Approval Status of New Drug During 1971-1981
Approval Status of New Drug During 1971-1981
Approval Status of New Drug During 1971-1981
S. No
Drug
Indication
Date of Approval
1.
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
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.
28.
Nov,1971
29.
Nov,1971
30.
31.
Spiramycin Injection
Testolactone
Nov,1971
Nov,1971
32.
Dec,1971
Anti-obesity drug
Coccodiosis
-
Dec,1971
Jan,1972
Jan,1972
Jan,1972
Mar,1972
Apr,1972
39.
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.
Preservative
Local Anesthetic
Sep,1972
Sep,1972
48.
Fluphenazine Deconate
Antipsychotic
Sep,1972
49.
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.
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.
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
72.
73.
81.
82.
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
Jul,1973
93.
Jul,1973
94.
95.
96.
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.
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
Feb,1974
Feb,1974
119.
Feb,1974
116.
Mar,1974
Oral contraceptive
Apr,1974
Topical corticosteroid
Apr,1974
May,1974
May,1974
May,1974
Jul, 1974
Jul, 1974
Jul, 1974
Jul, 1974
131. Pimozide
Jul,1974
Aug, 1974
Oct,1974
Oct,1974
Nov,1974
Anesthetic
Dec,1974
Dec,1974
Sep, 1974
Sep,1974
Dec,1974
140. Desamino-oxytocin
Dec,1974
141. Virginiamycin
Feb,1975
Feb,1975
Feb,1975
Mar,1975
Mar,1975
Apr,1975
Apr,1975
150. Clotrimazole
May,1975
May,1975
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
Feb,1975
Mar,1975
Jun,1975
Jun,1975
Jul,1975
Jul,1975
Antihypertensive
Jul,1975
158. Carbadox
Jul,1975
159. Desoximetasone
Jul,1975
Jul,1975
Aug,1975
Aug,1975
Aug,1975
Aug,1975
Sep, 1975
Sep,1975
Sep,1975
Oct,1975
169. Trofosfamide
Indicated in treatment of
lymphogranulomatosis,
lymphosarcoma reticulosacrcimo
ovarian carcinoma, and carcinoma of
breast.
Nov, 1975
Vasodilating Agent
Vasodilating Agent
Nov, 1975
Nov, 1975
Dec,1975
Jan,1976
Jan,1976
Jan,1976
176. Glydiazinamide
Feb,1976
Antibiotic
Mar,1976
Antibiotic
Mar,1976
Antibiotic
Mar, 1976
Apr,1976
May, 1976
May, 1976
Antihypertensive
Jun, 1976
188. Halcinomide
May, 1976
May, 1976
May, 1976
May, 1976
Jul,1976
Jul,1976
Anti-cancer drug
-
Aug, 1976
Aug,1976
Sep,1976
Nov,1976
Nov,1976
Dec,1976
Dec,1976
Anti-emetic
Dec,1976
198. Fusafungin
Jan,1977
199. Flupenthixol
Indicated in psychiatric or
schizophrenic cases where sedative
and hypnotics effects are contra
indicated
Jan,1977
Jan,1977
Feb,1977
Feb,1977
Fungal Antibiotic
cerebral angiography and urography
(X-ray contrast media)
Mar,1977
Apr, 1977
May, 1977
May,1977
Jun, 1977
208. 1-(2-tetrahydrofuryl)-5-flourouracil
Jun, 1977
Antipsychotic
Jul,1977
Jul,1977
Sep, 1977
Vasodilating Agent
Indicated for treatment of
trichomoniasis
veterinary Drug
For treatment of post-operative
respiratory depression and
respiratory depression due to
poisoning
Sep,1977
Sep,1977
Oct, 1977
Oct, 1977
Sep, 1977
Sep,1977
Oct,1977
Nov,1977
Nov,1977
Dec,1977
Dec,1977
Dec,1977
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
Cardiac glycoside
Mar,1978
Mar,1978
Apr,1978
Apr,1978
Jun, 1978
Jun, 1978
Jun,1978
Polypeptide hormone
Indicated in infection of respiratory
tract, skin & mucosa, bone infection.
