FIXED DOSE COMBINATIONS APPROVED BY DCG (I) SINCE 1961 TILL FEBRUARY, 2013

# 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. Name of Drug Cyanocobalamine + Zinc tannic acid complex Cobalt glutamate + Copper Glycinate Fibrinolysin + Desoxyribonuclease Tablets of Norethisterone acetate + Ethinyl oestradiol Tablets of Norethynodrel and Ethinyl Estradiol 3-methyl ether Broxyquinoline + Brobenzoxalidine Testosterone decanoate + Isocaproate Combination of L Oxethazaine + Aluminium hydroxide + Magnesium Hydroxide Amylobarbitone + Dihydrochloride Capsule Trifluperazine Indication Date of approval Jan-61 Aug-61 Feb-62 Nov-62 Dec-62 May-63 Jan-64 Jun-66 Feb-67 Apr-67 Jun-67 May-67 May-67 May-67 Jun-67 Jul-67 Jul-68 Aug-68 Jan-69 Jan-69 Feb-69 Jan-69

Lynestronol 2.5mg + Mestranol 0.075mg Tablet Northynodrel 2.5mg + Mestranol 0.1mg Norethisterone 2mg and Mestranol 0.1mg Mestranol 4mg + Ethinyloestradial 0.05mg Tablet Norethisterane acetate + ethinyl estradiol Aluminium sodium silicate + Magnesium hydroxide + Methypolysiloxane Tablet Ammoidin + Amidine Fluocortolene + Flucortolene Caproate Norgestrel + Ethinyloestradiol Tablet Folic Acid 0.5mg + Ferrous Sulphate 150mg Capsule Tetracycline HCl 250mg + Broxyquinoline 200mg + Brobenzoxadine 40mg Methyldopa 250mg + HCTZ 15mg Tablet dl Norgestrel + 17 alpha hydroxy progesterone caproate + Norethisterone acetate + 17 alpha acetoxy progesterone Diphenoxylate HCl 2.5mg + Atropine Sulphate 0.025mg tablet Vitamin A,D & E

23. 24.

Jul-69 Jul-69

25.

Lutin 0.1gm + Vit 0.1gm + Vit K1 2.5mg + Dicalcium Phosphate 0.1gm + Carlozochrome Salicylate 1mg tablet Vit K 1 5mg + Calcium Lactolionate 100 m g+ Carlozocrome Salicylate 2.5mg + Phenol 0.5% + Lignocaine Hcl 1% injection Phenylmethylamine-amino benzene Sulphate 15mg + Phenylmethylamine Hcl 10mg tablet Phenylmethylamine-amino benzene Sulphate 1.5% w/w + Phenylmethylamine Hcl 1.5% w/w ointment Colistin Sulphate (300000 IU) 0.154gm + Pectin 0.196gm + Kaolin 2.625gm per 30ml suspension Atropine Sulphate 0.06mg + Hyoscyamine sulphate 0.30mg + Scopolamine hydrobromide 0.035mg + Phenobarbatal 64.8mg capsule Di iodochlorhydroxyquinoline 300mg + Berberine Hcl 40mg + Homatropine methylbromide 0.8mg tablet Ethynodiol diacetate 1mg + Ethinyloestradiol 0.05mg Lynestronol 2.5mg + Ethinyloestradiol 50mcg Methandienone BP 25mg + Benzyl alcohol in sterile solution 9% w/v/ml Trimethoprin 80mg/20mg + sulphamethoxazole 400mg/100mg tablet Trimethoprin 40mg + 200mg/5ml suspension sulphamethoxazole

Jul-69

26.

Jul-69

27. 28.

Jul-69 Jul-69

29.

Sep-69

30.

Dec-69

31.

Jan-70 Feb-70 Sep-70 Apr-70 Jul-70 Jul-70 Sep-70

32. 33. 34. 35. 36. 37. 38.

Chlordentoin 1% + Benzyl bromide chloride 0.05% per 100gm cream Ambodryl 100mg + Aspirin 190mg + Phenacetin 65mg + Caffiene 15mg + Phenylephrine HCl 10mg + Aluminium hydroxide gel 100mg tablet Ethynodial diacetate 1mg + Mestranal 0.05mg tablet Dried yeast powder 250mg + Saccharomyces ceribial containig NLT 10 million living cells Capsule Hydroflumethiazide 25mg/50mg + Rauwalfia 50mg/50mg Tablets D - norgestrel 0.25mg + Ethinyl estradiol 0.05mg Tablet

Nov-70

39. 40.

Jan-71 Jan-71 Mar-71 Apr-71

41. 42.

43.

44. 45. 46. 47. 48. 49. 50.

Pyridine 3-carboxylic acid hydroxy methylamide 0.125gm + Choline Bitartrate Tablet Alpha chymotrypsin 60mg + Ethyl nicotinate 200mg per 20gm ointment Phenyl propalamine HCl 50mg + Isoprapamide 2.5mg + Diphenyl pyralline HCl 5mg capsule DL - norgestrel 0.25mg + Ethinyl estradiol 0.05mg Tablet Dihydroxy acetate 15%w/v + Alcohol 95% 45%w/v lotion Psoralen 10mg + Copper Sulphate 2mg Tablet Dexamethasone 0.125mg + Indomethacin 25mg Capsule Yeast tannic acid compound 250mg lodochlorohydroxyquinoline 150mg Benzalconium chloride 10mg Tablet + +

Jul-71 Sep-71 Sep-71 Sep-71 Oct-71 Oct-71 Nov-71

Nov-71

51. 52. 53.

Amylase + Cellulose + Protinase + Pencreatic enzyme + Lipase Capsule Reserpine 0.1mg + Clopamide Dihydroergocristine 0.5mg Tablet 5mg +

Dec-71 Jan-72 Jun-72 Jul-72 Oct-72 Oct-72 Nov-72 Dec-72 Mar-73 May-73

54. 55. 56. 57.

Calcium gluconate 50mg + Iso thipendyl HCl 4mg + Acetylsalicylic acid 200mg + Caffine 30mg per dosage Chlorphenoxamine HCl 12mg + Caffeine 30mg Tablet Flumethasone Pivalate 0.02% + lodochlorohydroxyquinoline 1% ear drops Cape aloes 16mg + Podophyllin resin 4.2mg + Licorice powder 5.462 mg per Tabler N - butanol 0.52gm + Citric Acid 0.0025gm + Physiological sodium chloride add to 5ml per 5 ml Paracetamol 300mg + D-propoxyphene HCl 25mg per tablet Theophylline anhydrous 100mg + Ephedrine HCl 10mg + Diazepam 1mg + Prednisolone 1.5mg tablet Dybendal 0.5%w/w + Allantoin 0.2%w/w + Boric Acid 1%w/w + Menthol 0.08% v/w

58. 59.

60.

61.

62.

63. 64.

Sod. 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 Parbendazole 4%w/w + Ethixygin 0.125% w/w + Extracted soya flour added to 100% suspension Hydrocarticosone acetate 1%w/w + Nitrofurazone 0.2%w/w cream Activated Methylpolysiloxane 125mg + Magnesium Hydroxide 100mg + Aluminium Hydroxide 5gm per 5ml solution Chlordiazepoxide 5mg + Clidimium bromide 2.5mg per tablet Nitrofurazane 0.06gm + urea 6.21gm bolus Lynestrenal 1mg + Ethinylestradiol 50mcg tablet Trimethoprim & Sulphadoxine Dried ferrous sulphate eq. to 50mg of elemental iron + Ascorbic acid 300mg + Sod. Bicarbomate 84mg + Talcum 12mg capsule Erythromycin Propionate eq. to 50mg of Erythromycin + Benzyl alcohol 0.02ml + Lidocaine 0.02gm per ml Inj. Beclomethasone Dipropionate 0.025% + Neomycin Sulphate 0.5% Ointment & Cream Beclomethasone Dipropionate 0.025% Chinoform 3% Ointment & Cream +

May-73

Jun-73 Jun-73

Jun-73

65. 66. 67. 68. 69.

Jul-73 Aug-73 Sep-73 Sep-73 Dec-73

70.

Mar-74 Apr-74 Apr-74 Jul-74 Aug-74 May-75 Jul-75 Sep-75 Jan-75 Jul-75 Aug-75 Oct-75

71. 72. 73. 74. 75. 76. 77. 78. 79. 80. 81.

Trimethoprim 4%w/v + Sulphadoxime 20%w/v Dl - Norgestrel 0.5mg + Ethinyl estradiol 0.03mg Tablet Mixture of sodium Salt + Methyl glucamine salt of 35 diacetamido- 2,4,6-triodobenzoic acid Autolysate of -subtilis+- megatherium Trimethoprim+sulfamoxole Zoalene 25% + Ethoxygim 0.125% premix Clonidine HCl 100mcg + HCTZ 20mg Tablet/Capsule Benzoyl peroxide 10%w/w + Precipitated Sulphur 5%w/w per 20gm cream Triamterene 50mg + HCTZ 25mg tablet

82.

83.

84.

85. 86. 87. 88.

Combipack of 21 active tablet contains Noretihsterone acetate 1mg + Ethinyl oestradioal 30mcg & 7 Haematinic tablets contain Ferrous Fumarate 60mg Caffein 100mg + Ergotamine tartrate 1mg + Analgin 250mg + Trifluperazine HCl 1mg Capsule Paracetamol 120mg + Diphenylpyralime HCl 1.5mg + Phenylpropanolamine HCl 10mg per 5ml expectorant Trimethoprim 80mg + Sulphamethoxazole 400mg per 5ml infusion DL- Norgestrel 300mcg + Ethinyl oestradiol 30mcg Tablet Tolnaytate 10mg + Nystatin 100,000 Units per gm cream 40mg of elemental iron in a complex of iron polymaltose + Vit. B6- 2mg + Vit. B12 40mcg tablet 50mg of elemental iron in a complex of iron polymaltose aq. solution + Vit. B6 2mg + Vit. B12 5mcg Syrup Neomycin Sulohate 910mg + Polymyxin B Sulphate 300000 units + Zinc bacitracin 25000units + Propellent to maba 210gm aerosol pouch of 210gm Norethisterone 1mg + Ethinyl estradiol 30mcg Tablet Sodium salt of loxitalamic acid 5.13gm + Meglumine salt of loxitalamic acid 10.26gm per 20ml Inj. PVP/VA resin 5% + Benzalkonium chloride 0.10% + Lignocaine HCl 0.25% + D-panthanol DAB-7DDR 2% aerosol pack of 85gm Metronodazole 40mg + Furazolidone 30mg + Kaolin 1gm + Pectin 20mg per 5ml suspension Diazepam 5mg + Paracetamol 500mg tablet Orphenadrine citrate 35mg + Paracetamol 450mg tablet Neomycin + Bacitracin+ Polymix B Sulphate ointment Clonidine HCl 0.1mg/0.2mg + Chlorthalidone 15mg/15mg Tablet Sulfametopyrazine 500mg + Pyrimethamine 25mg tablet

Oct-75

Mar-76

May-76 Oct-76 Oct-76 Feb-77 Feb-77

89.

Feb-77

90.

Mar-77

91. 92.

Jun-77 Sep-77

93.

Sep-77

94. 95. 96. 97. 98. 99.

Oct-77 Oct-77 Nov-77 Nov-77 Dec-77 May-78

100. 101.

Fluocortolone caproate 0.25gm + Flucortolone Trimethylacetate 0.25gm per 100gm cream Dimethyl polysiloxone 100mg + Enzyme concentrate Aspergilluss oryzae 120mg + Protease 126 units + Cellulase 185 units + Hemicellulose 64 units + Amylase 1.3 units + papaverine HCl 25mg Capsule Lignocaine 50mg + Aluminium Hydroxide 300mg + Magnesium hydroxide 100mg + Activated dimethicone 20NF 50mg Tablet & 5 ml suspension Fluprednylidene acetate 0.1% + Gentamicin Sulphate 0.1% + 5-Chloro-8-hydroxygluconate 0.5% Cream Fluocortolone trimethylacetae 0.92mg + Flucartolone caproate 0.95mg + Clemizole undecyclate 10mg + Cinclocamic HCl per gm ointment Fluocortolone trimethylacetae 0.612mg + Flucartolone caproate 0.630mg + Clemizole undecyclate 5mg + Cinclocamic HCl 1mg Suppositories Propoxyphene Napasylate 100mg + Paracetamol 650mg Capsule Sod. Chloride 20.047mg + Pot. Chloride 0.522gm + Mag. Chloride 0.366gm + Cal. Chloride 0.859gm + Sod. Acetate 19.047gm per 100ml Dialysis fluid Sod. Chloride 20.475mg + Pot. Chloride 0.783gm + Mag. Chloride 0.534gm + Cal. Chloride 0.972gm + Sod. Acetate 19.054gm per 100ml Dialysis fluid Fluocortolone 2.5mg + Fluocartalone caproate 2.5mg + Neomycin Sulphate 5mg per gm ointment Trimethoprim 160mg + Sulphamethoxazole 800mg per 3 ml Inj. Metronodazole 100mg + Furazolidone 30mg + Kaolin & Pectin per 5ml suspension Lynestrenal 0.75mg + Ethinylestradiol 37.5mcg tablet Chlorpromazine 50mg + Trifluroperazine 5mg + Trihexyphenidyl 2mg tablet Halcinonide 1mg + Neomycin sulphate eq. to 2.5mg of neomycin base ointment/cream

Jun-78

Aug-78

102.

Sep-78

103.

Oct-78

104.

Oct-78

105.

Oct-78

106. 107.

Nov-78

Nov-78

108.

Nov-78

109.

Nov-78 Jan-79 Mar-79 Apr-79 May-79 Jul-79

110. 111. 112. 113. 114.

115. 116. 117. 118. 119. 120.

Clidinium bromide 2.5mg + Diazepam 2.5mg + Analgin 500mg tablet Amiloride 5mg + HCTZ 50mg Tablet Diazepam 2.5mg + Sorbide Dihitrate 10mg Tablet Propranolol 40mg + Hydrallazime 25mg tablet Fluprednidene acetate 0.1% + Gentamicin as Sulphate 0.1% Cream Sterile powder of colistin sulphomethate sodium eq. to 1000000 Units + Dilucame HCl 2mg per vial Inj. Phenylbutazone 125mg + Propyphenazone 125 mg tablets combipack of 22 tablets of Lynestrenol 1mg + Ethynyloestradiol 50mcg & 6 placebo tablets of Ferrous Fumerate 60mg Diethylamine Salicylate 10mg + Nopoxamine 1gm per 100gm ointment Phenyl dimethyl isopropyl pyrazolone 150mg + Diethyl dioxotetrahydro pyridine 50mg + Paracetamol 250mg + Caffeine (Anhydrous) 46.75mg Hydroxyethyltheophylline 231mg + Theophylline monohydrate 69mg SR Tablet Calender 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 Acetylsalicyclic acid 350mg + Al. Hydroxide 90mg + Mg. Hydroxide 90mg tablet Terbutaline sulphate 1.5mg+Guaphenesine 66.5 mg per 5ml syrup Propranolol HCl 40 mg+HCTZ 25 mg tablets Metoprolol tartarate mg+Hydroclorothiazide 12.5 mg 100

Sep-79 Sep-79 Dec-79 Feb-80 Feb-80 Feb-80 Feb-80

121. 122.

Jun-80

123. 124.

Mar-80

Nov-80

125. 126.

Jun-81

Jun-81

127. 128. 129. 130. 131. 132. 133.

Nov-81 Oct-82 Oct-82 Oct-82 Oct-82 Oct-82 Nov-82

Propranolol Hcl 80 mg+Bendrafluazide 2.5 mg capsule Paracetamol 450 mg+Chlormezanone 100 mg tablet Megaldrate 400 mg+Simethicone 60 mg chewable tablet

134. 135. 136. 137. 138. 139. 140.

Megaldrate 400 mg+Simethicone 60 mg per 5ml Suspension Bumetanide 0.5mg+Potassium Chloride 523 mg tablet Ampicillin 3.5gm+ Probenecid 1.0gm single vial Rifampicin300mg/450mg/600mg+INH 200mg/300mg/300mg Desogestrel 0.15 mg+Ethinylestradiol 0.03 mg each tablets Levodopa+Carbidopa Betamethasone Dipropionate 6.43 mg + Betamethasone Sodium Phosphate 2.63 mg each vial Frusemide 20mg/20mg + Spironolactone 50mg/100mg each capsule/tablet Levamisole 50 mg+Mebendazole 200mg tablet Tinidazole 150mg+Diloxonide Furoate 250mg tablet Ibuprofen 400mg+ Paracetamol 325mg tablet Clestabol 500mg+Neomycin Sulphate 500mg per 100gm cream Levodopa 100mg/200mg+Benserazide 25mg/50mg each capsule Hydrotalcite 500mg + Smithicone (activated) 125mg Tablet & Hydrotalcite 500mg + Smithicone (activated) 125mg per 5ml Suspension Acebutolol HCl 200mg + HCTZ 12.5mg Biclotymol 0.198gm+Glyceryl Galacolate 0.200gm+Pholcodine 0.133gm+Chlorphenaramine maleate 0.0133gm per 100ml Syrup (for adult) Biclotymol 0.150gm+Glyceryl Galacolate 0.200gm+Pholcodine 0.100gm+Chlorphenaramine maleate 0.01gm per 100ml (for children) Metoclopramide 5 mg+Dimethyl polysiloxane 250 mg tablet Sulphadiazine tablet Sulphadiazine suspension 400mg+Trimethoprim 200mg+Trimethoprim 80mg 40mg

Nov-82 Feb-83 Feb-83 Jun-83 Nov-83 Dec-83 Jul-84 Sep-84 Sep-84 Sep-84 Oct-84 Jun-85 Nov-85

141. 142. 143. 144. 145. 146. 147.

Jun-86 Aug-86 May-86

148. 149.

150.

May-86

151. 152. 153.

Aug-85 Jan-87 Jan-87

154. 155.

Carenecaine 2% with Adrenaline & Carenecaine 4% with Adrenaline Injectio Amoxycillin trihydrate 250mg+Potassium Clavulanic eq. to Clavulanic acid 125mg each tablet Framycetin Sulphate 1% + Hydrocortisone Acetate 1% + Miconazole nitrate 2% Amoxycillin 500mg/1gm+Clavulanic 100mg/200mg each vial Injection acid

Feb-87 Feb-87 Apr-87 May-87

156. 157. 158.

159. 160. 161. 162. 163.

7 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 Fresemide 20mg+Potassium chloride 750mg each tablet Neutral insulin and Insulin Zinc suspension Gestodene 75mcg + Ethinylestradiol 30mcg tablet Licomycin 50mg + Spectinomycin 100mg for vetarnary use Lincomycin 300mg + Neomycin 200mg + Methyl Prednisolone 5mg per 10ml Infusion Solution Amiloride 5mg / 5mg + Frusemide 20mg/40mg tablet Metoprolol 50mg + HCTZ 12.5mg Tablet Captopril 25/50mg + HCTZ 15/25mg Eicosapentaenoic acid (EPA) 180mg Docoshexaenoic acid (DHA) 120mg +

Jan-88

Mar-89 Sep-87 Jul-88 Oct-88 Mar-89 Jun-89 Jun-89 Jul-89 Sep-89 Jan-90 May-90

164. 165. 166. 167. 168. 169.

170.

Atenolol BP 50mg+Nifedipine SR 20mg capsule Alpha chloropyridazine sodium 10gm + trimethoprim 2gm per 100gm powder for vetarnary use Amoxicillin 250/500mg + Carbocistine for respiratory infections characterised 150mg/150mg capsule by excessive or viscous mucous Contraindication in pregnancy Amoxicillin 125mg + Carbocistine 75mg per for respiratory infections characterised 5ml syrup by excessive or viscous mucous Contraindication in pregnancy Acetyl salicylic acid 100mg + Cal. Carbonate 30mg + Anhydrous citric acid 10mg Tablet

Apr-91

171.

Apr-91

172.

Sep-91

173. 174.

Ampicillin Sodium 0.5gm + Sulbactum Sodium 1gm per vial Injection Pinene 17mg+camphene 5mg+Cineol 2mg+Menthone 6mg+Menthol 32mg +Borneol 5mg+Olive oil 33mg capsule Ampicillin Sodium 0.25/0.5gm + Sulbactum Sodium 1gm/2gm per vial Injection Cinnarazine 20mg + Domperidone 15mg tablet prevention 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.

Sep-91

Sep-91

175. 176.

06.05.1992

01/02/1992

177.

Triclabendazole 5gm/12gm + Levamisole treatment and control of mature and 3.75gm/7.5gm per 100ml Suspension for developing immature infections of Veternary use ostertragia, trichostrongylus, cooperis, nematodirus, oesophagastomum and dictyocaulus and all forms of liver fluke infection in sheep/cattle. Pseudoehedrine HCl 30mg + Ibuprofen 200mg for the relief of nasal congestion, tablet headache, fever, bodyache and pain associated with sinusitis, flu and common cold. Enalapril 10mg/20mg + HCTZ 12.5mg/25mg hypertension in patients for whom tablet combination therapy is appropriate Ferrous glycine Sulphate CR 100mg (eq. to For the prophylaxis of iron and folic elemental iron)+Folic acid 0.5mg tablet acid deficiencies during pregnancy Frusemide 40mg/20mg+Potassium 600mg/300mg tablet Cisapride + M.P.S. Chewable tablet Chloride NM Management 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 constipation

01/07/1992

178.

28.09.1992

179. 180. 181. 182.

08.10.1992 03.11.1992 26.02.1993

03.05.1993

183.

Etofylline-300mg, Salbutamol (as sulphate)- NM 4mg SR Capsules

14.06.1993

184.

Norgestimate 180gm/215gm/250gm + oral contraceptives Ethinyl oestradiol 35gm/35gm/35gm Tablets (Triphasic oral contraceptive tablets) Oxytetracycline HCL-500mg+Furazolidone- Intrauterine infusion for veternary 500mg+Clioquinol-500mg per 100 gm syringe Levamisole-1.5%+Oxyclozanide-3.0% for veternary use Suspension Framycetin sulphate 1%+Dexamethasone In the treatment of dermatologic 0.1%+Clotrimazole 1% Cream disorders caused or complicated by infections by bacteria and/or fungi along with inflammation (I) Rice based ORS citrate containing each Oral Rehydration Salts 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 50.0gm EryThropoietin 2000 IU/4000 IU + Mannitol In the treatment of anemia due to 40mg/40MG + NaCl 7mg/7MG + Monobasic chronic renal failure and stage renal Sod. Phosphate 2.8mg/2.8mg + Dibasic Sod. disease Phosphate 8mg/8mg + Human Albumin 5mg/5mg Lyophilised 2 ml Inj. Spiramycin 0.75MIU/1.50MIU+Metronidazole NM 1.25mg/250mg film coated Tablets Sultamicillin(as Tosylate) 375mg eq. Sulbactam 147.0 mg + Ampicillin 220 mg Film coated tablets. Cephalexin-250mg/500mg+ Bromhexine (as RTI charaterized by excessive or HCl) 4MG/8MG Capsules viscid mucous Cephalexin monohydrate eq. to cephalaxin RTI charaterized by excessive or 125mg/250mg+ Bromhexine Hcl eq. to viscid mucous Bromhexine 2mg/4mg per 5ml of reconstituted suspension. Carbidopa (Anhydrous) 50mg+Levodopa200mg C.R.tablet Cephalaxin monohydrate eq. to cephalexin 500mg/250mg+Carbocisteine 150mg/150mg Capsules Cephalaxin anhydrous 250mg+Carbocisteine 150mg per 5 ml suspension

29.06.1993

185. 186. 187.

5.07.1993 29.09.1993

28.10.1993

188.

9.12.1993

189.

15/06/1905

190. 191.

15.03.1994 06.05.1994 16.09.1994

192. 193.

27.01.1995

194. 195.

19.10.1994 30.10.1994 30.10.1994

196.

197.

198.

