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,1!1
2. 2-t"ymyl-oxy-met"yl glyoxalidine
"ydroc"loride #asal Spray
- Jan,1!1
3. Hamycin Suspension - Jan,1!1
4. $errous Sulp"ate Sustained
%elease Tablet 1&0 mg
- Jan,1!1
5. Hydroxyurea USP 'apsules, &00mg Anti-neoplastic agent Jan,1!1
6. (bupro)en *P Tablets, &0 mg Anti-r"eumatic +ar,1!1
7. Hydro)lumet"ia,ide Tablet 2& mg - +ar,1!1
8. '"lorp"enoxamine Hydroc"loride
Tablets 12 mg
- +ar,1!1
. -psilon amino caporic acid (n.ection
2&0 mg
- +ar,1!1
1!. (bupro)en *P Tablets, 200 mg Anti-r"eumatic +ar,1!1
11. *e/erine Hydroc"loride Tablets,
&0mg
+usculotropic 0 Spasmolytic +ar,1!1
12. Panc"romium *romide (n.ection,
1mg2ml
- Apr,1!1
13. -p"edrine Sulp"ate Sustained
%elease 'apsule !& mg
- +ay,1!1
14. 3-di"ydroxyp"enylalanine
Tablet2'apsule &00 mg
- +ay,1!1
15. %i)ampicin USP Tablets, 1&0mg Anti-T4*4 Jun,1!1
16. 5uinestral Tablets, 2&mcg -strogenic Steroid Jul,1!1
17. 6etamine Hydroc"loride Anest"etic agent Aug,1!1
18. 7lybenclamide Tablet & mg Sep,1!1
1. +ebe/erine Hydroc"loride Tablet
100 mg
+uculo-tropic spasmolytic 8ct,1!1
2!. Para-aminomet"ylben,oic acid
(n.ection &0 mg
- 8ct,1!1
21. 9i"ydroxyacetone 3otion - 8ct,1!1
22. 3actobacillus Sporengenes Tablet,
&02100 million
- 8ct,1!1
23. :east Tannic Acid 'ompound Anti-diarr"eal agent 8ct,1!1
24. 'ep"alexin *road Spectrum Antibiotic 8ct,1!1
25. Salbutamol Sulp"ate *P *ronc"ial Ast"ma 8ct,1!1
26. P"eiramine +aleate Tablet - #o/,1!1
27. Propranolol Hydroc"loride Tablet 10
mg
- #o/,1!1
28. Propranolol Hydroc"loride (n.ection
1 mg2ml
- #o/,1!1
2. Tetranicotinoyl $ructose - #o/,1!1
3!. Spiramycin (n.ection - #o/,1!1
31. Testolactone - #o/,1!1
32. Tetranicolinoyl $ructose Tablets 2&0
mg
- 9ec,1!1
33. Prednisolone (4P Tablets 10 mg - 9ec,1!1
34. ;,&-9initro-o-toluamide - Jan,1!2
35. $en)luramine Hydroc"loride Anti-obesity drug Jan,1!2
36. 'lopidal 'occodiosis Jan,1!2
37. Testolactone Tablets &0 mg - +ar,1!2
38. $en)luramine Hydroc"loride Tablets
20 mg
- Apr,1!2
3. $erric Sodium 'itrate - Apr,1!2
4!. Prot"ionamide *4P4 Anti-T4*4 9rug Jun,1!2
41. Sarcolysin (4P4 Anti-cancer drug Jun,1!2
42. 9oxepin Hydroc"loride Psyc"otic 9rug Jul,1!2
43. *iperiden Hydroc"loride Par<insonism Jul,1!2
44. Pyrantel Pamoate U4S4P4 Anti-Helmint"ic Jul,1!2
45. 9oxepin Hydroc"loride
Tablets2'apsule29ragee
Psyc"otic 9rug Sep,1!2
46. 2-*romo-2-nitropropan-1,;-diol Preser/ati/e Sep,1!2
47. *upi/acine Hydroc"loride 3ocal Anest"etic Sep,1!2
48. $lup"ena,ine 9econate Antipsyc"otic Sep,1!2
4. +arcaine 042& =204&= >it" or
>it"out adranaline
- Sep,1!2
5!. Propranolol Hydroc"loride - 8ct,1!2
51. '"loramp"enicol - 8ct,1!2
52. *iperiden lactate (n.ection & mg Par<insonism 8ct,1!2
53. 'yclandelate ?asodilating Agent 8ct,1!2
54. Po/idone (odine Solution 10 = - #o/,1!2
55. Po/idone (odine 7argle 04& = - #o/,1!2
56. $errous Sulp"ate Sustained
%elease Tablet 1@0 mg
- #o/,1!2
57. 3it"ium 'arbonate 'apsule 2&0 mg - #o/,1!2
58. 8xyclo,amide ?ertinary 9rug #o/,1!2
5. Sodium c"romoglycate Anti-ast"matic #o/,1!2
6!. 9oxycycline Hydroc"loride Tablet
100 mg
- 9ec,1!2
61. (sopropylt"ioimida,olidione Tablet &
mg
9ec,1!2
62. 3incomycin Hydroc"loride 'apsule
&00 mg
9ec,1!2
63. +itomycin ' (n.ection 2 mg 9ec,1!2
64. Amantadine Hydroc"loride Par<insonism 9ec,1!2
65. 9aunorubicin Anti-cancer drug 9ec,1!2
66. 'ypro"eptadine Hydroc"loride
Tablet 1 mg
Jan,1!;
67. Tri)luperidal Hydroc"loride $eb,1!;
68. -t"acrynic Acid U4S4P #on-t"ia,ide saluretic diuretic $eb,1!;
6. *eclomet"asone 9ipropionate Topical corticosteroid $eb,1!;
7!. Aantinol #icotinate Tablet &00 mg $eb,1!;
71. Salbutamol Sulp"ate *P Tablet 1
mg
*ronc"ial Ast"ma $eb,1!;
72. 'yclandelate Tablet 200 mg ?asodilating Agent $eb,1!;
73. -t"acrynic Acid U4S4P Tablet 2&mg2
&0 mg
#on-t"ia,ide saluretic diuretic $eb,1!;
74. Parbenda,ole Treatment o) Helmint"iasis $eb,1!;
75. -t"acridine 3actate Anti-diarr"eal $eb,1!;
76. Stano,olol Tablet 2 mg +ar,1!;
77. 8xy)edrine 'oronary ?asodilator Apr,1!;
78. 3-Asparginase Anti-cancer drug +ay,1!;
7. Polyglycalic acid sutures Sutures +ay,1!;
8!. Tri)luperidal Hydroc"loride (n.ection
1 mg2ml
+ay,1!;
81. Tri)luperidal Hydroc"loride Tablet
042&mg204&mg
+ay,1!;
82. Tri)luperidal Hydroc"loride 8ral
liBuid, &mg2&ml
#euroleptic agent +ay,1!;
83. #itra,epam Jun, 1!;
84. 8xyprenolol Hydroc"loride *eta-bloc<er Jun,1!;
85. $luraltadone Jun,1!;
86. 8xprenolol Hydroc"loride C *loc<er Jun,1!;
87. $uraltadone Jun,1!;
88. 'arbencillin Sodium Antibiotic Jun,1!;
8. 3incomycin Syrup 2&0 mg2&ml Jun,1!;
!. Prenylamine lactate Tablet @0 mg Jun,1!;
1. 8xy)edrine Tablet D mg 'oronary ?asodilator, )or angina
pectoris, myocardial in)arction 0
coronary insu))iciency4
Jul,1!;
2. 8xy)edrine Solution 10 mg 'oronary ?asodilator, )or angina
pectoris, myocardial in)arction 0
coronary insu))iciency4
Jul,1!;
3. 8xy)edrine (n.ection 2 mg2ml 'oronary ?asodilator, )or angina
pectoris, myocardial in)arction 0
coronary insu))iciency4
Jul,1!;
4. Tetramisole Hydroc"loride ;0= >2> Jul,1!;
5. $uraltadone po>der 20 = >2> poultry disease only Aug,1!;
6. Alp"ac"ymotrypsin in.ection
&mg2/ial
Aug,1!;
7. Penta,ocine Tablet &0 mg Aug,1!;
8. +orantel tartrate Aug,1!;
. 'arbencillin Sodium (n.ection 1 g
/ial
Antibiotic Aug,1!;
1!!. 3ora,epam Psyc"iatric drug Sep,1!;
1!1. $lup"ena,ine 9econate (n.ection
2mg2ml
Antipsyc"otic Sep,1!;
1!2. #itra,epam Tablet & mg Anti-epileptic Sep,1!;
1!3. 3yndiol (n.ection Sep,1!;
1!4. Pindolol *eta-bloc<ing agent Sep,1!;
1!5. #itroxa,epine Hydroc"loride
(n.ection 2& mg22ml
Sep,1!;
1!6. #itroxa,epine Hydroc"lorideTablet
2& mg
8ct,1!;
1!7. Pindolol Tablet & mg *eta-bloc<ing agent #o/, 1!;
1!8. Aprotonin Acute Pancreatitis #o/,1!;
1!. *leomycin Anti-cancer drug 9ec,1!;
11!. 'arbenoxolone sodium 7astric Ulcer 9ec,1!;
111. +alat"ion dusting po>der 1= 9ec,1!;
112. 3ora,epam Tablet 1mg, 2 mg Psyc"iatric drug 9ec,1!;
113. *etamet"asone-1!-ben,oate Topical anti-in)lammatory steroid 9ec,1!;
114. T"iop"anate ?ertinary Anti-Helmint"ic 9ec,1!;
115. 'arbenoxolone sodium Tablet &0
mg
7astric Ulcer Jan,1!1
116. Aprotonin (n.ection 100000 6(U2&ml,
2000006(U210ml
Acute Pancreatitis Jan,1!1
117. +eglumine 3ocarbate A-ray contrast media $eb,1!1
118. Tinida,ole Tablets, 1&0 mg $or treatment o) tric"omoniasis and
intestinal ameobisis
$eb,1!1
11. 'lomip"ene 'itrate *4P4 Tablet,
&0mg
(nduction o) o/ulation in patients >it"
persistent o/ulatory dys)unction >"o
desire pregnancy
$eb,1!1
12!. #itro)urantoin *P sensiti/ity dis<
100 mcg2200 mcg
+ar,1!1
121. 9-#orgestrol Tablet 040; mg 8ral contracepti/e Apr,1!1
122. *eclomet"asone 9ipropionate
0402&= cream 0 ointment
Topical corticosteroid Apr,1!1
123. 3ido)la,ine Tablets, @0mg (ndicated in treatment o) isc"emic
"eart disease and prop"ylaxis and
a)ter treatment o) myocardial
in)arction
+ay,1!1
124. Sodium $usidate 8intment,
20mg2gm
$or treatment o) stap"ylococcal
in)ections suc" as abscesses,
/aricose ulcer4
+ay,1!1
125. @ aminopenicillanic acid 'apsule,
2&0 0 &00 mg
$or treatment o) respiratory trac<, 7(
tract 0 7enital Urinary Tract
in)ections4
+ay,1!1
126. Tretinoin 040&= ?anis"ing cream Jul, 1!1
127. Tretinoin 040&= lotion Jul, 1!1
128. Tretinoin 040&= se>ab Jul, 1!1
12. 9-pencillamine Tablets, ;00mg (n t"e treatment o) +etallic poisoning
EilsonFs diseases
Jul, 1!1
13!. +esterolone Tablet 10 mg (n t"e treatment o) potency
disturbances, in)ertility 0 "ypo-
gonadism
Jul,1!1
131. Pimo,ide (n t"e treatment o) c"ronic
sc"i,op"renia
Aug, 1!1
132. 8xolinic acid $or treatment o) acute and c"ronic
UT(
Sep, 1!1
133. (soptin Hydroc"loride (n.ection & mg2
2ml
- Sep,1!1
134. +icona,ole $or treatment o) onyc"omycosis,
dermatop"ytosis and /ul/o/aginitis4
8ct,1!1
135. Salbutamol Sulp"ate -lixir 2mg2&ml - 8ct,1!1
136. +ebenda,ole Tablets, 100mg $or treatment o) enterobiasis
ascarissis tric"uriasis
ancylostomiasis strongyloidiasis
large round >orm >"ip>orm
"oo<>orm 0 t"read>orm
#o/,1!1
137. *upi/acaine Hydroc"loride
Hyperbaric solution 10mg2ml
Anest"etic 9ec,1!1
138. Pimo,ide Tablet 1mg, 1 mg #euroleptic agent 0 anti-psyc"otic
agent
9ec,1!1
13. +icona,ole 'ream 2= Topical anti-)ungal 0 anti-bacterial
agent
9ec,1!1
14!. 9esamino-oxytocin (ndicated in t"e treatment o)
induction o) labor )or /arious reasons
and )or adeBuate uterine actions
9ec,1!1
141. ?irginiamycin (ndicated )or gro>t" proportion in
poultry pigs and )or pre/ention and
treatment )or s>ine dysentery4
$eb,1!&
142. -xtract o) centella asiatica (ndicated in treatment o) ulcers,
burns, strain gra)ts, bed sores etc4
$eb,1!&
143. #i)lumic acid (ndicated in r"eumatoid art"ritis,
osteo art"ritis
$eb,1!&
144. 'lonidine (ndicated in treatment o)
"ypertension
$eb,1!&
145. Testolactone (n.ection 100 mg2ml - +ar,1!&
146. #itroglycerine Sustained %elease
tablet 24@ mg
- +ar,1!&
147. lynestrenol *P Tablet 24& mg - +ar,1!&
148. 9oxorubicin "ydroc"loride (n.ection
10 mg2/ial
(ndicated in t"e treatment o) /arious
types o) neoplasia bot" acute and
c"ronic leu<emia lymp"omata4 So)t
tissue sarcomata breast and lung
cancer4
Apr,1!&
14. *eta"istine 9i"yroc"loride (ndicated in t"e Treatment o) meniers
syndrome c"aracteri,ed by uni- 0 bi-
lateral tinnitus, /ertigo usually
accompanied by sensorineural
"earing loss
Apr,1!&
15!. 'lotrima,ole (ndicated against certain bacteria,
proto,oa and against certain
organisms >"ic" are sensiti/e to
metronida,ole
+ay,1!&
151. (n.4 8) a mixture o) sod4 Salt 0
met"yl glucamine salt o) ;,&-
diacetamido-2,1,@-triiodoben,oic
acid
A-ray contrast media +ay,1!&
152. 'lotrima,ole ?aginal Tablets 041 gm Anti-)ungal 0 3ocal anti-tric"omanial
