
and vagina.
Indicated in the
treatment of Upper & lower respiratory
tract infections, urinary tract infection, skin
infections, post-operative infections.
Indicated in the
treatment of hypertension only
Indicated for the
control of various helminthic infections
such as round worm.
Indicated in the
treatment of acute chronic peripheral and
cerebral vasculometabolic disorders,
Raynaud's syndromes and all syndromes
due to altered peripheral loss.
Indicate for the relief
of symptoms of depression in patients with
neurotic or reactive depressive disorders
as well as endogenous and psychotic
depressions, depression accompanied by
anxiety and agitation.
Indicated for
treatment after explosive of rabies for preexposure prophylaxis.
Indicated in treatment of adult hookworm
infestations.
--

Sep-85

To be used only in
the manufacture of capsules containing this
drug in combination with Levodopa for the
treatment of Parkinsons disease.
Indicated in the
management of all grades of hypertension
angina pectoris and control of
tachyarrhythmia.
Indicated in the
management of all grades of hypertension
angina pectoris and control of
tachyarrhythmia.
Indicated for use in
anaesthesia to relax muscle during surgical
procedures and to facilitate controlled
ventilation.
For second trimester
abortions only
In the treatment of
infections brought about the larvae of the
pork tapeworm in the Central Nervous
system.

Nov-85

Oct-85
Oct-85

Oct-85
Oct-85
Oct-85

Nov-85

Nov-85
Nov-85
Nov-85

Dec-85

Dec-85

Jan-86

Jan-86
Feb-86

S
No

Drug

Indication

Date of
Approval

66

Albendazole tablet 200mg /

400 mg
Albendazole suspension
200mg / 5 ml
ranitidine injection 50 mg /2
ml
Pentoxifylline dragees 400 mg
infectious bursal disease
vaccine
Buserelin Acetate (Lutenizing
Hormone)

--

Feb-86

--

Feb-86

--

Feb.86
March.86
March.86

67
68
69
70

72

Buprenorphine

73

Receptal injection

-For treatment of infectious bursal disease

in poultry
Indicated in the
treatment of infertility of ovarian origin for
the induction of ovulation and improvement
of conception rate in cows, mares &
rabbits.
Indicated in the
treatment of post -operative pain, premedication before surgery & myocardial
pain.
--

74

Venoprin injection

--

Apr-86

75

Noristerat injection

Apr-86

76
77
78
79

Biclotymol
Dynoprost inj. 5 mg
Carboprost Tromethamine
Lopamidol Sterile Sol

80

Iohexol Sterile Sol.

81

Medroxy progesterone acetate

Tablet

82

Amikacin injection

83

Vecuronium Bromide

84

Luprostiol

85

Flutamide

86

Nitroglycerin injection

Indicated for
contraception
Respiratory Infections, Bronchitis
-Vet. Only
Indicated in
neuroradiology angiography urography
arthrography etc.
( X-ray Contrast medium)
Indicated in
neuroradiology angiography urography
arthrography etc.
( X-ray Contrast medium)
Indicated in the
treatment of secondary amenorrhea and
functional uterine bleeding to hormonal
imbalance only.
Indicated in the
treatment of serious infections due to
amikacin sensitive organisms
Indicated for use in
anaesthetic to relax muscle during surgical
procedures and to facilitate, contracted
ventilation.
Indicated in the
treatment of corpora luteal, induction of
abortion etc.
Indicated for palliative
treatment of advanced prostatic cancer
only
Indicated in the
treatment of angina pectoris myocardial
infection etc.

71

Drug

Indication

Apr-86

Apr-86

Apr-86

May-86
May.86
May-86
Jun-86

Jun-86

Jun-86

Jun-86
Jun-86

Jun-86
Jun-86
Jun-86

Date of

No

Approval

87
88

Gugulipid
Hydrotalcite

--

89

Flutamide tablet

90

Prosolvine inj. 7.5 mg/ ml

--

Jun-86

91

Estramustine Phosphate
capsule
Prednimustine tablet

Jul-86

Indicated in
treatment of flatulence hyperacidity gastritis
heart burn, dyspepsia etc.
anti-cancer

Jun.86
Jun-86
Jun-86

94

Polyestradiol Phosphate
injection
Epirubicin injection

95
96

Doxorubicin inj. 10 mg
Tiamulin Hydrogen Fumarate

97

Piroxicam tablet

98
99

Tiamulin soluble granules

Tiaprofenic Acid

100

Secadrex tablet

Indicated in the
treatment of prostatic carcinoma.
Indicated in the
treatment of chronic lymphocytic
leukaemia, Non- Hodgkins lymphoma
and breast cancer
Indicated in the
treatment of prostatic carcinoma
In the treatment of
breast cancer, Malignant lymphomas, soft
tissue sarcoma gastric lung and ovarian
carcinomas.
-In the prevention and treatment of
mycoplasma induced disease of the
respiratory tract including complication due
& secondary infections only (Vet. Use
only).
In the treatment of
rheumatoid arthritis, osteo. Arthritis
ankylosing spondylitis, cervical spondylitis
and other musculoskeletal disorders.
-In the treatment of
post-operative period, sprains fracture
various traumatic conditions.
--

101

Debriphor beads

--

Aug-86

102

Articaine Hydrochloride

Aug-86

103
104

Clobetasone -17- butyrate

cream/ointment 0.05%
Reproterol Hydrochloride

105

Clostebol acetate

106

Ketoconazole tablet 200 mg

and Ketoconazole suspension
20mg/ml

107

ketoconazole vaccine(Killed)

For Spinal infiltration dental surgical &

epidural anaesthesia
In the treatment of mild eczema, dermatitis
and other steroid responsive disorders
In the treatment of conditions involving
reversible airways obstruction viz.
bronchial asthma, bronchitis etc.
Preparation containing the drug with
Neomycin shall be indicated in the
treatment of infected wounds and & 2nd
degree burns.
In the treatment of systemic fungal
injections, candidiasis chronic
mucocutaneous candidiasis Vaginal
candidiasis etc.
in the treatment of parvo-virus infections in
dogs only

Indication

Date of
Approval

92

93

S
No

Drug

10 mg

Jul-86

Jul-86
Jul-86

Jul-86
Jul-86

Aug-86

Aug-86
Aug-86
Aug-86

Sep-86
Sep-86
Sep-86

Oct-86

Oct-86

108

Canine Distemper

109

Sucralfate tablet 1 gm.

110

Propafenone Hydrochloride

111

Tiaprofenic Acid tablet 200 mg

and 300 mg
Centbutindole

112
113
114
115

Clobetasone butyrate
creams/ointments 0.05 %
Labetalol Hydrochloride

Vaccine against canine distemper

parvovirus infectious canine hepatitis and
leptospirosis.
In the treatment of gastric duodenal and
benign ulcer.
Indication in the treatment of ventricular
extra systoles supra ventricular tachycardia
etc.
--

Nov-86

Neuroleptic agent

Dec.86
--

Indication in the treatment of all forms of

hypertension ( except Hypertension of
pregnancy)
--

Nov-86
Nov-86
Dec.86

Dec.86
Dec-86

117

Propofenonen tablets 150 mg/

300 mg
Propofenonen injection 70 mg/
20 ml ampoule
Repreterol tablet 20mg

118

Repreterol syrup 10mg/ 5 ml

--

Jan.87

119

Labetalol Hydrochloride tablet

50 mg/ 100mg/ 200 mg
Hepatitis B Vaccine

--

Jan.87

116

120
121
122

124

Centbutindole tablets 1.5 mg

Carbocaine injection 2 % -20
mg
Sulprostone injection 500 mcg/
ampoule
Bleomycin Injection

