Name of DrugIndicationDate of approval
1Cyanocobalamine + Zinc tannic acid complexJan-61
2Cobalt glutamate + Copper GlycinateAug-61
3Fibrinolysin + DesoxyribonucleaseFeb-62
4Tablets of Norethisterone acetate + Ethinyl
oestradiol
Nov-62
5Tablets of Norethynodrel and Ethinyl Estradiol 3-methyl etherDec-62
6Broxyquinoline + BrobenzoxalidineMay-63
7Testosterone decanoate + IsocaproateJan-64
8Combination of L Oxethazaine + Aluminium hydroxide + Magnesium HydroxideJun-66
9Amylobarbitone + Trifluperazine Dihydrochloride CapsuleFeb-67
10Lynestronol 2.5mg + Mestranol 0.075mg TabletApr-67
11Northynodrel 2.5mg + Mestranol 0.1mgJun-67
12Norethisterone 2mg and Mestranol 0.1mgMay-67
13Mestranol 4mg + Ethinyloestradial 0.05mg
Tablet
May-67
14Norethisterane acetate + ethinyl estradiolMay-67
15Aluminium sodium silicate + Magnesium hydroxide + Methypolysiloxane TabletJun-67
16Ammoidin + AmidineJul-67
17Fluocortolene + Flucortolene CaproateJul-68
18Norgestrel + Ethinyloestradiol TabletAug-68
19Folic Acid 0.5mg + Ferrous Sulphate 150mg
Capsule
Jan-69
20Tetracycline HCl 250mg + Broxyquinoline 200mg + Brobenzoxadine 40mgJan-69
21Methyldopa 250mg + HCTZ 15mg TabletFeb-69
22dl Norgestrel + 17 alpha hydroxy progesterone caproate + Norethisterone acetate + 17 alpha acetoxy progesteroneJan-69
23Diphenoxylate HCl 2.5mg + Atropine Sulphate 0.025mg tabletJul-69
24Vitamin A,D & EJul-69
25Lutin 0.1gm + Vit 0.1gm + Vit K1 2.5mg + Dicalcium Phosphate 0.1gm + Carlozochrome Salicylate 1mg tabletJul-69
26Vit K 1 5mg + Calcium Lactolionate 100 m g+ Carlozocrome Salicylate 2.5mg + Phenol 0.5%
+ Lignocaine Hcl 1% injection
Jul-69
27Phenylmethylamine-amino benzene Sulphate 15mg + Phenylmethylamine Hcl 10mg tabletJul-69
28Phenylmethylamine-amino benzene Sulphate 1.5% w/w + Phenylmethylamine Hcl 1.5% w/w
ointment
Jul-69
29Colistin Sulphate (300000 IU) 0.154gm +
Pectin 0.196gm + Kaolin 2.625gm per 30ml suspension
Sep-69
30Atropine Sulphate 0.06mg + Hyoscyamine sulphate 0.30mg + Scopolamine hydrobromide 0.035mg + Phenobarbatal 64.8mg capsuleDec-69
31Di iodochlorhydroxyquinoline 300mg + Berberine Hcl 40mg + Homatropine
methylbromide 0.8mg tablet
Jan-70
32Ethynodiol diacetate 1mg + Ethinyloestradiol
0.05mg
Feb-70
33Lynestronol 2.5mg + Ethinyloestradiol 50mcgSep-70
34Methandienone BP 25mg + Benzyl alcohol in sterile solution 9% w/v/mlApr-70
35Trimethoprin 80mg/20mg + sulphamethoxazole 400mg/100mg tabletJul-70
36Trimethoprin 40mg + sulphamethoxazole 200mg/5ml suspensionJul-70
37Chlordentoin 1% + Benzyl bromide chloride 0.05% per 100gm creamSep-70
38Ambodryl 100mg + Aspirin 190mg + Phenacetin 65mg + Caffiene 15mg + Phenylephrine HCl 10mg + Aluminium
hydroxide gel 100mg tablet
Nov-70
39Ethynodial diacetate 1mg + Mestranal 0.05mg
tablet
Jan-71
40Dried yeast powder 250mg + Saccharomyces
ceribial containig NLT 10 million living cells Capsule
Jan-71
41Hydroflumethiazide 25mg/50mg + Rauwalfia 50mg/50mg TabletsMar-71
42D - norgestrel 0.25mg + Ethinyl estradiol
0.05mg Tablet
Apr-71
43Pyridine 3-carboxylic acid hydroxy methylamide 0.125gm + Choline Bitartrate
Tablet
Jul-71
44Alpha chymotrypsin 60mg + Ethyl nicotinate 200mg per 20gm ointmentSep-71
45Phenyl propalamine HCl 50mg + Isoprapamide 2.5mg + Diphenyl pyralline HCl 5mg capsuleSep-71
46DL - norgestrel 0.25mg + Ethinyl estradiol 0.05mg TabletSep-71
47Dihydroxy acetate 15%w/v + Alcohol 95% - 45%w/v lotionOct-71
48Psoralen 10mg + Copper Sulphate 2mg TabletOct-71
49Dexamethasone 0.125mg + Indomethacin 25mg CapsuleNov-71
50Yeast tannic acid compound 250mg + lodochlorohydroxyquinoline 150mg + Benzalconium chloride 10mg TabletNov-71
51Amylase + Cellulose + Protinase + Pencreatic enzyme + Lipase CapsuleDec-71
52Reserpine 0.1mg + Clopamide 5mg + Dihydroergocristine 0.5mg TabletJan-72
53Calcium gluconate 50mg + Iso thipendyl HCl 4mg + Acetylsalicylic acid 200mg + Caffine
30mg per dosage
Jun-72
54Chlorphenoxamine HCl 12mg + Caffeine 30mg
Tablet
Jul-72
55Flumethasone Pivalate 0.02% + lodochlorohydroxyquinoline 1% ear dropsOct-72
56Cape aloes 16mg + Podophyllin resin 4.2mg + Licorice powder 5.462 mg per TablerOct-72
57N - butanol 0.52gm + Citric Acid 0.0025gm +
Physiological sodium chloride add to 5ml per 5 ml
Nov-72
58Paracetamol 300mg + D-propoxyphene HCl 25mg per tabletDec-72
59Theophylline anhydrous 100mg + Ephedrine HCl 10mg + Diazepam 1mg + Prednisolone
1.5mg tablet
Mar-73
60Dybendal 0.5%w/w + Allantoin 0.2%w/w + Boric Acid 1%w/w + Menthol 0.08% v/wMay-73
61Sod. Chloride 558mg + Pot. Chloride 14.9 mg + Mag. Chloride 10.16mg + Cal. Chloride dihydrate 21.9mg + 20/6 Molar Sod. Lactate
1.34 ml + Dextrase Anhydrous 1.5gm per 100ml
May-73
62Parbendazole 4%w/w + Ethixygin 0.125% w/w
+ Extracted soya flour added to 100% suspension
Jun-73
63Hydrocarticosone acetate 1%w/w + Nitrofurazone 0.2%w/w creamJun-73
64Activated Methylpolysiloxane 125mg + Magnesium Hydroxide 100mg + Aluminium Hydroxide 5gm per 5ml solutionJun-73
65Chlordiazepoxide 5mg + Clidimium bromide 2.5mg per tabletJul-73
66Nitrofurazane 0.06gm + urea 6.21gm bolusAug-73
67Lynestrenal 1mg + Ethinylestradiol 50mcg
tablet
Sep-73
68Trimethoprim & SulphadoxineSep-73
69Dried ferrous sulphate eq. to 50mg of elemental iron + Ascorbic acid 300mg + Sod. Bicarbomate 84mg + Talcum 12mg capsuleDec-73
70Erythromycin Propionate eq. to 50mg of Erythromycin + Benzyl alcohol 0.02ml +
Lidocaine 0.02gm per ml Inj.
Mar-74
71Beclomethasone Dipropionate 0.025% + Neomycin Sulphate 0.5% Ointment & CreamApr-74
72Beclomethasone Dipropionate 0.025% + Chinoform 3% Ointment & CreamApr-74
73Trimethoprim 4%w/v + Sulphadoxime 20%w/vJul-74
74Dl - Norgestrel 0.5mg + Ethinyl estradiol
0.03mg Tablet
Aug-74
75Mixture of sodium Salt + Methyl glucamine salt of 35 diacetamido- 2,4,6-triodobenzoic acidMay-75
76Autolysate of β-subtilis+β- megatheriumJul-75
77Trimethoprim+sulfamoxoleSep-75
78Zoalene 25% + Ethoxygim 0.125% premixJan-75
79Clonidine HCl 100mcg + HCTZ 20mg
Tablet/Capsule
Jul-75
80Benzoyl peroxide 10%w/w + Precipitated Sulphur 5%w/w per 20gm creamAug-75
81Triamterene 50mg + HCTZ 25mg tabletOct-75
82Combipack of 21 active tablet contains Noretihsterone acetate 1mg + Ethinyl oestradioal 30mcg & 7 Haematinic tablets
contain Ferrous Fumarate 60mg
Oct-75
83Caffein 100mg + Ergotamine tartrate 1mg + Analgin 250mg + Trifluperazine HCl 1mg
Capsule
Mar-76
84Paracetamol 120mg + Diphenylpyralime HCl
1.5mg + Phenylpropanolamine HCl 10mg per 5ml expectorant
May-76
85Trimethoprim 80mg + Sulphamethoxazole 400mg per 5ml infusionOct-76
86DL- Norgestrel 300mcg + Ethinyl oestradiol 30mcg TabletOct-76
87Tolnaytate 10mg + Nystatin 100,000 Units per gm creamFeb-77
8840mg of elemental iron in a complex of iron
polymaltose + Vit. B6- 2mg + Vit. B12 40mcg tablet
Feb-77
8950mg of elemental iron in a complex of iron polymaltose aq. solution + Vit. B6 2mg + Vit.
B12 5mcg Syrup
Feb-77
90Neomycin Sulohate 910mg + Polymyxin B Sulphate 300000 units + Zinc bacitracin 25000units + Propellent to maba 210gm aerosol
pouch of 210gm
Mar-77
91Norethisterone 1mg + Ethinyl estradiol 30mcg
Tablet
Jun-77
92Sodium salt of loxitalamic acid 5.13gm +
Meglumine salt of loxitalamic acid 10.26gm per 20ml Inj.
Sep-77
93PVP/VA resin 5% + Benzalkonium chloride 0.10% + Lignocaine HCl 0.25% + D-panthanol DAB-7DDR 2% aerosol pack of 85gmSep-77
94Metronodazole 40mg + Furazolidone 30mg + Kaolin 1gm + Pectin 20mg per 5ml suspensionOct-77
95Diazepam 5mg + Paracetamol 500mg tabletOct-77
96Orphenadrine citrate 35mg + Paracetamol
450mg tablet
Nov-77
97Neomycin + Bacitracin+ Polymix B Sulphate ointmentNov-77
98Clonidine HCl 0.1mg/0.2mg + Chlorthalidone 15mg/15mg TabletDec-77
99Sulfametopyrazine 500mg + Pyrimethamine
25mg tablet
May-78
100Fluocortolone caproate 0.25gm + Flucortolone Trimethylacetate 0.25gm per 100gm creamJun-78
101Dimethyl polysiloxone 100mg + Enzyme concentrate Aspergilluss oryzae 120mg + Protease 126 units + Cellulase 185 units + Hemicellulose 64 units + Amylase 1.3 units +
papaverine HCl 25mg Capsule
Aug-78
102Lignocaine 50mg + Aluminium Hydroxide 300mg + Magnesium hydroxide 100mg + Activated dimethicone 20NF 50mg Tablet & 5
ml suspension
Sep-78
103Fluprednylidene acetate 0.1% + Gentamicin Sulphate 0.1% + 5-Chloro-8-hydroxygluconate
0.5% Cream
Oct-78
104Fluocortolone trimethylacetae 0.92mg + Flucartolone caproate 0.95mg + Clemizole undecyclate 10mg + Cinclocamic HCl per gm
ointment
Oct-78
105Fluocortolone trimethylacetae 0.612mg + Flucartolone caproate 0.630mg + Clemizole undecyclate 5mg + Cinclocamic HCl 1mg
Suppositories
Oct-78
106Propoxyphene Napasylate 100mg + Paracetamol 650mg CapsuleNov-78
107Sod. Chloride 20.047mg + Pot. Chloride 0.522gm + Mag. Chloride 0.366gm + Cal. Chloride 0.859gm + Sod. Acetate 19.047gm per
100ml Dialysis fluid
Nov-78
108Sod. Chloride 20.475mg + Pot. Chloride 0.783gm + Mag. Chloride 0.534gm + Cal.
Chloride 0.972gm + Sod. Acetate 19.054gm per 100ml Dialysis fluid
Nov-78
109Fluocortolone 2.5mg + Fluocartalone caproate 2.5mg + Neomycin Sulphate 5mg per gm
ointment
Nov-78
110Trimethoprim 160mg + Sulphamethoxazole 800mg per 3 ml Inj.Jan-79
111Metronodazole 100mg + Furazolidone 30mg + Kaolin & Pectin per 5ml suspensionMar-79
112Lynestrenal 0.75mg + Ethinylestradiol 37.5mcg
tablet
Apr-79
113Chlorpromazine 50mg + Trifluroperazine 5mg
+ Trihexyphenidyl 2mg tablet
May-79
114Halcinonide 1mg + Neomycin sulphate eq. to 2.5mg of neomycin base ointment/creamJul-79
115Clidinium bromide 2.5mg + Diazepam 2.5mg + Analgin 500mg tabletSep-79
116Amiloride 5mg + HCTZ 50mg TabletSep-79
117Diazepam 2.5mg + Sorbide Dihitrate 10mg
Tablet
Dec-79
118Propranolol 40mg + Hydrallazime 25mg tabletFeb-80
119Fluprednidene acetate 0.1% + Gentamicin as Sulphate 0.1% CreamFeb-80
120Sterile powder of colistin sulphomethate sodium eq. to 1000000 Units + Dilucame HCl 2mg per
vial Inj.
Feb-80
121Phenylbutazone 125mg + Propyphenazone 125 mg tabletsFeb-80
122combipack of 22 tablets of Lynestrenol 1mg + Ethynyloestradiol 50mcg & 6 placebo tablets of Ferrous Fumerate 60mgJun-80
123Diethylamine Salicylate 10mg + Nopoxamine 1gm per 100gm ointmentMar-80
124Phenyl dimethyl isopropyl pyrazolone 150mg + Diethyl dioxotetrahydro pyridine 50mg + Paracetamol 250mg + Caffeine (Anhydrous)
46.75mg
Nov-80
125Hydroxyethyltheophylline 231mg + Theophylline monohydrate 69mg SR TabletJun-81
126Calender pack containing 21 days1. Levonorgestrel 0.05mg + Ethinyloestradiol 0.03mg Tablet 2. Levonorgestrel 0.075mg + Ethinyloestradiol 0.04mg Tablet 3. Levonorgestrel 0.125mg + Ethinyloestradiol
0.03mg Tablet and 7 inactive tablets extra
Jun-81
127Acetylsalicyclic acid 350mg + Al. Hydroxide 90mg + Mg. Hydroxide 90mg tabletNov-81
128Terbutaline sulphate 1.5mg+Guaphenesine 66.5 mg per 5ml syrupOct-82
129Propranolol HCl 40 mg+HCTZ 25 mg tabletsOct-82
130Metoprolol tartarate 100
mg+Hydroclorothiazide 12.5 mg
Oct-82
131Propranolol Hcl 80 mg+Bendrafluazide 2.5 mg
capsule
Oct-82
132Paracetamol 450 mg+Chlormezanone 100 mg
tablet
Oct-82
133Megaldrate 400 mg+Simethicone 60 mg chewable tabletNov-82
134Megaldrate 400 mg+Simethicone 60 mg per 5ml SuspensionNov-82
135Bumetanide 0.5mg+Potassium Chloride 523 mgFeb-83
tablet
136Ampicillin 3.5gm+ Probenecid 1.0gm single
vial
Feb-83
137Rifampicin300mg/450mg/600mg+INH 200mg/300mg/300mgJun-83
138Desogestrel 0.15 mg+Ethinylestradiol 0.03 mg each tabletsNov-83
139Levodopa+CarbidopaDec-83
140Betamethasone Dipropionate 6.43 mg + Betamethasone Sodium Phosphate 2.63 mg each
vial
Jul-84
141Frusemide 20mg/20mg + Spironolactone 50mg/100mg each capsule/tabletSep-84
142Levamisole 50 mg+Mebendazole 200mg tabletSep-84
143Tinidazole 150mg+Diloxonide Furoate 250mg
tablet
Sep-84
144Ibuprofen 400mg+ Paracetamol 325mg tabletOct-84
145Clestabol 500mg+Neomycin Sulphate 500mg per 100gm creamJun-85
146Levodopa 100mg/200mg+Benserazide 25mg/50mg each capsuleNov-85
147Hydrotalcite 500mg + Smithicone (activated) 125mg Tablet & Hydrotalcite 500mg + Smithicone (activated) 125mg per 5ml
Suspension
Jun-86
148Acebutolol HCl 200mg + HCTZ 12.5mgAug-86
149Biclotymol 0.198gm+Glyceryl Galacolate 0.200gm+Pholcodine 0.133gm+Chlorphenaramine maleate 0.0133gm
per 100ml Syrup (for adult)
May-86
150Biclotymol 0.150gm+Glyceryl Galacolate 0.200gm+Pholcodine 0.100gm+Chlorphenaramine maleate 0.01gm
per 100ml (for children)
May-86
151Metoclopramide 5 mg+Dimethyl polysiloxane 250 mg tabletAug-85
152Sulphadiazine 400mg+Trimethoprim 80mg
tablet
Jan-87
153Sulphadiazine 200mg+Trimethoprim 40mg
suspension
Jan-87
154Carenecaine 2% with Adrenaline & Carenecaine 4% with Adrenaline InjectioFeb-87
155Amoxycillin trihydrate 250mg+Potassium Clavulanic eq. to Clavulanic acid 125mg each
tablet
Feb-87
156Framycetin Sulphate 1% + Hydrocortisone Acetate 1% + Miconazole nitrate 2%Apr-87
157Amoxycillin 500mg/1gm+Clavulanic acid 100mg/200mg each vial InjectionMay-87
1587 pills of 0.5mg Norethindrone & 35 mcg ethinylestradiol Tablets, 7 pills of 0.75mg Norethindrone & 35 mcg ethinylestradiol Tablets and 7 pills of 1mg Norethindrone & 35
mcg ethinylestradiol Tablets
Jan-88
159Fresemide 20mg+Potassium chloride 750mg
each tablet
Mar-89
160Neutral insulin and Insulin Zinc suspensionSep-87
161Gestodene 75mcg + Ethinylestradiol 30mcg
tablet
Jul-88
162Levodopa 100mg/250mg + Carbidopa 10mg/25mg Tablet/CapsulesFor the symptomatic symptoms of idiopathic
Parkinson's Disease
02/09/88
163Licomycin 50mg + Spectinomycin 100mg for vetarnary useOct-88
164Frusemide 20mg +Potassium Chloride IP 750mg tablet07/03/89
165Lincomycin 300mg + Neomycin 200mg +
Methyl Prednisolone 5mg per 10ml Infusion Solution
Mar-89
166Amiloride 5mg / 5mg + Frusemide 20mg/40mg
tablet
Jun-89
167Metoprolol 50mg + HCTZ 12.5mg TabletJun-89
168Captopril 25/50mg + HCTZ 15/25mgJul-89
169Eicosapentaenoic acid (EPA) 180mg + Docoshexaenoic acid (DHA) 120mgSep-89
170Atenolol BP 50mg+Nifedipine SR 20mg
capsule
Jan-90
171Alpha chloropyridazine sodium 10gm + trimethoprim 2gm per 100gm powder for
vetarnary use
May-90
172Each 5 ml reconstituted syrup contains:
Amoxycillin as trihydrate 125mg + Clavulanic Acid 31.25mg as potassium salt suspension
07/08/90
173Potassium Clavulanic Eq. to Clavulanic Acid 125mg + Amoxycillin Trihydrate Eq.For the treatment of bacterial infections such as sinusitis
otitis modia tonsititis, acute
05/04/90
to Amoxycillin 250mg tabletand chronic bronchitis, skin and post operative pain.
174Clavulanic acid (As potassium salt) 200mg
+ Amoxycillin (As sodium salt) 1gm injection
For the treatment of bacterial infection such as sinusitis otitis modia tonsititis, acute and chronic bronchitis, skin and soft tisse infections pelvic infections ostoomylitis post
operative pain.
07/08/90
175Amoxicillin 250/500mg + Carbocistine 150mg/150mg capsulefor respiratory infections characterised by excessive or viscous mucous Contraindication in pregnancyApr-91
176Amoxicillin 125mg + Carbocistine 75mg per 5ml syrupfor respiratory infections characterised by excessive or viscous mucous Contraindication in pregnancyApr-91
177Acetyl salicylic acid 100mg + Cal. Carbonate 30mg + Anhydrous citric acid 10mg TabletSep-91
178Ampicillin Sodium 0.5gm + Sulbactum Sodium 1gm per vial InjectionSep-91
179Pinene 17mg+camphene 5mg+Cineol 2mg+Menthone 6mg+Menthol 32mg +Borneol 5mg+Olive oil 33mg capsuleSep-91
180Ampicillin Sodium 0.25/0.5gm + Sulbactum Sodium 1gm/2gm per vial Injection06/05/92
181Cinnarazine 20mg + Domperidone 15mg tabletprevention of symptoms caused by vestibular disorders and vertigo/motion sickness, nausea, dizziness, headache, vomiting, sensation of fullness when there is a delay in gastric emptying.01/02/92
182Triclabendazole 5gm/12gm + Levamisole 3.75gm/7.5gm per 100ml Suspension for Veternary usetreatment and control of mature and developing immature infections of ostertragia, trichostrongylus, cooperis, nematodirus, oesophagastomum and dictyocaulus and all forms of liver fluke infection in sheep/cattle.01/07/92
183Pseudoehedrine HCl 30mg + Ibuprofen 200mg tabletfor the relief of nasal congestion, headache, fever, bodyache and pain associated with sinusitis, flu and
common cold.
28/09/92
184Enalapril 10mg/20mg + HCTZ 12.5mg/25mg tablethypertension in patients for whom combination therapy is appropriate08/10/92
185Ferrous glycine Sulphate CR 100mg (eq. to elemental iron)+Folic acid 0.5mg tabletFor the prophylaxis of iron and folic acid deficiencies during pregnancy03/11/92
186Frusemide 40mg/20mg+Potassium Chloride 600mg/300mg tabletNM26/02/93
187Cisapride + M.P.S. Chewable tabletManagement of dyspepsia due to functional causes, petic ulcer, and oesophagitis, prevention and therapy of reflux oesophagitis, gastroporesis, due to diabetic neurophatic, anorexia, nausea, vagotomy, post operative causes, radiation therapy, gastritis intestinal psends obstractive uremia ulcerative and non ulcertive dyspepsia, restoration of intestinal moltitity is chronic constipation03/05/93
188Etofylline-300mg, Salbutamol (as sulphate)- 4mg SR CapsulesNM14/06/93
189Norgestimate 180?gm/215?gm/250?gm + Ethinyl oestradiol 35?gm/35?gm/35?gm Tablets (Triphasic oral contraceptive tablets)oral contraceptives29/06/93
190Oxytetracycline HCL-500mg+Furazolidone- 500mg+Clioquinol-500mg per 100 gm syringeIntrauterine infusion for veterinary05/07/93
191Levamisole-1.5%+Oxyclozanide-3.0%
Suspension
for veterinary use29/09/93
192Framycetin sulphate 1%+Dexamethasone 0.1%+Clotrimazole 1% CreamIn the treatment of dermatologic disorders caused or complicated by infections by bacteria and/or fungi along with inflammation28/10/93
193(I) Rice based ORS citrate containing each sachet: Nacl 3.5g+KCl 1.5g+Sodium Citrate 2.9gm+Extruded Rice 50.0gm. (II) Rice based ORS electrolytes containing each sachet: Nacl 1.25gm+ KCl 1.50gm+Sodium Citrate 2.90gm+ Extruded Rice 50.0gmOral Rehydration Salts09/12/93
194EryThropoietin 2000 IU/4000 IU + Mannitol 40mg/40MG + NaCl 7mg/7MG + Monobasic Sod. Phosphate 2.8mg/2.8mg + Dibasic Sod. Phosphate 8mg/8mg + Human Albumin 5mg/5mg Lyophilised 2 ml Inj.In the treatment of anemia due to chronic renal failure and stage renal disease15/06/05
195Spiramycin 0.75MIU/1.50MIU+Metronidazole 1.25mg/250mg film coated TabletsNM15/03/94
196Sultamicillin(as Tosylate) 375mg eq. Sulbactam
147.0 mg + Ampicillin 220 mg Film coated tablets.
06/05/94
197Cephalexin-250mg/500mg+ Bromhexine (as HCl) 4MG/8MG CapsulesRTI characterized by excessive or viscid mucous16/09/94
198Cephalexin monohydrate eq. to cephalaxin 125mg/250mg+ Bromhexine Hcl eq. to Bromhexine 2mg/4mg per 5ml of reconstituted
suspension.
RTI characterized by excessive or viscid mucous27/01/95
199Carbidopa (Anhydrous) 50mg + Levodopa- 200mg C.R.tablet12/10/94
200Cephalaxin monohydrate eq. to cephalexin
500mg/250mg+Carbocisteine 150mg/150mg Capsules
30/10/94
201Cephalaxin anhydrous 250mg+Carbocisteine 150mg per 5 ml suspension30/10/94
202ZnSO4 0.660mg (heptahydrate eq. to elemental Zinc 0.15mg)+CuSO4 0.236mg (Pentahydrate eq. to elmetnal copper 0.06mg)+Chromic chloride 1.83mg (anhydrous eq. to elemental chromium 0.6mg)+MnSO4 0.047mg(monohydrate eq. to elemental maganies 0.025mg+Benzyl alchol 1%
(preservative)Trace metal additive infusion (TMA Infusion)
08/10/94
203Clostridium botulinum toxin type A - Hemagglutinin complex 100 units Human Serum Albumium 0.5mg+ NaCl 0.9 mgFor the treatment of blepharospasm hemifacial spasm & associated focal dystominal13/01/94
204Taurolidine 2g + Povidone 5g per 100ml13/01/94
205Taurolidine 2.5g + Povidone 6.25g per 500ml13/01/94
206Amoxycillin 500mg + Potassium Clavulanate 100mg injection03/10/94
207Amoxycillin (Present as amoxicillin trihydrate IP) 500mg + Clavulanic Acid (Present as potassium clavulanate USP) 125mg film coated tabletsFor the treatment of bacterial infections such as sinusitis otitis media, tonsillitis, acute and chronic bronchitis, skin and soft tissue infections, pelvic infections, ocsteromylitis, post operative
pain.
06/01/95
208Terfenadine 60mg+Pseudoephedrine HCL 120mg as E.R. tablets24/03/95
209Tinidazole 600mg+Norfloxacin 400mg tablets09/05/95
210Policresulen 50mg+Cinchocaine 10mg per gram ointment07/07/95
211Nonoxynol 2% w/v+Chlorometoxylenol 0.5%
w/v
26/07/95
212Ergometrine 500mcg+Oxytocin 5 units per ml
injection
28/07/95
213Nitrendipine 10mg/20mg+Atenolol 30mg/30mg tabletsMild to moderate hypertension not responding to monotherapy with either of the drug19/09/95
214Lactic acid 1.0% w/v+ Lactoserum 0.9% w/v (for topical use)06/11/95
215Amlodipine 5mg/2.5mg+Enalapril Maleate 5mg/2.5mg tabletsFor the treatment of hypertension only16/11/95
216Lisinopril 10mg/20mg/5mg+Hydrochlorothiazide 12.5mg/25mg/12.5mg uncoated tabletFor the treatment of patients with hypertension who are not adequately controlled on monotherapy23/11/95
217Glibenclamide 2.5mg+Metformin 400mg Film coated Tabletsnon insulin dependent diabites mallitus patients poorly controled with sulphonyluren or biguanide alone30/11/95
218Zinc Gluconate 87.1% mg (eq. to elemental Zinc 12.5mg) Ascorbic acid 100mg+ Sodium Ascorbate 170mg (eq. to 150 mg of Acorbic
acid) chewable tablet
12/12/95
219Mono ammonium glycyrrhizinate 4mg (as Glycyrrhizin) + Amino acetic acid 40mg + L- Cyptein HCl 2mg per 2 ml Inj.for the management of sub acute hepatic failure14/12/95
220Polyvinyl Alochol 14mg+Povidone 6mg+Chlorbutanol 5mg per ml eye dropsfor relief from burning, irritation and discomfort due to dryness of the eye11/01/96
221Glibenclamide IP 2.5mg + Metformin IP 400mg film coated tabletsFor the management of type II diabetes mellitus when single drug therapy, diet and exercise
do not result in adequate glycemic control
06/02/96
222NaCl-0.125gm+KCl 0.150gm+NaHCO3-
0.250gm+Citric acid (anhydrous)-0.577gm+ Dextrose (anhydrous) 2.650gm ORS Tablets
ORS Tablets22/04/96
223Polyvinyl Alcohol 14mg/30mg+Benzalkonium chloride-8.05mg per ml Opthalmic solution16/05/96
224Amlodipine besylate eq. to Amlodipine 5mg+ Atenolol 50mg Besylate uncoated tabletsMild to moderate hypertension16/05/96
225Lignocaine(base) 2%+ Silver Sulphadiazine 1%+ Chlorhexidine Glulonate 02% creamTemporary pain relief & to prevent infection in cuts & burn, wounds, nicks, scrapes, scratches abersion
herper zoster, bed sores
18/06/96
226Sterile Amoxyllin Sodium eq. to Amoxycillin 500gm/1gm+Sterile Sulbactam Sodium eq. to
Sulbactam 250mg/500mg (each vial) inj. (IM/IV)
Antibiotic21/06/96
227Clobetasol Propionate 0.05 % w/w+Ammonium lactate 12 % w/w geldry hyper keratotic steriod responsive dermatoses inflammatory manifestatin of psoriasis (excluding wide spread plague psoriasis)07/08/96
228Ramipril 2.5mg/5mg+Hydrochlorothiazide 12.5mg/25mg tabletMild to moderate hypertension in patients (in when combination therapy is appropriate) who have been established on the individual
components given in the same proportion
26/08/96
229Loratidine 5mg+Pseudoephedrine 120mg (ER) tabletsfor the relief of symptoms of seasonal allergic rhinitis21/08/96
230Fluorometholone 1mg+ Neomycin sulphate 3.5mg (as base)+Benzalkonium chloride 0.04mg per ml Ophthalmic suspensionIn the treatment of infected inflammatory ocular condition04/09/96
231Clindamycin 1%+Tretinoin 0.025% Topical gelMild to moderate acne vulgaris only18/11/96
232Glibenclamide 5mg+ Metfermin 500mg Tabletsnon insulin dependent diabites mallitus patients poorly controlled with sulphonyluren or biguanide alone26/11/96
233Ticarcilin 3gm+ Clavulanic Acid 100mg (per vial) injectionFor the treatment of Bacterial infections caused by susceptible organisms in pediatric patients (age > 3 months) subject to all other conditions
stipulated in initial permission of the drug remaining same.
30/10/96
234Amlodipine besylate Eq. to Amlodipine 5mg + Lisinoril eq. to Lisinopril anhydrous 5mg tabletmild to moderate hypertension27/03/97
235Flurometholone 10 mg+Gentamicin 3 mg (as sulphate) per ml Eye DropsThe infection of the anterior segment of the eye due to bacteria susceptible to gentamicin.28/04/97
236Methyl valerate 100mg+ Quinine Anhydrous 15mg+ Camphor 10mg+ Oil of eucalyptus
10mg capsule
used as an anti smoking agent06/06/97
237Cetirizine Dihydrochloride 5mg (Immediate
release)+Pseudoephedrine HCl 120mg (SR) tablet
for the treatment of seasonal allergic rhinitis.09/09/97
238Combipack containing : 1 capsule of Omeprazole 20mg cap, 1 tablet of Clarithromycin 250mg tab & 1 tablet of Tinidazole 500mg tab II. Omeprazole 20mg cap+Amoxycillin 750mg tab+Tinidazole 500
mg
for indication of H. Pylori associated with peptic ulcer09/09/97
239Combipack containing : 1 capsule of Omeprazole 20mg cap, 1 tablet of Amoxycillin 750mg & 1 tablet of Tinidazole 500 mgfor indication of H. Pylori associated with peptic ulcer09/09/97
240Propoxur 1gm + Flomethrion 0.225 gm per 10mg of collor for veternary usefor protection and control of ticks and flea on dogs03/02/97
241Levovist 4gm & 2.5gm granules per 20 ml vial(1gm granules contains Galactose 999mg + Palmetic acid 1 mg)one and two dimensional Doppler sonography blood flow imaging in (Contrast Media) patients where there is an insufficientDoppler signal
intensity and for bB mode control echo cardiography.