agent
Jun,1!&
153. 'lotrima,ole 1gm2100gm cream Anti-)ungal 0 3ocal anti-tric"omanial
agent
Jun,1!&
154. 'lotrima,ole 1gm2100ml Solution Anti-)ungal 0 3ocal anti-tric"omanial
agent
Jun,1!&
155. ?irginiamycin 2= premix Antibiotic Jul,1!&
156. 'lonidine Hcl Tablet 2'apsule 100
mcg
Anti"ypertensi/e Jul,1!&
157. 'lonidine Hcl Tablet 1&0 mcg Anti"ypertensi/e Jul,1!&
158. 'arbadox (ndicated in t"e treatment o) s>ine
dysentery and bacterial enteritis4
Jul,1!&
15. 9esoximetasone (ndicated in management o) /arious
acute and c"ronic dermatitis /i,
ec,ema, nummular ec,ema in)antile
ec,ema, atopic dermatitis4
Jul,1!&
16!. Alp"ac"ymotrypsin Tablet 2& c"g
units
- Jul,1!&
161. 9imetrida,ole 7ro>t" promotant in poultry Aug,1!&
162. Sodium $luaride *P Tablet 20 mg - Aug,1!&
163. Urea ;0 = solution )or (ntra-
amniotic use
- Aug,1!&
164. +icona,ole #itrate Po>der 20
mg2gm
Topical anti-)ungal 0 anti-bacterial
agent
Aug,1!&
165. +alat"ion lotion 04& = - Sep, 1!&
166. 9esoximetasone 8intment
24&mg2gm
Topical corticosteroid Sep,1!&
167. Pentoxi)ylline (ndicated in t"e treatment o) arteril
and aterio /enous circulatory
disorders
Sep,1!&
168. Sodium '"loride 20= Hypertonic
saline )or (ntra-amniotic use
- 8ct,1!&
16. Tro)os)amide (ndicated in treatment o)
lymp"ogranulomatosis,
lymp"osarcoma reticulosacrcimo
o/arian carcinoma, and carcinoma o)
breast4
#o/, 1!&
17!. Pentoxi)ylline 9ragee 100 mg ?asodilating Agent #o/, 1!&
171. Pentoxi)ylline (n.ection 100mg2&ml ?asodilating Agent #o/, 1!&
172. *eclomet"asone 9ipropionate +9(
&0 mcg
- 9ec,1!&
173. 'ep"radine (ndicated in treatment o) in)ections o)
7(, 7entio urinary, respiratory and
so)t tissue4
Jan,1!@
174. +e)enamic acid (ndicated in treatment o) acute and
c"ronic pain, post-operati/e and
post-partum pain, "eadac"e,
traumatic pain, muscular pain4
Jan,1!@
175. 'atalin GSodium 1-"ydroxy-&-oxo-
&H-PyridoG;42-aH p"enoxa,ine-;-
carboxylateH
(ndicated in t"e treatment o) cataract Jan,1!@
176. 7lydia,inamide (ndicated in treatment o) diabetes $eb,1!@
177. 'ep"radine 'apsule 2&02&00 mg Antibiotic +ar,1!@
178. 'ep"radine (n.ection
2&0mg2&00mg21g2/ial
Antibiotic +ar,1!@
17. 'ep"radine Suspension 2&02&ml Antibiotic +ar, 1!@
18!. +etronida,ole Suspension 12&
mg2&ml
- Apr,1!@
181. -xtract o) centella asiatica 2=
in.ection
Treatment o) ulcers, strain gra)ts, bed
sores
+ay, 1!@
182. -xtract o) centella asiatica 200 mg
Tablet
Treatment o) ulcers, strain gra)ts, bed
sores
+ay, 1!@
183. -xtract o) centella asiatica 8intment
1=
Treatment o) ulcers, strain gra)ts, bed
sores
+ay, 1!@
184. -xtract o) centella asiatica Po>der
2=
Treatment o) ulcers, strain gra)ts, bed
sores
+ay, 1!@
185. 8xibenda,ole premix 14;;= >2> (ndicated in t"e treatment o) gastro-
intestinal mematodes, in)ection o)
cattle, s"eep, "orses and ot"er
domestic animals4
+ay, 1!@
186. Aminosidine Sulp"ate (n.4 ?ial,
&00mg
(ndicated in t"e treatment o) styp"ylo
coccus sepsis, in)ection o)
respiratory tract due to styp"ylo
coccus and pneumo coccus in)ection
o) t"e urinary tract due to - coli, P
/ulgaris, gonococcus in)ections4
%esistant to ot"er antibiotics4
+ay, 1!@
187. 'lonidine Hcl (n.ection 1&0mcg2ml Anti"ypertensi/e Jun, 1!@
188. Halcinomide (ndicated in t"e treatment o) /arious
common dermatosis
Jul,1!@
18. 9exc"lorop"eniramine maleate
Tablet 2 mg
- Jul,1!@
1!. Tro)os)amide Tablet &0 mg Anti-cancer drug Aug, 1!@
11. +etronida,ole Suspension 200
mg2&ml
- Aug,1!@
12. 9isodium c"romoglycate #asal
drops 2=
- Sep,1!@
13. ?alet"amate bromide - #o/,1!@
14. Asiaticoside - #o/,1!@
15. 3operamide (ndicated in acute diarr"ea due to
)ood poisoning and /iral in)ections4
9ec,1!@
16. Tetramisole Hydroc"loride Syrup
&0mg2&ml
- 9ec,1!@
17. +etclopramide Anti-emetic 9ec,1!@
18. $usa)ungin (ndicated in t"e treatment o) sinusitis,
p"aryngitis, sour t"roat, laryngitis,
bronc"itis, pre/ention o) respiratory
complication
Jan,1!!
1. $lupent"ixol (ndicated in psyc"iatric or
sc"i,op"renic cases >"ere sedati/e
and "ypnotics e))ects are contra
indicated
Jan,1!!
2!!. (sometanidium '"loride (ndicated in treatment o) cardiac
arr"yt"mias including atrial
)ibrillation, /entricular tac"ycardia,
arr"yt"mia
Jan,1!!
2!1. (ron Polymaltose eB to -lemental
(ron 9rops &0 mg2ml
- $eb,1!!
2!2. $lupentixol Hydroc"loride Tablet 04&
mg
- $eb,1!!
2!3. $usa)ungin aerosol 2& mg $ungal Antibiotic +ar,1!!
2!4. 3oxitalmic Acid cerebral angiograp"y and urograp"y
GA-ray contrast mediaH
Apr, 1!!
2!5. 9ot"iepin Hydroc"loride (ndicated in treatment o) psyc"otic
depression neurotic depression,
anxiety depression
+ay, 1!!
2!6. #oret"isterone *P Tablet 04;& mg - +ay,1!!
2!7. 9isopyramide 'apsule 100 mg - Jun, 1!!
2!8. 1-G2-tetra"ydro)urylH-&-)lourouracil (ndicated in treatment o) cancer o)
stomac", colon, rectum, breast 0
lung4
Jun, 1!!
2!. $lup"ena,ine 9econate 9epot
(n.ection 20 mg2ml
Antipsyc"otic Jul,1!!
21!. 'yclandelate 'apsule 200 mg ?asodilating Agent Jul,1!!
211. #imora,ole (ndicated )or treatment o)
tric"omoniasis
Sep, 1!!
212. Suramin (n.4 /eterinary 9rug Sep, 1!!
213. 9oxapram Hydroc"loride $or treatment o) post-operati/e
respiratory depression and
respiratory depression due to
poisoning
Sep,1!!
214. Sul)inpyra,one Tablet 100 mg - Sep,1!!
215. Sul)inpyra,one 'apsule 200 mg - Sep,1!!
216. -t"acridine lactate (n.ection 1mg2ml - 8ct, 1!!
217. #imora,ole Tablet 2&0 mg (ndicated )or treatment o)
tric"omoniasis
8ct, 1!!
218. Penta,ocine 3actate (n.ection ;0
mg2ml
- 8ct,1!!
21. &-$luorouracil 'apsule 2&0 mg - #o/,1!!
22!. 8rp"enedrine 'itrate (n.ection
@0mg22ml
- #o/,1!!
221. $luprednylidine 21-Acetate (ndicated in treatment o) allergic
pruritus and in)lammatory dermatosis
9ec,1!!
222. *eta-met"yl 9igoxin - 9ec,1!!
223. 2-Pyrrolidone Acetamide (ndicated in treatment )or be"a/ior
and psyc"otic problems in old age
and mental retardation in c"ildren
9ec,1!!
224. 9ia,epam (n.ection &mg2ml - 9ec,1!!
225. 7entamycin (n.ection 2 mg2ml - Jan,1!D
226. $luprednylidine 21-Acetate 'ream
041=
Topical 'orticosteroid Jan,1!D
227. 2-Pyrrolidone Acetamide 'apsule
100 mg
Psyc"otic 9rug Jan,1!D
228. 2-Pyrrolidone Acetamide (n.ection
200mg2ml
Psyc"otic 9rug Jan,1!D
22. 9iet"ylamine Salicylate 'ream 10=
>2>
- +ar,1!D
23!. *eta-met"yl 9igoxin Tablet 041 mg 0
040& mg
'ardiac glycoside +ar,1!D
231. *eta-met"yl 9igoxin 3iBuid 04@ mg 'ardiac glycoside +ar,1!D
232. *eta-met"yl 9igoxin (n.ection 041
mg
'ardiac glycoside +ar,1!D
233. +et"yl predinsolone (ndicated )or conditions reBuiring
glucocorticoid acti/ity including
collagen diseases allergic diseases,
"yper sensiti/ity reactions
+ar,1!D
234. #-p"enylet"ylant"ranilic acid
'apsule ;00 mg
- Apr,1!D
235. '"lorp"eniramine maleate USP
Sustained %elease Tablet D mg
- Apr,1!D
236. Sulp"ametopyra,ine T"e drug in combination >it"
pyrimet"amine )or t"e treatment o)
cases o) malaria >"ic" are resistant
to c"loroBuine
Jun, 1!D
237. $la/onoids -xtracted )rom %utacea
GAurantiaceaeH containing standard
amount o) 9iosmin
(ndicated in t"e treatment o)
Hemorr"oids
Jun, 1!D
238. +icona,ole #itrate ?aginal Passary
100 mg
- Jun,1!D
23. Soyabean Protein ;;42 g21&0 g - Jun,1!D
24!. Salcatonin Polypeptide "ormone Jul, 1!D
241. 9icloxacillin Sodium (ndicated in in)ection o) respiratory
tract, s<in 0 mucosa, bone in)ection4
Jul, 1!D
242. Sotalol (ndicated in treatment o) angina
pectoris4 Hyper tension cardiac
arr"yt"mias
Aug, 1!D
243. 9ia,oxide (ndicated )or reduction o) blood
pressure in malignant "ypertension
Aug, 1!D
244. Po/idone (odine USP Scrub 1= - Sep, 1!D
245. Po/idone (odine USP Solution &= - Sep, 1!D
246. Po/idone (odine USP 8intment &= - Sep, 1!D
247. ()os)amide (ndicated in t"e treatment o) o/arian
breast testicular carcinoma
"ypernap"roma, pancreatic
carcinoma and malignant lymp"oma
Sep,1!D
248. Iinc Sulp"ate (P 'apsule 220 mg - Sep,1!D
24. Human Placental -xtract (n.ection - Sep,1!D
25!. (ndapamide Hemi"ydrate Tablets,
24&mg
$or mild to moderate "ypertension 8ct, 1!D
251. 7lucagon (n.ection (ndicated in t"e treatment o) se/ere
"ypoglycemic reactions in diabetic
patients
8ct, 1!D
252. Amitryptylline Hydroc"loride Tablet
!& mg
- 8ct,1!D
253. 8xymeta,oline Hydroc"loride 042&=
GPaediatricH
8ct,1!D
254. *leomycin (n.ection & mg Anti-cancer drug 8ct,1!D
255. +etronida,ole (n.ection (? 2mg2ml - #o/,1!D
256. '"oline Salicylate solution D4!= - #o/,1!D
257. 9oxapram Hydroc"loride (n.ection
20mg2/ial
- #o/,1!D
258. Amoxycillin (ndicated in treatment o) UT(,
%espiratory, 7enito Urinary, -#T 0
so)t tissue in)ections
9ec,1!D
25. *enorylate Treatment o) "eadac"e, body ac"e,
)e/er, r"initis sinusitis
9ec,1!D
26!. +ebenda,ole Suspension 100
mg2&ml
*road Spectrum Antibiotic 9ec,1!D
261. Tric"lormet"ia,ide Tablets, 2mg (n t"e treatment o) "epatic cirr"osis,
edema "ypertension4
9ec,1!D
262. 'ralant"amine Hydrobromide Tablet
0 (n.ection
Treatment o) neuritis, poliomyelitis 0
in)antile cerebral palsies
9ec,1!D
263. *enorylate Tablet 2&0 mg Analgesic 0 Anti-pyretic 9ec,1!D
264. *enorylate Suspension 2g2&ml Analgesic 0 Anti-pyretic 9ec,1!D
265. &-$luorouracil 8ral Solution
2&0mg2&ml
- Jan,1!
266. Salbutamol Sulp"ate (n.ection
&0mg2&ml
*ronc"ial Ast"ma Jan,1!
267. Amoxycillin 'apsule 2&0mg 0
&00mg
Antibiotic Jan,1!
268. Amoxycillin Syrup 12&mg2&ml 0
2&0mg2&ml
Antibiotic Jan,1!
26. Amoxycillin Paediatric Suspension
12&mg2142& ml
Antibiotic Jan,1!
27!. (mipramine Pamoate 'apsule !&
mg2 1&0 mg
(ndicated in t"e treatment o) all )orms
o) depression
Jan,1!
271. #aproxen Tablets 2&0 mg (ndicated in treatment o) r"eumatoid
art"ritis
Jan,1!