Jun,1978
Jul, 1978
Jul, 1978
242. Sotalol
Aug, 1978
243. Diazoxide
Aug, 1978
Sep, 1978
Sep, 1978
Sep, 1978
247. Ifosfamide
Sep,1978
Sep,1978
Sep,1978
Oct, 1978
Oct, 1978
Oct,1978
Anti-cancer drug
-
Oct,1978
Nov,1978
Nov,1978
Nov,1978
Dec,1978
Dec,1978
259. Benorylate
Oct,1978
Dec,1978
Dec,1978
Dec,1978
Dec,1978
Dec,1978
Jan,1979
Bronchial Asthma
Jan,1979
Antibiotic
Jan,1979
Antibiotic
Jan,1979
Antibiotic
Jan,1979
Jan,1979
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
Apr, 1979
Apr,1979
Apr,1979
Apr,1979
Indicated in treatment of
hemorrhoids
Antibiotic
May,1979
Jun,1979
Jul, 1979
Jul, 1979
Jul,1979
Topical corticosteroid
Jul,1979
Aug,1979
Antibiotic
Aug,1979
Antibiotic
Aug,1979
Aug,1979
Sep, 1979
Sep, 1979
Sep, 1979
Sep, 1979
Sep, 1979
Sep,1979
Jun,1979
Sep, 1979
Sep,1979
Oct, 1979
Oct, 1979
Nov, 1979
Nov, 1979
Nov,1979
Nov,1979
--
Nov,1979
Anesthetic agent
Dec,1979
Jan,1980
Mar, 1980
311.
Mar,1980
Bronchial Asthma
Mar,1980
May, 1980
May,1980
May,1980
May,1980
Jun, 1980
Jun, 1980
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
Aug, 1980
Aug, 1980
Aug, 1980
Aug,1980
Aug,1980
Oct,1980
Anti-allergic
For relief of dysuria urgency,
nocturia, suprapubic pain, frequency,
Incontinence prostatitis, urethritis,
urethrotrigenitis, vaso urethral
spasms.
Nov, 1980
Nov,1980
Topical Antifungal
Dec,1980
Topical Antifungal
Dec,1980
Dec,1980
Mar,1981
Mar,1981
Apr, 1981
341. Sulphadoxine
Apr, 1981
342. Procarbazine
Apr, 1981
Apr, 1981
Apr, 1981
Apr,1981
Indicated in treatment of
Tuberculosis
Jun, 1981
347. Azabiperidol
Sep,1981
348. Clindamycin
Oct,1981
Oct,1981
350. Metrizamide
351. Sodium-2-mercepto-ethane
sulphonate
Nov, 1981
Dec,1981
Drug
Nitroglycerin ointment
Danazol capsule
100mg/200mg
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
Indication
Date of
Approval
Jan-82
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
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
S
No
Drug
Indication
Date of
Approval
30
Aug-85
31
32
---
Aug-85
38
Spectinomycin hydrochloride
39
40
41
42
43
Nadolol
44
Testosterone Undecanoate
capsules 40 mg
45
46
47
Aug-85
36
37
48
Econazole ophthalmic
ointment 1%
Propranolol HCl SR tablets
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
53
54
55
56
57
58
59
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
--
Feb-86
--
Feb-86
--
Feb.86
March.86
March.86
67
68
69
70
72
Buprenorphine
73
Receptal injection
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
81
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
--
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
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
105
Clostebol acetate
106
107
ketoconazole vaccine(Killed)
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
110
Propafenone Hydrochloride
111
112
113
114
115
Clobetasone butyrate
creams/ointments 0.05 %
Labetalol Hydrochloride
Nov-86
Neuroleptic agent
Dec.86
--
Nov-86
Nov-86
Dec.86
Dec.86
Dec-86
117
118
--
Jan.87
119
--
Jan.87
116
120
121
122
124
125
Clavulanic Acid
126
Trazadone
127
128
129
Tobramycin ophthalmic
solution 0.03% per vial
Acyclovir Tablets/ Cream/
Ointment/ Ophthalmic
Ointment
123
130
131
Jan.87
--
Jan.87
--
Jan.87
Jan.87
---
Feb.87
Feb.87
--
Feb.87
Feb-87
Feb-87
Mar-87
Marc.87
Mar-87
April.87
May-87
Jun-87
S
No
Drug
Indication
Date of
Approval
132
--
Jun-87
133
Jul-87
134
Alclometasone Dipropionate
cream/ointment0.05%
135
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
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
Nov-87
Nov-87
--
Dec.87
--
Dec-87
Nov-87
Dec-87
Dec-87
Dec-87
Dec-87
Dec.87
Jan-88
Jan-88
Jan-88
162
163
Amineptine
Astemizole
164
165
166
Budesonide
Penfluridol tablet 20 mg
Aclarubicin HCl
167
168
169
170
171
172
Minoxidil
Benzydamine topical analgesic
173
174
Melagenina Lotion
175
Amrinone Lactate
176
177
Minocycline
178
180
181
182
Ceftazidime Pentahydrate
183
184
185
Astemizole Susp.