125

Clavulanic Acid

126

Trazadone

127
128

Infectious coryza vaccine

Polidocanol Injection

129

Tobramycin ophthalmic
solution 0.03% per vial
Acyclovir Tablets/ Cream/
Ointment/ Ophthalmic
Ointment

123

130

131

Cefotaxime Sodium injection

0.25, 0.5, 1 and 2 gm./ vial

Jan.87

--

Jan.87

--

Jan.87

For treatment of hepatitis B virus infection

Jan.87

---

Feb.87
Feb.87

--

Feb.87

Indication in the treatment of prostatic

carcinoma ,breast cancer, melanoma and
carcinomas of the head neck and lungs
To be used in combination with Amoxicillin
only in the treatment of Bacterial injections
Indicated in the treatment of all types of
depression
-Indicated in the treatment of sclerosation of
various cutaneous veins and oesophageal
varicose haemorrhoids haemangioma
--

Feb-87

Indicated in the treatment of herpes

simplex virus infections of the skin
including initial and recurrent genital
herpeslabialise herpes simplex keratitis
--

Feb-87
Mar-87
Marc.87
Mar-87
April.87
May-87

Jun-87

S
No

Drug

Indication

Date of
Approval

132

Diclofenac sodium injection 75

mg/ 3 ml ampoule
Diltiazam

--

Jun-87

133

Indicated in the treatment of angina

Jul-87

134

Alclometasone Dipropionate
cream/ointment0.05%

135

Trazodone tablet 25 mg/ 50

mg/ 100 mg
Bromocriptine Mesylate tab.
2.5 mg, 5 mg and 10 mg

136

137

Carbocisteine

138
139
140
141

Nova-T
Flumequine
Stanozolol injection 50 mg/ ml
Neutral insulin and Insulin Zinc
suspension
Broncospasmin tablet 20 mg
Broncospasmin elixir 10 mg/
5ml
Broncospasmin respiratory
solution 10 mg/ml
Broncospasmin injection 0.09
mg/ml
Clobetasol Propionate
cloxacillin benzathine intramammary infusion 500 mg
Rabies Veterinary
Vaccine(inactive)
Domperidone tablet 10 mg ,
oral drops 10 mg/ml and
suspension 10 mg/ml, rectal
suppositories 30 mg
Norfloxacin tablet 400 mg/ 800
mg and ODT 100 mg

142
143
144
145
146
147
148
149

150

151
152

Influenza Vaccine
Ozothine tablet 60 mg

153

Ozothine syrup 60 mg /5 ml

154

Auranofin capsules 3 mg

155
156

Chenodeoxycholic acid
Buprenorphine sublingual
tablets 0.2 mg
Propranolol HCL SR capsules
80 mg
Measles, mumps and rubella
vaccine
Etoposide Capsule

157
158
159
160
161

Diclofenac Sodium SR Tab.

75/100mg
Bezafibrate

pectoris and chronic stable angina only

Indicated for the relief of the inflammatory
and pruritic manifestations of corticosteroid
responsive dermatomes
-In the treatment of prolactin dependent
menstrual cycle disorders female infertility
pre-menstrual syndrome hyper
prelactinoma in men. .
Indicated as an adjunctive therapy in
respiratory disorders
IUD
RTI
-In the treatment of insulin requiring
diabetes by inj. or infusion
---

Jul-87
Jul-87
Jul-87

Aug-87
Aug-87
Sep-87
Sep.87
Sep-87
Oct. 87
Oct. 87

--

oct.87

--

Oct. 87

---

Oct-87
Oct.87

--

Nov-87

Indicated in the treatment as gastric motility

disorder etc.

Nov-87

In the treatment as acute

uncomplicated/complicated chronic,
recurrent urinary tract injections including
pyelonephritis cystitis, urethritis &
gonococcal infections.
For treatment of influenza in equine
In the treatment of acute chronic infections
of respiratory tract..
In the treatment of acute chronic infections
of respiratory tract..
In the treatment of rheumatoid arthritis and
in children with Juvenile rheumatoid
arthritis.
---

Nov-87

--

Dec.87

--

Dec-87

Nov-87
Dec-87
Dec-87
Dec-87
Dec-87
Dec.87

In the treatment of small cell lung cancer,

malignant lymphomas acute etc.
--

Jan-88

In all form of hyper lipoproteinaemia.

Jan-88

Jan-88

162
163

Amineptine
Astemizole

164
165
166

Budesonide
Penfluridol tablet 20 mg
Aclarubicin HCl

167

Etoposide injection 100mg/ 5

ml ampoule
Zidovudine Capsules

168

169
170

Silver sulphadiazine eye

ointment. 1%
Ceftriaxone sodium

171
172

Minoxidil
Benzydamine topical analgesic

173

Interferon alpha injection

174

Melagenina Lotion

175

Amrinone Lactate

176

Ethamsylate tablet 250 mg/

500 mg

177

Minocycline

178

180
181

Alprazolam tablets 0.25

mg/0 .5 mg/ 1 mg
Cefuroxime injection 250 mg/
500 mg / 1 gm. per vial
Tertatolol Hydrochloride
Cyclosporine

182

Ceftazidime Pentahydrate

183

Gemfibrozil Capsules 300 mg /

900 mg

184
185

Astemizole Susp.
Triclabendazole

186
187

Cephalexin tablet 1gm

Rabies vaccine(inactivated)

188

Purified chick Embryo Cell

vaccine
Gliclazide

179

189

In the treatment of all types of depression

In the treatment of allergic rhinitis allergic
conjunctivitis chronic urticaria & other
allergic conditions.
In the treatment of bronchial asthma
In the treatment of schizophrenia etc.
In the treatment of acute leukaemia,
malignant lymphoma, stomach, lung
cancer etc.
--

Jan-88
Feb-88

In the treatment of short term management

of serious man infestation of human
immuno deficiency virus (H.I.V) injection in
patients.
--

Apr-88

Indicated in the treatment of UTI, lower

respiratory tract infections.
In the treatment of male pattern baldness
In the treatment of musculo-skeletal pain
only
In the treatment of multiple myeloma hairy
cell leukaemia etc.
Re-pigmenting treatment of skin in
depigmented of areas of in patients
suffering from vitilgo.
For the short term management of
congestive heart failure
In the treatment of small vessel
haemorrhage menorrhagia (including IUD
users) prophylaxis of periventricular
haemorrhage is neonates.
In the treatment of UTI, respiratory, skin,
soft tissue, ENT injections.
In the treatment of anxiety associated with
depression
In the treatment of respiratory tract
injection UTI, ENT soft-tissue injections.
In the treatment of hypertension
Indicated in immuno suppression in organ
transplants
For UTI, respiratory ,skin, soft tissue GI
infections etc.
For the treatment of adult patients with very
high triglyceryl levels (Type IV - hyper
lipidemia)
-In the treatment of chronic fasciola
gigantica F. hepatica in sheep goats cattle
and buffaloes.
-For treatment after exposure to rabies and
for pre-exposure prophylaxis
For treatment after exposure to rabies and
for pre-exposure prophylaxis
In the treatment of all types of maturity
onset diabetes without or with obesity in

Apr-88

Feb-88
Mar-88
Mar-88
Mar-88

Apr-88

Apr-88
Apr-88
May-88
May-88
May-88
May-88

May-88
Jun-88
Jun-88
Jun-88
Jun-88
Jun-88
Aug-88
Aug-88
Sep-88
Oct-88
Nov-88
Nov-88
Nov-88

adults.
Prevention of coccidiosis
To be used in combination with
Ethingloestradiol for contraception.
In the treatment of gastric &duodenal
ulcers

190
191

Salinomycin premix 6%
Desogestrel

192

Tri Potassium Dicitrate

Bisulphate

193

Lipoproteins extracted from

human placenta lotion 50%

--

Jan-89

194

Salinomycin

--

Jan.89

195

Cefadroxyl tablet/ capsule

500mg/ 1 gm

196

Cefadroxyl oral suspension

125/250 per 5 ml

197
198

KFD Vaccine
Tripotassium Dicitrate
Bisulphate
Mitoxantrone HCl injection 2
mg

199
200

Equine Influenza

201
202

Anti-Rabies Vaccine
Parvovirus vaccine

203

Carboplatin

204

Famotidine

205

Ciprofloxacin Hydrochloride
Monohydrate tab 250/ 500/
700 mg of
Ciprofloxacin Hydrochloride
Monohydrate infusion 100 mg/
50 ml & 200 mg/100 ml
Sodium Hyaluronate sol.