272. Allergen extracts Jan,1!
273. $enbenda,ole (ndicated in treatment o)
gastrointestinal nematodes in)ections
o) li/e stoc<s
Jan,1!
274. '"lorp"enoxamine -mbonate Syrup
1!4&mg2&ml
+ar, 1!
275. 'arboprost Tromet"amine Sterile
Solution 2&0 mcg2ml
$or treatment o) second trimester
abortions only
+ar, 1!
276. +icona,ole #itrate Solution 2= +ar,1!
277. ()os)amide (n.ection
200mg2&00mg21g2/ial
+ar,1!
278. 'lemastine Treatment o) r"initis urticaria, pruritus
itc"ing dermatoses
Apr, 1!
27. (soxuprine Hydroc"loride Sustained
%elease Tablet 10 mg
- Apr,1!
28!. (bupro)en Suspension 100mg2&ml - Apr,1!
281. 8xy)edrine Tablet 21 mg - Apr,1!
282. #i)lumic acid 'apsule 2&0 mg - +ay,1!
283. 9iosmin Tablet2'apsule 1&0 mg (ndicated in treatment o)
"emorr"oids
Jun,1!
284. Amoxycillin (n.ection
2&0mg2&00mg21g2/ial
Antibiotic Jun,1!
285. $lurbipro)en Tablet &0 mg 0 100 mg (ndicated in r"eumatoid art"ritis,
osteoart"ritis and allied disorders
Jul, 1!
286. 'lopamide Tablet 20 mg (ndicated in t"e treatment o) edema
o) cardiac, "epatic or renal region
and "ypertension only4
Jul, 1!
287. Sodium #itroprusside USP (n.ection
&0mg2/ial
- Jul,1!
288. 9esoximetasone 8intment 040&= Topical corticosteroid Jul,1!
28. Tetracycline Sustained %elease
'apsule 2&0 mg
- Aug,1!
2!. @ aminopenicillanic acid (n.ection
2&0 0 &00 mg
Antibiotic Aug,1!
21. @ aminopenicillanic acid 8ral
Suspension 12&mg2&ml, 2&0mg2&ml
Antibiotic Aug,1!
22. 9icloxacillin Sodium 'apsule 12&
mg 0 2&0 mg
- Aug,1!
23. #atamycin cream 2= (ndicated in treatment o) /aginal
irritation and disc"arge due to
monilial, tric"omonial in)ection
Sep, 1!
24. *etamet"asone 9ipropionate
8intment 04&mg2g
(ndicated o) treatment o) Psoriasis
contact dermatitis, atopic dermatitis,
neuro dermatitis senile pruritus
Sep, 1!
25. Sil/er Sulp"adia,ine 'ream 1= >2> (ndicated in treatment o) burns and
>ound in)ections
Sep, 1!
26. *rom"exine Hydroc"loride Tablet D
mg
(ndicated in treatment o) bronc"itis
and ot"er conditions >"ere sputum is
troublesome
Sep, 1!
27. *rom"exine Hydroc"loride -lixir
1mg2&ml
(ndicated in treatment o) bronc"itis
and ot"er conditions >"ere sputum is
troublesome
Sep, 1!
28. Amiloride H'l Tablet & mg (ndicated in treatment o) edema and
"ypertension
Sep, 1!
2. 9ioctyl Sodium Sul)osuccinate USP
-ar 9rop &=
- Sep,1!
3!!. 9icloxacillin Sodium 8ral Solution
@24& mg
- Sep,1!
3!1. #atamycin ?aginal Tablets 2& mg - 8ct, 1!
3!2. Albenda,ole Suspension 24& = >2/
0 10= >2/
(ndicated in control o) 7astro
(ntestinal round >arm, tap >arm,
lung >arm and adult li/er )lu<es in
cattle and s"eepFs4
8ct, 1!
3!3. Terbutamine Sulp"ate Tablet & mg (ndicated in treatment o) ast"ma #o/, 1!
3!4. Terbutamine Sulp"ate Syrup 04;
mg2ml
(ndicated in treatment o) ast"ma #o/, 1!
3!5. 9ila,ep Tablets &0 mg (ndicated in treatment o) coronary
insu))iciency, coronary sclerosis,
angina pectoris as >ell as )or
prop"ylaxis and )ollo> up treatment
o) myocardial in)arction4
#o/,1!
3!6. Terbutaline Sulp"ate Tablet 24& mg
0 & mg
- #o/,1!
3!7. Terbutaline Sulp"ate Syrup
04;mg2ml
-- #o/,1!
3!8. 7lycopyrrolate (n.ection 042 mg2ml Anest"etic agent 9ec,1!
3!. 9opamine H'l (n.ection 200 mg2&ml (ndicated )or treatment o)
"emodynamic imbalances present in
t"e s"oc< syndrome due to
myocardial in)raction, trauma
endotoxic septicemia, open "eart
surgery and renal )ailure4
Jan,1D0
31!. -striol Succinate Tablet 2 mg (ndicated in treatment o) local and
general complaints arising )rom
diminis"ed estrogen production a)ter
menopause and a)ter surgical
remo/al o) o/ary4
+ar, 1D0
311. Amoxicillin 9ispersible Tablet 12&
mg
- +ar,1D0
312. Salbutamol Sulp"ate Sustained
%elease Tablet D mg
*ronc"ial Ast"ma +ar,1D0
313. Tyl/alosin Tartarate Aid in treatment o) c"ronic
respiratory disease in c"ic<en and )or
maintaining >eig"t gain )eed
e))iciency4
+ay, 1D0
314. 'imetidine (n.ection 100mg2ml (ndicated )or treatment o) benign
gastric duodenal recurrent and
stomal ulceration, re)lux esop"agitis
+ay,1D0
315. 'imetidine Tablet2'apsule 200 mg (ndicated )or treatment o) benign
gastric duodenal recurrent and
stomal ulceration, re)lux esop"agitis
+ay,1D0
316. 'imetidine Syrup 200mg2&ml (ndicated )or treatment o) benign
gastric duodenal recurrent and
stomal ulceration, re)lux esop"agitis
+ay,1D0
317. Trimeta,idine 9i"ydroc"loride Tablet
; mg
(ndicated in treatment o) angina
pectoris and intermittent claudication
Jun, 1D0
318. 'ytrabine (n.ection (ndicated in treatment o) acute
myeloid leu<emia
Jun, 1D0
31. Tamoxi)en 'itrate (ndicated in treatment o) breast
cancer in pre and post-menopausal
>omen
Jun,1D0
32!. Aipamid Tablet 10 mg Jul, 1D0
321. Halo)uginone $or pre/ention and treatment o)
poultry coccidiosis
Jul, 1D0
322. +et"icillin Sodium indicated in treatment o) in)ections
due to penicillinase producing
stap"ylococci
Jul, 1D0
323. Terbutaline Sulp"ate (n.ection 04&
mg2ml
- Jul,1D0
324. 3e/amisole Hydroc"loride (n.ection
1&= 0 ;0= >2/
- Jul,1D0
325. 3e/amisole (n.ection 1D42= >2/ - Jul,1D0
326. +edrysone 8p"t"almic Suspension
140=
- Jul,1D0
327. *umetionide Tablet 1 mg (ndicated in treatment o) edema
associate >it" congesti/e "eart
)ailure, coronary edema, "epatic
ascites and renal disease including
nep"ortic syndrome
Aug, 1D0
328. *umetionide (n.ection 042& mg2ml (ndicated in treatment o) edema
associate >it" congesti/e "eart
)ailure, coronary edema, "epatic
ascites and renal disease including
nep"ritic syndrome
Aug, 1D0
32. 3omustine 'apsule 10 mg, 10 mg 0
100 mg
- Aug, 1D0
33!. 5uinpramine Sulp"ate - Aug,1D0
331. 5uinpramine '"loride Aug,1D0
332. $enpipramide +et"obromide and
para-piperdinoet"oxy o-
carboxymet"oxy ben,op"enol
"ydroc"loride
- 8ct,1D0
333. A,atidine +aleate Tablet 1 mg Anti-allergic #o/, 1D0
334. $la/oxate H'l Tablet 100 mg $or relie) o) dysuria urgency,
nocturia, suprapubic pain, )reBuency,
(ncontinence prostatitis, uret"ritis,
uret"rotrigenitis, /aso uret"ral
spasms4
#o/,1D0
335. -cona,ole #itrate 'ream 1= Topical Anti)ungal 9ec,1D0
336. -cona,ole #itrate ?aginal Tablets
1&0 mg
Topical Anti)ungal 9ec,1D0
337. 'ep"alot"in Sodium (n t"e treatment o) (n)ections o) so)t
tissue, respiratory and urinary tract,
meningitis, ot"er in)ections due to
susceptible organisms and in t"e
treatment o) in)ection due to penicillin
resistant strains o) stap"ylococci4
9ec,1D0
338. Plantago 8/ata G(sapgolH seed "us<
G(4PH
- +ar,1D1
33. +esterolone Tablet 2& mg - +ar,1D1
34!. 6etopro)en Tablets2'apsule &0mg (ndicated in t"e treatment o)
r"eumatoid art"ritis osteoart"ritis,
an<ylosing spondylitis, gout4
Apr, 1D1
341. Sulp"adoxine (ndicated )or t"e treatment o) cases
o) malaria >"ic" are resistant to
c"loroBuine
Apr, 1D1
342. Procarba,ine $or treatment o) Hodg<inFs disease Apr, 1D1
343. (nacti/ated rabies /accine GHuman
9iploid cellH
$or t"e treatment o) rabies4 Apr, 1D1
344. Sisomicin Sulp"ate (ndicated in treatment o) and
systemic and local in)ections o)
<idney, genito urinary tract, 3%T(,
septicemia, so)t tissue in)ections, 7(T
in)ections, in)ection o) '#S peritonitis
or pel/ic
Apr, 1D1
345. Tamoxi)en 'itrate 'apsule 10 mg Apr,1D1
346. Teri,idone (ndicated in treatment o)
Tuberculosis
Jun, 1D1
347. A,abiperidol (ndicated in treatment o) acute and
c"ronic sc"i,op"renia anxiety,
neurosis, manic depressi/e
psyc"osis 0 "yper <inetic c"ildren4
Sep,1D1
348. 'lindamycin (ndicated in treatment o) gram
positi/e organism pat"ogen,
stap"ylococci and streptococci,
pneumococci etc4
8ct,1D1
34. Sodium ?alporate (ndicated in treatment o) all )orms o)
epilepsies
8ct,1D1
35!. +etri,amide (ndicated in lumber t"oracic cer/ical
0 total columnar myelograp"y, direct
/entriculograp"y etc4
#o/, 1D1
351. Sodium-2-mercepto-et"ane
sulp"onate
(ndicated )or pre/ention o) urotoxic
side e))ects associated >it"
treatment o) malignant tumors by
oxa,ap"osp"orines
9ec,1D1
Approval Status of New Drug during 1982-1992
S
No
Drug Indication Date of
Approval
1 #itroglycerin ointment $or treatment o) Angina Pectoris due to
coronary artery disease
Jan-D2
2 9ana,ol capsule
100mg2200mg
(ndicated in t"e treatment o) endometriosis,
gynaecomastia, )ibrocystic mastitis,
precocious puberty and pubertal breast
"ypertrop"y
+ar-D2
3 +etoprolol Tartrate tablet &0
mg2100mg
(ndicated in treatment o) "ypertension +ar-D2
4 'isplatin in.ection 10 mg2 &0
mg per /ial
(ndicated in t"e treatment o) metastatic
testicular and o/arian cancer
Apr-D2
5 Uro<inase )or (n.ection (ndicated in treatment o) pulmonary
embolism and t"romboembolic disorders
in/ol/ing deep /eins
+ay-D2
6 %osoxacin 'apsules 1&0 mg (ndicated in treatment o) gonorr"oeal
Uret"ritis
Jul-D2
7 +agaldrate tab 100 mg -- #o/-D2
8 $enbenda,ole -- Jan-D;
+easles +umps %ubella
?accine
-- $eb-D;
1! -t"acridine lactate 100 mg2
200 mg
-- Jun-D;
11 %i)ampicin syrup -- Jun-D;
12 Trimet"oprim tablet 100 mg -- Jun-D;
13 9isopyramide in.4 100 mg2& ml
0 1&0 mg2!4& ml
-- Aug-D;
14 Tinida,ole suspension !& mg2&
ml
-- 9ec-D;
15 Ponderax S% tab4@0 mg -- Sep-D1
16 #i)edipine capsules & mg2 10
mg
-- 9ec-D1
17 Septopal *eads and '"ains $or treatment o) *ones and So)t Tissue
in)ections
Jan-D&
18 Timolol +aleate op"4 Solution
24& mg2ml
$or treatment o) '"ronic 8pen angle
7laucoma , 8cular Hypertension
Jul-D&
1 $lura,epam capsules 1& mg2
;0 mg
-- Aug-D&
2! Tona,oline H'l nasal drop
040D= sol4
#asal 9econgestant Aug-D&
21 +etoprolol in.4 1 mg2ml -- Aug-D&
22 Pra,iBuantel tablet @00 mg -- Aug-D&
23 #imustine H'l in.4 2& mg2 &0
mg per /ial
-- Aug-D&
24 'arboBuone tablet 042& mg2
04& mg
-- Aug-D&
25 'arboBuone in.4 1 mg2 /ial -- Aug-D&
26 'entbucridine in.4 04& = anaest"etic Aug-D&
27 -tomidate in.42 mg2 ml -- Aug-D&
28 'innari,ine tablet 2& mg21&
mg
-- Aug-D&
2 -- Aug-D&
+ianserin H'l tablet 102202;0
mg
S
No
Drug Indication Date of
Approval
3! #etilmicin sulp"ate in.4 10 mg2
2& mg2 100 mg per ml
(ndicated in t"e treatment o) Septicaemia
including neonatal sepsis and ot"er se/ere
systemic in)ections4
Aug-D&
31 %anitidine tablet 1&0 mg -- Aug-D&
32 Hydrocortisone *utyrate
cream2 ointment 0410 =
-- Aug-D&
33 +exiletine in.4 2&0 mg2 10 ml -- Aug-D&
34 +exiletine capsules &021&0
mg
--
35 (sosorbide +ononitrate tablet
202102@0 mg
(ndicated in t"e treatment o) 'H9 and
anti-anginal
Aug-D&
36 Aminoglutet"imide -- Aug-D&
37 Atenolol tablet &0 mg2 100 mg (n t"e treatment o) "ypertension angina
pectoris cardiac arr"yt"mias
Sep-D&
38 Spectinomycin "ydroc"loride (ndicated in t"e treatment o) acute
gonorr"oeal uret"ritis 0 proctitis in male
and acute gonorr"oeal cer/icitis 0 proctitis
in )emale
Sep-D&
