ࡱ>               7 ^bjbjUU .r7|7| SlbbbbT,{_^^^^^^^$a =cH^u^_U5__U_U_U]^_U^_U_U+^ghh E3|bqAghK_0{_ hc7U(ch_U LIST OF DRUGS APPROVED DURING 1999Sl.No.Name of DrugPharmacological ClassificationDate of Approval1GlimepirideAntidiabeticagent22.01.992MycophenolateMofetilImmunosuppressant07.02.993MeloxicamNSAID16.02.994TetrabenazinePre-Synaptic monoamine depleting agent10.03.995DoxazosinMesylateAntihypertensive agent11.03.996NafarelinAcetateAntiendometrioticagent; gonadotropininhibitor17.03.997MilrinoneLactateInj.Cardiotonic17.05.998BrimonidineTartrateAlpha2-adrenoreceptor agonist, adjunct in glaucoma18.05.999NabumetoneNSAID18.05.9910ZolpidemSedative-Hypnotic28.05.9911BasiliximabInj.Immunosuppressant28.05.9912TopotecanHydrochlorideAntineoplastic15.06.9913FludarabinePhosphate IVInj.Antineoplastic26.06.9914ZuclopenthixolAcetateAntimaniac&antischizoprenic29.07.9915Piperacillin-TazobactamInj.Antibiotic13.08.9916TopiramateAntiepileptic23.08.9917EptifibatidePlatletAggregation Inhibitor25.08.9918AtorvastatinAntihyperlipidemic; HMG- CoAreductaseinhibitor17.09.9919SulpirideAntipsychotic26.10.9920BambuterolBronchodilator13.12.9921BulaquineAntimalarial21.12.9922FenofibrateLipid lowering agent22.12.9923SibutramineHydrochlorideAppetite suppressant23.12.99 LIST OF DRUGS APPROVED DURING 2000Sl.No.Name of DrugPharmacological ClassificationDate of Approval24OxiconazoleAntifungal17.01.200025TemozolomideAntineoplastic17.01.200026OlanzapineAntipsychotic27.01.200027FluvoxamineMaleateAntidepressant21.02.200028CelecoxibNSAID22.02.200029NevirapineAnti HIV06.03.200030RepaglinideAntidiabetic23.03.200031GanciclovirAntiviral05.04.200032TrapidilAdjunct in angioplasty11.05.200033CerivastatinLipid lowering agent11.05.200034RofecoxibNSAID26.06.200035IrbesartanAntihypertensive26.06.200036RosiglitazoneMaleateAntidiabetic28.06.200037GranisetronAntiemetic05.07.200038RituximabAntineoplastic10.07.200039TrastuzumabAntineoplastic10.07.200040RosiglitazoneAntidiabetic14.07.200041MoclobemideAntidepressant28.07.200042CandesartanAntihypertensive31.08.200043VenlafaxineHdrochlorideAntidepressant18.09.200044ParoxetineHydrochlorideAntidepressant04.10.200045IomeprolContrast medium05.10.200046CapecitabineAntineoplastic12.10.200047DaclizumabImmunosuppressive agent12.10.200048PioglitazoneHydrochlorideAntidiabetic17.10.200049DidanosineAntiHIV15.11.200050Octy.loniumBromideIrritable bowel syndrome12.12.200051PravastatinLipid lowering agent20.12.2000 LIST OF DRUGS APPROVED DURING 2001Sl.No.Name of DrugPharmacological ClassificationDate of Approval52SildenafilCitrateMale Erectile Dysfunction08.01.200153TriflusalPlatelet Aggregation Inhibitor17.01.200154ThymosinAlfa-1Inj.Immunomodulator (for chronic Hepatitis-B)17.01.200155VinorelbinTartrateInj.Antineoplastic aggregation inhibitor17.01.200156Broncho-VaxomAntiasthamatic, immune boosting drugFeb, 200157IndinavirSulphateAntiviral (Anti-HIV)01.02.200158ButenafineHClcreamAntifungal14.02.200159MirtazapineAntidepressant14.02.200160ClopidogrelAntithrombotic; platelet aggregation inhibitor22.02.200161MosaprideProkineticagent, GERD12.03.200162DonepezilHClFor Alzheimer's Dementia20.03.200163BupropionSRSmoking cessation adjunct10.04.200164RaloxifeneHClMenopausal osteoporosis04.05.200165EfavirenzAnti-HIV06.06.200166MoxifloxacinAntibacterial26.06.200167MisoprostolAntiulceragent21.06.200168Human Recombinant Granulocyte Colony Stimulating FactorInj.Haemopoieticstimulant, antineutropenic29.06.200169NelfinavirMesylateAnti-HIV02.07.200170Ciprofloxacin 1g SRAntibacterialAug, 200171Tolterodine-L-TartrateOveractive Bladder13.09.200172EbastineAntiallergic28.09.200173LeflunomideAnti-rheumatoid Arthritis01.10.200174CitalopramHydrobromideAntidepressant03.10.200175GatifloxacinAntibacterial03.10.200176LinezolidAntibacterial04.10.200177GenirelixAntigonadotropinreleasing hormone (fertility drug)08.10.200178RacecadotrilAntidiarrhoel10.10.200179CefdinirAntibacterial10.10.200180IobitridolContrast Medium17.10.200181EstemestaneAntineoplastic18.10.200182DecapeptideForVitiligo22.10.200183OxcarbazepineAntiepileptic30.10.200184DesloratidineAntiallergic30.10.200185ZolendronicAcidForHypercalcaemia05.11.200178RacecadotrilAntiasthmatic(Leukotriene Receptor Antagonist)03.12.200187RopiniroleDopamine Agonist (for Parkinson's Disease)03.12.200188EsomeprazoleMag.Antiulcer04.12.200189Etanercept-Recomb.Antirheumatic, Tumor Necrosis Factor Receptor07.12.200190ImatinibMesylateAnticancer09.12.200191ValsartanAntihypertensive10.12.200192RabeprazoleAntiulcer; Proton pump inhibitor27.12.2001 LIST OF DRUGS APPROVED DURING 2001Sl.No.Name of DrugPharmacological ClassificationDate of Approval93Bimatoprost(Ophthalmic Sol.)Anti-Glaucoma08.01.200294MeropenemInj.Beta-lactumAntibiotic08.01.200295FosinoprilSodiumAntihypertensive10.01.200296DivalproaxSodiumAntiepileptic17.01.200297ZaleplonSedative-Hypnotic17.01.200298TizanidineSRMultiple Sclerosis06.02.200299ThymogenInj.Anticancer12.02.2002100MontelukastSodiumAntiasthmatic(Leukotriene Receptor Antagonist)13.02.2002100AMethyl CobalaminPeripheral Neuropathy13-02.2002101MifepristoneProgesterone Antagonist13.02.2002102DexarazoxaneInjectionCardio Protective Agent26.02.2002103TranexamicAcidAntifibrinolytic06.03.2002104BicalutamideAnticancer07.03.2002105LoteprednolEtabonate OphtalmicSol.Corticosteroid, ophthalmic anti-inflammatory15.03.2002106ApraclonidineOphthalmic Sol.Alpha 2-adrenoreceptor agonist15.03.2002107MizolastineAntiallergic15.03.2002108MiltefosineForKalazar15.03.2002109ZiprasidoneHClFor Schizophrenia18.03.2002110ABACAVIRAnti HIV22.03.2002110NadifloxacinCreamAntibacterial;antiacne28.03.2002111MeloxicamInj. (Vet)NSAID02.04.2002112MesalazineSRBowel disease (inflammatory)04.04.2002113TamsulosinHClFor BPH04.04.2002114FamciclovirAntiviral11.04.2002115NateglinideAntidiabetic01.05.2002116LercanidineHClAntihypertensive07.05.2002117ItopirideCapsulesGastroProkineticAgent09.05.2002118AlprostadilInjectionFor Erectile Dysfunction09.05.2002119VimpocetineVasodilator13.05.2002120QuetiapineFumerateAntipsychotic31.05.2002121IsotretinoinSoft Gel Cap.For Acnevulgaris21.06.2002122NebivololHClAntihypertensive12.07.2002123SirolimusImmunosuppressant15.07.2002124DrotrecoginalphaFor severe sepsis23.07.2002125PygenumAfricumFor BPH30.07.2002126ValdecoxibNSAID01.08.2002127ThalidomideFor Leprosy12.08.2002128S (-)AmlodipineBesylateAnti-hypertensive16.08.2002129CabergolineForhyperprolactemia05.09.2002130ButarphenolTartarateOpoidAnalgesic11.09.2002131GemtuzumabFor Myeloid Leukemia12.09.2002132QuinaprilAnti Hypertensive19.09.2002133ValacyclovirAnti-viral25.09.2002134FosphenytoinSod.Anti-Epileptic01.10.2002135CeftiofurSodium &CeftiofurHClAntibiotic (For Veterinary Use)08.10.2002136MetaxaloneMuscle Relaxant08.10.2002137MegluminegadotericContrast media16.10.2002138CefepineHClAnti-Biotic30.10.2002139AcamprosateCalciumFor Alcohol dependency30.10.2002140AztreonamAnti-Bacterial01.11.2002141TegaserodMaleateFor irritable bowel syndrome01.11.2002142ParecoxibInj.NSAID01.11.2002143BalsalezideDisodiumFor ulcerative colitis12.11.2002144Cefetemet-piroxilAntibacterial14.11.2002145TelmisartanAntihypertensive25.11.2002146LevocetrizineAnti-Histaminic12.12.2002147PoractantaFor respiratory distress in preterm babies24.12.2002148ReboxetineAnti-depressant31.12.2002 LIST OF DRUGS APPROVED DURING 2003Sl.No.Name of DrugPharmacological ClassificationDate of Approval149CefprozilAntibiotic10-01-2003150CilostazolForintermittentclaudication.23-01-2003151EscitalopramOxalate.Anti depressant24.01.2003152AnastrazoleAnti cancer10.02.2003153RizatriptanAntimigrain27.02.2003154Gadobenate(DimeglumineIV Injection)MRI Contrast Medium07.03.2003155TacrolimusOintmentImmuno-modulator10-03-2003156MetolazoneDiuretic23.04.2003157TiotropiumBromideAntiasthematic16.04.2003158GadoversetamideInjectionMRI Contrast Medium04.06.2003159TorsamideDiuretic09.06.2003160CyproteroneTabletForProstaticCancer10-06-2003161AripiprazoleAnti schizophrenia11.06.2003162AzelaicAcidAnti-Acne08-07-2003163BendrofluazideDiuretic24.07.2003164Imipenem+CilastatinAnti-Bacterial25-07-2003165VinpocetinAnti-pychotic01.08.2003166TirofibanHClI.VAnti-Platelet12.08.2003167TeriparatideFor Osteoporosis04-09-2003168CladribineAnti-Cancer09-09-2003169TadalafilFor Erectile Dysfunction11-09-2003170S-AtenololAnti-hypertensive11-09-2003171RosuvastatinLipid lowering Agent12-09-2003172TazaroteneAnti-Acne12.09.2003173AceclofenacNSAID15-09-2003174IbopamineHClOpthalmic03-10-2003175TrandolaprilAnti-Hypertensive03-10-2003176DorzolamideOpthalmic03-10-2003177FenoverineAnti-spasmodic08-10-2003178RisedronateSodiumFor Osteoporosis17-10-2003179FondaparinaxSodiumLMWH22-10-2003180MetadoxineFor Hepatic Disorder24-10-2003181ValgancyclovirFor CMV20-11-2003182IsopropylUnoprostoneOphthalmic25-11-2003183AmorolfineAnti-Fungal25-11-2003184FluvastatinSodiumLipid Lowering Agent25-11-2003185ModafinilFor sleeping disorder15-12-2003186SufentanilCitrateAnesthetic Agent17-12-2003187EzetimibeLipid Lowering Agent18-12-2003 LIST OF DRUGS DURING 2004S.NOName Of DrugPharmacological ClassificationDate of Approval188DutasterideFor BPH16-02-2004189GefitinibAnti-cancer17-02-2004190ImidaprilAnti-hypertensive23-02-2004191AdefovirDipivoxilAnti-Viral (Hepatitis-B)04-03-2004192EtoricoxibNSAID05-03-2004193DiacereinFor Osteoarthritis12-03-2004194NitazoxanideAnti-Diarrhoeal17-03-2004195TrolamineCream (0.67%)For Topical use20-03-2004196NeotameSweetening Agent22-04-2004197Oxybutynine E.R. tabletsFor Neurogenic bladder disorder05-05-2004198Cabergoline 1 mg/2 mg/4 mg tabletsFor Parkinsons disease07-05-2004199Rabeprazole Sodium Injection 20For organ rejection21-05-2004205Cefdinir Dispersible tablet (125mg)Anti-biotic27-05-2004206Linezolid (600 mg) TabletFor Osteomyelitis in adults30-05-2004207FDC of Gatifloxacin 0.3% + Dexamethasone Phos. 0.1% w/w Eye dropsFor post-operative inflammatory and bacterial infection of eyes.15-06-2004208Cefprozil Dispersible Tablet (125 mg/ 250 mg)Anti-biotic22-06-2004209Divalproex Sodium E.R. Tablets (750mg/1000 mg)Anti-Epileptic24-06-2004210Lithium Carbonate ER (450mg) tabletAnti-Depression28-06-2004211Nimesulide Injection 75mg/ml.For short-term treatment of post-operative pain.28-06-2004212FDC of Esomeprazole20 mg/40 mg + Domperidone 30 mg SR CapsuleFor GERD29-06-2004.213Aceclofenac (100 mg) + Paracetamol(500 mg)For acute painful condition in adults29-06-2004214.FDC of Lamivudine 300 mg (E.R) + Zidovudine600 mg (E.R) + Nevirapine 400 mg tabletsAnti-AIDS15-07-2004215.Levosalbutamol Tablet 1 mg/2mg & Syrup 1 mg/5 ml.For Obstructive airway disease16-07-2004216.Memantine HCltablet5 mg/10 mg.For dementia of Alzheimers type19-07-2004217.Pimcrolimus 10 mg/gm creamFor atopic dermatitis23-07-2004218.FDC of Rabeprazole (20 mg) + Mosapride S.R. (15 mg) TabletFor GERD27-07-2004219.Rebamipide 100 mg tabletFor gastric ulcer28-07-2004220.Cefetamet Pivoxil Suspension 250 mg/5mlAnti-biotic09-08-2004221.Diclofenac Transdermal patch 100 mg/50 Cm2ForOsteoarthritis & soft tissue injury10-08-2004222.Fluconazole Gel(0.5%)Anti-fungal12-08-2004223.FDC of Atorvastatin(10 mg/20 mg) + Ezetimibe (10 mg) TableFor Hypercholesterolemia13-08-2004224.Miglitol Tablet25 mg/50 mg/100 mgAnti-Diabetic18-08-2004225.FDC of Buprenorphin 2 mg + Naloxone (0.5 mg)For Opiod Dependency19-08-2004226.FDC of Sucralfate0.07 + metronidazole 0.01 gm + Lignocain 0.04 gm per gram of creamFor bedsore, haemorrhoid fistula and anal fussure19-08-2004227.Citicholine Tablet 500 mg & Injection 250 mg/mlMembrane permeability enhancer20-08-2004228.FDC of Glibenclamide 2.5 mg/ 5 mg + Metformin SR 500 mg tabletAnti-diabetic20-08-2004229.Lamotrigine S.R. tablet 50 mg/100 mg/200 mgAnti-Epileptic26-08-2004230Moxifloxacin Eye drops (0.5%)For bacterial conjunctivitis26-08-2004231Risperidone long-acting suspension for injection 25 mg/37.5 mg/50 mg per vialFor Schizophrenia26-08-2004232Escitalopram (10mg) + Clonazepam (0.5mg)For co-morbid depression & anxiety disorder.27-08-2004234Everolimus Tablets(0.25 mg/ 0.5 mg/0.75 mg/1.0 mg)Immunosuppressant30-08-2004235Dorzolamide (20 mg) + Timolol (5 mg) per mlEye dropsFor reduction of elevated IOP.01-09-2004236Gemcitabine(1.4 gm/vial)Anti-cancer01-09-2004237b -arteether Injection (150 mg/2 ml)Anti-malaria01-09-2004238Ziprasidone powder for injection(after reconstitution 20 mg/ml)Anti-psychotic03-09-2004239Voriconazole Tablet(50 mg/200mg)Infusion (200 mg/vial)Anti-fungal09-09-2004240FDC of Nebivolol(5 mg) +S(-)Amlodipine (2.5 mg ) tabletAnti-hypertensive14-09-2004241Amlodipine (5 mg) + Ramipril (2.5 mg) tabletAnti-hypertensive24-09-2004242FDC of Rabeprazole Sodium (20 mg) +Domperidone(30 mg) S.RCapsuleFor GERD04-10-2004243Cefuroxime Axetil ER tablets(500 mg/1000mg)Anti-biotic06-10-2004244Diclofenac Transdermal Patch (200 mg/75 cm2)For pain relief.06-10-2004245Gatifloxacin Eye Ointment (1%)Ophthalmic use06-10-2004246Nimesulide Injection (100 mg/ml)(Veterinary)Veterinary use08-10-2004247Isotretinoin Gel (0.05%)For acne11-10-2004248FDC of Epi-Growth Factor (1 gm) + Silversulphadiazine CreamFor Burns19-10-2004249FDC of Amlodipine (5mg/10 mg) + Atorvastatin (10/20/40 mg)For co-existing hypertension & hyperlipidemia20-10-2004250Levosalbutamol rotacaps (100 mcg/capsule) & inhaler (50 mcg /actuation)For obstructive airway disease.20-10-2004251Celecoxib Injection(100 mg/ml)For acute pain28-10-2004252Orlistat (120 mg) CapsuleAnti-obesity27-10-2004253Duloxetine HCl(20,30,40mg) TabletAnti-depressant02-11-2004254Deflazacort (1,6,30mg) tabletAnti-asthma, anti-arthritis.02-11-2004255Atomoxetine HCl(10,18, 25 & 40mg ) capsuleFor ADHD09-11-2004256Ursodeoxycholic acid S.R. Capsule (450mg)For dissolution of gall stones01-12-2004257Methylphenidate HCl (18, 36, 54 mg) E.R. tabletFor ADHD08-12-2004258FDC of Lovastatin (20mg) + Nicacin ER (500mg) tabletFor Lipid-lowering20-12-2004259FDC of Gatifloxacin (400mg) + Ambroxol HCl (75mg) tabletRTI in adults.21-12-2004260 FDC of Nebivolol HCl (5mg) + Hydrochlorothiazide (12.5mg) tabletAnti-hypertensive22-12-2004261FDC of Atorvastatin Calcium (10mg) +Finofibrate (160mg) tabletFor hyperlipidemia22-12-2004262Calcium Polycarbophil (500mg) tabletFor constipation23-12-2004263Pantoprazole (40mg) + Domperidone (20mg)( 10mg IR + 10mg SR)GERD23-12-2004264Imiquimod Cream 5% w/wFor warts in adults28-12-2004265Entacapone (200mg) tabletFor Parkinsons disease30-12-2004 LIST OF DRUGS APPROVED DURING 2005S.NoName Of DrugPharmacological ClassificationDate of Approval267Centbucridine (0.5%) + Feracrylem (3%)For hemorrhoid & anal fissure11-01-2005268Atenolol (25mg, 50mg) + HCTZ (12.5mg)Anti-Hypertensive13-01-2005269Levocetirizine Syrup (2.5mg/5ml)For allergic rhinitis & urticaria13-01-2005270Pitavastatin (1mg/2mg) TabletLipid Lowering agent14-01-2005271Ofloxacin (200mg) + Ornidazole (500mg)For diarrhea of mixed infection20-01-2005272Bacillus calusii spores suspension (2billion/5ml vial)For alteration of intestinal bacterial flora28-01-2005273Lamivudine (40mg) +Nevirapine (70mg +Stavudine (10mg) (in 5ml) powder for suspensionAnti-HIV.28-01-2005274Diflorasone Diacetate Cream (0.5mg/gm)For corticosteroid responsive dermatoses08-02-2005275Etonogestrel (11.7mg) + Ethinylestradiol (2.7mg) Contraceptive ringsFor Contraceptive in women15-02-2005276Metaxalone (400mg) + Diclofenac Potassium (50mg) tabletFor acute painful musculoskeletal condition in adult22-02-2005277Tranexamic Acid (500mg) + Mefenamic acid (250mg) tabletFor primary dysmenorrhoea and pain associated with menorrhagia in women22-02-2005278Fluconazole (2%) + Zinc Pyrethione (1%) suspensionFor seborrhoic dermatitis22-02-2005279Azelaic acid Cream (15%)For the treatment of inflammatory papules and pustules of mild to moderate rosacea23-02-2005280Levodropropizine oral suspension (30mg/5ml)For non-productive cough in adults25-02-2005281Duloxetine HCl (60mg) tablet (additional strength)28-02-2005282Desloratadine (2.5mg) + Ambroxol (30mg) +Guiphenasine (50mg) + Menthol 1mg/5ml SyrupFor productive cough02-03-2005283Levofloxacin Ophthalmic Solution (0.5%)For susceptible bacterial conjunctivitis04-03-2005284Metformin Oral Solution (100mg/ml)For type-II diabetes mellitus04-03-2005285Tirofiban (0.25mg/ml injection) (additional strength)For acute coronary syndrome including patients undergoing PTCA or atherectomy09-03-2005286Omeprazole (20mg) Enteric coated + Domperidone (30mg)(S.R.) capsuleFor GERD not responding to Omeprazole.10-03-2005287Stavudine powder for suspensionFor HIV-1 infusion11-03-2005288Erdosteine (150mg/300mg) CapsulesFor chronic obstructive bronchitis 11-03-2005289Tazarotene (1mg) +Mometasone Furoate (1mg) per gram creamFor plaque psoriasis01-04-2005290Levetiracetam (250mg,500mg, 750mg)TabletsAsadjunctive therapy in treatment of partial onset seizures in adults with epilepsy.04-04-2005291Esomeprazole Sodium For injectionFor GERD in patients with esophagitis and/or severe symptoms of reflux as an alternative to oral therapy when oral intake is not appropriate04-04-2005292Rupatadine (10mg) tabletFor perinial allergic rhinitis05-04-2005293Acesulfame PotassiumAs sweetener in pharmaceutical preparation05-04-2005294Buprenorphine (0.4mg) + Naloxone (0.1mg) sublingual tabletFor opioid dependence06-04-2005295Lamivudine (40mg) +Stavudine (10mg/5ml) reconstituted solutionFor HIV infection08-04-2005296S(-) Metoprolol Succinate S.R. tablets (equivalent to S(-) Metoprolol Tartrate 12.5mg/25mg/50mg)For Hypertension15-04-2005297R(-) Ondansetron (2mg/4mg) tabletFor chemotherapeutic induced nausea and vomiting15-04-2005298Balanced salt intra ocular irrigating solution enriched with glutathione Dextrose, bicarbonateFor intraocular irrigating during intraocular surgical procedures26-04-2005299Gliclazide M.R. (30mg/60mg)+ Metformin HCl (500mg) ER TabletFor type-II diabetes27-04-2005300Drosperinone (3mg) + Ethinylestradiol (0.035mg tablet)Oral Contraceptive11-05-2005301Simvastatin (10/20mg) + Ezetimibe (10mg) TabFor primaryHypercholesterolemia 11-05-2005302Ramipril (5mg) + Telmisartan (40mg) tabletFor Hypertension11-05-2005303Intralipid 30%For patients with essential fatty acid deficiencies12-05-2005304Montelukast Granules (4mg/pack)For Prophylaxis and chronic treatment of asthma in adult and pediatric patients of 12 months age and older17-05-2005305Bortezomib for injection (3.5mg/vial)For the treatment of myeloma patients18-05-2005306Nelfinavir 625mg tablet (addl.strength)For HIV patients20-05-2005 307Sevelamer (400mg/800mg) tabletFor control of serum phosphorus in patients with chronic kidney disease and hemodialysis.20-05-2005308S(-)Pantoprazole (10mg/20mg) tabletFor gastric ulcer, duodenal ulcer & GERD20-05-2005309Tazarotene (0.05%) + Mometasone Furoate (0.1%) Cream (addl.strength)For Plaque psoriasis24-05-2005310R (-) Ondansetron oral Solution (1mg/5ml)For Chemotherapy induced nausea and vomiting24-05-2005311Gatifloxacin (200mg) +Ornidazole (500mg) tabletFor diarrhoea of mixed infection in adults06-06-2005312Combikit of 2 tablet of Stavudine (40mg) + Lamivudine (150mg) each& 1 tablet of Efavirenz (600mg)For HIV infection in adults07-06-2005313Combikit of 2 tablet of Lamivudine (150mg) + Zidovudine (300mg) each and 1 tablet of Egavirenz (600mg)For HIV infection in adults07-06-2005314Aceclofenac gel 1.5% alongwith linseed oil, menthol, Salicylate, CapsaicinFor pain, swelling etc08-06-2005315Emtricitabine (200mg) capsuleFor HIV infection in adults09-06-2005316Eplerenone Tablet (25mg/50mg)For hypertension10-06-2005317Strontium Ranelate Granules (2gm/Sachet)For post-menopausal women with Osteoporosis14-06-2005318Lamivudine 30/60mg + Stavudine 6mg/12mg + Nevirapine 50mg/100mg dispersible tabletFor pediatric patients with HIV infection14-06-2005319Nitazoxanide (500mg) + Ofloxacin(200mg) TabletFor urogenital infection in adults.30-06-2005320Midazolam Maleate BulkAnesthetic05-07-2005321Calcium Polycarbophil (500mg) TabletIBS06-07-2005322FDC ofPapain + Urea OintmentFor debriment of necrotic tissues.11-07-2005323Testosterone Gel 1%.For replacement therapy in male with Testosterone deficiencies and hypogonadotropic hypogonadism12-07-2005324Erlotinib Hydrochloride (25mg/100mg/150mg TabletFor metastatic non-small cell lung cancer.13-07-2005325Chloroquine Phosphate eye drops (0.3mg/ml)For dry eye syndrome13-07-2005326Mecobalamine E.R. tablet (1500mcg)For neuropathic pain19-07-2005327Olmesartan Medoxomil (5mg/20mg/40mg) TabletAnti-hypertension21-07-2005328Ursodeoxycholic Acid (500mg) S.R TabletAddl. Strength20-07-2005329FDC of Amlodipine (5mg) + Bisoprolol (2.5mg)Anti-hypertension21-07-2005330FDC of Ceftriaxone (500mg/100mg) + Tazobactum (12.5mg/62.5mg) InjectionAnti-bacterial21-07-2005331Feropenem Sodium(150mg/200mg) TabletAnti-bacterial21-07-2005332Levodopa (50mg/100mg/150mg) + Carbidopa (12.5mg/25mg/37.5mg + Entacapone (200mg) tabletFor Parkinsons disease25-07-2005333Saquinavir (as mesylate) 500mg TabletAddl. Strength.25-07-2005334Pramipexole Di-hydrochloride Tablet (0.125mg/0.25mg/0.5mg/1mg/1.5mg).For Parkinsons disease25-07-2005335FDC of Atorvastatin (10mg) + Niacin (375mg/500mg E.R) CapsuleFor Hypercholesterolemia26-07-2005336FDC of Levocetirizine (5mg) + Ambroxol (75mg S.R) CapsuleAnti-histaminic & mucolytic29-07-2005337FDC of Gabapentin (300mg) + Methylcobalamin (500mcg) TabletFor neuropathic pain in adults.05-08-2005338Phenytoin Sodium (300mg) tabletAddl. Strength05-08-2005339FDC of Calciptriol (50mcg) + Betamethasone Dipro (0.5mg/gm) OintmentFor psoriasis vulgaris.12-08-2005340FDC of Glimepiride (1mg/2mg) + Pioglitazone (15mg)+ Metformin (500mg E.R) TabletAnti-diabetic12-08-2005341Tenofovir Disoproxil Fumarate Tablet (300mg)Anti-HIV17-08-2005342Sucralfate (7%) + Povidone Iodine (5%) OintmentAnti-infective18-08-2005343Bivalirudin Injection(250mg/vial)Anti-coagulant in PTCA25-08-2005344Efavirenz Oral Solution (30mg/ml)Anti-AIDS25-08-2005345Didanosine Powder for oral solution (2gm/4gm per bottles)Anti-AIDS26-08-2005346Sodium Valproate (750mg/1000mg) C.R. TabletAddl. Strength26-08-2005347Oxcarbazepine S.R. (150mg/300mg/600mg) TabletAnti-epileptic08-09-2005348AcitretinFor sever psoriasis in adults.09-09-2005349Dried IVY Leaf Extract (0.7gm/100ml)Cough Syrup15-09-2005350Nimesulide 1% + Methyl Salicylate 5%.AerosolFor local application in acute pain.16-09-2005351Feracrylum (1%) +Metronidazole 1%)Antiseptic gel.16-09-2005352FDC of Methylcobalamin (1500mcg E.R) + Pyridoxine (20mg) + Folic Acid (5mg) TabletFor hyper-homocysteinemia16-09-2005353Ketorolac Tromethamine 0.4% Eye drops (addl. Strength)Ophthalmic20-09-2005354Levetiracetam Oral Solution (100mg/ml)Anti-epileptic22-09-2005355Zinc (Gluconate) oral solution (20mg/5ml)For acute diarrhoea05-10-2005356Trimebutine MaleateFor irritable bowel syndrome10-10-2005357Enalapril (2.5mg/5mg) + HCTZ (12.5) Tablet(Addl. Strength)For Hypertension17-10-2005358Oseltamivir(as phosphate) Capsule (75mg) & oral suspension (12mg/ml)For influenzae25-10-2005358Cetirizine HCl drops (10mg/ml)Anti-histaminic08-11-2005359Lanthanum CarbonateChewable tablet (250mg/500mg)For the treatment of hyperphosphatemia.09-11-2005360Ambroxol HCl 75mg (S.R) + Desloratadine 5mg Capsule.For relief of productive cough.10-11-2005361Sodium Hyaluronate 0.1% eye drops (addl. Strength)Ophthalmic use.10-11-2005362FDC of S-Metoprolol Succinate Tartrateequivalent to Metoprolol Tartrate (E.R) 25/50mg + HCTZ (12.5mg) Tablet.For essential hypertension11-11-2005363Stavudine 10mg+Lamivudine 40mg+ Nevirapine 70mg dispersible tabletFor HIV infection11-11-2005364Voglibose (0.2mg/0.3mg) TabletAnti-diabetic17-11-2005365Lactitol Sachet(10gm/20gm).For the treatment of constipation.21-11-2005366Aspirin Bolus (Vet.) 6gm/bolus)For Veterinary use.21-11-2005367Domperidone (10mg) + Activaed dimethicone (125mg) chewable tabletFor dyspepsia, colicy pain & GERD.22-11-2005368Moxifloxacin (0.5%) + Dexamethasone Phosphate (0.1%) Eye dropsFor Ophthalmic use.24-11-2005369Pregabalin capsule (75/150/300mg)For neuropathic pain.25-11-2005370Methotrexate Topical gel (1%)Addl. StrengthPsoriasis.25-11-2005371Brimonidine Tartrate (2mg/1.5mg) + Timolol (as HCl) 5mg/ml.Ophthalmic25-11-2005372Testosterone Spray(25mg)For replacement therapy in males with testosterone deficiency.29-11-2005373Omeprazole Powder for suspension (20mg/Sachet)Anti-ulcer30-11-2005374Doxazosin (as Mesylate) 4mg/8mg E.R. TabletFor hypertension30-11-2005375Amlodipine (as besylate) 5mg + Bisoprolol 5mg Tablet (Addl. Strength)For hypertension30-11-2005376FDC of Olmesartan Medoxomil (20mg/40mg/40mg) + HCTZ(12.5mg/12.5mg/25mg)For essential hypertension02-12-2005377Phenylephrine 2.5% Eye dropsOphthalmic02-12-2005378Entecavir Tablet (0.5mg/1.0mg) & oral solution (0.05mg/ml).For chronic Hepatitis-B infection.05-12-2005379Ketorolac Tromethamine 5mg + Ofloxacin 3mg/ml Eye dropsOphthalmic07-12-2005380Hyoscine-N-Butylbromide (10mg) + Paracetamol 500mg TabletFor spasmodic pain08-12-2005381Amlodipine (as besylate ) 5mg + Losartan Pot. 50mgFor hypertension08-12-2005382Travoprost Eye drops (40mcg/ml)For glaucoma & ocular hypertension.08-12-2005383Ceftriaxone (as sodium) (500mg/1000mg) + Sulbactam (as sodium) (250mg/500mg) powder for injection.For LRTI08-12-2005384Atomoxetine (as HCl) Sachet (10/18/25/40mg)For ADHD15-12-2005385Levofloxacin Oph. Solu. (1.5%) 15mg/ml. (Addl. Strength).Ophthalmic16-12-2005386Zonisamide (100mg) capsuleAnti-epileptic21-12-2005387Methimazole Tablet ( 5mg/10mg)For hyperthyroidism.22-12-2005388Caspofungin Acetate injection (50mg/70mg per vial).For invasive candidiasis fungal infection.23-12-2005 LIST OF DRUGS APPROVED DURING 2006S.NoName Of DrugPharmacological ClassificationDate of Approval1Cefprozil Powder for oral suspension (125mg/5ml)Antibiotic6/1/20062Nebivolol (as HCl) 5mg + Valsartan 80mgFor hypertension17/01/20063Combikit of Tamsulosin HCl 0.4mg M.R capsule (10 no.) & Dutasteride Soft Gelatin Capsule 0.5mg (10no.)For BPH 19/01/20064Alendronate Sodium (equiv. to Alendronic acid 70mg) + Cholecalciferol 70mcg (equiv. to 2800 I.U Vit.D) TabletFor osteoporosis1/2/20065Atenolol 50mg + HCTZ 25mg (addl. Strength)For hypertension3/2/20066Tamsulosin HCl (MR) 0.4mg + Dutasteride 0.5mg tabletFor BPH6/2/20067Erdosteine Powder for oral suspension 35mg/mlFor chronic obstructive bronchitis6/2/20068Moxifloxacin Eye Ointment (5mg/gm)For ophthalmic use.6/2/20069Dexibuprofen Tablet (200mg/300mg/400mg)For OA, RA & ankylosing spondylitis6/2/200610Pegaptinib Sodium Injection (0.3mg). For neovascular (wet) age related macular degeneration.6/2/200611Ciclesonide Inhaler 80/160mcg per actuationFor persistent Asthma6/2/200612Metoprolol Succinate equiv. to Metoprolol Tartrate 50mg + Amlodipine (as besylate) 5mgFor hypertension7/2/200613Doxofylline Tablet (400mg)For bronchial asthma & COPD.8/2/200614Zanamavir inhalation powder 5mg/blisterFor influenzae 13/02/200615Testosterone Transdermal Spray (12.5mg/spray) (addl. Lower strength)For replacement therapy in males with Testosterone deficiency.15/02/200616Cefetamet Pivoxil Hcl oral suspension 250mg/mlAnti-biotic16/02/200617Voriconazole Powder for oral soluion (40mg/ml)Anti-fungal21/02/200618Desflurane liquid for inhalation (240mg/bottle).For induction & maintenance of anaesthesia.22/02/200619Aceclofenac 200mg (S.R) tabletNSAID22/02/200620Tenofovir Disoproxil Fumarate (300mg) + Emtricitabine (200mg) tabletFor HIV-1 infection23/02/200621Levetiracetam Oral Solution (100mg/ml).Anti-epileptic24/02/200622Atomoxetine 60mg capsule (Addl. Strength)For ADHD27/02/200623Diclofenac Sodium (75/50mg) as (E.C) + Misoprostol 200mcg.For OA & RA28/02/200624Fluorescein Sodium Solution for Injection (100mg/ml)Ophthalmological diagnostic agent2/3/200625Cefditeron (as pivoxil) 200mg tabletAnti-biotic3/3/200626Sodium Hyaluronate Cream 0.2%For leg ulcer, diabetic ulcer etc.16/03/200627Saquinavir (500mg) tablet (addl. Strength)Anti-AIDS20/03/200628Eflornithine HCl Cream (139mg/gm)For reduction of unwanted facial hair in women.22/03/200629Propionyl-L-Carnitine HCl Tablet (500mg) & injection 300mg/vialChronic congestive heart failure22/03/200630Tobramycin Inhalation solution (300mg/5ml)For chronic pulmonary infection cystic fibrosis.22/03/200631Lactulose Enema (20%)For constipation & hepatic encepthalopathy28/03/200632Haloperidol Tablet (0.5mg) (addl. Lower strength)As approved earlier.30/03/200633Cholestyramine Powder for oral suspension (4gm/sachet)For hypercholesterolaemia30/03/200634Doxofylline Syrup (20mg/ml)For bronchial asthma & COPD.30/03/200635Resperidone Tablet & Syrup (addl. Ind)Acute mania & mixed episode in bipolar-I disorder.4/4/200636D-trans Fentantyl Transdermal patchesFor pain5/4/200637Pantoprazole (as Sodium) (E.C) 40mg + Itopride (150mg) S.RFor GERD8/4/200638Oseltamivir formulation (additional indication)For Prophylaxis of influenzae in adult and children >14 years of age24/04/200639Atazanavir (100/150/200mg)Anti-HIV in adults.24/04/200640Nicorandil E.R Tablet (10mg/20mg)Angina Pectoris24/04/200641Amlodipine (as besylate) 5mg + HCTZ 12.5mg TabletFor hypertension24/04/200642Nadifloxacin Gel 1%Acne vulgaris10/5/200643Formoterol Fumarate (6mcg) + Fluticasone Propionate (100/250/500mcg) dry powder inhalerFor Asthma & COPD10/5/200644Midazolam (as maleate) 7.5mg/15mg tablet For insomnia10/5/200645Olmesartan (as Medoxomil) 10mg (addl. Strength)Anti-hypertensive18/05/200646Pregabalin Capsule 25/50/100/200mg (addl. Strength)Same as approved.19/05/200647Oxcarbazepine S.R 450mg/900mg (addl. Strength).Anti-epileptic19/05/200648Ciclesonide rotacaps (200/400mcg)For Asthma19/05/200649Itopride 150mg capsule (S.R)For GERD 22/05/200650Nevibolol (as HCl) 5mg + Amlodipine (as besylate) 5mg/10mgFor hypertension24/05/200651Levocetrizine 5mg + Ambroxol Hydrochloride SR (75mg) tabletFor production cough24/05/200652Ibandronic Acid Tablet (150mg) addl. StrengthSame as approved.25/05/200653Zonisamide capsule 25/50mg (addl. Strength)Same as approved.25/05/200654Perflutren liquid microsphere injectable suspensionFor diagnostic use31/05/200655Cyclosporin Eye drops (0.1%) (addl. Strength)For Ophthalmic use2/6/200656Gatifloxacin (0.3%) + Prednisolone Acetate (1%) eye dropsFor Ophthalmic use2/6/200657Amlodipine (as besylate) 5mg+ Metoprolol Succinate equivalent to Metoprolol Tartrate 50mg.For hypertension5/6/200658Nadifloxacin (1%) + Miconazole Nitrate (2%) + Mometasone Furoate (0.1%) CreamFor dermatoses6/6/200659Bemiparin Sodium Solution for injection(5000/7500/10,000 I.U).For deep vein thrombosis8/6/200660Icodextrin 7.5% peritoneal dialysis solutionFor peritoneal dialysis8/6/200661Lamotrigin 200mg tablet (addl. Strength) dispersible tablet (5mg/50mg/100mg/200mgAnti-epileptic8/6/200662Amoxycillin 1000mg + Clavulanate Potassium 62.5mg E.R tabletAnti-biotic8/6/200663Lopinavir 200mg + Ritonavir 50mg Tablet (addl. Strength)Anti-HIV8/6/200664Olopatadine Ophthalmic solution( 0.1%)For allergic conjunctivitis8/6/200665Ferrous ascorbate (equivalent to 50mg Iron) + Folic acid 1.5mg.For iron deficiency anemia8/6/200666Methyl Prednisolone Aceponate Cream (0.1%)For atopic dermatitis15/06/200667Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet (addl. Strength)As loading dose for prevention of in-stent restenosis in PCI22/06/200668Levofloxacin 0.5% Ear dropsFor otitis media27/06/200669Olmesartan 40mg + HCTZ 25mg tablet (addl. Strength)Anti-hypertensive28/06/200670Buclizine HCl tablet (25mg) & Syrup 6mg/5mlAs appetite stimulant28/06/200671Ceftriaxone (as sodium) 250mg + Tazobactam 31.25 mg for injection (addl. Strength)Anti-biotic5/7/200672Bimatoprost 300mg + Timolol (as maleate) 5mg/ml eye dropsFor reduction of IOP5/7/200673Mebeverine HCl 135mg + Isabgula husk 3.5gm sachet.Irritable bowel syndrome6/7/200674Solifenacin Succinate Tablet (5mg/10mg).For overactive bladder with urge urinary incontinence urgency & urinary frequency6/7/200675Zolpidem Tartrate E.R tablet (6.25mg/12.5mg).For insomnia10/7/200676Deferasirox dispersible tablet 125/250/500mg.For chronic iron overload due to blood transfusion10/7/200677Vitamin C 500mcg + Zinc Citrate 2.2mg + Selenium 60mcg tablet.For vitamin C deficiency12/7/200678Lamivudine 40mg + Stavudine 10mg dispersible tablet.For HIV infection12/7/200679Levocetrizine 2.5/5mg + Ambroxol 30mg/5ml of syrupFor productive cough20/07/200680Cefixime 200mg + Pot. Clavulanate (125mg) tabletAnti-biotic20/07/200681ISMN SR 30mg + Aspirin75/150mg tablet (addl. Strength).Same as approved20/07/200682Clobestasol Propionate (0.05%) + Calcipotriol Ointment (0.005%) Ointment.For plaque psoriasis20/07/200683Sodium Hyaluronate Injection (1%).For OA26/07/200684Forskolin Eye drop (1%).For open angle glaucoma27/07/200685Baclofen E.R capsule (30mg)For spasticity1/8/200686Amisulpiride Tablet (50/100/200mg)For schizophrenic disorder1/8/200687Quetiapine S.R tablet 200/300mg.For psychotic disorder1/8/200688Lumiracoxib Tablet (100/200/400mg).For OA, RA acute pain & primary dysmenorrhoea1/8/200689Tenofovir Disoproxil Fumarate300mg + Emtricitabin 200mg + Efavirenz 600mg tabletFor HIV-1 infection1/8/200690Oxandrolone Tablet (2.5/10mg)To promote weight gain4/8/200691Erdosteine 150mg + Guaiphenesin 50mg + Terbutaline 1.25mg per 5ml syrupMucolytic8/8/200692Rosiglitazone (as maleate)2mg + Glibenclamide 5mg + MetFormin 500mg tabletAnti Diabetic8/8/200693L- Lysine Hcl Ointment (150mg/gm)For wounds of various etiology8/8/200694Levocitirizine 2 Hcl 5mg+ Ambroxol Hcl SR 75mg + Pseudoephedrine Hcl 120mg SR CapsulesFor SAR, PAR & Chronic idiopathic urticatia9/8/200695Alprazolam SR 0.25mg + Sertraline (As Hcl) 25mg/50mg tabletFor Panic disorder with or without agoraphobia9/8/200696Dexibuprofen 200mg/300mg +Paracetamol 500mg tabletFor RA, OA & ankolysing spondylosis10/8/200697ISMN SR 60mg + Metoprolol Succinate ER 25/50mgFor angina & Hypertension10/8/200698Aspirin 75mg / 150mg + Glycine 37.5mg/75mg tabletFor prevention of acute coronary syndrome in patients with CAD prophylaxis against stroke10/8/200699Combipack of 21 tablet of Quinin sulphate 600mg each & 8 capsule of Doxycycline (as Hcl) 100mg each)For P. Falciparam malaria10/8/2006100Pravastatin 40mg tablet (Additional strength)As Approved10/8/2006101Olanzapine powder For oral suspensian (10mg/5ml)For schizophrenia in adults11/8/2006102Cefepem (as Hcl) 0.5/1gm + Amikacin (as sulphate) 0.125/0.250gm Inj.Antibiotic11/8/2006103Lamivudine 20mg + Nevirapine 35mg + Stavudine 5mg tabletAnti HIV11/8/2006104Nadifloxacin (10mg/gm) + Mometasone Furoate (1mg/gm) creamFor mixed infection of skin17/08/06105Premetrexed(Disodium) powder For solution For Inj. 500mg/vialAnti Cancer21/08/06106Gliclazide 40mg/80mg + MetFormin Hcl 500mg + Rosiglitazone 2mg tabletAnt- diabetic22/08/06107Tiropramide Hcl (100mg) tabletFor abdominal spasmodic pain, colics of hepatobilliary track, abdominal colics22/08/06108Eperisone Hcl (50mg ) tabletFor neck-shoulder ormsyndrome scapula hum oral per arthritis and low back pain23/08/06109Caroverine cap. 20mg & Inj. 40mg/2mlFor abdominal pain & tinnitus in adult23/08/06110Paclitaxel nanoparticle Inj. (20mg/ml)For metastatic breast cancer23/08/06111Amoxycillin 250mg + Dicloxacillin 250mg cap.Anti biotic28/08/06112Rifaximine 200mg tab.For infections diarrhea in adults28/08/06113Tigecycline powder For Inj. 50mg/vialFor skin & skin structure infection & intra abdominal infection28/08/06114Stavudine SR 100mg tabletAnti HIV29/08/06115Cefixime (50mg/100mg) + Clavulanic acid 31.125mg/62.5mg per ml dry syrup & tabletAntibiotic29/08/06116Ciclsonide 80mcg/160mcg + Formotorol 4.5mg inhalerAnti asthratic29/08/06117Ciclsonide 100mcg/ 200mcg/400mcg + Formotorol Fumarate 6mg rotacapsAnti asthmatic29/08/06118Abacavir Sulphate syrup 20mg/mlFor HIV Infection29/08/06119S(-) pantoprazole (as sodium) 20mg (E.C.) + Domperidome SR 30mg tabletFOR GERD30/08/06120Cefadroxil 500mg + Clavulanic acid 125mg tabletAntibiotic30/08/06121Cefadroxil 250mg + Clavulanic acid 62.5mg dispersible tabletAntibiotic30/08/06122Cefadroxil 250mg + Clavulanic acid 62.5mg per 5ml syrupAntibiotic30/08/06123Human Insulin (r-DNA) Powder inhalerFor type-I & Type-2 Diabetes30/08/06124Fulvestrant Inj. 250mg/5ml prefilled syringeAnti Cancer30/08/06125S(-) Pantoprazole (as Sodium) Inj. 20mg/vialForpeptic ulcer, GERD & Zollinger Ellison Syndrome30/08/06126Dasatinib tablet 20mg/50mg/70mg tabletFor chronic hepatitis B infection30/08/06127Telbivudine 600mg tabletFor chronic hepatitis B infection30/08/06128Aprepitant cap (80mg/125mg)For chemotherapy induced nausea & vomiting30/08/06129Telmisartan 40mg + Amlodipine (as Besylate) 5mg tabletFor essential hypertension30/08/06130Gemifloxacin (as msylate) 320mg tabletAntibiotic30/08/06131Ceftazidime 500mg /1000mg + Tazobactum (as sodium) 62.5mg/125mg per vial for injectionAntibiotic30/08/06132Cefepime (As Hcl) 500mg/1000mg + Tazobactum (as Sodium) 62.5mg/125mgAntibiotic30/08/06133Paromomycin Inj. 375mg/mlFor visceral leishmaniasis (Kalaazar)30/08/06134Cefixime 100mg + Cloxacillin (as Sodium) 500mg + Lactobacillus (45 million spore)tab.Antibiotic31/08/06135Alprazolam Dispersible Tab. 0.125mg/0.25mg/0.50mgFor anxiety20/09/06136Epinastine Hcl (0.05%) Opthlamic solutionFor allergic conjunctivitis22/09/06137Levofloxacin tablet (250mg /500mg) & Infusion 5mg/ml (For additional indication)For prostatitis26/09/06138Feracrylum 1% mouth gargle 10mg/mlAs hacmostatic agent in dental surgery28/09/06139Aceclofenac Inj. (150mg/ml)For pain in post operative & post traumatic cases28/09/06140combipack of one cap. Of aprepitant .125mg & two cap. Of aprepitant 80mg each (combipack)As Approved10/10/2006141Formoterol fumarate 6mcg + Fluficasone propinate 50mcg/125mcg/250mcg MDIFor Asthma & COPD14/10/06142Amlodipine 25mg + Metoprolol 25mg (additional lower strength)1/11/2006143Estrogen vaginal tablet 25mcgFor atropic viginitis2/11/2006144Esomeprazole 40mg (E.C.) + Itopride 150mg SR CapsulesFor GERD13/11/06145Cefixime 200mg + Cloxacillin 500mg (ER) + Lactobacillus 90 million Spore tab. (additional strength)Antibiotic14/11/06146Cefixime dispersible tablet 400mg (new dosage Form)Antibiotic22/11/06147Trandalopril 1mg/2mg/4mg/2mg + Verapamil (ER) 240mg/240mg/240mg/180mgAnti hypertensive23/11/06148Ciclesonide 160mcg/320mcg cap. for inhalationAnti asthmatic28/11/06149Rabeprazole 20mg (EC) + Itopride SR 150mgFor GERD28/11/06150Metoprolol succinate 25mg /50mg ER + HCTZ 12.5mgAnti hypertensive30/11/06151Atorvastatin 5mg + Fenofibrate 160mg (additional strength)As Approved1/12/2006152Aceclofenac Inj. 50mg/ml (additional strength)As Approved1/12/2006153Amisulpride 400mg tablet (additional strength)As Approved1/12/2006154Misoprostol tablet 25mcg/100mcg/200mcg (additional strength indicationFor cervical ripening, prevention of post partum haemorrhage & First trimester of aboration with mifepristone8/12/2006155Atazanavir 150mg + Ritonavir 50mg capsulesAnti HIV12/12/2006156Mebeverine Hcl 135mg + Chlordiazepoxide 5mg tabletFor IBS12/12/2006157Ampicillin 250mg + Dicloxacillin 250mg tabletAntibiotic13/12/06158Etoricoxib 10mg + Methyl Salicylate 100mg + Mentol 50mg + Linseedoril 30mg per gm. of GelFor acute Musculoskeletal pain14/12/06159Racecadotril dispersible tablet (10mg/30mg) (new dosage Form)For diarrhea15/12/06160Gabapentin ER 450/600/900mg tabletFor naturopathic pain & partial Seizures15/12/06161Aceclofenac dispersible tablet 100mg (new dosage form)As Approved21/12/06 LIST OF APPROVED DRUG FROM 01.01.2007 TO 31.12.2007 S.No.Drug NameIndicationDate of Approval1R-Ondansetron (As Hcl. Dihydrate) (1mg/ml) injectionChemotherapy induced nausea & vomiting12.01.072Torsemide 10mg + Amiloride 5mg tabletsEdema Associated with congestive heart failure & hypertension17.01.073Fexofenadine suspension (30mg/5ml)SeAsonal allergic rhinitis & chronic idiopathic urticaria19.01.074Sildenafil Citrate 20mg TabletFor pulmonary osterial hypertension23.01.075Pioglitazone 15mg/30mg + MetFormin ER 1000mg tablet (additional strength)As approved23.01.076FluvAstatin Tablet (As calcium) 10mg/20mg/40mg (additional strength)As approved29.01.077Halobetazol Propionate Cream (0.05%)Corticosteroid responsive dermatomes02.02.078Eszopiclone tablet (1mg/2mg/3mg)For insomnia07.02.079Diltiazem Hcl. 2% gelFor anal fissure07.02.0710Nalbuphine injection 10mg/20mg per ml.For moderate to severe pain07.02.0711Levonorgestrel 1.5mg tabletsFor emergency contraceptive07.02.0712Pantaprazole sodium 20mg/40mg Tablet (with sodium bicarbonate As buffer)For gAstric ulcer, duodenal ulcer, Z. E Syndrome, GERD07.02.0713levofloxacin (250mg/500mg) + ambroxol SR 75mg tabletFor lower respiratory tract infection in adult08.02.0714Testosterone cypionate (100mg/200mg) + Cotton seed oil 736/566mg per ml injectionFor testosterone deficiency (i) primary hypogonadism (ii) Hypogonadotropine hypogonadism08.02.0715Rosiglitazone 1mg + Metofmin Hcl 500mg tablet (additional strength)As approved08.02.0716Loteprednol Etabonate 5mg + Tobramycine 3mg per ml ophthalmic solutionFor steroid responsive inflammatory ocular condition14.02.0717Amlodipine (As besylate) 5mg + Metoprolol (As succinate) ER 25mg (additional strength)As approved14.02.0718Glibeneclamide 5mg + MetFormin SR 850mg tablet (additional strength)As approved15.02.0719Aceclofenac injection (150mg/3ml)For short term treatment of pain due to post operative and post traumatic cAses19.02.0720Metoprolol (As succinate) 50mg/25mg ER) + Amlodipine 5mg/2.5mg tablet (For additional indication)Angina pectoris in adults20.02.0721Ramipril 10mg + HCTZ 12.5mg tablet (additional strength)As approved20.02.0722Amlodipine (As besylate) 5mg/5mg/10mg + valsartan 80mg/160mg/160mg tabletEssential hypertension21.02.0723Glatiramer Acetate injection (20mg/ml)Multiple sclerosis21.02.0724Baclofen ER (GRS) Capsule 45mg/60mg (additional strength)As approved22.02.0725Amlodipine (As besylate )5mg/10mg + Perindopril 4mg tabletFor hypertension23.02.0726Olopatadine Hcl. Tablet 2.5mg/5mgAllergic nAsal inflammation hives, itching with skin diseAses26.02.0727Metoprolol (As succinate) ER 25mg/50mg + Ramipril 2.5mg/5mgEssential hypertension26.02.0728Rabeprazole Sodium 20mg/10mg with sodium bicarbonate As bufferFor Duodenal ulcer, G.U, Z.E.S. & GERD26.02.0729Ciclesonide 160mcg/320mcg + Formoterol Fumarate (12mcg) (Dry powder inhaler additional strength)As approved27.02.0730Moxonidine tablet 0.2mg/0.3mg/0.4mgFor hypertension27.02.0731Ceftriaxone (As sodium) 125mg/250mg + Sulbactam (As sodium) 62.5mg/125mg For injection (additional strength)As approved01.03.0732Quetiapine (As fumarate) SR 400mg tablet (additional strength)As approved05.03.0733Cabergoline 1mg tablet (additional strength)For Hyperprolactinemia06.03.0734Levofloxacin Oral Solution (each 240ml bottle contains Levofloxacin 125mg/5ml.)Antibiotic (For adult use only)07.03.0735Clindamycin 1% + Isotretinoin 0.05% gelFor acne08.03.0736Estradiol topical emulsion 2.5mg/gmVasomotor symptoms Associated with menopause16.03.0737Levosalbutamol MDI (50mcg/actuation) & Dry Powder inhaler (100mcg/capsule) (New Dosage Form)As approved16.03.0738Polonosetron (As Hcl.) For Injection 0.25mg/5mlChemotherapy induced nausea & Vomiting20.03.0739Cifixime 200mg + Erdosteine 300mg CapsulesAcute Exacerbation of chronic bronchitis21.03.0740Aminophylline CR 225/350mgAsthma, COPD, Bronchitis21.03.0741Etoricoxib 10mg + Methyl salicylate 20mg per gm. of creamAcute Musenlosleteal pain21.03.0742Eberconazole cream (1%)Dermatophyte infection of skin such As T-corporis, T-c, T-Pedis22.03.0743ISMN 60mg Sr + Atenolol 50mg/100mgFor angina pectoris23.03.0744Levonorgestrel 0.03mg tabletFor control of fertility23.03.0745Bortezomib 2mg/vial (additional pack size)As approved28.03.0746Comb kit of two capsule of Azaranari 150mg each + 1 tablet of Ritonavir 100mg)For HIV infection02.04.0747Mecobalamine 500mcg + Alpha Lipoic acid 100mg soft gelatin capsuleFor diabetic neuropathy02.04.0748Propofol 10mg + Lignocaem 1mg per ml injectionFor induction of anesthesia04.04.0749Ezetimibe 10mg + Fenofibrate 160mg tabletFor combined hypertipidemia04.04.0750Methylprednisolone Acrponate topical solution 0.1%Atopic dermatitis (eczema) inflammatory and allergic skin reaction04.04.0751Citicoline (750mg) tablet (additional strength), syrup 500mg/5ml (new dosage Form) (not For children)As approved10.04.0752Ertapenem For injection (1gm/vial)Antibiotic10.04.0753Letrozole 2.5mg tablet (for additional indication)For induction of ovulation in anovulatory infertility ( additional indication)10.04.0754Quetiapine SR Tablets 50mg ( additional strength)As approved10.04.0755Metoprolol (As succinate) 25mg + Amlodipine (As besylate) 5mg (additional strength)As approved10.04.0756Sunitinib Maleate Capsules 12.5mg/25mg/50mgFor G.I. Stromal tumor, advanced renal cell carcinoma10.04.0757Comb pack of 1 bottle of ciprofloxacin Injection (200mg/100ml) & 1 bottle of Ornidazole injection 500mg/100ml)Antibiotic20.04.0758Aprepitant 40mg capsules (additional strength)Prevention of post-operative nausea & vomiting (additional indication)24.04.0759Olopatadime Ophthalmic solution (0.2%) (additional Strength)As approved24.04.0760Combi pack of 1 tablet of Residronate sodium (35mg) + 6 tablet of calcium carbonate equivalent to 500mg calcium eachFor osteoporosis in postmenopausal women01.05.0761Levocetirizem 2Hcl. Dispersible tablet (2.5mg)For allergic rhinitis & chronic urticaria08.05.0762Amlodipine (As besylate) 10mg + Perindopril 8mg tablets (additional strength)As approved07.05.0763Etodolac ER tablets 400mg/500mgFor osteoarthritis & rheumatoid arthritis09.05.0764Levosulpiride tablet (25mg)For G.I. problem like fanatical dyspepsia, nausea, vomiting and diabetic gAstroperisis10.05.0765Rimonabant tablet 20mgFor Obese Patients BMIe" 30kg/m2 or overweight patients BMIe" 27kg/m2 with Associated risk factors such As type-I diabetes or dyslipidemia11.05.0766Lactitol monohydrate Syrup 66.67/100mlFor constipation14.05.0767S(-) Metoprolol (As succinate) 25mg + S(-) Amlodipine (As besylate 2.5/5mgFor essential hypertension16.05.0768Amlexanox Oral PAste (5%)For apthous ulcers in people with normal immune system16.05.0769Lenalidomide capsule (5mg/10mg/15mg/25mg)For transfusion