28/11/97
242Cloxacillin sodium 200mg+Colistine sulphate
50000 units per 10 ml Intrammamary infusion (vet)
04/03/98
243Ambroxol+Pseudoephedmine+Chlorpheniramin e maleats tabs/suspension/syrupFor the symptomatic relief of bronchospasm in bronchial asthma &
chronic bronchitis
26/02/98
244Glipizide 2.5mg/5mg
250mg/500mg tablet
for non insulin dependent
mellitus
20/03/98
245Perindopril 2mg/4mg+Indepamide 0.625mg/1.25mg tabletmild to moderate hypertension24/03/98
246Benazapril Hcl
5mg/10mg/20mg/20mg+Hydrochlorothiazide 6.25mg/12.5mg/12.5mg/25mg tablet
mild to moderate hypertension only21/05/98
247Flupenthixol dihydrochloride eq. to flupenthixol 0.5mg + Melitracen Hcl eq. to Melitracen 10mg sugar coated TabletIn the treatment of psychogenic depression depressive neureoses marked depression and psychotic
affections accompanied by by anxiety and apathy.
28/10/98
248Butafostane 10gm + Cyanocobalamine 0.005gm per 100ml Solutionfor veterinary04/03/98
249Amoxycillin 875mg + 125mg tabletsFor the treatment of mild to moderate bacterial lower respiratory tract infections in
adult patients
27/01/99
250Lidocaine 2%+Prilocaine 2.5% w/w creamAs a topical an aesthetic for use on normal intact skin for local anaesthesiaMay, 1999
251Bisoprolol Fumarate (2:1) 2.5mg/5mg+Hydrochlorthiazide-6.25mg/6.25
mg Tablet
mild to moderate hypertension13/05/99
252Combipack of 1 tablet of Fluconazole 150mg , 1 film coated tablet of Azithormycin dihydrate eq. to Azithromycin 1gm & 2 fillm caoted tablet of Secnidazole 1gm07/06/99
253Losartan Potassium 50mg+Hydrochlorothiazide 12.5mg film coated Tabletfor treatment of mild to moderate hypertension.08/06/99
254Ambroxol HCl 15mg+ Salbulamol 1mg +
Guaiphenesin 50mg+ Methol 1mg per 5 ml syrup
For the symptomatic relief of
bronchospasm in bronchial asthma & chronic bronchitis
16/06/99
255Combipack of 1 vial of Ifosfamide 1gm & Mesna 100mg/ml30/07/99
256Glutaraldehyde 15% +cocobenzyl dimethyl ammonium chloride10% + dye <0.1% + perfume 6% + soften water-0.5% per litrefor the control of diseases in animal premises24/08/99
257Alkyl dimethyl benzoyl ammonium chloride 5%+ Nonyl phenolethoxide 6%+Inert ingredient
89%
Disinfectant for cleaner for vet use23/08/99
258Fexofenadine 120mg+Psendoephedrine sulphate USP in ER form 180mg tabletAllergic and seasonal rhinitis only17/09/99
259Loratadine 10mg+Psendoephedrine sulphate in ER form 180mg film coated TabletAllergic and seasonal rhinitis only17/09/99
260Ciprofloxacin 0.3%w/v+ Dexomethasone 0.1% w/v eye dropsFor post operative steroid responsive inflammatory ocular conditions when bacterial ocular infections or a risk of bacterial ocular infections exists.29/09/99
261Fenbandazole(vet) 2.5%(w/w)/1.5%(w/w)
+Oxyclonazide (vet) 7.5%w/w/4.5%(w/w) per ml
in treatment of roundworms , lungworms, flukes in cattles & sheep
only
04/10/99
262Fenbandazole 175mg+Oxycloganide 525mg bolusin treatment of roundworms , lungworms, flukes in cattles & sheep
only
04/10/99
263Combikit of 2 enteric coated tablet of Pantoprazole 40mg ,2 film coated tablet of Amoxycillin 750mg & 2 film coated tablet of
Tinidazole 500mg.
15/10/99
264Ambroxol 30mg+Gnaiphenesin 100mg+Menthol 1mg+Psendoephedrine 60mg
per 5ml syrup
cough congestion29/10/99
265Lamivudine 150mg+Zidovudine 300 tabletsfor the treatment of HIV Infection26/11/99
266Amoxycillin 250mg+Clavulanic acid 150mg dispersible tabletAntibiotic23/12/99
267Combipack
Estradiol
for oral contraceptive in women only29/05/00
268Ciprofloxacin (0.3%)+Dexomethasone (0.1%) eye dropsFor post operative steroid responsive inflammatory ocular conditions when bacterial ocular infections or a risk of bacterial ocular infections exists.17/07/99
269Medronic acid 10 mg + Stannous chloride. 2H2O-1mg per vial injectionDiagnosis and study of priamary cancer metastatic bone lesion and other bone diseases. Paget's disease osteomylitis fractures23/02/99
270Diclofenac Sodium 1mg + Gentamycin Sodium 3mg per mlInflammation of the interior sagment of the eye when there is a risk of bacterial occular infection26/03/99
271Piperacillin sodium eq. to piperacillin 4gm/2gm
+ Tazobactum sodium 500mg/250mg per vial injection
In the treatment of lower RTI/UTI/intra abdominal infections, skin and skin structure infections, bacterial septicemia polymicrobic
infection
13/08/99
272Sodium valproate 333mg/133.5mg + Valproic acid 145mg/58.0mg corresponding to Sodium Valproate 500mg/200mg Film coated CR TabletsIndicated in the management of simple and complex absence seizures, myoclonic and generalised tonic-clonic
(grand-mal) seizures
23/08/99
273Conjugated Estrogens 0.625mg/0.625mg + MPA 2.5mg/5mg sugar coated tabletIndicated in women with an intact uterus to reduce the risk of endometrial and prevention an management of osteoporosis and vasomotor symptoms associated with estrogen defiency13/09/99
274Diptheria+Tetanus Toxoid + Pertussis vaccine adsorbed and Haemophilu b CRM 197 Conjugate vaccinefor active immunisation of children (2months -5 years) agaist Diptheria, tetanus Pertussis and haemophilus b
diseases
12/10/99
275Isoniazid 300mg+Ethambutol 800mg+Vitamin B6 10mg tabletanti TB drugs20/01/00
276Timolol maleate 5mg (as based)+Pilocarpine Hcl 20mg per ml opthalmic solutionfor reduction of intra ocular pressure in patients & ocular hypertension or open angle glaucoma25/01/00
277Combipack of 1 tab of Estradiol 2mg & 1 tab of Estradiol 2mg+ Dydrogestrone 10mgfor treatment of women intact uterus for the symptoms of estrogen deficiency as consequence of the menopause or after overectomy and for the prevention of post menopausal
osteoporosis
01/02/00
278Sulbactam Sod. Eq. Sulbactam 500mg+ Cefoperazone sodium Eq. Cefoperazone 500mg each vial injection (IV/IM)for treatment of RTI, UTI (lower & upper), Septicemia, Meningitis, Skin & Soft tissue infection, Endometritis, Other infection of genital tract, Intra abdominal infection bone & joint
infection.
16/03/00
279Fluticasone Propionate 500mcg/250mcg/100mcg + Salmeterol (as the xinofoate) 50mcg AccuhalerFor Regular treatment of Bronchial Asthma where use of a Bronchodilator and an inhaled corticosteroids are appropriate29/03/00
280Sodium Hyaluronate 30mg + Chodroitin Sulfate 40mg each ml opthalmic solutionas a surgical aid in anterior segment procedure including cataract extracter and intraoccular lans implatation04/04/00
281Sulbactam Sod. Eq. Sulbactam 1000mg
+ Cefoperazone sodium Eq. Cefoperazone 1000mg each vial injection (IV/IM) (Additional Strength)
for treatment of RTI, UTI (lower & upper), Septicemia, Meningitis, Skin & Soft tissue infection, Endometritis Other infection of genital tract, Intra abdominal infection bone & joint
infection
04/04/00
282Combipack of 7 blue tab of Desogestrel 0.025mg+ethinyl estradiol 0.04mg & 15 white tab of Desogestrel 0.125mg+ethiyl estradiol
0.03mg
for oral contraceptive in women only29/05/00
283Combipack of 1 tablet of Gestodene 60mcg+Ethinyl estradiol 15mcg & 24 tablets + 4 dummy tablets per packOral contraceptive for women.17/02/00
284Aminomix -2 Infusion Solution Solution A 500ml & 7 Solution B 500mlFor complete parenteral nutrition.04/07/00
285Fluorometholone USP 1mg+Gentamicin 3mg (as sulphate) per ml eye dropsThe infection of the anterior segment of the eye due to bacteria susceptible to gentamicin.28/07/00
286Ambroxol HCl 15mg+ Guaiphenesin 100mg+
Ethanol 95% eq to Ethanol 5% v/v per 5 ml oral liquid
for treatment of cough.18/08/00
287Combipack of one bottle of (1000ml) contains: Amino acid 7% w/v+glucose 10% with electroytes injectable filled upto 750ml & one bottle fat emulsion 20% w/v in 250mlshort term parenteral nutrition via peripheral route pre & post operative mitrition; nutrition in cancer patients, short bowel syndrome, inflammatory Bowel disease, Trasition period between IV, nutrition and normal food.28/08/00
288Soyabean oil USP 0.60gm+ Glycerol
Intravenous solution
Parenteral condition.28/08/00
289Mono basic Sodium Phosphate Monohydrate 276mg+Dibasic sodium Phosphate Heptahydrate 268mg per ml injectionPateint on parenteral nutrition, increased excrection and decreased absorption of phosphorus, 'X' linked familial hypophosphalaemia, decreased respiratory alkalosis, chronic alcoholism and patients of phosphate binding agents31/08/00
290Salmeterol Xinafoate eq. to Salmeterol 25mcg+Fluticasone propionate 50mcg/125mcg/250mcg per actuationfor regular treatment of brochial asthma where the use of a brochodilator and an inhaled
cortcosteroid are approproiate.
09/11/00
291Salbutamol sulphate eq. to Salbutamol 100mg +
+Ipratropium Bromide BP 200mcg inhaler
In the treatment of chronic obstrutive pulmonary disease06/03/00
292Sulperazone (Sulbactam Sodium) + Cefoperazone Sodium06/03/00
293Fluticasone Propionate
500mcg/250mcg/100mcg + Salmoterol (as the xinafoate) 50mcg/50mcg/50mcg inhalation
powder
For regular intreatment of bronchial asthma where the use of a bronchodialator and an inhalated
corticosteroid are appropriate
29/03/00
294Clottable protein 75-115mg + Trace of Fibronogen 70-110mg + Plasma Fibronectin 2- 9mg + Factor XIII 10-50 U2 + Plasminogen 40-120mcg + Aprotinin solution 300 KIU/ml3
per ml of reonstituted tissueol solution
For acheiving hemostasis to seal or glue tissues and to support wound healing30/05/00
295Combipack of FDC Gestodene 60mg + Ethinyl Estradiol 0.15mg & 4 Dummy TabletsOral contraceptive for women18/07/00
296DTP + Hepatitis b Vaccine (Multidose vial of 5 ml containing 10 doses.27/07/00
297Lopinavir80mg + Ritonavir 20mg per 5 ml oral solution, Lopinavir 133.3mg + Ritonavir 33.3
mg Capsule
For the treatment of HIV infection in combination with other anti-retroviral
agents
18/01/01
298Multi Organ Preservative Solution Component A: (1000ml/2000ml/4000ml) Each 100ml contains : Glucose anhydrous 3.57gms component B: (20ml/40ml/80ml) Supplementary Electrolyte Solution : Potassium. Dihydrogen Phosphate 10.76gm+ Pot. Mono Hydrogen Phosphate 37.74gm + KCL-5.7 gm +Sodium Bicarbonate IP 4.3 g + Hydrochloric acid ( to adjust pH)31/01/01
299Irbesartan 150mg/300mg+ Hydrochlothiazide- 12.5mg/ 12.5mg tabletfor mild to moderate hypertension31/01/01
300Amino acid 5% w/v IV Infusion with & without electrolytesfor perenteral nutrition in patients with protein depletion condition07/02/01
301Ipratropium Bromide 500mcg+Salbutamol sulphate eq. to Salbutamol 2.5mg per 2.5 ml
respiratory solution
for Bronchospasm in patients suffering from chronic pulmonary
disorders
03/04/01
302Levonorgestrel 0.25mg+Ethinyl Estradiol 0.05mg tabletsfor emergency contraception in women only till such time the never option like Levonorgestrel (0.75mg) in available in market.07/06/01
303Cefoperazone sod. Eq. to Cefoperazone 1g/2g+ Sulbactum Sod. Eq. to Sulbactum 0.5g/1g each vial Injectionfor specific subset of patients (immuno compromised febrile neutropenic cancer patients)12/06/01
304Salmeterol (as Xinofoate) 25mcg/25mcg/25mcg+Fluticasone Propionate
BP 50mcg/125mcg/250mcg per actuation Inhaler
Bronchial asthma where use of cronchodilator & an inhaled corticosteroide are appropriate.05/07/01
305Intravenous Fat Emulsion with Medium chain triglyceride Solution (10%) : Soyabean Oil USP 5gm+ Medium chain triglycries BP 5gm+ Egg lecithin 1.20g+Glyccerol IP 2.50gm+ water for injection q.s. per 100ml solutionfor patients requireing parental nutrition in enrgy deplition as well as essential fatty acid deficiency states11/07/01
306Intravenous Fat Emulsion with Medium chain triglyceride Solution (20%) : Soyabean Oil USP 10gm+ Medium chain triglycries BP 10gm+Egg lecithin 1.20gm+Glyccerol IP 2.50gm+ water for injection q.s. per 100ml solutionfor patients requireing parental nutrition in enrgy deplition as well as essential fatty acid deficiency states11/07/01
307Stavudine 30mg/40mg + Lamivudine 150 mg
/150mg+ Neviramine 200mg/200mg tablet
HIV infection in adult patoients . Once patients have been stablised on the maintenance regimen of Neviramine
200 mg BD and have demonstrated adequate tolrability to Neviramine.
26/07/01
308Formoteral Fumarate 6mcg/6mcg + Budesonide
B.P. 100/200mg Capsule Inhaler
Asthma where use of combination of inhaled regular conticestiroid & long acting β-agonist is appropriate17/08/01
309Ambroxol (as Hcl) S.R. 7.5mg+ Doxycyline Hcl 100mg tabletacute and chronic illness of RT with pathological inspiration of mucous ( In case of acute attecks of chronic branchitis, inflammation of the paranasal sinuses). Caused by doxycyline sensitive actiological agents23/08/01
310Ambroxol Hcl 30mg+ Guaiphenesin 200mg
tablet
for cough & congestion10/09/01
311Triple Chamber bags for peritoneal dialysis solution :Compartment A)[ 61 ml] Dextrose IP eq. to dextrose anhydrous 453.0gm+Nacl IP 5.67gm water for injection q.s. each 1000ml Compartment B) [104 ml]Dextrose IP eq. to dextrose anhydrous 453.0gm+Nacl IP 5.67gm water for injection q.s. Compartment C) [1969ml] Nacl IP 5.67gm+CaCl 2 IP 0.279gm+MgCl2 IP 0.165gm+Sodium lactate solution BP eq. to sodium lactate 4.259 gm water for injection, each 1000 ml water for
injection q.s.
for peritoneal dialysis25/09/01
312Rosiglitazone maleate eq. to Rosiglitazone 2 mg+Metformin IP 500mg tabletPatients with type 2 diabeties mellitus when dist exercise and the single agent do not result Rosiglitazone 2mg in adequate glycemic control11/10/01
313β-Carotene (30% dispension) 15mg (eq. to vit. A 7500 I.U)+ Vit. E acetate-25mg+Vit. C- 100mg+Pyridoxine HCL (Vit. B6) 1.5mg+ Cyanocobalamin (vit. B12) 5mcg+ Folic acid- 400mcg+Zinc as Zno-15mg+Selenium as SeO2 100mg+copper (element) as CuSO4 1mg Capsule10/10/01
314Loperamide
tablet
for control of acute diarrhoea in adults
only
16/10/01
315Combikit of 10 ml of Oxymetazoline 0.05% & 15 ml of NaCl solution 2%symptomatic relief of nasal mucosal congestion & adjective therapy of middle ear infection associated with acute/chronic rhinitis, common cold,
sinusitis.
12/10/01
316Sodium Picosulphate 5mg+liquid Paraffin 4.8ml liquid paraffin per 15ml solutionfor constipation in adults.09/11/01
317Formotorol fumarate-6mcg/6mcg+Budesonide 100mcg/200mcg per actuationpersistent asthma where use of a combination of inhaled corticosteroids therapy long acting β-agonist has been found to be appropriate.19/11/01
318Ritonavir 33.3mg + Lopenavir 133.3mg soft gelatin capsuleIn the treatment of HIV infection in
combination with other retroviral agents
18/01/01
319Ritonavir 20mg + Lopenavir 80 per ml oral solutionIn the treatment of HIV infection in
combination with other retroviral agents
18/01/01
320Pyrantel embonate 14.4mg + Febental 15mg per ml suspension for Veternary usefor the treatment of infestation caused by round worms, ascarids, hook
worms, whip worm in puppies young dogs
23/04/01
321Meglunine Ioxaglate sodium + Sodium Ioxaglate injectionUrography, angiography, anthrography, G.I. examinaiton, hystosalpingography, sialography16/08/01
322Candesartan Cilexetil-
16mg+Hydrochlorothiazide-12.5mg tablet
Essential hypertension (not for intial therapy)03/01/02
323Mosapride Citrate dihydrate eq. to Mosapride cotrate-5mg+MPS (Methyl Polysiloxane 125mg chewable tabletsGastro esophageal reflux disorders GI sysmtoms (hurt burn voimating) associated with chronic gastritis30/01/02
324Mometasone furoate 0.1% w/w+Terbinafine Hcl 1% w/w CreamTopical fungal infection associated with inflammation & Pruritus.16/01/02
325Combikit of 1 tablet of Pioglitazone HCl eq. to Pioglitazone-15mg & 2 Tablet of Metformin HCl 500mgPatients with type II diabetes mallitus when diet, exercise & the single agent do not result in adequate glyceanic
control
18/02/02
326Rosiglitazone 4mg+Metformin 500mg tabletPatients with type 2 diabeties mellitus when dist exercise and the single agent do not result Rosiglitazone 2mg in adequate glycemic control21/02/02
327Formoterol fumarate 6mcg+Budesonide- 400mcg capsuleAsthma where use of combination of inhaled regular conticestiroid & long acting β-agonist is appropriate07/03/02
328Butenafine HCl 10mg+ Betamethasone Dipropionate eq. to Betamethasone 0.5mg
cream
Superficial fungal infections dermatophytis infections15/03/02
329Amlodipine (as besylate)- 2.5mg/5mg+Benazepril-10mg/20mg capsulehypertension22/03/02
330Heparin Sodium 2 units + Sodium Chloride 9mg per mlAs an aid in the maintenance of cather cannule potency.26/03/02
331Nitroglycerine-10/20/40mg+Dextrose Hydrous 5gm Injectionfor treatment of perioperative hypertension for control of congestive heart failure in setling of acute MI, angina Bectoris in patients who have not responeded to sublingual mitroglycerine and β-blokers for intra operative hypertension02/04/02
332Dopamine HCl-80/160/320mg+Dextrose hydrous-5gm each 100ml contains injectionfor the correction of hemodtnamic inbalances percent in the shock syndrom due to myocardial infractions trauna. Endotoxic speticomia open heart surgery, renal failure & chronic cardiac decompensation as in congestive failure.02/04/02
333Linezolid 2mg+Dextrose-5% per ml injectioncomplicated/uncomplicated skin & skin structure infections/community acquired pneumonia.01/04/02
334Sodium Pyrolidone Carboxylic acid 2.5% w/w+ Sodium Lactate solu. Eq. to Sodium Lactate 2.5% w/w+Vit. E 1% w/w+ Olive Oil 3% w/w
cream
drug scaly condition associated with atopy, hyperkeratosis & other Eczemas15/04/02
335Formotnol fumarate 6mcg+ Budesonide BP 400mcg per actuation inhaler MDI/DPIasthma where use of combination of inhaled regular cortico stuoid is long acting β-agonist is atopropriate23/04/02
336Coumaphos 3% + Propoxur 2% + Sulphanilamide 5% powder for vetfor use as a larvicidal bacterostatic
wound dressing in catle, sheep, pigs and horses
23/04/02
337L- Isoleucine 0.335gm+ L-Lencine 0.500gm+L-Valine 0.380gm+L- Lysine 0.550gm+ L-Methionine 0.120gm+ L- Pnenylalanine 0.210gm+ L-Threomine 0.185gm+ L-Tryptophan 0.100 + L-Ariginine 0.420gm+ L-Histidine 0.190gm+L-Alanine 0.400gm+L-aspartic acid 0.300gm+L-Lystine 0.095gm+L-Glutanic acid 0.500gm+Amino acetic acid IP 0.200gm+L-proline 0.150gm+L- serine 0.200gm+L-Tyrosine 0.45gm+L- ornithine Hcl 0.144gm+Taurine 0.030gm per
100 ml injection
for prophylaxis and therapeutic treatment of protein depletion in childern where oral/enteral nutrition is impossible/impracticable23/04/02
338Sucralfate 0.07gm+Metronidazole 0.01gm
cream
Bedsore, Haemorrhoids, fistulac &
fissures.
29/04/02
339Glycopyrrolate-500mcg+ Neostigmine Methyl sulfate-2500mcg per 5 ml injectionreversal of residual non-deporarising competitive nemomuscula block11/04/02
340Betamethasone Diprop 0.064%+ Salicylic acid- 3% each ml lotionfor treatment of Keratosis, ichthylsis lichen planus & dru scaly conditions of
skin.
14/05/02
341Isosorbid-mononitrate (SR pellets) 60mg+Aspirin 75mg CapsuleFor prophylaxis of angina and prevention of Myocardial infarction.16/07/02
342Mefenamic acid 500mg+Tizanidine 2mg12/07/02
343Latanoprost 50mcg+ Timolol maleate eq. to Timolol 50mg each ml eye dropsreduction of intra ocular pressure in patients with open angle glaucoma & ocular hypertension.02/08/02
344Sodium Ferric Gluconate complex with sucrose eq. to elemental iron 6.25mg (12.5mg/ml)treatment of iron deficiency anemia in patients under-going chronic hemodialysis who are receiving supplemental crythropoitin therapy.05/09/02
345Tobramycin sulphate eq. to Tobramycin 3mg+ Flurometholone 1mg per ml Opthalmic suspensionSTEROID RESPONSIVE INFLAMMATORY OCULAR CONDITIONS FOR WHICH A CORTICISTUOID IS INDICATED & WHERE SUPERFICIAL OCULAR BACTERIAL INFECTION EXISTS.12/09/02
346Rosiglitazone maleate eq.to Rosiglitazone- 2mg/4mg+ Metformin HCl (SR) 500mg /500mg Tablettreatment of patients with type-II diabetes where diets exercise and the single agent do not result in adequate
glycemic control.
11/09/02
347Betamethasone Diprop. 0.064mg + Gentamycin Sulphate Eq to Gentamycin 1mg per ml suspension Lotiontreatment of infectent dermatoses infection eczema & contact dermatitis topical.25/09/02
348Combipack of 2 capsule of Omeprazole 20mg , 2 Tablets of Clarithromycin 500mg & 4 capsule of Amoxycillin 500mg.for eradication of H.Pylori in patients with active chronic gastritis, gastric ulcer & duodenal ulcer.01/10/02
349S(-) Amlodipine-2.5mg/2.5mg +Atenolol
25/50mg tablet
mild to moderate hypertension17/10/02
350S(-) Amlodipine-2.5mg/2.5mg +Losartan Potasium 25mg/50mg tabletmild to moderate hypertension17/10/02
351S(-) Amlodipine 5.0mg +Losartan Potasium
50mg tablet
mild to moderate hypertension17/04/03
352Gadoteric acid 27.932gm+ Meglunine 9.76gm each 100ml for I.V. Inj.magnetic imaging diagnostics investigation including MR
angiograply.
23/10/02
353Pioglitazone HCl eq. to Pioglitazone 15mg/15mg+ Glimepiride 1mg/2mg tablettreatment of type-II diabetes as 2nd line therapy when diet, exercise & initial therapy with glitazone or urea donot results in adequate glycemic
control.
25/10/02
354Pioglitazone 15mg+Metformin 500mg (O.D.)
tablets
For second line therapy in type-II
diabetes
18/10/02
355Glimepiride1mg/2mg + Metformin Hcl I.P.500mg/500mg in SR form tabletfor patients with type diabetes mellitus when diet exercise & the agent do not result in adequate glycemic control.13/11/02
356Bioceramic composite materials: a) Each glass vial contains; Hydroxyapatite 100% granules b) each glass contains: hydroxyapatite 90% granules +β tri clacium phosphate 10% granules
c) Each vial contains: Hydroxyapatite paste as 30% and 18% suspension
for acute cases of bone deformities only as bone grafting material.22/11/02
357Rosiglitazone maleate eq. to Rosiglitazone 2mg+Glimepiride 1mg tabletType II diabetes Mellitus where diet, exercise and single agent do not result in adequate glycemic control.14/11/02
358Each gm contains:-
Capae Extract 0.1 gm+ Heparin Sodium I.P 50 IU + Allantoin B.P 0.01gm Gel
Hypertropic kelodial scars, movement restricting and cosmetically disfiguning scars after operations amputatruos, burns and accidents and framatic tedon contractum cicatricial
strictures
15/03/02
359Combikit of 1 capsule of Glucosamine Sulphate 500mg & Chondroitin Sulphate capsule 400mgfor supportive treatment of osteoarthritis in adults30/09/02
360Aremther 20mg + Lumefantrine 120mg tabletFor the treatment of P. Falcipharum malaria cases resistant to both chloroquine and sulphadoxine
pyrimethamine combination
26/12/02
361Glycapyrrolate 500mcg + Neostigmine 2500 mcg per 5 ml injection04/11/02
362Aspirin 150mg + ISMN 60mg SR TabletsFor prophylaxis of angina and prevention of Myocardial infarction.07/11/02
363Glimepiride 1mg/2mg + Metformin 500mg SR TabletFor the treatment of patients with Type II diabetes mellitus, when diet, exercise and single agent do not result in adequate glycemic contrl.13/11/02
364Aspirin 75mg/75mg + Clopidogrel 150mg/150mg TabletFor the treatment of angina, myocardial infarction and stroke26/11/02
365Clopedogrel bisulphate eq. to Clopidogrel 75mg + Aspirin IP (as enteric coated tablets) 75mg/150mg capsulesFor the treatment of angina, myocardial infarction and stroke.27/11/02
366Each 5ml contains Codeine Phosphate 10mg + Triprolidine HCl 1.25mg syrupFor symptomatic treatment of dry cough18/02/03
367Cefpodoxime 100mg + Ofloxacin 100mg Dispersible Tablet (Additional Dosage form)For the Treatment of Lower and upper respiratory tract infection and Typhoid fever in adults only29/11/12
368Each gm of ointment contains
Mometasone Furoate 0.1% + Salicylic Acid 5 % ointment
In treatment of plaque Psoriasis24/12/02
369S(-)Amlodipine 2.5mg + Ramipril 2.5mg Tabletfor treatment of essential hypertension02/10/03
370S(-) Amlodipine 2.5mg/5mg + Atenolol
8mg/8mg Tablet
09/07/03
371Nadifloxacin 10mg + Miconazole 20mg creamFor mixed infection of skin09/03/03
372Formoterol 4.5mcg/4.5mcg + Budesonide 80/160 mcg InhalerAsthma where use of combination of inhaled regular conticestiroid & long acting β-agonist is appropriate16/10/03
373Lercanidipine 10mg + Atenolol 50mg Tablet17/10/03
374Metronidazole 10mg + Benzocaine 200mg Gel09/11/03
375Fexofenadine 60mg + Pseudoephedrine120mg CR CapsuleAllergic and seasonal rhinitis only17/12/03
376Metformin 500mg CR + Glipizide 5mg CR
Tablet
17/12/03
377Tramadol HCl 37.5mg+Paracetamol 325mg tabletfor short term (five days or less) management of acute pain in adults.09/01/03
378Ramipril 2.5mg+S(-) Amlodipine Besylate eq. to S(-) Amlodipine 2.5mg tablet and capsulefor treatment of essential hypertension11/02/03
379Olanzapine 5mg/10mg+ Fluoxetine HCl eq. to Fluoxetine 20mg/20mg tabletfor treatment of resistant depression only.18/02/03
380Ciprofloxacin HCl eq. to Ciprofloxacin 500mg+ Ornidazole 500mg film coated tabletfor treatment of diarrhoea of mixed infection in adults patients only.03/02/03
381Quinapril HCl eq. to Quinapril 10mg/20mg, Hydrochorothiazide 12.5mg/12.5mg film coated
tablet
for treatment of mild to moderate hypertension10/02/03
382Aspirin 25mg+ Dipyridamole BP 200mg (ER) capsuleFor reduction of the risk of stroke in patients who had transient ischmia of the brain of completed ischemic strok
due to thrombosis.
27/02/03
383combipack of 28 Tablets of Cyproteron acetate 2mg & 7 Tablets of Ethinyl Estradiol 0.035mg.Androgen dependent disease in women
such as acne, alopecia & mild of hirsution
20/02/03
384Pioglitazone HCl eq. to Pioglitazone 30mg/30mg+ Glimepiride 1mg/2mg uncoated tablet (additional strength)treatment of type-II diabetes as 2nd line therapy when diet, exercise & initial therapy with glitazone or urea donot results in adequate glycemic
control.
13/03/03
385S(-) Amlodipine 2.5mg+Lisinopril 5mg tabletfor treatment of mild to moderate hypertension.10/03/03
386Valsartan 80mg/160mg/160mg+HCTZ 12.5mg/12.5mg/25mg tabletfor treatment of mild to moderate hypertension.18/03/03
387S (-) Amlodipine 2.5mg/5mg+Atenolol 50mg/50mg tabletfor treatment of essential hypertension & angina Pectoris.25/03/03
388Montelukast Sod. Eq. to Montelukast 10mg/10mg+ Bambuterol HCl BP 10mg/20mg
film coated tablet
for treatment of chronic asthma10/04/03
389Montelukast Sod. Eq. to Montelukast 5mg/5mg+ Bambuterol HCl BP 5mg/10mg film
coated tablet
for treatment of chronic asthma04/06/03
390Adapalene1mg +Clindamycin Phosphate eq. to Clindamycin 10mg per gram Gelfor treatment of acne vulgaris.01/05/03
391Rosiglitazone 2mg/4mg+Metformin SR 1000mg/1000mg tabletfor the treatment of patients with type- 2 Diabetes Mellitus single agent do not result inadequate glycaemic control20/05/03
392S(-) Amlodipine 5mg+Atenolol 50mg tabletFor the treatmen of essential hypertension & Angina Pectoris09/07/03
393Telmisartan 40mg/80mg+ Hydrochlorthiazide 12.5mg/12.5mg tabletfor treatment of hypertension as 2nd line therapy.29/08/03
394Ramipril BP 2.5mg/5mg+Candesartan cilexatil eq. to candesartan 8mg/8mg bilayer tabletfor mild to moderate essential
hypertension and congestive Heart failure (CHF)
01/08/03
395Prednisolone10mg + Ofloxacin 3mg per ml eye
drop
04/07/03
396Metromidazile (as benzoate) 10mg+Benzocaine 200mg per gram topical gelfor treatment of gingivitis.01/09/03
397Losarten 50mg/50mg + Ramipril 2.5mg/5.0mg
tabs
mild to moderate hypertension10/09/03
398Lamivudine150mg+ Zidovudine 300mg+Abacavir as sulphate 300mg tabletAlone or in combination with other antiretro virl agents for treatment for HIV-1 infection.03/10/03
399Nadifloxacin 10mg+Clobetasol propionate 500mcg each gram gel & creamfor treatment of skin associated with bacterial infection including contact dermatitis, seborrlocal dermatitis an infective eczema.06/10/03
400Formoterol fumarate 4mcg/6mcg+Budesonide- 80mcg/160mcgAsthma where use of combination of inhaled regular conticestiroid & long acting β-agonist is appropriate16/10/03
401Valsarten 80mg + S(-) Amlodipine (as besylate) 2.5mg capsulefor treatment of hypertension01/11/03
402Combipack (Triple chambered bag) of amino
acid+electrolytes; Dextrose 15% / 30% IV fat emulsion
01/11/03
403Glimeperide 1mg+Rosiglitazone 4mgFor the treatment of type-II NIDDH12/12/03
404Sterile Cefotaxime sodium USP eq. to Cefotaxime 500mg/1000mg+Sterile Sulbactam 250mg/500mg per vial injectionfor the treatment of lower respiratory tract injection and genito urinary tract infection.26/12/03
405Imipenem (as anhydrous) 250mg /500mg + Cilastatin Sodium eq. Cilastatin 250mg/500mg per vialfor the treatment of Seriuos lower respiratory /UTI, Intraabdominal , bone and joint infections, endocarditis and bacterial septicemia25/07/03
406Raubasine 10mg+ Almitrine 30mg film coated tabletFor the corrective treatment of systoms due to abnormal mental deficiency and age related hypoxia in elderly patients11/08/03
407Ramipril 2.5mg/5mg + Losartan Potassium 50mg/50mg tabletMild to moderate hypertension12/09/03
408Gemcitabine in combine with cisplatinfor additional indication
409Natiglinide 60mg/120mg + Metformin HCl 500mg/500mg (SR) tabletIn patients with type-II diabetes in adequately controlled by diet, exercise and maximally tolerated dose of Metformin alone08/01/04
410Lopinavir+Ritonavir16/01/04
411S(-) Alenolol 25mg+Hydrochlorthiazide 12.5mg
tablets
For the treatment of hypertension only16/01/04
412Desloratadine 2.5mg/5mg+ Pseudoephodrine (SR) 120mg/180mg tabletFor the treatment of seasonal allergic rhinitis in adults.01/01/04
413Levocetirizine HCl 2.5mg/5mg+ Pseudoephodrine HCl SR 120mg/120mg tabletfor the treatment of seasonal allergic rhinitis.29/01/04
414Amlodipine Besylate eq.to Amlodipine 5mg + Atorvastatin calcium eq. to Atorvastatin 10mg each tabletsFor the treatment of co-existing essential hypertension and hyperlipidacmia11/02/04
415S(-) Amlodipine Besylate eq. to S(-)
Amlodipine-2.5mg+Atorvastatin cal eq. to Atorvastatin 10mg tablet
For the treatment of co-existing
essential hypertension and hyper lipidaemia in adults.