ZnSO4 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) Clostridium botulinum toxin type A - For the treatment of blepharospasm Hemagglutinin complex 100 units Human hemifacial spasm & associated focal Serum Albumium 0.5mg+ NaCl 0.9 mg dystominal Taurolidine 2g + Povidone 5g per 100ml Taurolidine 2.5g + Povidone 6.25g per 500ml Terfenadine 60mg+Pseudoephedrine 120mg as E.R. tablets Policresulen 50mg+Cinchocaine gram ointment HCL

08.10.1994

13.01.1994 13.01.1994 13.01.1994 24.03.1995 09.05.1995 07.07.1995 26.07.1995 28.07.1995 19.09.1995

199. 200. 201. 202. 203. 204. 205. 206.

Tinidazole 600mg+Norfloxacin 400mg tablets 10mg per

Nonoxynol 2% w/v+Chlorometoxylenol 0.5% w/v Ergometrine 500mcg+Oxytocin 5 units per ml injection Nitrendipine 10mg/20mg+Atenolol 30mg/30mg Mild to moderate hypertension not tablets responding to monotherapy with either of the drug Lactic acid 1.0% w/v+ Lactoserum 0.9% w/v (for topical use) Amlodipine 5mg/2.5mg+Enalapril 5mg/2.5mg tablets Lisinopril 10mg/20mg/5mg+Hydrochlorothiazide 12.5mg/25mg/12.5mg uncoated tablet Maleate For the treatment of hypertension only For the treatment of patients with hypertension who are not adequately controlled on monotherapy

207. 208. 209.

06.11.1995 16.11.1995

23.11.1995

210.

Glibenclamide 2.5mg+Metformin 400mg Film non insulin dependent diabites mallitus coated Tablets patients poorly controled with sulphonyluren or biguanide alone Zinc 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 Mono ammonium glycyrrhizinate 4mg (as for the management of Glycyrrhizin) + Amino acetic acid 40mg + L- hepatic failure Cyptein HCl 2mg per 2 ml Inj.

30.11.1995

211.

12.12.1995 subacute 14.12.1995

212.

213. 214.

Polyvinyl Alochol 14mg+Povidone for relief from burning, irritation and 6mg+Chlorbutanol 5mg per ml eye drops discomfort due to dryness of the eye NaCl-0.125gm+KCl 0.150gm+NaHCO3- ORS Tablets 0.250gm+Citric acid (anhydrous)-0.577gm+ Dextrose (anhydrous) 2.650gm ORS Tablets Polyvinyl Alcohol 14mg/30mg+Benzalkonium chloride-8.05mg per ml Opthalmic solution Amlodipine besylate eq. to Amlodipine 5mg+ Atenolol 50mg Besylate tablets Mild to moderate hypertension

11.01.1996

22.04.1996

215. 216. 217.

16.05.1996 20.05.1996

218.

219.

Lignocaine(base) 2%+ Silver Sulphadiazine Temporary pain relief & to prevent 1%+ Chlorhexidine Glulonate 02% cream infection in cuts & burn, wounds, nicks, scrapes, scratches abersion herper zoster, bed sores Sterile Amoxyllin Sodium eq. to Amoxycillin Antibiotic 500gm/1gm+Sterile Sulbactam Sodium eq. to Sulbactam 250mg/500mg (each vial) inj. (IM/IV) Clobetasol Propionate 0.05 % w/w+Ammonium dry hyper keratotic steriod responsive lactate 12 % w/w gel dermato ses inflammatory manifestatin of psoriasis (excluding wide spread plague psoriasis) Ramipril 2.5mg/5mg+Hydrochlorothiazide Mild to moderate hypertension in 12.5mg/25mg tablet patients (in when combination therappy is appropiate) who have been established on the individual components given in the same proportion Loratidine 5mg+Pseudoephedrine 120mg (ER) for the relief of symptoms of seasonal tablets allergic rhinitis Fluorometholone 1mg+ Neomycin sulphate In the treatment of infected 3.5mg (as base)+Benzalkonium chloride inflammatory ocular condition 0.04mg per ml Ophthalmic suspension Clindamycin 1%+Tretinoin 0.025% Topical gel Glibenclamide 5mg+ Metfermin 500mg Tablets Mild to moderate acne vulgaris only non insulin dependent diabites mallitus patients poorly controled with sulphonyluren or biguanide alone

18.06.1996

21.06.1996

07.08.1996

220.

26.08.1996

221. 222.

21.08.1996

04.09.1996 18.11.1996 26.11.1996

223. 224.

225.

226.

Ticarcilin 3gm+ Clavulanic Acid 100mg (per For the treatment of Bacterial vial) injection 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. Amlodipine besylate Eq. to Amlodipine 5mg + mild to moderate hypertension Lisinoril eq. to Lisinopril anhydrous 5mg tablet

30.10.1996

27.03.1997

227.

Flurometholone 10 mg+Gentamicin 3 mg (as The infection of the anterior segment sulphate) per ml Eye Drops of the eye due to bacteria susceptible to gentamicin. Methyl valerate 100mg+ Quinine Anhydrous 15mg+ Camphor 10mg+ Oil of eucalyptus 10mg capsule Cetirizine Dihydrochloride 5mg (Immediate release)+Pseudoephedrine HCl 120mg (SR) tablet Combipack 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 Combipack containing : 1 capsule of Omeprazole 20mg cap, 1 tablet of Amoxycillin 750mg & 1 tablet of Tinidazole 500 mg used as an anti smoking agent

28.04.1997

228.

06.06.1997 for the treatment of seasonal allergic rhinitis. for indication of H. Pylori associated with peptic ulcer 09.09.1997

229.

09.09.1997

230.

231.

for indication of H. Pylori associated with peptic ulcer

09.09.1997

232. 233.

Propoxur 1gm + Flomethrion 0.225 gm per for protection and control of ticks and 10mg of collor for veternary use flea on dogs Levovist 4gm & 2.5gm granules per 20 ml one and two dimensional dopller vial(1gm granules contains Galactose 999mg + sonography blood flow imaging in Palmetic acid 1 mg) (Contrast Media) patients where there is an unsufficiant doppler signal intensity and for bB mode conrol echo cardiography. Cloxacillin sodium 200mg+Colistine sulphate 50000 units per 10 ml Intrammamary infusion (vet) Ambroxol+Pseudoephedmine+Chlorpheniramin For the symptomatic relief of e maleats tabs/suspension/syrup bronchospasm in bronchial asthma & chronic bronchitis Glipizide 2.5mg/5mg +Metformin for non insulin dependent diabitis 250mg/500mg tablet mellitus Perindopril 2mg/4mg+Indepamide mild to moderate essential 0.625mg/1.25mg tablet hypertension Benazapril Hcl mild to moderate hypertension only 5mg/10mg/20mg/20mg+Hydrochlorothiazide 6.25mg/12.5mg/12.5mg/25mg tablet Flupenthixol dihydrochloride eq. to flupenthixol In the treatment of psychogenic 0.5mg + Melitracen Hcl eq. to Melitracen 10mg depression depressive neureoses sugar coated Tablet marked depression and psychotic affections accomapanied by by anxiety and apathy. Butafostane 10gm + Cyanocobalamine 0.005gm for veternary per 100ml Solution

03.02.1997

28.11.1997

234.

04.03.1998

235.

26.02.1998 20/03/1998 24.03.1998

236. 237. 238.

21.05.1998

239.

28.10.1998

240.

04.03.1998

241. 242.

Lidocaine 2%+Prilocaine 2.5% w/w cream

As a topical an aesthetic for use on normal intact skin for local anaesthesia

May, 1999 13.05.1999

243.

Bisoprolol Fumarate (2:1) mild to moderate hypertension 2.5mg/5mg+Hydrochlorthiazide-6.25mg/6.25 mg Tablet Combipack of 1 tablet of Fluconazole 150mg , 1 film coated tablet of Azithormycin dihydrate eq. to Azithromycin 1gm & 2 fillm caoted tablet of Secnidazole 1gm Losartan Potassium 50mg+Hydrochlorothiazide for treatment of mild to moderate 12.5mg film coated Tablet hypertension. Ambroxol HCl 15mg+ Salbulamol 1mg + For the symptomatic relief of Guaiphenesin 50mg+ Methol 1mg per 5 ml bronchospasm in bronchial asthma & syrup chronic bronchitis Combipack of 1 vial of Ifosfamide 1gm & Mesna 100mg/ml Glutaraldehyde 15% +cocobenzyl dimethyl for the control of diseases in animal ammonium chloride10% + dye <0.1% + premises perfume 6% + soften water-0.5% per litre Alkyl dimethyl benzoyl ammonium chloride Disinfectant for cleaner for vet use 5%+ Nonyl phenolethoxide 6%+Inert ingredient 89% Fexofenadine 120mg+Psendoephedrine sulphate Allergic and seasonal rhinitis only USP in ER form 180mg tablet Loratadine 10mg+Psendoephedrine sulphate in Allergic and seasonal rhinitis only ER form 180mg film coated Tablet Ciprofloxacin 0.3%w/v+ Dexomethasone 0.1% For post operative steroid responsive w/v eye drops inflammatory ocular conditions when bacterial ocular infections or a risk of bacterial ocular infections exists. Fenbandazole(vet) 2.5%(w/w)/1.5%(w/w) +Oxyclonazide (vet) 7.5%w/w/4.5%(w/w) per ml Fenbandazole 175mg+Oxycloganide 525mg bolus in treatment of lungworms, flukes in only in treatment of lungworms, flukes in only roundworms , cattles & sheep roundworms , cattles & sheep

07.06.1999

244. 245.

08.06.1999 16.06.1999 30.07.1999

246. 247.

24.08.1999

248.

23.08.1999 17.09.1999 17.09.1999

249. 250. 251.

29.09.1999

252.

04.10.1999

253.

04.10.1999

254.

255.

256.

Combikit of 2 enteric coated tablet of Pantoprazole 40mg ,2 film coated tablet of Amoxycillin 750mg & 2 film coated tablet of Tinidazole 500mg. Ambroxol 30mg+Gnaiphenesin cough congestion 100mg+Menthol 1mg+Psendoephedrine 60mg per 5ml syrup Lamivudine 150mg+Zidovudine 300 tablets for the treatment of HIV Infection

15.10.1999

29.10.1999 26.11.1999

257. 258. 259.

Amoxycillin 250mg+Clavulanic acid 150mg Antibiotic dispersible tablet Combipack of Desogestral and Ethinyl for oral contraceptive in women only Estradiol Ciprofloxacin (0.3%)+Dexomethasone (0.1%) For post operative steroid responsive eye drops inflammatory ocular conditions when bacterial ocular infections or a risk of bacterial ocular infections exists. Medronic acid 10 mg + Stannous chloride. Diagnosis and study of priamary 2H2O-1mg per vial injection cancer metastatic bone lesion and other bone diseases. Paget's disease osteomylitis fractures Diclofenac Sodium 1mg + Gentamycin Sodium Inflammation of the interior sagment 3mg per ml of the eye when there is a risk of bacterial occular infection Piperacillin sodium eq. to piperacillin 4gm/2gm In the treatment of lower + Tazobactum sodium 500mg/250mg per vial RTI/UTI/intra abdominal infections, injection skin and skin structure infections, bacterial septicemia polymicrobic infection Conjugated Estrogens 0.625mg/0.625mg + Indicated in women with an intact MPA 2.5mg/5mg sugar coated tablet uterus to reduce the risk of endometrial and prevention an management of osteoporosis and vasomotor symptoms associated with estrogen defiency Diptheria+Tetanus Toxoid + Pertussis vaccine for active immunisation of children adsorbed and Haemophilu b CRM 197 (2months -5 years) agaist Diptheria, Conjugate vaccine tetanus Pertussis and haemophilus b diseases Isoniazid 300mg+Ethambutol 800mg+Vitamin anti TB drugs B6 10mg tablet Timolol maleate 5mg (as based)+Pilocarpine for reduction of intra ocular pressure in Hcl 20mg per ml opthalmic solution patients & ocular hypertension or open angle glaucoma Combipack of 1 tab of Estradiol 2mg & 1 tab of for treatment of women intact uterus Estradiol 2mg+ Dydrogestrone 10mg for the symptoms of estrogen deficiency as consequence of the menopause or after overectomy and for the prevention of post menopausal osteoporosis

23.12.1999 29.05.2000

17.07.1999

260.

23.02.1999

261.

26.03.1999

262.

13.08.1999

263.

13.09.1999

264.

12.10.1999

265. 266.

20.01.2000

25.01.2000

267.

01.02.2000

268.

269.

Sulbactam Sod. Eq. Sulbactam 500mg+ for treatment of RTI, UTI (lower & Cefoperazone sodium Eq. Cefoperazone 500mg upper), Septicemia, Meningitis, Skin & each vial injection (IV/IM) Soft tissue infection, Endometritis, Other infection of genital tract, Intra abdominal infection bone & joint infection. Sodium Hyaluronate 30mg+Chodroitin Sulfate as a surgical aid in anterior segment 40mg each ml opthalmic solution procedure including cataract extracter and intraoccular lans implatation Combipack of 7 blue tab of Desogestrel for oral contraceptive in women only 0.025mg+ethinyl estradiol 0.04mg & 15 white tab of Desogestrel 0.125mg+ethiyl estradiol 0.03mg Combipack of 1 tablet of Gestodene oral contraceptive for women. 60mcg+Ethinyl estradiol 15mcg & 24 tablets + 4 dummy tablets per pack Aminomix -2 Infusion Solution Solution A For complete parenteral nutrition. 500ml & 7 Solution B 500ml Fluorometholone USP 1mg+Gentamicin 3mg The infection of the anterior segment (as sulphate) per ml eye drops of the eye due to bacteria susceptible to gentamicin. Ambroxol HCl 15mg+ Guaiphenesin 100mg+ Ethanol 95% eq to Ethanol 5% v/v per 5 ml oral liquid Combipack 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 250ml for treatment of cough.

16.03.2000

04.04.2000

270.

29.05.2000

271.

17.02.2000

272. 273.

04.07.2000

28.07.2000

274.

18.08.2000 short 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. Parenteral nutrition in critical care condition.

275.

28.08.2000

276.

277.

Soyabean oil USP 10.0gm+ Egg Lecithin 0.60gm+ Glycerol IP 2.5gm per 100ml Intravenous solution Mono basic Sodium Phosphate Monohydrate 276mg+Dibasic sodium Phosphate Heptahydrate 268mg per ml injection

28.08.2000

278.

Pateint on parenteral nutrition, increased excrection and decreased absorption of phosphorus, 'X' linked familial hypophosphalaemia, decreased respiratory alkalosis, chronic alcoholism and patients of phosphate binding agents Salmeterol Xinafoate eq. to Salmeterol for regular treatment of brochial 25mcg+Fluticasone propionate asthma where the use of a 50mcg/125mcg/250mcg per actuation brochodilator and an inhaled cortcosteroid are approproiate.

31.08.2000

09.11.2000

279. 280. 281.

Salbutamol sulphate eq. to Salbutamol 100mg + In the treatment of chronic obstrutive +Ipratropium Bromide BP 200mcg inhaler pulmonary disease Sulperazone (Sulbactam Cefoperazone Sodium Sodium) + For regular intreatment of bronchial asthma where the use of a bronchodialator and an inhalated corticosteroid are appropriate For acheiving hemostasis to seal or glue tissues and to support wound healing

06.03.2000 06.03.2000

282.

283. 284. 285.

Fluticasone Propionate 500mcg/250mcg/100mcg + Salmoterol (as the xinafoate) 50mcg/50mcg/50mcg inhalation powder Clottable protein 75-115mg + Trace of Fibronogen 70-110mg + Plasma Fibronectin 29mg + Factor XIII 10-50 U2 + Plasminogen 40-120mcg + Aprotinin solution 300 KIU/ml3 per ml of reonstituted tissueol solution Combipack of FDC Gestodene 60mg + Ethinyl Estradiol 0.15mg & 4 Dummy Tablets DTP + Hepatitis b Vaccine (Multidose vial of 5 ml containing 10 doses.

29.03.2000

30.05.2000

Oral contraceptive for women

18.07.2000 27.07.2000 18.01.2001

286.

Lopinavir80mg + Ritonavir 20mg per 5 ml oral For the treatment of HIV infection in solution, Lopinavir 133.3mg + Ritonavir 33.3 combination with other anti-retroviral mg Capsule agents Multi 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) Irbesartan 150mg/300mg+ Hydrochlothiazide- for mild to moderate hypertension 12.5mg/ 12.5mg tablet Amino acid 5% w/v IV Infusion with & without for perenteral nutrition in patients with electrolytes protein depletion condition Ipratropium Bromide 500mcg+Salbutamol sulphate eq. to Salbutamol 2.5mg per 2.5 ml respiratory solution Levonorgestrel 0.25mg+Ethinyl Estradiol 0.05mg tablets for Bronchospasm in patients suffering from chronic pulmonary disorders for emergency contraception in women only till such time the never option like Levonorgestrel (0.75mg) in available in market.

31.01.2001

287. 288. 289.

31.01.2001 07.02.2001 03.04.2001

290.

07.06.2001

291.

Cefoperazone sod. Eq. to Cefoperazone 1g/2g+ for specific subset of patients (immuno Sulbactum Sod. Eq. to Sulbactum 0.5g/1g each compromised febrile neutropenic vial Injection cancer patients)

12.06.2001

292.

293.

Salmeterol (as Xinofoate) 25mcg/25mcg/25mcg+Fluticasone Propionate BP 50mcg/125mcg/250mcg per actuation Inhaler Intravenous 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 solution

Bronchial asthma where use of cronchodilator & an inhaled corticosteroide are appropriate. for patients requireing parental nutrition in enrgy deplition as well as essential fatty acid deficiency states

05.07.2001

11.07.2001

294.

Intravenous Fat Emulsion with Medium chain for patients requireing parental triglyceride Solution (20%) : Soyabean Oil USP nutrition in enrgy deplition as well as 10gm+ Medium chain triglycries BP 10gm+Egg essential fatty acid deficiency states lecithin 1.20gm+Glyccerol IP 2.50gm+ water for injection q.s. per 100ml solution Stavudine 30mg/40mg + Lamivudine 150 mg HIV infection in adult patoients . Once /150mg+ Neviramine 200mg/200mg tablet patients have been stablised on the maintenance regimen of Neviramine 200 mg BD and have demonstrated adequate tolrability to Neviramine. Formoteral Fumarate 6mcg/6mcg + Budesonide Asthma where use of combination of B.P. 100/200mg Capsule Inhaler inhaled regular conticestiroid & long acting -agonist is appropriate Ambroxol (as Hcl) S.R. 7.5mg+ Doxycyline acute and chronic illness of RT with Hcl 100mg tablet pathological inspiration of mucous ( In case of acute attecks of chronic branchitis, inflammation of the paranasal sinuses). Caused by doxycyline sensitive actiological agents Ambroxol Hcl 30mg+ Guaiphenesin 200mg for cough & congestion tablet Triple Chamber bags for peritoneal dialysis 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.

11.07.2001

295.

26.07.2001

296.

17.08.2001

297.

23.08.2001

298. 299.

10.09.2001

25.09.2001

300.

Rosiglitazone maleate eq. to Rosiglitazone 2 Patients with type 2 diabeties mellitus mg+Metformin IP 500mg tablet when dist exercise and the single agent do not result Rosiglitazone 2mg in adequate glycemic control -Carotene (30% dispension) 15mg (eq. to vit. A 7500 I.U)+ Vit. E acetate-25mg+Vit. C100mg+Pyridoxine HCL (Vit. B6) 1.5mg+ Cyanocobalamin (vit. B12) 5mcg+ Folic acid400mcg+Zinc as Zno-15mg+Selenium as SeO2 100mg+copper (element) as CuSO4 1mg Capsule Loperamide Hcl 2mg+Simethicone 125mg tablet Combikit of 10 ml of Oxymetazoline 0.05% & 15 ml of NaCl solution 2%

11.10.2001

301.

10.10.2001

302. 303.

304. 305.

for control of acute diarrhoea in adults only symptomatic relief of nasal mucosal congestion & adjective therapy of middle ear infection associated with acute/chronic rhinitis, common cold, sinusitis. Sodium Picosulphate 5mg+liquid Paraffin 4.8ml for constipation in adults. liquid paraffin per 15ml solution Formotorol fumarate-6mcg/6mcg+Budesonide persistent asthma where use of a 100mcg/200mcg per actuation combination of inhaled corticosteroids therapy long acting -agonist has been found to be appropriate. Ritonavir 33.3mg + Lopenavir 133.3mg soft In the treatment of HIV infection in gelatin capsule combination with other retroviral agents Ritonavir 20mg + Lopenavir 80 per ml oral In the treatment of HIV infection in solution combination with other retroviral agents Pyrantel embonate 14.4mg + Febental 15mg per for the treatment of infestation caused ml suspension for Veternary use by round worms, ascarids, hook worms, whip worm in puppies young dogs Meglunine Ioxaglate sodium + Sodium Urography, angiography, Ioxaglate injection anthrography, G.I. examinaiton, hystosalpingography, sialography Candesartan Cilexetil- Essential hypertension (not for intial 16mg+Hydrochlorothiazide-12.5mg tablet therapy) Mosapride Citrate dihydrate eq. to Mosapride Gastro esophageal reflux disorders GI cotrate-5mg+MPS (Methyl Polysiloxane 125mg sysmtoms (hurt burn voimating) chewable tablets associated with chronic gastritis Mometasone furoate 0.1% w/w+Terbinafine Topical fungal infection associated Hcl 1% w/w Cream with inflammation & Pruritus.

16.10.2001

12.10.2001

09.11.2001

19.11.2001

306.

18.01.2001

307.

18.01.2001

308.

23.04.2001

309.

16.08.2001

310. 311.

03.01.2002

30.01.2002

312.

16.01.2002

313.

314.

Combikit of 1 tablet of Pioglitazone HCl eq. to Patients with type II diabetes mallitus Pioglitazone-15mg & 2 Tablet of Metformin when diet, exercise & the single agent HCl 500mg do not result in adequate glyceanic control Rosiglitazone 4mg+Metformin 500mg tablet Patients with type 2 diabeties mellitus when dist exercise and the single agent do not result Rosiglitazone 2mg in adequate glycemic control Formoterol fumarate 400mcg capsule 6mcg+Budesonide- Asthma where use of combination of inhaled regular conticestiroid & long acting -agonist is appropriate infections

18.02.2002

21.02.2002

315.

07.03.2002

316.

317. 318. 319.

Butenafine HCl 10mg+ Betamethasone Superficial fungal Dipropionate eq. to Betamethasone 0.5mg dermatophytis infections cream Amlodipine (as besylate)- hypertension 2.5mg/5mg+Benazepril-10mg/20mg capsule

15.03.2002 22.03.2002 26.03.2002

Heparin Sodium 2 units + Sodium Chloride As an aid in the maintenance of cather 9mg per ml cannule potency. Nitroglycerine-10/20/40mg+Dextrose Hydrous for treatment of perioperative 5gm Injection hypertension for control of congestive heart failure in setling of acute MI, angina Bectoris in patients who have not responeded to sublingual mitroglycerine and -blokers for intra operative hypertension Dopamine HCl-80/160/320mg+Dextrose for the correction of hemodtnamic hydrous-5gm each 100ml contains injection 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. Linezolid 2mg+Dextrose-5% per ml injection complicated/uncomplicated skin & skin structure infections/community acquired pneumonia. Sodium 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 Formotnol fumarate 6mcg+ Budesonide BP 400mcg per actuation inhaler MDI/DPI Coumaphos 3% + Propoxur Sulphanilamide 5% powder for vet 2% drug scaly condition associated with atopy, hyperkeratosis & other Eczemas

02.04.2002

320.

02.04.2002

321.

01.04.2002

322.

15.04.2002

323.

asthma where use of combination of inhaled regular cortico stuoid is long acting -agonist is atopropriate

23.04.2002

324.

+ for use as a larvicidal bacterostatic wound dressing in catle, sheep, pigs and horses

23.04.2002

325.

326. 327. 328.