dependent anemia due to myalodysplastic syndrom Associated with deletion 5q cytogenic abnormality16.05.0770Cefotaxim (As sodium) 0.5mg/1gm + Sulbactam (As sodium) 250mg/500mg injection (for additional indication)For surgical prophylaxis (additional indication)18.05.0771Lornoxicam tablet 4mg/ 8mgFor Osteoarthritis rheumatoid arthritis21.05.0772Atenolol 25mg/50mg + Indapamide SR 1.5mgFor essential hypertension21.05.0773Livetiracetam conc. for infusion 100mg/ml (new dosage form)As adjunctive therapy in partial onset seizures in adults with epilepsy when oral administration is temporarily not feasible21.05.0774Eplerstat tablet 50mgFor abnormality of vibration sense and abnormal change in heart rate associated with diabetic peripheral neuropathy25.05.0775Citicoline tablet 200mg (additional strength)As approved25.05.0776Varenicline (As tartrate) 0.5mg/1mg tabletsAs an aid to smoking cessation treatment in adults29.05.0777Azithromycin eye drops 1%Conjunctivitis06.06.0778Ciclesonide Nasal Spray 50mcg/sprayFor seasonal & perennial allergic rhinitis in adults, adolescents aged e" 12 years08.06.0779Ceftazidime 500mg/1000mg + Sulbactam (As Sodium) 250mg/500mg For injectionAntibiotic08.06.0780Isotretinoin 0.05% + Erythromycin 2% gelFor acne08.06.0781Aliskiren Tablet 150mg/300mgFor hypertension08.06.0782Glimepiride 1mg/2mg. + Metformin SR 1000mg tablet (additional strength)As approved08.06.0783Cefditorene pivoxil dispersible tablet (30mg/50mg) (New Dosage form for children)As approved08.06.0784Dexrabeprazole sodium Enteric Coated tablet 5mg/10mgFor Duodenal ulcer, Gastric ulcer & GERD13.06.0785Renolazine Extend ReleAse tablet (500mg)For Chronic Angina14.06.0786Phenytoin sodium ER capsules (300mg) (New dosage form)For control of generalized toni-clonic and treatment & prevention of seizures occurring during or following neurosurgery14.06.0787Alfuzocin Hcl. ER (10mg) + Dutasteride 0.5mg tabletFor BPH in men with enlarged prostate14.06.0788Cefepime injection 500mg/1gm/2gm (For additional indication)For bacterial meningitis in children14.06.0789Tranexamic acid mouthwash (50mg/ml)For prevention of oral hemorrhage in anticoagulant treated patients undergoing oral surgery15.06.0790Deflazocort oral suspension (6mg/5ml) (new Dosage Form)As approved15.06.0791Tolterodine tartrate ER 4mg + Tamsulocin Hcl. ER 0.4mg tabletFor BPH with overactive bladder15.06.0792Omeprazole 20mg/40mg + Sodium Bicarbonate 1100mg capsulesFor duodenal ulcer, gastric ulcer & GERD15.06.0793Dexrabeprazole Sodium E. coated tablet 5mg/10mg.For duodenal ulcer, gastric ulcer and GERD.13-06-2007.94Cefepime Injection (New indication)For bacterial meningitis in children.14-06-2007.95Phenytoin Sodium E.R (300mg)For control of generalised tonic-clonic (grand-mal) and prevention and treatment of seizures occuring during or following neurosurgery.14-6-2007.96Tranexamic acid Mouth Wash (50mg/ml)For prevention of oral hemorrhage in anticoagulant treated patients undergoing oral surgery.15.6.2007.97Deflazacort Oral Suspension (6mg/5ml) (New dosage form)For asthma, rheumatoid arthritis when glucocorticosteriod therapy is warranted.15-06-2007.98Tolterodine Tartrate 4mg (ER) + Tamsulosin HCL 0.4mg Capsule.For BPH with overaction bladder in Adults only.15-06-2007.99Omeprazole (E.coated) 40mg + Sodium Bicarbonate 1100mg capsule.For gastric ulcer, duodenal ulcer and GERD.18-6-2007.100Mebeverine HCl prolonged release capsule (200mg).For irritable bowel syndrome19-06-2007.101Azithromycin 500mg + Ambroxol S.R (75mg) Tablet.For RTI caused by susceptible organisms in adults.05-07-2007.102Pholcodiene Syrup (4mg/5ml).For symptomatic relief of dry ticklish and unproductive coughs in children above 1 years.06-07-2007.103Exenatide Injection -pre-filled pen (250mcg/ml).For adjunctive therapy to improve glycemic control in patients with Type-II diabetes mellitus, who have not achieved adequate glycemic control with Metformin, a sulfonyl urea or a combination of metformin and sulfonylurea.06-07-2007.104Moxifloxacin HCL (0.5%) + Ketorolac Tromethamine 0.5% Ophthalmic Solution.For reduction of post-operative inflammatory conditions of the eyes.11-07-2007.105Levofloxacin (15mg) + Prednisolone Acetate 10mg per ml eye drops.For post-operative steriod responsive inflammatory ocular conditions when ocular bacterial infections or a risk of bacterial infection exists.11-07-2007.106Mecobalamine 500/1500mcg + Alpha Lipoic Acid 100mg + Inositol 100mg + Folic Acid 0.5/1.5mg + Chromium Polynicotinate 65mcg/200mcg+ Selenium Dioxide18/55mcg + Benfotiamine 50/150mg capsuleFor Vitamins and Mineral deficiency states in adult patients39275107Loteprednol Etabonate (0.5%) + Levofloxacin (1.5%) Eye drops.For post-operative steriod responsive inflammatory ocular conditions when ocular bacterial infections or a risk of bacterial infection exists.12-07-2007.108Clotrimazole (10mg) + Methyl-prednisolone aceponate 1mg/gm of cream.For fungal infection of skin associated with inflammation.12-7-2007.109Capecitabin Tablet (150mg/500mg). (for additional indication).(i). First line treatment of advanced gastric cancer in combination with platinum based regimen.(ii). Treatment of patients with locally advanced or metastatic breast cancer in combination with docetaxel following failure of cytotoxic chemotherapy.16-07-2007.110Rifabutin Capsule (150mg).For treatment of pulmonary T.B only in patients co-infected with HIV. (It should never be used as a substitute to Rifampicin in T.B patients without HIV co-infection).16-07-2007.111Lapatinib (as Ditosylate) (250mg) Tablet.In combination with capecitabine it is indicated in patients with advanced or metastatic breast cancer whose tumour overexpress HER2and who have receivedprior therapy including trastuzumab.24-07-2007.112Levocetirizine Di-HCl mouth dissolving tablets (5mg) (new dosage form).For the treatment of allergic rhinitis and chronic urticaria.25-07-2007.113Idaravone Injection (1.5mg/ml).For improvement of neurologic symptoms, disorders of activitis of daily living and functional disorder associated with acute ischemic stroke.26-07-2007.114Diclofenac Sodium (75mg/ml) Injection (addl. Strength).For management of painful conditions in post-operative cases, rheumatoid arthritis and osteoarthritis.30-07-2007.115Cefpodoxime (as Proxetil) (100mg/200mg) + Clavulanic acid (62.5/125mg) tablet.For LRTI, URTI and UTI.30-07-2007.116Atorvastatin (40mg) + Ezetimibe (10mg) Tablet (addl. Strength).As approved.30-07-2007.117Cefepime (250mg) + Tazobactam (31.25mg) Injection (addl. Strength).As approved.30-07-2007.118VSL # 3 (Probiotic Blend) sachetFor rotavirus diarrhoea in children.31-07-2007.119Sorafenib (as Tosylate) (200mg) Tablet.For advanced renal cell carcinoma.31-07-2007.120Methylcobalamin (500mcg) + Alpha Lipoic Acid (100mg) + Pyridoxine (3mg) + Folic acid (1.5mg) Soft Gelatin Capsule.For diabetic neuropathy.31-07-2007.121Halobetasol Propionate (0.5mg) + Salicylic Acid 30mg per gm of ointment.For plaque psoriasis.01-08-2007.122Combipack of 12 tablet of Artesunate (50mg) each + 3 tablet of each containing Sulfadoxine (500mg) + Pyrmethamine (25mg) Tablet. (Addl. Strength)As Approved01-08-2007.123Omeprazole (20mg/40mg)+Sod. Bicarbonate-600mg+ Mg.Hydroxide-700mg .chew tab.For duodenal, gastric ulcer, GERD, and erosive esophagitis,1/8/2007124Deferasirox dispersible tablet (400mg) (addl. Strength).As approved17-08-2007.125Tegafur (100mg) + Uracil (224mg) capsule.For first line treatment of metastatic colorectal cancer in combination with calcium folinate.22-08-2007.126Bortezomib Injection (additional indication)For the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.05-09-2007.127Amlodipine (5mg) + Nebivolol (5mg) tablet (addl. Strength).As approved.06-09-2007.128Ceftazidine (2gm) + Sulbactam (1gm) Injection ( addl. strength for additional indication).For serious abdominal infection.06-09-2007.129Polyethylin Glycol 400 (0.4%) + Propylene Glycol (0.3%).For temprory relief of dryness, irritation burning, stinging, grittiness or foreign body sensation caused due to environmental factors.18-9-2007.130Resperidone E.R. (long-acting) injection (12.5mg/vial) (addl. strength).As approved.25-09-2007.131Levocetirizine Di-HCl syrup (2.5mg/5ml) (for use in children 2 years and above).As approved.26-09-2007.132R-Sibutramine Capsule (2.5mg/5mg)As an adjunctive therapy for the management of obesity including weight loss and maintenance of weight loss in pateints whose BMI is 30Kg/m2or higher.26-09-2007.133Cefuroxime Axetil (250mg) + Clavulanic Acid (125mg) Tablet.For adult patients with infection caused susceptible micro-organisms including S.aureus viz UTI, upper and lower RTI and gonoccoccal urethritis.27-09-2007.134Sulphur Hexafluoride Powder and solvent for dispersion for injection (45mcg/ml).For diagnostic use in echocardiography doppler of macrovasculature an doppler of microvasculature.28-09-2007.135Ondansetron orally disintegrating tablet (4mg/8mg) (additional dosage form)For chemotherapy induced nausea and vomiting28-09-2007.136Cefuroxime Axetil (250mg) + Clavulanic acid (125mg) tablet.For UTI, URTI and LRTI and gonococcal urethritis.05-10-2007.137Cefuroxime-125/250/500mg +Clav.Acid-31.25/62.5/125mgFor adult patients with infection caused by susceptible microbs,including s.aureus.(e.g-UTI,Upper&lower RTI & gonococcal urethrities)5/10/2007138Amiodarone Injection (additional Indication).For cardiopulmonary resuscitation in the event of cardiac arrest related to ventricular fibrilation resistant to external electric shock.05-10-2007.139Risedronate Sodium tablet (35mg) (additional indication)For osteoporosis in men at high risk of fracture.08-10-2007.140Sucralfate (70mg ) + Metronidazole (10mg) + Povidone Iodine (50mg) per gram of Ointment.For infected wounds and ulcers.09-10-2007.141Levetiracetam Tablet (addl. indication)(i) (i) As monotherapy in partial onset seizures with or without secondary generalisation in patients with 16 years of age with newly diagnosed epilepsy. (ii) As adjunctive therapy in myoclonic seizures in adults and adolescents from 12 years of age with Juvenile myoclonic epilepsy. In primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.09-10-2007.142Combipack of two tablet of chloroquine phosphate (250mg) each + 14 tablet of Proguanil HCl (100mg) eachFor drug resistant malaria.10-10-2007.143Paclitaxel (protein bound particle) for injectable suspension (paclitaxel (100mg) + Albumin Human 900mg per 20ml.For breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.11-10-2007.144Olmesartan Medoxomil (20mg) + Amlodipine Besylate (5mg) Tablet.For mild to moderate hypertension.15-10-2007.145Atorvastatin Calcium (10mg ) + Ramipril (2.5mg/5mg) tabletFor treatment of patients with both hypertension and hypercholesterolemia.15-10-2007.146Omeprazole(20mg) + Sodium bicarbonate (1100mg) tablet (addl. strength).As approved.15-10-2007.147Moxifloxacin HCl (5mg) + Prednisolone Acetate (10mg)per ml. (eye drops)For inflammation after ocular surgery and where a risk of bacterial ocular infection exists.16-10-2007.148Methylcobalamine (500mcg) + Alpha Lipoic acid (100mg) + Pyridoxine HCl (1.5mg) + Thiamine (2mg) + Calcium Picolinate (200mg) tablet.For diabetic neuropathy.16-10-2007.149Satranidazole (300mg) + Ofloxacin (200mg) Tablet.For diarrhoea of mixed infection in adults.18-10-2007.150Methylcobalamin 500mcg+beta carotine-10.33mg+alpha lipoic acid 100mg+B6 1.5mg+B1 2mg & Cr.polynicotinate.For adult patients with diabetic neuropathy.18-10-2007.151Calcium Pidolate equivalent to Calcium 500mg + Vit-D3250 IUFor osteoporosis and calcium deficiency state.23-10-2007.152Etizolam Tablet (0.5mg/1mg).For anxiety disorder associated with depression.29-10-2007.153Oxaprozine Tablet (600mg)For relief of signs and symptoms of osteoarthritis, rheumatoid arthritis.30-10-2007.154Prulifloxacin (600mg) Tablet.For acute uncomplicated lower urinary tract infection (simple cystitis), complicated lower UTI, acute exacerbation of chronic bronchitis.30-10-2007.155Cilostazole E.R Tablet (100mg/200mg).For management intermittent claudication.30-10-2007.156Atorvastatin Calcium (10mg) + Fenofibrate (145mg) (addl. strength)As Approved30-10-2007.157Sitagliptin Tablet (25mg/50mg/100mg).As adjunct to diet and exercise to improve glycemic control in patients with type-II diabetes.30-10-2007.158Miglitol (50mg) + Metformin HCl SR (500mg) tablet.For adult with Type-II diabetes mellitus where simple drug therapy, diet and exercise do not result in adequate glycemic control.31-10-2007.159Mupirocin (2%) + Methylprednisolone Aceponate (0.1%) Cream.For atopic dermatitis.31-10-2007.160Methyl cobalamine 500mcg+folic acid1.5mg+B5-5mg,+Zn.sulphate 25mg+Cr.Polynicotinate 200mcg+selenium-65mcg+inositol-1.5mg + alpha lipoic acid 100mg capsuleFor Vitamins and mineral deficiency states.31.10.07161Methylcobalamine 500mcg+folic acid1.5mg+ alpha lipoic acid 300mg +Benfothiamine-50mg. capsuleFor diabetic neuropathy13.11.07162Methyl prednisolone aceponate-1mg + salicylic acid-50mg ointmentFor treatment of psoriasis19.11.07163Propanol 50gm+povidone iodine-1gm in 100ml solutionFor surgical & hygenic hand disinfection.19.11.07164Propanol-18 gm+Ethenol(100%)-45gm in 100ml solution -do-19.11.07165Voglibose disp.tab.0.2mg/0.3mgAs Approved20.11.07166Ceftriaxone 2gm+ Tazobactum 250mg for injectionAs Approved21.11.07167Methylprednisolone aceponate-1mg + Mupirocin-20mg. creamFor the treatment of atopic dermatitis21.11.07168Citicholine(as Sod.)-200mg/500mg/750mg granules per sachet.As Approved26.11.07169Butarphenol tartrate 10mg/ml nasal sprayFor management of pain in patients using opioid analgesics.26.11.07170Deferasirox 100mg dis.tablet(addl. strength)As Approved28.11.07171Methyl cobalamine 500mcg+folic acid1.5mg+B6-3mg,+Zn.sulphate 61.8mg+Ca.Pantothenate 10mg+ Niacinamide-50mg +chrimium-50mcg capsuleFor Vitamins and mineral deficiency patients.29.11.07172Mecobalamin0.5mg+ Pyridoxine 50mg + Benfotiamine100mg capsuleFor the treatment of diabetic Neuropathy29.11.07173Methylcobalamine 500mcg+folic acid 1.5mg+ alpha lipoic acid 100mg +B6-3mg+Thiamine 10mg capsuleFor diabetic neuropathy29.11.07174Doxophylline-400mg+Salbutamol(as sulphate)-2mg/4mg TabletsFor treatment of Bronchial asthma in adults29.11.07175Gatifloxacin (as sequihydrate)-3mg + Flurbiprofen sod.