10/02/04
416Zidovudine 600mg ER + Lamivudine 300mg
ER
for the treatment of HIV.01/03/04
417Elemental iron (as carbonyl modified release) 45mg+Folic acid 1.5mg+ vitamin B12-15mcg film coated tabletFor the treatment of nutritromal of deficiency anemia in adults only.19/04/04
418Esomeprazole Magnesium eq. to Esomeprazole 20mg/40mg (as enteric coated pellets)+Domperidone maleate BP Eq. to Domperidone 30mg/30mg SR Capsulesfor the treatment of adult patients with gastro esophlgal reflux disease (GERD) not responding to esomeprazole alone.01/06/04
419Aceclofenac 100mg+Paracetamol 500mg tabletsfor acute painful, conditions in adults
only
08/07/04
420Rabeprazole 20mg+Mosapride 15mg SR tabletFor the treatment of GERD not
responding adequately to rabeprazole alone
27/07/04
421Atorvastin 10mg/20mg+ Ezatimib 10mg/10mg tabletFor the treatment of patients with primary hypercholesterolemia13/08/04
422Buprenorphine HCl eq. to Buprenorphine 2mg+Naloxone Hcl eq.to Naloxone 0.5mg sublingnal tabletsFor opioid dependence01/08/04
423Sucralfate 0.07gm+ Metronidazole 0.01gm+ Lignocaine 0.04gm per gram creamfor the treatment of Bedsore,
laemorohoids, fistutae and oral fischers.
23/08/04
424Combi kit of 5 tablets each I) Pseudoephedrine HCl 120mg ER+Cetirizine HCl 5.0mg (orange tablet) & II) Pseudoephedrine Hcl ER 120mg
+Tripolidine2.5mg (Blue tablets)
for the treatment of symptometic relief of allergic rhinitis in adults only.01/08/04
425Glibenclamide 2.5mg/5mg+Metformin 500mg/500mg SR tabletnon insulin dependent diabites mallitus patients poorly controled with sulphonyluren or biguanide alone20/08/04
426Escitalopram (as oxalate) 10mg + Clonazepam 0.5mg Tabletfor treatment of patients with comorbid depression and anxiety
disorders
31/08/04
427Dorzolamide 2% + Timolol 0.5% eye dropsFor reduction of elevated intra ocular pressure in patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to beta
blockers
28/08/04
428S(-)Amlodipine 2.5mg + Nebivolol 5mg TabletsFor the treatment of essential
hypertension
13/09/04
429Combikit of 1 tablet of Efavirenz 600mg , 1 tablet of Lamivudine 300mg & 1 capsule of Didavosine (250 mg/400mg) (delayed Release)for the treatment of HIV infection.20/09/04
430Peracetic Acid (NLT 4.5% ) +
Peroxide (NLT 24%) Disinfectant livestock species.
Disinfectant for the livestock species.01/09/04
431FDC of Amlodipine (5mg/10 Atorvastatin (10/20/40 mg) TabletFor co-existing hypertension & hyperlipidemia20/10/04
432Conjugated Estrogens 0.3/0.45mg + Medroxy Progesterone Acetate 1.5/1.5mg Tablets26/10/04
433Amlodipine 5 mg + Ramipril 2.5mg capsulefor treatment of essential hypertension04/10/04
434Atorvastatin 10mg/20mg Ezetimibe10mg/10mg tabletFor the treatment of patients with primary hypercholesterolemia08/11/04
435Combikit of 2 tablets of Stavudine 30mg/40mg
+ Lamuvidine 150mg/150mg & 1 tablets of Nevirapine 200mg.
for HIV infection is adults who have been stablised on the maintenance regimen of Nevirapine 200mg BD and have demonstrated adequate tolability to Nevirapine22/11/04
436Gatifloxacin sesquihydroate eq. Gatifloxacin
400mg + Ambroxol HCl SR 75mg film coated bilayered Tablet
for the treatment of respiratory tract
infection by susceptible organism in adults.
24/12/04
437Nabivolol Hcl eq. Nabivolol 5 mg + HCTZ 12.5mg Tabletsfor the treatment hypertension23/12/04
438Atorvastatin Calcium eq. Atorvastatin 10 mg + Fenofibrate (micronised) 160mg film coated tabletsfor the treatment of combined hyperlipidaemia in patients with normal hepatic and renal function24/12/04
439Tranexamic Acid 250mg + Ethamsylate 250mg film coated Tabletfor the treatment of abnormal blood loss due to menorrhagia, local fibronolysis and intraoperative /post
operative hemorrhage
29/12/04
440Lovastatin 20mg + Niacin 500mg ER form film coated Tabletsfor the treatment of primary hyperlipidmia anad mixed dyslipidimia in patients treated with i) lovastatin who require furtherlowering or HDL raising or ii) with niacin who require further LDL lowering. It is not indicated for initial therapy.24/12/04
441Pantoprazole Sodium sesquihydrate eq. Pantoprazole 40 mg/40mg + Domperidone 20mg/20mg( 10 mg IR+ 10mg SR) Capsulefor the tretment of GERD not responding to pentoprazole24/12/04
442S (-) Amlodipine besilate Eq.
Amlodipine 2.5mg/5mg + 12.5mg/12.5mg tablet
Mild to moferate hypertension15/04/04
443Valdecoxib 20mg + Paracetamol 500mg TabletFor the treatment of acute pain in adults only20/09/04
444Nateglinide 60/120 mg + Metformin500mg/500mg SR Tablet01/08/04
445Tamsulosin 0.4mg + Finastride 5mg MR CapsuleFor the treatment of signs and symptoms of Benign Prostatic
Hyperplasia (BPH)
17/03/04
446Clindamycin 1% + Benzoyl peroxide 5% creamFor topical treatment of inflammatory acne vulgaris10/09/04
447Tiotropium Br 18mcg + Formoterol 12mcg
Rotacap
For treatment of COPD22/04/04
448Tiotropium Br 9mcg + Femoterol 12mcg
Inhaler
For treatment of COPD26/04/04
449Pioglotazone 15mg/30mg + Metformin500mg/500mg ER TabletFor second line therapy in type-II diabetes26/04/04
450Gatifloxacin 3mg+ Dexamethasone 1mg Eye DropFor post operative steroid responsive inflammatory ocular conditions when bacterial ocular infections or a risk of bacterial ocular infections exists.18/06/04
451Rabeprazole 20mg + Domperidone 30mg SR CapsuleFor the treatment of GERD not
responding adequately to rabeprazole alone
10/08/04
452Tiotropium Bromide Monohydrate Eq. to Tiotropium 18mcg+Formoterol Fumarate 12mcg dry powder inhalerFor the treatment of Chronic Obstructive Pulmonary Disease (COPD).22/11/04
453Nebivolol 5mg + HCTZ 12.5mg tabletsfor the treatment of essential
hypertension
23/12/04
454Tiotropium Bromide monohydrate Eq. to Tiotropium 9mcg + Formoterol Fumarate dehydrate eq. to Formoterol Fumarate 6mcg meter dose inhalerFor the treatment of Chronic Obstructive Pulmonary Disease (COPD).24/12/04
455Tranexamic Acid 25mg/50mg + Ethamsylate 12.5mg/12.5mg TabletFor the treatment of hypertension only13/01/05
456Ezetimibe 10mg/10mg + Simvastatin 10mg/20mg FC TabletFor the treatment of patients with primary hypercholesterolemia05/11/05
457Omeprazole 20mg (EC) + Domperidone 10mg CapsuleFor the treatment of GERD not responding to omeprazole alone07/05/05
458Lamivudine 300mg + Abacavir 600mg TabletsFor the treatment of HIV infection in
adults
06/07/05
459Lamivudine 150mg + Stavudine 40mg + Efavirenz 600mg Combikit TabletFor the treatment of HIV infection in adults06/08/05
460Lamivudine 150mg + Zidovudine 300mg + Efavirenz 600mg CombipackFor the treatment of HIV infection in adults06/08/05
461Losartan 50mg + Atenolol 50mgFor the treatment of systemic essential hypertension in adults only27/06/05
462Ceftriaxone 0.125/0.25/0.5/1g + Tazobactam 15.625/31.25/62.5/125mg injectionFor the treatment of patients with community acquired pneumonia and lower respiratory tract+E408 infections21/07/05
463Atorvaststin 10mg + Nicotinic Acid 375mg/500mg (ER) TabletsFor the treatment of patients with primary hypercholesterolemia and mixed dyslipidemia when response to single drug is inadequate28/07/05
464Stavudine 6mg/12mg + Lamivudine 30mg/60mg Dispersible TabletFor the treatment of HIV infection in children08/05/05
465Calcipotriol 50mcg + Betamethasone 0.5mg
Ointment
For the treatment of psoriasis vulgaris16/08/05
466Methylcobalamin 1500mcg (ER) + Pyridoxine 20mg IR + Folic Acid 5mg tabletsFor the management of hyperhomocysteinemia19/09/05
467S(-)Metoprolol 25/50mg (ER) + HCTZ 12.5mg/12.5mg (IR) TabletsFor the treatment of mild to moderate hypertension in adults11/11/05
468Stavudine 10mg + Lamivudine 40mg + Nevirapine 70mg Dispersible TabletFor the treatment of HIV Infection11/11/05
469Centbucridine (0.5%) + Feracrylem (3%) GelFor hemorrhoid & anal fissure01/11/05
470Atenolol (25mg, 50mg) + HCTZ (12.5mg, 12.5 mg ) TabletAnti-Hypertensive13/01/05
471Ofloxacin (200mg) + Ornidazole (500mg)
Tablets
For diarrhea of mixed infection20/01/05
472Lamivudine (40mg) +Nevirapine (70mg +Stavudine (10mg) per 5ml powder
for suspension
Anti-HIV.28/01/05
473Etonogestrel (11.7mg) + Ethinylestradiol (2.7mg) Contraceptive ringsFor Contraceptive in women15/02/05
474Metaxalone (400mg) + Diclofenac Potassium (50mg) tabletFor acute painful musculoskeletal condition in adult22/02/05
475Tranexamic Acid (500mg) + Mefenamic acid (250mg) tabletFor primary dysmenorrhoea and pain associated with menorrhagia in women22/02/05
476Fluconazole (2%) + Zinc Pyrethione (1%) suspensionFor seborrhoic dermatitis22/02/05
477Desloratadine (2.5mg) + Ambroxol (30mg)
+Guiphenasine (50mg) + Menthol 1mg/5ml Syrup
For productive cough03/02/05
478Omeprazole (20mg) Enteric coated + Domperidone (30mg) (S.R.) capsuleFor GERD not responding to Omeprazole.03/10/05
479Tazarotene (1mg) +Mometasone Furoate (1mg) per gram creamFor plaque psoriasis04/01/05
480Pioglitazone Hydrochloride Eq. to Pioglitazone 15mg/30mg + Metformin HCl IP 500mg (ER) tabletsSecond line therapy on type-II diabetes.25/02/05
481Buprenorphine (0.4mg) + Naloxone (0.1mg) sublingual tabletFor opioid dependence04/06/05
482Lamivudine (40mg) +Stavudine (10mg) per 5ml) reconstituted solutionFor HIV infection04/08/05
483S(-) Metoprolol Succinate S.R. tablets
(equivalent to S(-) Metoprolol Tartrate 12.5mg/25mg/50mg)
For Hypertension15/04/05
484Gliclazide M.R. (30mg/60mg/ 80mg)+Metformin HCl (500mg/500mg/500mg)
ER Tablet
For type-II diabetes27/04/05
485Drosperinone (3mg) + Ethinylestradiol
(0.035mg tablet)
Oral Contraceptive05/11/05
486Simvastatin (10/20mg) + Ezetimibe (10mg/10mg) TabletsFor primary Hypercholesterolemia05/11/05
487Ramipril (5mg) + Telmisartan (40mg) tabletFor Hypertension05/11/05
488Tazarotene (0.05%) + Mometasone Furoate (0.1%) Cream (addl.strength)For Plaque psoriasis24/05/05
489Gatifloxacin (200mg) +Ornidazole (500mg)
tablet
For diarrhoea of mixed infection in
adults
06/06/05
490Combikit of 2 tablet of Stavudine (40mg) + Lamivudine (150mg) each & 1 tablet of Efavirenz (600mg)For HIV infection in adults06/07/05
491Combikit of 2 tablet of Lamivudine (150mg) + Zidovudine (300mg) each and 1 tablet of Egavirenz (600mg)For HIV infection in adults06/07/05
492Aceclofenac gel 1.5% alongwith linseed oil, menthol, Salicylate, Capsaicin gelFor pain, swelling etc06/08/05
493Lamivudine 30/60mg + Stavudine 6mg/12mg + Nevirapine 50mg/100mg dispersible tabletFor pediatric patients with HIV infection14/06/05
494Nitazoxanide (500mg) + Ofloxacin (200mg)
Tablet
For urogenital infection in adults.30/06/05
495FDC of Papain + Urea OintmentFor debriment of necrotic tissues.07/11/05
496FDC of Amlodipine (5mg/5mg) + Bisoprolol (2.5mg/5mg) tabletAnti-hypertension21/07/05
497FDC of Ceftriaxone (500mg/1000mg) + Tazobactum (62.5mg/125mg) InjectionAnti-bacterial21/07/05
498Levodopa (50mg/100mg/150mg) + Carbidopa (12.5mg/25mg/37.5mg + Entacapone (200mg)For Parkinson’s disease25/07/05
tablet
499FDC of Atorvastatin (10mg) + Niacin (375mg/500mg E.R) CapsuleFor Hypercholesterolemia26/07/05
500FDC of Levocetirizine (5mg) + Ambroxol (75mg S.R) CapsuleAnti-histaminic & mucolytic29/07/05
501FDC of Gabapentin (300mg) + Methylcobalamin (500mcg) TabletFor neuropathic pain in adults.08/05/05
502FDC of Calciptriol (50mcg) + Betamethasone Dipro (0.5mg) per gm OintmentFor psoriasis vulgaris.08/12/05
503FDC of Glimepiride (1mg/2mg) + Pioglitazone (15mg)+ Metformin (500mg E.R) uncoated TabletAs 3rd line treatment of type-II diabetes mellitus when diet, exercise and the single agents and second line therapy with two drugs do nto result in
adequate glycemic control
16/08/05
504Sucralfate (7%) + Povidone Iodine (5%)
Ointment
Anti-infective18/08/05
505Nimesulide 1% + Methyl Salicylate 5%.
Aerosol
Aerosol For local application in acute
pain.
16/09/05
506Feracrylum (1%) + Metronidazole 1%) GelAntiseptic gel.16/09/05
507FDC of Methylcobalamin (1500mcg E.R) + Pyridoxine (20mg) + Folic Acid (5mg) TabletFor hyper-homocysteinemia16/09/05
508Enalapril (2.5mg/5mg) + HCTZ (12.5) Tablet (Addl. Strength)For Hypertension17/10/05
509Ambroxol HCl 75mg (S.R) + Desloratadine 5mg Capsule.For relief of productive cough.11/10/05
510FDC of S-Metoprolol Succinate Tartrate equivalent to Metoprolol Tartrate (E.R) 25/50mg + HCTZ (12.5mg) Tablet.For essential hypertension11/11/05
511Stavudine 10mg+Lamivudine 40mg+ Nevirapine 70mg dispersible tabletFor HIV infection11/11/05
512Domperidone (10mg) + Activaed dimethicone (125mg) chewable tabletFor dyspepsia, colicy pain & GERD.22/11/05
513Moxifloxacin (0.5%) + Dexamethasone Phosphate (0.1%) Eye dropsFor Ophthalmic use.24/11/05
514Brimonidine Tartrate (2mg/1.5mg) + Timolol (as HCl) (5mg/5mg per) ml.Ophthalmic25/11/05
515Amlodipine (as besylate) 5mg + Bisoprolol 5mg Tablet (Addl. Strength)For hypertension30/11/05
516FDC of Olmesartan Medoxomil (20mg/40mg/40mg) +
HCTZ(12.5mg/12.5mg/25mg)
For essential hypertension12/02/05
517Entecavir Tablet (0.5mg/1.0mg) & oral solution (0.05mg/0.05mg) per ml.For chronic Hepatitis-B infection.12/05/05
518Ketorolac Tromethamine 5mg + Ofloxacin 3mg per ml Eye dropsOphthalmic12/07/05
519Hyoscine-N-Butylbromide (10mg) + Paracetamol 500mg TabletFor spasmodic pain12/08/05
520Amlodipine (as besylate ) 5mg + Losartan Pot. 50mg tablet.For hypertension12/08/05
521Ceftriaxone (as sodium) (500mg/1000mg) +
Sulbactam (as sodium) (250mg/500mg) powder for injection.
For LRTI12/08/05
522Nebivolol (as HCl) 5mg + Valsartan 80mgFor hypertension17/01/06
523Combikit of Tamsulosin HCl 0.4mg M.R capsule (10 no.) & Dutasteride Soft Gelatin
Capsule 0.5mg (10no.)
For BPH19/01/06
524Alendronate Sodium (equiv. to Alendronic acid 70mg) + Cholecalciferol 70mcg (equiv. to 2800
I.U Vit.D) Tablet
For osteoporosis02/01/06
525Aspirin 150mg+ Clopidogrel 300mg Tablet (additional strength)For the treatment of angina, myocardial infarction and stroke26/11/02
526Atenolol 50mg + HCTZ 25mg (addl. Strength)For hypertension02/03/06
527Tamsulosin HCl (MR) 0.4mg + Dutasteride 0.5mg tabletFor BPH06/02/06
528Metoprolol Succinate equiv. to Metoprolol Tartrate 50mg + Amlodipine (as besylate) 5mgFor hypertension02/07/06
529Tenofovir Disoproxil Fumarate (300mg) + Emtricitabine (200mg) tabletFor HIV-1 infection23/02/06
530Diclofenac Sodium (75/50mg) as (E.C) + Misoprostol 200mcg.For OA & RA28/02/06
531Pantoprazole (as Sodium) (E.C) 40mg + Itopride (150mg) S.RFor GERD04/08/06
532Amlodipine (as besylate) 5mg/2.5mg + HCTZ 12.5mg/12.5mg TabletFor hypertension24/04/06
533Formoterol Fumarate (6mcg/6mcg/6mcg) + Fluticasone Propionate (100/250/500mcg) dry powder inhaler & MDIFor Asthma & COPD05/10/06
534Nevibolol (as HCl) 5mg + Amlodipine (as besylate) 5mg/10mg film coated tabletsFor hypertension24/05/06
535Levocetrizine 5mg + Ambroxol Hydrochloride SR (75mg) tabletFor production cough24/05/06
536Gatifloxacin (0.3%) + Prednisolone Acetate (1%) eye dropsFor Ophthalmic use06/02/06
537Amlodipine (as besylate) 5mg + Metoprolol Succinate equivalent to Metoprolol Tartrate
50mg.
For hypertension06/05/06
538Nadifloxacin (1%) + Miconazole Nitrate (2%) + Mometasone Furoate (0.1%) CreamFor dermatoses06/06/06
539Lamotrigin 200mg tablet (addl. Strength) dispersible tablet (5mg/50mg/100mg/200mgAnti-epileptic06/08/06
540Amoxycillin 1000mg + Clavulanate Potassium 62.5mg E.R tabletAnti-biotic06/08/06
541Lopinavir 200mg + Ritonavir 50mg Tablet (addl. Strength)For the treatment of patients with HIV infection06/08/06
542Ferrous ascorbate (equivalent to 50mg Iron) + Folic acid 1.5mg. Film coated tabletFor iron deficiency anemia06/08/06
543Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet (addl. Indication)As loading dose for prevention of in- stent restenosis in PCI22/06/06
544Olmesartan 40mg + HCTZ 25mg tablet (addl.
Strength)
Anti-hypertensive28/05/06
545Ceftriaxone (as sodium) 250mg + Tazobactam
31.25 mg for injection (addl. Strength)
Anti-bacterial07/05/06
546Bimatoprost 300mg + Timolol (as maleate) 5mg/ml eye dropsFor reduction of IOP07/05/06
547Mebeverine HCl 135mg + Isabgula husk 3.5gm
sachet.
Irritable bowel syndrome07/06/06
548Vitamin C 500mcg + Zinc Citrate 2.2mg + Selenium 60mcg tablet.For vitamin C deficiency07/12/06
549Lamivudine 40mg + Stavudine 10mg
dispersible tablet.
For HIV infection07/12/06
550Levocetrizine 2.5/5mg + Ambroxol 30mg/30mg per 5ml of syrupFor productive cough20/07/06
551Cefixime 200mg + Pot. Clavulanate (125mg)
tablet
Anti-biotic20/07/06
552ISMN SR 30mg/30mg + Aspirin75/150mg film coated tablet(addl. Strength)For prophylaxis of angina and prevention of Myocardial infarction.20/07/06
553Clobestasol Propionate (0.05%) + Calcipotriol Ointment (0.005%) Ointment.For plaque psoriasis20/07/06
554Tenofovir Disoproxil Fumarate300mg + Emtricitabin 200mg + Efavirenz 600mg tabletFor HIV-1 infection08/01/06
555Erdosteine 150mg + Guaiphenesin 50mg + Terbutaline 1.25mg per 5ml syrupMucolytic08/08/06
556Rosiglitazone (as maleate)2mg + Glibenclamide 5mg + MetFormin 500mg tabletAnti Diabetic08/08/06
557Levocitirizine 2 Hcl 5mg+ Ambroxol Hcl SR 75mg + Pseudoephedrine Hcl 120mg SRFor SAR, PAR & Chronic idiopathic urticatia08/09/06
558Alprazolam SR 0.25mg + Sertraline (As Hcl) 25mg/50mg tabletFor Panic disorder with or without agoraphobia08/09/06
559Dexibuprofen 200mg/300mg +Paracetamol 500mg tabletFor RA, OA & ankolysing spondylosis08/10/06
560ISMN SR 60mg/60mg + Metoprolol Succinate ER 25/50mg film coated tabletFor angina & Hypertension08/10/06
561Aspirin 75mg / 150mg + Glycine 37.5mg/75mg tabletFor prevention of acute coronary syndrome in patients with CAD prophylaxis against stroke08/10/06
562Combipack of 21 tablet of Quinine sulphate
600mg each & 8 capsule of Doxycycline (as Hcl) 100mg each
For P. Falciparam malaria08/10/06
563Cefepem (as Hcl) 0.5/1gm + Amikacin (as sulphate) 0.125/0.250gm InjectionAntibiotic08/11/06
564Lamivudine 20mg Stavudine 5mg tabletAnti HIV08/11/06
565Nadifloxacin (10mg/gm) + Mometasone Furoate (1mg/gm) creamFor mixed infection of skin17/08/06
566Gliclazide 40mg/80mg + MetFormin Hcl 500mg + Rosiglitazone 2mg tabletAnt- diabetic22/08/06
567Amoxycillin 250mg + Dicloxacillin 250mg cap.Anti biotic28/08/06
568For the reduction of IOP in patients with open angle glaucoma, who are insufficiently responsive to
topical beta blockers or prostaglandin analogues
Bimatoprost 0.3mg + Timolol Maleate IP
Eq. to Timolol 5.0mg eye drops28/08/06
569Cefixime (50mg/100mg) + Clavulanic acid 31.125mg/62.5mg per ml dry syrup & tabletAntibiotic29/08/06
570Ciclsonide 80mcg/160mcg + Formotorol 4.5mg/4.5mg inhaler (rotacap)Anti asthratic29/08/06
571Ciclsonide 100mcg/ 200mcg/400mcg + Formotorol Fumarate 6mg rotacapsAnti asthmatic29/08/06
572S(-) pantoprazole (as sodium) 20mg (E.C.) + Domperidome SR 30mg tabletfor the tretment of GERD not responding to pentoprazole30/08/06
573Cefadroxil 500mg + Clavulanic acid 125mg film coated tabletsFor the treatment of adult patients with infections caused by susceptible microorganismsincluding S. aureus , viz. Urinary ract Infection, Lower
Respiratory Tract Infections, and gonococcal urethritis
30/08/06
574Cefadroxil 250mg + Clavulanic acid 62.5mg dispersible tabletFor the treatment of adult patients with infections caused by susceptible microorganismsincluding S. aureus , viz. Urinary ract Infection, Lower Respiratory Tract Infections, and
gonococcal urethritis
30/08/06
575Cefadroxil 250mg + Clavulanic acid 62.5mg per 5ml syrupFor the treatment of adult patients with infections caused by susceptible microorganismsincluding S. aureus , viz. Urinary ract Infection, Lower
Respiratory Tract Infections, and gonococcal urethritis
30/08/06
576Telmisartan 40mg + Amlodipine (as Besylate) 5mg tabletFor essential hypertension30/08/06
577Ceftazidime 500mg /1000mg + Tazobactum (as sodium) 62.5mg/125mg per vial for injectionAntibiotic30/08/06
578Cefepime (As Hcl) 500mg/1000mg + Tazobactum (as Sodium) 62.5mg/125mg per injectionFor the treatment of uncomplicated and complicated UTI, uncomplicated skin and skin structure infections, and complicated intra-abdominal infections; Additional indication LRTI including pneumonia & Bronchitis; septicaemia;empiric treatment in
febrile neutropenic patients
30/08/06
579Cefixime 100mg/200mg + Cloxacillin (as Sodium) 500mg/500mg + Lactobacillus (45 /90 Million spore)tabletAntibiotic31/08/06
580Levofloxacin tablet (250mg /500mg) & Infusion 5mg/ml (For additional indication)For prostatitis26/09/06
581combipack of one cap. Of aprepitant .125mg & two cap. Of aprepitant 80mg each (combipack)As Approved10/10/06
582Formoterol fumarate 6mcg + Fluficasone propinate 50mcg/125mcg/250mcg MDIFor Asthma & COPD14/10/06
583Amlodipine 25mg + Metoprolol 25mg (additional lower strength) tabletFor hypertension11/01/06
584Esomeprazole 40mg (E.C.) + Itopride 150mg SR CapsulesFor GERD13/11/06
585Cefixime 200mg + Cloxacillin 500mg (ER) + Lactobacillus 90 million Spore tab. (additional strength) tabletAntibiotic14/11/06
586Trandalopril 1mg/2mg/4mg/2mg + Verapamil (ER) 240mg/240mg/240mg/180mg tabletAnti hypertensive23/11/06
587Rabeprazole 20mg (EC) + Itopride SR 150mg
capsule
For GERD28/11/06
588Metoprolol succinate 25mg /50mg ER + HCTZ 12.5mg tabletsAnti hypertensive30/11/06
589Atorvastatin 5mg + Fenofibrate 160mg (additional strength)tabletsFor the treatment of combined hyperlipidemia in patients with normal hepatic and renal functions.12/01/06
590Atazanavir 150mg + Ritonavir 50mg capsulesAnti HIV12/12/06
591Mebeverine Hcl 135mg + Chlordiazepoxide
5mg tablet
For IBS12/12/06
592Ampicillin 250mg + Dicloxacillin 250mg tabletAntibiotic13/12/06
593Etoricoxib 10mg + Methyl Salicylate 100mg + Mentol 50mg + Linseedoril 30mg per gm. of
Gel
For acute Musculoskeletal pain14/12/06
594Nebivolol 5mg + Amlodipine 10mg FC TabletFor the management of essential hypertension in adults only06/09/06
595Artesunate 150mg/200mg + Sulphadoxine
500mg/750mg + Pyrimethamine 25/37.5mg Combipack
For the treatment of P. falciparum
resistant malaria patients (age 9-14 yrs and above)
25/07/06
596Ciclosonide 80mcg/160mcg/200mcg/400mcg + Formoterol 4.5mcg/4.5mcg/6mcg/6mcg Inhaler & RotacapsFor the treatment of patients with bronchial asthma where use of said combination is found appropriate29/08/06
597Combipack of Estradiol + Dydrogesterone : 1. Each pack contains 28 tablets of Estradiol 1 mg
+ Dydrogesterone 5 mg. 2. Each combipack contains 28 tablet: each of 14 tablets contains estradiol 1mg & other each of 14 tablets contain estradiol 1 mg + Dydrogesterone 10 mg.