LIsoleucine 0.335gm+ L-Lencine 0.500gm+L-Valine 0.380gm+LLysine 0.550gm+ L-Methionine 0.120gm+ LPnenylalanine 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+Lserine 0.200gm+L-Tyrosine 0.45gm+Lornithine Hcl 0.144gm+Taurine 0.030gm per 100 ml injection Sucralfate 0.07gm+Metronidazole 0.01gm cream Glycopyrrolate-500mcg+ Neostigmine Methyl sulfate-2500mcg per 5 ml injection

for prophylaxis and therapeutic treatment of protein depletion in childern where oral/enteral nutrition is impossible/impracticable 23.04.2002

Bedsore, Haemorrhoids, fistulac & fissures. reversal of residual non-deporarising competitive nemomuscula block

29.04.2002 11.04.2002 14.05.2002 16.07.2002 12.07.2002 02.08.2002

329. 330. 331.

Betamethasone Diprop 0.064%+ Salicylic acid- for treatment of Keratosis, ichthylsis 3% each ml lotion lichen planus & dru scaly conditions of skin. Isosorbid-mononitrate (SR pellets) For prophylaxis of angina and 60mg+Aspirin 75mg Capsule prevention of Myocardial infarction. Mefenamic acid 500mg+Tizanidine 2mg Latanoprost 50mcg+ Timolol maleate eq. to reduction of intra ocular pressure in Timolol 50mg each ml eye drops patients with open angle glaucoma & ocular hypertension. Sodium Ferric Gluconate complex with sucrose treatment of iron deficiency anemia in eq. to elemental iron 6.25mg (12.5mg/ml) patients under-going chronic hemodialysis who are receiving supplemental crythropoitin therapy. Tobramycin sulphate eq. to Tobramycin 3mg+ STEROID RESPONSIVE Flurometholone 1mg per ml Opthalmic INFLAMMATORY OCULAR suspension CONDITIONS FOR WHICH A CORTICISTUOID IS INDICATED & WHERE SUPERFICIAL OCULAR BACTERIAL INFECTION EXISTS. Rosiglitazone maleate eq.to Rosiglitazone- treatment of patients with type-II 2mg/4mg+ Metformin HCl (SR) 500mg /500mg diabetes where diets exercise and the Tablet single agent do not result in adequate glycemic control. Betamethasone Diprop. 0.064mg + Gentamycin treatment of infectent dermatoses Sulphate Eq to Gentamycin 1mg per ml infection eczema & contact dermatitis suspension Lotion topical.

332.

05.09.2002

333.

12.09.2002

334.

11.09.2002

335.

25.09.2002

336.

Combipack of 2 capsule of Omeprazole 20mg , for eradication of H.Pylori in patients 2 Tablets of Clarithromycin 500mg & 4 capsule with active chronic gastritis, gastric of Amoxycillin 500mg. ulcer & duodenal ulcer. S(-) Amlodipine-2.5mg/2.5mg 25/50mg tablet S(-) Amlodipine-2.5mg/2.5mg Potasium 25mg/50mg tablet +Atenolol mild to moderate hypertension +Losartan mild to moderate hypertension

01.10.2002 17.10.2002 17.10.2002 17.04.2003 23.10.2002

337. 338. 339. 340.

341.

342. 343.

S(-) Amlodipine 5.0mg +Losartan Potasium mild to moderate hypertension 50mg tablet Gadoteric acid 27.932gm+ Meglunine 9.76gm magnetic imaging diagnostics each 100ml for I.V. Inj. investigation including MR angiograply. Pioglitazone HCl eq. to Pioglitazone treatment of type-II diabetes as 2nd 15mg/15mg+ Glimepiride 1mg/2mg tablet line therapy when diet, exercise & initial therapy with glitazone or urea donot results in adequate glycemic control. Pioglitazone 15mg+Metformin 500mg (O.D.) For second line therapy in type-II tablets diabetes Glimepiride1mg/2mg+Metformin Hcl for patients with type diabetes mellitus I.P.500mg/500mg in SR form tablet when diet exercise & the agent do not result in adequate glycemic control. Bioceramic composite materials: a) Each glass vial contains; Hydroxyapatite 100% granules b) each glass contains: hydroxyapatite 90% granules + tri clacium phosphate 10% granules c) Each vial contains: Hydroxyapatite paste as 30% and 18% suspension Rosiglitazone maleate eq. to Rosiglitazone 2mg+Glimepiride 1mg tablet Extract cepae 1gm + Heparin sodium 500IU + Allantion 0.1gm per gm gel for acute cases of bone deformities only as bone grafting material.

25.10.2002

18.10.2002 13.11.2002

344.

22.11.2002

345.

Type II diabetes Mellitus where diet, exercise and single agent do not result in adequate glycemic control.

14.11.2002

346.

347. 348.

Hypertropic kelodial scars, movement restricting and cosmetically disfiguning scars after operations amputatruos, burns and accidents and framatic tedon contractum cicatricial strictures Combikit of 1 capsule of Glucosamine Sulphate for supportive treatment of 500mg & Chondroitin Sulphate capsule 400mg osteoarthritis in adults Aremther 20mg + Lumefantrine 120mg tablet For the treatment of P. Falcipharum malaria cases resistant to both chloroquine and sulphadoxine pyrimethamine combination

15.03.2002

30.09.2002

26.12.2002 04.11.2002

349.

Glycapyrrolate 500mcg + Neostigmine 2500 mcg per 5 ml injection

350. 351.

Aspirin 150mg + ISMN 60mg SR Tablets

For prophylaxis of angina and prevention of Myocardial infarction.

07.11.2002 13.11.2002

Glimepiride 1mg/2mg + Metformin 500mg SR For the treatment of patients with Type Tablet II diabetes mellitus, when diet, exercise and single agent do not result in adequate glycemic contrl. Aspirin 75mg/75mg 150mg/150mg Tablet + Clopidogrel For the treatment of angina, myocardial infarction and stroke for treatment of essential hypertension

352. 353. 354. 355. 356.

26.11.2002 02.10.2003 09.7.2003 09.3.2003 16.10.2003

S(-)Amlodipine 2.5mg + Ramipril 2.5mg Tablet

S(-) Amlodipine 2.5mg/5mg + Atenolol 8mg/8mg Tablet Nadifloxacin 10mg + Miconazole 20mg cream For mixed infection of skin Formoterol 4.5mcg/4.5mcg 80/160 mcg Inhaler + Budesonide Asthma where use of combination of inhaled regular conticestiroid & long acting -agonist is appropriate

357. 358. 359. 360. 361. 362. 363. 364. 365.

Lercanidipine 10mg + Atenolol 50mg Tablet Metronidazole 10mg + Benzocaine 200mg Gel Fexofenadine 60mg + Pseudoephedrine120mg Allergic and seasonal rhinitis only CR Capsule Metformin 500mg CR + Glipizide 5mg CR Tablet Tramadol HCl 37.5mg+Paracetamol 325mg for short term (five days or less) tablet management of acute pain in adults. Ramipril 2.5mg+S(-) Amlodipine Besylate eq. for treatment of essential hypertension to S(-) Amlodipine 2.5mg tablet and capsule Olanzapine 5mg/10mg+ Fluoxetine HCl eq. to for treatment of resistant depression Fluoxetine 20mg/20mg tablet only. Ciprofloxacin HCl eq. to Ciprofloxacin 500mg+ Ornidazole 500mg film coated tablet Quinapril HCl eq. to Quinapril 10mg/20mg, Hydrochorothiazide 12.5mg/12.5mg film coated tablet Aspirin 25mg+ Dipyridamole BP 200mg (ER) capsule for treatment of diarrhoea of mixed infection in adults patients only. for treatment of mild to moderate hypertension

17.10.2003 09.11.2003 17.12.2003 17.12.2003 09.01.2003 11.02.2003 18.02.2003 03.02.2003 10.02.2003

366.

367.

For reduction of the risk of stroke in patients who had transient ischmia of the brain of completed ischemic strok due to thrombosis. combipack of 28 Tablets of Cyproteron acetate Androgen dependent disease in women 2mg & 7 Tablets of Ethinyl Estradiol 0.035mg. such as acne, alopecia & mild of hirsution

27.02.2003

20.02.2003

368.

369. 370. 371. 372.

Pioglitazone HCl eq. to Pioglitazone treatment of type-II diabetes as 2nd 30mg/30mg+ Glimepiride 1mg/2mg uncoated line therapy when diet, exercise & tablet (additional strength) initial therapy with glitazone or urea donot results in adequate glycemic control. S(-) Amlodipine 2.5mg+Lisinopril 5mg tablet for treatment of mild to moderate hypertension. Valsartan 80mg/160mg/160mg+HCTZ for treatment of mild to moderate 12.5mg/12.5mg/25mg tablet hypertension. S (-) Amlodipine 50mg/50mg tablet 2.5mg/5mg+Atenolol for treatment of essential hypertension & angina Pectoris.

13.03.2003

10.03.2003 18.03.2003 25.03.2003 10.04.2003

373.

374. 375.

Montelukast Sod. Eq. to Montelukast for treatment of chronic asthma 10mg/10mg+ Bambuterol HCl BP 10mg/20mg film coated tablet Montelukast Sod. Eq. to Montelukast for treatment of chronic asthma 5mg/5mg+ Bambuterol HCl BP 5mg/10mg film coated tablet Adapalene1mg +Clindamycin Phosphate eq. to for treatment of acne vulgaris. Clindamycin 10mg per gram Gel Rosiglitazone 2mg/4mg+Metformin 1000mg/1000mg tablet S(-) Amlodipine 5mg+Atenolol 50mg tablet SR for the treatment of patients with type2 Diabetes Mellitus single agent do not result inadequate glycaemic control For the treatmen of essential hypertension & Angina Pectoris

04.06.2003 01.05.2003

20.05.2003

376. 377. 378.

09.07.2003 29.08.2003 01.08.2003 04.07.2003 1.09.2003 10.09.2003 03.10.2003

Telmisartan 40mg/80mg+ Hydrochlorthiazide for treatment of hypertension as 2nd 12.5mg/12.5mg tablet line therapy. Ramipril BP 2.5mg/5mg+Candesartan cilexatil for mild to moderate essential eq. to candesartan 8mg/8mg bilayer tablet hypertension and congestive Heart failure (CHF) Prednisolone10mg + Ofloxacin 3mg per ml eye drop Metromidazile (as benzoate) 10mg+Benzocaine for treatment of gingivitis. 200mg per gram topical gel Losarten 50mg/50mg + Ramipril 2.5mg/5.0mg mild to moderate hypertension tabs Lamivudine150mg+ Zidovudine Alone or in combination with other 300mg+Abacavir as sulphate 300mg tablet antiretro virl agents for treatment for HIV-1 infection. Nadifloxacin 10mg+Clobetasol 500mcg each gram gel & cream propionate for treatment of skin associated with bacterial infection including contact dermatitis, seborrlocal dermatitis an infective eczema.

379. 380. 381. 382.

383.

06.10.2003

384.

Formoterol fumarate 4mcg/6mcg+Budesonide- Asthma where use of combination of 80mcg/160mcg inhaled regular conticestiroid & long acting -agonist is appropriate Valsarten 80mg + S(-) Amlodipine (as besylate) for treatment of hypertension 2.5mg capsule Combipack (Triple chambered bag) of amino acid+electrolytes; Dextrose 15% / 30% IV fat emulsion Glimeperide 1mg+Rosiglitazone 4mg For the treatment of type-II NIDDH Sterile Cefotaxime sodium USP eq. to for the treatment of lower respiratory Cefotaxime 500mg/1000mg+Sterile Sulbactam tract injection and genito urinary tract 250mg/500mg per vial injection infection. Imipenem (as anhydrous) 250mg /500mg + for the treatment of Seriuos lower Cilastatin Sodium eq. Cilastatin 250mg/500mg respiratory /UTI, Intraabdominal , per vial bone and joint infections, endocarditis and bacterial septicemia Raubasine 10mg+ Almitrine 30mg film coated For the corrective treatment of systoms tablet due to abnormal mental deficiency and age related hypoxia in elderly patients Ramipril 2.5mg/5mg + Losartan Potassium Mild to moderate hypertension 50mg/50mg tablet Gemcitabine in combine with cisplatin for additional indication Natiglinide 60mg/120mg + Metformin HCl In patients with type-II diabetes in 500mg/500mg (SR) tablet adequately controlled by diet, exercise and maximally tolerated dose of Metformin alone Lopinavir+Ritonavir S(-) Alenolol 25mg+Hydrochlorthiazide 12.5mg For the treatment of hypertension only tablets Desloratadine 2.5mg/5mg+ Pseudoephodrine For the treatment of seasonal allergic (SR) 120mg/180mg tablet rhinitis in adults. Levocetirizine HCl 2.5mg/5mg+ for the treatment of seasonal allergic Pseudoephodrine HCl SR 120mg/120mg tablet rhinitis. Amlodipine Besylate eq.to Amlodipine 5mg + For the treatment of co-existing Atorvastatin calcium eq. to Atorvastatin 10mg essential hypertension and each tablets hyperlipidacmia S(-) Amlodipine Besylate eq. to S(-) Amlodipine-2.5mg+Atorvastatin cal eq. to Atorvastatin 10mg tablet Zidovudine 600mg ER + Lamivudine 300mg ER For the treatment of co-existing essential hypertension and hyper lipidaemia in adults. for the treatment of HIV.

16.10.2003

385. 386.

01.11.2003 01.11.2003 12.12.2003 26.12.2003

387. 388.

389.

25.07.2003

390.

11.08.2003

391. 392. 393.

12.09.2003

08.01.2004

394. 395. 396. 397. 398.

16.01.2004 16.01.2004 01.01.2004 29.01.2004

11.02.2004

399.

10.02.2004 01.03.2004

400.

401.

Elemental iron (as carbonyl modified release) For the treatment of nutritromal of 45mg+Folic acid 1.5mg+ vitamin B12-15mcg deficiency anemia in adults only. film coated tablet Esomeprazole Magnesium eq. to Esomeprazole for the treatment of adult patients with 20mg/40mg (as enteric coated gastro esophlgal reflux disease pellets)+Domperidone maleate BP Eq. to (GERD) not responding to Domperidone 30mg/30mg SR Capsules esomeprazole alone. Aceclofenac 100mg+Paracetamol 500mg tablets for acute painful, conditions in adults only Rabeprazole 20mg+Mosapride 15mg SR tablet For the treatment of GERD not responding adequately to rabeprazole alone Atorvastin 10mg/20mg+ Ezatimib 10mg/10mg For the treatment of patients with tablet primary hypercholesterolemia Buprenorphine HCl eq. to Buprenorphine For opioid dependence 2mg+Naloxone Hcl eq.to Naloxone 0.5mg sublingnal tablets Sucralfate 0.07gm+ Metronidazole 0.01gm+ Lignocaine 0.04gm per gram cream for the treatment of Bedsore, laemorohoids, fistutae and oral fischers. Combi kit of 5 tablets each I) Pseudoephedrine for the treatment of symptometic relief HCl 120mg ER+Cetirizine HCl 5.0mg (orange of allergic rhinitis in adults only. tablet) & II) Pseudoephedrine Hcl ER 120mg +Tripolidine2.5mg (Blue tablets) Glibenclamide 2.5mg/5mg+Metformin non insulin dependent diabites mallitus 500mg/500mg SR tablet patients poorly controled with sulphonyluren or biguanide alone Escitalopram (as oxalate) 10mg + Clonazepam for treatment of patients with 0.5mg Tablet comorbid depression and anxiety disorders Dorzolamide 2% + Timolol 0.5% eye drops For reduction of elevated intra ocular pressure in patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to beta blockers S(-)Amlodipine 2.5mg + Nebivolol 5mg Tablets For the treatment of essential hypertension Combikit of 1 tablet of Efavirenz 600mg , 1 for the treatment of HIV infection. tablet of Lamivudine 300mg & 1 capsule of Didavosine (250 mg/400mg) (delayed Release) Peracetic Acid (NLT 4.5% ) + Hydrogen Disinfectant for the livestock species. Peroxide (NLT 24%) Disinfectant liquid for livestock species.

19.04.2004

402.

01.06.2004

403. 404.

08.07.2004 27.07.2004 13.08.2004

405. 406.

01.08.2004

407.

23.08.2004

408.

01.08.2004

409.

20.08.2004

410.

31.08.2004

411.

28.08.2004

412. 413.

13.09.2004 20.09.2004

414.

01.09.2004

415. 416. 417. 418.

Conjugated Estrogens 0.3/0.45mg + Medroxy Progesterone Acetate 1.5/1.5mg Tablets Amlodipine 5 mg + Ramipril 2.5mg capsule Atorvastatin 10mg/20mg + Ezetimibe10mg/10mg tablet Combikit of 2 tablets of Stavudine 30mg/40mg + Lamuvidine 150mg/150mg & 1 tablets of Nevirapine 200mg. for treatment of essential hypertension For the treatment of patients with primary hypercholesterolemia for HIV infection is adults who have been stablised on the maintenance regimen of Nevirapine 200mg BD and have demonstrated adequate tolability to Nevirapine for the treatment of respiratory tract infection by susceptible organism in adults. for the treatment of essential hypertension

26.10.2004 04.10.2004 08.11.2004

22.11.2004

419.

420. 421.

Gatifloxacin sesquihydroate eq. Gatifloxacin 400mg + Ambroxol HCl SR 75mg film coated bilayered Tablet Nabivolol Hcl eq. Nabivolol 5 mg + HCTZ 12.5mg Tablets

24.12.2004 23.12.2004

Atorvastatin Calcium eq. Atorvastatin 10 mg + for the treatment of combined Fenofibrate (micronised) 160mg film coated hyperlipidaemia in patients with tablets normal hepatic and renal function Tranexamic Acid 250mg + Ethamsylate 250mg for the treatment of abnormal blood film coated Tablet loss due to menorrhagia, local fibronolysis and intraoperative /post operative hemorrhage Lovastatin 20mg + Niacin 500mg ER form film for the treatment of primary coated Tablets 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. Pantoprazole Sodium sesquihydrate eq. for the tretment of GERD not Pantoprazole 40 mg/40mg + Domperidone responding to pentoprazole 20mg/20mg( 10 mg IR+ 10mg SR) Capsule S (-) Amlodipine besilate Eq. to S (-) Mild to moferate hypertension Amlodipine 2.5mg/5mg + HCTZ 12.5mg/12.5mg tablet Valdecoxib 20mg + Paracetamol 500mg Tablet For the treatment of acute pain in adults only Nateglinide 60/120 mg Metformin500mg/500mg SR Tablet +

24.12.2004

422.

29.12.2004

423.

24.12.2004

424.

24.12.2004

425.

15.04.2004 20.09.2004 01.8.2004 17.03.2004

426. 427. 428.

429.

Tamsulosin 0.4mg + Finastride 5mg MR For the treatment of signs and Capsule symptoms of Benign Prostatic Hyperplasia (BPH) Clindamycin 1% + Benzoyl peroxide 5% cream For topical treatment of inflammatory acne vulgaris

10.9.2004

430. 431. 432. 433.

Tiotropium Br 18mcg + Formoterol 12mcg For treatment of COPD Rotacap Tiotropium Br 9mcg + Femoterol 12mcg For treatment of COPD Inhaler Pioglotazone 15mg/30mg + For second line therapy in type-II Metformin500mg/500mg ER Tablet diabetes Gatifloxacin 3mg+ Dexamethasone 1mg Eye For post operative steroid responsive Drop inflammatory ocular conditions when bacterial ocular infections or a risk of bacterial ocular infections exists. Rabeprazole 20mg + Domperidone 30mg SR For the treatment of GERD not Capsule responding adequately to rabeprazole alone Nebivolol 5mg + HCTZ 12.5mg tablets for the treatment of essential hypertension Tranexamic Acid 25mg/50mg + Ethamsylate For the treatment of hypertension only 12.5mg/12.5mg Tablet Ezetimibe 10mg/10mg 10mg/20mg FC Tablet + Simvastatin For the treatment of patients with primary hypercholesterolemia

22.04.2004 26.04.2004 26.04.2004 18.06.2004

434.

10.08.2004

435. 436. 437. 438. 439. 440. 441. 442. 443.

23.12.2004 13.01.2005 05.11.2005 07.05.2005 06.07.2005 06.08.2005 06.08.2005 27.06.2005 21.07.2005

Omeprazole 20mg (EC) + Domperidone 10mg For the treatment of GERD not Capsule responding to omeprazole alone Lamivudine 300mg + Abacavir 600mg Tablets For the treatment of HIV infection in adults Lamivudine 150mg + Stavudine 40mg + For the treatment of HIV infection in Efavirenz 600mg Combikit Tablet adults Lamivudine 150mg + Zidovudine 300mg + For the treatment of HIV infection in Efavirenz 600mg Combipack adults Losartan 50mg + Atenolol 50mg For the treatment of systemic essential hypertension in adults only

Ceftriaxone 0.125/0.25/0.5/1g + Tazobactam For the treatment of patients with 15.625/31.25/62.5/125mg injection community acquired pneumonia and lower respiratory tract+E408 infections Atorvaststin 10mg + 375mg/500mg (ER) Tablets Nicotinic Acid For the treatment of patients with primary hypercholesterolemia and mixed dyslipidemia when response to single drug is inadequate

444.

28.07.2005

445. 446. 447.

Stavudine 6mg/12mg + 30mg/60mg Dispersible Tablet

Lamivudine For the treatment of HIV infection in children

08.05.2005 16.08.2005 19.09.2005

Calcipotriol 50mcg + Betamethasone 0.5mg For the treatment of psoriasis vulgaris Ointment Methylcobalamin 1500mcg (ER) + Pyridoxine For the management of 20mg IR + Folic Acid 5mg tablets hyperhomocysteinemia

448. 449. 450. 451. 452. 453.

S(-)Metoprolol 25/50mg (ER) 12.5mg/12.5mg (IR) Tablets

HCTZ For the treatment of mild to moderate hypertension in adults

11.11.2005 11.11.2005 01/11/2005 13-01-2005 20-01-2005 28-01-2005 15-02-2005 22-02-2005 22-02-2005 22-02-2005 03/02/2005

Stavudine 10mg + Lamivudine 40mg + For the treatment of HIV Infection Nevirapine 70mg Dispersible Tablet Centbucridine (0.5%) + Feracrylem (3%) Gel Atenolol (25mg, 50mg) + HCTZ (12.5mg, 12.5 mg ) Tablet For hemorrhoid & anal fissure Anti-Hypertensive

454. 455. 456. 457. 458.

Ofloxacin (200mg) + Ornidazole (500mg) For diarrhea of mixed infection Tablets Lamivudine (40mg) +Nevirapine Anti-HIV. (70mg +Stavudine (10mg) per 5ml powder for suspension Etonogestrel (11.7mg) + Ethinylestradiol For Contraceptive in women (2.7mg) Contraceptive rings Metaxalone (400mg) + Diclofenac Potassium For acute painful (50mg) tablet condition in adult musculoskeletal

Tranexamic Acid (500mg) + Mefenamic acid For primary dysmenorrhoea and pain (250mg) tablet associated with menorrhagia in women Fluconazole (2%) + Zinc Pyrethione (1%) suspension Desloratadine (2.5mg) + Ambroxol (30mg) +Guiphenasine (50mg) + Menthol 1mg/5ml Syrup Omeprazole (20mg) Enteric coated + Domperidone (30mg) (S.R.) capsule For seborrhoic dermatitis For productive cough

459. 460. 461. 462. 463.

For GERD Omeprazole.

not

responding

to

03/10/2005 04/01/2005 04/06/2005 04/08/2005 15-04-2005

Tazarotene (1mg) +Mometasone Furoate (1mg) For plaque psoriasis per gram cream Buprenorphine (0.4mg) + Naloxone (0.1mg) sublingual tablet For opioid dependence

Lamivudine (40mg) +Stavudine (10mg) per For HIV infection 5ml) reconstituted solution S(-) Metoprolol Succinate S.R. tablets (equivalent to S(-) Metoprolol Tartrate 12.5mg/25mg/50mg) Gliclazide M.R. (30mg/60mg/ 80mg)+Metformin HCl (500mg/500mg/500mg) ER Tablet Drosperinone (3mg) + Ethinylestradiol (0.035mg tablet) Simvastatin (10/20mg) + Ezetimibe (10mg/10mg) Tablets Ramipril (5mg) + Telmisartan (40mg) tablet For Hypertension

464.