-0.3mg/ml eye drops.For reduction of post-operative inflammatory conditions of eye ,when bacterial infection exists.29.11.07176Sertanidazole-300mg+ Ofloxacin-200mg tabletFor treatment of diarrhoea of mixed infection in adults patients.29.11.07177Zoledronic acid 5mg/100ml solution for infusion (addl. indication).Post-menopausal osteoporosis.6-12-2007.178Olmesartan medoximil-20mg + Ramipril-5mg. tabletFor treatment of essential hypertention.12.6.07179Levosulpiride Tablet (50mg/100mg) (addl. strength for addl. indication).For depression and schizophrenia in adults.12.6.07180Combipack of 12 Artesunate 50mg tablets & 6 Mefloquin-250mg tabletsFor drug resistant P.falciparum malaria infection.12.6.07181Pregabalin-75mg/150mg +Methylcobalamine 500mcg capFor the treatment of adult patients with peripheral neuropathy.12.10.07182Doxycycline-100mg +L.bacillus spores-5 billionFor adult patients prone to intrabdominal bacterial infection & Antibiotic associated diarrhoea12.11.07183Cefprozil 250mg/500mg+Clav. Acid-62.5mg /125mg. tabFor the treatment of adult patients with upper&lower RTI, Skin & Skin structure infection12.11.07184Dextrometharpahan HBr-10mg+Chlorphenaramine maleate-2mg /5ml syrup.For the temporary relief of cough due to throat irritation, sneezing & ruunning nose.12.11.07185Lornoxicam 8mg /2ml inj.For Short-term treatment of mild to moderate pain, when oral administration is inappropriate(i.e after dental surgery)12.11.07186Apomorphine HCL-2mg/3mg Sublingual tablet.For erectile dysfunction in adult men.12.11.07187Escitlopram (as oxalate)10mg + Clonazepam-0.5mg tablet (addl. Strength).For comobid depression and anxiety disorder.12.12.07188Doxophylline injection-10mg /mlFor bronchial asthama & COPD in adult patients, when oral therapy is in approriate.31.12.07 LIST OF APPROVED DRUG FROM 01.01.08 TO 31.12.08 S. No.Drug NameIndicationApproval Date1Me-salicylate 30% + Menthol 10% + camphor 4% CreamFor temporary relief from pain, swelling & inflammation due to musculoskeletal disorder29.11.072Voglibose 0.2mg/0.3mg tablet (Mouth dissolving)For improvement of parantial hyperphemia in diabetis mellitus only. When diet and/or exercise or oral, hypoglyceamic drug or insulin preparation in addition to diet and or exercise do not result in adequate glycemic control.28.12.073Hydroxychloroquine 400mg tablets (Additional Strength)Same as Approved31.01.084ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol tartrate 25mg/50mg tablets (Additional Strength)Same as Approved02.01.085Halobetasol 0.05% + Clotrimazole 1.0% creamFor the treatment of steroid responsive fungal infections including eczema and psoriasis04.01.086Citicholine Syrup 750mg/5mlFor the treatment of disturbance of consciousness resulting from head injuries, brain operation and acute stage of cerebral infarction in adults only04.01.087Levodopa 200mg + Carbidopa 50mg C.R. tabletFor Parkinson's Disease08.01.088Nanocrystalline Silver Gel 0.002%For the treatment of burns and wound infections04.01.089Cinitapride (as hydrogen tartrate) 1mg tabletFor the treatment of gastroesophageal reflux disease and functional inconveniences of the gastrointestinal motility04.01.0810Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg tabletFor the treatment of adult patients with HIV infection07.01.0811Cefixime 200mg/100mg + Lactic acid bacillus 2.5 billion spores tablet & dispersible tabletFor the treatment of Urinary tract infections, respiratory tract infections, biliary tract infections in adult patients prone to antibiotic associated diarrhoea07.01.0812D-Trans Fentanyl Metrix system (12mcg/hr.) (Additional Strength)Same as Approved07.01.0813Ceftazidime 500mg + Tobramycin 60mg per vial (Injection)For the treatment of lower respiratory tract infection caused by pseudomonas aeruginosa08.01.0814Atazanavir 300mg capsules (Additional strength)Same as approved08.01.0815Ertapenem for injection 1gm/vial (additional indication)For the prophylaxis of surgical site infections following elective colorectal surgery15.01.0816Vildagliptin Tablets 50mg/100mgAs an adjunct to diet and exercise to improve glycemic control in patients with type-II diabetes mellitus18.01.0817Atorvastatin 10mg + Aspirin 75/150mg CapsulesFor the treatment of dyslipidemia associated with atherosclerotic arterial disease with risk of myocardial infarction, stroke or peripheral vascular disease18.01.0818Smatriptan (as succinate ) 50mg + Naproxen sodium 550mg tabletsFor the treatment of acute migraine22.01.0819Sodium Valproate 666mg + valproic acid 290mg equivalent as sodium valproate 1000mg C.R. tablet (Additional Strength)Same as Approved24.01.0820Cefepime (as hydrochloride) 2000/1000/500mg + Sulbactam (as sodium) 1000/500/250mg per vial of injectionFor serious CRTI, uncomplicated and complicated UTI, Uncomplicated skin & skin structure, infection acute exacerbation of chronic bronchitis & intraabdominal infection.24.01.0821Paclitaxel Nanoparticle Solution for Injection 20mg/ml (Additional indication)Ovarian cancer, non-small cell lung cancer and AIDS related Kaposis Sarcoma22.01.0822Sorafenib tablets 200mg (Additional Indication)For hepatocellular Carcenoma22.01.0823Zanamavir inhalation powder 5mg/blister (Additional Indication)For prophylaxes and treatment of both influenza A & B in adults and children (greater than or equal to 5 years)22.01.0824Mycophenolate Mofetil Capsule 250mg, 500mg & Oral suspension 200mg/ml (Additional Indication)For the prophylaxis of acute organ rejection in patients receiving allogeneic hepatic transplantation23.01.0825Combikit 4 tablets of Alendronate sodium trihydrate equivalent to Alendronic acid 70mg each + 24 tablets of Calcium carbonate 1250mg (equivalent to 500mg Calcium) + cholecalciferol-250IUFor the treatment of osteoporosis in post-menopausal women23.01.0826Aceclofenac injection 150mg/mlFor short term treatment of pain due to post operative and post traumatic cases23.01.0827Atorvastatin 10mg + Fenofibrate 80mg tablet (Additional Indication)For the treatment of combined hyperlipidemia in patients with normal hepatic and renal functions.25.01.0828Sodium Valproate 499.5mg + Valproic acid 217.5mg equivalent as sodium valproate- 750mg CR tablet (Additional Strength)Same as Approved24.01.0829Diclofenac 50mg + Serratiopeptidase 10mg enteric coated tabletFor the treatment of acute pain in adults24.01.0830Gabapentin 100mg + methylcobalamin 500mcg tablets (Additional Strength)Same as Approved24.01.0831Cefpirome (as sulphate) 500/1000mg/2000mg + Sulbactam (as sodium ) 250mg/500mg/1000mg powder for injectionFor the treatment of infection caused by sensitive organisms viz. lower RTI, complicated UTI, Septicemia, bacteremia24.01.0832Metformin HCl ER 500mg + Fenofibrate 80mg/160mg tabletFor the treatment of Type-II diabetes associated with mixed dyslipidemia25.01.0833Salicylic acid 10mg/20mg (Foaming facewash solution)For the treatment of acne vulgaris28.01.0834Ozagrel Hcl. Tablets 100mg/200mgFor the treatment of bronchial asthma28.01.0835Rivastigmine transdermal patch (each patch of 5m2, 10m2,15m2& 20m2contain Rivastigmine base 9/18/27/36mg respectivelyFor the treatment of patients with mild to moderately severe dementia of the Alzheimer type and dementia associated with Parkinsons disease28.01.0836Daptomycin powder for concentrate for solution for infusion (350mg/500mg per vial)For the treatment of complicated skin and skin structure infections and for staphylococus aureus bloodstream infections (bacteremia)28.01.0837Dextromethorphan Orodispersible strip 5.5mg/11mgFor the relief of persistent dry irritating cough in adult patients only28.01.0838Diclofenac sodium 50mg + Dicyclomine HCl 20mg per ml of injectionFor the treatment of acute colicky pain in adults28.01.0839Travoprost 40mcg + Timolol (as Maleate) 5mg per ml of eye dropsFor decrease of intraocular pressure in patients with open angle glaucoma or ocular hypertension, who are insufficiently responsive to topical beta blockers or prostaglandin analogues28.01.0840Amoxicillin 250mg/125mg + Cloxacillin 250mg/125mg + Lactic Acid Bacillus 1.7 Billion sporesFor RTI, SRS of tissue infection, bons & joint infection, ENT infection in adults prone to antibiotic associated diarrhoea30.01.0841Amoxicillin 250mg + Lacto- Bacillus 1.7 billion SporesFor RTI, SRS of tissue infection, bons & joint infection, ENT infection in adults prone to antibiotic associated diarrhoea31.01.0842Mecobalamin1500mcg +Alpha Lipoic Acid100mg+Benfothiamine15mg+B63mg+Calcium Pantothenate25mg+Folic Acid 1.5mg+Zinc oxide22.5mg+Chromium picolinate65mcg+Inositol10mcg+Lutein5mg capsuleFor Vitamins and Minerals deficiency states in adult patients30.01.0843Methylcobalamine 750mcg + Alphalipoic acid 100mg + Benfothiamine 7.5mg + B6 1.5mg + Calcium pantothenate25mg + Nicotinamide 50mg + Folic acid0.75mg capsuleFor Vitamins and Minerals deficiency states in adult patients30.01.0844Mecobalamin500mcg + Alpha Lipoic Acid200mg + Benfotiamin 10mg + Pyridoxine3mg + Biotin5mg + Folic acid 1.5mg capsuleFor Vitamins deficiency states in adult patients30.01.0845Amoxycillin 250mg + Cloxacillin 250mg + Lactobacillus 2 billion spores capsulesFor the treatment of lower RTI, skin & soft tissue bone & joint infections, ENT infections in adult patients prone to antibiotic associated diarrhoea30.01.0846Tiotropium (as Tiotropium Bromide Monohydrate) 18mcg + Formoterol Fumarate Dihydro. 12mcg + Ciclesomide 400mcg per capsulesAs 3rd line treatment of sever cases of COPD when monotherapy and second line therapy with two drugs do not respond adequately31.01.0847Metoprolol Succinate Equivalent to Metoprolol Tartrate [ER 25/50mg] + Atorvastatin (As calcium ) 10mg tabletsFor the treatment of patient with both essential hypertension and hypercholesterolemia28.01.0848Levocetrizine Di HCl Dispersible tablet 5mg/10mg (New Dosage form)For allergic rhinitis & chronic urticaria28.01.0849Oseltamivir 30mg & 45mg Capsules (Additional Strength)Same as Approved28.01.0850Fondaparinax Sodium injection (Additional Indication)Treatment of acute coronary syndrome (ACS) with and without ST-segment elevation28.01.0851Camostat Mesylate tablets 100mgFor remission of acute symptoms of chronic pancreatitis and post-operative reflux esophagitis29.01.0852Hyaluronic Acid Salt 25mg + Cross-Linked Hyaluronic acid 25mg per ml in prefilledsyringeFor intradermal implantation and facial soft tissue agumentation30.01.0853Ursodeoxycholic acid tablets 600mgFor the treatment of patients with chronic cholestatic liver disease30.01.0854Dalteparin Sodium Injection(Additional Indication)For the extended treatment of symptomatic venous thromboembolism (VTE) proximal deep thrombosis (DVT) and/or pulmonary embolism (PE), to reduce the recurrence of VTE in patients with cancer30.01.0855Beclomethasone Dipropionate 0.25mg + Econazole 10mg + Neomycin 5mg per gm of CreamFor the topical treatment of bacterial and fungal infections30.01.0856Exenatide injection (Each 2ml vial contains- Exenatide 5mcg/10mcg per 0.2ml ) (Additional Strength)For adjunctive therapy to improve glycemic control in patients with type-II diabetes mellitus, who have not achieved adequate glycemic control with metformin, a sulfonylurea or a combination of metformin and a sulfonylureas30.01.0857Diclofenac Sodium 50mg + Paracetamol 500mg tabletsFor the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis30.01.0858Gabapentin SR 600mg tabletsAs adjunctive therapy in the treatment of partial seizures of epilepsy30.01.0859Memantine 5mg /10mg + Donepezil 5mg TabletsFor moderate to severe Alzheimer's disease31.01.0860Doxifluridine Capsules 100mg/200mgFor carcinoma of the stomach, colon, rectum, breast, uterine, cervix and bladder31.01.0861Haemodialysis Powder/Liquid Form containing citrateFor use for patients being treated by hemodialysis31.01.0862Carmustine (polifeprosan 20 with carmustine Implant (Wafer)1:- In newly diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation. 2:- In recurrent glioblastoma multiforme patients as an adjunct to surgery31.01.0863Cimetropium Bromide tablet 50mgFor the treatment of irritable bowel syndrome31.01.0864CyclobenzaprineHcl. Tablets 5mg/10mgAs adjunct to rest and physical therapy for relief of muscle spasm associated with acute painful musculoskeletal conditions31.01.0865Sertaconazole Nitrate Cream 2%,For the topical treatment of the superficial mycosis like dermatophytosis31.01.0866Cefpodoxime 50mg + Clavulanic acid 31.25mg dispersible tablet & dry syrup (Additional strength)Same as Approved31.01.0867Darifenacin (as hydrobromide) 7.5mg/15mg ER tabletsFor the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency31.01.0868Amoxycillin 125mg/250mg/500mg + Lactobacillus 1.66 billion Spores (Capsules)For the treatment of respiratory tract infection, skin and soft tissue infections & antibiotics associated diarrhoea in adult patients31.01.0869Halobetasol 0.5mg + Miconazole 20mg per gram CreamFor steroid responsive dermatoses associated with superficial fungal infection of skin31.01.0870Montelucast 10mg + Levocetirizine 5mg film coated tabletsFor the treatment of allergic rhinitis in adults only31.01.0871Hydroquinone 2% + Tretinoin 0.025% (w/w) Momentasone 0.10% GelFor short term intermittent treatment of moderate to severe melasma of the face in the presence of measures for sun avoidance including use of sun screen31.01.0872Phenylephrine 5mg + Chlorpheniramine maleate 0.5mg + Paracetamol 125mg + sodium citrate 60mg + Menthol 1mg (per 5ml) SyrupFor the treatment of common cold and cough associated with fever31.01.0873Diclofenac Sodium 100mg (SR Pellets) + Rabeprazole Sodium 20mg (E.C Pellets) CapsulesFor treatment of painful inflammatory conditions associated with gastroduodenal ulcers31.01.0874Ciclesonide 160mcg/320mcg/Formoterol 12mcg + Tiotropium 18mcg Dry powder inhalerAs third line treatment of severe cases of COPD, when monotherapy and second line therapy with two drugs do not respond adequately31.01.0875VSL # (Combination of lactic acid bacteria (VSL # 3)For the treatment of irritable bowel syndrome31.01.0876Clostimethate Sodium of 1,00,000IU InjectionFor the treatment of serious infection caused Gram-Ve bacteria including LRTI, UTI, where commonly used anti bacterial agent may be infective because of bacterial resistance31.01.0877Ramipril 5mg + HCTZ 12.5mg tablets (Additional Strength)Same as Approved20.02.0878Metronidazole CR tablet 600mgFor the treatment of amoebiasis, urogenital trichomoniasis & giardiasis21.02.0879Quetiapine fumarate SR tabletsfor the additional indication "acute manic episode associated with bipolar disorder21.02.0880Atorvastatin Calcium 80mg tablets (Additional Strength)additional Strength (it should not be used routinely because of increased risk of adverse events. It should be reserved for patients who are considered to be at higher risk after careful risk assessment25.02.0881Euphorbia Prostrata Dry Extract (ethanolic 80% (v/v) (35-70) :100mg tabletFor the treatment of haemorrhoid29.02.0882Amtolmetin Guacil tablets 600mgFor the treatment of osteoarthritis & rheumatoid arthritis07.03.0883Brimonidine Tartrate Opthalmic solution 0.1% (with purite as preservation 0.0005%) (additional strength)For lowering of IOP in patients with open angle glaucoma occular hypertension07.03.0884Methoxsalen USP-20mg Tablet1:- For repigmentation of idiopathic vitiligo alongwith phototherapy. 