For the treatment of Hormone Replacement Therapy (HRT) in estrogen deficiency in postmenopausal women with a uterus and prevention of osteoporosis in postmenopausal women who are intolerant of other products approved for prevention of osteoporosis14/11/06
598Combikit of one film coated tablet of Risendronate Sodium 35mg & six film coated tablet of Calcium Carbonate 1250 mg (Eq. to
500mg Cl)
For the treatment of osteoporosis in postmenopausal women05/07/07
599Ceftazidime 250mg + Tazobactam 31.25mg Injection(Additional Strength) For the treatment of hospital acquired infections like nosocomial pneumonia, uncomplicated skin and skin structure infections31/07/07
600NaCl 0.52g + KCl 0.3g + Sod. Citrate 0.58g +
Dextrose Anh. 2.7g per 200ml ORS in Liquid form
For oral rehydration in various etiology23/07/07
601Methylcobalamin 500mcg + Alpha Lipoic Acid 100mg + Pyridoxine 1.5mg + Folic Acid 3mg Soft Gelatin CapsuleFor the treatment of diabetic neuropathy31/07/07
602Cefpodoxime 200/100mg + Clavulanate Potassium 125/62.5mg TabletsFor the treatment of lower and upper respiratory tract infection,
uncomplicated skin infection and urinary tract infection
30/07/07
603Methylcobalamin 500/750/1500mcg + Alpha Lipoic Acid 100/200 + Pyridoxine 1.0/1.5/3mg
+ Folic Acid 0.5/0.75/1.5mg Soft Gelatin Capsules
For the treatment of diabetic neuropathy26/09/07
604Pantoprazole 40mg EC + Domperidone 30mg SR Capsulesfor the tretment of GERD not responding to pentoprazole18/05/05
605Pantoprazole 20mg EC + Domperidone 10mg Capsulesfor the tretment of GERD not responding to pentoprazole14/07/07
606Cefuroxime 250mg + Clavulanic Acid 125mg FC tablet/Dry syrupFor the treatment of adult patients with infections caused by susceptible microorganisms including S. aureus, viz., urinary tract infections, upper and lower respiratory tract infections and gonococcal urethritis.10/05/07
607Methylcobalamin 500mcg + Folic acid 1.5mg + B5 - 5gm + Zinc Sulphate 25mg + Chromium Polynicotinate 200mcg + selenium 65mcg + B6 1.5mg + inositol 100mg + Alpha lipoic acid 50mcg Capsules(Each inner capsule contains - Streptococcus Faccalis T-110 JPC 30 Million;Clostridium butyricum TO-A 2 Million;Bacillusmesentericus TO-A JPC 1 Million;Lactic acid bacillus 50 Million)For vitamin & mineral deficiency states and for restoration of intestinal microflora31/10/07
608Mecobalamin 500mcg + Alpha Lipoic Acid 100mg + Folic acid 1.5mg + Benfotiamine 50mg Soft gelatin CapsulesFor the treatment of diabetic neuropathy in adults13/11/07
609Mecobalamin 500mcg + Zinc Sulphate 61.8mg
+ Calcium Patothenate 10mg + Pyridoxine 3mg
+ Folic Acid 1.5mg + Niacinamide 50mg + Chromium 50mcg Tablets
For vitamin & mineral deficiency states29/11/07
610Mecobalamine 1500mcg + Alphalipoic Acid 100mg + Thiamine mononitrate 10mg + Pyridoxine 3mg + Folic Acid 1.5mg CapsuleFor the treatment of diabetic neuropathy29/11/07
611Mecobalamine 1500mcg + Alpha Lipoic Acid 200mg + Inositol 100mg + Folic Acid 1.5mg + Chromium Polynicotinate 200mcg + Seleno Methionine 55mcg + Zinc Monomethionine
25mg Capsule
For Vitamins and Mineral deficiency states in adult patients12/07/07
612Mecobalamine 500mcg+ Alpha Lipoic Acid 100mg + Inositol 100mg + Folic Acid 0.5mg + Chromium Polynicotinate 65mcg + Selenium Dioxide 18mcg CapsulesFor Vitamins and Mineral deficiency states in adult patients12/07/07
613Methylcobalamin 500mcg + Pyridoxine 3mg + Folic acid 1.5mg + Eicosahexanoic acid 90mg + Docosahexanoic acid 60mg + Vit E 25 IU + Vit C 100mg + Zinc 15mg + Selenium 60mcg
Capsule
For vitamin and mineral deficiency states in adult patients28/12/07
614Methylcobalamin 500mcg + Calcium 250mg + Calcitriol 0.25mcg + Folic Acid 1.5mg + Pyridoxine 3mg + Zinc 7.5mg CapsulesFor vitamin and mineral deficiency states in adult patients28/12/07
615Torsemide 10mg + Amiloride 5mg tabletsEdema Associated with congestive heart failure & hypertension17/01/07
616Pioglitazone 15mg/30mg + MetFormin ER 1000mg tablet (additional strength)For second line therapy in type-II diabetes23/01/07
617Pantaprazole sodium 20mg/40mg Tablet (with sodium bicarbonate As buffer)For gAstric ulcer, duodenal ulcer, Z. E Syndrome, GERD07/02/07
618levofloxacin (250mg/500mg) + ambroxol SR 75mg tabletFor lower respiratory tract infection in adult08/02/07
619Testosterone cypionate (100mg/200mg) + Cotton seed oil 736/566mg per ml injectionFor testosterone deficiency (i) primary hypogonadism (ii) Hypogonadotropine hypogonadism08/02/07
620Rosiglitazone 1mg + Metformin Hcl 500mg tablet (additional strength)Patients with type 2 diabeties mellitus when dist exercise and the single agent do not result Rosiglitazone 2mg in adequate glycemic control08/02/07
621Loteprednol Etabonate 5mg + Tobramycine 3mg per ml ophthalmic solutionFor steroid responsive inflammatory ocular condition14/02/07
622Amlodipine (As besylate) 5mg + Metoprolol (As succinate) ER 25mg (additional
strength)tablets
For hypertension14/02/07
623Glibeneclamide 5mg + Metformin SR 850mg tablet (additional strength)non insulin dependent diabites mallitus patients poorly controled with sulphonyluren or biguanide alone15/02/07
624Metoprolol (As succinate) 50mg/25mg ER) +
Amlodipine 5mg/2.5mg tablet (For additional indication)
Angina pectoris in adults20/02/07
625Ramipril 10mg + HCTZ 12.5mg tablet (additional strength)Mild to moderate hypertension in patients (in when combination therappy is appropiate) who have been established on the individual
components given in the same proportion
20/02/07
626Amlodipine (As besylate) 5mg/5mg/10mg + valsartan 80mg/160mg/160mg tabletEssential hypertension21/02/07
627Amlodipine (As besylate )5mg/10mg + Perindopril 4mg tabletFor hypertension23/02/07
628Rosuvastatin calcium eq. to Rosuvastatin 10mg + Ezetimibe 10mg tabletsFor the treatment of patients with primary
hypercholesterolemia.
23/02/07
629Metoprolol (As succinate) ER 25mg/50mg + Ramipril 2.5mg/5mg tabletsEssential hypertension26/02/07
630Rabeprazole Sodium 20mg/10mg with sodium bicarbonate As bufferFor Duodenal ulcer, G.U, Z.E.S. & GERD26/02/07
631Ciclesonide 160mcg/320mcg + Formoterol Fumarate 12mcg/12mcg (Dry powder inhaler additional strength) rotacapAs approved27/02/07
632Ceftriaxone (As sodium) 125mg/250mg + Sulbactam (As sodium) 62.5mg/125mg For injection (additional strength) injectionFor LRTI01/03/07
633Clindamycin 1% + Isotretinoin 0.05% gelFor acne08/03/07
634Cifixime 200mg + Erdosteine 300mg CapsulesAcute Exacerbation of chronic
bronchitis
21/03/07
635Etoricoxib 10mg + Methyl salicylate 20mg per gm. of creamAcute Musenlosleteal pain21/03/07
636ISMN 60mg / 60mg SR + Atenolol 50mg/100mg film coated tabletFor angina pectoris23/03/07
637Comb kit of two capsule of Azaranari 150mg each + 1 tablet of Ritonavir 100mg)For HIV infection02/04/07
638Mecobalamine 500mcg + Alpha Lipoic acid 100mg soft gelatin capsuleFor diabetic neuropathy02/04/07
639Propofol 10mg + Lignocaem 1mg per ml
injection
For induction of anesthesia04/04/07
640Ezetimibe 10mg + Fenofibrate 160mg tabletFor combined hypertipidemia04/04/07
641Metoprolol (As succinate) 25mg + Amlodipine (As besylate) 5mg (additional strength) tabletFor hypertension10/04/07
642Combipack of 1 bottle of ciprofloxacin Injection (200mg/100ml) & 1 bottle of Ornidazole injection 500mg/100ml)Antibiotic20/04/07
643Combi pack of 1 tablet of Residronate sodium (35mg) + 6 tablet of calcium carbonate equivalent to 500mg calcium eachFor osteoporosis in postmenopausal women01/05/07
644Amlodipine (As besylate) 10mg + Perindopril 8mg tablets (additional strength) tabletFor hypertension07/05/07
645S(-) Metoprolol (As succinate) 25mg + S(-) Amlodipine (As besylate 2.5/5mgFor essential hypertension16/05/07
646Cefotaxim (As sodium) 0.5mg/1gm + Sulbactam (As sodium) 250mg/500mg injection (for additional indication)For surgical prophylaxis (additional indication)18/05/07
647Atenolol 25mg/50mg + Indapamide SR 1.5mg
tablet
For essential hypertension21/05/07
648Ceftazidime 500mg/1000mg + Sulbactam (As Sodium) 250mg/500mg For injectionAntibiotic08/06/07
649Isotretinoin 0.05% + Erythromycin 2% gelFor acne08/06/07
650Glimepiride 1mg/2mg. + Metformin SR 1000mg tablet (additional strength) tabletfor patients with type diabetes mellitus when diet exercise & the agent do not result in adequate glycemic control.08/06/07
651Alfuzocin Hcl. ER (10mg) + Dutasteride 0.5mg
tablet
For BPH in men with enlarged prostate14/06/07
652Tolterodine tartrate ER 4mg + Tamsulocin Hcl. ER 0.4mg tabletFor BPH with overactive bladder15/06/07
653Omeprazole 20mg/40mg + Sodium Bicarbonate 1100mg capsulesFor duodenal ulcer, gastric ulcer & GERD15/06/07
654Tolterodine Tartrate 4mg (ER) + Tamsulosin HCL 0.4mg Capsule.For BPH with overaction bladder in Adults only.15-06-2007.
655Omeprazole (E.coated) 40mg + Sodium Bicarbonate 1100mg capsule.For gastric ulcer, duodenal ulcer and GERD.18-6-2007.
656Azithromycin 500mg + Ambroxol S.R (75mg) Tablet.For RTI caused by susceptible organisms in adults.05-07-2007.
657Moxifloxacin HCL (0.5%) + Ketorolac Tromethamine 0.5% Ophthalmic Solution.For reduction of post-operative inflammatory conditions of the eyes.11-07-2007.
658Levofloxacin (15mg) + Prednisolone Acetate 10mg per ml eye drops.For post-operative steriod responsive inflammatory ocular conditions when ocular bacterial infections or a risk of bacterial infection exists.11-07-2007.
659Mecobalamine 500/1500mcg + Alpha Lipoic Acid 100mg + Inositol 100mg + Folic Acid 0.5/1.5mg + Chromium Polynicotinate 65mcg/200mcg+ Selenium Dioxide18/55mcg +
Benfotiamine 50/150mg capsule
For Vitamins and Mineral deficiency states in adult patients12/07/07
660Loteprednol Etabonate (0.5%) + Levofloxacin (1.5%) Eye drops.For post-operative steriod responsive inflammatory ocular conditions when ocular bacterial infections or a risk of bacterial infection exists.12-07-2007.
661Clotrimazole (10mg) + Methyl-prednisolone aceponate 1mg/gm of cream.For fungal infection of skin associated with inflammation.12-7-2007.
662Cefpodoxime (as Proxetil) (100mg/200mg) + Clavulanic acid (62.5/125mg) tablet.For LRTI, URTI and UTI.30-07-2007.
663Atorvastatin (40mg) + Ezetimibe (10mg) Tablet (addl. Strength).For the treatment of patients with primary hypercholesterolemia30-07-2007.
664Cefepime (250mg) + Tazobactam (31.25mg) Injection (addl. Strength).For the treatment of uncomplicated and complicated UTI, uncomplicated skin and skin structure infections, and complicated intra-abdominal infections; Additional indication LRTI including pneumonia & Bronchitis;
septicaemia;empiric treatment in febrile neutropenic patients
30-07-2007.
665Methylcobalamin (500mcg) + Alpha Lipoic Acid (100mg) + Pyridoxine (3mg) + Folic acid (1.5mg) Soft Gelatin Capsule.For diabetic neuropathy.31-07-2007.
666Halobetasol Propionate (0.5mg) + Salicylic Acid 30mg per gm of ointment.For plaque psoriasis.01-08-2007.
667Combipack of 12 tablet of Artesunate (50mg) each + 3 tablet of each containing Sulfadoxine
(500mg) + Pyrmethamine (25mg) Tablet. (Addl. Strength)
For the treatment of P. falciparum resistant malaria patients01-08-2007.
668Omeprazole (20mg/40mg)+Sod. Bicarbonate- 600mg+ Mg.Hydroxide-700mg .chew tab.For duodenal, gastric ulcer, GERD, and erosive esophagitis,08/01/07
669Tegafur (100mg) + Uracil (224mg) capsule.For first line treatment of metastatic colorectal cancer in combination with calcium folinate.22-08-2007.
670Amlodipine (5mg) + Nebivolol (5mg) tablet (addl. Strength).For the treatment of essential hypertension06-09-2007.
671Ceftazidine (2gm) + Sulbactam (1gm)
Injection (addl. strength for additional indication).
For serious abdominal infection.06-09-2007.
672Polyethylin Glycol 400 (0.4%) + Propylene
Glycol (0.3%).
For temprory relief of dryness, irritation burning, stinging, grittiness or foreign body sensation caused due to environmental factors.18-9-2007.
673Cefuroxime Axetil (250mg) + Clavulanic Acid (125mg) Tablet.For adult patients with infection caused susceptible micro-organisms including S.aureus viz UTI, upper and lower RTI and gonoccoccal urethritis.27-09-2007.
674Cefuroxime Axetil (250mg) + Clavulanic acid (125mg) tablet.For UTI, URTI and LRTI and gonococcal urethritis.05-10-2007.
675Cefuroxime-125/250/500mg +Clavulanic Acid- 31.25/62.5/125mg film coated tabletFor adult patients with infection caused by susceptible
microbs,including s.aureus.(e.g- UTI,Upper&lower RTI & gonococcal
urethrities)
10/05/07
676Sucralfate (70mg ) + Metronidazole (10mg) + Povidone Iodine (50mg) per gram of Ointment.For infected wounds and ulcers.09-10-2007.
677Combipack of two tablet of chloroquine phosphate (250mg) each + 14 tablet of Proguanil HCl (100mg) eachFor drug resistant malaria.10-10-2007.
678Paclitaxel (protein bound particle) for injectable suspension (paclitaxel (100mg) + Albumin Human 900mg per 20ml injectionFor breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.11-10-2007.
679Olmesartan Medoxomil (20mg) + Amlodipine Besylate (5mg) Tablet.For mild to moderate hypertension.15-10-2007.
680Atorvastatin Calcium (10mg ) + Ramipril (2.5mg/5mg) tabletFor treatment of patients with both hypertension and
hypercholesterolemia.
15-10-2007.
681Omeprazole (20mg) + Sodium bicarbonate (1100mg) tablet (addl. strength).For duodenal ulcer, gastric ulcer & GERD15-10-2007.
682Moxifloxacin HCl (5mg) + Prednisolone Acetate (10mg)per ml. (eye drops)For inflammation after ocular surgery and where a risk of bacterial ocular infection exists.16-10-2007.
683Methylcobalamine (500mcg) + Alpha Lipoic acid (100mg) + Pyridoxine HCl (1.5mg) + Thiamine (2mg) + Calcium Picolinate (200mg)
tablet.
For diabetic neuropathy.16-10-2007.
684Satranidazole (300mg) + Ofloxacin (200mg)
Tablet.
For diarrhoea of mixed infection in
adults.
18-10-2007.
685Methylcobalamin 500mcg+beta carotine- 10.33mg+alpha lipoic acid 100mg+B6 1.5mg+B1 2mg & Chromium Polynicotinate
soft gelatin capsule
For adult patients with diabetic neuropathy.18-10-2007.
686Calcium Pidolate equivalent to Calcium 500mg
+ Vit-D3 250 IU powder for oral use
For osteoporosis and calcium deficiency state.23-10-2007.
687Atorvastatin Calcium (10mg) + Fenofibrate (145mg) (addl. strength) tabletFor the treatment of combined hyperlipidemia in patients with normal hepatic and renal functions.30-10-2007.
688Miglitol (50mg) + Metformin HCl SR (500mg) tablet.For adult with Type-II diabetes mellitus where simple drug therapy, diet and exercise do not result in adequate glycemic control.31-10-2007.
689Mupirocin (2%) + Methylprednisolone Aceponate (0.1%) Cream.For atopic dermatitis.31-10-2007.
690Methyl cobalamine 500mcg+folic acid1.5mg+B5-5mg,+Zn.sulphate 25mg+Cr.Polynicotinate 200mcg+selenium- 65mcg+inositol-1.5mg + alpha lipoic acid –
100mg capsule
For Vitamins and mineral deficiency states.31/10/07
691Methylcobalamine 500mcg+folic acid1.5mg+ alpha lipoic acid –300mg +Benfothiamine-50mg. CapsuleFor diabetic neuropathy13/11/07
692Methyl prednisolone aceponate-1mg + salicylic acid-50mg ointmentFor treatment of psoriasis19/11/07
693Propanol 50gm+povidone iodine-1gm in 100ml
solution
For surgical & hygenic hand
disinfection.
19/11/07
694Propanol-18 gm+Ethenol(100%)-45gm in
100ml solution
For surgical & hygenic hand
disinfection.
19/11/07
695Ceftriaxone –2gm+ Tazobactum 250mg for
injection
Anti-bacterial21/11/07
696Methylprednisolone aceponate-1mg + Mupirocin-20mg. creamFor the treatment of atopic dermatitis21/11/07
697Methyl cobalamine 500mcg+folic acid1.5mg+B6-3mg,+Zn.sulphate
61.8mg+Ca.Pantothenate 10mg+ Niacinamide- 50mg +chrimium-50mcg capsule
For Vitamins and mineral deficiency patients.29/11/07
698Mecobalamin0.5mg + Pyridoxine 50mg + Benfotiamine100mg capsuleFor the treatment of diabetic Neuropathy29/11/07
699Methylcobalamine 500mcg+folic acid 1.5mg+ alpha lipoic acid –100mg +B6-3mg+Thiamine
10mg capsule
For diabetic neuropathy29/11/07
700Doxophylline-400mg+Salbutamol(as sulphate)- 2mg/4mg TabletsFor treatment of Bronchial asthma in adults29/11/07
701Gatifloxacin (as sequihydrate)-3mg + Flurbiprofen sod.-0.3mg/ml eye drops.For reduction of post-operative inflammatory conditions of eye ,when bacterial infection exists.29/11/07
702Sertanidazole-300mg+ Ofloxacin-200mg tabletFor treatment of diarrhoea of mixed infection in adults patients.29/11/07
703Olmesartan medoximil-20mg + Ramipril-5mg.
Tablet
For treatment of essential hypertention.12/06/07
704Combipack of 12 Artesunate –50mg tablets & 6 Mefloquin-250mg tabletsFor drug resistant P.falciparum malaria infection.12/06/07
705Pregabalin-75mg/150mg +Methylcobalamine 500mcg capFor the treatment of adult patients with peripheral neuropathy.12/10/07
706Doxycycline-100mg +L.bacillus spores-5 billion capsule pelletsFor adult patients prone to intrabdominal bacterial infection & Antibiotic associated diarrhoea12/11/07
707Cefprozil 250mg/500mg+Clav. Acid-62.5mg
/125mg. tab
For the treatment of adult patients with upper&lower RTI, Skin & Skin structure infection12/11/07
708Dextrometharpahan HBr- 10mg+Chlorphenaramine maleate-2mg /5ml
syrup.
For the temporary relief of cough due to throat irritation, sneezing &
ruunning nose.
12/11/07
709Ramipril BP 2.5mg/5mg + Telmisartan 40mg uncoated tabletFor the treatment of mild to moderate hypertension in
adults
11/12/07
710Escitlopram (as oxalate)10mg + Clonazepam- 0.5mg tablet (addl. Strength).For comobid depression and anxiety disorder.12/12/07
711Me-salicylate 30% + Menthol 10% + camphor 4% CreamFor temporary relief from pain, swelling & inflammation due to musculoskeletal disorder29/11/07
712Streptococcus thermophilus 45% + Bifidobacteria (B.longum, B.infantis,B.breve) 45% + Lactobacillus acidophillus 3% + Lactobacillus casei 2% + Lactobacillus
delbruecki susp. 3% Bulgaris 2% + Lactobacillus plantarum
For management of rotavirus diarrhoea in children01/08/07
713Drospirenone 3mg/3mg + Ethinyl Estradiol 0.02mg/0.03mg TabletsFor the use as oral contraceptive for women28/03/08
714Amlodipine 2.5/5/5mg + Metoprolol 25/50/25mg CapsulesAdditional Indication :- For the Treatment of Ischemic Heart Disease/Coronary Heart Disease16/07/08
715Mecobalamin 1000mcg + Vit B1 10mg + Vit B6 3mg + Folic Acid 1mg + Calcium Pantothenate 50mg + Niacinamide 45mg tabletsFor vitamin and mineral deficiency states in adult patients01/03/08
716Methylcobalamin 500mcg + Vit A 5000IU + Vit E25IU + Ascorbic Acid 100mg + Vit B1 10mg + Riboflavin 10mg + Pyridoxine 3mg + Niacinamide 500mcg + Folic Acid 50mg + Calcium Pantothenate 1mg + Zinc Oxide 12.5mg + Cupric Oxide 15mg + Sodium Selenate 2.5mg + Manganese Chloride 60mg+ Manganese 1.4mg + Chromium 65mcg tabletsFor vitamin and mineral deficiency states in adult patients01/03/08
717Methylcobalamin 500mcg + Beta Carotene 20.66mg + Vit A 5000IU + Alpha Lipoic Acid 50mg + Folic Acid 1.5mg + Selenium 163.6mcg
+ Calcium Pantothenate 10mg + Vit B1 1.5mg
+ Vit B6 + Vit E 25IU tablets
For vitamin and mineral deficiency states in adult patients01/03/08
718Diclofenac 10mg + Serratiopeptidase 10/15mg tab & Cap. On 20/8/08For the treatment of acute pain in adults24/01/08
719Amoxycillin 250mg + Dicloxacillin 250mg + Lactobacillus 2.5 million spores capsulesFor the treatment of lower RTI, skin and soft tissue, bone and joint infections and ENT infections in adult
patients prone to antibiotic induced diarrhoea
29/01/08
720Beclomethasone Dipropionate 0.25mg + Econazole 10mg + Neomycin 5mg creamFor the topical treatment of bacterial and fungal infections30/01/08
721Methylcobalamin 750mcg + Alpha Lipoic Acid 100mg + Folic Acid 300mcg capsulesFor the treatment of diabetic neuropathy30/01/08
722Methylcobalamine 750mcg + Adenosylcobalamin 500mcg + Folic Acid 1.5mg + Elemental Iron 100mg capsulesFor Mineral & Vitamins deficiency states in adult patients30/01/08
723Methylcobalamin 500mcg + Ascorbic acid 100mg + Niacinamide 50mg + Vit E 25mg + Calcium Pantothenate 12.5mg+ Vit B1 10mg + Riboflavin 10mg + Vit B6 3mg + Vit A 5000IU
+ Folic Acid 1mg + Zinc Oxide 15mg + Copper Gluconate 2.5mg + Manganese 1.4mg + Chromium 65mcg + Selenium 60mcg tablets
For Mineral & Vitamins deficiency states in adult patients30/01/08
724Ciclesonide 100mg/200mg + Formoterol 6mcg/6mcg + Tiotropium 9mcg/9mcg RotacapsAs third line treatment of severe cases of COPD, when monotherapy and second line therapy with two drugs do not respond adequately.31/01/08
725Phenylephrine 5mg + Chlorpheniramine maleate 0.5mg + Paracetamol 125mg + Sodium Citrate 60mg + Menthol 1mg syrupFor the treatment of common cold and cough associated with fever31/01/08
726Streptococcus thermophilus 45% w/w + Bifidobacteria (B.longum, B.infantis,B.breve) 45% w/w + Lactobacillus acidophillus 3% w/w
+ Lactobacillus casei 2% w/w + Lactobacillus delbruecki susp. Bulgaris 3% w/w +
Lactobacillus plantarum 2% w/w capsules
For the treatment of irritable bowel syndrome31/01/08
727Methylcobalamin 500mcg + Alpha Lipoic Acid 50mg + Folic Acid 1.5mg + Selenium Dioxide 163.6mcg + Calcium Pantothenate 10mg + Vit
B1 10mg + Vit B6 1.5mg + Vit E 25IU + Beta Carotene 20.66mg tablet
For vitamins & minerals deficiency states in adult patients31/01/08
728Atenolol 25/50mg + Chlorthalidone 6.25 mg
tablets
For the treatment of essential
hypertension
31/01/08
729Cefpodoxime 100mg + Clavulanate Potassium
62.5 mg Dispersible Tablet/Dry Syrup
For LRTI, URTI and UTI.31/01/08
730Methylcobalamin 500mcg + VitA 5000IU + Vit E 25mg + Vit C 75mg + Vit D3 400IU + Folic Acid 1.5mg + Biotin 150mcg + Vit B1 5mg + Riboflavin 5mg + Vit B6 1.5mg + Niacinamide 50mg + Calcium Pantothenate 10mg + L- Glutamic acid 50mg + Chromium Picolinate 250mcg + Selenium 70mcg + Zinc Sulphate 55mg + Copper Sulphate 2mg + Manganese sulphate 5mg + Sodium Molybdate 25mcg + Manganesium Oxide 10mg sugar coated tabletsFor Vitamins and Minerals deficiency states in adult patients19/02/08
731Mecobalamin 1500mcg + Alpha lipoic acid 100mg + Inositol 100mg + Vit.A 5000IU + Vit B1 10mg + Pyridoxine 1.5mg + Vit E 25IU + Calcium Pantothenate 10mg + Folic Acid 1500mcg + Chromium 200mcg + Selenium
163.6mcg tablet
For Vitamins and Minerals deficiency states in adult patients25/02/08
732Methylcobalamin 1500mcg + Alpha lipoic acid 200mcg + Folic acid 1.5mg + Biotin 30mcg + Pyridoxine 3mg capsulesFor Vitamins and Minerals deficiency states in adult patients03/07/08
733Mecobalamin 0.5mg + Alpha Lipoic Acid
100mg + Benfotiamin 100mg + Pyridoxine 50mg fim coated tablet
For the treatment of diabetic Neuropathy10/03/08
734Methylcobalamin 1500mcg + Pyridoxine 1.5mg
+ Folic acid 5mg capsules
For the treatment of hyperhomocysteinemia03/07/08
735Mecobalamin 500mcg + Vit A 5000IU + Vit D3 400IU + Vit E 25IU + Vit B1 10mg +Riboflavin 10mg + B6 3mg + Niacinamide 50mg+ Calcium Pantothenate 12.5mg + Vit C 100mg + Folic acid 1500mcg+ Biotin 60mcg + L- Glutamic acid 100mg + Dl-Methionine 25mg
+Magnesium oxide 30mg + Manganese 2.5mg
+ Copper 2.5mg + Zinc 22.5mg + Chromium 100mcg + Selenium 60mcg tablets
For Vitamins and Minerals deficiency states in adult patients03/07/08
736Methylcobalamin 1500mcg + Alpha Lipoic Acid 100mg + Folic Acid 1.5mg + Selenium Dioxide 163.6mg + Calcium Pantothenate 10mg
+ Vit B1 10mg + Vit B6 1.5mg + Vit E 25IU + Vit A 5000IU + Inositol 100mg + Chromium polynicotinate 200mcg soft gelatin capsules
For Vitamins and Minerals deficiency states in adult patients03/07/08
737Mecobalamin 1500mcg + Alpha Lipoic Acid
100mg + B1 10mg + B6 3mg + Folic Acid 1.5mg capsules
For Vitamins and Minerals deficiency states in adult patients03/07/08
738Methylcobalamin 500mcg + Vit C 75mg + Vit B6 10mg + Folic Acid 5mg + Carbonyl Iron
100mg capsules
For the treatment of iron deficiency anemia28/03/08
739Methylcobalamin 500mcg + Alpha lipoic acid 100mg + Beta Carotene 5.17mcg + Vit B1 2mg
+ Vit B2 2mg + Vit B6 1.5mg + Vit C 50mg + Vit D3 200IU + Vit E 10IU + Niacinamide 25mg + Folic Acid 50mg + Calcium Patothenate 5mg + Chromium Picolinate 2.5mg
+ Selenium Di oxide 1.4mg + Zinc Oxide 65mcg + Copper Sulphate 15mg + Manganese Sulphate 60mcg + Lutein 1mg tablet
For Vitamins and Minerals deficiency states in adult patients04/07/08
740Rabeprazole Sodium ( with Sodium bicarbonate as buffer)For the treatment of gastric ulcer, duodenal ulcer,Zollinger Ellison Syndrome and Gastro-Esophageal
reflux disease
28/04/08
741Olmesartan 40mg + Ramipril 5mg TabletFor the treatment
hypertension
19/08/08
742Pantoprazole Sodium (with Sodium Bicarbonate as Buffer)For the treatment of gastric ulcer, duodenal ulcer,Zollinger Ellison
Syndrome and Gastro-Esophageal reflux disease
28/04/08
743Methylcobalamin 150mg + Pyridoxine 12.5mg
+ Alpha Lipoic Acid + Inositol + Folic Acid
For the treatment Neuropathy05/09/08
744Amlodipine Besylate BP Eq. to Amlodpine 5mg + Losartan Potassium USP 25mg/50mg film coated tabletsFor the treatment of mild to moderate hypertension in adults.14/05/08
745Esomeprazole (with Sodium bicarbonate as Buffer)For the treatment of GERD, gastric
and duodenal ulcer, Zollinger-Ellison syndrome
14/05/08
746Methylcobalamin 500mcg + VitA 5000IU + Vit D3 400IU + Vit E 25mg + Calcium Pantothenate 50mg + L- Glutamic Acid 50mg
+Vit B1 10mg + Riboflavin 10mg + Vit B6 3mg+ Niacinamide 50mg + Vit C 75mg+ Biotin 260mcg + Folic Acid 1mg + Zinc Sulphate 60mg + Chromium Picolinate 150mcg + Selenium 100mcg + Manganese Sulphate 200mcg + Magnesium Hydroxide 10mg +
Copper Sulphate 200mcg Tablet
For vitamins & minerals deficiency states14/05/08
747Atorvastatin 5/10/5mg + Telmisartan 20/20/40 mgFor the treatment of co-existing essential hypertension and hyperlipidemia in adult patients22/05/08
748Chlorpheniramine Maleate IP 2mg + Dextromethorphan Hydrobromide IP 10mg + Phenylephrine Hydrochloride
IP 5mg Softgel Capsule
Approved for more than 4 years
749Nimesulide 100mg 500mg TabletsApproved for more than 4 years
750Mecobalamin 1500mcg+ Alpha lipoic acid 100mg+ Vit B6 3mg + Folic acid 1.5mg + Zinc 15mg + Chromium 60mcg + Selenium 65mcg+ Biotin 100mcg + Inositol 2mg TabletFor vitamin and mineral deficiency states06/09/08
751Thiocolchicoside 4/8mg 50/100mg FC TabletFor the treatment of acute low back pain and other musculoskeletal painful & inflammatory conditions in adult
patients
06/11/08
752Vildagliptin 50/50/50mg 500/850/1000mg TabletFor the treatment of Type II diabetes mellitus when single drug therapy along with diet, exercise do not result in adequate glycemic control21/07/08
753Tenofovir Fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg FC TabletFor the treatment of HIV infection in adults23/07/08
754Metolazone 2.5/5mg + 50mg/50mg FC TabletFor the treatment of oedema associated with congestive heart failure, cirrhosis and nephr1tic syndrome25/08/08
755Diacerin 50mg + Glucosamine 1500mg TabletsAs initial therapy in adult patients with osteoarthritis of knee and hip joints09/04/08
756Tamsulosin Hydrochloride 0.4mg + Tolterodine tartrate 2mg ER capsule08/10/08
757Drotaverine 80mg + Aceclofenac 100mg TabletFor the treatment of adult patients with muscular pain associated with spasm15/09/08
758Losartan 25/25/50/50mg + Chlorthalidone 6.25/12.5/6.25/12.5mg FC TabletFor the treatment of mild to moderate hypertension in adult patients whose blood pressure is not adequately controlled by monotherapy15/09/08
759Methylcobalamin 1500mcg Acid 300mg CapsuleFor adult neuropathy.14/10/08
760Methylcobalamin 500mcg + L- Arginine 13.28mg + L- Histidine 3.71mg + L- Isoleucine 5.9mg + L- Leucine 18.3mg + L- Lysine 25mg
+ DL Methiononie 18.4mg + L- Phenylalanine 5mg + L- Threonine 4.2mg + L- Tryptophan 5mg + L- Valine 6.7mg + 5-Hydroxy Anthranilic acid 0.2mg + Vit A 2500IU + Cholecalciferol 200IU + Tocopherol Acetate 7.5IU + Vit B1 5mg + Riboflavin 1.5mg + Nicotinamide 40mg + Calcium Patothenate 30mcg + Vit b6 0.75mg + Vit C 4mg + Biotin 20.5mg + Folic Acid 7.43mg + Copper sulphate 1.4mg + Ferrous sulphate 0.1mg + Magnesium sulphate 10mcg + Potassium iodide15mg + Sodium selenite200mcg + Zinc sulphate + Chromium polynicotinate
For the treatment of vitamin deficiency states in adults14/10/08
761Calcitriol 0.25mcg + Calcium 200mg + Zinc 7.5mg CapsulesFor the treatment of hypocalcaemia and/or osteoporosis11/04/08
762Ferrous bisglycinate 60mg + Folic acid 1mg + Zinc Bis glycinate 15mg + Methylcobalamine
500mcg FC Tablet
For the treatment of vitamin deficiency states in adults14/10/08
763doxyphylline 2mg + Terbutaline 120mg per 5
ml Syrup
For symptomatic treatment of cough24/12/08
764ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol tartrate 25mg/50mg tablets (Additional Strength)For angina & Hypertension02/01/08
765Halobetasol 0.05% + Clotrimazole 1.0% creamFor the treatment of steroid responsive fungal infections including eczema and psoriasis04/01/08
766Levodopa 200mg + Carbidopa 50mg C.R. tabletFor Parkinson's Disease08/01/08
767Ceftazidime 500mg + Tobramycin 60mg per injectionFor the treatment of lower respiratory tract infection caused by pseudomonas
aeruginosa.