3 Tobramycin in.4 10210 mg per
ml
(n t"e treatment o) serious bacterial
in)ections suc" as sceptical lo>er
respiratory tract in)ections , serious central
ner/ous system in)ections, abdominal l
in)ections complicated and recurrent
urinary tract in)ections 0 s<in and bone
in)ections
Sep-D&
4! +onensin Sodium premix (n t"e treatment o) 'occidiosis in c"ic<en
and "ens
Sep-D&
41 'e)a,olin Sodium in.4 2&0 mg,
&00 mg 0 1 gm4 per /ial
(n t"e treatment o) serious in)ections due 0
susceptible organisms, respiratory tract
in)ections urinary biliary tract in)ections4
Sep-D&
42 9iclo)enac Sodium tablet
2&2&0 mg
(n t"e treatment o)
r"eumatoid art"ritis ,osteoart"ritis
an<ylosing spondylitis gout, pain)ul post
operatic pain )ollo>ing dental surgery etc4
Sep-D&
43 #adolol (n t"e treatment
angina pectoris, cardiac arr"yt"mias and
essential "ypertension
Sep-D&
44 Testosterone Undecanoate
capsules 10 mg
(ndicated )or
replacement t"erapy in cases o)
"ypogonadism and male climacteric in t"e
treatment o) gynaecomastia
Sep-D&
45 9extranomer sac"et 1 gm4 0 @
gm4 per sac"et
(n cleansing secreting
>ounds li<e /enous stasis ulcers,
decubitus ,ulcers in)ected traumatic ulcers
0 in)ected tumours
Sep-D&
46 Serratio peptidase tablet & mg (ndication )or t"e
remission o) /arious in)lammatory
disorders including post-operati/e
in)lammation and traumatic in.ury4
Sep-D&
47 'imetidine in.4 100 mg2 ml -- Sep-D&
48 -cona,ole op"t"almic
ointment 1=
in treatment o) )ungal in)ection o) t"e eye Sep-D&
4 Propranolol H'l S% tablets -- Sep-D&
D021@0 mg
S
No
Drug Indication Date of
Approval
5! *leomycin 8il Suspension
in.ection4
(ndicated in t"e
treatment o) cancer
Sep-D&
51 'iclopirox 8lamine solution2
cream 10 mg2 ml
(ndicated in t"e
treatment o) )ungal in)ections o) t"e s<in
and /agina4
8ct-D&
52 *acampicillin tablet 100 mg (ndicated in t"e
treatment o) Upper 0 lo>er respiratory
tract in)ections, urinary tract in)ection, s<in
in)ections, post-operati/e in)ections4
8ct-D&
53 'aptopril tablet 2&2&0 mg (ndicated in t"e
treatment o) "ypertension only
8ct-D&
54 (/ermectin solution 10 = >2/
and 1= >2/ in.ection
(ndicated )or t"e
control o) /arious "elmint"ic in)ections
suc" as round >orm4
8ct-D&
55 #icergoline sugar coated
tablet,& mg2 ;0 mg
(ndicated in t"e
treatment o) acute c"ronic perip"eral and
cerebral /asculometabolic disorders,
%aynaudJs syndromes and all syndromes
due to altered perip"eral loss4
8ct-D&
56 Amoxapine tablet 2&2 &02 100
mg
(ndicate )or t"e relie)
o) symptoms o) depression in patients >it"
neurotic or reacti/e depressi/e disorders
as >ell as endogenous and psyc"otic
depressions, depression accompanied by
anxiety and agitation4
#o/-D&
57 Puri)ied c"ic< -mbryo (ndicated )or
treatment a)ter explosi/e o) rabies )or pre-
exposure prop"ylaxis4
#o/-D&
58 amoseanate tablet 2&0 mg4 (ndicated in treatment o) adult "oo<>orm
in)estations4
#o/-D&
5 Satranida,ole tablet 1&0 mg -- #o/-D&
6! *ensera,ide Hydroc"loride To be used only in
t"e manu)acture o) capsules containing t"is
drug in combination >it" 3e/odopa )or t"e
treatment o) Par<insonFs disease4
#o/-D&
61 Acebutolol Hydroc"loride
capsule 100 mg2 200 mg2 100
mg
(ndicated in t"e
management o) all grades o) "ypertension
angina pectoris and control o)
tac"yarr"yt"mia4
9ec-D&
62 Acebutolol Hydroc"loride
in.ection & mg
(ndicated in t"e
management o) all grades o) "ypertension
angina pectoris and control o)
tac"yarr"yt"mia4
9ec-D&
63 Atracurium 9ibesylate
(n.ection
(ndicated )or use in
anaest"esia to relax muscle during surgical
procedures and to )acilitate controlled
/entilation4
Jan-D@
64 Sulprostone in.ection $or second trimester
abortions only
Jan-D@
65 Pra,iBuantel tablet (n t"e treatment o)
in)ections broug"t about t"e lar/ae o) t"e
por< tape>orm in t"e 'entral #er/ous
system4
$eb-D@
S
No
Drug Indication Date of
Approval
66 Albenda,ole tablet 200mg 2
100 mg
-- $eb-D@
67 Albenda,ole suspension
200mg 2 & ml
-- $eb-D@
68 ranitidine in.ection &0 mg 22
ml
-- $eb4D@
6 Pentoxi)ylline dragees 100 mg -- +arc"4D@
7! in)ectious bursal disease
/accine
$or treatment o) in)ectious bursal disease
in poultry
+arc"4D@
71 *userelin Acetate G3uteni,ing
HormoneH
(ndicated in t"e
treatment o) in)ertility o) o/arian origin )or
t"e induction o) o/ulation and impro/ement
o) conception rate in co>s, mares 0
rabbits4
Apr-D@
72 *uprenorp"ine (ndicated in t"e
treatment o) post -operati/e pain, pre-
medication be)ore surgery 0 myocardial
pain4
Apr-D@
73 %eceptal in.ection -- Apr-D@
74 ?enoprin in.ection -- Apr-D@
75 #oristerat in.ection (ndicated )or
contraception
Apr-D@
76 *iclotymol %espiratory (n)ections, *ronc"itis +ay-D@
77 9ynoprost in.4 & mg -- +ay4D@
78 'arboprost Tromet"amine ?et4 8nly +ay-D@
7 3opamidol Sterile Sol (ndicated in
neuroradiology angiograp"y urograp"y
art"rograp"y etc4
G A-ray 'ontrast mediumH
Jun-D@
8! (o"exol Sterile Sol4 (ndicated in
neuroradiology angiograp"y urograp"y
art"rograp"y etc4
G A-ray 'ontrast mediumH
Jun-D@
81 +edroxy progesterone acetate
Tablet
(ndicated in t"e
treatment o) secondary amenorr"ea and
)unctional uterine bleeding to "ormonal
imbalance only4
Jun-D@
82 Ami<acin in.ection (ndicated in t"e
treatment o) serious in)ections due to
ami<acin sensiti/e organisms
Jun-D@
83 ?ecuronium *romide (ndicated )or use in
anaest"etic to relax muscle during surgical
procedures and to )acilitate, contracted
/entilation4
Jun-D@
84 3uprostiol (ndicated in t"e
treatment o) corpora luteal, induction o)
abortion etc4
Jun-D@
85 $lutamide (ndicated )or palliati/e
treatment o) ad/anced prostatic cancer
only
Jun-D@
86 #itroglycerin in.ection (ndicated in t"e
treatment o) angina pectoris myocardial
in)ection etc4
Jun-D@
S Drug Indication Date of
No Approval
87 7ugulipid -- Jun4D@
88 Hydrotalcite (ndicated in
treatment o) )latulence "yperacidity gastritis
"eart burn, dyspepsia etc4
Jun-D@
8 $lutamide tablet anti-cancer Jun-D@
! Prosol/ine in.4 !4& mg2 ml -- Jun-D@
1 -stramustine P"osp"ate
capsule
(ndicated in t"e
treatment o) prostatic carcinoma4
Jul-D@
2 Prednimustine tablet (ndicated in t"e
treatment o) c"ronic lymp"ocytic
leu<aemia, #on- Hodg<inFs lymp"oma
and breast cancer
Jul-D@
3 Polyestradiol P"osp"ate
in.ection
(ndicated in t"e
treatment o) prostatic carcinoma
Jul-D@
4 -pirubicin in.ection (n t"e treatment o)
breast cancer, +alignant lymp"omas, so)t
tissue sarcoma gastric lung and o/arian
carcinomas4
Jul-D@
5 9oxorubicin in.4 10 mg -- Jul-D@
6 Tiamulin Hydrogen $umarate (n t"e pre/ention and treatment o)
mycoplasma induced disease o) t"e
respiratory tract including complication due
0 secondary in)ections only G?et4 Use
onlyH4
Jul-D@
7 Piroxicam tablet 10 mg (n t"e treatment o)
r"eumatoid art"ritis, osteo4 Art"ritis
an<ylosing spondylitis, cer/ical spondylitis
and ot"er musculos<eletal disorders4
Aug-D@
8 Tiamulin soluble granules -- Aug-D@
Tiapro)enic Acid (n t"e treatment o)
post-operati/e period, sprains )racture
/arious traumatic conditions4
Aug-D@
1!! Secadrex tablet -- Aug-D@
1!1 9ebrip"or beads -- Aug-D@
1!2 Articaine Hydroc"loride $or Spinal in)iltration dental surgical 0
epidural anaest"esia
Aug-D@
1!3 'lobetasone -1!- butyrate
cream2ointment 040&=
(n t"e treatment o) mild ec,ema, dermatitis
and ot"er steroid responsi/e disorders
Sep-D@
1!4 %eproterol Hydroc"loride (n t"e treatment o) conditions in/ol/ing
re/ersible air>ays obstruction /i,4
bronc"ial ast"ma, bronc"itis etc4
Sep-D@
1!5 'lostebol acetate Preparation containing t"e drug >it"
#eomycin s"all be indicated in t"e
treatment o) in)ected >ounds and 0 2nd
degree burns4
Sep-D@
1!6 6etocona,ole tablet 200 mg
and 6etocona,ole suspension
20mg2ml
(n t"e treatment o) systemic )ungal
in.ections, candidiasis c"ronic
mucocutaneous candidiasis ?aginal
candidiasis etc4
8ct-D@
1!7 <etocona,ole /accineG6illedH in t"e treatment o) par/o-/irus in)ections in
dogs only
8ct-D@
S
No
Drug Indication Date of
Approval
1!8 'anine 9istemper ?accine against canine distemper
par/o/irus in)ectious canine "epatitis and
leptospirosis4
#o/-D@
1! Sucral)ate tablet 1 gm4 (n t"e treatment o) gastric duodenal and
benign ulcer4
#o/-D@
11! Propa)enone Hydroc"loride (ndication in t"e treatment o) /entricular
extra systoles supra /entricular tac"ycardia
etc4
#o/-D@
111 Tiapro)enic Acid tablet 200 mg
and ;00 mg
-- 9ec4D@
112 'entbutindole #euroleptic agent 9ec4D@
113 'lobetasone butyrate
creams2ointments 040& =
-- 9ec4D@
114 3abetalol Hydroc"loride (ndication in t"e treatment o) all )orms o)
"ypertension G except Hypertension o)
pregnancyH
9ec-D@
115 Propo)enonen tablets 1&0 mg2
;00 mg
-- Jan4D!
116 Propo)enonen in.ection !0 mg2
20 ml ampoule
-- Jan4D!
117 %epreterol tablet 20mg -- Jan4D!
118 %epreterol syrup 10mg2 & ml -- Jan4D!
11 3abetalol Hydroc"loride tablet
&0 mg2 100mg2 200 mg
-- Jan4D!
12! Hepatitis * ?accine $or treatment o) "epatitis * /irus in)ection Jan4D!
121 'entbutindole tablets 14& mg -- $eb4D!
122 'arbocaine in.ection 2 = -20
mg
-- $eb4D!
123 Sulprostone in.ection &00 mcg2
ampoule
-- $eb4D!
124 *leomycin (n.ection (ndication in t"e treatment o) prostatic
carcinoma ,breast cancer, melanoma and
carcinomas o) t"e "ead nec< and lungs
$eb-D!
125 'la/ulanic Acid To be used in combination >it" Amoxicillin
only in t"e treatment o) *acterial in.ections
$eb-D!
126 Tra,adone (ndicated in t"e treatment o) all types o)
depression
+ar-D!
127 (n)ectious cory,a /accine -- +arc4D!
128 Polidocanol (n.ection (ndicated in t"e treatment o) sclerosation o)
/arious cutaneous /eins and oesop"ageal
/aricose "aemorr"oids "aemangioma
+ar-D!
12 Tobramycin op"t"almic
solution 040;= per /ial
-- April4D!
13! Acyclo/ir Tablets2 'ream2
8intment2 8p"t"almic
8intment
(ndicated in t"e treatment o) "erpes
simplex /irus in)ections o) t"e s<in
including initial and recurrent genital
"erpeslabialise "erpes simplex <eratitis
+ay-D!
131 'e)otaxime Sodium in.ection
042&, 04&, 1 and 2 gm42 /ial
-- Jun-D!
S
No
Drug Indication Date of
Approval
132 9iclo)enac sodium in.ection !&
mg2 ; ml ampoule
-- Jun-D!
133 9iltia,am (ndicated in t"e treatment o) angina Jul-D!
pectoris and c"ronic stable angina only
134 Alclometasone 9ipropionate
cream2ointment040&=
(ndicated )or t"e relie) o) t"e in)lammatory
and pruritic mani)estations o) corticosteroid
responsi/e dermatomes
Jul-D!
135 Tra,odone tablet 2& mg2 &0
mg2 100 mg
-- Jul-D!
136 *romocriptine +esylate tab4
24& mg, & mg and 10 mg
(n t"e treatment o) prolactin dependent
menstrual cycle disorders )emale in)ertility
pre-menstrual syndrome "yper
prelactinoma in men4 4
Jul-D!