206
207
208
209
210
211
212
213
214

5-Aminosalicyclic acid
Miconazole Eye drops 1%
Flurbiprofen Eye drops 0.03%
Ketoprofen CT Tab. 100mg
Diltiazem SR Tab. 90/120mg
Diltiazem MR Tab. 30/60mg
Recombinant Human Tissue
Type plasminogen activator

215

Desmopressin Nasal Sol/

Nasal Spray/ Injection
Enalapril Maleate
Piperacillin Sodium

216
217

Dec-88
Jan-89
Jan-89

In the treatment of UTI, skin & skin

structure infections caused by S.coci or
streptococci pharyngitis tonsillitis,
respiratory tract infections only.
In the treatment of UTI, skin & skin
structure infections caused by S.coci or
streptococci pharyngitis tonsillitis,
respiratory tract infections only.
---

Feb-89

In the treatment of acute non-lymphatic

leukaemia, breast cancer non-Hodgkins
lymphoma.
Vaccine against influenza respiratory
diseases, caused by EHI virus, prevention
of abortion due & EHI virus infection.
Vaccine against rabies
Immunization as healthy dogs against
canine parvovirus infections.
Advance stage of ovarian cancer small cell
carcinoma of lungs.
In the treatment of duodenal & peptic ulcer
Zollinger Ellison syndrome.
Indicated in the treatment of respiratory
tract infection UTI. Skin and soft tissue,
severe systemic injections surgical.
Indicated in the treatment of respiratory
tract infection UTI. Skin and soft tissue,
severe systemic injections surgical.
To be supplied against to prescription of a
ophthalmologist only
-for fungal infection of eye
----To be supplied for use in Hospital, nursing
times and against the prescription of
specialist
--

Mar-89

-In the treatment of systemic and local

infections pre-operative infections

Feb-89

Mar-89
Mar-89

Mar-89
Mar-89
Mar-89
Mar-89
May-89
May-89
May-89
Jun-89
Jun-89
Jul-89
Jul-89
Jul-89
Jul-89
Jul-89
Jul-89
Aug-89
Aug-89
Aug-89

218

Flavophospholipol

219
220
221

Nifedipine Sustained Release

tablets 20 mg
Purified chick Embryo vaccine
Lofepramine

222

Haloperidol Deaconate

223
224
225

Naproxen Tablets
Ranitidine syrup 150 mg/10 ml
Ofloxacin

226
227
228

Dinoprostone tablet 0.5 mg

Norfloxacin eye drops 0.3%
Tinidazole Infusion 2mg/ml in
400 ml, 2mg/ml in 800ml
Pentoxyphylline SR

229
230
231
232
233

Cyclo Pentolate HCl

Ophthalmic Solution
Tropic amide Sterile
Ophthalmic Solution
Ibuprofen CR Tab 600mg

234
235
236

Fluoxetine Hydrochloride Cap

20 mg
Terbutaline Nebulising Solution
Famotidine Injection
Diazinon

237

Amiodarone HCl

238

Pinaverium Bromide

239

Piroxicam Gel

240
241
242

Trimethoprim powder 100gm

Oxytetracycline
injection200mg/ml
Cefuroxime axetil

243
244
245
246

Ceftizoxime
Deltamethrine
Prazosin Hydrochloride
Flurbiprofen SR Cap. 200mg

247

Coligen

248

L- Carnitine

prophylaxis, obstructive and gynae

infection UTI neo-natal and life threatening
paediatric infections.
Used as feed additive in farm animals and
poultry Farm-bird.
--

Sep-89
Nov-89

-In the treatment of depressive condition

only
For the management of chronic
schizophrenia
--In treatment of respiratory tract infection,
UTI ,Gynaecological Infections skin/soft
tissue infection
for the induction of labour
-In the treatment of infections

Dec-89
Jan-90

Indicate for purpose as for plane

conventional dosage
For mydriasis and cycloplegia

Mar-90

for mydriasis and cycloplegia in diagnostic

procedure
For chronic arthritic disorder and painful
musculoskeletal conditions
for the treatment of depression

Mar-90

for acute asthmas

Mar-90
Apr-90
Apr-90

-In the treatment for control of ectoparasites

in livestock
Control of ventricular and supra ventricular
arrhythmias where other drugs cannot be
used including arrhythmias wolf Parkinson
white Syndrome
In the treatment of spastic colon, irritable
bowel syndrome, biliary dyskinesia and for
radiological investigation
In the treatment of musculo-skeletal
inflammatory disorders
-treatment of anaplasmosis and their
annulata infection
for lower &upper respiratory tract injection
upper UTI skin and soft tissue infection etc.
---Rheumatoid arthritis, osteoarthritis,
ankylosing spondylitis
for the prevention of
calf scours, due to infection with
enteropatho genic-Ecoli organism
--

Feb-90
Feb-90
Feb-90
Feb-90
Feb-90
Feb-90
Mar-90

Mar-90

Mar-90
Mar-90

Apr-90

Apr-90
Apr-90
May-90
May-90
May-90
May-90
Jun-90
Jun-90
Jun-90
Jun-90
Jun-90

249

Isoflurane

250

Iopromide

251

Prenoxdiazine HCl

252

Terfinadine

253

Loxapine

254

Buspirone HCl

255

Mometasone Furoate

256
257

Orthoclone Sterile
Ribavirin

258

Flunarizine HCl

259
260
261

Salazopyrin Tab.ER 500mg

Centchroman Tab. 30mg
Xylazine HCl

262
263
264

Ciprofloxacin Hydrochloride
eye drops 0.3% w/v
Diclofenac Gel 1gm
Cefaclor

265

Omeprazole

266

Nefopam

267
268
269

Butalex
Idarubicin Hydrochloride
Kitotifen

270

Pefloxacin Mesylate Dihydrate

271
272

Ofloxacin Infusion 2mg/ml

Nitrendipine tablet 10/ 20 mg

273

Roxatidine Acetate HCl

274

Isosorbide mononitrate SR
tab. 50mg
Rabbit Anti Human Thymocyte
immunoglobulin
Felodipine
Pirarubicin HCl Injection
Horse antihuman lymphocyte
globulin