For type-II diabetes 27-04-2005 Oral Contraceptive For primary Hypercholesterolemia For Hypertension 05/11/2005 05/11/2005 05/11/2005

465. 466. 467.

468. 469. 470.

Tazarotene (0.05%) + Mometasone Furoate For Plaque psoriasis (0.1%) Cream (addl.strength) Gatifloxacin (200mg) +Ornidazole (500mg) tablet Combikit of 2 tablet of Stavudine (40mg) + Lamivudine (150mg) each & 1 tablet of Efavirenz (600mg) Combikit of 2 tablet of Lamivudine (150mg) + Zidovudine (300mg) each and 1 tablet of Egavirenz (600mg) For diarrhoea of mixed infection in adults For HIV infection in adults

24.05.2005 06/06/2005 06/07/2005

471.

For HIV infection in adults 06/07/2005

472. 473. 474. 475. 476. 477. 478.

Aceclofenac gel 1.5% alongwith linseed oil, For pain, swelling etc menthol, Salicylate, Capsaicin gel Lamivudine 30/60mg + Stavudine 6mg/12mg + Nevirapine 50mg/100mg dispersible tablet For pediatric infection patients with HIV

06/08/2005 14-06-2005 30-06-2005 07/11/2005 21-07-2005 21-07-2005 25-07-2005 26-07-2005 29-07-2005 08/05/2005 08/12/2005 08/12/2005 18-08-2005 16-09-2005 16-09-2005 16-09-2005

Nitazoxanide (500mg) + Ofloxacin (200mg) For urogenital infection in adults. Tablet FDC of Papain + Urea Ointment For debriment of necrotic tissues. FDC of Amlodipine (5mg/5mg) + Bisoprolol Anti-hypertension (2.5mg/5mg) tablet FDC of Ceftriaxone (500mg/1000mg) Tazobactum (62.5mg/125mg) Injection + Anti-bacterial

479. 480. 481. 482. 483. 484. 485. 486. 487.

Levodopa (50mg/100mg/150mg) + Carbidopa For Parkinsons disease (12.5mg/25mg/37.5mg + Entacapone (200mg) tablet FDC of Atorvastatin (10mg) + Niacin For Hypercholesterolemia (375mg/500mg E.R) Capsule FDC of Levocetirizine (5mg) + Ambroxol Anti-histaminic & mucolytic (75mg S.R) Capsule FDC of Gabapentin (300mg) Methylcobalamin (500mcg) Tablet + For neuropathic pain in adults.

FDC of Calciptriol (50mcg) + Betamethasone For psoriasis vulgaris. Dipro (0.5mg) per gm Ointment FDC of Glimepiride (1mg/2mg) + Pioglitazone Anti-diabetic (15mg)+ Metformin (500mg E.R) Tablet Sucralfate (7%) + Povidone Iodine (5%) Ointment Nimesulide 1% + Methyl Salicylate 5%. Aerosol Feracrylum (1%) + Metronidazole 1%) Gel Anti-infective Aerosol For local application in acute pain. Antiseptic gel.

FDC of Methylcobalamin (1500mcg E.R) + For hyper-homocysteinemia Pyridoxine (20mg) + Folic Acid (5mg) Tablet

488. 489. 490.

Enalapril (2.5mg/5mg) Tablet (Addl. Strength)

HCTZ

(12.5) For Hypertension

17-10-2005 11/10/2005

Ambroxol HCl 75mg (S.R) + Desloratadine For relief of productive cough. 5mg Capsule. FDC of S-Metoprolol Succinate For essential hypertension Tartrate equivalent to Metoprolol Tartrate (E.R) 25/50mg + HCTZ (12.5mg) Tablet. Stavudine 10mg+Lamivudine Nevirapine 70mg dispersible tablet 40mg+ For HIV infection

11/11/2005

491. 492. 493. 494. 495. 496.

11/11/2005 22-11-2005 24-11-2005 25-11-2005 30-11-2005 12/02/2005 12/05/2005 12/07/2005 12/08/2005 12/08/2005 12/08/2005 17/01/2006 19/01/2006

Domperidone (10mg) + Activaed dimethicone For dyspepsia, colicy pain & GERD. (125mg) chewable tablet Moxifloxacin (0.5%) + Phosphate (0.1%) Eye drops Dexamethasone For Ophthalmic use.

Brimonidine Tartrate (2mg/1.5mg) + Timolol Ophthalmic (as HCl) (5mg/5mg per) ml. Amlodipine (as besylate) 5mg + Bisoprolol 5mg For hypertension Tablet (Addl. Strength) FDC of Olmesartan Medoxomil For essential hypertension (20mg/40mg/40mg) + HCTZ(12.5mg/12.5mg/25mg) Entecavir Tablet (0.5mg/1.0mg) & oral solution For chronic Hepatitis-B infection. (0.05mg/0.05mg) per ml. Ketorolac Tromethamine 5mg + Ofloxacin 3mg Ophthalmic per ml Eye drops Hyoscine-N-Butylbromide Paracetamol 500mg Tablet (10mg) + For spasmodic pain

497. 498. 499. 500. 501.

Amlodipine (as besylate ) 5mg + Losartan Pot. For hypertension 50mg tablet. Ceftriaxone (as sodium) (500mg/1000mg) + For LRTI Sulbactam (as sodium) (250mg/500mg) powder for injection. Nebivolol (as HCl) 5mg + Valsartan 80mg For hypertension Combikit of Tamsulosin HCl 0.4mg M.R For BPH capsule (10 no.) & Dutasteride Soft Gelatin Capsule 0.5mg (10no.) Alendronate Sodium (equiv. to Alendronic acid For osteoporosis 70mg) + Cholecalciferol 70mcg (equiv. to 2800 I.U Vit.D) Tablet Aspirin 150mg+ Clopidogrel 300mg Tablet For the treatment of angina, (additional strength) myocardial infarction and stroke Atenolol 50mg + HCTZ 25mg (addl. Strength) For hypertension

502. 503.

504.

02/01/2006 26.11.2002 02/03/2006

505. 506.

507. 508. 509. 510. 511. 512. 513.

Tamsulosin HCl (MR) 0.4mg + Dutasteride For BPH 0.5mg tablet Metoprolol Succinate equiv. to Metoprolol For hypertension Tartrate 50mg + Amlodipine (as besylate) 5mg Tenofovir Disoproxil Fumarate (300mg) + For HIV-1 infection Emtricitabine (200mg) tablet Diclofenac Sodium (75/50mg) as (E.C) + For OA & RA Misoprostol 200mcg. Pantoprazole (as Sodium) (E.C) 40mg + For GERD Itopride (150mg) S.R Amlodipine (as besylate) 5mg/2.5mg + HCTZ For hypertension 12.5mg/12.5mg Tablet Formoterol Fumarate (6mcg/6mcg/6mcg) + For Asthma & COPD Fluticasone Propionate (100/250/500mcg) dry powder inhaler & MDI Nevibolol (as HCl) 5mg + Amlodipine (as For hypertension besylate) 5mg/10mg film coated tablets Levocetrizine 5mg + Ambroxol Hydrochloride For production cough SR (75mg) tablet Gatifloxacin (0.3%) + Prednisolone Acetate For Ophthalmic use (1%) eye drops Amlodipine (as besylate) 5mg + Metoprolol For hypertension Succinate equivalent to Metoprolol Tartrate 50mg. Nadifloxacin (1%) + Miconazole Nitrate (2%) + For dermatoses Mometasone Furoate (0.1%) Cream Lamotrigin 200mg tablet (addl. Strength) Anti-epileptic dispersible tablet (5mg/50mg/100mg/200mg Amoxycillin 1000mg + Clavulanate Potassium Anti-biotic 62.5mg E.R tablet Lopinavir 200mg + Ritonavir 50mg Tablet For the treatment of patients with HIV (addl. Strength) infection Ferrous ascorbate (equivalent to 50mg Iron) + For iron deficiency anemia Folic acid 1.5mg. Film coated tablet Aspirin 150mg + Clopidogrel (as bisulphate) As loading dose for prevention of in300mg tablet (addl. Strength) stent restenosis in PCI Olmesartan 40mg + HCTZ 25mg tablet (addl. Anti-hypertensive Strength) Ceftriaxone (as sodium) 250mg + Tazobactam Anti-bacterial 31.25 mg for injection (addl. Strength)

02/06/2006 02/07/2006 23/02/2006 28/02/2006 04/08/2006 24/04/2006

05/10/2006

514. 515. 516. 517.

24/05/2006 24/05/2006 06/02/2006 06/05/2006 06/06/2006 06/08/2006 06/08/2006 06/08/2006 06/08/2006 22/06/2006 28/06/2006 07/05/2006

518. 519. 520. 521. 522. 523. 524. 525.

526. 527. 528. 529. 530. 531. 532. 533. 534. 535. 536. 537.

Bimatoprost 300mg + Timolol (as maleate) For reduction of IOP 5mg/ml eye drops Mebeverine HCl 135mg + Isabgula husk 3.5gm Irritable bowel syndrome sachet. Vitamin C 500mcg + Zinc Citrate 2.2mg + For vitamin C deficiency Selenium 60mcg tablet. Lamivudine 40mg + Stavudine 10mg For HIV infection dispersible tablet. Levocetrizine 2.5/5mg + Ambroxol 30mg/30mg For productive cough per 5ml of syrup Cefixime 200mg + Pot. Clavulanate (125mg) Anti-biotic tablet ISMN SR 30mg/30mg + Aspirin75/150mg film For prophylaxis of angina and coated tablet(addl. Strength) prevention of Myocardial infarction. Clobestasol Propionate (0.05%) + Calcipotriol For plaque psoriasis Ointment (0.005%) Ointment. Tenofovir Disoproxil Fumarate300mg + For HIV-1 infection Emtricitabin 200mg + Efavirenz 600mg tablet Erdosteine 150mg + Guaiphenesin 50mg + Mucolytic Terbutaline 1.25mg per 5ml syrup Rosiglitazone (as maleate)2mg + Glibenclamide Anti Diabetic 5mg + MetFormin 500mg tablet Levocitirizine 2 Hcl 5mg+ Ambroxol Hcl SR 75mg + Pseudoephedrine Hcl 120mg SR Capsules Alprazolam SR 0.25mg + Sertraline (As Hcl) 25mg/50mg tablet Dexibuprofen 500mg tablet 200mg/300mg For SAR, PAR & Chronic idiopathic urticatia For Panic disorder with or without agoraphobia

07/05/2006 07/06/2006 07/12/2006 07/12/2006 20/07/2006 20/07/2006 20/07/2006 20/07/2006 08/01/2006 08/08/2006 08/08/2006 08/09/2006 08/09/2006 08/10/2006 08/10/2006

538. 539. 540. 541.

+Paracetamol For RA, OA & ankolysing spondylosis

ISMN SR 60mg/60mg + Metoprolol Succinate For angina & Hypertension ER 25/50mg film coated tablet Aspirin 75mg / 150mg + Glycine 37.5mg/75mg For prevention of acute coronary tablet syndrome in patients with CAD prophylaxis against stroke Combipack of 21 tablet of Quinine sulphate For P. Falciparam malaria 600mg each & 8 capsule of Doxycycline (as Hcl) 100mg each Cefepem (as Hcl) 0.5/1gm + Amikacin (as Antibiotic sulphate) 0.125/0.250gm Injection Lamivudine 20mg + Nevirapine 35mg + Anti HIV Stavudine 5mg tablet

08/10/2006

542.

08/10/2006 08/11/2006 08/11/2006

543. 544.

545. 546. 547. 548. 549. 550. 551. 552.

Nadifloxacin (10mg/gm) Furoate (1mg/gm) cream

Mometasone For mixed infection of skin

17/08/06 22/08/06 28/08/06 29/08/06 29/08/06 29/08/06 not 30/08/06

Gliclazide 40mg/80mg + MetFormin Hcl Ant- diabetic 500mg + Rosiglitazone 2mg tablet Amoxycillin 250mg + Dicloxacillin 250mg cap. Anti biotic Cefixime (50mg/100mg) + Clavulanic acid Antibiotic 31.125mg/62.5mg per ml dry syrup & tablet Ciclsonide 80mcg/160mcg + 4.5mg/4.5mg inhaler (rotacap) Formotorol Anti asthratic + Anti asthmatic

Ciclsonide 100mcg/ 200mcg/400mcg Formotorol Fumarate 6mg rotacaps

S(-) pantoprazole (as sodium) 20mg (E.C.) + for the tretment of GERD Domperidome SR 30mg tablet responding to pentoprazole

553.

554.

555. 556. 557.

Cefadroxil 500mg + Clavulanic acid 125mg For the treatment of adult patients with film coated tablets infections caused by susceptible microorganismsincluding S. aureus , viz. Urinary ract Infection, Lower Respiratory Tract Infections, and gonococcal urethritis Cefadroxil 250mg + Clavulanic acid 62.5mg For the treatment of adult patients with dispersible tablet infections caused by susceptible microorganismsincluding S. aureus , viz. Urinary ract Infection, Lower Respiratory Tract Infections, and gonococcal urethritis Cefadroxil 250mg + Clavulanic acid 62.5mg per For the treatment of adult patients with 5ml syrup infections caused by susceptible microorganismsincluding S. aureus , viz. Urinary ract Infection, Lower Respiratory Tract Infections, and gonococcal urethritis Telmisartan 40mg + Amlodipine (as Besylate) For essential hypertension 5mg tablet Ceftazidime 500mg /1000mg + Tazobactum (as Antibiotic sodium) 62.5mg/125mg per vial for injection Cefepime (As Hcl) 500mg/1000mg + For the treatment of uncomplicated Tazobactum (as Sodium) 62.5mg/125mg per and complicated UTI, uncomplicated injection 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

30/08/06

30/08/06

30/08/06 30/08/06

30/08/06

558.

Cefixime 100mg/200mg + Cloxacillin (as Antibiotic Sodium) 500mg/500mg + Lactobacillus (45 /90 Million spore)tablet Levofloxacin tablet (250mg /500mg) & Infusion For prostatitis 5mg/ml (For additional indication) combipack of one cap. Of aprepitant .125mg & two cap. Of aprepitant 80mg each (combipack) As Approved

31/08/06

559. 560. 561. 562. 563. 564.

26/09/06 10/10/2006 14/10/06 11/01/2006 13/11/06

Formoterol fumarate 6mcg + Fluficasone For Asthma & COPD propinate 50mcg/125mcg/250mcg MDI Amlodipine 25mg + Metoprolol (additional lower strength) tablet 25mg For hypertension

Esomeprazole 40mg (E.C.) + Itopride 150mg For GERD SR Capsules Cefixime 200mg + Cloxacillin 500mg (ER) + Lactobacillus 90 million Spore tab. (additional strength) tablet Trandalopril 1mg/2mg/4mg/2mg + Verapamil (ER) 240mg/240mg/240mg/180mg tablet Antibiotic

14/11/06 Anti hypertensive

565. 566. 567. 568.

23/11/06 28/11/06 30/11/06

Rabeprazole 20mg (EC) + Itopride SR 150mg For GERD capsule Metoprolol succinate 25mg /50mg ER + HCTZ Anti hypertensive 12.5mg tablets Atorvastatin 5mg + Fenofibrate (additional strength)tablets 160mg For the treatment of combined hyperlipidemia in patients with normal hepatic and renal functions. Anti HIV

12/01/2006 12/12/2006 12/12/2006 13/12/06 14/12/06 06.09.2006 25.07.2006

569. 570. 571. 572.

Atazanavir 150mg + Ritonavir 50mg capsules

Mebeverine Hcl 135mg + Chlordiazepoxide For IBS 5mg tablet Ampicillin 250mg + Dicloxacillin 250mg tablet Antibiotic Etoricoxib 10mg + Methyl Salicylate 100mg + For acute Musculoskeletal pain Mentol 50mg + Linseedoril 30mg per gm. of Gel Nebivolol 5mg + Amlodipine 10mg FC Tablet For the management of essential hypertension in adults only Artesunate 150mg/200mg + Sulphadoxine 500mg/750mg + Pyrimethamine 25/37.5mg Combipack Ciclosonide 80mcg/160mcg/200mcg/400mcg + Formoterol 4.5mcg/4.5mcg/6mcg/6mcg Inhaler & Rotacaps For the treatment of P. falciparum resistant malaria patients (age 9-14 yrs and above) For the treatment of patients with bronchial asthma where use of said combination is found appropriate

573. 574.

575.

29.08.2006

576.

Combipack 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 osteoporosis For the treatment of osteoporosis in postmenopausal women

14.11.2006

577.

578.

Combikit of one film coated tablet of Risendronate Sodium 35mg & six film coated tablet of Calcium Carbonate 1250 mg (Eq. to 500mg Cl) Ceftazidime 250mg + Tazobactam 31.25mg Injection

05.07.2007

(Additional Strength) For the treatment of hospital acquired infections like nosocomial pneumonia, uncomplicated skin and skin structure infections For oral etiology rehydration in various

31.07.2007

579.

580.

NaCl 0.52g + KCl 0.3g + Sod. Citrate 0.58g + Dextrose Anh. 2.7g per 200ml ORS in Liquid form Methylcobalamin 500mcg + Alpha Lipoic Acid 100mg + Pyridoxine 1.5mg + Folic Acid 3mg Soft Gelatin Capsule Cefpodoxime 200/100mg + Potassium 125/62.5mg Tablets

23.07.2007

For the treatment neuropathy

of

diabetic

31.07.2007

581.

582.

583. 584. 585.

Clavulanate For the treatment of lower and upper respiratory tract infection, uncomplicated skin infection and urinary tract infection Methylcobalamin 500/750/1500mcg + Alpha For the treatment of diabetic Lipoic Acid 100/200 + Pyridoxine 1.0/1.5/3mg neuropathy + Folic Acid 0.5/0.75/1.5mg Soft Gelatin Capsules Pantoprazole 40mg EC + Domperidone 30mg for the tretment of GERD not SR Capsules responding to pentoprazole Pantoprazole 20mg EC + Domperidone 10mg for the tretment of GERD Capsules responding to pentoprazole not

30.07.2007

26.09.2007

04.09.2007 14.07.2007 10.05.2007

Cefuroxime 250mg + Clavulanic Acid 125mg For the treatment of adult patients with FC tablet/Dry syrup infections caused by susceptible microorganisms including S. aureus, viz., urinary tract infections, upper and lower respiratory tract infections and gonococcal urethritis.

586.

Methylcobalamin 500mcg + Folic acid 1.5mg + For vitamin & mineral deficiency B5 - 5gm + Zinc Sulphate 25mg + Chromium states and for restoration of intestinal Polynicotinate 200mcg + selenium 65mcg + B6 microflora 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) Mecobalamin 500mcg + Alpha Lipoic Acid For the treatment 100mg + Folic acid 1.5mg + Benfotiamine neuropathy in adults 50mg Soft gelatin Capsules of diabetic

31.10.2007

587.

13.11.2007

588.

Mecobalamin 500mcg + Zinc Sulphate 61.8mg For vitamin & mineral deficiency + Calcium Patothenate 10mg + Pyridoxine 3mg states + Folic Acid 1.5mg + Niacinamide 50mg + Chromium 50mcg Tablets Mecobalamine 1500mcg + Alphalipoic Acid For the treatment 100mg + Thiamine mononitrate 10mg + neuropathy Pyridoxine 3mg + Folic Acid 1.5mg Capsule Mecobalamine 1500mcg + Alpha Lipoic Acid 200mg + Inositol 100mg + Folic Acid 1.5mg + Chromium Polynicotinate 200mcg + Seleno Methionine 55mcg + Zinc Monomethionine 25mg Capsule Mecobalamine 500mcg+ Alpha Lipoic Acid 100mg + Inositol 100mg + Folic Acid 0.5mg + Chromium Polynicotinate 65mcg + Selenium Dioxide 18mcg Capsules Methylcobalamin 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 Methylcobalamin 500mcg + Calcium 250mg + Calcitriol 0.25mcg + Folic Acid 1.5mg + Pyridoxine 3mg + Zinc 7.5mg Capsules Torsemide 10mg + Amiloride 5mg tablets of diabetic

29.11.2007

589.

29.11.2007

590.

For Vitamins and Mineral deficiency states in adult patients

12.07.2007

591.

For Vitamins and Mineral deficiency states in adult patients

12.07.2007

592.

For vitamin and mineral deficiency states in adult patients

28.12.2007

593.

For vitamin and mineral deficiency states in adult patients Edema Associated with congestive heart failure & hypertension

28.12.2007

594. 595. 596.

17.01.07 23.01.07 07.02.07

Pioglitazone 15mg/30mg + MetFormin ER For second line therapy in type-II 1000mg tablet (additional strength) diabetes Pantaprazole sodium 20mg/40mg Tablet (with For gAstric ulcer, duodenal ulcer, Z. E sodium bicarbonate As buffer) Syndrome, GERD

597. 598.

levofloxacin (250mg/500mg) + ambroxol SR For lower respiratory tract infection in 75mg tablet adult Testosterone cypionate (100mg/200mg) Cotton seed oil 736/566mg per ml injection + For testosterone deficiency (i) primary hypogonadism (ii) Hypogonadotropine hypogonadism

08.02.07

08.02.07

599.

Rosiglitazone 1mg + Metformin Hcl 500mg Patients with type 2 diabeties mellitus tablet (additional strength) when dist exercise and the single agent do not result Rosiglitazone 2mg in adequate glycemic control Loteprednol Etabonate 5mg + Tobramycine For steroid responsive inflammatory 3mg per ml ophthalmic solution ocular condition Amlodipine (As besylate) 5mg + Metoprolol For hypertension (As succinate) ER 25mg (additional strength)tablets Glibeneclamide 5mg + Metformin SR 850mg non insulin dependent diabites mallitus tablet (additional strength) patients poorly controled with sulphonyluren or biguanide alone Metoprolol (As succinate) 50mg/25mg ER) + Angina pectoris in adults Amlodipine 5mg/2.5mg tablet (For additional indication) Ramipril 10mg + HCTZ 12.5mg tablet Mild to moderate hypertension in (additional strength) patients (in when combination therappy is appropiate) who have been established on the individual components given in the same proportion Amlodipine (As besylate) 5mg/5mg/10mg + Essential hypertension valsartan 80mg/160mg/160mg tablet Amlodipine (As besylate Perindopril 4mg tablet )5mg/10mg + For hypertension Essential hypertension

08.02.07

600. 601.

14.02.07 14.02.07

602.

15.02.07

603.

20.02.07

604.

20.02.07

605. 606. 607. 608. 609.

21.02.07 23.02.07 26.02.07 26.02.07

Metoprolol (As succinate) ER 25mg/50mg + Ramipril 2.5mg/5mg tablets

Rabeprazole Sodium 20mg/10mg with sodium For Duodenal ulcer, G.U, Z.E.S. & bicarbonate As buffer GERD Ciclesonide 160mcg/320mcg + Formoterol As approved Fumarate 12mcg/12mcg (Dry powder inhaler additional strength) rotacap Ceftriaxone (As sodium) 125mg/250mg + For LRTI Sulbactam (As sodium) 62.5mg/125mg For injection (additional strength) injection Clindamycin 1% + Isotretinoin 0.05% gel Cifixime 200mg + Erdosteine 300mg Capsules For acne Acute Exacerbation bronchitis of chronic

27.02.07

610.

01.03.07 08.03.07 21.03.07

611. 612.

613. 614. 615. 616. 617. 618. 619. 620.