137 'arbocisteine (ndicated as an ad.uncti/e t"erapy in
respiratory disorders
Aug-D!
138 #o/a-T (U9 Aug-D!
13 $lumeBuine %T( Sep-D!
14! Stano,olol in.ection &0 mg2 ml -- Sep4D!
141 #eutral insulin and (nsulin Iinc
suspension
(n t"e treatment o) insulin reBuiring
diabetes by in.4 or in)usion
Sep-D!
142 *roncospasmin tablet 20 mg -- 8ct4 D!
143 *roncospasmin elixir 10 mg2
&ml
-- 8ct4 D!
144 *roncospasmin respiratory
solution 10 mg2ml
-- oct4D!
145 *roncospasmin in.ection 040
mg2ml
-- 8ct4 D!
146 'lobetasol Propionate -- 8ct-D!
147 cloxacillin ben,at"ine intra-
mammary in)usion &00 mg
-- 8ct4D!
148 %abies ?eterinary
?accineGinacti/eH
-- #o/-D!
14 9omperidone tablet 10 mg ,
oral drops 10 mg2ml and
suspension 10 mg2ml, rectal
suppositories ;0 mg
(ndicated in t"e treatment as gastric motility
disorder etc4
#o/-D!
15! #or)loxacin tablet 100 mg2 D00
mg and 89T 100 mg
(n t"e treatment as acute
uncomplicated2complicated c"ronic,
recurrent urinary tract in.ections including
pyelonep"ritis cystitis, uret"ritis 0
gonococcal in)ections4
#o/-D!
151 (n)luen,a ?accine $or treatment o) in)luen,a in eBuine #o/-D!
152 8,ot"ine tablet @0 mg (n t"e treatment o) acute c"ronic in)ections
o) respiratory tract44
9ec-D!
153 8,ot"ine syrup @0 mg 2& ml (n t"e treatment o) acute c"ronic in)ections
o) respiratory tract44
9ec-D!
154 Aurano)in capsules ; mg (n t"e treatment o) r"eumatoid art"ritis and
in c"ildren >it" Ju/enile r"eumatoid
art"ritis4
9ec-D!
155 '"enodeoxyc"olic acid -- 9ec-D!
156 *uprenorp"ine sublingual
tablets 042 mg
-- 9ec4D!
157 Propranolol H'3 S% capsules
D0 mg
-- 9ec4D!
158 +easles, mumps and rubella
/accine
-- 9ec-D!
15 -toposide 'apsule (n t"e treatment o) small cell lung cancer,
malignant lymp"omas acute etc4
Jan-DD
16! 9iclo)enac Sodium S% Tab4
!&2100mg
-- Jan-DD
161 *e,a)ibrate (n all )orm o) "yper lipoproteinaemia4 Jan-DD
162 Amineptine (n t"e treatment o) all types o) depression Jan-DD
163 Astemi,ole (n t"e treatment o) allergic r"initis allergic
con.uncti/itis c"ronic urticaria 0 ot"er
allergic conditions4
$eb-DD
164 *udesonide (n t"e treatment o) bronc"ial ast"ma $eb-DD
165 Pen)luridol tablet 20 mg (n t"e treatment o) sc"i,op"renia etc4 +ar-DD
166 Aclarubicin H'l (n t"e treatment o) acute leu<aemia,
malignant lymp"oma, stomac", lung
cancer etc4
+ar-DD
167 -toposide in.ection 100mg2 &
ml ampoule
-- +ar-DD
168 Iido/udine 'apsules (n t"e treatment o) s"ort term management
o) serious man in)estation o) "uman
immuno de)iciency /irus GH4(4?H in.ection in
patients4
Apr-DD
16 Sil/er sulp"adia,ine eye
ointment4 1=
-- Apr-DD
17! 'e)triaxone sodium (ndicated in t"e treatment o) UT(, lo>er
respiratory tract in)ections4
Apr-DD
171 +inoxidil (n t"e treatment o) male pattern baldness Apr-DD
172 *en,ydamine topical analgesic (n t"e treatment o) musculo-s<eletal pain
only
Apr-DD
173 (nter)eron alp"a in.ection (n t"e treatment o) multiple myeloma "airy
cell leu<aemia etc4
+ay-DD
174 +elagenina 3otion %e-pigmenting treatment o) s<in in
depigmented o) areas o) in patients
su))ering )rom /itilgo4
+ay-DD
175 Amrinone 3actate $or t"e s"ort term management o)
congesti/e "eart )ailure
+ay-DD
176 -t"amsylate tablet 2&0 mg2
&00 mg
(n t"e treatment o) small /essel
"aemorr"age menorr"agia Gincluding (U9
usersH prop"ylaxis o) peri/entricular
"aemorr"age is neonates4
+ay-DD
177 +inocycline (n t"e treatment o) UT(, respiratory, s<in,
so)t tissue, -#T in.ections4
+ay-DD
178 Alpra,olam tablets 042&
mg20 4& mg2 1 mg
(n t"e treatment o) anxiety associated >it"
depression
Jun-DD
17 'e)uroxime in.ection 2&0 mg2
&00 mg 2 1 gm4 per /ial
(n t"e treatment o) respiratory tract
in.ection UT(, -#T so)t-tissue in.ections4
Jun-DD
18! Tertatolol Hydroc"loride (n t"e treatment o) "ypertension Jun-DD
181 'yclosporine (ndicated in immuno suppression in organ
transplants
Jun-DD
182 'e)ta,idime Penta"ydrate $or UT(, respiratory ,s<in, so)t tissue 7(
in)ections etc4
Jun-DD
183 7em)ibro,il 'apsules ;00 mg 2
00 mg
$or t"e treatment o) adult patients >it" /ery
"ig" triglyceryl le/els GType (? - "yper
lipidemiaH
Aug-DD
184 Astemi,ole Susp4 -- Aug-DD
185 Triclabenda,ole (n t"e treatment o) c"ronic )asciola
gigantica $4 "epatica in s"eep goats cattle
and bu))aloes4
Sep-DD
186 'ep"alexin tablet 1gm -- 8ct-DD
187 %abies /accineGinacti/atedH $or treatment a)ter exposure to rabies and
)or pre-exposure prop"ylaxis
#o/-DD
188 Puri)ied c"ic< -mbryo 'ell
/accine
$or treatment a)ter exposure to rabies and
)or pre-exposure prop"ylaxis
#o/-DD
18 7licla,ide (n t"e treatment o) all types o) maturity
onset diabetes >it"out or >it" obesity in
#o/-DD
adults4
1! Salinomycin premix @= Pre/ention o) coccidiosis 9ec-DD
11 9esogestrel To be used in combination >it"
-t"ingloestradiol )or contraception4
Jan-D
12 Tri Potassium 9icitrate
*isulp"ate
(n t"e treatment o) gastric 0duodenal
ulcers
Jan-D
13 3ipoproteins extracted )rom
"uman placenta lotion &0=
-- Jan-D
14 Salinomycin -- Jan4D
15 'e)adroxyl tablet2 capsule
&00mg2 1 gm
(n t"e treatment o) UT(, s<in 0 s<in
structure in)ections caused by S4coci or
streptococci p"aryngitis tonsillitis,
respiratory tract in)ections only4
$eb-D
16 'e)adroxyl oral suspension
12&22&0 per & ml
(n t"e treatment o) UT(, s<in 0 s<in
structure in)ections caused by S4coci or
streptococci p"aryngitis tonsillitis,
respiratory tract in)ections only4
$eb-D
17 6$9 ?accine -- +ar-D
18 Tripotassium 9icitrate
*isulp"ate
-- +ar-D
1 +itoxantrone H'l in.ection 2
mg
(n t"e treatment o) acute non-lymp"atic
leu<aemia, breast cancer non-Hodg<inFs
lymp"oma4
+ar-D
2!! -Buine (n)luen,a ?accine against in)luen,a respiratory
diseases, caused by -H( /irus, pre/ention
o) abortion due 0 -H( /irus in)ection4
+ar-D
2!1 Anti-%abies ?accine ?accine against rabies +ar-D
2!2 Par/o/irus /accine (mmuni,ation as "ealt"y dogs against
canine par/o/irus in)ections4
+ar-D
2!3 'arboplatin Ad/ance stage o) o/arian cancer small cell
carcinoma o) lungs4
+ar-D
2!4 $amotidine (n t"e treatment o) duodenal 0 peptic ulcer
Iollinger -llison syndrome4
+ay-D
2!5 'ipro)loxacin Hydroc"loride
+ono"ydrate tab 2&02 &002
!00 mg o)
(ndicated in t"e treatment o) respiratory
tract in)ection UT(4 S<in and so)t tissue,
se/ere systemic in.ections surgical4
+ay-D
2!6 'ipro)loxacin Hydroc"loride
+ono"ydrate in)usion 100 mg2
&0 ml 0 200 mg2100 ml
(ndicated in t"e treatment o) respiratory
tract in)ection UT(4 S<in and so)t tissue,
se/ere systemic in.ections surgical4
+ay-D
2!7 Sodium Hyaluronate sol4 To be supplied against to prescription o) a
op"t"almologist only
Jun-D
2!8 &-Aminosalicyclic acid -- Jun-D
2! +icona,ole -ye drops 1= )or )ungal in)ection o) eye Jul-D
21! $lurbipro)en -ye drops 040;= -- Jul-D
211 6etopro)en 'T Tab4 100mg -- Jul-D
212 9iltia,em S% Tab4 02120mg -- Jul-D
213 9iltia,em +% Tab4 ;02@0mg -- Jul-D
214 %ecombinant Human Tissue
Type plasminogen acti/ator
To be supplied )or use in Hospital, nursing
times and against t"e prescription o)
specialist
Jul-D
215 9esmopressin #asal Sol2
#asal Spray2 (n.ection
-- Aug-D
216 -nalapril +aleate -- Aug-D
217 Piperacillin Sodium (n t"e treatment o) systemic and local
in)ections pre-operati/e in)ections
Aug-D
prop"ylaxis, obstructi/e and gynae
in)ection UT( neo-natal and li)e t"reatening
paediatric in)ections4
218 $la/op"osp"olipol Used as )eed additi/e in )arm animals and
poultry $arm-bird4
Sep-D
21 #i)edipine Sustained %elease
tablets 20 mg
-- #o/-D
22! Puri)ied c"ic< -mbryo /accine -- 9ec-D
221 3o)epramine (n t"e treatment o) depressi/e condition
only
Jan-0
222 Haloperidol 9eaconate $or t"e management o) c"ronic
sc"i,op"renia
$eb-0
223 #aproxen Tablets -- $eb-0
224 %anitidine syrup 1&0 mg210 ml -- $eb-0
225 8)loxacin (n treatment o) respiratory tract in)ection,
UT( ,7ynaecological (n)ections s<in2so)t
tissue in)ection
$eb-0
226 9inoprostone tablet 04& mg )or t"e induction o) labour $eb-0
227 #or)loxacin eye drops 04;= -- $eb-0
228 Tinida,ole (n)usion 2mg2ml in
100 ml, 2mg2ml in D00ml
(n t"e treatment o) in)ections +ar-0
22 Pentoxyp"ylline S% (ndicate )or purpose as )or plane
con/entional dosage
+ar-0
23! 'yclo Pentolate H'l
8p"t"almic Solution
$or mydriasis and cycloplegia +ar-0
231 Tropic amide Sterile
8p"t"almic Solution
)or mydriasis and cycloplegia in diagnostic
procedure
+ar-0
232 (bupro)en '% Tab @00mg $or c"ronic art"ritic disorder and pain)ul
musculos<eletal conditions
+ar-0
233 $luoxetine Hydroc"loride 'ap
20 mg
)or t"e treatment o) depression +ar-0
234 Terbutaline #ebulising Solution )or acute ast"mas +ar-0
235 $amotidine (n.ection -- Apr-0
236 9ia,inon (n t"e treatment )or control o) ectoparasites
in li/estoc<
Apr-0
237 Amiodarone H'l 'ontrol o) /entricular and supra /entricular
arr"yt"mias >"ere ot"er drugs cannot be
used including arr"yt"mias >ol) Par<inson
>"ite Syndrome
Apr-0
238 Pina/erium *romide (n t"e treatment o) spastic colon, irritable
bo>el syndrome, biliary dys<inesia and )or
radiological in/estigation
Apr-0
23 Piroxicam 7el (n t"e treatment o) musculo-s<eletal
in)lammatory disorders
Apr-0
24! Trimet"oprim po>der 100gm -- +ay-0
241 8xytetracycline
in.ection200mg2ml
treatment o) anaplasmosis and t"eir
annulata in)ection
+ay-0
242 'e)uroxime axetil )or lo>er 0upper respiratory tract in.ection
upper UT( s<in and so)t tissue in)ection etc4
+ay-0
243 'e)ti,oxime -- +ay-0
244 9eltamet"rine -- Jun-0
245 Pra,osin Hydroc"loride -- Jun-0
246 $lurbipro)en S% 'ap4 200mg %"eumatoid art"ritis, osteoart"ritis,
an<ylosing spondylitis
Jun-0
247 'oligen )or t"e pre/ention o)
cal) scours, due to in)ection >it"
enteropat"o genic--coli organism
Jun-0
248 3- 'arnitine -- Jun-0
24 (so)lurane Used )or induction
and maintenance o) general anaest"esia
Jul-0
25! (opromide Used as a
contrast medium )or uro-angiograp"y
Jul-0
251 Prenoxdia,ine H'l (ndicated in relie) o) coug" o) bronc"ial
origin
Jul-0
252 Ter)inadine Allergic r"initis allergic dermatological
condition and ot"er "istaminic disorders4
Sep-0
253 3oxapine $or t"e management o) t"e mani)estation
o) psyc"otic disorders4
Sep-0
254 *uspirone H'l (ndicated in t"e treatment o) anxiety and
tension states
8ct-0
255 +ometasone $uroate Steroid responsi/e dermatitis , ec,ema, or
atopic dermatitis
8ct-0
256 8rt"oclone Sterile -- 8ct-0
257 %iba/irin acute "epatitis /iral respiratory and "erpes
in)ection
#o/-0
258 $lunari,ine H'l as a maintenance treatment )or classical
and common migraine
#o/-0
25 Sala,opyrin Tab4-% &00mg )or r"eumatoid #o/-0
26! 'entc"roman Tab4 ;0mg used as sedati/e #o/-0
261 Ayla,ine H'l Used as a sedati/e analgesic and muscle
relaxant properties )or use in "orses, dogs,
and cattleFs
#o/-0
262 'ipro)loxacin Hydroc"loride
eye drops 04;= >2/
treatment o) external ocular in)ection o) t"e
eye
$eb-1
263 9iclo)enac 7el 1gm -- +ar-1
264 'e)aclor (n respiratory in)ection, -#T in)ection UT
in)ections, s<in and s<in structure in)ections
Apr-1
265 8mepra,ole s"ort term treatment o) duodenal 2gastric
ulcers2re)lux oesop"tiagitis2management o)
,ollinger -llison syndrome
Apr-1
266 #e)opam Acute and c"ronic pain, including
postoperati/e pain, dental pain, musculo
s<eletal pain, acute traumatic pain, and