275
276
277
278

Used for induction

and maintenance of general anaesthesia
Used as a
contrast medium for uro-angiography
Indicated in relief of cough of bronchial
origin
Allergic rhinitis allergic dermatological
condition and other histaminic disorders.
For the management of the manifestation
of psychotic disorders.
Indicated in the treatment of anxiety and
tension states
Steroid responsive dermatitis , eczema, or
atopic dermatitis
-acute hepatitis viral respiratory and herpes
infection
as a maintenance treatment for classical
and common migraine
for rheumatoid
used as sedative
Used as a sedative analgesic and muscle
relaxant properties for use in horses, dogs,
and cattles
treatment of external ocular infection of the
eye
-In respiratory infection, ENT infection UT
infections, skin and skin structure infections
short term treatment of duodenal /gastric
ulcers/reflux oesophtiagitis/management of
zollinger Ellison syndrome
Acute and chronic pain, including
postoperative pain, dental pain, musculo
skeletal pain, acute traumatic pain, and
cancer pain.
In the treatment of Bovine theileriosis
-In prophylactic treatment of bronchial
asthma, symptomatic improvement of
allergic conditions including rhinitis.
In the treatment of serve injection in adults
caused by sensitive microorganism(gram
-ve pathogens and staphylococci)
RTI, UTI, skin & soft tissue infection
In the treatment of mild to moderate
hypertension
Disorders in the upper gastric intestinal i.e.
duodenal ulcers benign gastric ulcers.
prophylaxis of angina pectoris
-In the treatment of hypertension
-For aplastic Anaemia

Jul-90
Jul-90
Jul-90
Sep-90
Sep-90
Oct-90
Oct-90
Oct-90
Nov-90
Nov-90
Nov-90
Nov-90
Nov-90
Feb-91
Mar-91
Apr-91
Apr-91
Apr-91

Apr-91
May-91
May-91
May-91
May-91
May-91
May-91
May-91
May-91
May-91
May-91
May-91

279

Ramipril

280

Selegiline HCl

281
282
283

Piroxicam inj. 20mg/ml

Perindopril
Ethamsylate Inj. 250mg

284

Nilutamide Tablets

285

Lisinopril

286

Ofloxacin eye drops 3mg/ml

287

Clomipramine HCl tablets HCL

10 mg/ 25 mg/ 50 mg

288

Clomipramine HCl capsule 50

mg

289

Bisoprolol Fumarate

290
291

Amsacrine Injection
Fucidic Acid hemihydrate

292

Sodium Enoxaparin

293

Roxithromycin

294

Metoclopramide CR Tab. 15mg

295

Ketorolac Tromethamine tablet

10 mg

296

Ketorolac Tromethamine
injection 30 mg/ ampoule

297

Betaxolol Hydrochloride
ophthalmic 0.5 %W/V/ 5 ml
Oral Polio vaccine

298

Indicated in the
treatment of hypertension /cardiac failure
and also for myocardial infarction.
In the treatment of
Parkinsons disease
Treatment of muscular skeletal disorders
In the treatment of Hypertension
Treatment of small vessel haemorrhage,
menorrhagia, prophylaxis of periventricular
haemorrhage in neonates.
In the treatment of metastatic or localised
cancer of the prostate
Essential hypertension and in patients with
congestive heart failure.
treatment of external infections of the eye
and to adnexa caused by susceptible
bacteria
Obsessive compulsive disorders, phobic
states and depression (When sedation is
required)
Obsessive compulsive disorders, phobic
states and depression (When sedation is
required)
Hypertension, coronary heart disease
(angina pectoris)
-Bacterial infection of the eye caused by
susceptible organism in conjunctivitis
blepharits keratitis, dacryocystitis It can be
used for prophylaxis in ophthalmic surgery
and in connection with removal of foreign
bodies.
As a prophylactic in the treatment of
thromboembolic disorder during
orthopaedic surgery, general surgery and
haemodialysis.
Sensitive strain infections of ENT.
Bronchopul monary tract injection, genital
except for gonocoecal. Infections
prophylaxis of meningoco-ecal. Meningitis
in exposed subject.
to restore normal coordination and the
together upper digestive tract and relieve
symptoms of gastro duodenal dysfunction
including heartburn, dyspepsia, nausea
and vomiting associated with such
conditions as reflux oesophagitis, gastritis,
duodenitis and hiatus hernia
In the treatment of short term management
of post-operative pain and musco-skeletal
pain
In the treatment of short term management
of post-operative pain and musco-skeletal
pain
Ocular hypertension and chronic open
angle glaucoma
--

Aug-91
Aug-91
Aug-91
Sep-91
Sep-91
Oct-91
Nov-91
Dec-91
Feb-92
Feb-92
Feb-92
Feb-92
Mar-92

Mar-92

Mar-92

Apr-92

Apr-92
Apr-92
May-92
May-92

299
300

Gadopentetic acid
dimeglumine salt injection
469.01 mg
Pyridoxine HCl CR tab.100mg

301

Cephacetrile concentrated
infusion 235 mg

302

Korsolex concentrated
instrument disinfectant
Sterillium rub in disinfectant for
hands
Bacillocid special
Feracrylum Acid
Polyelectrolyte
Loratadine tablet 10 mg

303
304
305
306
307

Dexfenfluramine HCl capsule

15 mg

308

Bacillus calmette guerin

vaccine

309

Candur P. Parvovirus

310

Naloxone HCL

311

Nimodipine tab 30 mg,

inj.10mg/50 ml

312

Ginkgo Biloba film coated tab.

40 mg

313
314
315
316
317
318

Hamycin cream 0.1%

Clindamycin Gel 1%
Itrolan
Pipecuronium Bromide
Cisapride
Tetrachlorodecaoxide oxoferin

Cranial and spinal magnetic resonance

tomography

May-92

Deficiency of vit. B6 caused by usage of

oral contraceptive pill
Mastitis caused by streptococcus agalactial
STr dysgalactial, streuteris staphylococcus,
aureus, (Both penicillin sensitive and
resistant strain) gram (Negative)-ve
bacterial including E Coli and klebsiella.
--

May-92

--

May-92

---

May-92
May-92

In treatment of
allergic rhinitis acute coryza chronic
idiopathic urticaria.
Indicated in
association with diet in the treatment of
uncomplicated obesity complicated obesity
in adults, of refractory obesity and of
obesity involving disorders of dietary
behaviours (carbohydrate compulsion)
To be indicated for intravesical use in the
treatment of primary and relapse
carcinoma in-situ of the urinary bladder.
For active immunization of dogs against
parvovirus infection
for the complete partial reversal of narcotic
depression including respiratory
depression induced opioids including
natural and synthetic narcotics,
propoxyphene methadone, and certain
narcotic -antagonist analgesics
nalbuphine,pentazocine, are butorphenol
In the treatment and prevention of
ischaemic neurological deficit occurring
due to arterial spasm following subarachnoid haemorrhage
In the treatment of disorders in the
functioning of the brain (reduced
intellectual ability and alertness). Giddiness
buzzing in the ears, head-ache poor
memory, weakening of the voice resulting
from anxiety.
-acne vulgaris
Contrast Medium
-Gastro intestinal disorders
Tissue repair of
wounds with impaired healing such as
infected wounds, delayed post traumatic
and post-operative wound healing and
delayed healing after operation

Jun-92

May-92

May-92

Jun-92

Jun-92
Jul-92
Jul-92

Aug-92

Sep-92

Sep-92
Oct-92
Oct-92
Nov-92
Nov-92
Nov-92

319
320
321

Tetrachlorodecaoxide Sol.
1.037 mg/100ml
Ipratropium Bromide inhaler 20
mcg
Benoxinate Hydrochloride oph.
Solution

--

Nov-92

--

Nov-92

For use as an anaesthesia of cornea and

conjunctivitis for ophthalmic procedure.

Nov-92

Approval Status of New Drug during 1993-1998

S.No

Drug

1.

Human Erythropoietin Injection

2.

Tramadol Hydrochloride Injection 50

mg per 1 ml and 100 mg per 2 ml
ampoule
Ticlopidine HCL 250 mg tablet

3.