Etoricoxib 10mg + Methyl salicylate 20mg per Acute Musenlosleteal pain gm. of cream ISMN 60mg / 60mg SR 50mg/100mg film coated tablet + Atenolol For angina pectoris

21.03.07 23.03.07 02.04.07 02.04.07 04.04.07 04.04.07 10.04.07

Comb kit of two capsule of Azaranari 150mg For HIV infection each + 1 tablet of Ritonavir 100mg) Mecobalamine 500mcg + Alpha Lipoic acid For diabetic neuropathy 100mg soft gelatin capsule Propofol 10mg + Lignocaem 1mg per ml For induction of anesthesia injection Ezetimibe 10mg + Fenofibrate 160mg tablet For combined hypertipidemia Metoprolol (As succinate) 25mg + Amlodipine For hypertension (As besylate) 5mg (additional strength) tablet Combipack of 1 bottle of ciprofloxacin Injection Antibiotic (200mg/100ml) & 1 bottle of Ornidazole injection 500mg/100ml) Combi pack of 1 tablet of Residronate sodium For osteoporosis in postmenopausal (35mg) + 6 tablet of calcium carbonate women equivalent to 500mg calcium each Amlodipine (As besylate) 10mg + Perindopril For hypertension 8mg tablets (additional strength) tablet S(-) Metoprolol (As succinate) 25mg + S(-) For essential hypertension Amlodipine (As besylate 2.5/5mg Cefotaxim (As sodium) 0.5mg/1gm + For surgical prophylaxis (additional Sulbactam (As sodium) 250mg/500mg injection indication) (for additional indication) Atenolol 25mg/50mg + Indapamide SR 1.5mg For essential hypertension tablet Ceftazidime 500mg/1000mg + Sulbactam (As Antibiotic Sodium) 250mg/500mg For injection Isotretinoin 0.05% + Erythromycin 2% gel Glimepiride 1mg/2mg. + Metformin 1000mg tablet (additional strength) tablet For acne SR for patients with type diabetes mellitus when diet exercise & the agent do not result in adequate glycemic control.

20.04.07

621.

01.05.07

622. 623. 624.

07.05.07 16.05.07

18.05.07 21.05.07 08.06.07 08.06.07 08.06.07 14.06.07 15.06.07 15.06.07

625. 626. 627. 628.

629. 630. 631.

Alfuzocin Hcl. ER (10mg) + Dutasteride 0.5mg For BPH in men with enlarged prostate tablet Tolterodine tartrate ER 4mg + Tamsulocin Hcl. For BPH with overactive bladder ER 0.4mg tablet Omeprazole 20mg/40mg + Sodium Bicarbonate For duodenal ulcer, gastric ulcer & 1100mg capsules GERD

632. 633. 634. 635. 636.

Tolterodine Tartrate 4mg (ER) + Tamsulosin For BPH with overaction bladder in HCL 0.4mg Capsule. Adults only. Omeprazole (E.coated) 40mg Bicarbonate 1100mg capsule. + Sodium For gastric ulcer, duodenal ulcer and GERD. For RTI caused organisms in adults. by susceptible

15-06-2007. 18-6-2007. 05-07-2007. 11-07-2007.

Azithromycin 500mg + Ambroxol S.R (75mg) Tablet.

Moxifloxacin HCL (0.5%) + Ketorolac For reduction of post-operative Tromethamine 0.5% Ophthalmic Solution. inflammatory conditions of the eyes. Levofloxacin (15mg) + Prednisolone Acetate For post-operative steriod responsive 10mg per ml eye drops. inflammatory ocular conditions when ocular bacterial infections or a risk of bacterial infection exists. Mecobalamine 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 Loteprednol Etabonate (0.5%) + Levofloxacin (1.5%) Eye drops. For Vitamins and Mineral deficiency states in adult patients

11-07-2007.

637.

12/07/2007

638.

For post-operative steriod responsive inflammatory ocular conditions when ocular bacterial infections or a risk of bacterial infection exists.

12-07-2007.

639. 640. 641. 642.

Clotrimazole (10mg) + Methyl-prednisolone For fungal infection of skin associated aceponate 1mg/gm of cream. with inflammation. Cefpodoxime (as Proxetil) (100mg/200mg) + For LRTI, URTI and UTI. Clavulanic acid (62.5/125mg) tablet. Atorvastatin (40mg) + Ezetimibe (10mg) Tablet For the treatment of patients with (addl. Strength). primary hypercholesterolemia Cefepime (250mg) + Tazobactam (31.25mg) For the treatment of uncomplicated Injection (addl. Strength). 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 Methylcobalamin (500mcg) + Alpha Lipoic For diabetic neuropathy. Acid (100mg) + Pyridoxine (3mg) + Folic acid (1.5mg) Soft Gelatin Capsule. Halobetasol Propionate (0.5mg) + Salicylic For plaque psoriasis. Acid 30mg per gm of ointment.

12-7-2007. 30-07-2007. 30-07-2007.

30-07-2007.

643.

31-07-2007.

644.

01-08-2007.

645.

646. 647.

Combipack of 12 tablet of Artesunate (50mg) each + 3 tablet of each containing Sulfadoxine (500mg) + Pyrmethamine (25mg) Tablet. (Addl. Strength) Omeprazole (20mg/40mg)+Sod. Bicarbonate600mg+ Mg.Hydroxide-700mg .chew tab. Tegafur (100mg) + Uracil (224mg) capsule.

For the treatment of P. falciparum resistant malaria patients

01-08-2007.

For duodenal, gastric ulcer, GERD, and erosive esophagitis, For first line treatment of metastatic colorectal cancer in combination with calcium folinate. of essential

08/01/2007

22-08-2007.

648. 649.

Amlodipine (5mg) + Nebivolol (5mg) tablet For the treatment (addl. Strength). hypertension

06-09-2007. 06-09-2007.

650.

Ceftazidine (2gm) + Sulbactam (1gm) For serious abdominal infection. Injection ( addl. strength for additional indication). Polyethylin Glycol 400 (0.4%) + Propylene For temprory relief of dryness, Glycol (0.3%). irritation burning, stinging, grittiness or foreign body sensation caused due to environmental factors. Cefuroxime Axetil (250mg) + Clavulanic Acid For adult patients with infection (125mg) Tablet. caused susceptible micro-organisms including S.aureus viz UTI, upper and lower RTI and gonoccoccal urethritis. Cefuroxime Axetil (250mg) + Clavulanic acid For UTI, URTI and (125mg) tablet. gonococcal urethritis. LRTI and

18-9-2007.

651.

27-09-2007.

652. 653.

05-10-2007.

654. 655.

Cefuroxime-125/250/500mg +Clavulanic Acid- For adult patients with infection 31.25/62.5/125mg film coated tablet caused by susceptible microbs,including s.aureus.(e.gUTI,Upper&lower RTI & gonococcal urethrities) Sucralfate (70mg ) + Metronidazole (10mg) + For infected wounds and ulcers. Povidone Iodine (50mg) per gram of Ointment. Combipack of two tablet of chloroquine For drug resistant malaria. phosphate (250mg) each + 14 tablet of Proguanil HCl (100mg) each Paclitaxel (protein bound particle) for injectable For breast cancer after failure of suspension (paclitaxel (100mg) + Albumin combination chemotherapy for Human 900mg per 20ml injection metastatic disease or relapse within 6 months of adjuvant chemotherapy. Olmesartan Medoxomil (20mg) + Amlodipine For mild to moderate hypertension. Besylate (5mg) Tablet. Atorvastatin Calcium (10mg ) + Ramipril For treatment of patients with both (2.5mg/5mg) tablet hypertension and hypercholesterolemia.

10/05/2007

09-10-2007.

10-10-2007.

656.

11-10-2007.

657. 658.

15-10-2007. 15-10-2007.

659. 660.

Omeprazole(20mg) + Sodium (1100mg) tablet (addl. strength).

bicarbonate For duodenal ulcer, gastric ulcer & GERD

15-10-2007.

Moxifloxacin HCl (5mg) + Prednisolone For inflammation after ocular surgery Acetate (10mg)per ml. (eye drops) and where a risk of bacterial ocular infection exists. Methylcobalamine (500mcg) + Alpha Lipoic acid (100mg) + Pyridoxine HCl (1.5mg) + Thiamine (2mg) + Calcium Picolinate (200mg) tablet. Satranidazole (300mg) + Ofloxacin (200mg) Tablet. Methylcobalamin 500mcg+beta carotine10.33mg+alpha lipoic acid 100mg+B6 1.5mg+B1 2mg & Chromium Polynicotinate soft gelatin capsule Calcium Pidolate equivalent to Calcium 500mg + Vit-D3 250 IU powder for oral use For diabetic neuropathy.

16-10-2007.

661.

16-10-2007. For diarrhoea of mixed infection in adults. For adult patients with diabetic neuropathy.

662. 663.

18-10-2007.

18-10-2007.

664. 665.

For osteoporosis deficiency state.

and

calcium

23-10-2007.

Atorvastatin Calcium (10mg) + Fenofibrate For the treatment of combined (145mg) (addl. strength) tablet hyperlipidemia in patients with normal hepatic and renal functions. Miglitol (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.

30-10-2007.

666.

31-10-2007.

667. 668.

Mupirocin (2%) + Methylprednisolone For atopic dermatitis. Aceponate (0.1%) Cream. Methyl cobalamine 500mcg+folic acid1.5mg+B5-5mg,+Zn.sulphate 25mg+Cr.Polynicotinate 200mcg+selenium65mcg+inositol-1.5mg + alpha lipoic acid 100mg capsule Methylcobalamine 500mcg+folic acid1.5mg+ alpha lipoic acid 300mg +Benfothiamine50mg. capsule Methyl prednisolone aceponate-1mg + salicylic acid-50mg ointment Propanol 50gm+povidone iodine-1gm in 100ml solution Propanol-18 gm+Ethenol(100%)-45gm in 100ml solution Ceftriaxone 2gm+ Tazobactum 250mg for injection Methylprednisolone aceponate-1mg + Mupirocin-20mg. cream For Vitamins and mineral deficiency states.

31-10-2007.

31.10.07

669.

For diabetic neuropathy 13.11.07 For treatment of psoriasis For surgical disinfection. For surgical disinfection. Anti-bacterial & & hygenic hygenic hand hand 19.11.07 19.11.07 19.11.07 21.11.07 21.11.07

670. 671. 672. 673. 674.

For the treatment of atopic dermatitis

675.

676. 677.

Methyl cobalamine 500mcg+folic acid1.5mg+B6-3mg,+Zn.sulphate 61.8mg+Ca.Pantothenate 10mg+ Niacinamide50mg +chrimium-50mcg capsule Mecobalamin0.5mg + Pyridoxine 50mg + Benfotiamine100mg capsule

For Vitamins and mineral deficiency patients.

29.11.07

For the treatment Neuropathy

of

diabetic

29.11.07 29.11.07 29.11.07

678. 679.

Methylcobalamine 500mcg+folic acid 1.5mg+ For diabetic neuropathy alpha lipoic acid 100mg +B6-3mg+Thiamine 10mg capsule Doxophylline-400mg+Salbutamol(as sulphate)- For treatment of Bronchial asthma in 2mg/4mg Tablets adults Gatifloxacin (as sequihydrate)-3mg Flurbiprofen sod.-0.3mg/ml eye drops. + For reduction of post-operative inflammatory conditions of eye ,when bacterial infection exists. For treatment of diarrhoea of mixed infection in adults patients.

29.11.07

680. 681. 682. 683. 684.

Sertanidazole-300mg+ Ofloxacin-200mg tablet

29.11.07 12.6.07 12.6.07 12.10.07

Olmesartan medoximil-20mg + Ramipril-5mg. For treatment of essential hypertention. tablet Combipack of 12 Artesunate 50mg tablets & 6 For drug resistant P.falciparum malaria Mefloquin-250mg tablets infection. Pregabalin-75mg/150mg 500mcg cap Doxycycline-100mg billion capsule pellets +Methylcobalamine For the treatment of adult patients with peripheral neuropathy. spores-5 For adult patients prone to intrabdominal bacterial infection & Antibiotic associated diarrhoea

+L.bacillus

12.11.07

685.

Cefprozil 250mg/500mg+Clav. Acid-62.5mg For the treatment of adult patients with /125mg. tab upper&lower RTI, Skin & Skin structure infection Dextrometharpahan HBr10mg+Chlorphenaramine maleate-2mg /5ml syrup. Escitlopram (as oxalate)10mg + Clonazepam0.5mg tablet (addl. Strength). For the temporary relief of cough due to throat irritation, sneezing & ruunning nose. For comobid depression and anxiety disorder.

12.11.07

686.

12.11.07 12.12.07

687. 688.

Me-salicylate 30% + Menthol 10% + camphor For temporary relief from pain, 4% Cream swelling & inflammation due to musculoskeletal disorder Streptococcus thermophilus 45% + For management of rotavirus diarrhoea Bifidobacteria (B.longum, B.infantis,B.breve) in children 45% + Lactobacillus acidophillus 3% + Lactobacillus casei 2% + Lactobacillus delbruecki susp. 3% Bulgaris 2% + Lactobacillus plantarum

29.11.07 01.08.2007

689.

690. 691.

Drospirenone 3mg/3mg + Ethinyl Estradiol For the use as oral contraceptive for 0.02mg/0.03mg Tablets women Amlodipine 2.5/5/5mg 25/50/25mg Capsules + Metoprolol Additional Indication :- For the Treatment of Ischemic Heart Disease/Coronary Heart Disease

28.03.2008 16.07.2008

692.

Mecobalamin 1000mcg + Vit B1 10mg + Vit For vitamin and mineral deficiency B6 3mg + Folic Acid 1mg + Calcium states in adult patients Pantothenate 50mg + Niacinamide 45mg tablets Methylcobalamin 500mcg + Vit A 5000IU + For vitamin and mineral deficiency Vit E25IU + Ascorbic Acid 100mg + Vit B1 states in adult patients 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 tbalets Methylcobalamin 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 Diclofenac 10mg + Serratiopeptidase 10/15mg tab & Cap. On 20/8/08 For vitamin and mineral deficiency states in adult patients

01.03.2008

693.

01.03.2008

694.

01.03.2008

695. 696.

For the treatment of acute pain in adults

24.01.2008 29.01.2008

697. 698. 699.

Amoxycillin 250mg + Dicloxacillin 250mg + For the treatment of lower RTI, skin Lactobacillus 2.5 million spores capsules and soft tissue, bone and joint infections and ENT infections in adult patients prone to antibiotic induced diarrhoea Beclomethasone Dipropionate 0.25mg + For the topical treatment of bacterial Econazole 10mg + Neomycin 5mg cream and fungal infections Methylcobalamin 750mcg + Alpha Lipoic Acid For the treatment 100mg + Folic Acid 300mcg capsules neuropathy of diabetic

30.01.2008 30.01.2008 30.01.2008

Methylcobalamine 750mcg + For Mineral & Vitamins deficiency Adenosylcobalamin 500mcg + Folic Acid states in adult patients 1.5mg + Elemental Iron 100mg capsules Methylcobalamin 500mcg + Ascorbic acid For Mineral & Vitamins deficiency 100mg + Niacinamide 50mg + Vit E 25mg + states in adult patients 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

700.

30.01.2008

701.

Ciclesonide 100mg/200mg + Formoterol As third line treatment of severe cases 6mcg/6mcg + Tiotropium 9mcg/9mcg Rotacaps of COPD, when monotherapy and second line therapy with two drugs do not respond adequately. Phenylephrine 5mg + Chlorpheniramine For the treatment of common cold and maleate 0.5mg + Paracetamol 125mg + Sodium cough associated with fever Citrate 60mg + Menthol 1mg syrup Streptococcus 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 Methylcobalamin 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 Atenolol 25/50mg + Chlorthalidone 6.25 mg tablets Cefpodoxime 100mg + Clavulanate Potassium 62.5 mg Dispersible Tablet/Dry Syrup For the treatment of irritable bowel syndrome

31.01.2008

702.

31.01.2008

703.

31.01.2008

704.

For vitamins & minerals deficiency states in adult patients

31.01.2008

705. 706. 707.

For the treatment of hypertension For LRTI, URTI and UTI.

essential

31.01.2008 31.01.2008 19.02.2008

Methylcobalamin 500mcg + VitA 5000IU + Vit For Vitamins and Minerals deficiency E 25mg + Vit C 75mg + Vit D3 400IU + Folic states in adult patients Acid 1.5mg + Biotin 150mcg + Vit B1 5mg + Riboflavin 5mg + Vit B6 1.5mg + Niacinamide 50mg + Calcium Pantothenate 10mg + LGlutamic acid 50mg + Chromium Picolinate 250mcg + Selenium 70mcg + Zinc Sulphate 55mg + Copper Sulphate 2mg + Manganese sulphate 5mg + Sodium Molybdate 25mcg + Manganesium Oxide 10mg sugar coated tablets Mecobalamin 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 Methylcobalamin 1500mcg + Alpha lipoic acid 200mcg + Folic acid 1.5mg + Biotin 30mcg + Pyridoxine 3mg capsules Mecobalamin 0.5mg + Alpha Lipoic Acid 100mg + Benfotiamin 100mg + Pyridoxine 50mg tablet Methylcobalamin 1500mcg + Pyridoxine 1.5mg + Folic acid 5mg capsules For Vitamins and Minerals deficiency states in adult patients

708.

25.02.2008

709.

For Vitamins and Minerals deficiency states in adult patients For the treatment Neuropathy of diabetic

03.07.2008

710.

03.07.2008

711.

For the treatment hyperhomocysteinemia

of

03.07.2008

712.

Mecobalamin 500mcg + Vit A 5000IU + Vit D3 For Vitamins and Minerals deficiency 400IU + Vit E 25IU + Vit B1 10mg +Riboflavin states in adult patients 10mg + B6 3mg + Niacinamide 50mg+ Calcium Pantothenate 12.5mg + Vit C 100mg + Folic acid 1500mcg+ Biotin 60mcg + LGlutamic acid 100mg + Dl-Methionine 25mg +Magnesium oxide 30mg + Manganese 2.5mg + Copper 2.5mg + Zinc 22.5mg + Chromium 100mcg + Selenium 60mcg tablets Methylcobalamin 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 Mecobalamin 1500mcg + Alpha Lipoic Acid 100mg + B1 10mg + B6 3mg + Folic Acid 1.5mg capsules Methylcobalamin 500mcg + Vit C 75mg + Vit B6 10mg + Folic Acid 5mg + Carbonyl Iron 100mg capsules Methylcobalamin 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 patients

03.07.2008

713.

03.07.2008

714.

For Vitamins and Minerals deficiency states in adult patients For the treatment of iron deficiency anemia For Vitamins and Minerals deficiency states in adult patients

03.07.2008

715.

28.03.2008

716.

04.07.2008

717.

718. 719.

720. 721.

Rabeprazole Sodium ( with Sodium bicarbonate For the treatment of gastric ulcer, as buffer) duodenal ulcer,Zollinger Ellison Syndrome and Gastro-Esophageal reflux disease Olmesartan 40mg + Ramipril 5mg Tablet For the treatment of Essential hypertension Pantoprazole Sodium (with Sodium Bicarbonate For the treatment of gastric ulcer, as Buffer) duodenal ulcer,Zollinger Ellison Syndrome and Gastro-Esophageal reflux disease Methylcobalamin 150mg + Pyridoxine 12.5mg For the treatment of diabetic + Alpha Lipoic Acid + Inositol + Folic Acid Neuropathy Esomeprazole (with Sodium bicarbonate as For the treatment of GERD, gastric Buffer) and duodenal ulcer, Zollinger-Ellison syndrome

28.04.2008

19.08.2008 28.4.2008

05.09.2008 14.05.2008

722.

723.

Methylcobalamin 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 Atorvastatin 5/10/5mg + Telmisartan 20/20/40 mg

For vitamins & minerals deficiency states

14.05.2008

For the treatment of co-existing essential hypertension and hyperlipidemia in adult patients

22.05.2008

724.

Mecobalamin 1500mcg+ Alpha lipoic acid For vitamin and mineral deficiency 100mg+ Vit B6 3mg + Folic acid 1.5mg + Zinc states 15mg + Chromium 60mcg + Selenium 65mcg+ Biotin 100mcg + Inositol 2mg Tablet Thiocolchicoside 4/8mg 50/100mg FC Tablet + Ketoprofen For the treatment of acute low back pain and other musculoskeletal painful & inflammatory conditions in adult patients + Metformin For the treatment of Type II diabetes mellitus when single drug therapy along with diet, exercise do not result in adequate glycemic control

06.09.2008

725.

06.11.2008

726.

Vildagliptin 50/50/50mg 500/850/1000mg Tablet

21.07.2008

727. 728.

Tenofovir Fumarate 300mg + Lamivudine For the treatment of HIV infection in 300mg + Efavirenz 600mg FC Tablet adults Metolazone 2.5/5mg 50mg/50mg FC Tablet + Spironolactone For the treatment of oedema associated with congestive heart failure, cirrhosis and nephr1tic syndrome As initial therapy in adult patients with osteoarthritis of knee and hip joints For the treatment of adult patients with muscular pain associated with spasm

23.07.2008 25.08.2008

729. 730. 731.

Diacerin 50mg + Glucosamine 1500mg Tablets Drotaverine 80mg + Aceclofenac 100mg Tablet

09.04.2008 15.09.2008 15.09.2008

Losartan 25/25/50/50mg + Chlorthalidone For the treatment of mild to moderate 6.25/12.5/6.25/12.5mg FC Tablet hypertension in adult patients whose blood pressure is not adequately controlled by monotherapy Methylcobalamin 1500mcg + Alpha Lipoic For adult patients Acid 300mg Capsule neuropathy. with diabetic

732.

14.10.2008

733.

Methylcobalamin 500mcg + L- Arginine For the treatment of vitamin deficiency 13.28mg + L- Histidine 3.71mg + L- Isoleucine states in adults 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 Calcitriol 0.25mcg + Calcium 200mg + Zinc For the treatment of hypocalcaemia 7.5mg Capsules and/or osteoporosis Ferrous bisglycinate 60mg + Folic acid 1mg + Zinc Bis glycinate 15mg + Methylcobalamine 500mcg FC Tablet doxyphylline 2mg + Terbutaline 120mg per 5 ml Syrup ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol tartrate 25mg/50mg tablets (Additional Strength) Halobetasol 0.05% + Clotrimazole 1.0% cream For the treatment of vitamin deficiency states in adults For symptomatic treatment of cough For angina & Hypertension

14.10.2008

734. 735.

11.04.2008 14.10.2008

736. 737.

24.12.2008

02.01.08 For the treatment of steroid responsive fungal infections including eczema and psoriasis For Parkinson's Disease

738.

04.01.08 08.01.2008 08.01.2008

739. 740.

Levodopa 200mg + Carbidopa 50mg C.R. tablet

741. 742.

For the treatment of lower respiratory Ceftazidime 500mg + Tobramycin 60mg per tract infection caused by pseudomonas injection aeruginosa. Tenofovir disoproxil fumarate 300mg + For the treatment of adult patients with Lamivudine 300mg tablet HIV infection Cefixime 200mg/100mg + Lactic acid bacillus For the treatment of Urinary tract 2.5 billion spores tablet & dispersible tablet infections, respiratory tract infections, biliary tract infections in adult patients prone to antibiotic associated diarrhoea Ceftazidime 500mg + Tobramycin 60mg per For the treatment of lower respiratory vial (Injection) tract infection caused by pseudomonas aeruginosa

07.01.08

07.01.08

743.

08.01.08

744.

Atorvastatin Capsules

745. 746.

75/150mg For the treatment of dyslipidemia associated with atherosclerotic arterial disease with risk of myocardial infarction, stroke or peripheral vascular disease Smatriptan (as succinate ) 50mg + Naproxen For the treatment of acute migraine sodium 550mg tablets Sodium Valproate 666mg + valproic acid Same as Approved 290mg equivalent as sodium valproate 1000mg C.R. tablet (Additional Strength) Cefepime (as hydrochloride) 2000/1000/500mg For serious CRTI, uncomplicated and + Sulbactam (as sodium) 1000/500/250mg per complicated UTI, Uncomplicated skin vial of injection & skin structure, infection acute exacerbation of chronic bronchitis & intraabdominal infection. Combikit 4 tablets of Alendronate sodium trihydrate equivalent to Alendronic acid 70mg each + 24 tablets of Calcium carbonate 1250mg (equivalent to 500mg Calcium) + cholecalciferol-250IU Atorvastatin 10mg + Fenofibrate 80mg tablet (Additional Indication) For the treatment of osteoporosis in post-menopausal women

10mg

Aspirin

18.01.08

22.01.08

24.01.08

747.