cancer pain4
Apr-1
267 *utalex (n t"e treatment o) *o/ine t"eileriosis Apr-1
268 (darubicin Hydroc"loride -- +ay-1
26 6itoti)en (n prop"ylactic treatment o) bronc"ial
ast"ma, symptomatic impro/ement o)
allergic conditions including r"initis4
+ay-1
27! Pe)loxacin +esylate 9i"ydrate (n t"e treatment o) ser/e in.ection in adults
caused by sensiti/e microorganismGgram
-/e pat"ogens and stap"ylococciH
+ay-1
271 8)loxacin (n)usion 2mg2ml %T(, UT(, s<in 0 so)t tissue in)ection +ay-1
272 #itrendipine tablet 102 20 mg (n t"e treatment o) mild to moderate
"ypertension
+ay-1
273 %oxatidine Acetate H'l 9isorders in t"e upper gastric intestinal i4e4
duodenal ulcers benign gastric ulcers4
+ay-1
274 (sosorbide mononitrate S%
tab4 &0mg
prop"ylaxis o) angina pectoris +ay-1
275 %abbit Anti Human T"ymocyte
immunoglobulin
-- +ay-1
276 $elodipine (n t"e treatment o) "ypertension +ay-1
277 Pirarubicin H'l (n.ection -- +ay-1
278 Horse anti"uman lymp"ocyte
globulin
$or aplastic Anaemia +ay-1
27 %amipril (ndicated in t"e
treatment o) "ypertension 2cardiac )ailure
and also )or myocardial in)arction4
Aug-1
28! Selegiline H'l (n t"e treatment o)
Par<insonFs disease
Aug-1
281 Piroxicam in.4 20mg2ml Treatment o) muscular s<eletal disorders Aug-1
282 Perindopril (n t"e treatment o) Hypertension Sep-1
283 -t"amsylate (n.4 2&0mg Treatment o) small /essel "aemorr"age,
menorr"agia, prop"ylaxis o) peri/entricular
"aemorr"age in neonates4
Sep-1
284 #ilutamide Tablets (n t"e treatment o) metastatic or localised
cancer o) t"e prostate
8ct-1
285 3isinopril -ssential "ypertension and in patients >it"
congesti/e "eart )ailure4
#o/-1
286 8)loxacin eye drops ;mg2ml treatment o) external in)ections o) t"e eye
and to adnexa caused by susceptible
bacteria
9ec-1
287 'lomipramine H'l tablets H'3
10 mg2 2& mg2 &0 mg
8bsessi/e compulsi/e disorders, p"obic
states and depression GE"en sedation is
reBuiredH
$eb-2
288 'lomipramine H'l capsule &0
mg
8bsessi/e compulsi/e disorders, p"obic
states and depression GE"en sedation is
reBuiredH
$eb-2
28 *isoprolol $umarate Hypertension, coronary "eart disease
Gangina pectorisH
$eb-2
2! Amsacrine (n.ection -- $eb-2
21 $ucidic Acid "emi"ydrate *acterial in)ection o) t"e eye caused by
susceptible organism in con.uncti/itis
blep"arits <eratitis, dacryocystitis (t can be
used )or prop"ylaxis in op"t"almic surgery
and in connection >it" remo/al o) )oreign
bodies4
+ar-2
22 Sodium -noxaparin As a prop"ylactic in t"e treatment o)
t"romboembolic disorder during
ort"opaedic surgery, general surgery and
"aemodialysis4
+ar-2
23 %oxit"romycin Sensiti/e strain in)ections o) -#T4
*ronc"opul monary tract in.ection, genital
except )or gonocoecal4 (n)ections
prop"ylaxis o) meningoco-ecal4 +eningitis
in exposed sub.ect4
+ar-2
24 +etoclopramide '% Tab4 1&mg to restore normal coordination and t"e
toget"er upper digesti/e tract and relie/e
symptoms o) gastro duodenal dys)unction
including "eartburn, dyspepsia, nausea
and /omiting associated >it" suc"
conditions as re)lux oesop"agitis, gastritis,
duodenitis and "iatus "ernia
Apr-2
25 6etorolac Tromet"amine tablet
10 mg
(n t"e treatment o) s"ort term management
o) post-operati/e pain and musco-s<eletal
pain
Apr-2
26 6etorolac Tromet"amine
in.ection ;0 mg2 ampoule
(n t"e treatment o) s"ort term management
o) post-operati/e pain and musco-s<eletal
pain
Apr-2
27 *etaxolol Hydroc"loride
op"t"almic 04& =E2?2 & ml
8cular "ypertension and c"ronic open
angle glaucoma
+ay-2
28 8ral Polio /accine -- +ay-2
2 7adopentetic acid
dimeglumine salt in.ection
1@401 mg
'ranial and spinal magnetic resonance
tomograp"y
+ay-2
3!! Pyridoxine H'l '% tab4100mg 9e)iciency o) /it4 *@ caused by usage o)
oral contracepti/e pill
+ay-2
3!1 'ep"acetrile concentrated
in)usion 2;& mg
+astitis caused by streptococcus agalactial
STr dysgalactial, streuteris stap"ylococcus,
aureus, G*ot" penicillin sensiti/e and
resistant strainH gram G#egati/eH-/e
bacterial including - 'oli and <lebsiella4
+ay-2
3!2 6orsolex concentrated
instrument disin)ectant
-- +ay-2
3!3 Sterillium rub in disin)ectant )or
"ands
-- +ay-2
3!4 *acillocid special -- +ay-2
3!5 $eracrylum Acid
Polyelectrolyte
-- +ay-2
3!6 3oratadine tablet 10 mg (n treatment o)
allergic r"initis acute cory,a c"ronic
idiopat"ic urticaria4
Jun-2
3!7 9ex)en)luramine H'l capsule
1& mg
(ndicated in
association >it" diet in t"e treatment o)
uncomplicated obesity complicated obesity
in adults, o) re)ractory obesity and o)
obesity in/ol/ing disorders o) dietary
be"a/iours Gcarbo"ydrate compulsionH
Jun-2
3!8 *acillus calmette guerin
/accine
To be indicated )or intra/esical use in t"e
treatment o) primary and relapse
carcinoma in-situ o) t"e urinary bladder4
Jun-2
3! 'andur P4 Par/o/irus $or acti/e immuni,ation o) dogs against
par/o/irus in)ection
Jul-2
31! #aloxone H'3 )or t"e complete partial re/ersal o) narcotic
depression including respiratory
depression induced opioids including
natural and synt"etic narcotics,
propoxyp"ene met"adone, and certain
narcotic -antagonist analgesics
nalbup"ine,penta,ocine, are butorp"enol
Jul-2
311 #imodipine tab ;0 mg,
in.410mg2&0 ml
(n t"e treatment and pre/ention o)
isc"aemic neurological de)icit occurring
due to arterial spasm )ollo>ing sub-
arac"noid "aemorr"age
Aug-2
312 7in<go *iloba )ilm coated tab4
10 mg
(n t"e treatment o) disorders in t"e
)unctioning o) t"e brain Greduced
intellectual ability and alertnessH4 7iddiness
bu,,ing in t"e ears, "ead-ac"e poor
memory, >ea<ening o) t"e /oice resulting
)rom anxiety4
Sep-2
313 Hamycin cream 041= -- Sep-2
314 'lindamycin 7el 1= acne /ulgaris 8ct-2
315 (trolan 'ontrast +edium 8ct-2
316 Pipecuronium *romide -- #o/-2
317 'isapride 7astro intestinal disorders #o/-2
318 Tetrac"lorodecaoxide oxo)erin Tissue repair o)
>ounds >it" impaired "ealing suc" as
in)ected >ounds, delayed post traumatic
and post-operati/e >ound "ealing and
delayed "ealing a)ter operation
#o/-2
31 Tetrac"lorodecaoxide Sol4
140;! mg2100ml
-- #o/-2
32! (pratropium *romide in"aler 20
mcg
-- #o/-2
321 *enoxinate Hydroc"loride op"4
Solution
$or use as an anaest"esia o) cornea and
con.uncti/itis )or op"t"almic procedure4
#o/-2
Approval Status of New Drug during 1993-1998
S.No Drug Indication Date of
approval
1. Human -ryt"ropoietin (n.ection (n t"e treatment o) anaemia due
to c"ronic renal )ailure and end
stage renal disease
Jan-;
2. Tramadol Hydroc"loride (n.ection &0
mg per 1 ml and 100 mg per 2 ml
ampoule
Se/ere acute and c"ronic pain
diagnostic measures and surgical
pain4
2!4014;
3. Ticlopidine H'3 2&0 mg tablet $or t"e pre/ention o) 'erebro
and cardio /ascular accidents in
patient su))ering )rom arterial
insu))iciency in t"e legs and
cerebral /essels and correction
o) platelet disorder induced by
extra corporeal circuits during
surgery >it" extra cerebral
circulation on "aemodialysis
Garti)icial <idneyH
114024;
4. 'e)ixime capsules
100mg2200mg2100mg
(n t"e treatment o) UT(
respiratory tract in)ection, biliary
tract in)ection
214024;
5. $lecainide Acetate 100 mg Tablet 0
1&0 mg2ml
Anti-arr"yt"amic 2@2+ar2
;
6. $lucona,ole
'apsules&0mg2100mg2200mg21&0mg
and $lucona,ole in.ection -2mg2ml
$or t"e treatment systemic
candidiasis muscular candidiasis
cryptococosis pre/ention o)
)ungal in)ection in patients >it"
malignancy4
2@4014;
7. Tenoxicam tablet 20 mg %"eumatoid art"ritis,
osteoart"ritis, osteoporosis,
an<ylosing spondylitis, gout, non-
articular r"eumatic conditions4
22Apr2;
8. *en,a)ibrate retard tablet 100 mg -- April2;
. Paspat in.ection -- +ay2;
1!. 'isapride +anagement o) dyspepsia +ay2;
11. Secnida,oleTablet and oral
suspension G14 -ac" tab &00 mg2
1000 mg H and G24 -ac" 1&ml
suspension contains Secnida,ole-
&00mg,
(ntestinal amoebiasis, amoebic
"epatitis, tric"monial /aginitis,
bacterial /aginitis and giardiasis4
1;2+ay2
;
12. Amlodipine *esilate tablets &210 mg (ndicated in "ypertension, angina
pectoris4
12+ay2
;
13. +epartricin tablets &0000 Units $unctional disorder in benign
prostatic "ypertrop"y
2D2+ay2
;
14. #itroglycerin patc" 2&2&0 mg $or t"e treatment o) Angina
pectoris due to coronary artery
;2Jun2;
disease
15. 'etiri,ine 9i"ydroc"loride
tablets&210220 mg
Seasonal r"initis and
con.uncti/itis, perennial allergic
r"initis, pruritus and urticaria
2&2Jun2;
16. +aduramicin 1= >2> premix ?et $or t"e treatment as an aid )or
t"e pre/ention o) coccidiosis in
broiler c"ic<ens
!2Jul2;
17. (tracona,ole capsules -100mg Systematic aspergillosis and
candidosis, cryptococcosis,
"istoplasmosis, sportric"osis,
paracoccidioidomycossis,
blastomycosis and ot"er rarely
occurring systemic or tropical
mycosis4
202Jul2;
18. 7lucomannan Sac"ets G"erbal
medicineH G -ac" sac"ets containing
7lucomannan-04!&gm21404gm214;gmH
$or reduction o) blood glucose
le/el reduction serum lipid le/el
@2Sep2;
1. +etronida,ole Gs<in ointmentH gel 1 =
E2E
- 12Jul2;
2!. Ialcitabine $ilm 'oated Tablets
04;!&mg204!&0mg
$or t"e treatment o) Aids 2@2Jul2;
21. 'alcitriol So)t 7elatine 'aps 04&mcg
0 042&mcg
$or t"e treatment o) metabolic
bone diseases
2!2Aug2
;
22. Piribedil S4%4 Tablets &0mg Treatment o) impaired
attenti/eness, and2or memory or
)eelings o) giddiness in elderly,
pain)ul symptoms o) arterial
disease, idiopat"ic Par<inson
disease
2!2Sep2
;
23. 9obutamine H'3 (n.4 Gin)usion
concentrateH &0 mg2 ml
(ndicated >"en parenteral
t"erapy is necessary )or inotropic
support in t"e s"ort term
treatment o) cardiac
discompensation due to
depressed contractility resulting
eit"er t"an organic "eart disease
or )rom cardiac surgical
procedure4
128ct2;
24. #icardipine capsules 20mg2;0mg (n treatment o) "ypertension and
c"ronic stable angina pectoris
228ct2;
25. $lunisolide #asal Spray 0402&= >2> $or t"e prop"ylaxis and
treatment o) perennial and
seasonal allergic r"initis including
"ay )e/er4
;02#o/2
;
26. 'ol)osceril Palmitate in.ection 10Dmg
per /ial
#e> born babies >it" birt"
>eig"t o) !00gm or greater,
undergoing mec"anical
/entilation o) respiratory distress
syndrome, >"ose "eart rate and
129ec2;
arterial oxygenation are
continuously monitored4
27. Salmeterol (n"aler2Salmeterol
%otacap4 G-ac" actuation deli/ers-
Salmeterol Aina)oate-2&mcg -ac"
%otacaps contains Salmeterol
xina)oate eBl to Salmeterol-&0mcgH
3ong term regular treatment o)
re/ersible air>ay obstruction in
ast"ma and c"ronic bronc"itis
129ec2;
28. -nro)loxacin &= oral solution and
in.ection
K14 -ac" ml o) (n.ection contains
-nro)loxacin-100mg2&0mg
24 -ac" ml o) oral solution contains
-nro)loxacin -&0mg2100mgL
?et drug 202Jan21
2. 7adodiamide (? in.ection G-ac" (ml
(n.ection contains-7adodiamide
2D!mg eBul to 04&m mol Gin 10ml /ialH
'ontrast media 212Jan21
3!. 8ndansetron tabletM 1 mg 2D mg and
in.ectionM 1mg 2 ml 0 D mg21 ml
8n t"e treatment and
management o) nausea and
/omiting induced by cytotoxic
c"emot"erapy and radiot"erapy
122$eb2
1
31. 3ome)loxacinTablet 100mg (n t"e treatment o) mild to
moderate in)ections caused by
susceptible strains o) designated
micro-organism in %4T4(
uncomplicated and complicated
U4T4(4
202+ay2
1
32. A,it"romycin capsules2suspension