Triclabendazole
186
187
188
179
189
Jan-88
Feb-88
Apr-88
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
193
--
Jan-89
194
Salinomycin
--
Jan.89
195
196
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
216
217
Dec-88
Jan-89
Jan-89
Feb-89
Mar-89
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
222
Haloperidol Deaconate
223
224
225
Naproxen Tablets
Ranitidine syrup 150 mg/10 ml
Ofloxacin
226
227
228
229
230
231
232
233
234
235
236
237
Amiodarone HCl
238
Pinaverium Bromide
239
Piroxicam Gel
240
241
242
243
244
245
246
Ceftizoxime
Deltamethrine
Prazosin Hydrochloride
Flurbiprofen SR Cap. 200mg
247
Coligen
248
L- Carnitine
Sep-89
Nov-89
Dec-89
Jan-90
Mar-90
Mar-90
Mar-90
Apr-90
Apr-90
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
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
271
272
273
274
Isosorbide mononitrate SR
tab. 50mg
Rabbit Anti Human Thymocyte
immunoglobulin
Felodipine
Pirarubicin HCl Injection
Horse antihuman lymphocyte
globulin
275
276
277
278
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
284
Nilutamide Tablets
285
Lisinopril
286
287
288
289
Bisoprolol Fumarate
290
291
Amsacrine Injection
Fucidic Acid hemihydrate
292
Sodium Enoxaparin
293
Roxithromycin
294
295
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
308
309
Candur P. Parvovirus
310
Naloxone HCL
311
312
313
314
315
316
317
318
May-92
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
Nov-92
Drug
1.
2.
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.
7.
Tenoxicam tablet 20 mg
8.
9.
10.
11.
13/May/9
3
12.
19/May/9
3
13.
14.
28/May/9
3
3/Jun/93
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.
17.
18.
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
26/Jul/93
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.
23.
24.
29/Oct/93
25.
30/Nov/9
3
26.
1/Dec/93
4/Oct/93
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.
34.
35.
36.
37.
1/Dec/93
Vet drug
20/Jan/94
Contrast media
21/Jan/94
12/Feb/9
4
Contrast media
29/Dec/9
3
13/Jan/94
20/May/9
4
13/May/9
4
19/Jul/94
25/Aug/9
4
26/Aug/9
4
39.
40.
41.
42.
43.
Celiprolol Hydrochloride
tablets100mg/200mg/400mg
Lansoprazole capsules 15 mg/30 mg
44.
45.
46.
47.
48.
Clonazepam tablets
0.5mg/1.0mg/2.0mg
49.
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.
54.
6/Mar/95
55.
29/Mar/0
5
56.
57.
58.
59.
60.
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
24/Jan/96
51.
52.
53.
63.
64.
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.
66.
67.
68.
69.
70.
Thiocolchicoside tablet -4 MG
71.
72.
73.
74.
75.
76.
77.
78.
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
79.
80.
9/Jul/96
81.
In non-infected / infected
inflammatory ocular condition
26/Jul/96
82.
2/Aug/96
83.
3/Aug/96
84.
85.
86.
87.
88.
89.
Promegestone tabs
0.125mg/0.250mg/0.500mg
90.
91.
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.
94.
95.
96.
97.
98.
99.
100.
101.
102.
103.
104.
9/Oct/96
11/Oct/96
11/Nov/96
19/Nov/9
6
22/Nov/9
6
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.
106.
107.
Resperidone Liquid 1 mg / ml
108.
109.
110.
111.
112.
113.
114.
115.
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.
15/Jul/97
12/Jul/97
118.
119.
For B.P.H.
12/Sep/9
7
120.
22/Sep/9
7
121.
Post-menopausal osteoporosis
only.
18/Sep/9
7
122.
19/Sep/9
7
123.
Cefpirome injection
0.25g/0.5g/1.0g/2gm per vial
124.
125.
126.
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
129.
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
130.
131.
132.
133.
134.
135.
136.
137.
138.
139.
140.
141.
142.
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.
144.
145.
146.
147.
148.
149.
150.
151.
152.
Simvastatin tab
5mg/10mg/20mg/40mg
153.
154.
155.
156.
157.
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.
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