08/01/08
768Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg tabletFor the treatment of adult patients with HIV infection07/01/08
769Cefixime 200mg/100mg + Lactic acid bacillus
2.5 billion spores tablet & dispersible tablet
For the treatment of Urinary tract infections, respiratory tract infections, biliary tract infections in adult patients prone to antibiotic associated diarrhoea07/01/08
770Ceftazidime 500mg + Tobramycin 60mg per vial (Injection)For the treatment of lower respiratory tract infection caused by pseudomonas aeruginosa08/01/08
771Atorvastatin 10mg + Aspirin 75/150mg CapsulesFor the treatment of dyslipidemia associated with atherosclerotic arterial disease with risk of myocardial infarction, stroke or peripheral
vascular disease
18/01/08
772Smatriptan (as succinate ) 50mg + Naproxen sodium 550mg tabletsFor the treatment of acute migraine22/01/08
773Sodium Valproate 666mg + valproic acid 290mg equivalent as sodium valproate 1000mg
C.R. tablet (Additional Strength)
Same as Approved24/01/08
774Cefepime (as hydrochloride) 2000/1000/500mg
+ Sulbactam (as sodium) 1000/500/250mg per vial of injection
For serious CRTI, uncomplicated and complicated UTI, Uncomplicated skin & skin structure, infection acute exacerbation of chronic bronchitis & intraabdominal infection.24/01/08
775Combikit 4 tablets of Alendronate sodium trihydrate equivalent to Alendronic acid 70mg each + 24 tablets of Calcium carbonate 1250mg (equivalent to 500mg Calcium) +
cholecalciferol-250IU
For the treatment of osteoporosis in post-menopausal women23/01/08
776Atorvastatin 10mg + Fenofibrate 80mg tablet (Additional Indication)For the treatment of combined hyperlipidemia in patients with normal hepatic and renal functions.25/01/08
777Sodium Valproate 499.5mg + Valproic acid 217.5mg equivalent as sodium valproate- 750mg CR tablet (Additional Strength)Same as Approved24/01/08
778Diclofenac 50mg + Serratiopeptidase 10mg enteric coated tabletFor the treatment of acute pain in adults24/01/08
779Gabapentin 100mg + methylcobalamin 500mcg tablets (Additional Strength)For neuropathic pain in adults.24/01/08
780Cefpirome (as sulphate) 500/1000mg/2000mg + Sulbactam (as sodium ) 250mg/500mg/1000mg powder for injectionFor the treatment of infection caused by sensitive organisms viz. lower RTI, complicated UTI, Septicemia,
bacteremia
24/01/08
781Metformin HCl ER 500mg + Fenofibrate 80mg/160mg tabletFor the treatment of Type-II diabetes associated with mixed dyslipidemia25/01/08
782Diclofenac sodium 50mg + Dicyclomine HCl 20mg per ml of injectionFor the treatment of acute colicky pain in adults28/01/08
783Travoprost 40mcg + Timolol (as Maleate) 5mg per ml of eye dropsFor decrease of intraocular pressure in patients with open angle glaucoma or ocular hypertension, who are insufficiently responsive to topical beta blockers or prostaglandin analogues28/01/08
784Amoxicillin 250mg/125mg + Cloxacillin 250mg/125mg + Lactic Acid Bacillus 1.7 Billion sporesFor RTI, SRS of tissue infection, bons & joint infection, ENT infection in adults prone to antibiotic associated
diarrhoea
30/01/08
785Amoxicillin 250mg + Lacto- Bacillus 1.7 billion Spores capsuleFor RTI, SRS of tissue infection, bons & joint infection, ENT infection in adults prone to antibiotic associated
diarrhoea
31/01/08
786Mecobalamin1500mcg +Alpha Lipoic Acid100mg+Benfothiamine15mg+B63mg+Calc ium Pantothenate25mg+Folic Acid 1.5mg+Zinc oxide22.5mg+Chromium
picolinate65mcg+Inositol10mcg+Lutein5mg capsule
For Vitamins and Minerals deficiency states in adult patients30/01/08
787Methylcobalamine 750mcg + Alphalipoic acid 100mg + Benfothiamine 7.5mg + B6 1.5mg + Calcium pantothenate25mg + Nicotinamide 50mg + Folic acid0.75mg capsuleFor Vitamins and Minerals deficiency states in adult patients30/01/08
788Mecobalamin500mcg + Alpha Lipoic Acid200mg + Benfotiamin 10mg +
Pyridoxine3mg + Biotin5mg + Folic acid 1.5mg capsule
For Vitamins deficiency states in adult patients30/01/08
789Amoxycillin 250mg + Cloxacillin 250mg + Lactobacillus 2 billion spores capsulesFor the treatment of lower RTI, skin & soft tissue bone & joint infections, ENT infections in adult patients prone to antibiotic associated diarrhoea30/01/08
790Tiotropium (as Tiotropium Bromide Monohydrate) 18mcg + Formoterol Fumarate Dihydro. 12mcg + Ciclesomide 400mcg per capsulesAs 3rd line treatment of sever cases of COPD when monotherapy and second line therapy with two drugs do not respond adequately31/01/08
791Metoprolol Succinate Equivalent to Metoprolol Tartrate [ER 25/50mg] + Atorvastatin (As calcium ) 10mg tabletsFor the treatment of patient with both essential hypertension and hypercholesterolemia28/01/08
792Hyaluronic Acid Salt 25mg + Cross-Linked Hyaluronic acid 25mg per ml in prefilledsyringeFor intradermal implantation and facial soft tissue agumentation30/01/08
793Beclomethasone Dipropionate 0.25mg + Econazole 10mg + Neomycin 5mg per gm of
Cream
For the topical treatment of bacterial and fungal infections30/01/08
794Diclofenac Sodium 50mg + Paracetamol 500mg tabletsFor the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis30/01/08
795Memantine 5mg /10mg + Donepezil 5mg
Tablets
For moderate to severe Alzheimer's
disease
31/01/08
796Cefpodoxime 50mg + Clavulanic acid 31.25mg dispersible tablet & dry syrup (Additional
strength)
For LRTI, URTI and UTI.31/01/08
797Amoxycillin 125mg/250mg/500mg + Lactobacillus 1.66 billion Spores (Capsules)For the treatment of respiratory tract infection, skin and soft tissue infections & antibiotics associated diarrhoea in adult patients31/01/08
798Halobetasol 0.5mg + Miconazole 20mg per gram CreamFor steroid responsive dermatoses associated with superficial fungal infection of skin31/01/08
799Montelucast 10mg + Levocetirizine 5mg film coated tabletsFor the treatment of allergic rhinitis in adults only31/01/08
800Hydroquinone 2% + Tretinoin 0.025% (w/w)
Momentasone 0.10% Gel
For short term intermittent treatment of moderate to severe melasma of the face in the presence of measures for sun avoidance including use of sun
screen
31/01/08
801Phenylephrine 5mg + Chlorpheniramine maleate 0.5mg + Paracetamol 125mg + sodium citrate 60mg + Menthol 1mg (per 5ml) SyrupFor the treatment of common cold and cough associated with fever31/01/08
802Diclofenac Sodium 100mg (SR Pellets) + Rabeprazole Sodium 20mg (E.C Pellets) CapsulesFor treatment of painful inflammatory conditions associated with gastroduodenal ulcers31/01/08
803Ciclesonide 160mcg/320mcg/Formoterol 12mcg
+ Tiotropium 18mcg Dry powder inhaler
As third line treatment of severe cases of COPD, when monotherapy and second line therapy with two drugs do not respond adequately31/01/08
804Ramipril 5mg + HCTZ 12.5mg tablets (Additional Strength)Mild to moderate hypertension in patients (in when combination therappy is appropiate) who have been established on the individual
components given in the same proportion
20/02/08
805Betamethasone 0.05% +Miconazole 2% CreamFor the treatment of steroid responsive dermatoses associated with superficial fungal infections of the skin12/03/08
806Omeprazole 20mg/40mg + Sodium bicarbonate 1680mg per sachet powder for oral suspensionFor gastric ulcer, duodenal ulcer, and GERD12/03/08
807Mecobalamin 1000mcg+ Alpha Lipoic Acid 200mg+ vitamin B6 3mg + Folic Acid 1.5mg+ Inositol 100mg + Benfotiamine 100mg capsuleFor the treatment of diabetic neuropathy19/03/08
808ISMN 30mg SR + Atenolol 50mg tablets (Additional Strength)For angina pectoris19/03/08
809Ambroxol HCl. 15mg + Guiphenesin 50mg +
Terbutalin sulphate 1.25mg + Menthol 2.5mg per 5 ml of syrup
For symptomatic relief of
bronchospasm in bronchial asthma and chronic bronchitis
26/03/08
810Ambroxol HCl 30mg + Guaiphenesin 100mg + Terbutaline sulphate 2.5mg per 10ml SyrupFor the symptomatic relief of bronchospasm in bronchial asthma &
chronic bronchitis
26/03/08
811Drospirenone 3mg + Ethinyl estradiol 0.02mg tablets (Additional Strength)Oral contraceptive in women28/03/08
812Nimesulide 100mg ER + Levocetirizine HCl 5mg TabletsFor symptomatic treatment of acute rhinosinusitis28/03/08
813Methylcobalamin 1000mcg + Pyridoxine Hcl IP 100mg + Nicotinamide IP 100mg + D- Panthenol IP 50mg per 2 ml of injectionFor peripheral neuropathy31/03/08
814Lamivudine 20mg + Stavudine 5mg dispersible tablets (Additional Sgtrength)For HIV infection01/04/08
815Diclofenac Potassium 50mg + Serratiopeptidase (as enteric coated pellets) 15mg capsules (Additional Strength)For the treatment of acute pain in adults08/04/08
816Diacerin 50mg + Aceclofenac 100mg tabletsFor the treatment of adult patients with osteoarthritis of knee and or hip joints11/04/08
817Diacerin 50mg + Glucosamine sulphate 500mg tablets.For the treatment of adult patients with osteoarthritis of knee and hip joints21/04/08
818Sitagliptin ( As Phosphate) 50mg + Metformin Hcl. 500mg/1000mg Film coated tabletsAs an adjunct to diet & exercise to improve glycemic control in patients with type-two diabetes mellitus28/04/08
819Pregabalin 75mg/150mg + Methylcobalamin 750mcg capsules (Additional Strength)For the treatment of adult patients with peripheral neuropathy.05/08/08
820Aliskiren 150/150/300/300mg + HCTZ 12.5/25/12.5/25mg tabletsFor the treatment of essential hypertension in adult patients whose blood pressure is not adequately
controlled on monotherapy .
08/05/08
821Losartan Potassium 25mcg + Amlodipine (as besylate) 5mg tablets. (Additional Strength)mild to moderate hypertension14/05/08
822Halobetasol 0.05% + Salicylic acid 6% Ointment (additional Strength)For the treatment of plaque psoriasis14/05/08
823Sodium Chondroitin sulfate 40mg + sodium Hyaluronate 30mg per ml Intraocular Injection (additional strength)For use as a surgical aid in anterior segments procedure including catract extraction & intra-ocular lens
implantation
14/05/08
824Telmisartan 40 mg + Atorvastatin (as calcium) 10 mg TabletsFor coexisting essential hypertension & hyperlipidemia22/05/08
825Metolazone 2.5mg + Losartan Potassium 25mg/50mg tabletsFor hypertension in patients whose blood pressure is not adequately controlled in monotherapy28/05/08
826Metolazone 2.5mg + Ramipril 2.5mg/5mgFor essential hypertension in adult patients whose blood pressure is not adequately controlled on monotherapy28/05/08
827L-Isoleucine 9.20mg+L-Leucine HCL 9.45mg+L- Methionine 0.395mg+L- Phenylalanine 0.44mg+ L-Threonine0.30 mg+L-Tryptophen 2.14mg + L-Valine 0.70mg+ L-Alanine 8.90mg+ L-Arginine 8.40mg + L- Aspartic Acid 15.37mg+L histadine 0.20mg+ L- Proline 3.10mg +L-Serine 5.30mg+L- tyrosine 2.60mg+Glycine 0.40mg +WFI per 100mlinfusion26/06/08
828Doxercalciferol 0.5mcg/2.5mcg Soft Gelatin capsulesFor the treatment of secondary hyperthyroidism in patients with chronic kidney disease on dialysis29/05/08
829Diclofenac Sodium 50mg + Codeine Phosphate 50mg tabletsFor the treatment of adult patients with
signs & symptoms of acute painful conditions
02/06/08
830Dexrabeprazole 10mg (EC) + Domperidone 30mg SR CapsulesFor the treatment of Gastroeasophageal Reflux Disease (GERD) in patients not responding to dexrabeprazole alone09/06/08
831Diclofenac Diethylamine 1.16% w/w eq. to Diclofenac Sodium 1% w/w + (Methysalicylate
, Linseed Oil, Menthol)
For the treatmenmt of acute painful condition(Sweeling and inflammation due to musculoskeletal disorder09/06/08
832Thiocolchicoside 4mg/8mg 50mg/100mg tabletsFor acute low back pain & other musculoskeletal painful and inflammatory condition in adults11/06/08
833Cefotaxime sodium + Sulbactam sodium for injection (Additional Indication)For the treatment of lower respiratory tract infection in children24/06/08
834Artemether 40mg/80mg + Lumefantrine 240mg/480mg tablets (additional Strength)for the treatment of pf. Malaria cases resistanat to both chloroquine and Sulphadoxine - Pyremethamine
combination.
24/06/08
835Mecobalamin 0.5mg+ Alpha Lipoic Acid
100mg+ Benfotiamin100mg + Pyridoxine 50mg tablets
For the Neuropathy03/07/08
836Methylcobalamin 1500mcg + Alpha Lipoic Acid 200mg + Benfotiamine 50mg + Vit B6 3mg + Biotin 5mg + Folic Acid 1.5mg capsuleFor the Neuropathy04/07/08
837Metoprolol ER + Amlodipine tablets (Additional Indication)For coronary artery disease/ischaemic lheartt disease16/07/08
838Fenofovir Disoproxil fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg tablets18/07/08
839Vildagliptin 50mg/50mg/50mg + Metformin Hcl 500mg +850mg +1000mg tabletsFor the treatment of type_II diabetes mellitus when single drug therapy alongwith diet, exercise do not result in adequate glycemic control21/07/08
840Tenofovir Fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg TabletsFor the treatment of HIV infection in adults23/07/08
841Gatifloxacin 0.3% + Ketorolac Tramthamine 0.4% eye DropFor reduction of part operative inflammatory condition of eyes24/07/08
842Ketorolac Tromethamine 4mg + Gatifloxacin 3mg Eye DropsFor the reduction of post operative inflammatory conditions of the eye24/07/08
843Cefadroxyl (as monohydrate) 125mg + Clavulanic acid (as potassium) 31.25 per 5ml Syrup (Additional strength)For the treatment of adult patients with infections caused by susceptible microorganismsincluding S. aureus , viz. Urinary ract Infection, Lower
Respiratory Tract Infections, and gonococcal urethritis
25/07/08
844Artemether + Lumefantrine Dispersible tablet (40/80mg + 240/480mg ) (Additional Strength)for the treatment of pf. Malaria cases resistanat to both chloroquine and Sulphadoxine - Pyremethamine
combination.
05/08/08
845Ceftazidime + Tobramycin injection (1gm + 120mg) (Additional Strength)For the treatment of lower respiratory
tract infection caused by pseudomonas aeruginosa.
05/08/08
846Ceftriaxone 2gm + Sulbactam 1gm injection (Additional Indication)for the treatment of acute bacterial otitis media, skin & soft structure infections, UTI, uncomplicated gonorrhoea, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, intra abdominal infections, meningitis, surgical
prophylaxis
18/08/08
847Ambroxol + loratadine + Guaifenesin Syrup (30mg + 5mg + 50mg per 5ml)For the treatment of productive cough18/08/08
848Ferrous Ascorbate + Folic Acid + Zinc FC Tablets (100mg + 1.5 mg + 22.5 mg)For the treatment of iron deficiency anaemia18/08/08
849Sodium Chondroitin Sulphate + Sodium Hyaluronate injection (40mg + not more than 17mg per ml)For use as a surgical aid in anterior segments procedure including catract extraction & intra-ocular lens
implantation
25/08/08
850Metolazone + Spironolactone FC Tablets (2.5/5mg + 50mg)For the treatment of oedema associated with congestive heart failure, cirrhosis and nephritic syndrome25/08/08
851Ferrous Ascorbate + Folic Acid Suspension (Equiv. to elemental iron 30mg + 550mcg per 5ml) (New Dosage Form)For iron deficiency anemia27/08/08
852Lopinavir + Ritonavir (100 + 25mg) Tablets (additional strength)For the treatment of patients with HIV infection08/09/08
853Telmisartan + Ramipril (40mg + 2.5mg ) Tablets (Additional Strength)for the treatment of essential hypertension15/09/08
854Drotaverine + Aceclofenac (80mg + 100mg) TabletsFor the treatment of adult patients with muscular pain associated with spasm15/09/08
855Losartan + Chlorthalidone (25/25/50/50mg + 6.25/12.5/6.25/12.5mg) TabletsFor the treatment of mild to moderate hypertension in adult patients whose blood pressure is not adequately controlled by monotherapy15/09/08
856Olmesartan + Ramipril (40mg + 5mg) tablets (Additional Strength)for the treatment of essential hypertension15/09/08
857Fluconazole + Zinc Pyrethrone (Each 30/60ml bottle contains: 2% + 1%) LotionFor the treatment of seborrhoeic dermatitis15/09/08
858Etoricoxib + PCM (60mg + 500mg) TabletsFor the short term use in acute painful and inflammatory condition30/09/08
859Paracetamol + Meloxicam + Benzyl Alcohol + Lignocaine (5mg/ml + 150mg/ml + 1% + 1% ) InjectionIndicated for the treatment of mastitis, metritis, pneumonia, pleuritis, fever and relieving of acute pain in musculoskeletal disorders in animals30/09/08
860Calcium (as Calcium Citrate Malate) + Colecalciferol (as Colecalciferol Concentrate) + Folic Acid (250mg + 100IU + 50mcg) TabletsFor the treatment of calcium and Vitamin D deficiency states (pregnancy, lactation, growing
Children)
30/09/08
861Artemether + Lumefantrine (80mg + 480mg/5ml) Dry syrupfor the treatment of pf. Malaria cases resistanat to both chloroquine and Sulphadoxine - Pyremethamine
combination.
30/09/08
862Budesonide + Formoterol (80/160mcg + 4.5mcg) Inhalational Powder (Additional Indication)Indicated in the regular treatment of patients with moderate to severe COPD with frequent symptoms and a history of exacerbations17/10/08
863Azithromycin + Dexamethasone (10mg + 1mg) Eye DropsFor post operative steroid responsive inflammatory ocular condition when bacterial ocular infections or a risk of bacterial ocular infections exists.21/10/08
864Diclofenac + Thiocolchicoside (50mg (EC) + 8mg) CapsulesFor the treatment of acute inflammation conditions associated with spasm in adults only21/10/08
865Adapalene 0.1% + Benzoyl Peroxide 2.5% gelFor the treatment of acne vulgaris24/10/08
866Calcitriol + Calcium + Zinc (0.25mcg + 200mg
+ 7.5mg) Capsules
For the treatment of hypocalcaemia and/or osteoporosis04/11/08
867Atazanavir + Ritonavir(300mg + 100mg) FC TabletsFor the treatment of patients with HIV infection04/11/08
868Montelucast + Desloratidine(10mg + 5mg) FC TabletsFor the treatment of allergic rhinitis in adults only10/11/08
869Amlodipine + Metoprolol (2.5mg/5 mg + 25mg/50mg (ER) Tablets(additional strength)For hypertension10/11/08
870Losartan + HCTZ (100 mg + 25 mg) Tabletsfor treatment of mild to moderate hypertension.10/11/08
871Salicylic Acid + Coal Tar (3% + 1%) SolutionFor scaling of seborrhea, seborrheic dermatitis, psoriasis of scalp17/11/08
872Salicylic Acid + Coal Tar + Precipitated Sulphur (3% + 1% + 3%) OintmentFor the treatment of psoriasis and fungal skin infection17/11/08
873Thiocolchicoside + Etoricoxib(4mg + 60 mg) FC TabletsFor the acute treatment of inflammatory musculoskeletal
disorders associated with painful muscle spasm in adults.
17/11/08
874Tamsulosin (0.4mg MR Pellets + Tolterodine 2mg/4mg ER Pellets) CapsulesFor BPH with overaction bladder in Adults only.17/11/08
875Sumatriptan + Naproxen (50mg + 275mg) Tablets (additional strength)For the treatment of acute migraine24/11/08
876Amoxycillin + Clavulanic acid(1gm + 62.5mg ) FC TabletsFor the treatment and management of patients with community acquired pneumonia or acute bacterial sinusitis due to beta lactamase producing
pathogens
25/11/08
877Buprenorphine + Naloxone (2 mg/0.4mg + 0.5/0.1 mg) TabletsFor opioid dependence02/12/08
878Atorvastatin + Metformin(10mg + 500mg SR) TabletsAs adjunctive therapy to diet and exercise in patients with diabetic
dyslipidemia
04/12/08
879Rifampicin + INH + Piperine (200mg + 300mg
+ 10mg ) Capsules
For the treatment of adult patients with pulmonary tuberculosis11/12/08
880Rifampicin +Piperine (200mg + 10mg ) CapsulesFor the treatment of adult patients with pulmonary tuberculosis11/12/08
881Mifepristone + Misoprostol (1 tab of mifepristone 200mg and 4 tab of misoprostol 200mcg) CombipackFor the medical termination of intrauterine pregnancy (MTP) of up to 63 days gestation based on the first day of the last menstrual period16/12/08
882Salicylic Acid + Cetyl Alcohol + Stearyl Alcohol (2% + 2.65% + 0.26%) LotionFor the treatment of scaly dermatoses18/12/08
883Gemifloxacin + Ambroxol (320mg + 75mg SR) FC TabletsIndicated for the treatment of lower respiratory tract infections in adult
patients
24/12/08
884Ceftazidime + Sulbactam (500/1000mg + 250/500mg) Injection1. For LRTI infections, 2. for UTI - Complicated and uncomplicated, 3. for bacterial septicemia, 4. for bone and joint infections, 5. for gynaecologic infections including endometritis, pelvic cellutitis, and other infections of female genital tract, 6. for CNS infections including meningitis24/12/08
885Paracetamol + Phenylephrine Hydrochloride (Each 6gm Sachet contains: 500mg + 10mg)
Sachet
For the treatment of fever associated with cold, nasal congestion in adults24/12/08
886Carboinoxamine Maleate + Ammonium Chloride + Sodium Citrate (Each 5 ml contains: 2 mg + 120 mg + 120 mg) syrupFor symptomatic treatment of cough24/12/08
887Diclofenac + Thiocolchicoside (50 mg + 4 mg) Capsules (additional strength)For the treatment of acute inflammation conditions associated with spasm in adults only.24/12/08
888Methylcobalamin1500mcg + Calcium 200mg
+ Calcitriol 0.25mcg + Folic Acid1.5mg + Pyridoxine3mg Capsules
For the treatment of vitamin deficiency states in adults14/01/09
889Liquid Paraffin1.25ml + Milk of Magnesia 3.75ml + Sodium Picosulphate 3.33mg per 5mlFor symptomatic treatment of constipation in adults29/01/09
890Lornoxicam 4mg + Paracetamol 500mg film coated tabletsFor the short term use in acute painful & inflammatory conditions in adults05/02/09
891Cetrimide15% w/v + Chlorhexidine Gluconate
7.5% v/v + Isopropyl Alcohol 7.5% v/v Concentrate Solution
For cleansing of physically
contaminated wounds and for pre- operative disinfection
09/02/09
892Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) SolutionFor the treatment of dandruff09/02/09
893Hydroquinone 2%+ Tretinoin 0.05% + Hydrocortisone1%CreamFor the treatment of patients with skin hyperpigmentation23/02/09
894Doxyphylline 400 mg + Terbutaline 5mg tabletsFor the treatment of asthma and chronic obstructive pulmonary disease in adult patients only23/02/09
895Hydroquinone 20mg + Tretinoin 0.25mg + Fluocinolone Acetonide 0.1mg per gm CreamFor the treatment of melasma of face in adults23/02/09
896Ketoconazole 2% + Zinc Pyrithone 1% LotionFor the treatment of pityriasis and dandruff of the scalp23/02/09
897Lamivudine 30mg + Zidovudine 60mg
+Nevirapine 50mg Oral Suspension (Tablets for oral Suspension)
For the treatment of HIV patients23/02/09
898Glibenclamide 5mg + Pioglitazone 15mg + Metformin500mg film coated tabletsAs 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control23/02/09
899Aceclofenac 100mg + Tizanidine 2mg film coated tabletsFor the treatment of acute low back pain in adult patients only23/02/09
900Octinoxate 7.5% + Avobenzone 3% + Oxybenzone 3% + Titanium dioxide 2% lotionAs sunscreen lotion for prevention of sunburn skin23/02/09
901Cetrizine 5/10mg + Ambroxol 30mg per 5ml syrupFor the symptomatic relief of productive cough associated with allergic rhinitis, when both anti- histamine and mucolytic agents are
desired
23/02/09
902Thiamine Mononitrate IP 10.0mg + Riboflavin IP 10.0mg + Pyridoxine HCl IP 3.0mg + Vit. B12 IP 15.0mcg + Niacinamide IP 100.0mg + Calcium Pantothenate USP 50mg + Folic Acid
IP 1.5mg + Biotin USP 100.0mcg + Ascorbic Acid IP 150.0mg capsule
For various vitamins deficiency states26/02/09
903Thiamine Mononitrate IP 10mg + Riboflavin IP 10mg + Pyridoxine HCl IP 3mg + Vit. B12 IP 15mcg + Niacinamide IP 100mg + Calcium Pantothenate IP 50mg + Folic Acid IP 1.5mg + Biotin USP 100mcg + Ascorbic Acid IP 150mg
+ Zinc Sulphate monohydrate USP 41.4mg (eq.to 15mg elemental Zinc) capsule
For various vitamins deficiency states26/02/09
904Calamine 8% + Liquid Paraffin10% lotionAs antipruritic and smoothening agent26/02/09
905Nifedipine 0.3% + Lidocaine1.5% creamFor the treatment of anal fissures26/02/09
906Quinapril 20mg + HCTZ 25mg film coated tabletFor the treatment of mild to moderate hypertension in adult patients (in whom combination therapy is appropriate) who have been stabilized on the individual components given in
the same proportion
26/02/09
907Levodopa 100/100/250 + Carbidopa10/25/25mg mouth dissolving tabletFor the symptomatic symptoms of idiopathic Parkinson's Disease04/03/09
908Losartan 100mg+ HCTZ 25 mg tabletfor treatment of mild to moderate hypertension.16/03/09
909Butaphosphan 100g + Methyl Hydroxybenzoate
1gm + Cyanocobalamin50 gm Oral powder (Veterinary Drug)
As vitamin and phosphorous
supplement for livestock, shirmp and fish.
19/03/09
910Octinoxate 7.5%
Oxybenzone 3%
Oxide 2% lotion
A sunscreen lotion for prevention of sunburn skin19/03/09
911Omeprazole 20/40mg + Sodium Bicarbonate 600mg+ Magnesium Hydroxide 700mg sachetFor duodenal, gastric ulcer, GERD, and erosive esophagitis,19/03/09
912Ambroxol 30mg + Levo salbutamol 1mg+Guiphenesin 50mg /5ml syrupFor the symptomatic relief of
bronchospasm in bronchial asthma & chronic bronchitis
19/03/09
913Montelucast 4 mg+ Levocetrizine 2.5 mg tabletFor the treatment of allergic rhinitis for paedriatric dose03/03/09
914Theophylline 400mg SR + Montelukast10mg TabletFor the treatment of patients with bronchial asthma31/03/09
915Hyaluronic Acid Sodium Salt 0.2 gm + Silver Sulfadiazine 1.0 gm/25 gm tubeFor the treatment differentetiology31/03/09
916Hyaluronic Acid Sodium Salt 50 mg + Silver Sulfadiazine 1.0 gm/ 100 gm gauze pads impregneted with cream.For the treatment differentetiology31/03/09
917Telmisartan 80mg + Amlodipine 5mg tablet (Additional strength)For essential hypertension31/03/09
918Cetrizine 10 mg + Ambroxol 75 mg SR TabletFor symptomatic relief of productive cough associated with allergic rhinitis, when both anti-histamine and mucolytic agents are desired13/04/09
919Ciclesonide 200mcg + Formoterol 6mcg
+Tiotropium 9mcg MDI
Indicated as third line treatment of severe cases of COPD, whenmonotherapy and second line therapy with two drugs do not respond
adequately.
13/04/09
920Metoprolol 25mg/50mg + Chlorthalidone 12.5/
12.5 mg film coated bilayered Tablet
For the tretament of patients with mild to modrate essential hypertension13/04/09
921Metoprolol 25mg/50mg + Chlorthalidone 6.25 mg /12.5mg film coated bilayred tablet
(additional strength)
For the tretament of patients with mild to modrate essential hypertension25/04/09
922Albendazole 400 mg + Ivermectin 6 mg tabletFor the treatment of intestinalhelminthes and suppression ofmicrofilaraemia especially with
bancrofti infections
25/04/09
923Each ml contains Calamine 15% w/v + Zinc oxide 5% w/v + Bentonite 3% w/v+Glycerin 5%w/v + Sodium citrate 0.05 %
w/v lotion
For the tretament of pruritis and prickly heat08/05/09
924Each 1000 ml of emulsion contains: Medium chain triglycerides 100 gm + Soya oil 80 gm + Omega-3 acid triglycerides 20 gm + egg lecithin 12 gm + Glycerl 25 gm + Sodium oleate
0.30 gm + Alpha -tocopherol 0.20 gm
+ Ascorbypalmitate0.30 gm + Sodium hydroxide max. 0.06 gm + water for injection 784 gm emulsion for infusion
For the supply of fats, including essential omega-6 fatty acids and omega-3 fatty acids, as part of a parenteral nutrition regimen in adults iforal or enteral nutrition is impossible,inadequte or contraindicated.14/05/09
925Each 15 gm sachet contains: Lactulose 10 gm
+ Ispaghula husk 3.50 gm granules
For the treatment of chronic idiopathic constipation in adult patients only16/05/09
926Dexketoprofen 12.5 mg/25 mg + Paracetamol 500 mg film coated tabletsFor the treatment of Acute musculoskeletal pain18/05/09
927Each gm contains: Halobetasol 0.05% w/w
+ Mupirocin 2.0 % w/w gel
For the topical treatment of inflammatory dermatitis
with secondrybacterial infection
16/05/09
928Mometasone 0.1 % + Fusidic acid 2% cream/ointmentFor the treatment of dermatoses wheresecondry bacterial
and/or candidialinfection is present
25/04/09
929Thiocolchicoside 8 mg + Etoricoxib 60 mg tablets (additional strength)For the acute treatment of inflammatory musculoskeletal disorders associated with painful
muscle spasm in adults.
25/04/09
930Metoprolol 50/50/25 mg + Atorvastatin 20/10/10 mg + Ramipril 10/5/2.5 mg capsulesAs 2nd line treatment of patients with both essential hypertension and hypercholesterolemia who are not adequately controlled by combination of an anti-hypertensive
with lipid lowering agent.
01/07/09
931Voglibose 0.2 mg + Metformin 500mg TabletsAs 2nd line treatment of type II Diabetes mellitus when diet, exercise and the single agent do not result in adequate glycemic control.13/07/09
932Combipack of artesunate tablet and FDC Tablet of sulphadoxine + pyrimethamine Composition: A. combipa ck of 1 stip of 3 tablets ofartesunate 25 mg and
1 strip of 1 tablet of sulphadoxine 125mg+ pyrimethamine 6.25
mg B. combipa
ck of 1 stip of 3 tablets ofartesunate 50 mg and
1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25
mg C. Combipack of 1 stip of 3 tablets ofartesunate 100 mg and 1 strip of 2 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg D. combipack of 1 stip of 3
tablets ofartesunate 200 mg and 1 strip of 3 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg.