24.01.08

748.

23.01.08

749.

For the treatment of combined hyperlipidemia in patients with normal hepatic and renal functions.

25.01.08

750.

Sodium Valproate 499.5mg + Valproic acid Same as Approved 217.5mg equivalent as sodium valproate750mg CR tablet (Additional Strength) Diclofenac 50mg + Serratiopeptidase 10mg For the treatment of acute pain in enteric coated tablet adults Gabapentin 100mg + methylcobalamin 500mcg For neuropathic pain in adults. tablets (Additional Strength) Cefpirome (as sulphate) 500/1000mg/2000mg + For the treatment of infection caused Sulbactam (as sodium ) 250mg/500mg/1000mg by sensitive organisms viz. lower RTI, powder for injection complicated UTI, Septicemia, bacteremia Metformin HCl ER 500mg + Fenofibrate For the treatment of Type-II diabetes 80mg/160mg tablet associated with mixed dyslipidemia Diclofenac sodium 50mg + Dicyclomine HCl For the treatment of acute colicky pain 20mg per ml of injection in adults Travoprost 40mcg + Timolol (as Maleate) 5mg For decrease of intraocular pressure in per ml of eye drops patients with open angle glaucoma or ocular hypertension, who are insufficiently responsive to topical beta blockers or prostaglandin analogues

24.01.08

751. 752. 753.

24.01.08 24.01.08

24.01.08

754. 755. 756.

25.01.08 28.01.08

28.01.08

757.

758.

759.

760.

Amoxicillin 250mg/125mg + Cloxacillin For RTI, SRS of tissue infection, bons 250mg/125mg + Lactic Acid Bacillus 1.7 & joint infection, ENT infection in Billion spores adults prone to antibiotic associated diarrhoea Amoxicillin 250mg + Lacto- Bacillus 1.7 billion For RTI, SRS of tissue infection, bons Spores capsule & joint infection, ENT infection in adults prone to antibiotic associated diarrhoea Mecobalamin1500mcg +Alpha Lipoic For Vitamins and Minerals deficiency Acid100mg+Benfothiamine15mg+B63mg+Calc states in adult patients ium Pantothenate25mg+Folic Acid 1.5mg+Zinc oxide22.5mg+Chromium picolinate65mcg+Inositol10mcg+Lutein5mg capsule Methylcobalamine 750mcg + Alphalipoic acid For Vitamins and Minerals deficiency 100mg + Benfothiamine 7.5mg + B6 1.5mg + states in adult patients Calcium pantothenate25mg + Nicotinamide 50mg + Folic acid0.75mg capsule Mecobalamin500mcg + Alpha Lipoic Acid200mg + Benfotiamin 10mg + Pyridoxine3mg + Biotin5mg + Folic acid 1.5mg capsule Amoxycillin 250mg + Cloxacillin 250mg + Lactobacillus 2 billion spores capsules For Vitamins deficiency states in adult patients

30.01.08

31.01.08

30.01.08

30.01.08

761.

30.01.08

762.

For the treatment of lower RTI, skin & soft tissue bone & joint infections, ENT infections in adult patients prone to antibiotic associated diarrhoea As 3rd line treatment of sever cases of COPD when monotherapy and second line therapy with two drugs do not respond adequately

30.01.08

763.

Tiotropium (as Tiotropium Bromide Monohydrate) 18mcg + Formoterol Fumarate Dihydro. 12mcg + Ciclesomide 400mcg per capsules

31.01.08

764.

Metoprolol Succinate Equivalent to Metoprolol For the treatment of patient with both Tartrate [ER 25/50mg] + Atorvastatin (As essential hypertension and calcium ) 10mg tablets hypercholesterolemia Hyaluronic Acid Salt 25mg + Cross-Linked For intradermal implantation and facial Hyaluronic acid 25mg per ml in prefilledsyringe soft tissue agumentation Beclomethasone Dipropionate 0.25mg + Econazole 10mg + Neomycin 5mg per gm of Cream Diclofenac Sodium 50mg + Paracetamol 500mg tablets For the topical treatment of bacterial and fungal infections For the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis

28.01.08

765. 766.

30.01.08 30.01.08

767.

30.01.08

768.

Memantine 5mg /10mg + Donepezil 5mg For moderate to severe Alzheimer's Tablets disease

31.01.08

769.

770.

Cefpodoxime 50mg + Clavulanic acid 31.25mg For LRTI, URTI and UTI. dispersible tablet & dry syrup (Additional strength) Amoxycillin 125mg/250mg/500mg + For the treatment of respiratory tract Lactobacillus 1.66 billion Spores (Capsules) infection, skin and soft tissue infections & antibiotics associated diarrhoea in adult patients Halobetasol 0.5mg + Miconazole 20mg per For steroid responsive dermatoses gram Cream associated with superficial fungal infection of skin Montelucast 10mg + Levocetirizine 5mg film For the treatment of allergic rhinitis in coated tablets adults only Hydroquinone 2% + Tretinoin 0.025% (w/w) For short term intermittent treatment of Momentasone 0.10% Gel moderate to severe melasma of the face in the presence of measures for sun avoidance including use of sun screen Phenylephrine 5mg + Chlorpheniramine For the treatment of common cold and maleate 0.5mg + Paracetamol 125mg + sodium cough associated with fever citrate 60mg + Menthol 1mg (per 5ml) Syrup Diclofenac Sodium 100mg (SR Pellets) + For treatment of painful inflammatory Rabeprazole Sodium 20mg (E.C Pellets) conditions associated with Capsules gastroduodenal ulcers Ciclesonide 160mcg/320mcg/Formoterol 12mcg As third line treatment of severe cases + Tiotropium 18mcg Dry powder inhaler of COPD, when monotherapy and second line therapy with two drugs do not respond adequately Ramipril 5mg + HCTZ (Additional Strength) tablets 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 Betamethasone 0.05% +Miconazole 2% Cream For the treatment of steroid responsive dermatoses associated with superficial fungal infections of the skin Omeprazole 20mg/40mg + Sodium bicarbonate For gastric ulcer, duodenal ulcer, and 1680mg per sachet powder for oral suspension GERD Mecobalamin 1000mcg+ Alpha Lipoic Acid For the treatment 200mg+ vitamin B6 3mg + Folic Acid 1.5mg+ neuropathy Inositol 100mg + Benfotiamine 100mg capsule ISMN 30mg SR + Atenolol 50mg tablets For angina pectoris (Additional Strength) of diabetic 12.5mg

31.01.08

31.01.08

771.

31.01.08

772. 773.

31.01.08

31.01.08

774.

31.01.08

775.

31.01.08

776.

31.01.08

777.

20.02.08

778.

12.03.08

779. 780.

12.03.08

19.03.08

781.

19.03.08

782.

783.

Ambroxol HCl. 15mg + Guiphenesin 50mg + Terbutalin sulphate 1.25mg + Menthol 2.5mg per 5 ml of syrup Ambroxol HCl 30mg + Guaiphenesin 100mg + Terbutaline sulphate 2.5mg per 10ml Syrup

784. 785. 786.

For symptomatic relief of bronchospasm in bronchial asthma and chronic bronchitis For the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis Drospirenone 3mg + Ethinyl estradiol 0.02mg Oral contraceptive in women tablets (Additional Strength) Nimesulide 100mg ER + Levocetirizine HCl For symptomatic treatment of acute 5mg Tablets rhinosinusitis Methylcobalamin 1000mcg + Pyridoxine Hcl IP For peripheral neuropathy 100mg + Nicotinamide IP 100mg + DPanthenol IP 50mg per 2 ml of injection Lamivudine 20mg + Stavudine 5mg dispersible For HIV infection tablets (Additional Sgtrength) Diclofenac Potassium 50mg + Serratiopeptidase For the treatment of acute pain in (as enteric coated pellets) 15mg capsules adults (Additional Strength) Diacerin 50mg + Aceclofenac 100mg tablets For the treatment of adult patients with osteoarthritis of knee and or hip joints

26.03.08

26.03.08 28.03.08 28.03.08

31.03.08

787. 788.

01.04.08

08.04.08

789. 790. 791.

11.04.08 21.04.08

Diacerin 50mg + Glucosamine sulphate 500mg For the treatment of adult patients with tablets. osteoarthritis of knee and hip joints Sitagliptin ( As Phosphate) 50mg + Metformin As an adjunct to diet & exercise to Hcl. 500mg/1000mg Film coated tablets improve glycemic control in patients with type-two diabetes mellitus Pregabalin 75mg/150mg + Methylcobalamin For the treatment of adult patients with 750mcg capsules (Additional Strength) peripheral neuropathy. Aliskiren 150/150/300/300mg 12.5/25/12.5/25mg tablets HCTZ For the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled on monotherapy . Losartan Potassium 25mcg + Amlodipine (as mild to moderate hypertension besylate) 5mg tablets. (Additional Strength) Halobetasol 0.05% + Salicylic Ointment (additional Strength) acid 6% For the treatment of plaque psoriasis +

28.04.08

792. 793.

08.05.08

08.05.08

794. 795. 796.

14.05.08 14.05.08

797.

Sodium Chondroitin sulfate 40mg + sodium For use as a surgical aid in anterior Hyaluronate 30mg per ml Intraocular Injection segments procedure including catract (additional strength) extraction & intra-ocular lens implantation Telmisartan 40 mg + Atorvastatin (as calcium) For coexisting essential hypertension 10 mg Tablets & hyperlipidemia

14.05.08

22.05.08

798.

Metolazone 2.5mg + 25mg/50mg tablets

Losartan

Potassium For hypertension in patients whose blood pressure is not adequately controlled in monotherapy For essential hypertension in adult patients whose blood pressure is not adequately controlled on monotherapy

28.05.08

799.

Metolazone 2.5mg + Ramipril 2.5mg/5mg

28.05.08

800.

L-Isoleucine 9.20mg+L-Leucine HCL infusion 9.45mg+LMethionine 0.395mg+LPhenylalanine 0.44mg+ L-Threonine0.30 mg+L-Tryptophen 2.14mg + L-Valine 0.70mg+ L-Alanine 8.90mg+ L-Arginine 8.40mg + LAspartic Acid 15.37mg+L histadine 0.20mg+ LProline 3.10mg +L-Serine 5.30mg+L- tyrosine 2.60mg+Glycine 0.40mg +WFI per 100ml Doxercalciferol 0.5mcg/2.5mcg Soft Gelatin For the treatment of secondary capsules hyperthyroidism in patients with chronic kidney disease on dialysis Diclofenac Sodium 50mg + Codeine Phosphate For the treatment of adult patients with 50mg tablets signs & symptoms of acute painful conditions Dexrabeprazole 10mg (EC) + Domperidone For the treatment of Gastroeasophageal 30mg SR Capsules Reflux Disease (GERD) in patients not responding to dexrabeprazole alone Thiocolchicoside 4mg/8mg 50mg/100mg tablets + Ketoprofen For acute low back pain & other musculoskeletal painful and inflammatory condition in adults

26.06.2008

801.

29.05.08

802.

02.06.08

803.

09.06.08

804.

11.06.08

805. 806.

Cefotaxime sodium + Sulbactam sodium for For the treatment of lower respiratory injection (Additional Indication) tract infection in children Artemether 40mg/80mg + Lumefantrine for the treatment of pf. Malaria cases 240mg/480mg tablets (additional Strength) resistanat to both chloroquine and Sulphadoxine Pyremethamine combination. Mecobalamin 0.5mg+ Alpha Lipoic Acid For the treatment of diabetic 100mg+ Benfotiamin100mg + Pyridoxine 50mg Neuropathy tablets Methylcobalamin 1500mcg + Alpha Lipoic For the treatment of diabetic Acid 200mg + Benfotiamine 50mg + Vit B6 Neuropathy 3mg + Biotin 5mg + Folic Acid 1.5mg capsule Metoprolol ER + (Additional Indication) Amlodipine tablets For coronary artery disease/ischaemic lheartt disease

24.06.08

24.06.08

807.

03.07.08

808.

04.07.08

809. 810.

16.07.08 18.07.08

Fenofovir Disoproxil fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg tablets

811.

Vildagliptin 50mg/50mg/50mg + Metformin For the treatment of type_II diabetes Hcl 500mg +850mg +1000mg tablets mellitus when single drug therapy alongwith diet, exercise do not result in adequate glycemic control Tenofovir Fumarate 300mg + Lamivudine For the treatment of HIV infection in 300mg + Efavirenz 600mg Tablets adults Gatifloxacin 0.3% + Ketorolac Tramthamine For reduction of part operative 0.4% eye Drop inflammatory condition of eyes Ketorolac Tromethamine 4mg + Gatifloxacin For the reduction of post operative 3mg Eye Drops inflammatory conditions of the eye Cefadroxyl (as monohydrate) 125mg + For the treatment of adult patients with Clavulanic acid (as potassium) 31.25 per 5ml infections caused by susceptible Syrup (Additional strength) microorganismsincluding S. aureus , viz. Urinary ract Infection, Lower Respiratory Tract Infections, and gonococcal urethritis Artemether + Lumefantrine Dispersible tablet for the treatment of pf. Malaria cases (40/80mg + 240/480mg ) (Additional Strength) resistanat to both chloroquine and Sulphadoxine Pyremethamine combination. Ceftazidime + Tobramycin injection (1gm + For the treatment of lower respiratory 120mg) (Additional Strength) tract infection caused by pseudomonas aeruginosa. Ceftriaxone 2gm + Sulbactam 1gm injection for the treatment of acute bacterial (Additional Indication) otitis media, skin & soft structure infections, UTI, uncomplicated gonorrhoea, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, intra abdominal infections, meningitis, surgical prophylaxis Ambroxol + loratadine + Guaifenesin Syrup For the treatment of productive cough (30mg + 5mg + 50mg per 5ml) Ferrous Ascorbate + Folic Acid + Zinc FC For the treatment of iron deficiency Tablets (100mg + 1.5 mg + 22.5 mg) anaemia Sodium Chondroitin Sulphate + Sodium For use as a surgical aid in anterior Hyaluronate injection (40mg + not more than segments procedure including catract 17mg per ml) extraction & intra-ocular lens implantation Metolazone + Spironolactone FC Tablets For the treatment of oedema associated (2.5/5mg + 50mg) with congestive heart failure, cirrhosis and nephritic syndrome

21.07.08

812. 813. 814. 815.

23.07.08 24.07.08 24.07.08

25.07.08

816.

05.08.08

817.

05.08.08

818.

18.08.08

819. 820. 821.

18.08.08 18.08.08

25.08.08

822.

25.08.08

823.

Ferrous Ascorbate + Folic Acid Suspension For iron deficiency anemia (Equiv. to elemental iron 30mg + 550mcg per 5ml) (New Dosage Form) Lopinavir + Ritonavir (100 + 25mg) Tablets For the treatment of patients with HIV (additional strength) infection Telmisartan + Ramipril (40mg + 2.5mg ) Tablets (Additional Strength) Drotaverine + Aceclofenac (80mg + 100mg) Tablets for the treatment hypertension of essential

27.08.08

824. 825. 826. 827.

08.09.08 15.09.08 15.09.08

For the treatment of adult patients with muscular pain associated with spasm

Losartan + Chlorthalidone (25/25/50/50mg + For the treatment of mild to moderate 6.25/12.5/6.25/12.5mg) Tablets hypertension in adult patients whose blood pressure is not adequately controlled by monotherapy Olmesartan + Ramipril (40mg + 5mg) tablets for the treatment (Additional Strength) hypertension of essential

15.09.08

828. 829. 830. 831.

15.09.08 15.09.08 30.09.08

Fluconazole + Zinc Pyrethrone (Each 30/60ml For the treatment of seborrhoeic bottle contains: 2% + 1%) Lotion dermatitis Etoricoxib + PCM (60mg + 500mg) Tablets For the short term use in acute painful and inflammatory condition

Paracetamol + Meloxicam + Benzyl Alcohol + Indicated for the treatment of mastitis, Lignocaine (5mg/ml + 150mg/ml + 1% + 1% ) metritis, pneumonia, pleuritis, fever Injection and relieving of acute pain in musculoskeletal disorders in animals Calcium (as Calcium Citrate Malate) + For the treatment of calcium and Colecalciferol (as Colecalciferol Concentrate) + Vitamin D deficiency states Folic Acid (250mg + 100IU + 50mcg) Tablets (pregnancy, lactation, growing Children) Artemether + Lumefantrine (80mg + for the treatment of pf. Malaria cases 480mg/5ml) Dry syrup resistanat to both chloroquine and Sulphadoxine Pyremethamine combination. Budesonide + Formoterol (80/160mcg + Indicated in the regular treatment of 4.5mcg) Inhalational Powder (Additional patients with moderate to severe Indication) COPD with frequent symptoms and a history of exacerbations Azithromycin + Dexamethasone (10mg + 1mg) Eye Drops For post operative steroid responsive inflammatory ocular condition when bacterial ocular infections or a risk of bacterial ocular infections exists.

30.09.08

832.

30.09.08

833.

30.09.08

834.

17.10.08

835.

21.10.08

836.

Diclofenac + Thiocolchicoside (50mg (EC) + For the treatment of acute 8mg) Capsules inflammation conditions associated with spasm in adults only

21.10.08

837. 838. 839. 840. 841. 842. 843. 844. 845.

Adapalene 0.1% + Benzoyl Peroxide 2.5% gel

For the treatment of acne vulgaris

24.10.08 04.11.08 04.11.08 10.11.08 10.11.08 10.11.08 17.11.08 17.11.08

Calcitriol + Calcium + Zinc (0.25mcg + 200mg For the treatment of hypocalcaemia + 7.5mg) Capsules and/or osteoporosis Atazanavir + Ritonavir(300mg + 100mg) FC For the treatment of patients with HIV Tablets infection Montelucast + Desloratidine(10mg + 5mg) FC Tablets Amlodipine + Metoprolol (2.5mg/5 mg + 25mg/50mg (ER) Tablets(additional strength) Losartan + HCTZ (100 mg + 25 mg) Tablets Salicylic Acid + Coal Tar (3% + 1%) Solution For the treatment of allergic rhinitis in adults only For hypertension for treatment of mild to moderate hypertension. For scaling of seborrhea, seborrheic dermatitis, psoriasis of scalp

Salicylic Acid + Coal Tar + Precipitated For the treatment of psoriasis and Sulphur (3% + 1% + 3%) Ointment fungal skin infection Thiocolchicoside + Etoricoxib(4mg + 60 mg) FC Tablets For the acute treatment of inflammatory musculoskeletal disorders associated with painful muscle spasm in adults. Tamsulosin + Tolterodine (0.4mg MR Pellets + For BPH with overaction bladder in 2mg/4mg ER Pellets) Capsules Adults only. Sumatriptan + Naproxen (50mg + 275mg) Tablets (additional strength) For the treatment of acute migraine

17.11.08

846. 847. 848.

17.11.08 24.11.08

849. 850.

Amoxycillin + Clavulanic acid(1gm + 62.5mg ) For the treatment and management of FC Tablets patients with community acquired pneumonia or acute bacterial sinusitis due to beta lactamase producing pathogens Buprenorphine + Naloxone (2 mg/0.4mg + For opioid dependence 0.5/0.1 mg) Tablets Atorvastatin + Metformin(10mg + 500mg SR) Tablets As adjunctive therapy to diet and exercise in patients with diabetic dyslipidemia Rifampicin + INH + Piperine (200mg + 300mg For the treatment of adult patients with + 10mg ) Capsules pulmonary tuberculosis Rifampicin +Piperine (200mg + 10mg ) For the treatment of adult patients with Capsules pulmonary tuberculosis Mifepristone + Misoprostol (1 tab of For the medical termination of mifepristone 200mg and 4 tab of misoprostol intrauterine pregnancy (MTP) of up to 200mcg) Combipack 63 days gestation based on the first day of the last menstrual period

25.11.08

02.12.08 04.12.08 11.12.08 11.12.08

851. 852. 853.

16.12.08

854. 855.

Salicylic Acid + Cetyl Alcohol + Stearyl For the treatment of scaly dermatoses Alcohol (2% + 2.65% + 0.26%) Lotion Gemifloxacin + Ambroxol (320mg + 75mg SR) Indicated for the treatment of lower FC Tablets respiratory tract infections in adult patients Ceftazidime + Sulbactam (500/1000mg + 1. For LRTI infections, 2. for UTI 250/500mg) Injection 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 meningitis Paracetamol + Phenylephrine Hydrochloride For the treatment of fever associated (Each 6gm Sachet contains: 500mg + 10mg) with cold, nasal congestion in adults Sachet Carboinoxamine Maleate + Ammonium For symptomatic treatment of cough Chloride + Sodium Citrate (Each 5 ml contains: 2 mg + 120 mg + 120 mg) syrup Diclofenac + Thiocolchicoside (50 mg + 4 mg) For the treatment of acute Capsules (additional strength) inflammation conditions associated with spasm in adults only. Methylcobalamin1500mcg + Calcium 200mg For the treatment of vitamin deficiency + Calcitriol 0.25mcg + Folic Acid1.5mg + states in adults Pyridoxine3mg Capsules Liquid Paraffin1.25ml + Milk of Magnesia For symptomatic 3.75ml + Sodium Picosulphate 3.33mg per 5ml constipation in adults treatment of

18.12.08 24.12.08

856.

24.12.08

857.

24.12.08

858.

24.12.08

859.

24.12.08

860.

14.01.09

861. 862. 863.

29.01.09 05.02.09 09.02.09 09.02.09 23.02.09

Lornoxicam 4mg + Paracetamol 500mg film For the short term use in acute painful coated tablets & inflammatory conditions in adults Cetrimide15% w/v + Chlorhexidine Gluconate 7.5% v/v + Isopropyl Alcohol 7.5% v/v Concentrate Solution Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) Solution Hydroquinone 2%+ Tretinoin 0.05% Hydrocortisone1%Cream For cleansing of physically contaminated wounds and for preoperative disinfection For the treatment of dandruff

864. 865. 866.

+ For the treatment of patients with skin hyperpigmentation For the treatment of asthma and chronic obstructive pulmonary disease in adult patients only

Doxyphylline 400 mg + Terbutaline 5mg tablets

23.02.09

867. 868.

Hydroquinone 20mg + Tretinoin 0.25mg + For the treatment of melasma of face Fluocinolone Acetonide 0.1mg per gm Cream in adults Ketoconazole 2% + Zinc Pyrithone 1% Lotion For the treatment of pityriasis and dandruff of the scalp

23.02.09 23.02.09

869.

Lamivudine 30mg + Zidovudine 60mg For the treatment of HIV patients +Nevirapine 50mg Oral Suspension (Tablets for oral Suspension) Glibenclamide 5mg + Pioglitazone 15mg Metformin500mg film coated tablets + As 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 control film For the treatment of acute low back pain in adult patients only

23.02.09

870.

23.02.09

871. 872. 873.

Aceclofenac 100mg coated tablets

+ Tizanidine 2mg

23.02.09 23.02.09

Octinoxate 7.5% + Avobenzone 3% + As sunscreen lotion for prevention of Oxybenzone 3% + Titanium dioxide 2% lotion sunburn skin Cetrizine 5/10mg + Ambroxol 30mg per 5ml For the symptomatic relief of syrup productive cough associated with allergic rhinitis, when both antihistamine and mucolytic agents are desired Calamine 8% + Liquid Paraffin10% lotion As antipruritic and smoothening agent Nifedipine 0.3% + Lidocaine1.5% cream For the treatment of anal fissures Quinapril 20mg + HCTZ 25mg film coated For the treatment of mild to moderate tablet hypertension in adult patients (in whom combination therapy is appropriate) who have been stabilized on the individual components given in the same proportion Levodopa 100/100/250 + Carbidopa10/25/25mg For the symptomatic symptoms of mouth dissolving tablet idiopathic Parkinson's Disease Losartan 100mg+ HCTZ 25 mg tablet Butaphosphan 100g + Methyl Hydroxybenzoate 1gm + Cyanocobalamin50 gm Oral powder (Veterinary Drug) Octinoxate 7.5% + Avobenzone 2% + Oxybenzone 3% + Octocrylene 3%+ Zinc Oxide 2% lotion Omeprazole 20/40mg + Sodium Bicarbonate 600mg+ Magnesium Hydroxide 700mg sachet for treatment of mild to moderate hypertension. As vitamin and phosphorous supplement for livestock, shirmp and fish. A sunscreen lotion for prevention of sunburn skin For duodenal, gastric ulcer, GERD, and erosive esophagitis,

23.02.09

874. 875. 876.