Indication
In the treatment of anaemia due
to chronic renal failure and end
stage renal disease
Severe acute and chronic pain
diagnostic measures and surgical
pain.
For the prevention of Cerebro
and cardio vascular accidents in
patient suffering from arterial
insufficiency in the legs and
cerebral vessels and correction
of platelet disorder induced by
extra corporeal circuits during
surgery with extra cerebral
circulation on haemodialysis
(artificial kidney)
In the treatment of UTI
respiratory tract infection, biliary
tract infection
Anti-arrhythamic

Date of
approval
Jan-93
27.01.93
11.02.93

4.

Cefixime capsules
100mg/200mg/400mg

5.
6.

Flecainide Acetate 100 mg Tablet &

150 mg/ml
Fluconazole
Capsules50mg/100mg/200mg/150mg
and Fluconazole injection -2mg/ml

7.

Tenoxicam tablet 20 mg

8.
9.
10.

Benzafibrate retard tablet 400 mg

Paspat injection
Cisapride

11.

Intestinal amoebiasis, amoebic

hepatitis, trichmonial vaginitis,
bacterial vaginitis and giardiasis.

13/May/9
3

12.

SecnidazoleTablet and oral

suspension (1. Each tab 500 mg/
1000 mg ) and (2. Each 15ml
suspension contains Secnidazole500mg,
Amlodipine Besilate tablets 5/10 mg

Indicated in hypertension, angina

pectoris.

19/May/9
3

13.

Mepartricin tablets 50000 Units

14.

Nitroglycerin patch 25/50 mg

Functional disorder in benign

prostatic hypertrophy
For the treatment of Angina
pectoris due to coronary artery

28/May/9
3
3/Jun/93

For the treatment systemic

candidiasis muscular candidiasis
cryptococosis prevention of
fungal infection in patients with
malignancy.
Rheumatoid arthritis,
osteoarthritis, osteoporosis,
ankylosing spondylitis, gout, nonarticular rheumatic conditions.
--Management of dyspepsia

24.02.93
26/Mar/9
3
26.04.93

29/Apr/93

April/93
May/93
May/93

15.

Cetirizine Dihydrochloride
tablets5/10/20 mg

16.

Maduramicin 1% w/w premix Vet

17.

Itraconazole capsules -100mg

18.

Glucomannan Sachets (herbal

medicine) ( Each sachets containing
Glucomannan-0.75gm/1.0.gm/1.3gm)
Metronidazole (skin ointment) gel 1 %
W/W
Zalcitabine Film Coated Tablets
0.375mg/0.750mg
Calcitriol Soft Gelatine Caps 0.5mcg
& 0.25mcg

19.
20.
21.

disease
Seasonal rhinitis and
conjunctivitis, perennial allergic
rhinitis, pruritus and urticaria
For the treatment as an aid for
the prevention of coccidiosis in
broiler chickens
Systematic aspergillosis and
candidosis, cryptococcosis,
histoplasmosis, sportrichosis,
paracoccidioidomycossis,
blastomycosis and other rarely
occurring systemic or tropical
mycosis.
For reduction of blood glucose
level reduction serum lipid level

25/Jun/93
7/Jul/93
20/Jul/93

6/Sep/93

19/Jul/93

For the treatment of Aids

26/Jul/93

For the treatment of metabolic

bone diseases

27/Aug/9
3

Treatment of impaired
attentiveness, and/or memory or
feelings of giddiness in elderly,
painful symptoms of arterial
disease, idiopathic Parkinson
disease
Indicated when parenteral
therapy is necessary for inotropic
support in the short term
treatment of cardiac
discompensation due to
depressed contractility resulting
either than organic heart disease
or from cardiac surgical
procedure.

27/Sep/9
3

22.

Piribedil S.R. Tablets 50mg

23.

Dobutamine HCL Inj. (infusion

concentrate) 50 mg/ ml

24.

Nicardipine capsules 20mg/30mg

In treatment of hypertension and

chronic stable angina pectoris

29/Oct/93

25.

Flunisolide Nasal Spray 0.025% w/w

For the prophylaxis and

treatment of perennial and
seasonal allergic rhinitis including
hay fever.

30/Nov/9
3

26.

Colfosceril Palmitate injection 108mg

per vial

New born babies with birth

weight of 700gm or greater,
undergoing mechanical
ventilation of respiratory distress
syndrome, whose heart rate and

1/Dec/93

4/Oct/93

arterial oxygenation are

continuously monitored.
27.

28.

29.
30.

Salmeterol Inhaler/Salmeterol
Rotacap. (Each actuation deliversSalmeterol Xinafoate-25mcg Each
Rotacaps contains Salmeterol
xinafoate eql to Salmeterol-50mcg)
Enrofloxacin 5% oral solution and
injection
[1. Each ml of Injection contains
Enrofloxacin-100mg/50mg
2. Each ml of oral solution contains
Enrofloxacin -50mg/100mg]
Gadodiamide IV injection (Each Iml
Injection contains-Gadodiamide
287mg equl to 0.5m mol (in 10ml vial)
Ondansetron tablet: 4 mg /8 mg and
injection: 4mg 2 ml & 8 mg/4 ml

31.

LomefloxacinTablet 400mg

32.

Azithromycin capsules/suspension
[Each capsule contains : Azithromycin
dihydrate equl to 250mg of base
2.
Each 5ml contains: Azithromycin200mg/50mg]

33.

Terconazole Vaginal ovule/vaginal

cream [1. Each ovule contains:
Terconazole- 80mg
2. Terconazole vaginal cream
contains-Terconazole-0.8%.]
Ioversol Injection 160, 240 , 300, 320,
350
Botulinum Toxin.A 100 unit [Each Vial
contains Clostridium botulinum toxin
type-A - Hemagglutinin Complex
100units. Human. Serum albumin0.5mg
Nacl-0.9mg]
Paclitaxel injection [5ml single dose
vial contains-Paclitaxel-30mg]

34.
35.

36.
37.

Esmolol HCl injection

[1. Each 10ml ampoule contians:

Long term regular treatment of

reversible airway obstruction in
asthma and chronic bronchitis

1/Dec/93

Vet drug

20/Jan/94

Contrast media

21/Jan/94

On the treatment and

management of nausea and
vomiting induced by cytotoxic
chemotherapy and radiotherapy
In the treatment of mild to
moderate infections caused by
susceptible strains of designated
micro-organism in R.T.I
uncomplicated and complicated
U.T.I.
1. In the treatment of mild to
moderate susceptible infection
including R.T.I., uncomplicated
skin /skin structure, nongonoccoal urethritis cervicitis
2. For susceptible infection
including community acquired
pneumonia pelvic inflammatory
diseases.
For the local treatment of vulvo
vaginal candiasis (moniliasis)

12/Feb/9
4

Contrast media

29/Dec/9
3
13/Jan/94

For the treatment of

blepharaspasm hemifacial
spasms assocaited focal
dystonia
Advanced epithelical carcini of
the ovary after failure of first line
or subsequent chemotherapy.
Supraventricular tachycardia for
rapid central of ventricular rates

20/May/9
4

13/May/9
4

19/Jul/94

25/Aug/9
4
26/Aug/9
4

2.5/gm of Esmolol HCl.

2. Each 10ml vial contains: 100mg of
Esmolol HCl]
38.

Genotropin 4IU/12IU/16IU injection

39.

Chandonium Iodide injection2mg/ml

40.

Sultamicillin Tab [Each film coated

tablet contains: Sultamicillin( asTosylate)-375mg equl to sulbactam
147mg and Ampicillin 220mg)]

41.

Collagenase Ointment 250 units

42.

Closantel 15% oral solution

43.

Celiprolol Hydrochloride
tablets100mg/200mg/400mg
Lansoprazole capsules 15 mg/30 mg

44.