K-ac" capsule contains M A,it"romycin
di"ydrate eBul to 2&0mg o) base 24
-ac" &ml containsM A,it"romycin-
200mg2&0mgL
14 (n t"e treatment o) mild to
moderate susceptible in)ection
including %4T4(4, uncomplicated
s<in 2s<in structure, non-
gonoccoal uret"ritis cer/icitis
24 $or susceptible in)ection
including community acBuired
pneumonia pel/ic in)lammatory
diseases4
1;2+ay2
1
33. Tercona,ole ?aginal o/ule2/aginal
cream K14 -ac" o/ule containsM
Tercona,ole- D0mg
24 Tercona,ole /aginal cream
contains-Tercona,ole-04D=4L
$or t"e local treatment o) /ul/o
/aginal candiasis GmoniliasisH
12Jul21
34. (o/ersol (n.ection 1@0, 210 , ;00, ;20,
;&0
'ontrast media 229ec2
;
35. *otulinum Toxin4A 100 unit K-ac" ?ial
contains 'lostridium botulinum toxin
type-A - Hemagglutinin 'omplex
100units4 Human4 Serum albumin-
04&mg #acl-04mgL
$or t"e treatment o)
blep"araspasm "emi)acial
spasms assocaited )ocal
dystonia
1;2Jan21
36. Paclitaxel in.ection K&ml single dose
/ial contains-Paclitaxel-;0mgL
Ad/anced epit"elical carcini o)
t"e o/ary a)ter )ailure o) )irst line
or subseBuent c"emot"erapy4
2&2Aug2
1
37. -smolol H'l in.ection
K14 -ac" 10ml ampoule contiansM
Supra/entricular tac"ycardia )or
rapid central o) /entricular rates
2@2Aug2
1
24&2gm o) -smolol H'l4
24 -ac" 10ml /ial containsM 100mg o)
-smolol H'lL
patients >it" atrial )ibrillation or
atrial )lutter in per-operati/e,
post-operati/e circumstances
>"ere s"ort term control o)
/entricular rate is desirable
38. 7enotropin 1(U212(U21@(U in.ection S"ort stature due to inadeBuate
or )ailed incretion o) pituitary
gro>t" "ormone4
&2Sep21
3. '"andonium (odide in.ection2mg2ml #euro muscular bloc<ing agent 12+ar21
4!. Sultamicillin Tab K-ac" )ilm coated
tablet containsM SultamicillinG as-
TosylateH-;!&mg eBul to sulbactam
11!mg and Ampicillin 220mgHL
(n t"e treatment o) (ntra-
abdominal in)ection obstetrics,
and gynaecogicological
in)ections, s<in and so)t tissue
in)ection4 *one and .oint
in)ection, upper and lo>er
respiratory tract in)ections, -#T
in)ections, UT( , gonorr"oea and
surgical prop"ylaxis4
@2+ay21
41. 'ollagenase 8intment 2&0 units (n t"e treatment )or debriding
c"ronic dermal and se/erely burn
areas4
&2+ay21
42. 'losantel 1&= oral solution +ature and immature )asciola
species, "aemonc"us species,
strongylodes species and also )or
external parasites li<e oestrus
o/is boop"ilus microplus
"yalomma a anatolicum in cattle
and s"eep4
;28ct21
43. 'eliprolol Hydroc"loride
tablets100mg2200mg2100mg
+ild to moderate "ypertension,
angina pectoris
129ec21
44. 3ansopra,ole capsules 1& mg2;0 mg $or t"e treatment o) duodonal
ulcer, gastric ulcer, re)lex
oesop"agitis, ,ollinger ellison
syndrome
1@41241
45. 14 #imesulide tablets 100 mg
24#imesulide suspension-&0mg2 &ml
;4 #imesulide Transdermal 7el-1=
(n)lammatory condition including
.oint disorder suc" as r"eumatoid
art"ritis, post traumatic and post-
operati/e pain)ul condition and
)e/er
1;2Jan2&
46. 9iclo)enac sodium opt"almic solution
sterile 041= G1mg2mlH
(ndicated in post-operati/e
in)lammation in patients >"o
"a/e undergone cataract
operation
2!2Jan2&
47. Tera,osin Hcl tablet 1mg22mg2&mg (n t"e treatment o) essential
"ypertension and *PH
2!2Jan2&
48. 'lona,epam tablets
04&mg2140mg2240mg
(n t"e treatment o) petitmal and
its /ariant, a<inetic and
myoclonic sei,ures
2&2Jan2&
4. %itodrine H'3 tablet and in.ection
K-ac" tablet contains, %itodrine H'3-
10mg, %itodrine H'3 (n.ection eac" ml
contains-%itodrine H'3-USP 10mgL
Premature labour, acute )oetal
distress, pre/ention o) preterm
labour a)ter operations4
212$eb2
&
5!. %ilmenidine 9i"ydrogen P"osp"ate
tab4 1 mg
mild to moderate "ypertension 212$eb2
&
51. Tromantadine H'l oinment 1 gm
8intment
Herpes simplex in)ection o) t"e
s<in
2;2$eb2
&
52. Permet"rin cream &= (n)ection >it" sarcop"ytscabiec @2+ar2&
53. 'lo,apine tablets 2&mg2100mg (ndicated in t"e management o)
sc"i,op"renic patients
!2+ar2&
54. $ormestane 9epot (n.ection G(4+4H
2&0mg
$or t"e treatment o) ad/anced
stage o) breast cancer in >omen
>it" natural or arti)icially induced
post-menopausal status4
@2+ar2&
55. Altretamine caps -&0mg $or palliati/e treatment o) patient
>it" persistent or recurrent
o/arian cancer, )ollo>ing )irst line
t"erapy >it" cisplatin and 2or
al<ylating agent based
combination4
22+ar20
&
56. -tidronate-9isodium tablets 200mg Hypercalcemia induced by
/arious malignant disorders
102+ar2
&
57. Terbina)ine Tab4 2&0mg 2 cream 1= $ungal in)ection o) s<in, "air,
nails
22+ar2
&
58. 'larit"romycin tablets -2&0mg2&00mg o) mild to moderately se/ere
in)ection li<e acute exacerbation
o) c"ronic bronc"itis community
acBuired pneumonia including
in)ection due to c"lamydia,
mycoplasma spegiocella, acute
streptococcal p"aryngitis and
s<in 0 so)t tissue in)ection
222+ar2
&
5. Podop"yllotoxin Topical solution K-ac"
;-&ml contains, Podop"yllotoxin-04&=L
Ano-genital >arts non )acial
>arts only
&2+ay2&
6!. Silymarin tablet -!0mg supporti/e treatment in c"ronic
li/er disease and cirr"osis
222Jun2&
61. 3o/astatin 10mg220mg210mg %eduction o) total 393
'"olesterol in patients o) primary
"yper c"olesterolemia GType ((
a
0
((
b
"yper lipo-proteinemiaH
&28ct2&
62. Ambroxol tablet2liBuid2drops
K14 -ac" tab4 'ontains, Ambroxol
H'3-;0mg,
24 -ac" &ml liBuid contains, Ambroxol
H'3-;0mg,
;4 -ac" ml drops contains, Ambroxol
H'3-!4&mgL
Acute and c"ronic disease o) t"e
respiratory tract associated >it"
abnormal bronc"ial secretions in
particular acute attac< o) c"ronic
bronc"itis, ast"matic bronc"itis,
bronc"ial ast"ma4
129ec2&
63. 7emcitabine (n.ection (n t"e management o) non-small
cell lung cancer
212Jan2@
64. Sumatriptan tablets and in.ection
K-ac" )ilm coated tabs contains,
14 Sumatriptan Gas succinateH-
100mg2&0mg22&mg
24 Sumatriptan in.ection contains
Acute migraine attac<s >it" or
>it"out aura only >"ere t"ere is
a clear diagnosis
@2$eb2@
Sumatriptan as succinate @mg-per
04&mlL
65. Tacrine Hydroc"loride caps
10mg220mg2;0mg210mg
$or t"e treatment o) dementia in
patients >it" Al,"eimerFs
diseases o) mild to moderate
se/erity
112$eb2
@
66. #itroscanate tablets G?-TH
100mg2&00mg
$or control2eradication o)
Hoo<>orm2%ound>orm2Tape>or
m in puppies and adult dogs
12$eb2
@
67. 6etorolac Sterile 8p"t"almic solution
04&=
)or t"e relie) o) ocular itc"ing due
to seasonal allergic con.uncti/itis
only
12+ar2@
68. $luticasone Propionate ointment (n)lammatory and pruritic
mani)estation o) corticosteroid
responsi/e ec,ema dermatitis
1D2+ar2
@
6. Piroxicam *etacyclodextrin tabs 20
mg
Pain and in)lammation
associated >it" r"eumatoid
art"ritis, osteoart"ritis, acute
musculo-s<eletal pain, post-
operati/e pain and primary
dysmenorr"oea
2&2+ar2
@
7!. T"iocolc"icoside tablet -1 +7 As an ad.u/ant treatment in
pain)ul spasms associated >it"
degenerati/e /ertebral disorder
and /ertebral static problems,
torticollis, dorsal pain, lo>-bac<
pain, traumatologilcal and
neurological disorder4
2&2+ar2
@
71. Sulbutiamine tabs -200mg Symptomatic treatment o)
)unctional ast"enia
2;2+ar2
@
72. *ena,epril Hcl tabs &mg210mg220mg -ssential "ypertension and
congesti/e "eart )ailure
222Apr2@
73. 3e/obunolol Hydroc"loride op"t"almic
solution 24&+72&40+7
$or t"e control o) intra-ocular
pressure in c"ronic open angle
glaucoma and ocular
"ypertension
1@2+ay2
@
74. Terlipressin Acetate (n.ection (4?4
-1mg4
(n t"e treatment o) bleeding
oesop"ageal /arices4
222Jul2&
75. 9ano)loxacin +esylate in.ection G/etH
2&0 mg
*o/ine respiratory disease in
bee) cattle, non-lactating dairy
cattle cal/es caused by
pasteurella "aemolytica P
multocida and enteric in)ection
caused by -4coli 2salmonella sp4
2D2Jul2&
76. Salmon 'alcitonin (n.ection K14 -ac"
ampoule contains- Salmon 'alcitonin-
100 (U2ml 24 -ac" /ial
contains-Salmon 'alcitonin 100
(U22ml4L
Hypercalcemia pain associated
>it" ad/anced metastatic bone
cancer, PagetFs disease, post-
menopausal osteoporosis4
;2Aug2&
77. 7abapentin caps ;00mg2100mg -pilepsy ;2Aug2&
78. 9ocetaxel in.ection concentration
-D0mg G2ml2/ialH 0 20mg G04&ml2/ialH
(ndicated in t"e treatment o)
patients >it" locally ad/anced or
metastatic breast cancer and
202Jun2@
small cell lung cancer
7. 'arteolol Hcl tabs &mg, in t"e management o)
"ypertension and also in t"e
prop"ylactic management o)
patients >it" angina pectoris4
2Jul2@
8!. 'arteolol Hcl opt"almic solution 2=
>2/
(n ocular "ypertension, c"ronic
open angle glaucoma and some
secondary glaucomaFs
2Jul2@
81. $luoromet"olone 041= and
$luoromet"olone tarte liBui)ilm 042&=
opt"almic suspension
(n non-in)ected 2 in)ected
in)lammatory ocular condition
2@2Jul2@
82. Artemet"er (n.ection -D0mg (n se/ere malaria including
cerebral malaria and as a second
line in c"loroBuine resistant
malaria cases only4
22Aug2@
83. Artemet"er 'apsule 10mg (n se/ere malaria including
cerebral malaria and as a second
line in c"loroBuine resistant
malaria cases only4
;2Aug2@
84. 'entpropa,ine caps -20mg (n t"e treatment o) depression4 1@2Aug2
@
85. *enidipine Hcl tabs 1mg2Dmg Hypertension and long term
prop"ylactic management o)
Angina-pectoris
122Aug2
@
86. Iopiclone !4&+7 tablet S"ort term treatment o) insomnia,
transient, situational or c"ronic
insomnia and insomnia
secondary to psyc"iatric
disorders >"en it is debilitating or
se/ere4
1@2Aug2
@
87. Tibolone tablet 24&mg (n t"e treatment o) complaints
resulting )rom t"e natural or
surgical menopause4
1@28ct2@
88. 'ypermet"rin Hig"-cis G?-TH 100mg )or t"e control o) tic<s 1@2Sep2
@
8. Promegestone tabs
0412&mg2042&0mg204&00mg
7ynaecological conditions
c"aracterised by luteal
insu))iciency menstrual
irregularities due to o/ulation
disorders, dysmenorr"ea,
premenstrual syndrome,
mastodynia, dys)unctional uterine
bleeding menorr"agia du to
)ibromyomas, menopausal
syndrome4
2;2Sep2
@
!. #icardipine retard caps4 10mg2;0mg management o) "ypertension
and Angina pectoris
28ct2@
1. Artesunate tabs &0mg Promoted )or use in se/ere
malaria including cerebral
malaria and as a second line in
!28ct2@
c"loroBuine resistant malaria
cases only
2. $inasteride tablets &mg *enign prostatic "ypertrop"y only 28ct2@
3. #altrexone Hcl tabs &0mg (n t"e treatment o) narcotic
antagonist and alco"ol
dependence4
1128ct2@
4. Spar)loxacin tabs4 100mg2200mg,
100mg
'ommunity acBuired pneumonia,
acute exacerbation o) c"ronic
bronc"itis, ot"er lo>er respiratory
tract in)ection caused by
susceptible bacteria, acute
sinusitis, gonococcal and non-
gonococcal uret"ritis in males,
uncomplicated UT(, s<in, so)t
tissue in)ections, -#T in)ections4
112#o/2@
5. 'e)tibuten 'apsule2Suspension K-ac"
capsules contains ce)tibuten
200mg2100mg -ac" &ml
suspension contains ce)tibuten
0mg21D0mg L
Upper respiratory tract in)ection,
lo>er respiratory tract in)ection,
UT( and enteritis and
gastroenteritis4
12#o/2
@
6. Po/idone-(odine sterile op"t"almic
prep solution &40= >2/
)or prepping o) t"e periocular
region and irrigation o) t"e ocular
sur)aces
222#o/2
@
7. #or)loxacin po>der G/etH 10= Eide ?ariety 8) (n)ections
'aused *y Susceptible
7ramN?e And 7ram-?e
8rganism (ncluding +ixed
(n)ection (n Poultry
122+ar2
!