26.02.09 26.02.09

26.02.09

877. 878. 879.

04.03.09 16.03.09 19.03.09

880.

19.03.09 19.03.09 19.03.09 19.03.09 31.03.09

881. 882.

883. 884.

Ambroxol 30mg + Levo salbutamol For the symptomatic relief of 1mg+Guiphenesin 50mg /5ml syrup bronchospasm in bronchial asthma & chronic bronchitis Montelucast 4 mg+ Levocetrizine 2.5 mg tablet For the treatment of allergic rhinitis for paedriatric dose Theophylline 400mg SR + Montelukast10mg For the treatment of patients with Tablet bronchial asthma

885. 886.

Hyaluronic Acid Sodium Salt 0.2 gm + Silver For the treatment Sulfadiazine 1.0 gm/25 gm tube differentetiology Hyaluronic Acid Sodium Salt 50 mg + Silver For the treatment Sulfadiazine 1.0 gm/ 100 gm gauze differentetiology pads impregneted with cream.

of wound of of wound of

31.03.09

31.03.09

887. 888.

Telmisartan 80mg + Amlodipine 5mg tablet For essential hypertension (Additional strength) Cetrizine 10 mg + Ambroxol 75 mg SR Tablet For symptomatic relief of productive cough associated with allergic rhinitis, when both anti-histamine and mucolytic agents are desired

31.03.09

13.04.2009

889.

Ciclesonide 200mcg +Tiotropium 9mcg MDI

890. 891.

+ Formoterol 6mcg Indicated as third line treatment of severe cases of COPD, whenmonotherapy and second line therapy with two drugs do not respond adequately. Metoprolol 25mg/50mg + Chlorthalidone 12.5/ For the tretament of patients with mild 12.5 mg film coated bilayered Tablet to modrate essential hypertension Metoprolol 25mg/50mg + Chlorthalidone 6.25 For the tretament of patients with mild mg /12.5mg film coated bilayred tablet to modrate essential hypertension (additional strength) Albendazole 400 mg + Ivermectin 6 mg tablet For the treatment of intestinalhelminthes and suppression ofmicrofilaraemia especially with bancrofti infections Each ml contains Calamine 15% w/v + Zinc For the tretament of pruritis and oxide 5% w/v + Bentonite 3% prickly heat w/v+Glycerin 5%w/v + Sodium citrate 0.05 % w/v lotion Each 1000 ml of emulsion contains: Medium For the supply of fats, including chain triglycerides 100 gm + Soya oil 80 gm + essential omega-6 fatty acids and Omega-3 acid triglycerides 20 gm + egg omega-3 fatty acids, as part of a lecithin 12 gm + Glycerl 25 gm + Sodium oleate parenteral nutrition regimen 0.30 gm + Alpha -tocopherol 0.20 gm in adults iforal or enteral nutrition is + Ascorbypalmitate0.30 gm + Sodium impossible,inadequte or hydroxide max. 0.06 gm + water for injection contraindicated. 784 gm emulsion for infusion Each 15 gm sachet contains: Lactulose 10 gm For the treatment of chronic idiopathic + Ispaghula husk 3.50 gm granules constipation in adult patients only Dexketoprofen 12.5 mg/25 mg + Paracetamol For the treatment 500 mg film coated tablets musculoskeletal pain Each gm contains: Halobetasol 0.05% + Mupirocin 2.0 % w/w gel of Acute

13.04.2009

13.04.2009 25.04.2009

892.

25.04.2009

893.

08.05.2009

894.

14.05.2009

895. 896. 897.

16.05.2009 18.05.2009 16.05.09

w/w For the topical treatment of inflammatory dermatitis with secondrybacterial infection

898.

Mometasone 0.1 cream/ointment

+ Fusidic acid

2% For the treatment of dermatoses wheresecondry bacterial and/or candidialinfection is present

25.04.09

899.

900.

Thiocolchicoside 8 mg + Etoricoxib 60 mg For the acute treatment of tablets (additional strength) inflammatory musculoskeletal disorders associated with painful muscle spasm in adults. Metoprolol 50/50/25 mg + Atorvastatin As 2nd line treatment of patients 20/10/10 mg + Ramipril 10/5/2.5 mg capsules with both essential hypertension

25.04.09

and hypercholesterolemia who are not adequately controlled by combination of an anti-hypertensive with lipid lowering agent.
901. Voglibose 0.2 mg + Metformin 500mg Tablets As 2nd line treatment of type II Diabetes mellitus when diet, exercise and the single agent do not result in adequate glycemic control.

1.07.2009

13.07.2009

902.

Combipack of artesunate tablet and FDC For the treatment of P. falciparum Tablet of sulphadoxine + pyrimethamine resistant malaria patients 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. Simvastatin 20 mg + Ramipril 5mg + Atenolol For secondary prevention 50 mg + HCTZ 12.5 mg + Aspirin 100 mg (EC of coronoryheart disease/stroke in Pellets) Capsules patients where use of such combination is appropriate Sumatriptan 85 mg + Naproxen 500 mg Tablets For the treatment of acute migraine Aceclofenac(100mg) + Thiocolchicoside ( 8 For the treatment of acute mg) tablets inflammation conditions associated with spasm in adults only Aceclofenac(100mg) + Thiocolchicoside ( 4 For the treatment of acute mg) tablets (Additional strength) inflammation conditions associated with spasm in adults only

15.7.2009

903.

21.7.2009 3.08.2009 3.08.2009

904. 905.

906.

11.08.2009

907. 908.

Ofloxacin 2mg + Ornidazole 5 mg per ml for the treatment of diarrhoea of mixed Infusion infection in adult patients Artesunate (25/50/100mg) + Amodiaquine (67.5 For the treatment of uncomplicated mg/135/270mg) bilayerd Tablets malaria due to plasmodium falciparum strain in various age groups Ezetimibe 10 mg + Fenofibrate 145 mg Film For the treatment of combined coated tablets hyperlipidemia in patients with normal hepatic and renal function Isosorbibe 20 mg + Hydralazine 37.5 mg For the treatment of heart failure as an tablets adjunct to standard therapy in patients to improve survival, to prolong time to hospitalization for heart failure and to improve patients reported functional status. Cefixime 200 mg + Dicloxacillin ER 500 mg For the treatment of adult patients with Tablets Upper and Lower respiratory tract infections, skin and soft tissue infections Etodolac 300mg + Paracetamol 500mg film For the symptomatic treatment of acute coated tablet pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis Ambroxol 30 mg+ Terbutaline 2.5 mg + For symptomatic relief of Guaiphenesin 100mg + Menthol 2.5 mg per 5 bronchospasm in bronchial asthma and ml syrup (additional strength) chronic bronchitis Propofol 10 mg+ Lignocaine 2.5 mg per ml injection (addditional Strength) Mecobalamin 750 mg + Pyridoxine Hydrochloride1.5 mg + Nicotinamide 45 mg tablets Olmesartan (20/40mg )+ Atorvastatin 5/10/20mg film coated tablets For induction of anesthesia For the treatment neuropathy of diabetic

17.08.2009

01.09.2009

909.

01.09.2009

910.

18.09.2009

911.

22.09.2009

912.

20.10.2009

913.

27.10.2009

914. 915.

27.10.2009 27.10.2009

916.

For the treatment of co-existing essential hypertension and hyperlipidemia in adult patients

27.10.2009

917. 918. 919. 920.

Glucosamine sulphate potassium chloride 500 For the treatment of adult patients with mg + Ibuprofen IP 200mg film coated Tablets osteoarthritis of knee and/or hip joints Methylcobalamin 1500 mcg + Gabapentin SR For neuropathic pain in adults. 600 mg film coated tablets (additional strength) Rupatadine 10 mg + Montelukast 10 mg Tablets Eperisone 50 mg + Paracetamol 500 mg Tablets For the management of seasonal allergic rhinitis (SAR) For improvement of mytonic conditions caused by neck shoulder arm syndrome , scapulhumeral periarthritis and low back pain in adult patients only

03.11.2009 4.11.2009 10.11.2009

10.11.2009

921.

Lactobacillus Rhammnosus 1 billion cells + For the treatment of acute diarrhoea in Saccharomyces Boulardi 125 mg + Zinc children Enriched yeast 20 mg sachets & capsules Nimesulide 1.0% w/w + Ethanol 31% w/w For the local application in relieving topical solution pain in acute low backache, tendonitis, tenosinovitis and sprains Amlodipine 5mg/10mg/5mg/10mg/10mg + For the treatment Valsartan 160mg/160mg/160mg/160mg/320mg hypertension + Hydrochlorothizide 12.5mg/12.5mg/25mg/25mg/25mg Tablets of essential

4.11.2009

922.

17.11.2009

923.

24.11.2009

924.

S (+) Etodolac 150/200/300mg + Paracetamol For the symptomatic treatment of acute 500/500/500mg Tablets pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis Loteprednol etabonate 0.5% w/v + For the treatement of post operative Moxifloxacin 0.5% w/v opthalmic Suspension steriod responsive inflammatory ocular infections or risk of bacterial ocular infections exists Halometasone monohydrate 0.05% w/w + For the treatment of acute and chronic Fusidic acid 2.00% w/w cream infected eczematous dermatitis Glimepiride 1/2 mg + Metformin 500 mg + Atorvastatin 10 mg tablets For the treatment of type II diabetes mellitus associated with dyslipidemia

25.11.2009

925.

1.12.2009

926. 927. 928.

15.12.2009 17.12.2009 23.12.2009

929.

Xylometazoline 0.5 mg + Ipratropium 0.6 mg For symptomatic treatment of nasal Nasal spray congestion with running nose (rhinorrhea) Doxofylline 400 mg + Ambroxol 30 mg Tablets For the treatment of patients with bronchial asthma and COPD, when use of both the drug is appropriate Formoterol 6 mcg + Mometasone furoate For the treatment of patients with 100/200/400mcg Metered dose Inhaler & Dry bronchial asthma and COPD, where Powder Inhalation the use of combination is found appropriate Alendronate 70mg + Colealciferol 140mcg For the treatment of mixed infections (5600 IU) Tablets with roundworms and tapeworms in dogs Cefoperazone 500/1000mg + Tazobactum For the treatment of patients with both 62.5/125mg Injection essential hypertension and hypercholesterolemia Aceclofenac 200mg/200mg SR + Rabeprazole For the treatment of Painful 10mg/20mg Capsule inflammatory conditions associated with gastroduodenal ulcers.

23.12.2009

930.

30.12.2009 10.11.2009

931.

932.

4.11.2009

933.

01.07.2009

934.

Metformin Hcl 850mg + Sitagliptin Phosphate As an adjunct to diet & exercise to 50mg Tablet improve glycemic control in patients with type-two diabetes mellitus Acarbose 25mg/50mg 500mg/500mg FC Tablet + Metformin For the treatment of patients with Type II diabetes mellitus, when diet, exercise and single agent do not result in adequate glycemic control. + A sunscreen lotion for prevention of sunburn skin

15.12.2009

935.

23.02.2009

936. 937. 938.

Octinoxate 7.5%+ Avobenzone 2% Oxybenzone 3% + Zinc Oxide 2% Lotion

23.02.2009 23.02.2009 19.03.2009

Halobetasol 0.50mg + Fusidic acid 20mg Cream

939.

940. 941.

For the treatment of infected dermatoses Octinoxate 7.5% + Avobenzone 2% + A sunscreen lotion for prevention of Oxybenzone 3% + Octocrylene 3% + Zinc sunburn skin Oxide 2% Lotion Escitalopram 5mg + Clonazepam 0.5mg Tablet for treatment of patients with comorbid depression and anxiety disorders Lornoxicam 8mg + Paracetamol 500mg Tablet For the short term use in acute painful & inflammatory conditions in adults Comipack of Ibandronic acid 150mg + Calcium For the treatment of hypercalcaemia carbonate 500mg + Calcitriol 0.25mg + Zinc and/or osteporosis sulphate 20mg Diacerin 50mg + MSM 250mg + Glucosamine As initial therapy in adult patients with 750mg Tablet osteoarthritis of knee and hip joints Indapamide 1.5mg/1.5mg 2.5mg/2.5mg FC Tablet + Ramipril For the management of hypertension in subjects not responding to any diuretic or ace inhibitor monotherapy For the treatment of non-productive cough For iron, folic acid & omega-3-fatty acid deficiency For hygenic disinfection and surgical hand

20.05.2009

14.05.2009 05.03.2009

942. 943.

01.06.2009 08.07.2009

944.

945.

946. 947.

Levodropropizine Eur. Ph. 30mg + Chlorpheniramine maleate IP 2mg per 5 ml Syrup Ferrous ascorbate 100mg + Folic acid 1.1 mg tablet and Omega-3-fatty acid 200mg capsules combikit Propanol 1-ol 18gm + Ethanol 100% 45gm/100ml solution

06.07.09

01/08/2010 18/01/2010 19/01/2010

Aliskiren 150/160mg + Valsartan 300/320mg For the treatment of hypertension tablets

948.

Piroxicam 20mg tab& Paracetamol 500mg tab For treatment of fever and pain combikit 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. Artemether 20mg + Lumefantrine 120mg for the treatment of pf. Malaria cases Dispersible tablet (Additional Strength) resistanat to both chloroquine and Sulphadoxine Pyremethamine combination. Soybean oil 60gm + Triglycerides (medium Total parenteral nutrition following chain) 50gm + olive oil purified fish oil 30gm + major abdominal, major thoracic or dl-alpha-tocopherol 163-225mg + glycerol major urological surgery (anhydrous) 25gm + Egg lecithin 12gm + sodium hydroxide (to approx pH 8) + sodium pleate 0.3mg emulsion for infusion in 100ml. Cinnarizine 20mg + Dimenhydrinate 40mg For the treatment of vertigo tablets Pregabalin SR 75/150/300mg + For the treatment of adult patients with Methylcobalamin 1500mcg tablets peripheral neuropathy Sodium 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 Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tablets Cefixime 100mg/200mg 500mg/500mg tablets + Replacement of extracellular fluid losses in case of isotonic dehydration, especially if acidosis is being imminent or present

19/01/2010

949.

08.02.2010

950.

19/01/2010

951. 952. 953.

02/03/2010 02/09/2010

02/11/2010

954. 955.

For the treatment of patients with acute painful musculoskeletal conditions

02/12/2010

956.

957. 958.

Cloxacillin For the treatment of adult patients with upper & lower respiratory tract infections, skin and soft tissue infections Spironolactone 25mg + Furosemide 20mg For treatment of resistant oedema tablets associated with secondary hyperaldosteronism; resistant hypertension, chronic cardic failure and hepatic cirrhosis Olopatadine5mg + Ambroxol30mg tablets For the management of cough in adult patients only Methylcobalamin750mcg + For the treaetment of painful diabetic Pregabalin75/150mg + Vitamin B61.5mg + neuropathy in adults only Folic acid0.75mg + Benfothiamine7.5mg capsules

02/12/2010

03/05/2010

03/05/2010

03/05/2010

959.

960.

Calcium acetate 435mg + Magnesium carbonate For the management of 235mg tablets hyperphosphatemia in adults patients with renal failure being treated with dialysis (hemodialysis or peritoneal dialysis Dicyclomine2.5mg + Dried Aluminimum For the treatment of the symptoms of Hydroxide200mg + Light Magnesium functional gastrointestinal disorders Oxide100mg + Simethicone 20mg per 5ml like irratible bowel syndrome, suspension. functional dyspepsia, peptic ulcers., GERD which includes smooth muscle spasm, flatulence, abdominal distension, hyperacdity, gastric distress, bloting etc. Sertaconazole 2% w/v+ Zinc Pyrithione 1% w/v For the treatment in adults patients Shampoo with dandruff/seborrheic dermatitis of the scalp Amlodipine5mg + Ramipril10mg/5mg Tablets For the treatment of hypertension only (additional strength) Lidocaine7.5mg acutation spray + Prilocaine2.5mg per For the treatment of adult male patients with premature ejaculation

03/05/2010

03/05/2010

961.

03/05/2010 03/10/2010 03/12/2010

962. 963. 964.

965.

Drosperinone 3mg + Ethinyl Estradiol0.02mg For the treatment of symptoms of tablets premenstrual dysphoric disorders (PMDD) in women (additional indication) Miglitol 25 mg + Metformin 500mg tablets For adult with Type-II diabetes mellitus where simple drug therapy, diet and exercise do not result in adequate glycemic control. Propranolol 40mg (SR Pellets) + Fluarizine For the prophylaxis of migraine 5mg/10mg capsules Citicholine 500mg + Piracetam 400mg Tablets Diclofenac Tablets 50mg + For the treatment of acute stroke Chlorzoxazone500mg For the treatment of acute inflammation conditions associated with spasm in adults only

16/03/2010

16/03/2010

966. 967. 968.

16/03/2010 16/03/2010 16/03/2010

969.

970. 971.

Mecobalamin 750 mcg + Pyridoxine 1.5mg + For the treatment of diabetic Nicotinamide 45 mg + Benfotiamine 150mg neuropathy in adults Tablets Etoricoxib 1%+ Menthol 5% Spray For the topical treatment of acute musculoskeletal pain Pantoprazole 40mg + Cinitapride (ER) 3mg For the treatment of patients suffering Capsules from non-ulcer dyspepsia (NUD) or gasteroesophageal reflux disease (GERD) Atorvastatin 20mg + Ramipril 2.5mg/5mg For treatment of patients with both Capsules (additional strength) hypertension and

16/03/2010 16/03/2010

17/03/2010

972.

17/03/2010

hypercholesterolemia. 973. 974. 975. Lornoxicam 8mg/8mg + Thiocolchicoside For the treatment of patients with acute 4mg/8mg Tablets (additional strength) painful musculoskeletal conditions Lidocaine 2.5% w/w+Prilocaine 2.5% w/w Gel As a topical an aesthetic for use on (additional strength) normal intact skin for local anaesthesia Praziquntel 175mg + Pyrantel 504mg + For the treatment of mixed infections Febental 525mg Tablets with roundworms and tapeworms in dogs S(-)Metoprolol 25mg/50mg (ER) + Atorvastatin For the treatment of patients with both (IR)10mg tablets essential hypertension and hypercholesterolemia Atorvastatin10mg + Ramipril 5mg + Aspirin For secondary prophylaxis of ischemic (EC pellets) 75mg/150mg + Metoprolol (ER heart disease in patients where use of tablets) 25mg Capsules such combinations in appropriate Ibuprofen 400mg + Chlorzoxazone 500mg For the short term treatment of Tablets musculoskeletal pain associated with inflammation and spasm in adults only Doxophylline (SR) 400mg/800mg Montelukast 10mg/10mg Tablets Cefixime 100mg/200mg 100mg/200mg Tablets + + For the treatment of bronchial asthma in adults

23/03/2010 26/03/2010 30/03/2010

976.

01/04/2010

977.

04/05/2010

978.

04/07/2010

979. 980.

04/07/2010 26/04/2010

981.

982. 983.

Ofloxacin For the treatment of patients with typhoid fever and urinary tract infection in adults Liquid paraffin 6% + White soft paraffin For symptomatic relief of 15%w/v Cream dermatological condition associated with dry skin including atopic dermatitis, eczema, pruritus, ichthyosis, xerosis, psoriasis Telmisartan 40/80 mg+ Indapamide SR 1.5/1.5 For the treatment essential mg tablet hypertension one strip of 3 uncoated tablets of artesunate 150mg & one strip of 2 uncoated tablets of FDC of Sulphadoxine IP 500mg + Pyrimethamine IP 25mg Indapamide (SR) 1.5mg/1.5mg +Nebivolol 2.5mg/5mg tablet For the treatment of P. falciparum resistant malaria patients

29/04/2010

04/05/2010

04/05/2010

984. 985.

For the treatment of hypertension not controlled with monotherapy

05/12/2010

Cinitapride (ER) 3mg + Omeprazole (EC) 20mg For the treatment of gastirc Capsules ulcer,gastroesophageal reflux disease(GERD) & Dyspepsia not responding to omeprazole alone Dexketoprofen Trometamol Thiocolchicoside 4mg tablets 25mg + For the treatment of acute low back pain and other musculoskeletal painful & inflammatory conditions in adult patients

05/12/2010

986.

20/05/2010

987.

Fluticasone Propionate 50mcg/125mcg/250mcg For the maintenance treatment of + Salmeterol xinafoate 25mcg/25mcg/25mcg asthma and for the treatment of COPD Powder for inhalation associated with chronic bronchitis Cross linked Hyaluronic Acid Lidocaine 3mg Pre-filled syrings 24mg + For 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 For the treatment of acute painful inflammatory conditions in adults only

25/05/2010

988.

28/05/2010

989. 990.

Aceclofenac 1% w/w + Menthol 5% Spray

28/05/2010

Metformin SR 500mg/500mg + GliclazideSR As 3rd line treatment of type II 60mg/30mg + Pioglitazone 15mg/15mg tablets diabetes mellitus when diet, exercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control 3 tablets of artesunate 100mg + 3 tablets of Artesuante 50mg & 2 tablets of FDC of Pyrimethamine 25mg + Sulphadoxine 500mg combipack Calcium carbonate 600mg +Simethicone 80mg Chewable tablet Activated Dimethicone 50mg + Magnesium Hydroxide 250mg+ Dried Aluminium Hydroxide250 mg + Sorbitol (70%)1.25 gm /5ml Solution For the treatment of P. falciparum resistant malaria patients

28/05/2010

991.

28/05/2010

992.

To relive the uncomfortable symptoms of acid indigestion, heart burn, gas or sour stomach

28/05/2010

993.

994.

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 flatulence Aspirin 75mg + Simvastatin 10mg/20mg + For secondary prevention of coronory Lisinopril 5mg/10mg + Atenolol 25mg/50mg heart disease/stroke in patients where Tablets use of such combination is appropriate Methylcobalamin 1500mcg +Folic acid 0.7mg For the treatment +Niacinamide 12mg injection neuropathy in adults Methylcobalamin 1500mcg +Pyridoxine 100mg For the treatment +Nicotinamide 100mg injection neuropathy in adults of of diabetic diabetic

28/05/2010

06/01/2010

995. 996. 997.

23/06/2010 23/06/2010 23/06/2010

1 tablet of Tenofovir disoproxil 300mg + For the treatment of HIV infection in Lamivudine 300mg & 2 tablet of Nevirapine adults 200mg combipack

998.

Vitamin A (oily form) as palmiate 2000IU + For the treatment of vitamin deficiency Vitamin B1 1mg + Vitamin B2 1mg + Vitamin states in adults 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 Capsule Dexketoprofen1.25% w/w +Linseed Oil For the topical treatment of acute 3.0%w/w +Menthol 5%w/w +Methyl Salicylate musculoskeletal pain 10%w/w (12.5mg) Gel Cefuroxime Sodium 750/1500mg +Sulbactam For the treatment of mild to moderate Sodium 375/750mg Injection lower respiratory tract infection HPMC 0.3% +Dextran 0.1% + Glycerin 0.2% For the temporary relief of burning and eye drop 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 sun Cyanocobalamin 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 Methylparaben 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 Clonazepam IR 0.5mg/0.5mg+ Paroxetine CR 12.5/25mg Capsule For Mineral & Vitamins deficiency states in adult patients

23/06/2010

999.

07/06/2010

1000. 1001.

07/06/2010

07/06/2010

1002.

07/06/2010

1003.

For short term treatment of chronic wounds including stage III & IV pressure sores, leg ulcers For the treatment of patients with comorbid depression and axiety of essential

07/06/2010

1004. 1005. 1006. 1007. 1008.