2:- For symptomatic control of severe, recalcitrant, disabling psoriasis in conjunction with phototherapy07.03.0885Cefditoren pivoxil 400mg tablets (Additional Strength)Same as Approved11.03.0886Doxofylline ER tablets 400mg/800mg (addl. Strength)For the treatment of bronchial asthma & COPD in adults12.03.0887Betamethasone 0.05% +Miconazole 2% CreamFor the treatment of steroid responsive dermatoses associated with superficial fungal infections of the skin12.03.0888Premetrxed disodium injection 100mg/vial (Additional Strength)Same as Approved12.03.0889Omeprazole 20mg/40mg + Sodium bicarbonate 1680mg per sachet powder for oral suspensionFor gastric ulcer, duodenal ulcer, and GERD12.03.0890Mecobalamin 1000mcg+ Alpha Lipoic Acid 200mg+ vitamin B6 3mg + Folic Acid 1.5mg+ Inositol 100mg + Benfotiamine 100mg capsuleFor the treatment of diabetic neuropathy19.03.0891ISMN 30mg SR + Atenolol 50mg tablets (Additional Strength)Same as Approved19.03.0892Temozolamide capsules 140mg/180mg (Addl. Strength)Same as Approved31.03.0893Amisulpiride 300mg tablets (Additional Strength)Same as Approved20.03.0894Nifedipine SR Tablets 10mg/20mgFor the treatment of essential hypertension24.03.0895Ambroxol HCl. 15mg + Guiphenesin 50mg + Terbutalin sulphate 1.25mg + Menthol 2.5mg per 5 ml of syrupFor symptomatic relief of bronchospasm in bronchial asthma and chronic bronchitis26.03.0896Ambroxol HCl 30mg + Guaiphenesin 100mg + Terbutaline sulphate 2.5mg per 10ml SyrupFor the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis26.03.0897Boswellia Serrata 0.05gm/gm of CreamFor the treatment of mild to moderate psoriasis28.03.0898Etoricoxib injection 90mg/mlFor short term use in acute painful condition in adults only28.03.0899Drospirenone 3mg + Ethinyl estradiol 0.02mg tablets (Additional Strength)Oral contraceptive in women28.03.08100Nimesulide 100mg ER + Levocetirizine HCl 5mg TabletsFor symptomatic treatment of acute rhinosinusitis28.03.08101Dexketoprofen (as Trometamol ) tablets 12.5mg/25mgFor the treatment of mild to moderate pain, such as dental pain, dysmenorrhoea & musculoskeletal pain28.03.08102Nepafenac Opthalmic suspension (1mg/ml)For the treatment of pain and inflammation associated with cataract surgery31.03.08103Hylan GF 20 Injection (Synvisc) (Additional Indication)For pain management in patients suffering with osteoarthritis of the knee, hip, shoulder and ankle31.03.08104Docetaxel injection conc.For additional indication "advanced gastric adenocarcinoma, locally advanced squamous cell carcinoma of head & neck, Harmone refraetory metastatic prostrate cancer, locally advanced or metastatic breast cancer31.03.08105Methylcobalamin 1000mcg + Pyridoxine Hcl IP 100mg + Nicotinamide IP 100mg + D-Panthenol IP 50mg per 2 ml of injectionFor peripheral neuropathy31.03.08106Lamivudine 20mg + Stavudine 5mg dispersible tablets (Additional Sgtrength)Same as Approved01.04.08107Nicardipine Hcl. Injection 2.5mg/mlFor short-term treatment of hypertension when oral therapy is not feasible or not desirable07.04.08108Diclofenac Potassium 50mg + Serratiopeptidase (as enteric coated pellets) 15mg capsules (Additional Strength)For the treatment of acute pain in adults08.04.08109Diacerin 50mg + Aceclofenac 100mg tabletsFor the treatment of adult patients with osteoarthritis of knee and or hip joints11.04.08110Rabeprazole sodium Enteric coated pellets 15.4% w/w (20mg/129.83mg)Same as Approved16.04.08111Live freeze-dried lactic acid bacteria and bifidobacteria capsulesFor the treatment of irritable bowel syndrome10.04.08112Miltefosin Capsule 10mg/50mg (Additional Indication)Treatment of cutaneous leishmaniasis16.04.08113Silver Wound DressingAs an antimicrobial barrier for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic)16.04.08114Diacerin 50mg + Glucosamine sulphate 500mg tablets.For the treatment of adult patients with osteoarthritis of knee and hip joints21.04.08115Clostridium Botulinum type-A toxin haemagglutinin complex (Additional Indication)For focal spasticity, including the treatment of arm symptoms associated with focal spasticity in conjunction with physiotherapy22.04.08116Fluconazole Dispersible tablets 50mgFor the treatment of systemic candidiasis, mucosal candidiasis, prevention of fungal infections in patients with malignancy22.04.08117Lenalidomide Capsule 5mg/10mg/15mg/25mg (Additional Indication)In combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy22.04.08118Sitagliptin ( As Phosphate) 50mg + Metformin Hcl. 500mg/1000mg Film coated tabletsAs an adjunct to diet & exercise to improve glycemic control in patients with type-two diabetes mellitus28.04.08119Lansoprazole for injection 30mg/vialFor short term treatment of errosive esophagitis when patients are unable to take the oral formulation28.04.08120Naproxen Suspension 125mg/5mlFor the treatment of RA in children 5 years of age and above28.04.08121Sevelamer Carbonate 400mg/800mg tablets & sachet 400mg/800mgFor control of serum phosphorus in patients with chronic kidney disease on dialysis28.04.08122Rabeprazole Sodium (With Sodium bicarbonate as buffer) 10mg/20mg tabletsFor the treatment of gastric ulcer, duodenal ulcer, Zollinger Ellison Syndrome and GERD28.04.08123Pantoprazole Sodium (With Sodium bicarbonate as buffer) 20mg/40mg tabletsFor the treatment of gastric ulcer, duodenal ulcer, Zollinger Ellison Syndrome and GERD28.04.08124Cefdinir 250mg dispersible tablets & oral suspension 250mg/5mlFor the treatment of community acquired pneumonia, acute exacerabation of chronic bronchitis, uncomplicated skin and skin structure infection, Pharyngitis/tonsillitis29.04.08125Pregabalin capsules (Addl. Indication)management of fibromyalgia syndrome29.04.08126Pregabalin 75mg/150mg + Methylcobalamin 750mcg capsules (Additional Strength)Same as Approved08.05.08127Aliskiren 150/150/300/300mg + HCTZ 12.5/25/12.5/25mg tabletsFor the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled on monotherapy .08.05.08128Desmoprission lyophilisate Oral tablets 60mcg/120mcg/240mcg per tabletsFor diabetes insipidus and noctural emuresis08.05.08129Losartan Potassium 25mcg + Amlodipine (as besylate) 5mg tablets. (Additional Strength)Same as Approved14.05.08130Lecithin Liquid (each 5 ml contains lecithin 500mg equivalent to essential phospholipids 250mgFor alcoholic liver disease, drug induced hepatitis14.05.08131Halobetasol 0.05% + Salicylic acid 6% Ointment (additional Strength)For the treatment of plaque psoriasis14.05.08132Benzoyl Peroxide Medicated Solution (each textured pad contains 4.5%/6.5%/8.5% of solutionFor the topical treatment of acne vulgaris14.05.08133Deflazocort 24mg tablets (Additional strength)Same as Approved14.05.08134Sodium Chondroitin sulfate 40mg + sodium Hyaluronate 30mg per ml Intraocular Injection (additional strength)For use as a surgical aid in anterior segments procedure including catract extraction & intra-ocular lens implantation14.05.08135Esomeprazole (with Sodium bicarbonate as buffer) 20mg/40mg tabletsFor the treatment of GERD, gastric and duodenal ulcer, Zollinger-Ellison syndrome14.05.08136Telmisartan 40 mg + Atorvastatin (as calcium) 10 mg TabletsFor coexisting essential hypertension & hyperlipidemia22.05.08137Milnacipran Hcl. 25mg/50mg equivalent to Milnacipran free base 21.77 or 43.55 mg. tablet.For the treatment of adult patients with major depressive disorder22.05.08138Metolazone 2.5mg + Losartan Potassium 25mg/50mg tabletsFor hypertension in patients whose blood pressure is not adequately controlled in monotherapy28.05.08139Metolazone 2.5mg + Ramipril 2.5mg/5mgFor essential hypertension in adult patients whose blood pressure is not adequately controlled on monotherapy28.05.08140Doxercalciferol 0.5mcg/2.5mcg Soft Gelatin capsulesFor the treatment of secondary hyperthyroidism in patients with chronic kidney disease on dialysis29.05.08141Acebrophylline capsules 100mgFor the treatment of adult patients with chronic obstructive pulmonary disease and bronchial asthma29.05.08142Sofalcone Capsule (100mg/50mg)For the treatment of gastric ulcer and management of gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis or acute exacerbation of chronic gastritis02.06.08143S(+) Etodolac ER tablets 200mg/300mgFor the relief of pain and inflammation in patients with rheumatoid arthritis and osteoarthritis02.06.08144Diclofenac Sodium 50mg + Codeine Phosphate 50mg tabletsFor the treatment of adult patients with signs & symptoms of acute painful conditions02.06.08145Sodium Hyaluronate injectable gel (each 0.6ml. 1ml pre filled syringe contains, sodium Hyaluronate 20mg/ml, 22.5mg/mlFor intradermal implantation and facial soft tissue augmentation03.06.08146Amphotericin B Lipid suspension injection (25mg/vial) with lipid suspensionFor invasive fungal infection in patients who are refractory to or intolerant of conventional amphotericin B therapy03.06.08147Dexrabeprazole 10mg (EC) + Domperidone 30mg SR CapsulesFor the treatment of Gastroeasophageal Reflux Disease (GERD) in patients not responding to dexrabeprazole alone09.06.08148Thiocolchicoside 4mg/8mg + Ketoprofen 50mg/100mg tabletsFor acute low back pain & other musculoskeletal painful and inflammatory condition in adults11.06.08149Cefotaxime sodium + Sulbactam sodium for injection (Additional Indication)For the treatment of lower respiratory tract infection in children24.06.08150Artemether 40mg/80mg + Lumefantrine 240mg/480mg tablets (additional Strength)Same as Approved24.06.08151Mecobalamin 0.5mg+ Alpha Lipoic Acid 100mg+ Benfotiamin100mg + Pyridoxine 50mg tabletsFor the treatment of diabetic Neuropathy03.07.08152Ivabradine (Hcl.) 5mg/7.5mg TabletsFor the treatment of chronic stable anginapectoris in patients with normal sinus rhythm who have a contraindication or intolerance for Beta-blockers03.07.08153Methylcobalamin 1500mcg + Alpha Lipoic Acid 200mg + Benfotiamine 50mg + Vit B6 3mg + Biotin 5mg + Folic Acid 1.5mg capsuleFor the treatment of diabetic Neuropathy04.07.08154Amino Acid, Glucose Parentral Solution (Solution for intravenous infusion)Indicated to meet daily requirement of nitrogen (amino acids), energy (glucose) for patients needing parentral Nutrition08.07.08155Temoporfin 1mg/ml Injection (Additional Strength)Same as Approved08.07.08156Pazufloxacin Mesylate i.v. infusion 300mg/100ml & 500mg/100mlFor the treatment of RTI, UTI and abdominal infections in adults09.07.08157Metoprolol ER + Amlodipine tablets (Additional Indication)For coronary artery disease/ischaemic lheartt disease16.07.08158Fenofovir Disoproxil fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg tablets18.07.08159Vildagliptin 50mg/50mg/50mg + Metformin Hcl 500mg +850mg +1000mg tabletsFor the treatment of type_II diabetes mellitus when single drug therapy alongwith diet, exercise do not result in adequate glycemic control21.07.08160Testosterone Undecanoate 250mg/ml InjectionFor Testosterone replacement therapy of male hypogonadism when testosterone dificiency has been confirmed by clinical feature or biochemical tests22.07.08161Abatacept powder for injection 250mg/vialFor adult patients with severe active rheumatoid arthritis who had an inadequate response to one more DMARDs such as methotixate or TNF antagonists22.07.08162Actarit 100mg TabletsFor the treatment of rheumatoid arthritis patients22.07.08163Tenofovir Fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg TabletsFor the treatment of HIV infection in adults23.07.08164Bacillus Clausii Spores (2 Billion) Capsules (additional dosage form)Same as Approved23.07.08165Gatifloxacin 0.3% + Ketorolac Tramthamine 0.4% eye DropFor reduction of part operative inflammatory condition of eyes24.07.08166Ketorolac Tromethamine 4mg + Gatifloxacin 3mg Eye DropsFor the reduction of post operative inflammatory conditions of the eye24.07.08167Cefadroxyl (as monohydrate) 125mg + Clavulanic acid (as potassium) 31.25 per 5ml Syrup (Additional strength)Same as Approved25.07.08168Doxercalciferol (0.5/ 2.5mcg) Soft Gelatin Capsule (Additional Indication)For the treatment of secondary hyperparathyroidism in patients with stage 3 or stage 4 chronic kidney disease05.08.08169Artemether + Lumefantrine Dispersible tablet (40/80mg + 240/480mg ) (Additional Strength)Same as approved05.08.08170Ceftazidime + Tobramycin injection (1gm + 120mg) (Additional Strength)Same as approved05.08.08171Olopatadine Nasal Spray (0.6%)For the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older05.08.08172Loxoprofen Sodium tablet (60mg)For the symptomatic treatment of pain and inflammation condition in patients with osteoarthritis14.08.08173Dexibuprofen Suspension 50mg/5mlFor the treatment of mild to moderate pain, reduction of fever14.08.08174Bromfenac Sodium Eye Drop (0.09%)For the treatment of postoperative inflammation & reduction of postoperative ocular pain in patients who have undergone cataract extraction14.08.08175Ceftriaxone + Sulbactam injection (Additional Indication)for the treatment of acute bacterial otitis media, skin & soft structure infections, UTI, uncomplicated gonorrhoea, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, intra abdominal infections, meningitis, surgical prophylaxis18.08.08176Citicoline Chewable tablet (500mg)For the treatment of disturbance of consciousness as resulting from head injuries , brain operation and acute stage of cerebral infraction in adult only18.08.08177Ambroxol + loratadine + Guaifenesin Syrup (30mg + 5mg + 50mg per 5ml)For the treatment of productive cough18.08.08178Ferrous Ascorbate + Folic Acid + Zinc FC Tablets (100mg + 1.5 mg + 22.5 mg)For the treatment of iron deficiency anaemia18.08.08179Cyclobenzaprine 7.5mg tablets (Additional Strength)Same as approved18.08.08180S-Metoprolol Succinate Oral Solution (Each Ml contains: S-Metoprolol Succinate 9.5mg equal to S-Metoprolol Tartrate 10mg)For the treatment of haemo-dynamically stably patients with definite or suspected acute Myocardial Infarction to reduce cardio-vascular mortality.19.08.08181Doxorubicin HCl Pegylated Liposomal Injection (20/50MG) (Additional Indication)In combination with bortezumab for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant23.08.08182Povidone Iodine Sachet (containing Effervescent Granules) Each 2gm Sachet contains: 175mg (available iodine 17.5mg)As mouthwash for oral hygeine in various oropharyngeal conditions, surgery, dental infections, and halitosis25.08.08183Sodium Chondroitin Sulphate + Sodium Hyaluronate injection (40mg + not more than 17mg per ml)Same as approved25.08.08184Metolazone + Spironolactone FC Tablets (2.5/5mg + 50mg)For the treatment of oedema associated with congestive heart failure, cirrhosis and nephritic syndrome25.08.08185Tretinoin Microsphere Gel (0.1% W/V)For topical treatment of acne vulgaris26.08.08186Misoprostol 50Mcg tablet (Additional Strength)Same as approved26.08.08187Ferrous Ascorbate + Folic Acid Suspension (Equiv. to elemental iron 30mg + 550mcg per 5ml) (New Dosage Form)Same as approved27.08.08188Guaiphenesin ER Tablet (600mg)For the treatment of productive cough accompanied by phlegm28.08.08189Clopidogrel 300mg Tablet (addl. Strength)As approved02.09.08190Capecitabine 150/500mg Tablets (addl. Indication)For the treatment of patients with metastatic colorectal cancer02.09.08191Lopinavir + Ritonavir (100 + 25mg) Tablets (additional strength)For the treatment of patients with HIV infection08.09.08192Ixabepilone lyophilized powder inj. 15mg/45mg per vialin combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated.13.09.08193Halometasone (as monohydrate ) 0.05% CreamFor the relief of inflammatory and pruritic manifestation of non-infected corticosteroid responsive dermatoses like eczema13.09.08194Calcium and Magnesium 24% (Veterinary) injectable solution.For the treatment of milk fever, hypocalcaemia tetanies and disorders of calcium metabolism in dairy cattle.13.09.08195Telmisartan + Ramipril (40mg + 2.5mg ) Tablets (Additional Strength)for the treatment of essential hypertension15.09.08196Drotaverine + Aceclofenac (80mg + 100mg) TabletsFor the treatment of adult patients with muscular pain associated with spasm15.09.08197Losartan + Chlorthalidone (25/25/50/50mg + 6.25/12.5/6.25/12.5mg) TabletsFor the treatment of mild to moderate hypertension in adult patients whose blood pressure is not adequately controlled by monotherapy15.09.08198Olmesartan + Ramipril (40mg + 5mg) tablets (Additional Strength)for the treatment of essential hypertension15.09.08199Fluconazole + Zinc Pyrethrone (Each 30/60ml bottle contains: 2% + 1%) LotionFor the treatment of seborrhoeic dermatitis15.09.08200Citicoline CR Tab 1000mgFor the treatment of patients with serious cerebral injuries of vascular traumatic nature with or without loss of consciousness & for treatment of degenerative damages & chronic cerebral vascular injuries in senile dementia.16.09.08201Montelukast Suspension 5mg/5ml1. For the treatment of Prophylaxis & chronic treatment of Asthma in Pediatrics patients 12 months of age & older. 