For the treatment of P. falciparum resistant malaria patients15/07/09
933Simvastatin 20 mg + Ramipril 5mg + Atenolol 50 mg + HCTZ 12.5 mg + Aspirin 100 mg (EC Pellets) CapsulesFor secondary prevention of coronoryheart disease/stroke in patients where use of such
combination is appropriate
21/07/09
934Sumatriptan 85 mg + Naproxen 500 mg TabletsFor the treatment of acute migraine03/08/09
935Aceclofenac(100mg) + Thiocolchicoside ( 8 mg) tabletsFor the treatment of acute inflammation conditions associated with spasm in adults only03/08/09
936Aceclofenac(100mg) + Thiocolchicoside ( 4 mg) tablets (Additional strength)For the treatment of acute inflammation conditions associated with spasm in adults only11/08/09
937Ofloxacin 2mg + Ornidazole 5 mg per ml Infusionfor the treatment of diarrhoea of mixed infection in adult patients17/08/09
938Artesunate (25/50/100mg) + Amodiaquine (67.5 mg/135/270mg) bilayerd TabletsFor the treatment of uncomplicated malaria due to plasmodium falciparum strain in various age groups01/09/09
939Ezetimibe 10 mg + Fenofibrate 145 mg Film coated tabletsFor the treatment of combined hyperlipidemia in patients with normal hepatic and renal function01/09/09
940Isosorbibe 20 mg + Hydralazine 37.5 mg tabletsFor the treatment of heart failure as an adjunct to standard therapy in patients to improve survival, to prolong time to hospitalization for heart failure and to
improve patients reported functional status.
18/09/09
941Cefixime 200 mg + Dicloxacillin ER 500 mg TabletsFor the treatment of adult patients with Upper and Lower respiratory tract infections, skin and soft tissue
infections
22/09/09
942Etodolac 300mg + Paracetamol 500mg film coated tabletFor the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis20/10/09
943Ambroxol 30 mg+ Terbutaline 2.5 mg + Guaiphenesin 100mg + Menthol 2.5 mg per 5 ml syrup (additional strength)For symptomatic relief of bronchospasm in bronchial asthma and chronic bronchitis27/10/09
944Propofol 10 mg+ Lignocaine 2.5 mg per ml injection (addditional Strength)For induction of anesthesia27/10/09
945Mecobalamin 750 mg + Pyridoxine Hydrochloride1.5 mg + Nicotinamide 45 mg
tablets
For the treatment of diabetic neuropathy27/10/09
946Olmesartan (20/40mg )+ Atorvastatin 5/10/20mg film coated tabletsFor the treatment of co-existing essential hypertension and hyperlipidemia in adult patients27/10/09
947Glucosamine sulphate potassium chloride 500 mg + Ibuprofen IP 200mg film coated TabletsFor the treatment of adult patients with osteoarthritis of knee and/or hip joints03/11/09
948Methylcobalamin 1500 mcg + Gabapentin SR 600 mg film coated tablets (additional strength)For neuropathic pain in adults.04/11/09
949Rupatadine 10 mg + Montelukast 10 mg TabletsFor the management of seasonal allergic rhinitis (SAR)10/11/09
950Eperisone 50 mg + Paracetamol 500 mg TabletsFor improvement of mytonic conditions caused by neck shoulder arm syndrome , scapulhumeral periarthritis and low back pain in adult
patients only
10/11/09
951Lactobacillus Rhammnosus 1 billion cells + Saccharomyces Boulardi 125 mg + Zinc Enriched yeast 20 mg sachets & capsulesFor the treatment of acute diarrhoea in children04/11/09
952Nimesulide 1.0% w/w + Ethanol 31% w/w topical solutionFor the local application in relieving pain in acute low backache, tendonitis, tenosinovitis and sprains17/11/09
953Amlodipine 5mg/10mg/5mg/10mg/10mg + Valsartan 160mg/160mg/160mg/160mg/320mg
+ Hydrochlorothizide
12.5mg/12.5mg/25mg/25mg/25mg Tablets
For the treatment of essential hypertension24/11/09
954S (+) Etodolac 150/200/300mg + Paracetamol 500/500/500mg TabletsFor the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis25/11/09
955Loteprednol etabonate 0.5% w/v + Moxifloxacin 0.5% w/v opthalmic SuspensionFor the treatement of post operative steriod responsive inflammatory ocular infections or risk of bacterial ocular
infections exists
01/12/09
956Halometasone monohydrate 0.05% w/w + Fusidic acid 2.00% w/w creamFor the treatment of acute and chronic infected eczematous dermatitis15/12/09
957Glimepiride 1/2 mg + Metformin 500 mg + Atorvastatin 10 mg tabletsFor the treatment of type II diabetes mellitus associated with dyslipidemia17/12/09
958Xylometazoline 0.5 mg + Ipratropium 0.6 mg Nasal sprayFor symptomatic treatment of nasal
congestion with running nose (rhinorrhea)
23/12/09
959Doxofylline 400 mg + Ambroxol 30 mg TabletsFor the treatment of patients with bronchial asthma and COPD, when use of both the drug is appropriate23/12/09
960Formoterol 6 mcg + Mometasone furoate 100/200/400mcg Metered dose Inhaler & Dry Powder InhalationFor the treatment of patients with bronchial asthma and COPD, where the use of combination is found
appropriate
30/12/09
961Alendronate 70mg + Colealciferol 140mcg (5600 IU) TabletsFor the treatment of mixed infections with roundworms and tapeworms in
dogs
10/11/09
962Cefoperazone 500/1000mg + Tazobactum 62.5/125mg InjectionFor the treatment of patients with both essential hypertension and hypercholesterolemia04/11/09
963Aceclofenac 200mg/200mg SR + Rabeprazole 10mg/20mg CapsuleFor the treatment of Painful inflammatory conditions associated with gastroduodenal ulcers.01/07/09
964Metformin Hcl 850mg + Sitagliptin Phosphate 50mg TabletAs an adjunct to diet & exercise to improve glycemic control in patients with type-two diabetes mellitus15/12/09
965Acarbose 25mg/50mg + Metformin 500mg/500mg FC TabletFor the treatment of patients with Type II diabetes mellitus, when diet, exercise and single agent do not result in adequate glycemic control.23/02/09
966Octinoxate 7.5%+ Avobenzone 2% + Oxybenzone 3% + Zinc Oxide 2% LotionA sunscreen lotion for prevention of sunburn skin23/02/09
967Halobetasol 0.50mg + Fusidic acid 20mg CreamFor the treatment of infected
dermatoses
23/02/09
968Octinoxate 7.5% + Avobenzone 2% +
Oxybenzone 3% + Octocrylene 3% + Zinc Oxide 2% Lotion
A sunscreen lotion for prevention of sunburn skin19/03/09
969Escitalopram 5mg + Clonazepam 0.5mg Tabletfor treatment of patients with
comorbid depression and anxiety disorders
13/12/07
970Lornoxicam 8mg + Paracetamol 500mg TabletFor the short term use in acute painful & inflammatory conditions in adults14/05/09
971Comipack of Ibandronic acid 150mg + Calcium carbonate 500mg + Calcitriol 0.25mg + Zinc sulphate 20mgFor the treatment of hypercalcaemia and/or osteporosis05/03/09
972Diacerin 50mg + MSM 250mg + Glucosamine 750mg TabletAs initial therapy in adult patients with osteoarthritis of knee and hip joints01/06/09
973Indapamide 1.5mg/1.5mg + Ramipril 2.5mg/2.5mg FC TabletFor the management of hypertension in subjects not responding to any diuretic or ace inhibitor monotherapy08/07/09
974Levodropropizine Eur. Ph. 30mg +
Chlorpheniramine maleate IP 2mg per 5 ml Syrup
For the treatment of non-productive cough06/07/09
975Ferrous ascorbate 100mg + Folic acid 1.1 mg
tablet and Omega-3-fatty acid 200mg capsules combikit
For iron, folic acid & omega-3-fatty acid deficiency01/08/10
976Propanol 1-ol 18gm + Ethanol 100% 45gm/100ml solutionFor hygenic and surgical hand disinfection18/01/10
977Aliskiren 150/160mg + Valsartan 300/320mg
tablets
For the treatment of hypertension19/01/10
978Piroxicam 20mg tab& Paracetamol 500mg tab combikitFor treatment of fever and pain associated with acute upper respiratory tract inflammation, acute musculoskeletal disorders, pain after operative intervetion and following trauma, chronic condition like rheumatoid arthritis, osteoarthritis etc for short term management of acute painful episodes.19/01/10
979Artemether 20mg + Lumefantrine 120mg Dispersible tablet (Additional Strength)for the treatment of pf. Malaria cases resistanat to both chloroquine and Sulphadoxine - Pyremethamine
combination.
08/02/10
980Soybean oil 60gm + Triglycerides (medium chain) 50gm + olive oil purified fish oil 30gm + dl-alpha-tocopherol 163-225mg + glycerol (anhydrous) 25gm + Egg lecithin 12gm + sodium hydroxide (to approx pH 8) + sodium
pleate 0.3mg emulsion for infusion in 100ml.
Total parenteral nutrition following major abdominal, major thoracic or major urological surgery19/01/10
981Cinnarizine 20mg + Dimenhydrinate 40mg tabletsFor the treatment of vertigo02/03/10
982Pregabalin SR 75/150/300mg + Methylcobalamin 1500mcg tabletsFor the treatment of adult patients with peripheral neuropathy02/09/10
983Sodium chloride 6.80gm + Potassium chloride
0.30 gm + Calcium chloride dihydrate 0.37gm + Magnesium chloride hexahydrate 0.20gm + Sodium acetate trihydrate 3.27gm + L-malic acid 0.67gm in 1000ml solution for
infusion
Replacement of extracellular fluid losses in case of isotonic dehydration, especially if acidosis is being imminent or present02/11/10
984Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tabletsFor the treatment of patients with acute painful musculoskeletal conditions02/12/10
985Cefixime 100mg/200mg + Cloxacillin 500mg/500mg tabletsFor the treatment of adult patients with upper & lower respiratory tract infections, skin and soft tissue
infections
02/12/10
986Spironolactone 25mg + Furosemide 20mg tabletsFor treatment of resistant oedema associated with secondary hyperaldosteronism; resistant
hypertension, chronic cardic failure and hepatic cirrhosis
03/05/10
987Olopatadine5mg + Ambroxol30mg tabletsFor the management of cough in adult patients only03/05/10
988Methylcobalamin750mcg + Pregabalin75/150mg + Vitamin B61.5mg + Folic acid0.75mg + Benfothiamine7.5mg
capsules
For the treaetment of painful diabetic neuropathy in adults only03/05/10
989Calcium acetate 435mg + Magnesium carbonate 235mg tabletsFor the management of hyperphosphatemia in adults patients with renal failure being treated with dialysis (hemodialysis or peritoneal
dialysis
03/05/10
990Dicyclomine2.5mg + Dried Aluminimum Hydroxide200mg + Light Magnesium Oxide100mg + Simethicone 20mg per 5ml suspension.For the treatment of the symptoms of functional gastrointestinal disorders like irratible bowel syndrome, functional dyspepsia, peptic ulcers., GERD which includes smooth muscle spasm, flatulence, abdominal distension, hyperacdity, gastric distress, bloting etc.03/05/10
991Sertaconazole 2% w/v+ Zinc Pyrithione 1% w/v ShampooFor the treatment in adults patients with dandruff/seborrheic dermatitis of
the scalp
03/05/10
992Amlodipine5mg + Ramipril10mg/5mg Tablets (additional strength)For the treatment of hypertension only03/10/10
993Lidocaine7.5mg + Prilocaine2.5mg per acutation sprayFor the treatment of adult male patients with premature ejaculation03/12/10
994Drosperinone 3mg + Ethinyl Estradiol0.02mg tabletsFor the treatment of symptoms of premenstrual dysphoric disorders (PMDD) in women (additional
indication)
16/03/10
995Miglitol 25 mg + Metformin 500mg tabletsFor adult with Type-II diabetes mellitus where simple drug therapy, diet and exercise do not result in adequate glycemic control.16/03/10
996Propranolol 40mg (SR Pellets) + Fluarizine 5mg/10mg capsulesFor the prophylaxis of migraine16/03/10
997Citicholine 500mg + Piracetam 400mg TabletsFor the treatment of acute stroke16/03/10
998Diclofenac 50mg + Chlorzoxazone500mg TabletsFor the treatment of acute inflammation conditions associated with spasm in adults only16/03/10
999Mecobalamin 750 mcg + Pyridoxine 1.5mg +
Nicotinamide 45 mg + Benfotiamine 150mg Tablets
For the treatment of diabetic neuropathy in adults16/03/10
1000Etoricoxib 1%+ Menthol 5% SprayFor the topical treatment of acute musculoskeletal pain16/03/10
1001Pantoprazole 40mg + Cinitapride (ER) 3mg CapsulesFor the treatment of patients suffering from non-ulcer dyspepsia (NUD) or gasteroesophageal reflux disease
(GERD)
17/03/10
1002Atorvastatin 20mg + Ramipril 2.5mg/5mg Capsules (additional strength)For treatment of patients with both hypertension and
hypercholesterolemia.
17/03/10
1003Lornoxicam 8mg/8mg + Thiocolchicoside 4mg/8mg Tablets (additional strength)For the treatment of patients with acute painful musculoskeletal conditions23/03/10
1004Lidocaine 2.5% w/w+Prilocaine 2.5% w/w Gel (additional strength)As a topical an aesthetic for use on normal intact skin for local anaesthesia26/03/10
1005Praziquntel 175mg + Pyrantel 504mg + Febental 525mg TabletsFor the treatment of mixed infections
with roundworms and tapeworms in dogs
30/03/10
1006S(-)Metoprolol 25mg/50mg (ER) + Atorvastatin (IR)10mg tabletsFor the treatment of patients with both essential hypertension and hypercholesterolemia01/04/10
1007Atorvastatin Calcium IP Eq. to Atorvastatin 5mg + Fenofibrate BP 145mg film coated tablet (additional strengths)For treatment of combined hyperlipidemia in patients with normal hepatic and renal function.29/04/10
1008Atorvastatin10mg + Ramipril 5mg + Aspirin (EC pellets) 75mg/150mg + Metoprolol (ER tablets) 25mg CapsulesFor secondary prophylaxis of ischemic heart disease in patients where use of such combinations in appropriate04/05/10
1009Ibuprofen 400mg + Chlorzoxazone 500mg TabletsFor the short term treatment of musculoskeletal pain associated with inflammation and spasm in adults only04/07/10
1010Doxophylline (SR) 400mg/800mg + Montelukast 10mg/10mg TabletsFor the treatment of bronchial asthma in adults04/07/10
1011Cefixime 100mg/200mg + Ofloxacin 100mg/200mg TabletsFor the treatment of patients with typhoid fever and urinary tract
infection in adults
26/04/10
1012Liquid paraffin 6% + White soft paraffin 15%w/v CreamFor symptomatic relief of dermatological condition associated with dry skin including atopic dermatitis, eczema, pruritus,
ichthyosis, xerosis, psoriasis
29/04/10
1013Telmisartan 40/80 mg+ Indapamide SR 1.5/1.5 mg tabletFor the treatment essential hypertension04/05/10
1014one strip of 3 uncoated tablets of artesunate 150mg & one strip of 2 uncoated tablets of FDC of Sulphadoxine IP 500mg + Pyrimethamine IP
25mg
For the treatment of P. falciparum resistant malaria patients04/05/10
1015Indapamide (SR) 1.5mg/1.5mg +Nebivolol 2.5mg/5mg tabletFor the treatment of hypertension not controlled with monotherapy05/12/10
1016Cinitapride (ER) 3mg + Omeprazole (EC) 20mg CapsulesFor the treatment of gastirc ulcer,gastroesophageal reflux disease(GERD) & Dyspepsia not responding to omeprazole alone05/12/10
1017Dexketoprofen Trometamol 25mg + Thiocolchicoside 4mg tabletsFor the treatment of acute low back pain and other musculoskeletal painful & inflammatory conditions in adult
patients
20/05/10
1018Fluticasone Propionate 50mcg/125mcg/250mcg
+ Salmeterol xinafoate 25mcg/25mcg/25mcg Powder for inhalation
For the maintenance treatment of asthma and for the treatment of COPD associated with chronic bronchitis25/05/10
1019Cross linked Hyaluronic Acid 24mg + Lidocaine 3mg Pre-filled syringsFor filling any medium sized depression of the skin via mid dermis injection as well as for lip definition. The presence of lidocaine is meant to reduce the patients pain during the
treatment
28/05/10
1020Aceclofenac 1% w/w + Menthol 5% SprayFor the treatment of acute painful inflammatory conditions in adults only28/05/10
1021Metformin SR 500mg/500mg + GliclazideSR 60mg/30mg + Pioglitazone 15mg/15mg tabletsAs 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control28/05/10
10223 tablets of artesunate 100mg + 3 tablets of Artesuante 50mg & 2 tablets of FDC of Pyrimethamine 25mg + Sulphadoxine 500mg
combipack
For the treatment of P. falciparum resistant malaria patients28/05/10
1023Calcium carbonate 600mg +Simethicone 80mg Chewable tabletTo relive the uncomfortable symptoms of acid indigestion, heart burn, gas or sour stomach28/05/10
1024Activated Dimethicone 50mg + Magnesium Hydroxide 250mg+ Dried Aluminium Hydroxide250 mg + Sorbitol (70%)1.25 gm
/5ml Solution
For treatment of symptoms of hyperacidity (e.g. heartburn, epigastric discomfort, or their equivalents) that are often associated with dyspepsia, peptic ulcers, gastritis, peptic esophagitis and indicated for relief of flatulence28/05/10
1025Aspirin 75mg + Simvastatin 10mg/20mg + Lisinopril 5mg/10mg + Atenolol 25mg/50mg TabletsFor secondary prevention of coronory heart disease/stroke in patients where use of such combination is appropriate06/01/10
1026Methylcobalamin 1500mcg +Folic acid 0.7mg
+Niacinamide 12mg injection
For the treatment of diabetic neuropathy in adults23/06/10
1027Methylcobalamin 1500mcg +Pyridoxine 100mg
+Nicotinamide 100mg injection
For the treatment of diabetic neuropathy in adults23/06/10
10281 tablet of Tenofovir disoproxil 300mg +
Lamivudine 300mg & 2 tablet of Nevirapine 200mg combipack
For the treatment of HIV infection in adults23/06/10
1029Vitamin A (oily form) as palmiate 2000IU + Vitamin B1 1mg + Vitamin B2 1mg + Vitamin B6 1.34mg + Vitamin B12 1mcg + Ascorbic acid 33.3mg + Vitamin D3 200IU + Folic acid 0.3mg + Calcium pantothenate 1mg + Niacinamide 15mg + Dibasic calcium phosphate 100mg + Phosphorus 77mg+ Ferrous fumarate 50mg + Copper 0.01mg+ Potassium iodide 0.0015mg + Heavy magnesium oxide 1mg + Manganse sulphate 0.01mg + Potassium sulphate 1mg + Zinc sulphate 0.15mg CapsuleFor the treatment of vitamin deficiency states in adults23/06/10
1030Dexketoprofen1.25% w/w +Linseed Oil 3.0%w/w +Menthol 5%w/w +Methyl Salicylate 10%w/w (12.5mg) GelFor the topical treatment of acute musculoskeletal pain07/06/10
1031Cefuroxime Sodium 750/1500mg +Sulbactam Sodium 375/750mg InjectionFor the treatment of mild to moderate lower respiratory tract infection07/06/10
1032HPMC 0.3% +Dextran 0.1% + Glycerin 0.2% eye dropFor the temporary relief of burning and irritation due to dryness of the eye and for use as a protection against further irritation. For the temporary relief of discomfort due to minorirritations of the eyes or to exposure to wind or sun07/06/10
1033Cyanocobalamin 15mcg+Chromium Picolinate USP 250mcg+Folic Acid USP 1500 mcg+Nicotinamlide IP100 mg+Pyridoxine 3mg
+Selenius Acid USP 100mcg+Zinc Sulfate Monohydrate USP 61.8 mg eq. to 22.5 mg
Tablet
For Mineral & Vitamins deficiency states in adult patients07/06/10
1034Methylparaben 0.15%w/w +Propyl paraben 0.05%w/w+Glycerin 20%w/w +CMC 1.74%w/w +Allantoin 0.5%w/w +Benzyl
alcohol 0.5%w/w. GEL
For short term treatment of chronic wounds including stage III & IV pressure sores, leg ulcers07/06/10
1035Clonazepam IR 0.5mg/0.5mg+ Paroxetine CR 12.5/25mg CapsuleFor the treatment of patients with co- morbid depression and axiety07/08/10
1036Metoprolol succinate ER 25/50 mg+Telmisartan 20/40mg TabletFor the treatment of essential hypertension16/07/10
1037Etodolac 300/300mg +Thiocolchicoside 4/8mgFor the treatment of patients with acute painful musculoskeletal conditions19/07/10
1038Celecoxib 100/200mg +Diacerein 50/50mg CapsuleFor the treatment of adult patients with osteoarthritis of knee and/or hip joints19/07/10
1039Metoprolol succinate ER 25mg+50mg + Olmesartan 20/20mg TabletFor the treatment of essential hypertension19/07/10
10401 tablet of Atazanavir 300mg & 1 tablet of ritonavir Ritonavir 100mg & FDC of Tenofovir Disoproxil fumarate 300mg + Lamivudine 300mg (Each Co-pack contains :- 1 capsule of Atazanavir 300mg & 1 Tablet of Ritonavir 100mg & 1 Tablet of FDC of Tenofovir
Disoproxil Fumarate 300mg + Lamivudine 300mg)
For the treatment of HIV infections in adults19/07/10
1041Gliclazide 40/80mg+Metformin 500mg+Pioglitazone15mg TabletAs 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control19/07/10
1042Metformin 500/850/1000mg+Sitagliptin Phosphate 50/50/50mg Tablet(Additional Indication)A) FDC is indicated as triple combination therapy with a PPARy agonist (i.e a thiazolidinedione) as an adjunct to diet and exercise in patients inadequtely controlled on their maximal tolerated dose of metfomin and a PPARy agonist. B) FDC is also indicated as add-on to insulin(i.e triple combination therapy) as an adjucnjt to diet and exercise to improve glycemic contrl in patients when stable dosage of insulin and metformin alone do not provide adequte control.08/02/10
1043S(+) Etodolac 5/10%w/w + Camphor 4%w/w + Menthol 10%w/w + Methyl salicylate 5%w/w + Linseed oil 3%w/w gelFor the painful & inflammatory conditions associated with joint, tendons, ligaments and muscles08/05/10
1044Cefpodoxime 100/200mg+Dicloxacillin ER 500/500mg TabletFor the treatment of lower RI, Skin and soft tissue, bone and joint infections and ENT infections in adult patients prone to antibiotic induced diarrhoea08/06/10
1045Voglibose 0.3mg + Metformin (SR) 500mg TabletAs 2nd line treatment of type II Diabetes mellitus when diet, exercise and the single agent do not result in adequate glycemic control.08/06/10
1046Olmesartan 40mg + Amlodipine 5mg Tablet (Additional Strength)Additional indication: 1. For the treatmenmt of hypertension alone or with other antihypertensive agents 2. To use as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals08/09/10
1047Metformin 500/500mg + Repaglinide 1/2mg TabletIndicated as an adjunct to diet and excersice to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide & metformin or who have inadequte glycemic control on a meglotinide alone or metformin20/08/10
1048Rosuvastatin 5/10/20mg+Fenofibrate 67/145/160mg TabletFor the treatment of combined hyperlipidemia in patients with normal hepatic and renal function23/08/10
1049Rosuvastatin 5/10mg +Fenofibrate 145/67 mg TabletFor the treatment of combined hyperlipidemia in patients with normal hepatic and renal function23/08/10
1050Fexofenadine 120mg + Montelukast 10mg Chewable tabletFor treatment of allergic rhinitis in adults only31/08/10
1051Cefixime SR 200mg/400mg + Ofloxacin SR 200mg/400mg TabletFor the treatment of patients with
typhoid fever and urinary tract infection in adults
31/08/10
1052Etodolac 400mg/400mg + Thiocolchicoside 4mg/8mg tablet (additional strength)For the treatment of patients with acute painful musculoskeletal conditions09/09/10
1053Lornoxicam 4mg + Eperisone 50mg tabletFor the improvement of myotonic conditions caused by neck shoulder arm syndrome, scapulumeral periarthiritis and low back pain in adult
patients only
13/09/10
1054Beclomethasone Dipropionate IP 0.025% w/w
+ Neomycin sulphate IP 0.5% w/w cream
Additional lower strength15/09/10
1055Amlodipine 5mg/2.5mg + Valsartan 320mg/80mg + HCTZ 12.5mg/12.5mg tablet
(additional strength)
For the treatment of essential hypertension21/09/10
1056Paracetamol 500mg/500mg +Thioclchicoside 4mg/8mg tabletFor the treatment of acute inflammation conditions associated with spasm in adults only21/09/10
1057Ketorolac Tromethamine 0.4% w/v
+Moxifloxacin 0.5% w/v Opthalmic solution (Additional strength)
For reduction of post-operative inflammatory conditions of the eyes.21/09/10
1058Etodolac 400mg + Paracetamol IP 500mg tablet (additional strength)For the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis01/10/10
1059Dried Aluminium Hydroxide Gel IP 600mg
+Magnesium Hydroxide IP 300mg
+Simethicone IP 25mg +Oxetacaine BP 10mg per 5ml suspension
For the treatment of symptoms of functional gastrointestinal disorders like irritable bowel syndrome, functional dyspepsia, peptic ulcer, gasteroesophagal reflux disease which include smooth muscle spasms, flatulence, abdominal distension,
hyperacidity, gastric distress, bloting etc.
05/10/10
1060S(-) Metoprolol Succinate ER Eq. to S (-) Metoprolol tartarate 25mg/50mg + Clopidogrel (IR) 75mg/75mg tabletFor the treatment of essential hypertension who need antiplatelet therapy especially for prophylaxis of
atherombotic event.
07/10/10
1061Drosperinone + Ethinylestradiol tablets Same as approvedFor the treatment of moderate acne vulgaris in adult females, who have no known contraindications to oral contraceptive therapy, and have achieved menarche. It should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.09/10/10
1062Etodolac USP 400mg +Tolperisone HCL 150mg tabletFor the treatment of acute inflammation conditions associated with spasm in adults only11/10/10
1063Citicoline 500mg +Piracetam 400mg per 5 ml syrup (additonal dosage)For the treatment of acute stroke11/10/10
1064Thiocolchicoside 0.25% +Methyl salicylate IP 100mg +Menthol IP 50mg +Absolute alchol IP 50mg per gm gelFor the topical treatment of painful muscles spasms of skeletal musculature11/10/10
1065Amlodipine Besylate IP Eq. to Amlodipine 10mg/5mg/2.5mg + Telmisartan
80mg/40mg/20mg + HCTZ 25mg/12.5mg/12.5mg tablet
For the treatment of essential hypertension12/10/10
1066Pregabalin 150mg/75mg +Methylcobalamin 750mcg +Alpha lipoic acid 100mg +Pyridoxine 3mg +Folic acid 1.5mg capsuleFor the treatment of painful diabetic neuropathy in adults only12/10/10
1067Ferrous bisglycinate 60mg + Zinc sulphate monohydrate Eq. to Zinc 14mg + Copper as copper sulphate 1 mg + Selenium as selenomethionine 70mcg + Vitamin B6 IP 10mg + Methylcobalamin 1500mcg + Folic acid 5mg + Fish oil 10/40 (DHA 200mg) 500mg
capsule.
For Vitamin and mineral deficiency13/10/10
1068Combipack of 21 tablets of FDC of Ethinylestradiol IP 0.03 mg + Levonorgestrel IP 0.15 mg and 7 tablets of Ferrous Fumarate IP 75mg (Eq. to 24.375 mg of
Ferrous iron)
As contraceptive pill for women13/10/10
1069Amitriptyline Hydrochloride IP 4%w/w +
Ketamine HCL eq. to Ketamine 2% w/w per gm cream.
For the treatment of patients suffering from neuralgia13/10/10
1070Paracetamol IP 500mg + Phenylephrine HCL IP 5mg +Caffeine (anhydrous) IP 30mg + Diphenhydramine HCL IP 25mg tablet.For the treatment of fever associated with cold, nasal congestion in adults13/10/10
1071Levocetirizine dihydrochloride 2.5mg
+Montelukast 5mg dispersible tablet
For the treatment of allergic rhinitis13/10/10
1072Calcium citrate maleate Eq. to elemental calcium 250mg +Vitamin D3 IP 200 IU tabletFor the treatment of calcium and Vitamin D deficiency states13/10/10
1073Levonorgesterel 100mcg +Ethniyl estradiol IP 20mcg tablet(Additional indication) For the treatment of moderate acne vulgaris in women more than 18 years of age who have no therapy contraindications to oral contraceptive therapy, desire contraceptiopn, and have achieved menarche13/10/10
1074Eberconazole 1% w/w + Mometasone Furate USP 0.1% w/w creamFor the treatment of mild to moderate inflammed cutaneous mycoses13/10/10
1075Tolperisone HCL 150mg + Paracetamol IP 500mg tabletFor the treatment of patients with acute painful musculoskeletal conditions21/10/10
1076Solution for haemofiltration and haemodialysis (Each unit contains two compartments A & B. Before reconstitution: • 1000ml of electrolyte solution in Compartment A contains Calcium Chloride. 2H2O .....5.145gm, Magnesium Chloride. 2H2O.... 2.033gm, Lactic Acid....5.4gm,
• 1000ml of buffer solution in Compartment B contains: Sodium Chloride....6.45gm, Sodium Bicarbonate....3.090gm )
For treatment of acute kidney disease (renal failure), as substitution solution in continuous haemofiltration and haemodiafiltration and as a dialysis solution in continuous haemodialysis.23/12/10
1077Pyridoxine HCL IP 3mg + Nicotinamide IP 100mg + Cyanocobalamin IP 15mcg + Folic acid IP 500mcg + Chromium Picolinate USP
250mcg Tablet
For Mineral & Vitamins deficiency states in adult patients23/12/10
1078Rosuvastatin Calcium IP 5mg/10mg + Fenofibrate BP 160mg/160mg tablet (Additional strength)For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function29/12/10
1079Chlorhexidine gluconate IP 1%w/v + Ethyl Alcohol IP 61%w/v SolutionSurgical hand scrub & healthcare personnel hand wash29/12/10
1080Streptococcus faecalis T-110 JPC 30 million + Clostridium butyricum TO-A 2 million + Bacillus mesentericus TO-A JPC 1 million + Lactic acid bacillus (lactobacillus sporogenes)
50 million Capsules
For restoration of intestinal microflora15/03/10
1081Levocetirizine 2.5mg + Montelukast 4mg Dispersible Tablet & SyrupFor the treatment of allergic rhinitis13/01/10
1082Streptococcus faecalis 30million + Clostridium butyricum 2million + Bacillus mesentericus 1million+ Lactic acid bacillus 50million (lactobacillus sporogenes) CapsulesFor restoration of intestinal microflora15/03/10
1083Niacin 1000mg ER + Laropiprant 20mg TabletFor the treatment of dyslipidemia, particularly in patients with combined mixed dyslipidemia (characterized by elevated levels of LDL-chloesterol and triglycerides and low HDL- chloesterol) and in patyients with primary hypercholesterolemia (heterozygous familial and non- familial) In combination with HMG- CoA eductase inhibitor when cholesterol lowering effect of HMG- CoA reductase inhibitor monotherapy is inadequate. it can be used as monotherapy only in patientys in whom HMG-CoA reductase inhibitors
are considered ainappropriate or not tolearted
31/03/10
1084Diclofenac 100mg (EC) + Thiocolchicoside 8mg CapsuleFor secondary prophylaxis of ischemic heart disease in patients where use of such combinations in appropriate06/07/10
1085Imipenem 50mg + Clistatin 50mg InjectionFor the treatment of P. falciparum resistant malaria patients14/07/10
1086Isphghula 3.5gm + Lactitol 10gm per 15gm SachetFor the treatment of patients with constipation25/10/10
1087Chlorhexidine gluconate IP 1%w/v + Ethyl Alcohol IP 61%w/v SyrupFor treatment of allergic rhinitis in adults only29/12/10
1088Alpha Lipoic Acid USP 100mg + Methylcobalamin 1500mcg + Vitamin B6 IP 3mg + Folic Acid IP 1.5mg + Benfotiamine 50mg + Biotin USP 5mg + Chromium
Picolinate USP Eq. to Chromuim 200mcg Capsule
For the treatment of diabetic neuropathy03/01/11
1089Moxifloxacin HCl BP 0.5% w/v + Bromfenac Sodium 0.09% w/v Eye dropFor the reduction of post operative inflammatory conditions of the eye05/01/11
1090Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Cyanocobalamin IP 15mcg + Zinc Sulphate Monohydrate Eq. to Elemental Zinc
22.5mg Tablet
For the treatment of iron deficiency anaemia05/01/11
1091S (+) Etodolac 300mg +Thiocolchicoside 8mg TabletFor the treatment of patients with acute painful musculoskeletal conditions05/01/11
1092Beclomethasone Dipropionate IP 100mcg + Formoterol Fumarate Dihydrate BP Eq. to Formoterol Fumarate 6 mcg Metered Dose
Inhaler
For the treatment of bronchial asthma where use of inhaled corticosteroid therapy found appropriate05/01/11
1093Amlodipine Besilate IP Eq. to Amlodipine 5mg
+ Indapamide USP SR 1.5mg Tablet
For the treatment of mild to moderate hypertension05/01/11
1094Metformin HCl IP 500mg + Alpha Lipoic Acid USP 200mg TabletFor the treatment of patients with diabetic polyneuropathy05/01/11
1095Spironolactone IP 25mg + Furosemide IP 40mg TabletFor treatment of resistant oedema associated with secondary hyperaldosteronism; resistant
hypertension, chronic cardic failure and hepatic cirrhosis
05/01/11
1096Methylcobalamin 500mcg + Folic Acid IP 1.5mg + Zinc Sulphate IP 25mg + Chromium Polynicotinate 200mcg + Selenium as Sodium Selenite USP 65 mcg + Inositol 100mg + Alpha Lipoic Acid 50mg + Streptococcus faecalis 30 Millions (30 lakh) + Clostridium butyricum 2 Million (20 lakh) + Bacillus mesentericus 1 Million (10 lakh) + Lactic acid bacillus 50 Million (500lakh) CapsuleFor Vitamins and Minerals deficiency states in adult patients11/01/11
1097Hydroquinone USP 2% w/w + Tretinoin USP 0.025% w/w + Allantoin USP 1%w/w GelFor treatment of hyper pigmentry disorders31/01/11
1098Each bowel preparatory kit contains:One sachet of powder for reconstitution contains: Polyethylene glycol 3350NF: 210gm + Sodium Bicarbonate IP 2.86gm + Sodium Chloride IP 5.6gm + Potassium Chloride IP 0.74gmFor bowel cleansing prior to colonoscopy in adult patients only11/02/11
1099Meropenem IP 1000mg + Sulbactam sodium USP 500mg injectionFor the treatment of lower respiratory tract infection caused by gram negative bacteria in adults only15/03/11
1100Adenosylcobalamin 15mcg + Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Zinc Sulphate USP Eq. to Elemental Zinc 22.5mg tabletFor the treatment of iron deficiency anaemia in adults only21/03/11
1101Aspirin (EC Tablets) 75mg/75mg/150mg
+Rosuvastatin (Granules) 5mg/10mg/10mg Capsules
For the treatment of dyslipidemia associated with arthersclerotic arterial disease with risk of Myocardial infarction, stroke or peripheral
vascular disease.