45.

1. Nimesulide tablets 100 mg

2.Nimesulide suspension-50mg/ 5ml
3. Nimesulide Transdermal Gel-1%

46.

Diclofenac sodium opthalmic solution

sterile 0.1% (1mg/ml)

47.

Terazosin Hcl tablet 1mg/2mg/5mg

48.

Clonazepam tablets
0.5mg/1.0mg/2.0mg

49.

Ritodrine HCL tablet and injection

[Each tablet contains, Ritodrine HCL10mg, Ritodrine HCL Injection each ml
contains-Ritodrine HCL-USP 10mg]

patients with atrial fibrillation or

atrial flutter in per-operative,
post-operative circumstances
where short term control of
ventricular rate is desirable
Short stature due to inadequate
or failed incretion of pituitary
growth hormone.
Neuro muscular blocking agent
In the treatment of Intraabdominal infection obstetrics,
and gynaecogicological
infections, skin and soft tissue
infection. Bone and joint
infection, upper and lower
respiratory tract infections, ENT
infections, UTI , gonorrhoea and
surgical prophylaxis.
In the treatment for debriding
chronic dermal and severely burn
areas.
Mature and immature fasciola
species, haemonchus species,
strongylodes species and also for
external parasites like oestrus
ovis boophilus microplus
hyalomma a anatolicum in cattle
and sheep.
Mild to moderate hypertension,
angina pectoris
For the treatment of duodonal
ulcer, gastric ulcer, reflex
oesophagitis, zollinger ellison
syndrome
Inflammatory condition including
joint disorder such as rheumatoid
arthritis, post traumatic and postoperative painful condition and
fever
Indicated in post-operative
inflammation in patients who
have undergone cataract
operation
In the treatment of essential
hypertension and BPH
In the treatment of petitmal and
its variant, akinetic and
myoclonic seizures
Premature labour, acute foetal
distress, prevention of preterm
labour after operations.

5/Sep/94
1/Mar/94
6/May/94

5/May/94
3/Oct/94

1/Dec/94
16.12.94

13/Jan/95

27/Jan/95

27/Jan/95
25/Jan/95
21/Feb/9
5

50.

Rilmenidine Dihydrogen Phosphate

tab. 1 mg
Tromantadine HCl oinment 1 gm
Ointment
Permethrin cream 5%
Clozapine tablets 25mg/100mg

mild to moderate hypertension

54.

Formestane Depot Injection (I.M.)

250mg

For the treatment of advanced

stage of breast cancer in women
with natural or artificially induced
post-menopausal status.

6/Mar/95

55.

Altretamine caps -50mg

29/Mar/0
5

56.

Etidronate-Disodium tablets 200mg

57.

Terbinafine Tab. 250mg / cream 1%

58.

Clarithromycin tablets -250mg/500mg

59.
60.

Podophyllotoxin Topical solution [Each

3-5ml contains, Podophyllotoxin-0.5%]
Silymarin tablet -70mg

61.

Lovastatin 10mg/20mg/40mg

62.

Ambroxol tablet/liquid/drops
[1. Each tab. Contains, Ambroxol
HCL-30mg,
2. Each 5ml liquid contains, Ambroxol
HCL-30mg,
3. Each ml drops contains, Ambroxol
HCL-7.5mg]
Gemcitabine Injection

For palliative treatment of patient

with persistent or recurrent
ovarian cancer, following first line
therapy with cisplatin and /or
alkylating agent based
combination.
Hypercalcemia induced by
various malignant disorders
Fungal infection of skin, hair,
nails
of mild to moderately severe
infection like acute exacerbation
of chronic bronchitis community
acquired pneumonia including
infection due to chlamydia,
mycoplasma spegiocella, acute
streptococcal pharyngitis and
skin & soft tissue infection
Ano-genital warts non facial
warts only
supportive treatment in chronic
liver disease and cirrhosis
Reduction of total LDL
Cholesterol in patients of primary
hyper cholesterolemia (Type IIa&
IIb hyper lipo-proteinemia)
Acute and chronic disease of the
respiratory tract associated with
abnormal bronchial secretions in
particular acute attack of chronic
bronchitis, asthmatic bronchitis,
bronchial asthma.
In the management of non-small
cell lung cancer
Acute migraine attacks with or
without aura only where there is
a clear diagnosis

24/Jan/96

51.
52.
53.

63.
64.

Sumatriptan tablets and injection

[Each film coated tabs contains,
1. Sumatriptan (as succinate)100mg/50mg/25mg
2. Sumatriptan injection contains

Herpes simplex infection of the

skin
Infection with sarcophytscabiec
Indicated in the management of
schizophrenic patients

21/Feb/9
5
23/Feb/9
5
6/Mar/95
7/Mar/95

10/Mar/9
5
29/Mar/9
5
22/Mar/9
5

5/May/95
22/Jun/95
5/Oct/95

1/Dec/95

6/Feb/96

65.

Sumatriptan as succinate 6mg-per

0.5ml]
Tacrine Hydrochloride caps
10mg/20mg/30mg/40mg

66.

Nitroscanate tablets (VET)

100mg/500mg

67.

Ketorolac Sterile Ophthalmic solution

0.5%

68.

Fluticasone Propionate ointment

69.

Piroxicam Betacyclodextrin tabs 20

mg

70.

Thiocolchicoside tablet -4 MG

71.

Sulbutiamine tabs -200mg

72.

Benazepril Hcl tabs 5mg/10mg/20mg

73.

Levobunolol Hydrochloride ophthalmic

solution 2.5MG/5.0MG

74.

Terlipressin Acetate Injection I.V.

-1mg.
Danofloxacin Mesylate injection (vet)
250 mg

75.

76.

77.
78.

Salmon Calcitonin Injection [1. Each

ampoule contains- Salmon Calcitonin100 IU/ml
2. Each vial
contains-Salmon Calcitonin 400
IU/2ml.]
Gabapentin caps 300mg/400mg
Docetaxel injection concentration
-80mg (2ml/vial) & 20mg (0.5ml/vial)

For the treatment of dementia in

patients with Alzheimers
diseases of mild to moderate
severity
For control/eradication of
Hookworm/Roundworm/Tapewor
m in puppies and adult dogs
for the relief of ocular itching due
to seasonal allergic conjunctivitis
only
Inflammatory and pruritic
manifestation of corticosteroid
responsive eczema dermatitis
Pain and inflammation
associated with rheumatoid
arthritis, osteoarthritis, acute
musculo-skeletal pain, postoperative pain and primary
dysmenorrhoea
As an adjuvant treatment in
painful spasms associated with
degenerative vertebral disorder
and vertebral static problems,
torticollis, dorsal pain, low-back
pain, traumatologilcal and
neurological disorder.
Symptomatic treatment of
functional asthenia
Essential hypertension and
congestive heart failure
For the control of intra-ocular
pressure in chronic open angle
glaucoma and ocular
hypertension
In the treatment of bleeding
oesophageal varices.
Bovine respiratory disease in
beef cattle, non-lactating dairy
cattle calves caused by
pasteurella haemolytica P
multocida and enteric infection
caused by E.coli /salmonella sp.
Hypercalcemia pain associated
with advanced metastatic bone
cancer, Pagets disease, postmenopausal osteoporosis.

14/Feb/9
6

Epilepsy
Indicated in the treatment of
patients with locally advanced or
metastatic breast cancer and

3/Aug/95
20/Jun/96

19/Feb/9
6
1/Mar/96
18/Mar/9
6
25/Mar/9
6

25/Mar/9
6

23/Mar/9
6
22/Apr/96
16/May/9
6
22/Jul/95
28/Jul/95

3/Aug/95

small cell lung cancer

in the management of
hypertension and also in the
prophylactic management of
patients with angina pectoris.