07/08/2010 16/07/10 19/07/10 19/07/10 19/07/10

Metoprolol succinate ER 25/50 mg+Telmisartan For the treatment 20/40mg Tablet hypertension Etodolac 300/300mg +Thiocolchicoside 4/8mg

For the treatment of patients with acute painful musculoskeletal conditions

Celecoxib 100/200mg +Diacerein 50/50mg For the treatment of adult patients with Capsule osteoarthritis of knee and/or hip joints Metoprolol succinate ER Olmesartan 20/20mg Tablet 25mg+50mg + For the treatment hypertension of essential

1009.

1010.

1 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) Gliclazide 40/80mg+Metformin 500mg+Pioglitazone15mg Tablet

For the treatment of HIV infections in adults 19/07/10

As 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 control

19/07/10

1011.

Metformin Phosphate Indication)

500/850/1000mg+Sitagliptin A) FDC is indicated as triple 50/50/50mg Tablet(Additional 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.

08/02/2010

1012.

S(+) Etodolac 5/10%w/w + Camphor 4%w/w + For the painful & inflammatory Menthol 10%w/w + Methyl salicylate 5%w/w + conditions associated with joint, Linseed oil 3%w/w gel tendons, ligaments and muscles Cefpodoxime 100/200mg+Dicloxacillin 500/500mg Tablet ER For the treatment of lower RI, Skin and soft tissue, bone and joint infections and ENT infections in adult patients prone to antibiotic induced diarrhoea

08/05/2010

1013.

08/06/2010

1014.

Voglibose 0.3mg + Metformin (SR) 500mg As 2nd line treatment of type II Tablet Diabetes mellitus when diet, exercise and the single agent do not result in adequate glycemic control. Olmesartan 40mg + Amlodipine 5mg Tablet Additional indication: 1. For the (Additional Strength) 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 goals

08/06/2010

1015.

08/09/2010

1016.

1017.

Metformin 500/500mg + Repaglinide 1/2mg Indicated as an adjunct to diet and Tablet 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 metformin Rosuvastatin 5/10/20mg+Fenofibrate For the treatment of combined 67/145/160mg Tablet hyperlipidemia in patients with normal hepatic and renal function Fexofenadine 120mg + Montelukast 10mg For treatment of allergic rhinitis in Chewable tablet adults only Cefixime SR 200mg/400mg + Ofloxacin SR For the treatment of patients with 200mg/400mg Tablet typhoid fever and urinary tract infection in adults Etodolac 400mg/400mg + Thiocolchicoside For the treatment of patients with acute 4mg/8mg tablet (additional strength) painful musculoskeletal conditions Lornoxicam 4mg + Eperisone 50mg tablet For the improvement of myotonic conditions caused by neck shoulder arm syndrome, scapulumeral periarthiritis and low back pain in adult patients only Beclomethasone Dipropionate IP 0.025% w/w Additional lower strength + Neomycin sulphate IP 0.5% w/w cream Amlodipine 5mg/2.5mg + Valsartan 320mg/80mg + HCTZ 12.5mg/12.5mg tablet (additional strength) Paracetamol 500mg/500mg +Thioclchicoside 4mg/8mg tablet Ketorolac Tromethamine 0.4% w/v +Moxifloxacin 0.5% w/v Opthalmic solution (Additional strength) Etodolac 400mg + Paracetamol IP 500mg tablet (additional strength) For the treatment hypertension of essential

20/08/10

23/08/10

1018. 1019.

31/08/10 31.08.10 09.09.10

1020. 1021.

13.09.10

1022. 1023.

15.09.10 21.09.10

1024.

For the treatment of acute inflammation conditions associated with spasm in adults only For reduction of post-operative inflammatory conditions of the eyes. For the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis 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.

21.09.10

1025.

21.09.10

1026.

01.10.10

1027.

Dried Aluminium Hydroxide Gel IP 600mg +Magnesium Hydroxide IP 300mg +Simethicone IP 25mg +Oxetacaine BP 10mg per 5ml syrup

05.10.10

1028.

1029.

S(-) Metoprolol Succinate ER Eq. to S (-) For the treatment of essential Metoprolol tartarate 25mg/50mg + Clopidogrel hypertension who need antiplatelet (IR) 75mg/75mg tablet therapy especially for prophylaxis of atherombotic event. Drosperinone + Ethinylestradiol tablets Same as For the treatment of moderate acne approved 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. Etodolac USP HCL 150mg tablet 400mg +Tolperisone For the treatment of acute inflammation conditions associated with spasm in adults only For the treatment of acute stroke

07.10.10

09.10.10

1030.

11.10.10

1031. 1032.

Citicoline 500mg +Piracetam 400mg per 5 ml syrup (additonal dosage)

11.10.10

Thiocolchicoside 0.25% +Methyl salicylate IP For the topical treatment of painful 100mg +Menthol IP 50mg +Absolute alchol IP muscles spasms of skeletal 50mg per gm gel musculature Amlodipine Besylate IP Eq. to Amlodipine 10mg/5mg/2.5mg +Telmisartan 80mg/40mg/20mg + HCTZ 25mg/12.5mg/12.5mg tablet Pregabalin 150mg/75mg +Methylcobalamin 750mcg +Alpha lipoic acid 100mg +Pyridoxine 3mg +Folic acid 1.5mg capsule Ferrous 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. Combipack 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) Amitriptyline Hydrochloride IP 4%w/w + Ketamine HCL eq. to Ketamine 2% w/w per gm cream. Paracetamol IP 500mg + Phenylephrine HCL IP 5mg +Caffeine (anhydrous) IP 30mg + Diphenhydramine HCL IP 25mg tablet. For the treatment hypertension of essential

11.10.10

1033.

12.10.10

1034.

For the treatment of painful diabetic neuropathy in adults only For Vitamin and mineral deficiency

12.10.10

1035.

13.10.10

1036.

As contraceptive pill for women 13.10.10

1037.

For the treatment of patients suffering from neuralgia For the treatment of fever associated with cold, nasal congestion in adults

13.10.10

1038.

13.10.10

1039. 1040. 1041.

Levocetirizine dihydrochloride +Montelukast 5mg dispersible tablet

2.5mg For the treatment of allergic rhinitis

13.10.10 13.10.10

Calcium citrate maleate Eq. to elemental For the treatment of calcium and calcium 250mg +Vitamin D3 IP 200 IU tablet Vitamin D deficiency states Levonorgesterel 100mcg +Ethniyl estradiol IP (Additional indication) For the 20mcg tablet 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 menarche Eberconazole 1% w/w + Mometasone Furate For the treatment of mild to moderate USP 0.1% w/w cream inflammed cutaneous mycoses Tolperisone HCL 150mg + Paracetamol IP For the treatment of patients with acute 500mg tablet painful musculoskeletal conditions Solution 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 ) Pyridoxine HCL IP 3mg + Nicotinamide IP 100mg + Cyanocobalamin IP 15mcg + Folic acid IP 500mcg + Chromium Picolinate USP 250mcg Tablet Rosuvastatin Calcium IP 5mg/10mg + Fenofibrate BP 160mg/160mg tablet (Additional strength) For treatment of acute kidney disease (renal failure), as substitution solution in continuous haemofiltration and haemodiafiltration and as a dialysis solution in continuous haemodialysis.

13.10.10

1042. 1043. 1044.

13.10.10 21.10.10

23.12.2010

1045.

For Mineral & Vitamins deficiency states in adult patients

23.12.2010

1046.

For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function

29.12.2010

1047. 1048.

Chlorhexidine gluconate IP 1%w/v + Ethyl Surgical hand scrub & healthcare Alcohol IP 61%w/v Solution personnel hand wash Streptococcus faecalis T-110 JPC 30 million + For restoration of intestinal microflora Clostridium butyricum TO-A 2 million + Bacillus mesentericus TO-A JPC 1 million + Lactic acid bacillus (lactobacillus sporogenes) 50 million Capsules Levocetirizine 2.5mg + Montelukast 4mg For the treatment of allergic rhinitis Dispersible Tablet & Syrup

29.12.2010

15-03-2010

1049.

13.01.2010

1050.

Streptococcus faecalis 30million + Clostridium For restoration of intestinal microflora butyricum 2million + Bacillus mesentericus 1million+ Lactic acid bacillus 50million (lactobacillus sporogenes) Capsules Niacin 1000mg ER + Laropiprant 20mg Tablet For the treatment of dyslipidemia, particularly in patients with combined mixed dyslipidemia (characterized by elevated levels of LDL-chloesterol and triglycerides and low HDLchloesterol) and in patyients with primary hypercholesterolemia (heterozygous familial and nonfamilial) In combination with HMGCoA eductase inhibitor when cholesterol lowering effect of HMGCoA 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 Diclofenac 100mg (EC) + Thiocolchicoside For secondary prophylaxis of ischemic 8mg Capsule heart disease in patients where use of such combinations in appropriate Imipenem 50mg + Clistatin 50mg Injection For the treatment of P. falciparum resistant malaria patients

15.03.2010

1051.

31.03.2010

1052.

06.07.2010

1053. 1054.

14.07.2010 25.10.2010

Isphghula 3.5gm + Lactitol 10gm per 15gm For the painful & inflammatory Sachet conditions associated with joint, tendons, ligaments and muscles Chlorhexidine gluconate IP 1%w/v + Ethyl For treatment of allergic rhinitis in Alcohol IP 61%w/v Syrup adults only Alpha 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 Moxifloxacin HCl BP 0.5% w/v + Bromfenac Sodium 0.09% w/v Eye drop Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Cyanocobalamin IP 15mcg + Zinc Sulphate Monohydrate Eq. to Elemental Zinc 22.5mg Tablet S (+) Etodolac 300mg +Thiocolchicoside 8mg Tablet For the treatment neuropathy of diabetic

1055. 1056.

29.12.2010

03.01.11

1057. 1058.

For the reduction of post operative inflammatory conditions of the eye For the treatment of iron deficiency anaemia

05.01.11

05.01.11

1059.

For the treatment of patients with acute painful musculoskeletal conditions

05.01.11

1060.

1061. 1062. 1063.

Beclomethasone Dipropionate IP 100mcg + Formoterol Fumarate Dihydrate BP Eq. to Formoterol Fumarate 6 mcg Metered Dose Inhaler Amlodipine Besilate IP Eq. to Amlodipine 5mg + Indapamide USP SR 1.5mg Tablet

For the treatment of bronchial asthma where use of inhaled corticosteroid therapy found appropriate For the treatment of mild to moderate hypertension

05.01.11

05.01.11 05.01.11

Metformin HCl IP 500mg + Alpha Lipoic Acid For the treatment of patients with USP 200mg Tablet diabetic polyneuropathy Spironolactone IP 25mg + Furosemide IP 40mg For treatment of resistant oedema Tablet associated with secondary hyperaldosteronism; resistant hypertension, chronic cardic failure and hepatic cirrhosis Methylcobalamin 500mcg + Folic Acid IP For Vitamins and Minerals deficiency 1.5mg + Zinc Sulphate IP 25mg + Chromium states in adult patients 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) Capsule Hydroquinone USP 2% w/w + Tretinoin USP For treatment of hyper pigmentry 0.025% w/w + Allantoin USP 1%w/w Gel disorders Each bowel preparatory kit contains:One sachet For bowel cleansing prior to of powder for reconstitution contains: colonoscopy in adult patients only Polyethylene glycol 3350NF: 210gm + Sodium Bicarbonate IP 2.86gm + Sodium Chloride IP 5.6gm + Potassium Chloride IP 0.74gm Meropenem IP 1000mg + Sulbactam sodium For the treatment of lower respiratory USP 500mg injection tract infection caused by gram negative bacteria in adults only Adenosylcobalamin 15mcg + Ferrous Ascorbate For the treatment of iron deficiency 100mg + Folic Acid IP 1.5mg + Zinc Sulphate anaemia in adults only USP Eq. to Elemental Zinc 22.5mg tablet Aspirin (EC +Rosuvastatin Capsules Tablets) 75mg/75mg/150mg For the treatment of dyslipidemia (Granules) 5mg/10mg/10mg associated with arthersclerotic arterial disease with risk of Myocardial infarction, stroke or peripheral vascular disease. Cefpodoxime IP 100mg/100mg/200mg/200mg For the Treatment of Lower and upper +Ofloxacin IP 100mg/200mg/100mg/200mg respiratory tract infection and Typhoid Tablets fever in adults only

05.01.11

1064.

11.01.11

1065. 1066.

31.01.11

11.02.11

1067.

15.03.11

1068.

21.03.11

1069.

30.03.11

1070.

16.04.11

1071.

Cefixime Trihydrate IP Eq. to Anhydrous For the treatment of patients with Cefixime 100mg/200mg + Ofloxacin IP typhoid fever and urinary tract 100mg/200mg Dispersible Tablet infection in adults Dexketoprofen 50mg + Dicyclomine 20mg per For the treatment of acute colicky pain 2ml Injection in adult patients Gatifloxacin 0.3% + Loteprednol Etabonate For Post-Operative Steroid repulsive 0.5% + Benzalkonium Chloride 0.01% w/v inflammatory Ocular conditions when Opthalmic suspension Ocular bacterial infections or a risk of bacterial infection exists Diclofenac (as EC Tablets) 25mg + Paracetamol For the symptomatic treatment of acute 325 mg Capsule pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis Amlodipine 10mg/10mg+ 40mg/80mg Tablets Telmisartan For essential hypertension treatment of rotavirus

20.04.11

1072. 1073.

28.04.11

19.05.11

1074.

31.05.11

1075. 1076.

31.05.11

1. PROBIO : Each sachet (1g) contains: For the Total Probiotic.... Not less than 1.25 Billion diarrhoea. 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

09.06.11

1077.

1078. 1079.

Paracetamol 325mg + Tramadol Hydrochloride Additional indication. (For 37.5 mg Tablets Symptomatic Treatment of Moderate To Severe Pain.) Fexofenadine 120mg + Montelukast 10mg For treatment of allergic rhinitis in Chewable tablet (additional Dosage form) adults only Each Combipack of 21 tablets contains : A) As contraceptive pill for women 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

21.06.11 07.07.11

27.07.11

1080. 1081.

Cefixime (SR) 400mg +Moxifloxacin (SR) 400 For the treatment of lower respiratory mg Tablets tract infections in adults only Alpha Lipoic acid 100mg + Folic acid 1.5mg + Methylcobalamin 1500mcg + Pyridoxine Hydrochloride 3mg + Vitamin D3 1000 IU Tablets Levosulpride (SR) 75mg + Rabeprazole sodium IP (EC Pellets) 20mg Capsule Each 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 Diclofenac sodium (SR) 100mg + Eperisone Hydrochloride (SR) 150mg Capsules For the treatment neuropathy of Diabetic

08.08.11

10.08.11

1082. 1083.

For the treatment of Gastrooesophageal Reflux Disease (GERD) For the treatment of HIV infection in adults.

19.08.11

23.08.11

1084.

For the treatment of patient with acute musculoskeletal spasm associated with low back pain.

24.08.11

1085.

Rosuvastatin Calcium eq. to Rosuvastatin For the treatment of combined 20mg/20mg + Fenofibrate BP 67.5mg/145mg hyperlipidemia in patients with normal Tablets hepatic and renal function Acyclovir 50g + Hydrocortisone 10mg Cream For the early treatment of recurrent cold sores in adult patients to reduce likelihood of ulcerative cold sores and to shorten the lesion healing time For topical treatment of inflammatory acne vulgaris (Additional lower strength) For temporary relief of burning and irritation due to dryness of the eye

24.08.11

1086.

30.08.11

1087.

1088. 1089.

Clindamycin Phosphate eq. to Clindamycin 1% w/w + Hydrous Benzoyl Peroxide eq. to Anhydrous Benzoyl peroxide 2.5% w/w topical gel Polyethylene glycol 0.4% w/v + Propylene Glycol 0.3% w/v Eye Drops

30.08.11

13.09.11

Metformin (ER )1000mg/500mg +Saxagliptin As an Adjunct to diet and exercise to 2.5 mg/5mg Tablets improve glycemic control in adults patients with type 2 diabetes mellitus when treatment with both Saxagliptin and Metformin is appropriate Ceftriaxone Sodium eq. to Ceftriaxone Sodium Additional Indication - For the 1000mg/2000mg + Sulbactam Sodium eq. treatment of urinary tract infections Sulbactam 500mg/1000mg.injection and lower respiratory tract infections, various bacteria Difluprednate 0.05% w/v + Moxifloxacin 0.5% For steroid responsive inflammatory w/v Eye Drops ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists

19.09.11

1090.

21.09.11

1091.

22.09.11

1092.

1093.

S(-) Amlodipine 2.5mg/5mg + Clopidogrel For the treatment of high risk 75mg/75mg Tablets 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 Each combipack contains : A) One tablet of For the treatment of Osteoporosis in Risedronate Sodium - Each film coated tablet post menopausal women 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

22.09.11

30.09.11

1094.

Akiskiren Hemifumarate eq. 150mg/150mg/300mg/300mg Besilate IP eq. to 5mg/10mg/5mg/10mg Tablets

1095.

1096.

to Aliskiren For the treatment of hypertension: a) +Amlodipine As initial therapy in the patient likely Amlodipine 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. Ferrous Ascorbate eq. to elemental iron 100mg For the treatment of Iron deficiency + Folic acid IP 1.1mg + Methylcobalamin anaemia 1.5mg +Zinc Sulphate monohydrate IP eq to elemental Zinc 22.5mg Tablets. (Additional strength) Arterolane Maleate 150mg + Piperaquine Treatment of acute uncomplicated Phosphate 750mg Tablet malaria infection due to

12.10.11

19.10.11

Plasmodium falciparum in adults.

19.10.11

24.10.11

1098.

Diclofenac Sodium IP (as sustained release For the treatment of acute Pellets) 100mg + Thiocolchicoside (as sustained inflammation conditions associated release pellets) 16mg Capsule. (New Dosage with spasm in adults only. Form)

15.11.11

1099. 1100.

1101.

Epalrestat 50mg + Methylcobalamin 500mcg Tablets Ketorolac Tromethamine IP 4.00mg + Olopatadine Hcl eq. to Olopatadine 1.00mg + Benzalkonium Chloride IP 0.05mg Ophthalmic solution Tramadol Hcl IP (As Immediate Release Layer) 50mg + Diclofenac Sodium IP (As Sustained Release Layer) 75mg Tablets Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension. (Additional Strength) Amlodipine 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 Each 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 Diabetic Neuropathy For the treatment of seasonal allergic conjunctivitis in adults only

16.11.11

21.11.11

For the symptomatic treatment of moderate to severe pain in adult patients For the treatment of asthma where the use of corticosteroid and long acting beta agonist in combination is appropriate For the treatment of essential hypertension

21.11.11

1102.

21.11.11

1103.

23.11.11

1104.

1105. 1106. 1107. 1108. 1109. 1110.

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. Rosuvastatin Calcium IP eq to Rosuvastatin For the treatment of patients with 5mg + Ezetimibe 10mg. (Additional Strength) primary hypercholesterolemia. Tolperisone Hcl IP 150mg + Diclofenac IP 50mg Tablets For the treatment of Patients with acute muscle/musculoskeletal spasm in adult

28.11.11

05.12.11 07.12.11 07.12.11 08.12.11 16.12.11

Paracetamol IP 325mg + Pamabrom USP 25mg For the treatment of patient with preTablets menstrual syndrome in adults only Dosulepine Hcl 50mg/75mg + Methylcobalamin For the treatment of neuropathic pain. 1500mcg/1500mcg Tablets Montelukast Sodium IP eq.to Montelukast For the treatment of relief of symptoms 10mg +Olopatadine Hcl 5mg Tablets of allergic rhinitis Amlodipine Besilate IP eq. to Amlodipine 5mg For the treatment of mild to moderate + Perindopril Erbumine BP 8mg Tablets. hypertension in adults only and or (Additional Strength). treatment of stable coronary artery disease in patients already controlled with Perindopril & Amlodipine given concurrently at same dose level

20.12.11

1111.

1112.

1113.

1114. 1115.

Iron Amino Acid Chelate as Ferrous For the treatment of Iron Deficiency Bisglycinate (75mg) eq. to Elemental Iron 15mg Anaemia + Folic acid IP 0.25mg + Vitamin B 12 IP 3.75mcg +Zinc Picolinate (26mg) eq. to Elemental Zinc 5.5mg Syrup Artemether 20mg + Lumefantrine 120mg Syrup for the treatment of pf. Malaria cases resistanat to both chloroquine and Sulphadoxine Pyramethamine combination. Rosuvastatin 5/5/5/10/10/10/20mg + For the treatment of essential Fenofibrate 67.5/145/160/67.5/145/160/160mg hypertension Tablet Montelukast 10mg + Fexofenadine 120mg Surgical hand scrub & healthcare Chewable Tablets (Additional dosage form) personnel hand wash Ornidazole IP 1 % w/w + Povidone Iodine IP For the prevention and treatment of (0.5% w/w available Iodine) 5% w/w Ointment surgical wound infections in adult patients undergoing surgery Aceclofenac IP (Sustained released pellets) For the treatment of acute 200mg/200mg + Thiocolchicoside IP (Sustained inflammation conditions associated released pellets) 8mg/16mg Capsules. (New with spasm in adults only Dosage Form) Budesonide IP 1mg/0.5mg + Formoterol In the regular treatment of patients Fumarate Dihydrate IP eq to Formoterol with moderate to severe Chronic Fumarate 20mcg/20mcg Respirator suspension. Obstructive Pulmonary Disease (Additional Indication) (COPD) with frequent symptoms and a history of exacerbations. Diclofenac Sodium IP (Enteric coated granules) For the treatment of Patients with acute 50mg + Eperisone Hcl IP (Tablet) 50mg Hard musculoskeletal spasm associated with Gelatin Capsules. (New Dosage Form) low back pain Cephalexin IP (as monohydrate) 200mg + Kanamycin IP (as monosulphate) 100,000 IU Suspension per 10 gm Intramammary Suspension For 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.

22.12.11

05.01.2011

19.02.2011

07.07.2011

03.01.12

1116.

04.01.12

1117.

04.01.12

1118.

06.01.12

1119.

07.03.12

1120.

1121.

Sterile Solution for Peritoneal Dialysis Each 1000 ml contains: Calcium chloride dihydrate 0.184 g/l + Glycine 0.51 g/l + LAlanine 0.951 g/l + L- Arginine 1.071 g/l + LIsoleucine 0.85 g/l + L- Histidine 0.714 g/l + LLeucine 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 Imipenem IP (Sterile) eq to anhydrous Imipenem 1 g + Cilastatin Sodium IP (sterile) eq to Cilastatin 1 g Powder for Injection (Additional strength)

As Nutritional supplements for malnourished renal failure patients (Albumin concentration lower than 35 g/litre) being maintained on peritoneal dialysis. 18.04.12

For the treatment of serious lower respiratory tract infections, urinary tract infections, intra-abdominal, bone and joint infection, endocardities and bacterial septiceimia

28.06.12

1122.

Diclofenac Diethylamine BP 4.64 % w/v Eq. to For the Treatment of Acute Lower Diclofenac Sodium IP 4.00 % + Absolute Back Pain Alcohol IP 10.00 % v/v Topical Solution Diclofenac Diethylamine BP 2.32 % w/v Eq to For the Treatment of Acute Lower Diclofenac Sodium 2.00 % w/v + Methyl Back Pain Salicylate IP 10.00% w/v + Menthol 5.00 % w/v + Absolute Alcohol IP 10.00 % v/v Topical Solution (Additional Strength) Telmisartan 20mg + Amlodipine Besylate Eq. For the Treatment to Amlodipine 2.5mg + Hydrochlorothizide Hypertension 6.25mg Tablets (Additional Strength) of Essential

21.12.12

1123.

01.01.2013

1124.

03.01.2013

1125.

Amlodipine besilate IP Eq. to Amlodipine 10mg For the treatment of mild to moderate + Indapamide SR 1.5 mg Tablet (Additional Hypertension Strength)

02.01.2013

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