30/03/11
1102Cefpodoxime IP 100mg/100mg/200mg/200mg
+Ofloxacin IP 100mg/200mg/100mg/200mg Tablets
For the Treatment of Lower and upper respiratory tract infection and Typhoid fever in adults only16/04/11
1103Cefixime Trihydrate IP Eq. to Anhydrous Cefixime 100mg/200mg + Ofloxacin IP 100mg/200mg Dispersible TabletFor the treatment of patients with typhoid fever and urinary tract infection in adults20/04/11
1104Dexketoprofen 50mg + Dicyclomine 20mg per 2ml InjectionFor the treatment of acute colicky pain in adult patients28/04/11
1105Gatifloxacin 0.3% + Loteprednol Etabonate 0.5% + Benzalkonium Chloride 0.01% w/v Opthalmic suspensionFor Post-Operative Steroid repulsive inflammatory Ocular conditions when Ocular bacterial infections or a risk of bacterial infection exists19/05/11
1106Diclofenac (as EC Tablets) 25mg + Paracetamol 325 mg CapsuleFor the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis31/05/11
1107Amlodipine 10mg/10mg+ Telmisartan 40mg/80mg TabletsFor essential hypertension31/05/11
11081. PROBIO : Each sachet (1g) contains: Total Probiotic.... Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii)
2. PROBIO & PREBIO (F)s Each sachet (1g) contains: Probio (CMP 5) Total Probiotic...Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii); Fructo Oligo Saccharides …. 100mg 3. PROBIO & PREBIO (D); Each sachet (1.3g) contains: Probio (CMP 5); Total probiotic... not less than 1.25 billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii); Fructo Oligo Saccharides...1000mg
For the treatment of rotavirus diarrhoea.09/06/11
1109Paracetamol 325mg + Tramadol Hydrochloride
37.5 mg Tablets
Additional indication. (For Symptomatic Treatment of Moderate
To Severe Pain.)
21/06/11
1110Fexofenadine 120mg + Montelukast 10mg Chewable tablet (additional Dosage form)For treatment of allergic rhinitis in adults only07/07/11
1111Each Combipack of 21 tablets contains : A) FDC of Norgestrel & Ethinyl estradiol tablets IP Each sugar coated white tablet contains: Norgestrel 0.30mg & Ethinyl estradiol 0.03mg
B) 7 tablets of Ferrous Fumarate: Each sugar coated tablet contains : - Ferrous Fumarate 75mg eq. to 24.375mg of ferrous iron
As contraceptive pill for women27/07/11
1112Cefixime (SR) 400mg +Moxifloxacin (SR) 400 mg TabletsFor the treatment of lower respiratory tract infections in adults only08/08/11
1113Alpha Lipoic acid 100mg + Folic acid 1.5mg + Methylcobalamin 1500mcg + Pyridoxine Hydrochloride 3mg + Vitamin D3 1000 IU
Tablets
For the treatment of Diabetic neuropathy10/08/11
1114Levosulpride (SR) 75mg + Rabeprazole sodium IP (EC Pellets) 20mg CapsuleFor the treatment of Gastro- oesophageal Reflux Disease (GERD)19/08/11
1115Each Combikit contains Part A - One film coated tablet of Tenofovir Disoproxil Fumarate 300mg eq. to Tenofovir 245mg + Emtricitabine 200mg. Part B - One film coated tablet of Atazanavir sulphate eq. to Atazanavir 300mg +
Ritonavir 100mg
For the treatment of HIV infection in adults.23/08/11
1116Diclofenac sodium (SR) 100mg + Eperisone Hydrochloride (SR) 150mg CapsulesFor the treatment of patient with acute musculoskeletal spasm associated with low back pain.24/08/11
1117Rosuvastatin Calcium eq. to Rosuvastatin 20mg/20mg + Fenofibrate BP 67.5mg/145mg TabletsFor the treatment of combined hyperlipidemia in patients with normal hepatic and renal function24/08/11
1118Acyclovir 50g + Hydrocortisone 10mg CreamFor the early treatment of recurrent cold sores in adult patients to reduce likelihood of ulcerative cold sores and to shorten the lesion healing time30/08/11
1119Clindamycin Phosphate eq. to Clindamycin 1% w/w + Hydrous Benzoyl Peroxide eq. to Anhydrous Benzoyl peroxide 2.5% w/w topical
gel
For topical treatment of inflammatory acne vulgaris (Additional lower strength)30/08/11
1120Polyethylene glycol 0.4% w/v + Propylene Glycol 0.3% w/v Eye DropsFor temporary relief of burning and irritation due to dryness of the eye13/09/11
1121Metformin (ER )1000mg/500mg +Saxagliptin
2.5 mg/5mg Tablets
As an Adjunct to diet and exercise to improve glycemic control in adults patients with type 2 diabetes mellitus when treatment with both Saxagliptin and Metformin is appropriate19/09/11
1122Ceftriaxone Sodium eq. to Ceftriaxone Sodium
+ Sulbactam Sodium eq. Sulbactam + Edetate Bi Sodium USNF (2000mg+1000mg+74mg &
1000mg + 500mg + 37mg) Injection
Additional Indication - For the treatment of urinary tract infections and lower respiratory tract infections,
various bacteria
21/09/11
1123Difluprednate 0.05% w/v + Moxifloxacin 0.5% w/v Eye DropsFor steroid responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial
ocular infection exists
22/09/11
1124S(-) Amlodipine 2.5mg/5mg + Clopidogrel 75mg/75mg TabletsFor the treatment of high risk hypertensives who need anti-platelet therapy especially for prophylaxis of artherothrombotic events in patients
with a history of recent stroke or established peripheral arterial disease
22/09/11
1125Each combipack contains : A) One tablet of Risedronate Sodium - Each film coated tablet contains: Risedronate Sodium (as Risedronate Sodium Hemi-Pentahydrate) - 35 mg
B) Six Capsules of FDC of Calcitriol +Calcium carbonate + Zinc Each soft gelatin capsule contains : Calcitriol IP - 0.25mcg Calcium Carbonate IP - 500mg (eq. to elemental calcium 200mg) Zinc (as Zinc Sulphate USP) 7.5 mg
For the treatment of Osteoporosis in post menopausal women30/09/11
1126Akiskiren Hemifumarate eq. to Aliskiren 150mg/150mg/300mg/300mg +Amlodipine Besilate IP eq. to Amlodipine 5mg/10mg/5mg/10mg TabletsFor the treatment of hypertension: a) As initial therapy in the patient likely to need multiple drugs to achieve blood pressure control. B) In the patients whose blood pressure is not adequately controlled with the Aliskiren alone or Amlodipine (or another di-hydropyridine calcium channel blocker) alone. C) As replacement therapy in patients already receiving Aliskiren and Amlodipine from separate tablets at the same dose level.12/10/11
1127Ferrous Ascorbate eq. to elemental iron 100mg
+ Folic acid IP 1.5 mg + Methylcobalamin 1.5mg +Zinc Sulphate monohydrate IP eq to elemental Zinc 22.5mg Tablets. (Additional
strength)
For the treatment of Iron deficiency anaemia19/10/11
1128Arterolane Maleate 150mg + Piperaquine Phosphate 750mg TabletTreatment of acute uncomplicated malaria infection due to Plasmodium falciparum in adults.19/10/11
1129Gatifloxacin IP eq. to Gatifloxacin (Anhydrous) 3.0mg + Difluprednate 0.5mg + Benzalkonium Chloride IP (As preservative) 0.01% w/v Eye DropsFor the treatment in the patients with inflammatory occular conditions where bacterial infection or a risk of bacterial occular infection exists24/10/11
1130Diclofenac Sodium IP (as sustained release Pellets) 100mg + Thiocolchicoside (as sustained release pellets) 16mg Capsule. (New Dosage
Form)
For the treatment of acute inflammation conditions associated with spasm in adults only.15/11/11
1131Epalrestat 50mg + Methylcobalamin 500mcg
Tablets
For the treatment of Diabetic
Neuropathy
16/11/11
1132Ketorolac Tromethamine IP 4.00mg + Olopatadine Hcl eq. to Olopatadine 1.00mg + Benzalkonium Chloride IP 0.05mg Ophthalmic
solution
For the treatment of seasonal allergic conjunctivitis in adults only21/11/11
1133Tramadol Hcl IP (As Immediate Release Layer) 50mg + Diclofenac Sodium IP (As Sustained Release Layer) 75mg TabletsFor the symptomatic treatment of moderate to severe pain in adult patients21/11/11
1134Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension.
(Additional Strength)
For the treatment of asthma where the use of corticosteroid and long acting beta agonist in combination is
appropriate
21/11/11
1135Amlodipine Besilate IP eq.to Amlodipine 10mg/5mg/5mg/5mg/2.5mg + Olmesartan Medoxomil 40mg/40mg/20mg/5mg/5mg + Hydrochlorothiazide IP
25mg/12.5mg/12.5mg/12.5mg/12.5mg Tablet
For the treatment of essential hypertension23/11/11
1136Each Combipack contains Part (A) One Strip of FDC of Ramipril + Amlodipine Tablets;- Each uncoated tablet contains Ramipril IP - 5mg, Amlodipine besylate IP eq to Amlodipine 5mg
B) Each Film coated tablet contains ;- Atorvastatin Calcium IP eq to Atorvastatin 10mg/20mg.
For the treatment of hypertension and as an adjunct to diet in patients to reduce elevated total cholesterol and triglyceride levels hypertension and dyslipidemia. The polypack should be used in patients for whom treatment with all of the three i.e Ramipril, Amlodipine and Atorvastatin is
appropriate.
28/11/11
1137Rosuvastatin Calcium IP eq to Rosuvastatin 5mg + Ezetimibe 10mg. (Additional Strength)For the treatment of patients with primary hypercholesterolemia.05/12/11
1138Tolperisone Hcl IP 150mg + Diclofenac IP 50mg TabletsFor the treatment of Patients with acute muscle/musculoskeletal spasm in adult07/12/11
1139Paracetamol IP 325mg + Pamabrom USP 25mg TabletsFor the treatment of patient with pre- menstrual syndrome in adults only07/12/11
1140Dosulepine Hcl 50mg/75mg + Methylcobalamin 1500mcg/1500mcg TabletsFor the treatment of neuropathic pain.08/12/11
1141Montelukast Sodium IP eq.to Montelukast 10mg +Olopatadine Hcl 5mg TabletsFor the treatment of relief of symptoms of allergic rhinitis16/12/11
1142Amlodipine Besilate IP eq. to Amlodipine 5mg
+ Perindopril Erbumine BP 8mg Tablets. (Additional Strength).
For the treatment of mild to moderate hypertension in adults only and or treatment of stable coronary artery disease in patients already controlled with Perindopril & Amlodipine given concurrently at same dose level20/12/11
1143Metoprolol succinate ER 25 mg+Telmisartan 40mg TabletFor the treatment of essential hypertension20/12/11
1144Iron Amino Acid Chelate as Ferrous Bisglycinate (75mg) eq. to Elemental Iron 15mg
+ Folic acid IP 0.25mg + Vitamin B 12 IP 3.75mcg +Zinc Picolinate (26mg) eq. to
Elemental Zinc 5.5mg Syrup
For the treatment of Iron Deficiency Anaemia22/12/11
1145Artemether 20mg + Lumefantrine 120mg Syrupfor the treatment of pf. Malaria cases resistanat to both chloroquine and Sulphadoxine - Pyramethamine
combination.
05/01/11
1146Rosuvastatin 5/5/5/10/10/10/20mg +
Fenofibrate 67.5/145/160/67.5/145/160/160mg Tablet
For the treatment of essential hypertension19/02/11
1147Omega-3 acid ethyl esters (90%) 1000mg
comprising (Eicosapentaenoic acid (EPA) ethyl ester 460mg + Docosahexaenoic acid (DHA) ethyl ester 380mg capsules (Additional Strength)
(a) Adjuvant treatment in secondary
prevention after myocardial infarction, in addition to other standard therapy (eq. statins, antiplatelet medicinal products, betablockers,ACE inhibitors). (b) Endogenous hypertriglyceridemia as a supplement to diet when dietary measures alone are insuffient to poduce an adequate response in type IV as monotherapy and in type IIb/III in combination with statins, when control of triglycerides is
insufficient.
16/03/11
1148Montelukast 10mg + Fexofenadine 120mg Chewable Tablets (Additional dosage form)Surgical hand scrub & healthcare personnel hand wash07/07/11
1149Ornidazole IP 1 % w/w + Povidone Iodine IP (0.5% w/w available Iodine) 5% w/w OintmentFor the prevention and treatment of surgical wound infections in adult patients undergoing surgery03/01/12
1150Aceclofenac IP (Sustained released pellets) 200mg/200mg + Thiocolchicoside IP (Sustained released pellets) 8mg/16mg Capsules. (New Dosage Form)For the treatment of acute inflammation conditions associated with spasm in adults only04/01/12
1151Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension. (Additional Indication)In the regular treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease
(COPD) with frequent symptoms and a history of exacerbations.
04/01/12
1152Diclofenac Sodium IP (Enteric coated granules) 50mg + Eperisone Hcl IP (Tablet) 50mg Hard Gelatin Capsules. (New Dosage Form)For the treatment of Patients with acute musculoskeletal spasm associated with low back pain06/01/12
1153Cephalexin IP (as monohydrate) 200mg + Kanamycin IP (as monosulphate) 100,000 IU Suspension per 10 gm Intramammary SuspensionFor the treatment of clinical mastitis in lactating dairy cows for bacteria susceptible to the combination of cephalexin and kanamycin such as Staphylococcus aureus, Streptococcus dysgalactiae, Streptococcus uberis and Escheria coli.07/03/12
1154Sterile Solution for Peritoneal Dialysis Each 1000 ml contains: Calcium chloride dihydrate 0.184 g/l + Glycine 0.51 g/l + L- Alanine 0.951 g/l + L- Arginine 1.071 g/l + L- Isoleucine 0.85 g/l + L- Histidine 0.714 g/l + L- Leucine 1.02 g/l + L- Lysine (as Hcl) 0.955 g/l
+ L-Methionine 0.85 g/l + L- Phenylalanine
0.57 g/l + L-Proline 0.595 g/l + L- Serine 0.51 g/l + L- Threonine 0.646 g/l + L-Tryptophan
0.27 g/l + L-Tyrosine 0.3 g/l + L-Valine 1.393 g/l + Magnesium chloride hexahydrate 0.051 g/l
+ Sodium chloride 5.38 g/l + Sodium lactate
4.48 g/l
As Nutritional supplements for malnourished renal failure patients (Albumin concentration lower than 35 g/litre) being maintained on peritoneal dialysis.18/04/12
1155Imipenem IP (Sterile) eq to anhydrous Imipenem 1 g + Cilastatin Sodium IP (sterile) eq to Cilastatin 1 g Powder for Injection (Additional strength)For the treatment of serious lower respiratory tract infections, urinary tract infections, intra-abdominal, bone and joint infection, endocardities and bacterial septiceimia28/06/12
1156Cefpodoxime 100mg + Ofloxacin 100mg Dispersible Tablet (Additional Dosage form)For the Treatment of Lower and upper respiratory tract infection and Typhoid fever in adults only29/11/12
1157Diclofenac Diethylamine BP 4.64 % w/v Eq. to Diclofenac Sodium IP 4.00 % + Absolute Alcohol IP 10.00 % v/v Topical SolutionFor the Treatment of Acute Lower Back Pain21/12/12
1158Diclofenac Diethylamine BP 2.32 % w/v Eq to Diclofenac Sodium 2.00 % w/v + Methyl Salicylate IP 10.00% w/v + Menthol 5.00 % w/v
+ Absolute Alcohol IP 10.00 % v/v Topical Solution (Additional Strength)
For the Treatment of Acute Lower Back Pain01/01/13
1159Telmisartan 20mg + Amlodipine Besylate Eq. to Amlodipine 2.5mg + Hydrochlorothizide 6.25mg Tablets (Additional Strength)For the Treatment of Essential Hypertension03/01/13
1160Amlodipine besilate IP Eq. to Amlodipine 10mg
+ Indapamide SR 1.5 mg Tablet (Additional Strength)
For the treatment of mild to moderate Hypertension02/01/13
1161Each sustained release tablet contains:
Tolperisone HCl 450mg + Diclofenac Sodium IP 100mg
(additional strength)
For the treatment of Patients with acute muscle/musculo skeletal spasm in adult12/04/13
1162Each uncoated bilayered tablet contains:
Telmisartan Ph. Eur IP 80mg +
Hydrochlorothiazide Ph. Eur 25mg
(additional strength)
For the treatment of hypertension as second line therapy14/05/13
1163Ferrous Sulphate eq. to Elemental Iron 100mg/20mg + Folic Acid IP 0.5mg/0.1mg Enteric coated tablets (Additional Dosage Form)For the treatment of Iron deficiency Anaemia15/07/13
1164Linagliptin 2.5mg/2.5mg/2.5mg + Metformin 500mg/850mg/1000mg
Film coated Tablets
As an adjunct to diet and exercise to improve glycemia control in adults with type II Diabetes
Mellitus when treatment with
26/07/13
Linagliptin and Metformin is appropriate.
1165Artemether 60mg +Lumefantrine 360mg (additional Strength) uncoated TabletsFor the treatment of pf malaria cases resistant to both chloroquine and sulfadoxine- pyremethamine combination29/07/13
1166Latanoprost 0.005% W/v +Timolol maleate 0.5% W/v (Presevative free) Opthalamic Solution (Additional Dosage Form)For reduction of elevated intra ocular pressure in patients with open angle glaucoma & ocular hypertension10/09/13
1167Metformin Hcl 500mg/850mg/1000mg+ Vildagliptin50mg/50mg/50mg Film coated Tablet ( additional indication)For the treatment of Type 2 Diabetes mellitus having HbA1c > 8% where diabetes is not adequately controlled by diet and exercise alone.22/10/13
1168S(-) Amlodipine besilate IP Eq to S(-) Amlodipine 5mg / 2.5mg + Hydrochlorothiazide IP 25mg/12.5mg
+Olmesartan Medoxomil 40 mg /40 mg Tablet
For the treatment of essential hypertension18/10/13
1169Each ml contains Dorzolamide Hydrochloride 2mg/ml + Timolol Maleate 5mg/ml ophthalmic solution (preservative free formulation of the approved FDC)For the treatment of elevated intra ocular pressure in patients with open angle glaucoma or pseudoexfloative glaucoma when topical beta- blockers monotherapy is not sufficient.18/11/13
1170Praziquantal 20mg+Pyrantel embonate 230mg Tablet ( Veterinary product)For the treatment mixed infestations with roundworms and tapeworms in Dogs25/11/13
1171Prasugrel Hydrochloride IP 10 mg (as film coated tablet) + Aspirin IP(as enteric coated tablets) 75 mg hard gelatine capsuleFor the percutaneous Coronary intervention(PCI)15/01/14
1172Glimepiride IP 0.5 mg+ Metformin Hydrochloride ER 500 mg uncoated bilayered tablets (additional strength)As an adjunct to diet and exercise in type 2 diabetes mellitus patients, when monotherapy is not able to achieve glycemic control.20/01/14
1173Each freeze-dried vial contains:
Tiletamine (as Hydrochloride ) 125 mg/250 mg+ Zolezepam(as hydrochloride ) 125 mg/250 mg freeze dried powder for injectable(veterinary
As restrain and general anesthesia for dogs, cats and wild animals20/01/14
product)
1174Pantoprazole Sodium IP Eq to Pantoprazole 40 mg (As Enteric coated pellets) + Levosulpiride 75 mg (as sustained release tablets) CapsulesFor short term treatment of GERD in adult patients who do not respond to PPI alone.27/01/14
1175Gestodene 75 mcg+ Ethinylestradiol BP 20 mcg sugar coated tablet(additional strength)For the prevention of Pregnancy03/02/14
1176Each ml contains
Minoxidil IP 5 %+ Finasteride IP 0.1% lipid Solution for topical application
For the treatment of androgenic alopecia in males.07/02/14
1177Esomeprazole 40 mg (as delayed release pellets)
+ Levosulpiride 75 mg (As extended release tablet) hard gelatine capsule.
For short term therapy of Gastroeasophageal Reflux Disease (GERD) in patients who do not respond to PPI alone13/02/14
1178Each gram contains
Mometasone Furoate IP 1 mg + Salicylic Acid IP 50 mg ointment (additional indication)
For the treatment of chronic plaque psoriasis19/02/14
1179Each combipack contains:
21 pills of FDC of levonorgestrel + ethinylestradiol tablets IP:
Each sugar coated tablet contains:
Levonorgestrel IP 150 mcg + ethinylestradiol IP 30 mcg
7 pills of placebo/inert tablets
As contraceptive pill for women.01/04/14
1180Each combipack contains:
One tablet of Tenofovir Disoproxil FumArate+ Emtricitabine IP
Each film coated tablet contains:
Tenofovir Disoproxil Fumarate IP 300 mg Emtricitabine IP 200 mg
Two tablets of Nevirapine IP Each tablet contains:
Nevirapine IP 200 mg
For the treatment of HIV-1 infection in adults.03/04/14
1181Each mouth dissolving tablet contains: Escitalopram Oxalate IP
Eq to Escitalopram 10 mg +
Clonazepam IP 0.5 mg (additional dosage form)
For treatment of patients with comorbid depression and anxiety disorder04/04/14
1182Each film coated tablets contains:
Indapamine USP(as sustained release form) 1.5 mg + Amlodipine Besilate IP Eq to Amlodipine 2.5 mg
(additional strength)
For the treatment of mild to moderate hypertension in elderly patients of age more than 65 years.09/05/14
1183Combipack
Each strip contains-
A. Sitagliptin Phosphate film coated tablets
Each film coated tablet contains: sitagliptin Phosphate monohydrate Eq to 100 mg of sitagliptin
B. Metformin Hydrochloride Sustained release Tablet IP. Each uncoated tablet contains: 1000 mg of metformin Hydrochloride IP
(additional strength)
As an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 Diabetes Mellitus.04/06/14
1184Each capsule contains: Indacaterol Maleate 110 mcg
Glycopyrronium Bromide 50 mcg inhalation powder, hard gelatin capsules
A once daily maintenance bronchodilator treatment to relieve symptoms and reduce exacerbations in patients with chronic Obstructive pulmonary disease COPD.22/07/14
1185Each gram of ointment contains-
Neomycin Sulphate IP 5 mg (3000 IU) +
Bacitracin Zinc IP 500 IU
(veterinary product)
Broad spectrum antibiotic skin ointment used for dressing of wounds, yoke gall, ulcers, cuts, abrasions, Foot rot, Udder impetigo, FMD lesions in hoof, post operative lesions & Burns.07/08/14
1186Each ml of injection contains:
Ivermectin IP 10 mg+ Clorsulon USP 100 mg (veterinary product)
For control and treatment of Liver fluke and Endoparasites like gastrointestinal and pulmonary nematodes, eye worms, skin and
muscle worms and ectoparasites like ticks, mites, lice and grubs.
07/08/14
1187Each 10 ml (two teaspoonfuls) of oral dosage form(tonic) contains:
1.25 g of liver fraction derived from
31.25 g of fresh liver yeast Extract 0.4 g
+ Nicotinic acid IP 24 mg+ Ethanol (95%) IP 1 ml + Alcohol Content 9.4 % v/v
(veterinary product)
Indicated for the treatment of anorexia, indigestion and liver disorders in sheep, goat and cattle and for supplementary treatment of Aflotoxicosis, mycotoxicosis and fatty liver Syndrome in poultry.07/08/14
1188Each 5 ml of the suspension contains:
Levamisole HCl IP 112.5 mg eq to levamisole
95.45 mg + Oxyclozanide IP 150 mg + Anhydrous Copper Sulphate BP eq to elemental copper 1.25 mg + Zinc sulphate monohydrate USP eq to elemental Zinc 0.4 mg + Cobalt sulphate eq to elemental cobalt 0.15 mg
(veterinary product)
For control and treatment of Gastrointestinal and pulmonary Nematodes, liver Flukes and Amphistomes.07/08/14
1189Each Film coated tablet contains:
Piperaquine tetraphosphate as Piperaquine Tetraphosphate Tetrahydrate (QP) 320 mg + Dihydroartemisinin (DHA) 40 mg
For the treatment of acute uncomplicated P. Falciparum malaria only for adult patients.18/09/14
1191Each Uncoated tablet contains: Ezetimibe 10 mg + Simvastatin 40 mg
(additional strength)
For the treatment of patients with primary hypercholesterolemia.23/09/14
1192Each combipack contains:
A. Each 5 ml of constituted suspension contains:
1. Amoxicillin Trihydarte IP eq to Amoxicillin
200 mg + Potassium Clavulanate IP eq to Clavulanic acid 28.5 mg
2. Amoxicillin Trihydarte IP eq to Amoxicillin
400 mg + Potassium Clavulanate IP eq to Clavulanic acid 57 mg
B. One vial of purified water IP Each Vial contains:
Purified water IP 30 ml
(additional Pack)
For the treatment of bacterial infection such as Sinusitis otitis media, Tonsilitis, acute and chronic bronchitis skin and soft tissue infections and post operative pain14/10/14
1193Each 1 ml of the constituted suspension contains:
Amoxicillin Trihydrate IP eq to Amoxicillin
80 mg+ Potassium Clavulanate IP eq to Clavulanic Acid 11.4 mg
(additional Strength)
For the treatment of infections due to susceptible isolates of the designated bacteria in the conditions such as lower Respiratory Tract Infections, Acute Bacterial Otitis Media, Sinusitis, Skin And Skin Stucture Infections, Urinary Tract Infections in Children more than 20 kg body weight.14/10/14
1194Each uncoated tablet Contains:
Ivermectin IP 2 mg + Praziquantel IP 50 mg (veterinary product)
Broad spectrum anthelmintic for the treatment and control of internal parasites( nematodes and cestodes) in dogs17/11/14
1195Each 5 ml (one teaspoonful) contains: Magnesium Hydroxide IP 98 mg Added as Magnesium Hydroxide paste Aluminium Hydroxide 0.291 g
(Added as Aluminium Hydroxide Paste)
Eq to 0.380g of Dried Aluminium Hydroxide gel IP
Oxetacaine BP 10 mg Liquid orals
For the treatment of dyspepsia and related symptoms17/12/14
1196Cream contains:
Gamma benzene Hexachloride IP 0.10% w/w Proflavin Hemisulphate 0.10%w/w Cetrimide
IP 0.45 % w/w
(veterinary product)
For dressing of maggot wounds, to protect wound from flies.02/01/15
1197Each film coated tablet contains:
Saxagliptin Hydrochloride eq. to Saxagliptin 5 mg
Metformin Hydrochloride IP 1000mg
(Extended Release Tablet) (Additional strength)
As an Adjunct to diet and exercise to improve glycemic control in adults patients with type 2 diabetes mellitus when treatment with both Saxagliptin and Metformin is appropriate07/01/15
1198Each ml contains:
Diminazene Diaceturate 70 mg+ Phenazone BP 375 mg + chlorocresol IP 0.1% w/v
Injectable dosing form
 For the treatment of: Babesiosis caused by B.bovis,
B.bigemina, B.motasi & B.canis.
 Trypanosomoisis caused by T.congolense, T.vivax, T.brucei & T.evansi.
 Theileriosis caused by T.annulata
13/02/15
(veterinary product)& T.mitans. It is to be used with Antibiotic in annulata infection.
 Especially suitable for mixed infection.
 Pyrexia of unknown etiology.
1199Each vial contains:
Quinapyramine Sulphate B vet C 1.5 g + Quinapyramine Chloride B vet C 1.0g
Injectable dosing Form (veterinary product)
Indicated as a preventive as well as curative in cases of Trypanosomniasis in cattle, buffalos, camel, horses, pigs and sheep.13/02/15
1200Each Vial contains
Sterile Morepenam IP eq. to Anhydrous Meropenam 1000mg +Sterile Sodium Carbonate IP Eq. to Sodium 90.2 mg +Sterile Sulbactum Sodium USP eq. to Sulbactum 500 mg injection
(veterinary product)
For the treatment of lower respiratory tract infection caused by gram negative bacteria in adults only.13/02/15
1201Miconazole Nitrate IP 2% w/w+ Fluocinolone Acetonide IP 0.01% w/w CreamFor the treatment of Candidal Intertrigo and seborrhoeic dermatitis.13/02/15
1202Each combipack contains:
1. One vial Containing:
Amoxycillin Sodium IP Eq. to Amoxycillin 200mg/2000mg/3000mg + Sulbactam Sodium USP Eq. to Sulbactam 100mg/1000mg/1500mg
2. One ampoule of Sterile water for injection IP 5ml/15ml/15ml
For the treatment of common bacterial infections where antibiotic therapy is indicated, including URTI, genito- urinary infection, skin and soft tissue infections, bone and joint infections and other infections.13/02/15
1203Each kit Contains:
1. 5 sachets of Oral Rehydration Salts (4.4 g each)
Each sachet contains:
Combikit of Dextrose Anhydrous IP 2.70g + Sodium Chloride IP 0.52g + Sodium Citrate IP
For the treatment of acute infectious diarrhea.05/03/15
0.58g + Potassium Chloride IP 0.30g
2. 14 tablets of elemental zinc
Each uncoated dispersible tablet contains:
Zinc Sulphate monohydrate IP Eq. to elemental Zinc 20mg.