79.

Carteolol Hcl tabs 5mg,

80.

Carteolol Hcl opthalmic solution 2%

w/v

In ocular hypertension, chronic

open angle glaucoma and some
secondary glaucomas

9/Jul/96

81.

In non-infected / infected
inflammatory ocular condition

26/Jul/96

82.

Fluorometholone 0.1% and

Fluorometholone tarte liquifilm 0.25%
opthalmic suspension
Artemether Injection -80mg

In severe malaria including

cerebral malaria and as a second
line in chloroquine resistant
malaria cases only.

2/Aug/96

83.

Artemether Capsule 40mg

3/Aug/96

84.

Centpropazine caps -20mg

In severe malaria including

cerebral malaria and as a second
line in chloroquine resistant
malaria cases only.
In the treatment of depression.

85.

Benidipine Hcl tabs 4mg/8mg

86.

Zopiclone 7.5MG tablet

87.

Tibolone tablet 2.5mg

88.

Cypermethrin High-cis (VET) 100mg

89.

Promegestone tabs
0.125mg/0.250mg/0.500mg

90.

Nicardipine retard caps. 40mg/30mg

91.

Artesunate tabs 50mg

Hypertension and long term

prophylactic management of
Angina-pectoris
Short term treatment of insomnia,
transient, situational or chronic
insomnia and insomnia
secondary to psychiatric
disorders when it is debilitating or
severe.
In the treatment of complaints
resulting from the natural or
surgical menopause.
for the control of ticks
Gynaecological conditions
characterised by luteal
insufficiency menstrual
irregularities due to ovulation
disorders, dysmenorrhea,
premenstrual syndrome,
mastodynia, dysfunctional uterine
bleeding menorrhagia du to
fibromyomas, menopausal
syndrome.
management of hypertension
and Angina pectoris
Promoted for use in severe
malaria including cerebral
malaria and as a second line in

9/Jul/96

16/Aug/9
6
12/Aug/9
6
16/Aug/9
6

16/Oct/96
16/Sep/9
6
23/Sep/9
6

9/Oct/96
7/Oct/96

92.
93.

Finasteride tablets 5mg

Naltrexone Hcl tabs 50mg

94.

Sparfloxacin tabs. 100mg/200mg,

400mg

95.

Ceftibuten Capsule/Suspension [Each

capsules contains ceftibuten
200mg/400mg
Each 5ml
suspension contains ceftibuten
90mg/180mg ]
Povidone-Iodine sterile ophthalmic
prep solution 5.0% w/v

96.
97.

Norfloxacin powder (vet) 10%

98.

Ornidazole tablet and infusion[Each

tab contains, Ornidazole-500mg,/
Ornidazole infusion-5mg/ml (100ml
infusion bottle)]
Nicorandil tabs 5mg/10mg/20mg

99.
100.

Nicorandil injection 2mg/12mg/48mg

101.

Arteether injection I.M. -150mg per

vial

102.

Creatine Phospate Inj [Each vial

contains creatine phospate 500mg/1g]

103.

Moxidectin inj (vet) 1% w/v

104.

Mefloquine Hcl tabs 250mg

chloroquine resistant malaria

cases only
Benign prostatic hypertrophy only
In the treatment of narcotic
antagonist and alcohol
dependence.
Community acquired pneumonia,
acute exacerbation of chronic
bronchitis, other lower respiratory
tract infection caused by
susceptible bacteria, acute
sinusitis, gonococcal and nongonococcal urethritis in males,
uncomplicated UTI, skin, soft
tissue infections, ENT infections.

9/Oct/96
11/Oct/96
11/Nov/96

Upper respiratory tract infection,

lower respiratory tract infection,
UTI and enteritis and
gastroenteritis.

19/Nov/9
6

for prepping of the periocular

region and irrigation of the ocular
surfaces
Wide Variety Of Infections
Caused By Susceptible
Gram+Ve And Gram-Ve
Organism Including Mixed
Infection In Poultry
In the treatment of susceptible
protozoal infection and anaerobic
bacterial infection only

22/Nov/9
6

For the prevention and long term

treatment of angina pectoris
For the prevention and long term
treatment of angina pectoris
Promoted for use in severe
malaria including cerebral
malaria and as a second line in
chloroquine resistant malaria
cases only
Deficient striated muscle activity,
Co-adjuvant in the treatment of
myocardial disorders, for addition
to cardioplegic solution as a
means of protection in heart
surgery.
In the treatment and control of
internal and external parasites in
cattle.
Use in severe malaria including
cerebral malaria and as a second

10/Jan/97

12/Mar/9
7

13/Jan/97

23/Mar/9
9
14/Jan/97

20/Jan/97

16/Jan/97
3/Mar/97

105.

Acarbose tabs 50mg/100mg

106.

Resperidone tabs 1mg/2mg/3mg/4mg

107.

Resperidone Liquid 1 mg / ml

108.

Glipizide GITS Tabs 5mg/10mg

109.

Etodolac tablet & Capsules [Each tab

contains Etodolac BP-200MG/400MG
Each caps contains Etodolac-300mg ]

110.

Artesunate injection 60mg

111.

Midazolam injection BP 1mg/ml &

5mg/ml

112.

Polyvidone eye drops 5%

113.
114.

Lacidipine tabs 2mg/4mg

Pyrazinamide dispersible tabs -250mg

115.

Adenosine injection 6 mg /2ml

line in chloroquine resistant

malaria cases only
non-insulin dependent type II
diabetes inadequately controlled
by diet and / or oral
hypoglycaemic agents
acute and chronic schizophrenic
psychoses and other in psychotic
conditions in which positive
symptoms and negative
symptoms are prominent
acute and chronic schizophrenic
psychoses and other in psychotic
conditions in which positive
symptoms and negative
symptoms are prominent
Non-insulin dependent diabetes
mellitus (Type-II)
Inflammation and painful
conditions in osteoarthritis, acute
attacks of gout and pseudo gout
pain following dental extraction,
post-operative and post
episiotomy pain, dysmenorrhoea,
and acute musculoskeletal pain.
Promoted for use in severe
malaria including cerebral
malaria and as a second line in
chloroquine resistant malaria
cases only
For preoperative sedation for
conscious sedation prior to short
diagnostic or endoscopic
procedure and for induction of
general anaesthesia prior to
administration of another
anaesthetic agent.
Symptomatic treatment of dry
eye conditions including keratoconjunctivitissicca
mild to moderate hypertension
Short course treatment of
tuberculosis in pediatric age
group.
Conversion to sinus rhythm of
paroxysmal supraventricular
tachycardia including that
associated with accessory
bypass tracts (wolf Parkinsonwhite syndrome) when clinically
advisable appropriate vagal
manoeuvres should be attempted
prior to adenosine administration.

6/Mar/97

3/Apr/97

14/May/9
7

21/Aug/9
6
10/Apr/97

2/Sep/96

15/Apr/97

30/Apr/97
5/May/97
6/Jun/97
8/Jul/97

116.
117.

Azelastine Nasal spray 0.01gm per

10ml
Stavudine caps
15MG/20MG/30MG/40MG

Allergic rhinitis and perennial

rhinitis.
In adult patients with advanced
HIV infection who are intolerant
of approved therapies.
Skin diseases where treatment
with topical corticosteroid is
appropriate.

15/Jul/97
12/Jul/97

118.

Prednicarbate Cream [Each gm of

cream contains, Prednicarbate-2.5mg]

119.

For B.P.H.

12/Sep/9
7

120.