8. 8rnida,ole tablet and in)usionK-ac"
tab contains, 8rnida,ole-&00mg,2
8rnida,ole in)usion-&mg2ml G100ml
in)usion bottleHL
(n t"e treatment o) susceptible
proto,oal in)ection and anaerobic
bacterial in)ection only
1;2Jan2!
. #icorandil tabs &mg210mg220mg $or t"e pre/ention and long term
treatment o) angina pectoris
102Jan2!
1!!. #icorandil in.ection 2mg212mg21Dmg $or t"e pre/ention and long term
treatment o) angina pectoris
2;2+ar2

1!1. Arteet"er in.ection (4+4 -1&0mg per

/ial
Promoted )or use in se/ere
malaria including cerebral
malaria and as a second line in
c"loroBuine resistant malaria
cases only
112Jan2!
1!2. 'reatine P"ospate (n. K-ac" /ial
contains creatine p"ospate &00mg21gL
9e)icient striated muscle acti/ity,
'o-ad.u/ant in t"e treatment o)
myocardial disorders, )or addition
to cardioplegic solution as a
means o) protection in "eart
surgery4
202Jan2!
1!3. +oxidectin in. G/etH 1= >2/ (n t"e treatment and control o)
internal and external parasites in
cattle4
1@2Jan2!
1!4. +e)loBuine Hcl tabs 2&0mg Use in se/ere malaria including
cerebral malaria and as a second
;2+ar2!
line in c"loroBuine resistant
malaria cases only
1!5. Acarbose tabs &0mg2100mg non-insulin dependent type ((
diabetes inadeBuately controlled
by diet and 2 or oral
"ypoglycaemic agents
@2+ar2!
1!6. %esperidone tabs 1mg22mg2;mg21mg acute and c"ronic sc"i,op"renic
psyc"oses and ot"er in psyc"otic
conditions in >"ic" positi/e
symptoms and negati/e
symptoms are prominent
;2Apr2!
1!7. %esperidone 3iBuid 1 mg 2 ml acute and c"ronic sc"i,op"renic
psyc"oses and ot"er in psyc"otic
conditions in >"ic" positi/e
symptoms and negati/e
symptoms are prominent
112+ay2
!
1!8. 7lipi,ide 7(TS Tabs &mg210mg #on-insulin dependent diabetes
mellitus GType-((H
212Aug2
@
1!. -todolac tablet 0 'apsules K-ac" tab
contains -todolac *P-200+72100+7
-ac" caps contains -todolac-;00mg L
(n)lammation and pain)ul
conditions in osteoart"ritis, acute
attac<s o) gout and pseudo gout
pain )ollo>ing dental extraction,
post-operati/e and post
episiotomy pain, dysmenorr"oea,
and acute musculos<eletal pain4
102Apr2!
11!. Artesunate in.ection @0mg Promoted )or use in se/ere
malaria including cerebral
malaria and as a second line in
c"loroBuine resistant malaria
cases only
22Sep2@
111. +ida,olam in.ection *P 1mg2ml 0
&mg2ml
$or preoperati/e sedation )or
conscious sedation prior to s"ort
diagnostic or endoscopic
procedure and )or induction o)
general anaest"esia prior to
administration o) anot"er
anaest"etic agent4
1&2Apr2!
112. Poly/idone eye drops &= Symptomatic treatment o) dry
eye conditions including <erato-
con.uncti/itissicca
;02Apr2!
113. 3acidipine tabs 2mg21mg mild to moderate "ypertension &2+ay2!
114. Pyra,inamide dispersible tabs -2&0mg S"ort course treatment o)
tuberculosis in pediatric age
group4
@2Jun2!
115. Adenosine in.ection @ mg 22ml 'on/ersion to sinus r"yt"m o)
paroxysmal supra/entricular
tac"ycardia including t"at
associated >it" accessory
bypass tracts G>ol) Par<inson-
>"ite syndromeH >"en clinically
ad/isable appropriate /agal
manoeu/res s"ould be attempted
prior to adenosine administration4
D2Jul2!
116. A,elastine #asal spray 0401gm per
10ml
Allergic r"initis and perennial
r"initis4
1&2Jul2!
117. Sta/udine caps
1&+7220+72;0+7210+7
(n adult patients >it" ad/anced
H(? in)ection >"o are intolerant
o) appro/ed t"erapies4
122Jul2!
118. Prednicarbate 'ream K-ac" gm o)
cream contains, Prednicarbate-24&mgL
S<in diseases >"ere treatment
>it" topical corticosteroid is
appropriate4
@2Aug2!
11. Serenoa-%epens capK-ac" so)t
gelatin caps contains 1@0mg lipid
extract to serenoa reponsL
$or *4P4H4 122Sep2
!
12!. 'alcium 9obesilate caps -&00mg '"ronic /enous insu))iciency o)
lo>er limbs only
222Sep2
!
121. Alendronate Sodium tab -10mg Post-menopausal osteoporosis
only4
1D2Sep2
!
122. 'e)podoxime Proxetil tab2syrup K-ac"
tab contains, 'e)podoxime $roxetil-
100mg, -ac" &ml suspension
contains 'e)podoxime Proxetil-10mgL
Acute bronc"itis, exacerbations
o) c"ronic bronc"itis, bronc"iolitis
pneumonia, sinusitis, recurrent
c"ronic tonsillitis, p"aryngitis,
acute otitis4
12Sep2
!
123. 'e)pirome in.ection
042&g204&g2140g22gm per /ial
(n)ections caused by ce)pirome
sensiti/e organism, lo>er
respiratory tract in)ection,
complicated upper and lo>er
urinary tract in)ections,
bacteraemia, and septicaemia4
2@2Sep2
!
124. (debenone tablets -;0mg (n t"e treatment or impro/ement
o) decreased /olition emotional
disturbances and speec"
disturbances associated >it"
seBuelae o) cerebral in)raction,
seBuelae o) cerebral
"aemorr"age, cerebral
arteriosclerosis4
2@2Sep2
!
125. 9oramectin 1= in.ection solution G/etH Treatment and control o) gastro-
intestinal round>orms,
3ung>orms, eye >orms, scre>
>orms in cattle4
1!28ct2!
126. *i)ona,ole cream2solution2po>der
K1gm o) cream2po>der contains
*i)ona,ole-0401gm and 1ml o)
solution contains *i)ana,ole-0401gmL
S<in mycosis caused by
dermatop"ytes, yeast moulds,
ot"er )ungi4
2D-11-!
127. Sodium Picosulp"ate Tab2Syrup K14
-ac" uncoated tab contains, Sodium
Picosulp"ate-&mg210mg 24 -ac" &ml
syrup contains, Sodium Picosulp"ate-
&mgL
'onstipation bo>el clearance
be)ore labour or surgery,
radiological examination4
112$eb2!
128. Tiaprost Trometamol in. G/etH 1&0mg (n inducing pasturition in co>s
and bu))alos
12$eb2
!
12. Teicoplanin $or (+2(? (n.ection use in serious gram N/e in)ection 12$eb2
100mg2200mg2100mg per /ial stap"ylococcal in)ection in
patients sensiti/e or
unresponsi/e to penicillinFs and
cep"alosporinFs 'AP9 related
peritonitis, prop"ylaxis in
ort"opaedic surgery at ris< o)
gram N/e in)ection4
!
13!. 'loba,am tablets &mg210mg220mg Acute and c"ronic anxiety states
and as an ad.uncti/e t"erapy in
patients >it" re)ractory epilepsy4
112#o/2!
131. 3euprolide acetate depot in.ection
;4!&mg per /ial
(ndicated )or t"e treatment o)
prostatic cancer only4
1029ec2
!
132. Sacc"aromyces boulardii
Gcaps2sac"etsHK-ac" capsule2sac"ets
contains Saec"aromyces boulardii
2D24&mgL
$or irritable bo>el syndrome,
antibiotic associated diarr"ea,
diarr"ea due to enteral )eeding in
adults only4
1D29ec2
!
133. (sepamicin in.ection 100mg22&0mg
per /ial
3o>er respiratory tract in)ection,
intra-abdominal in)ection, urinary
tract in)ection, s<in and so)t
tissue in)ection and septicemia4
2@29ec2
!
134. $lucona,ole 04;= >2/ $or )ungal corneal ulcers2<eratitis
only
12$eb2D
135. 'lotrima,ole so)t gel pessary 100+7 ?aginal candidiasis 1!2$eb2
D
136. Tol)enamic acid caps 200mg %"eumatoid art"ritis, osteo
art"ritis, an<ylosing spondylitis
and related conditions associated
>it" pain4
12+ar2D
137. +elatonin tab -;mg $or sleep disorder, .et lag, and
regulation o) circadian r"yt"m
disorder
122+ar2
D
138. *ip"enyl acetic acid gel -;400=>2> $or t"e relie) o) symptoms o) so)t
tissue in.uries, extra articular
r"eumatic or in)lammatory
conditions, acute in)lammatory
mani)estations o) osteo art"ritis
or <nee .oint pain and s>elling
)ollo>ing in.ury4
2!2Apr2D
13. (rinotecan H'l tri"ydrate solution )or
(? in)usion 20 mg 2ml in 2 ml 0 & ml
pac<si,e
$or t"e treatment o) colo-rectal
cancer
222+ay2
!
14!. 3amotrigine tab -2&mg Add on t"erapy )or partial and
secondary generali,ed tonic-
clonic sei,ures in adults not
belo> 1@ years o) age4
112+ay2
D
141. Propo)ol in.ection 10mg per ml (nduction and +aintenance o)
general anest"esia4
1D2+ay2
D
142. 'ipro)ibrate tabs -100mg (ndicated in treatment o) primary
"yper lipidaemia resistant to
appropriate dietary management
including c"olesterolaemia, "yper
triglyceriaemia and "yper
lipidaemia G$redric<eson types
12+ay2D
((a, ((b, ((( and (?H
143. Sertraline tab &0mg2100mg +a.or depressi/e disorders
obsessi/e compulsi/e disorders
G8'9H, panic disorder
2Jun2D
144. Sertraline tab 2&mg $or panic disorder only4 2Jun2D
145. 3osartan Potassium tablets
-2&mg2&0mg2100mg
mild to moderate "ypertension
only4
1@2Jun2D
146. %itona/ir 100mg in t"e treatment o) ad/anced H(?
in)ection by Buali)ied p"ysician
not belo> t"e age o) 12 years to
be administered4
D2Sep2!
147. Alpra,olam S% tab 14&mg S"ort term symptomatic
treatment o) anxiety including
anxious patients >it" symptoms
o) depression

148. 3ome)loxacin eye drops ;mg2ml *acterial in)ection o) t"e eye 222Jul2D
14. %i/astigmine capsules
04&mg2140mg214&mg2;mg21mg2&mg2@
mg
treatment o) patients >it" mild to
moderate dementia o) Al,"eimer
type
;12Jul2D
15!. 8xybutynin c"loride Tab2Syrup K 14
-ac" uncoated tab contains
8xybutynin c"loride-24&mg2&mg
24 -ac" &ml syrup contains
8xybutynin c"loride-24&mgL
$or urinary incontinence, urgency
and )reBuency in t"e unstable
bladder >"et"er due to
neurogenic bladder disorders or
to idiopat"ic detrusor instability
and nocturnal enuresis4
;2Sep2D
151. $exo)enadine Hcl tablet
-120mg21D0mg
(n t"e treatment o) relie) o)
symptoms associated >it"
seasonal allergic r"initis and
c"ronic idiopat"ic urticaria in
adults only4
1@2Sep2
D
152. Sim/astatin tab
&mg210mg220mg210mg
Primary "yperc"olesterolemia,
type ((a and type ((b alone or in
association >it" 'A94
2&2Sep2
!
153. 'ar/edilol 124&22&mg tablet -ssential "ypertension only 1@28ct2D
154. Pantopra,ole sod4 Tab 20 2 10mg $or t"e treatment o) gastric ulcer,
duodenal ulcer, moderate and
se/ere re)lux oesop"agitis4
29ec2D
155. Iido/udine G;00mgH tabs $or H(? 1D29ec2
D
156. 8xaliplatin $ree,e dried po>der )or (?
in.ection &0mg2100mg per /ial
$or treatment o) ad/anced
colorectal cancer4
2@28ct2D
157. ?indesine Sulp"ate (n.ection 1mg2&mg
per /ial
Acute lymp"ocytic leu<aemia o)
c"ild"ood resistant to /incristine
sulp"ate, non -Hodg<inFs
lymp"omas, malignant
melanoma, non-small cell
carcinoma o) t"e lung, blast crisis
o) c"ronic granulocytic leu<aemia
and carcinoma o) t"e breast4
2D28ct2D
Note" It #a$ %e &tated t'at t'e a%ove li&t of Ne( Drug& i& prepared a& per t'e
record& availa%le (it' t'e office of D)* +I,. In ca&e an$ incon&i&tenc$ i&
o%&erved- &a#e #a$ %e %roug't to t'e notice of D)* +I, for nece&&ar$ action.