1204Each 5 ml Contains:
Aluminium hydroxide paste eq. to Dried Aluminium hydroxide gel IP 250mg + Magnesium hydroxide paste eq. to Magnesium hydroxide IP 250mg + Simethicone Emulsion USP eq. to Simethicone 50mg + Oxetacaine BP 10mg
used for symptomatic relief of peptic ulcer and gastritis09/03/15
1205Each enteric coated tablet contains:
Dried Ferrous Sulphate Enteric Coated IP 150mg eq. to Elemental Iron 45 mg
Folic acid 0.4 mg (Additional strength)
For the treatment of iron deficiency anaemia.19/03/15
1206Each hard gelatin capsule contains:
Dried Ferrous Sulphate IP 150mg (As Enteric Coated granules) eq. to Elemental Iron 45 mg
Folic acid 0.5 mg. (Additional dosage form)
For the treatment of iron deficiency anaemia.19/03/15
1207Levamisole hydrochloride IP 15.0% w/w Eq. to Levamisole 12.7% w/w + Anhydrous Copper Sulphate BP Eq. to elemental Copper 0.16% w/w + Zinc Sulphate Monohydrate USP Eq. to elemental Zinc 0.05% w/w + Cobalt Sulphate Eq. to elemental Cobalt 0.02% w/w soluble powder for oral use.
(veterinary product)
For control and treatment of gastrointestinal and pulmonary nematodes30/04/15
1208Enrofloxacin 200 mg + Bromhexine HCl IP 15For the treatment of infectious diseases of poultry produced by Gram - positive30/04/15
mg oral solution.
(veterinary product)
bacterias, Gram - Negative bacteria and or mycoplasmas.
1209Ketoconazole IP 1.0 %w/w + Chlorhexidine Gluconate Solution IP Eq. to Chlorhexidine Gluconate 2.1 % w/w shampoo for topical use.
(veterinary product)
For management of problems related with bacterial and fungal dermatitis of dogs and cats.30/04/15
1210Cypermethrin 1.0% w/w + Miconazole Nitrate IP 2.0%w/w shampoo for topical application to hair coat.
(veterinary product)
Controls fungal infections, kills and repels external parasites like ticks, fleas, lice and mites, moisturizes, soothes, removes bad odour without masking perfume and leaves fragrance on dog skin.30/04/15
1211Levocetirizine Dihydrochloride IP 2.5mg/2.5mg/5mg + Montelukast Sodium IP Eq. to Montelukast 4mg/5mg/10mg orally disintegrating strip.
(Additional dosage form)
For treatment of allergic rhinitis30/04/15
1212Miconazole Nitrate IP 2%w/w + Flucinolone Acetonide IP 0.01%w/w creamFor the treatment of fungal infection.30/04/15
1213Gel contains:
Diclofenac Diethylamine BP eq to Diclofenac sodium 1 % w/w Methyl salicylate IP 10 % w/w Menthol IP 5 % w/w
Linsed oil BP 3.0 w/w
For the treatment of pain, swelling and inflammation due to musculo-skeletal disorders (such as sprains, strains, tendonitis, bursitis, hand, neck, shoulder pain, sciatica, muscle stiffness, joint pain, backache & lunago.30/01/08
1214Each film coated tablet contains: Ferrous ascorbate eq to Elemental Iron 100 mg/50 mg
Folic acid IP 1.5 mg
For the treatment of iron deficiency anemia.31/01/08
1215Oral Suspension:
Each 5ml of reconstituted suspension contains: Amoxicillin trihydrate USP e.q. to Amoxicillin
For the treatment of LRTI infections (e.g. Pneumonia, bronchitis), acute otitis media, sinusitis, UTI, skin & soft
tissue infections & bone & joint
09/12/03
400 mg
Caluvulanate Potassium e.q. to Clavulanic acid 57 mg
Dispersible Tablet:
Each dispersible tablet contains:
Amoxicillin trihydrate IP e.q. to Amoxicillin 400 mg
Caluvulanate Potassium e.q. to Clavulanic acid 57 mg
infections.
1216Each uncoated dispersible tablet contains:
Amoxycillin trihydrate IP e.q. to Amoxycillin 200 mg + Potassium caluvulanate e.q. to Clavulanic acid 28.5 mg
For the treatment of LRTI infections (e.g. Pneumonia, bronchitis), acute otitis media, sinusitis & UTI, skin & soft tissue infections & bone & joint infections.13/12/99
1217Each 5 ml conatins: Chlorpheniramine maleate 4 mg
Codeine phosphate 10 mg
For dry cough10/03/95
1218Each uncoated dispersible tablet contains:
Amoxycillin trihydrate IP e.q. to anhydrous Amoxycillin 250 mg/125 mg
Caluvulanate Potassium e.q. to Clavulanic acid
62.5 mg/31.25mg
For the treatment of LRTI infections (e.g. Pneumonia, bronchitis), acute otitis media, sinusitis, UTI, skin & soft tissue infections & bone & joint infections.28/01/91
1219Each 5ml of reconstituted suspension contains:
Amoxycillin trihydrate IP e.q. to Amoxycillin 200 mg
Caluvulanate Potassium e.q. to Clavulanic acid
28.5 mg
For the treatment of LRTI infections (e.g. Pneumonia, bronchitis), acute otitis media, sinusitis, UTI, skin & soft tissue infections & bone & joint infections.Old drug
1220Sodium Salicylate IP (Eq. to Salicylic acid IP 0.86% w/w) 1.0% w/w + Zinc Gluconate BP 0.5
% w/w + Pyridoxine HCl IP 0.5% w/w (Shampoo)
(veterinary product)
For the treatment & control of keratoseborrhea in dogs and cats08/06/15
1221Each Bolus contains:
Levamisole HCl IP 2.0gm + Oxyclozanide IP 4.0gm
(veterinary product) (Additional strength)
For the treatment of all flukes (Fasciola spp) & Tapeworm segmnts (Moniezia spp.) for cattle and sheep. Also for the various species of the nematodes.08/06/15
1222Spray dosing form contains:
Gamma benzene Hexachloride IP 0.10% w/v Proflavin Hemisulphate 0.10% w/v Cetrimide IP 0.45 % w/v
(veterinary product)
(Additional dosage form)
To kill maggots, to heal wound, to protect wound from flies.15/07/15
1223Each Bolus (Tablet) contains:
Levamisole HCl IP 1.5 g eq to levamisole 1.27 g + Oxyclozanide IP 2.0 g + Anhydrous Copper Sulphate BP eq to elemental copper 18.75 mg + Zinc sulphate monohydrate USP eq to elemental Zinc 6.0 mg + Cobalt sulphate eq to elemental cobalt 2.25 mg
(veterinary product)
For control and treatment of Gastrointestinal and pulmonary Nematodes, liver Flukes and Amphistomes.21/08/15
1224Teneligliptin Hydrobromide Hydrate Eq. to Teneligliptin 20mg
Metformin- 500mg/1000mg (ER) Tablets
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both teneligliptin and metformin is appropriate.05/01/16
1225Brinzolamide - 1.0% w/v
Timolol maleate – 0.683% w/v Eq. to Timolol 0.5% w/v
Ophthalmic suspension
Decrease of intraocular pressure (IOP) in adults patients with open angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.18/02/16
1226Emtricitabine 200mg
Tenofovir Disoproxil Fumarate 300mg eq. to
Tenofovir Disoproxil 245mg Tablet (additional Indication)
Indicated in Combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.17/02/16
1227Rifampicin - 75mg Isoniazid -50mg Pyrazinamide -150 mg dispersible tablet
(additional strength)
The combination is indicated for the treatment of tuberculosis in children, caused by Mycobacterium tuberculosis.08/03/16
1228Clopidogrel Bisulphate eq. to Clopidogrel 75mg
Aspirin 100mg tablets
(additional strength)
For the treatment of angina and myocardial infarction.15/03/16
1229Rifampicin 75mg Isoniazid 50mg dispersible tablet
(additional strength)
The combination is indicated for the treatment of tuberculosis in children, caused by Mycobacterium tuberculosis.11/03/16
1230Brinzolamide 10mg
Brimonidine Tartrate eq. to Brimonidine 2mg Ophthalmic suspension
For the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.30/03/16
1231Frontline Plus (Cats) contains:
Fipronil 9.8%
(S)-Methoprene 11.8% Frontline Plus (Dogs) contains: Fipronil 9.8%
(S)-Methoprene 8.8%
In Cats:
1. To be used against infestation with fleas, alone or in association with ticks and/or biting lice.
2 Elimination of fleas (Ctenocephalides spp.). Insecticidal efficacy against new infestations with adult fleas persists for 4 weeks.
Prevention of the multiplication of
13/04/16
Spot-on-solution (veterinary formulation)fleas by inhibiting the development of eggs (Ovicidal activity), larvae and pupae (larvicidal activity) originating from eggs laid by adult fleas for six weeks after application.
3. Elimination of ticks (Ixodes ricinus, Dermacentor variabilis, Rhipicephalus sanguineus). The product has a persistent acaricidal efficacy for up to 2 weeks against ticks (based on experimental data).
4. Elimination of biting lice (Felicola subrostratus).
The product can be used as part of treatment strategy for the control of Flea Allergy Dermatitis (FAD).
In Dogs:
1. To be used against infestation with fleas, alone or in association with ticks and/or biting lice.
2. Treatment of flea infestations (Ctenocephalides spp.). Insecticidal efficacy against new infestations with adult fleas persists for 8 weeks. Prevention of the multiplication of fleas by inhibiting the development of eggs (Ovicidal activity) and larvae and pupae (larvicidal activity) originating from eggs laid by adult fleas for eight weeks after application.
3. Treatment of tick infestations (Ixodes ricinus, Dermacentor variabilis, Dermacentor reticulates, Rhipicephalus sanguineus). The product has a persistent acaricidal efficacy for up to 4 weeks against ticks.
4. Treatment of infestations with biting lice (Trichodectes canis).
The product can be used as part of treatment strategy for the control of Flea Allergy Dermatitis (FAD).
1232Each Hard gelatin capsule contains: Rosuvastatin calcium IP
Eq. to Rosuvastatin (as film coated immediate release tablet) 5mg/10mg
Choline Fenofibrate IP
Eq. to Fenofibric acid (as delayed release tablets) 135mg/135mg
For the treatment of mixed dyslipidemia.16/06/16
1233α-Ketoisoleucine Calcium salt 67.0mg + α- Ketoleucine Calcium Salt 101.0mg + α- Ketophenylalanine Calcium Salt 68.0mg + α- Ketovaline Calcium Salt 86.0mg + α- Hydroxymethionine Calcium Salt 59.0mg + Lycine acetate 105.0mg (=75mg lysine) + Threonine 53.0mg + Tryptophan 23.0mg + Histidine 38.0mg + Tyrosine 30.0mg
Film coated tablets
16/06/16
1234Each tablet contains: Glibenclamide 2.5/5mg Metformin HCl IP 500mg (SR)For the management of type-II diabetes mellitus when single drug therapy, diet and exercise do not result in inadequate glycemic control.04/08/04
1235Each Hard Gelatin Capsules contains: Rosuvastatin Calcium
Eq. to Rosuvastatin (as film coated tablet) 20mg/20mg
Aspirin (as enteric coated tablet) 75mg/150mg (Additional strength)
For the treatment of dyslipdemia associated with arthersclerotic arterial disease with risk of Myocardial infarction, stroke or peripheral vascular disease.08/08/16
1236Each uncoated tablet contains: voglibose IP 0.2mg/0.3mg
Metformin Hydrochloride IP 1000mg/1000mg, tablet
(Additional Strength)
As 2nd line treatment of type II Diabetes mellitus when diet, exercise and the single agent do not result in adequate glycemic control.14/09/16
1237Each film coated tablets contains: Tenofovir Disoproxil Fumarate IP 300mg
Emtricitabine IP 200mg, tablets
(additional Indication)
Indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.04/10/16
1238Each Combikit Contains:
Part A:
Lamivudine and Tenofovir Disoproxil Fumarate Tablet IP (300mg/300mg)
Each film coated tablets contains: Lamivudine IP 300mg
Tenofovir Disoproxil Fumarate IP 300mg Eq. to Tenofovir Disoproxil 245mg
Part B:
Nevirapine Extended Release Tablets 400mg
Each Extended Release Tablets Contains: Nevirapine 400mg
For the treatment of HIV infection in adults.27/10/16
1239Each gram contains:
Tretinoin USP (As Microsphere) 0.4mg Clindamycin Phosphate USP Eq. to Clindamycin 10mg, Gel
For the topical treatment of acne vulgaris in patients 12 years or older.24/11/16
1240Each combikit contains: Part A:
Two tablets of Lamivudine with Zidovudine Tablets IP
Each Film coated tablets contains: Lamivudine IP 150mg
Zidovudine IP 300mg Part B:
One tablet of Atazanavir and Ritonavir Tablets
Each film coated tablets contains:
Atazanavir sulphate IP Eq. to Atazanavir 300mg
Ritonavir IP 100mg
For use as 2nd line treatment of HIV infection in adults.21/12/16
1241Amprolium HCl IP 16.67% w/w Sulfaquinoxaline IP 16.67% w/w Powder
(veterinary product)
For the treatment of Coccidiosis in poultry03/02/17
1242Each dispersible Tablet contains: Lamivudine IP 30mg Zidovudine IP 60mg
(Additional strength)
Indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in children.15/02/17
1243Each Combikit Contains: Part A:
Two film coated tablets of Darunavir Ethanolate
Each tablet contains:
Darunavir Ethanolate eq. to Darunavir 600mg
For the treatment of Human Immunodeficiency virus (HIV) infection in antiretroviral treatment experienced adult patients, such as those patients with HIV-1 strains resistant to more than one protease inhibitor and with other antiretroviral agents.09/05/17
Part B:
Two film coated tablets of Ritonavir Each film coated tablet contains: Ritonavir IP 100mg, tablets
1244Each film coated tablet contains:
Darunavir Ethanolate eq. to Darunavir 600mg
Ritonavir IP 100mg, tablets
For the treatment of Human Immunodeficiency virus (HIV) infection in antiretroviral treatment experienced adult patients, such as those patients with HIV-1 strains resistant to more than one protease inhibitor and with other
antiretroviral agents.
16/05/17
1245Each dose delivers: Budesonide 320 ?g/inhalation
Formoterol Fumarate Dihydrate 9?g/inhalation
(Additional strength)
It is indicated in the regular treatment of asthma where use of combination of inhaled regular corticosteroid & long acting β- agonist is appropiate and patients with moderate to severe COPD
with frequent symptoms and a history of exacerbations.
13/06/17
1246Each capsule contains: Lopinavir 40mg
Ritonavir 10mg oral pellets (capsules)
(Additional strength)
Combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients (14 days and older)12/06/17
1247Each Combikit contains: Part A:
One film coated tablet of Dolutegravir: Composition:
Each film coated tablet contains: Dolutegravir sodium eq. to Dolutegravir 50m Part B:
One bilayered film coated tablet of Lamivudine and Tenofovir Disoproxil Fumarate IP
Composition:
Each bilayered film coated tablet contains: Lamivudine IP 300mg
Tenofovir Disoproxil Fumarate IP 300mg
For the management of Human Immunodeficiency Virus (HIV) infection in adults weighing more than 40kg.12/06/17
1248Each Combikit contains:
Part A:
One film coated Tablet of Dolutegravir. Composition:
Each film coated tablet contains: Dolutegravir sodium eq. to Dolutegravir 50 Part B:
One film coated tablet of Abacavir and Lamivudine IP.
Composition:
Each film coated tablet contains:
Abacavir sulphate IP eq. to Abacavir 600 mg Lamivudine IP 300mg
For the treatment of Human Immunodeficiency Virus (HIV) infection in adults weighing more than 40kg.12/06/17
1249Each Film coated tablet contains: Tenofovir Disoproxil Fumarate IP 300mg Lamivudine IP 300mg
Efavirenz IP 400mg
(Additional strength)
For the treatment of Human Immunodeficiency virus-1 (HIV-1) infection in adults.09/06/17
1250Each film coated tablet contains:
Abacavir Sulphate IP eq .to Abacavir 60mg Lamivudine IP 30mg
(Additional strength)
In combination with other antiretroviral agents for the treatment of Human Immunodeficiency Virus (HIV) infection in children09/06/17
1251Each Combipack of 28 Tablets contains :
24 tablets of Drospirenone IP 3mg and Ethinylestradiol IP 0.02 mg
Each uncoated tablets contains: Drospirenone IP 3mg
Ethinylestradiol IP 0.02mg with 4 inert tablets
For oral contraceptive in women only30/06/17
1252Ledipasvir 90mg + Sofosbuvir 400mg TabletFor the treatment of chronic
hepatitis C (CHC) Genotype 1
08/12/15
infection in adults
1253Paclitaxel Nanoparticle injection Each vial contains:
Paclitaxel USP 100mg
Human Albumin IP 900 mg
For the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.20/02/09
1254Each gm of gel contains:
Haemocoagulase isolated from Bothrops Atrox or Bothrops Jararaca 0.2 CU
Chlorhexidine Gluconate solution 0.1% w/w
For the topical treatment of localized capillary haemorrhage & wound healing.04/08/04
1255Each gm of gel contains:
Haemocoagulase isolated from Bothrops Atrox or Bothrops Jararaca 1.0 CU
Chlorhexidine Gluconate solution 0.1% w/w
(additional strength)
For the topical treatment of localized capillary haemorrhage & wound healing.22/11/04
1256Each ml contains:
Moxifloxacin HCl Eq. to Moxifloxacin base 5mg
Dexamethasone Sodium Phosphate Eq. to
For post operative steroid responsive inflammatory ocular condition when bacterial ocular infection or risk of bacterial ocular infection exists.31/10/08
Dexamethasone Phosphate 1mg Ophthalmic solution
(Additional indication)
1257Each 5ml reconstituted oral suspension contains:
Artemether 40mg Lumefantrine 240mg
(Additional strength)
For the treatment of pf malaria cases resistant to both chloroquine and sulfadoxine-pyremethamine combination.21/09/10
1258Each combipack of 28 tablets contains:
21 tablets of Desogestrel 0.15mg and Ethinylestradiol 0.03 mg
Each uncoated tablets contains: Desogestrel BP 0.15mg
Ethinylestradiol IP 0.03mg with 7 inert tablets
(Additional strength)
For oral contraceptive in women only.06/07/17
1259Silver Sulfadiazine IP (Nanonized) 0.5% w/w
Chlorhexidine Gluconate Sloution IP
eq. to Chlorhexidine Gluconate 0.2% w/w
Topical cream
For the prevention and treatment of infection in thermal burn wound(s) up to 10% body surface area06/07/17
1260Each 100ml contains:
Iso propyl Alcohol IP ……75% v/v
Hydrogen Peroxide IP …....0.125% v/v
Glycerol IP…….1.45% v/v Solution
Hand Hygiene07/07/17
1261Each 100ml contains:
Ethanol IP……80% v/v Hydrogen Peroxide IP ……0.125% v/v
Glycerol IP ……1.45% v/v Solution
Hand Hygiene10/07/17
1262FDC of Glucose 13% + SMOFlipid 20% (Soya bean Oil + Triglycerides medium chain + Olive Oil, Refined + Fish Oil, Rich
in omega-3-acid) + Amino acid solution (Emulsion for Infusion)
Parenteral nutrition for patients. This is indicated in cases where oral or enteral nutrition is impossible, insufficient or contraindicated.26/07/17
Ingredient
A. Glucose 13%
Each 1000ml contains:
Glucose monohydrate corresponding to Glucose
(anhydrous) 130g
Water for Injections
B. Amino acid solution corresponding to
Aminoven 10% with addition of electrolytes Each 1000ml contains:
L-Alanine
L-Arginine
Glycine (Aminoacetic acid)
L-Histidine
L-Isoleucine
L-Leucine
L-Lysine acetate
corresponding to L-Lysine 6.6g
L-Methionine
L-Phenylalanine
L-Proline
L-Serine
Taurine
L-Threonine
L-Tryptophan
L-Tyrosine
L-Valine
Calcium chloride dihydrate corresponding to Calcium
Chloride 0.56g
Sodium glycerophosphate
hydrate corresponding to
Sodium glycerophosphate
Magnesium sulphate
heptahydrate corresponding to Magnesium sulphate 1.2g
Potassium chloride
Sodium acetate trihydrate corresponding to Sodium
acetate 3.4g
Zinc sulphate heptahydrate corresponding to Zinc
sulphate 0.0129g
Acetic acid glacial
Water for Injections
C. Lipid emulsion corresponding to SMOFLipid 20%
Each 1000ml contains:
Soya-bean oil, refined
Triglycerides, medium-chain
Olive oil, refined
Fish oil, rich in omega-3 acids
All-rac-α-Tocopherol
Purified egg phospholipids
Glycerol (anhydrous)
Sodium oleate
Sodium hydroxide
Water for Injections
1263FDC of Glucose 42% + Amino acid solution with electrolyte + Lipid Emulsion for InfusionParenteral nutrition for patients. This is indicated in cases where oral or enteral nutrition is impossible, insufficient or contraindicated.26/07/17
IngredientComposition (gm/ml)
A. Glucose 42%
Each 1000ml contains:
Glucose monohydrate
corresponding to Glucose (anhydrous) 420g
462g
Hydrochloric acidTo pH approx. 4
Water for Injectionsto 1000ml
B. Amino acid solution corresponding to Aminoven 10% with addition of electrolytes Each 1000ml contains:
L-Alanine14.0g
L-Arginine12.0g
Glycine (Aminoacetic acid)11.0g
L-Histidine3.0g
L-Isoleucine5.0g
L-Leucine7.4g
L-Lysine acetate corresponding to L-Lysine
6.6g
9.3g
L-Methionine4.3g
L-Phenylalanine5.1g
L-Proline11.2g
L-Serine6.5g
Taurine1.0g
L-Threonine4.4g
L-Tryptophan2.0g
L-Tyrosine0.4g
L-Valine6.2g
Calcium chloride dihydrate corresponding to Calcium
Chloride 0.56g
0.74g
Sodium glycerophosphate
hydrate corresponding to Sodium glycerophosphate
4.18g
Magnesium sulphate
heptahydrate corresponding to Magnesium sulphate 1.2g
2.47g
Potassium chloride4.48g
Sodium acetate trihydrate corresponding to Sodium
acetate 3.4g
5.62g
Zinc sulphate heptahydrate
corresponding to Zinc sulphate 0.0129g
0.023g
Acetic acid glacialTo pH approx.5.6
Water for Injectionsto 1000ml
C. Lipid emulsion corresponding to SMOFLipid 20%
Each 1000ml contains:
Soya-bean oil, refined60.0g
Triglycerides, medium-chain60.0g
Olive oil, refined50.0g
Fish oil, rich in omega-3 acids30.0g
All-rac-α-Tocopherol163-225g
Purified egg phospholipids12.0g
Glycerol (anhydrous)25.0g
Sodium oleate0.3g
Sodium hydroxideTo pH approx. 8
Water for InjectionsTo 1000ml
1264Each film coated tablet contains:
Darunavir Ethanolate
eq. to Darunavir………400mg
Ritonavir IP …………..50mg (Additional strength)
For the treatment of Human Immunodeficiency Virus (HIV-1) infection in treatment experienced adults and adolescents having body weight of atleast 40 kg.17/08/17
1265Diclofenac Diethylamine BP….2.32 % w/w (Eq. to Diclofenac Sodium 2% w/w)
Methyl Salicylate IP ………….10% w/w Menthol IP …………………... 5% w/w
Topical spray
For the local symptomatic relief of musculoskeletal pain (such as back pain, ankle pain, knee pain, shoulder pain, wrist pain) due to sprains, strains and sport injury.01/09/17
1266Diclofenac Diethylamine BP….2.32 % w/w (Eq. to Diclofenac Sodium 2% w/w)
Methyl Salicylate IP ………….10% w/w Menthol IP …………………... 5% w/w Topical Gel
For the treatment of pain, swelling and inflammation due to musculo- skeletal disorders (such as sprains, strains, tendonitis, bursitis, hard neck, shoulder pain, sciatica, muscle stiffness, joint pain,
backache, lumbago
01/09/17
1267Each ml contains:
Polythylene Glycol 400……….. 0.4% w/v Propylene Glycol ………………0.3% w/v Lubricating Eye Gel
For the temporary relief of ocular symptoms due to dryness of the eye, such as discomfort, burning and irritation.12/09/17
1268Milbemycin Oxime …….2.5mg/12.5mg
Praziquantel …………………..25mg/125mg Tablets
(Veterinary product)
Treatment of nematode and cestode infection in dogs.12/09/17
1269Each film coated tablet contains:
Losartan Potassium IP …………50mg Amlodipine Besylate IP
Eq. to Amlodipine ………………5mg
Hydrochlorothiazide IP…………12.5mg Tablets
For treatment of hypertension in patients who are not controlled with the dual drug therapy.14/09/17
1270Each film coated tablet contains: Olmesartan Medoxomil IP…….20mg/40mg Chlorthalidone IP……………..12.5mg Cilnidipine …………………….10mg
Tablets
For the treatment of essential hypertension.25/09/17
1271Each 5ml contains:
Ferrous Asparto-Glycinate eq. to Elemental Iron……………………….30mg
Methylcobalamn…………500 mcg
L-Methylfolate Calcium …..300 mcg Syrup
for the treatment of iron deficiency anemia09/10/17
1272Each film coated tablet contains: Dapagliflozin…….5mg / 5mg /10mg /10mg
Metformin HCL (extended release)……. 500mg /1000mg /500mg /1000mg
It is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both Dapagliflozin and Metformin is appropriate.16/10/17
1273Each film coated tablet contains: Empagliflozin…………………10mg/ 25mg
Linagliptin…………………….5mg / 5 mg
It is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus16/10/17
1274Each film coated tablet contains:
Empagliflozin……………..5mg/5mg/5mg/ 12.5mg/12.5mg/12.5mg
MetforminHcl…….500mg/850mg/1000mg/ 500mg / 850mg / 1000mg
It is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients with type 2 diabetes mellitus who are not adequately controlled on a regimen containing empagliflozin or Metformin, or in patients already being treated with both empagliflozin and Metformin.17/10/17
1275Each film coated tablet contains:
Darunavir Ethanolate
eq. to Darunavir………800mg
Ritonavir IP ………….100mg (Additional strength)
For the treatment of Human Immunodeficiency Virus (HIV-1) infection in treatment experienced adults and adolescents.02/11/17
1276Each Combikit contains: Part A:
One film coated tablet of FDC Tenofovir Disoproxil Fumarate+ Emtricitabine Tablets IP
Each film coated tablet contains:
Tenofovir Disoproxil Fumarate IP 300 mg Emtricitabine IP 200 mg
Part B:
One uncoated tablet of Nevirapine Extended Release Tablet
Each Extended release tablet contains: Nevirapine IP 400 mg
For the management of Human Immunodeficiency Virus (HIV) infection in adults.05/12/17
1277Each uncoated tablet contains:
Gliclazide B.P……………………..80mg Metformin Hydrochloride I.P…… 500mg
For the treatment of non-insulin dependent diabetes (Type-II) in adult patients where single drug therapy, diet and exercise do not
result in adequate glycemic control
21/02/06
1278Omeprazole powder for Oral Suspension (Sodium bicarbonate as buffer)
Each sachet contains:
Omeprazole………….20mg
For the treatment of active duodenal ulcer, Gastroesophageal Reflux Disease (GERD), erosive esophagitis and maintenance of healing of erosive esophagitis.03/07/07
1279Each Uncoated tablet contains: Perindoprill Erbumin B.P………8mg Indapamide BP………………...2.5mg
(Additional Strength)
For the treatment of hypertension09/06/14
1280Each film coated tablet contains: Sacubutril + Valsartan…… 50 (24+26)mg/
Sacubutril + Valsartan…… 100 (49+51)mg/
Sacubutril + Valsartan…200 (97+103)mg
To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction14/07/16
1281Each film coated tablet contains: Sofosbuvir…………. 400 mg
Velpatasvir…………. 100 mg
For the treatment of adult patients with -chronic Hepatitis C virus, Genotype 1,2,3,4,5 or 6 infection.
-without cirrhosis or with compensated cirrhosis
-with decompensated with chronic for use in combination with Ribavirin
04/05/17
1282Each Pre-dispensed dose contains: Fluticasone Furoate…………100 mcg Vilanterol Trifenatate……….25mcg (Powder for inhalation)Indicated for the maintenance treatment of the airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/ or emphysema and to reduce exacerbation of COPD in patients
with an exacerbation history.
29/06/17
1283Each uncoated tablet contains:
Arterolane Maleate IP Equivalent to Arterolane……………. 37.5mg
Piperaquine phosphate…..187.5 mg (Dispersible Tablets)
Indicated in children aged 6 months to 12 years for the treatment of
- acute uncomplicated Plasmodium falciparum malaria infection
- acute uncomplicated Plasmodium Vivax malaria infection
24/11/17
1284Each film coated tablet contains:
Emtricitabine IP…………….200mg/200mg
Tenofovir Alafenamide Hemifumarate Equivalent to
Tenofovir Alafenamide………10mg/25mg
In combination with other antiretroviral agents for treatment of Human Immunodeficiency Virus type-1 (HIV-1) infections in adults and adolescents with aged 12 years and older.10/01/18
1285Each film coated tablet contains:
Dolutegravir sodium equivalent to Dolutegravir …………………… 50mg
Lamivudine IP…………………. 300mg Tenofovir Disoproxil
Fumarate IP ……………………. 300mg
eq. to Tenofovir Disoproxil …… 245mg
For the management of Human Immunodeficiency Virus (HIV) infections in adults weighing more than 40kg.08/03/18
1286Each film coated tablet contains:
Abacavir Sulphate USP eq .to Abacavir………………..600mg
Dolutagravir Sodium eq. to Dolutagravir……………50mg
Lamivudine USP……….300mg
For the treatment of Human Immunodeficiency Virus (HIV) infection in adults weighing more than 40kg.12/03/18
1287Each combikit contains:
Part A: One film coated of Atazanavir Sulphate + Ritonavir tablet.
Each tablet contains:
Atazanavir Sulphate IP eq.to Atazanavir……………300mg
Ritonavir IP………….100mg
Part B: One film coated of Abacavir Sulphate + Lamivudine tablet
Each film coated tablet contains:
Abacavir Sulphate IP eq to Abacavir…………….600mg
Lamivudine IP………300mg
For management of Human Immunodeficiency Virus (HIV) infections13/03/18
1288Each ml cutaneous solution contains: Chlorhexidine gluconate solution IP
Eq. to Chlorhexidine gluconate ……. 20 mg
Isopropyl Alcohol IP …………… 0.70 ml
For disinfectant of the skin prior to invasive medical procedures and maintenance of device insertion sites.22/03/18
1289Each film coated tablet contains:
Canagliflozin + Metformin HCL
(50mg + 500mg, 50mg + 850mg, 50mg + 1000mg, 150mg+500mg, 150mg+850mg & 150mg + 1000mg)
Indicated as an adjunct to diet and exercise to improve glycaemic control in adult with type 2 diabetes mellitus when treatment with both Canagliflozin and metformin is appropriate.
Limitation?of?use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis.
27/03/18
1290Each ml contains:
i) Bupivacaine Hydrochloride IP 1.25mg Eq to anhydrous Bupivacaine Hydrochloride 1.185mg Fentanyl Citrate IP Eq to Fentanyl 2.0mcg Injection
ii) Bupivacaine Hydrochloride IP 1.0mg Eq to anhydrous Bupivacaine Hydrochloride 0.948mg
Fentanyl Citrate IP Eq to Fentanyl
2.0 mcg Injection
For maintaining the analgesia postoperatively. For maintaining analgesia during labour17/04/18
1291Each film coated tablet contains : Daclatasvir Dihydrochloride
Eq to Daclatasvir………..60 mg
Sofosbuvir……………....400 mg
For the treatment of patient with chronic Hepatitis C virus (HCV) genotype 3 infection12/06/18
1292Each vial contains:
Morepenam IP eq. to Anhydrous Meropenam……..1gm
Sodium Carbonate IP Eq. to
For the treatment of lower respiratory tract infection caused by gram negative bacteria in adults only.25/06/18
Sodium ……90.2 mg Sulbactum Sodium USP Eq. to
Sulbactum………1gm Injection
1293i) Each 38 cm Seresto Collar Contains:
(For Cats less than or equal to 8 Kg of body weight)
Imidacloprid…..1.25g Flumethrin….0.56g
ii) Each 38 cm Seresto Collar Contains:
(For Dogs less than or equal to 8 Kg of body weight)
Imidacloprid…..1.25g Flumethrin….0.56g
iii) Each 38 cm Seresto Collar Contains:
(For Dogs more than or equal to 8 Kg of body weight)
Imidacloprid…..4.5g Flumethrin….2.03g
For the treatment and prevention against fleas, Ticks & Lice and For reducing the risk of Vector-Borne Disease transmission.26/06/18
1294Each Film coated tablet contains:
Azilsartan Kamedoxomil eq to Azilsartan Medoxomil + Chlorthalidone IP
(40mg+25mg &40mg + 12.5mg)
For the treatment of mild to moderate hypertension09/07/18