Serenoa-Repens cap[Each soft

gelatin caps contains 160mg lipid
extract to serenoa repons]
Calcium Dobesilate caps -500mg

Chronic venous insufficiency of

lower limbs only

22/Sep/9
7

121.

Alendronate Sodium tab -10mg

Post-menopausal osteoporosis
only.

18/Sep/9
7

122.

Cefpodoxime Proxetil tab/syrup [Each

tab contains, Cefpodoxime Froxetil100mg, Each 5ml suspension
contains Cefpodoxime Proxetil-40mg]

19/Sep/9
7

123.

Cefpirome injection
0.25g/0.5g/1.0g/2gm per vial

124.

Idebenone tablets -30mg

125.

Doramectin 1% injection solution (vet)

126.

Constipation bowel clearance

before labour or surgery,
radiological examination.

11/Feb/97

128.

Bifonazole cream/solution/powder
[1gm of cream/powder contains
Bifonazole-0.01gm and 1ml of
solution contains Bifanazole-0.01gm]
Sodium Picosulphate Tab/Syrup [1.
Each uncoated tab contains, Sodium
Picosulphate-5mg/10mg 2. Each 5ml
syrup contains, Sodium Picosulphate5mg]
Tiaprost Trometamol inj (vet) 150mg

Acute bronchitis, exacerbations

of chronic bronchitis, bronchiolitis
pneumonia, sinusitis, recurrent
chronic tonsillitis, pharyngitis,
acute otitis.
Infections caused by cefpirome
sensitive organism, lower
respiratory tract infection,
complicated upper and lower
urinary tract infections,
bacteraemia, and septicaemia.
In the treatment or improvement
of decreased volition emotional
disturbances and speech
disturbances associated with
sequelae of cerebral infraction,
sequelae of cerebral
haemorrhage, cerebral
arteriosclerosis.
Treatment and control of gastrointestinal roundworms,
Lungworms, eye worms, screw
worms in cattle.
Skin mycosis caused by
dermatophytes, yeast moulds,
other fungi.

129.

Teicoplanin For IM/IV Injection

In inducing pasturition in cows

and buffalos
use in serious gram +ve infection

19/Feb/9
7
19/Feb/9

127.

6/Aug/97

26/Sep/9
7

26/Sep/9
7

17/Oct/97

28-11-97

100mg/200mg/400mg per vial

130.

Clobazam tablets 5mg/10mg/20mg

131.

Leuprolide acetate depot injection

3.75mg per vial
Saccharomyces boulardii
(caps/sachets)[Each capsule/sachets
contains Saecharomyces boulardii
282.5mg]
Isepamicin injection 100mg/250mg
per vial

132.

133.

134.

Fluconazole 0.3% w/v

135.

Clotrimazole soft gel pessary 100MG

136.

Tolfenamic acid caps 200mg

137.

Melatonin tab -3mg

138.

Biphenyl acetic acid gel -3.00%w/w

139.
140.

Irinotecan HCl trihydrate solution for

IV infusion 20 mg /ml in 2 ml & 5 ml
packsize
Lamotrigine tab -25mg

141.

Propofol injection 10mg per ml

142.

Ciprofibrate tabs -100mg

staphylococcal infection in
patients sensitive or
unresponsive to penicillins and
cephalosporins CAPD related
peritonitis, prophylaxis in
orthopaedic surgery at risk of
gram +ve infection.
Acute and chronic anxiety states
and as an adjunctive therapy in
patients with refractory epilepsy.
Indicated for the treatment of
prostatic cancer only.
For irritable bowel syndrome,
antibiotic associated diarrhea,
diarrhea due to enteral feeding in
adults only.
Lower respiratory tract infection,
intra-abdominal infection, urinary
tract infection, skin and soft
tissue infection and septicemia.
For fungal corneal ulcers/keratitis
only
Vaginal candidiasis
Rheumatoid arthritis, osteo
arthritis, ankylosing spondylitis
and related conditions associated
with pain.
For sleep disorder, jet lag, and
regulation of circadian rhythm
disorder
For the relief of symptoms of soft
tissue injuries, extra articular
rheumatic or inflammatory
conditions, acute inflammatory
manifestations of osteo arthritis
or knee joint pain and swelling
following injury.
For the treatment of colo-rectal
cancer
Add on therapy for partial and
secondary generalized tonicclonic seizures in adults not
below 16 years of age.
Induction and Maintenance of
general anesthesia.
Indicated in treatment of primary
hyper lipidaemia resistant to
appropriate dietary management
including cholesterolaemia, hyper
triglyceriaemia and hyper
lipidaemia (Fredrickeson types

11/Nov/97
10/Dec/9
7
18/Dec/9
7
26/Dec/9
7
4/Feb/98
17/Feb/9
8
4/Mar/98

12/Mar/9
8
27/Apr/98

22/May/9
7
14/May/9
8
18/May/9
8
1/May/98

143.

Sertraline tab 50mg/100mg

144.
145.
146.

Sertraline tab 25mg

Losartan Potassium tablets
-25mg/50mg/100mg
Ritonavir 100mg

147.

Alprazolam SR tab 1.5mg

148.
149.

Lomefloxacin eye drops 3mg/ml

Rivastigmine capsules
0.5mg/1.0mg/1.5mg/3mg/4mg/5mg/6
mg
Oxybutynin chloride Tab/Syrup [ 1.
Each uncoated tab contains
Oxybutynin chloride-2.5mg/5mg
2. Each 5ml syrup contains
Oxybutynin chloride-2.5mg]

150.

151.

Fexofenadine Hcl tablet

-120mg/180mg

152.

Simvastatin tab
5mg/10mg/20mg/40mg

153.
154.

Carvedilol 12.5/25mg tablet

Pantoprazole sod. Tab 20 / 40mg

155.

Zidovudine (300mg) tabs

156.

Oxaliplatin Freeze dried powder for IV

injection 50mg/100mg per vial
Vindesine Sulphate Injection 1mg/5mg
per vial

157.

IIa, IIb, III and IV)

Major depressive disorders
obsessive compulsive disorders
(OCD), panic disorder
For panic disorder only.
mild to moderate hypertension
only.
in the treatment of advanced HIV
infection by qualified physician
not below the age of 12 years to
be administered.
Short term symptomatic
treatment of anxiety including
anxious patients with symptoms
of depression
Bacterial infection of the eye
treatment of patients with mild to
moderate dementia of Alzheimer
type
For urinary incontinence, urgency
and frequency in the unstable
bladder whether due to
neurogenic bladder disorders or
to idiopathic detrusor instability
and nocturnal enuresis.
In the treatment of relief of
symptoms associated with
seasonal allergic rhinitis and
chronic idiopathic urticaria in
adults only.
Primary hypercholesterolemia,
type IIa and type IIb alone or in
association with CAD.
Essential hypertension only
For the treatment of gastric ulcer,
duodenal ulcer, moderate and
severe reflux oesophagitis.
For HIV
For treatment of advanced
colorectal cancer.
Acute lymphocytic leukaemia of
childhood resistant to vincristine
sulphate, non -Hodgkins
lymphomas, malignant
melanoma, non-small cell
carcinoma of the lung, blast crisis
of chronic granulocytic leukaemia
and carcinoma of the breast.

9/Jun/98
9/Jun/98
16/Jun/98
8/Sep/97

22/Jul/98
31/Jul/98
3/Sep/98

16/Sep/9
8

25/Sep/9
7
16/Oct/98
9/Dec/98
18/Dec/9
8
26/Oct/98
28/Oct/98

Note: It may be stated that the above list of New Drugs is prepared as per the
records available with the office of DCG (I). In case any inconsistency is
observed, same may be brought to the notice of DCG (I) for necessary action.