2. For relieving symptoms of seasonal allergic rhinitis in Pediatric patients 2 years of age & older & perennial allergic rhinitis in Pediatric Patients 6 months of age & older.16.09.08202Etoricoxib roll on Topical Solution 1% v/vFor the treatment of pain, swelling & inflammatory conditions due to arthritis.16.09.08203Risedronate Sodium 150mg Tablet (Additional Strength)As already approved16.09.08204Levosulpiride Inj. 25mg/ml, 2mlFor the treatment of depression and schizophrenia in adults when oral therapy is not possible26.09.08205Paliperidone ER Tablet 3mg / 6mg / 9mgFor the acute and maintenance treatment of schizophrenia26.09.08206Ceftiofur Crystalline free acid Suspension equi to Ceftiofur ---- 200 mg(veterinary)For treatment of bovine respiratory disease (BRD, Shipping fever, pneumonia) associated with Mannhenia haemolytica, Pasteurella multocida, andHistophilus somni in beef, non-lactating dairy, and lactating dairy cattle26.09.08207Ceftiofur HCl Suspension(as HCl salt) ----500mg (veterinary)For treatment of sub clinical mastitis in dairy cattle at the time of dry off asssociated with staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis.26.09.08208Ceftiofur HCl Suspension (as HCl salt) ----125mg (veterinary)For treatment of clinical mastitis in lactating dairy cattle asssociated with coagulase- negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli.26.09.08209Nitrofurantoin SR Tab. 100mgFor the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus26.09.08210Tolperisone HCl Tablet 50 / 100 / 150mgFor the relief of painful muscle spasms of the skeletal musculature26.09.08211Etoricoxib + PCM (60mg + 500mg) TabletsFor the short term use in acute painful and inflammatory condition30.09.08212Citicoline Oral DropsFor the treatment of disturbance of consciousness resulting from head injuries, brain operation & acute stage of cerebral infraction in adult.30.09.08213Paracetamol + Meloxicam + Benzyl Alcohol + Lignocaine (5mg/ml + 150mg/ml + 1% + 1% ) InjectionIndicated for the treatment of mastitis, metritis, pneumonia, pleuritis, fever and relieving of acute pain in musculoskeletal disorders in animals30.09.08214Calcium (as Calcium Citrate Malate) + Colecalciferol (as Colecalciferol Concentrate) + Folic Acid (250mg + 100IU + 50mcg) TabletsFor the treatment of calcium and Vitamin D deficiency states (pregnancy, lactation, growing Children)30.09.08215Artemether + Lumefantrine (80mg + 480mg/5ml) Dry syrupfor the treatment of chloroquine resistant/multidrug resitant on complicated malaria30.09.08216Cabergoline 1mg Tablets (Additional indication)For the treatment of hyperprolactinemia and inhibition of lactation.01.10.08217Pemetrexed disodium500mg / 100mg powder for sol. (Addl.indication )In combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology08.10.08218Tylvalosin tartrate oral soluble granules Sachet 62.5% w/w (Veterinary)For the prevention and treatment of mycoplasma induced chronic respiratory disease in broilers and breeders, the prevention and treatment of diseases due to clostridium perfringens (necrotic enteritis, wet litter, cholangiohepatitis), the prevention and treatment of ornithobacterium rhinotacheale (ORT)08.10.08219Bortezomib inj.3.5mg/vial (Additional Indication)Treatment of patients with multiple myeloma09.10.08220Sertaconazole Nitrate Vaginal Tab.500mgFor the treatment of vulvo-vaginal candidiasis in women09.10.08221Fosfomycin Tromethamine Sachet 3gmsFor the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of E.Coli and Entreococcus faecalis09.10.08222Ixabepilone lyophilized powder (additional Indication)As monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to cytotoxic chemotherapy. Previous therapy should have included as anthracycline, a taxane, and capecitabine09.10.08223Eprosartan Mesylate 400 mg / 600mg TabletsFor the treatment of essential hypertension11.10.08224Tretinoine Gel as Micro Sphere 0.04% % 0.1%For topical treatment of Acne vulgaris.14.10.08225Hydroxychloroquine Sulphate (Additional indication )For the treatment of systemic lupus erythematosus17.10.08226Budesonide + Formoterol (80/160mcg + 4.5mcg) Inhalational Powder (Additional Indication)Indicated in the regular treatment of patients with moderate to severe COPD with frequent symptoms and a history of exacerbations17.10.08227Azithromycin + Dexamethasone (10mg + 1mg) Eye DropsFor post operative steroid responsive inflammatory ocular condition when bacterial ocular infections or a risk of bacterial ocular infections exists.21.10.08228Diclofenac + Thiocolchicoside (50mg (EC) + 8mg) CapsulesFor the treatment of acute inflammation conditions associated with spasm in adults only21.10.08229Adapalene 0.1% + Benzoyl Peroxide 2.5% gelFor the treatment of acne vulgaris24.10.08230Aceclofenac Roll - On 1%For the treatment of acute musculoskeletal pain in patients24.10.08231Citicoline Troches 200/500mgFor the treatment of patients with serious cerebral injuries of vascular traumatic nature with or without loss of consciousness and for treatment of degenerative damages and chronic cerebral vascular injuries in senile dementia.31.10.08232Amisulpride S.R.Bilayered tablet 200/400mgFor acute and chronic schizophrenic disorders, in which positive symptoms and or negative symptoms are prominent, including patients characterised by predominant negative symptoms.03.11.08233Calcitriol + Calcium + Zinc (0.25mcg + 200mg + 7.5mg) CapsulesFor the treatment of hypocalcaemia and/or osteoporosis04.11.08234Atazanavir + Ritonavir(300mg + 100mg) FC TabletsFor the treatment of patients with HIV infection04.11.08235Timolol Maleate SR Eye Drops 5.0mg / mlFor the treatment of elevated intraocular pressure in patients with ocular hypertension or open angle glaucoma.08.11.08236Rosuvastatin Calcium tablets 5/10/20/40mg (Addl. Indication)1) As an adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 2)As an adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels.08.11.08237Paclitaxel inj.30/100/300mg vial (Addl. Indication)For the treatment of advanced gastric carcinoma08.11.08238Montelucast + Desloratidine(10mg + 5mg) FC TabletsFor the treatment of allergic rhinitis in adults only10.11.08239Amlodipine + Metoprolol (2.5/5 mg + 25/50mg (ER))TabletsAdditional Lower Strength10.11.08240Losartan + HCTZ (100 mg + 25 mg) TabletsAdditional Strength10.11.08241Phenyramidol HCl tablet 400mgFor the treatment of lumbago, integumental pain, musculoskeletal pain14.11.08242Salicylic Acid + Coal Tar (3% + 1%) SolutionFor scaling of seborrhea, seborrheic dermatitis, psoriasis of scalp17.11.08243Salicylic Acid + Coal Tar + Precipitated Sulphur (3% + 1% + 3%) OintmentFor the treatment of psoriasis and fungal skin infection17.11.08244Thiocolchicoside + Etoricoxib(4mg + 60 mg) FC TabletsFor the acute treatment of inflammatory musculoskeletal disorders associated with painful muscle spasm in adults.17.11.08245Tamsulosin + Tolterodine (0.4mg MR Pellets + 2mg/4mg ER Pellets) CapsulesAdditional Lower Strength17.11.08246Calcium Hypochlorite 4gm Sachet (Calcium Hypochlorite 0.542% Other Ingredients: 99.458%)For purification of contaminated ground water sources.23.11.08247Sumatriptan + Naproxen (50mg + 275mg) TabletsAdditional Lower Strength24.11.08248Amoxycillin + Clavulanic acid(1gm + 62.5mg ) FC TabletsFor the treatment and management of patients with community acquired pneumonia or acute bacterial sinusitis due to beta lactamase producing pathogens25.11.08249Buprenorphine + Naloxone (2 mg/0.4mg + 0.5/0.1 mg) TabletsAdditional Lower Strength02.12.08250Atorvastatin + Metformin(10mg + 500mg SR) TabletsAs adjunctive therapy to diet and exercise in patients with diabetic dyslipidemia04.12.08251Pemetrexed disodium 500mg / 100mg powder for sol. (Addl. Indication)As monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology04.12.08252Magnesuim Valproate Tablet 200mg/400mgFor the treatment of generalized or partial seizures as monotherapy or adjunctive therapy. For the treatment of maniac episodes associated with bipolar disorders. For prophylaxis of migraine headache in adults.04.12.08253Ursodeoxycholic Acid 300/600 SR Tablets (Additional Strength)For the dissolution of Radiolucent collestral goll stone, chronic cholestatic liver disease in particular primary biliary cirrhosis, primary sclerosing cholangitis & cholestasis associated with cyatic fibrosis.08.12.08254Rifampicin + INH + Piperine (200mg + 300mg + 10mg ) CapsulesFor the treatment of adult patients with pulmonary tuberculosis11.12.08255Rifampicin +Piperine (200mg + 10mg ) CapsulesFor the treatment of adult patients with pulmonary tuberculosis11.12.08256Amphotericin B Lipid suspension 50mg/ vial (Addl. Strength)Additional Strength12.12.08257Desmopressin Acetate tablet 0.1/0.2 mgFor the treatment of cranial diabetes insipidus , primary noctumal enuresis in patients.12.12.08258Mifepristone + Misoprostol (1 tab of mifepristone 200mg and 4 tab of misoprostol 200mcg) CombipackFor the medical termination of intrauterine pregnancy (MTP) of up to 63 days gestation based on the first day of the last menstrual period16.12.08259Lamotrigine MR Tablets 50/100mgFor the treatment of bipolar I disorder. (addl. Indication)17.12.08260Levosulpride Injection 25mg/2ml (Additional Strength)For the treatment of different Gastro intestinal problems like functional dyspepsia, nausea, vomiting & diabetic gastroparesis. For the treatment of schizophrenia and depression in adults.17.12.08261Cyclobenzaprine HCl ER Capsule 15/30mgAs an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful, musculoskeletal conditions.17.12.08262Docetaxel injection concentrate 80mg/2ml, 20mg/0.5ml (Additional Indication )In combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.17.12.08263Salicylic Acid + Cetyl Alcohol + Stearyl Alcohol (2% + 2.65% + 0.26%) LotionFor the treatment of scaly dermatoses18.12.08264Azathioprine 25mg TabletsAdditional Strength19.12.08265Paracetamol solution for infusion 10mg/mlFor short term treatment of moderate pain, especially following surgery and for the short term treatment of fever, when administration by i.v route is clinically justified23.12.08266Gemifloxacin + Ambroxol (320mg + 75mg SR) FC TabletsIndicated for the treatment of lower respiratory tract infections in adult patients24.12.08267Ceftazidime + Sulbactam (500/1000mg + 250/500mg) Injection1. For LRTI infections, 2. for UTI - Complicated and uncomplicated, 3. for bacterial septicemia, 4. for bone and joint infections, 5. for gynaecologic infections including endometritis, pelvic cellutitis, and other infections of female genital tract, 6. for CNS infections including meningitis24.12.08268Paracetamol + Phenylephrine Hydrochloride (Each 6gm Sachet contains: 500mg + 10mg) SachetFor the treatment of fever associated with cold, nasal congestion in adults24.12.08269Carboinoxamine Maleate + Ammonium Chloride + Sodium Citrate (Each 5 ml contains: 2 mg + 120 mg + 120 mg) syrupFor symptomatic treatment of cough24.12.08270Diclofenac + Thiocolchicoside (50 mg + 4 mg) CapsulesAdditional Lower Strength24.12.08 LIST OF APPROVED DRUG FROM 01.01.2009 TO 31.12.2009S. NO.DRUG NAMEINDICATIONAPPROVAL DATE1.Zoledronic Acid Injection 5mg/100ml (Addl. Indication) For the treatement of osteoporosis in post-menopausal women and in men who are at increased risk of fracture,including those with a recent low-trauma hip fracture.07.01.092.Misoprostol Tablet 600mcgAddl. Strength09.01.093.Acebrophylline Syrup 10mg/ mlFor the treatement of adult patients with chronic obstructive pulmonary disease(COPD) and bronchial asthma.09.01.094.Selamectin Tropical solution (for verterinary use.) 60mg/120mg per ml(I) For the treatement and lasting prevention of flea infestations,treatment and control of flea allergy dermatitis, prevention of heartworm disease,treatement and prevention of ear mites in dogs and cats; (II) For the treatement and prevention of sarcoptic mange,roundworms and for control of tick infestations in dogs.09.01.095.Methylcobalamin1500mcg + Calcium 200mg + Calcitriol 0.25mcg + Folic Acid1.5mg + Pyridoxine3mg CapsulesFor the treatment of vitamin deficiency states in adults14.01.096.Metoprolol tartrate tablets 50 mg (Addl. Indication)Adjunct to the treatement of Hyperthyroidism14.01.097.Cinacalet (as HCl) Tablet 30/60/90mgFor the treatment of secondary hyper parathyroidism in patients with chronic kidney diseases (CKD) on dialysis and for hypercalcemia in patients with parathyroid carcinoma14.01.098.Mycophenolate mofetil Capsules 250mg, Tablets 500mg, Oral suspension 200mg/ml (addl. Indication)For the prophylaxis of acute organ rejection in patients recieving allogenic hepatic transplantation.23.01.099.Liquid Paraffin1.25ml + Milk of Magnesia 3.75ml + Sodium Picosulphate 3.33mg per 5mlFor symptomatic treatment of constipation in adults29.01.0910.Ranolazine 1000mg ER Tabs (Additional Strength)Same as approved31.01.0911.Hyaluronic acid (cross linked) Pre-filled syringe 18mg/0.6ml and 24mg/0.8mlFor intradermal implantation and facial soft tissue augmentation31.01.0912.Caspofungin acetate Injection (Addl. Indication)For use in following: (I) Empirical therapy for presumed fungal infections in febrile neutropenic patients. (II) Treatment of Candidemia and the following Candida infections: Intra-abdominal abscesses, Peritonitis and Pleural space infections. (III) Treatment of Esophageal Candidiasis. (IV) Treatment of invasive Aspergillosis in patients who are refractory to or intolerant of other therapies (i.e, amphotericin B, lipid formulations of amphotericin B, and/or itraconazole)31.01.0913.Micafungin ( as sodium) Powder for solution for infusion 50mg / vialFor the treatment of patients with candidemia, acute disseminated candidiasis, candida peritonitis, abscess and esophageal candidiasis. For the prophylaxis of Candida infection in patients undergoing hematopoietic stem cell transplantation (HSCT)31.01.0914.Loteprednol Etabonate Nasal spray 0.1% w/vFor prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis.31.01.0915.Rasagiline (as mesylate ) Tablet 0.5mg/1mgFor the tratment of signs and symptoms of idiopathic Parkinson's disease as intial monotherapy and as an addition to levodopa.31.01.0916.Nicotine Polacrilex Gum 2mg & 4mg (Addl. Indication)To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco.03.02.0917.Closantel Injection100mg/ ml (for verterinary use.)For the infestation of trematodes, nematodes, cestodes and arthropods of domestic animals, including milch and other food producing animals.05.02.0918.Lornoxicam 4mg + Paracetamol 500mg film coated tabletsFor the short term use in acute painful & inflammatory conditions in adults05.02.0919.Cetrimide15% w/v + Chlorhexidine Gluconate 7.5% v/v + Isopropyl Alcohol 7.5% v/v Concentrate SolutionFor cleansing of physically contaminated wounds and for pre-operative disinfection09.02.0920.Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) SolutionFor the treatment of dandruff09.02.0921.Doripenem (as monohydrate) Injection 250mg/500mgFor the treatment of nosocomial pneumonia in adults.16.02.0922.Halobetasol Scalp Approved 0.05% w/vFor the relief of inflammatory and puritic manifestation of corticosteroid respensive dermatosis18.02.0923.Nicotine (as Polacrilex) Lozenges 2mg & 4mgTo reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco.18.02.0924.Tranexamic Acid Tab SR 750mgFor the treatment of menorrhagia20.02.0925.Betahistine Mesilate Tablet 6mg/12mgFor the treatment of dizziness and feeling of dizziness resulting from Meniere's disease, Meniere's syndrome and vertigo.20.02.0926.Abatacept Injection 250mg/vial (Addl. Indication)In moderately to severly active rheumatoid arithritis in adults and may be used as monotherapy or concomitantly with DMARD's other than TNF antagonists20.02.0927.Anidulafungin Injection (Lyophilized powder) 50mg/100mg per vialFor the treatment of invasive candidiasis including candidemia and esophageal candidiasis in adult patients.23.02.0928.Hydroquinone 2%+ Tretinoin 0.05% + Hydrocortisone1%CreamFor the treatment of patients with skin hyperpigmentation23.02.0929.Doxyphylline 400 mg + Terbutaline 5mg tabletsFor the treatment of asthma and chronic obstructive pulmonary disease in adult patients only23.02.0930.Hydroquinone 20mg + Tretinoin 0.25mg + Fluocinolone Acetonide 0.1mg per gm CreamFor the treatment of melasma of face in adults23.02.0931.Ketoconazole 2% + Zinc Pyrithone 1% LotionFor the treatment of pityriasis and dandruff of the scalp23.02.0932.Lamivudine 30mg + Zidovudine 60mg + Nevirapine 50mg Oral Suspension (Tablets for oral Suspension)For the treatment of HIV patients23.02.0933.Glibenclamide 5mg + Pioglitazone 15mg + Metformin500mg film coated tabletsAs 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control23.02.0934.Aceclofenac 100mg + Tizanidine 2mg film coated tabletsFor the treatment of acute low back pain in adult patients only23.02.0935.Octinoxate 7.5% + Avobenzone 3% + Oxybenzone 3% + Titanium dioxide 2% lotionAs sunscreen lotion for prevention of sunburn skin23.02.0936.Cetrizine 5/10mg + Ambroxol 30mg per 5ml syrupFor the symptomatic relief of productive cough associated with allergic rhinitis, when both anti-histamine and mucolytic agents are desired23.02.0937.Lidocaine Lozenges 200/300mgFor single agent anesthesia in upper gastro intestinal endoscopy.26.02.0938.Calamine 8% + Liquid Paraffin10% lotionAs antipruritic and smoothening agent26.02.0939.Nifedipine 0.3% + Lidocaine1.5% creamFor the treatment of anal fissures26.02.0940.Quinapril 20mg + HCTZ 25mg film coated tabletFor the treatment of mild to moderate hypertension in adult patients (in whom combination therapy is appropriate) who have been stabilized on the individual components given in the same proportion26.02.0941.Levodopa 100/100/250 + Carbidopa 10/25/25mg mouth dissolving tabletFor the symptomatic symptoms of idiopathic Parkinson's Disease04.03.0942.Paliperidone ER Tablets 1.5mgAddl. Strength04.03.0943.Losartan 100mg+ HCTZ 25 mg tabletAdditional higher strength16.03.0944.Darunavir(as ethanolate) Tablet 300mgFor the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment experienced adult patients, such as those patients with HIV-1 strains resistant to more than one protease inhibitor when co-administered with 100mg ritonavir, and with other antiretroviral agents.19.03.0945.Ropivacaine HCl Inj.2/5/7.5/10mgFor the production of local or regional anasthesia for surgery and for acute pain management.19.03.0946.Butaphosphan 100g + Methyl Hydroxybenzoate 1gm + Cyanocobalamin50 gm Oral powder (Veterinary Drug)As vitamin and phosphorous supplement for livestock, shirmp and fish.19.03.0947.Fluticasone furoate Nasal spray 27.5mcg per sprayFor the treatment of symptoms of allergic rhinitis.19.03.0948.Octinoxate 7.5% + Avobenzone 2% + Oxybenzone 3% + Octocrylene 3%+ Zinc Oxide 2% lotionA sunscreen lotion for prevention of sunburn skin19.03.0949.Omeprazole 20/40mg + Sodium Bicarbonate 600mg+ Magnesium Hydroxide 700mg sachetAdditional Strength19.03.0950.Ambroxol 30mg + Levo salbutamol 1mg+ Guiphenesin 50mg /5ml syrupFor the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis19.03.0951.Montelucast 4 mg+ Levocetrizine 2.5 mg tabletAdditional lower paedriatric dose19.03.0952.Surgical SealantTo be indicated for use in sealing suture lines along arterial and venous reconstructions.26.03.0953.Lidocaine Patch 700mg in aqueous base. (50 mg per gram adhesive)For the relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.26.03.0954.Bimatoprost Opthalmic solution 0.03%For the treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.30.03.0955.Trabectedin powder for concentrate for solution for infusion 1 mg/ vialFor the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to recieve these agents.30.03.0956.Acebrophylline Syrup 10mg/ml (Additional Indication)For the treatment of children (age 6to 12years) with chronic obstructive pulmonary disease(COPD) and bronchial asthma.30.03.0957.Mesalamine PR Tablets 1.2gmFor the induction of remission in patients with active, mild to moderate ulcerative colitis.30.03.0958.Mycophenolate Mofetil Tablets 750mg Additional StrengthSame as approved31.03.0959.Ketorolac Tromethamine Gel 2%w/wFor the treatment of muscle, joint and post-traumatic stress.31.03.0960.Theophylline 400mg SR + Montelukast 10mg TabletFor the treatment of patients with bronchial asthma31.03.0961.Hyaluronic Acid Sodium Salt 0.2 gm + Silver Sulfadiazine 1.0 gm/25 gm tube Hyaluronic Acid Sodium Salt 50 mg + Silver Sulfadiazine 1.0 gm/ 100 gm gauze pads impregneted with cream.For the treatment of wound of different etiology31.03.0962.Telmisartan 80mg + Amlodipine 5mg tabletAdditional higher strength31.03.0963.Hyaluronic Acid Sodium Salt (i) Each 15gm tube contains: Hyaluronic Acid Sodium Salt 0.2gm/100gm (ii) Sterile Gauze Pads impregnated with cream: Each gauze pad contains Hyaluronic Acid Sodium Salt 50/100mgFor the treatment of wound of different etiology31.03.0964. Abatacept Injection 250mg/vial (additional indication)For reducing signs and symptoms of moderately to severly active polyarticular juvenile idiopathic arthritis/juvenile rheumatoid arthritis in pediatric patients 6 years of age and older who have had an inadequate response to one or more DMARD's such as MTX 10.04.0965. Cetrizine 10 mg + Ambroxol 75 mg SR TabletFor symptomatic relief of productive cough associated with allergic rhinitis, when both anti-histamine and mucolytic agents are desired13.04.200966. Ciclesonide 200mcg + Formoterol 6mcg + Tiotropium 9mcg MDIIndicated as third line treatment of severe cases of COPD, when monotherapy and second line therapy with two drugs do not respond adequately.13.04.200967. Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 12.5mgFor the tretament of patients with mild to modrate essential hypertension13.04.200968. Milnacipran 25/50mg Caps (Addl. Indication)For the management of fibromylagia.15.04.200969. Lornoxicam SR 16mg TabsFor the symptomatic treatment of pain and inflammation in patients of osteoarthritis & rheumatoid arthritis25.04.200970. Palonosetron Hcl 0.075mg IV Inj (Addl. Strength)Same as approved25.04.200971. Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 6.25 mg /12.5mgAdditional strength25.04.200972. Albendazole 400 mg + Ivermectin 6 mg tablet For the treatment of intestinal helminthes and suppression of microfilaraemia especially with bancrofti infections 25.04.200973. Decitabine Lyophilized powder for injection 50mg/20ml vialFor treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes(refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international Prognostic Scoring System groups.25.04.200974. Retapamulin Ointment 1% For the topical treatment of bacterial skin and skin structure infections:- Primary impetigo, secondarily infected traumatic lesions, secondarily infected dermatoses.25.04.200975. Each ml contains Calamine 15% w/v + Zinc oxide 5% w/v + Bentonite 3% w/v+ Glycerin 5%w/v + Sodium citrate 0.05 % w/v lotion For the tretament of pruritis and prickly heat08.05.200976. Each 1000 ml of emulsion contains: Medium chain triglycerides 100 gm + Soya oil 80 gm + Omega-3 acid triglycerides 20 gm + egg lecithin 12 gm + Glycerl 25 gm + Sodium oleate 0.30 gm + Alpha -tocopherol 0.20 gm + Ascorbypalmitate 0.30 gm + Sodium hydroxide max. 0.06 gm + water for injection 784 gm emulsion for infusion For the supply of fats, including essential omega-6 fatty acids and omega-3 fatty acids, as part of a parenteral nutrition regimen in adults if oral or enteral nutrition is impossible, inadequte or contraindicated.14.05.200977. Sertaconazole Nitrate Powder 2% w/w & Lotion 2% w/vFor the topical treatment of the superficial fungal infections of the skin.02.05.200978. Amlodipine Tablets 5mg/10mg (additional indication)1. To reduce of fatal coronary heart disease and non-fatal myocardial infarction, and to reduce the risk of stroke. 2. To reduce the risk of coronary revascularization procedures and the need for hospitalization due to angina in patients with coronary artery disease. 02.05.200979. Clindamycin Phosphate Inj. 150mg/ml & Clindamycin HCl Capsules 150mg/300mg (additional indication)Prophylaxis of infection in neck and head surgery 02.05.200980. Each 15 gm sachet contains: Lactulose 10 gm + Ispaghula husk 3.50 gm granules For the treatment of chronic idiopathic constipation in adult patients only16.05.200981. Sucralose for use as sweetner in drug formulations09.05.200982. CarvedilolTablets 3.125/6.25/12.5/25mg (additional indication)To reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of d" 40% (with or without symptomatic heart failure) 09.05.200983. Dexketoprofen 12.5 mg/25 mg + Paracetamol 500 mg film coated tabletsFor the treatment of Acute musculoskeletal pain18.05.200984. Pregabalin SR Tablet 150/300mg For the treatment of peripheral neuropathic pain in adults16.05.200985. Guaiphenesin ER Tablet 1200mgFor the treatment of productive cough accompanied by Phlegm16.05.200986. Everolimus 5/10mg Tablets (Addl. Indication)Treatment of advance renal cell carcinoma16.05.200987. Nimesulide ER 200mg ( Additional Indication)Acute pain in Orthopaedic, ENT, Dental and Post Operative condition16.05.200988. Palonesetron Injection 0.25mg/5ml (Additional Indication)For treatment of Post Operative Nausea & vomiting16.05.200989. Bendamustine Hydrochloride Lyophilized powder Injection 100mg/ vialFor the treatment of patients with chronic lymphocytic leukemia.16.05.0990. Caffeine(as Citrate) 10mg / ml Injection For the short term treatment of apnoea of prematurity of infants between 28 and < 33 weeks gestational age.16.05.0991. Perindopril arginine 2.5mg/5mg/10mg film coated tablet For the treatment of arterial hypertension, congestive heart failure and coronary artery disease.16.05.0992. Each gm contains: Halobetasol 0.05% w/w + Mupirocin 2.0 % w/w gelFor the topical treatment of inflammatory dermatitis with secondry bacterial infection16.05.0993. Mometasone 0.1 % + Fusidic acid 2% cream/ointmentFor the treatment of dermatoses where secondry bacterial and/or candidial infection is present25.04.0994. Thiocolchicoside 8 mg + Etoricoxib 60 mg tabletsAdditional strength25.04.0995. Methadone Hydrochloride 5mg/10mg per ml syrup; 5mg/ 10mg/ 20mg / 40mg tabletFor the treatment of opiod dependence and in maintainence treatment for opioid dependence.28.05.0996. Trospium Chloride film coated tablet 20mgFor the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency, and urinary frequency.28.05.0997. Arformoterol (as Tartrate ) 15mcg / 2ml Inhalation Solution For the long term, twice daily (morning and evening) maintainence treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.29.05.0998. Zolmitriptan...5.0% w/v Benzalkonium Chloride NF ... 0.01% w/v Nasal sprayFor the acute treatment of migraine with or without aura in adults.29.05.0999.  Dexmedetomidine ( as HCl) 100mcg /ml Injection For sedation of initially and mechanically ventilated patients during treatment in an intensive care setting.29.05.09100. Levetiracetam SR Tablet 500/750/1000mgsame as approved 2.05.2009101. Glatiramer Acetate Injection (20mg/ ml) & Pre-filled syringe (20mg/ml)For the reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis.3.06.2009102.  Yttrium-90 Microspheres Injection (Yttrium-90...3GBq (at the time of calibration) per vial)For the treatment of unresectable metastatic liver tumors from primary colorectal cancer with intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine)3.06.2009103.  Luliconazole Cream 1%For the treatment of cutaneous mycosis viz. Tinea pedis, Tinea corporis, Tinea cruris. 3.06.2009104.  Magnesium Valporate Prolonged release tablet 600mg1) For the treatment of generelized or partial seizures as monothreapy or adjunctive threapy. 2) For prophylaxis of migraine headache in adults. 3) For the treatment of manic episodes associated with bi polar disorders 4.06.2009105. Tenofovir Disoproxil Fumerate 300mgFor the treatment of chronic Hepatitis B in adults19.6.2009106.  Bosentan (as monohydrate) Tablets 62.5/125mgFor the treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO Class III or IV symptoms, to improve excercise ability and decrease the rate of clinical worsening. 23.6.2009107. Lornoxicam 12 mg SR (additional strength)same as approved26.6.2009108.  Azithromycin SR Granules for oral suspension 2000mgfor the treatment for mild to moderate susceptible infection including RTI, uncomplicated skin/ skin structure, non gonococcal urethritis, cervicitis 26.6.2009109.  Metoprolol 50/50/25 mg + Atorvastatin 20/10/10 mg + Ramipril 10/5/2.5 mg capsules As 2nd line treatment of patients with both essential hypertension and hypercholesterolemia who are not adequately controlled by combination of an anti-hypertensive with lipid lowering agent.1.07.2009110. Methyl Phenidate ER Tablet 10/20/30mgFor the treatment of Attention Deficit Hyperactivity Disorder (ADHD)10.07.2009111. Dasatinib Tablets 100mg (addl. Strength)same as approved10.07.2009112.  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.13.7.2009113. Combipack of artesunate tablet and FDC Tablet of sulphadoxine + pyrimethamine Composition: A. combipack of 1 stip of 3 tablets of artesunate 25 mg and 1 strip of 1 tablet of sulphadoxine 125mg+ pyrimethamine 6.25 mg B. combipack of 1 stip of 3 tablets of artesunate 50 mg and 1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg C. combipack of 1 stip of 3 tablets of artesunate 100 mg and 1 strip of 2 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg D. combipack of 1 stip of 3 tablets of artesunate 200 mg and 1 strip of 3 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg.For the treatment of P. falciparum resistant malaria patients 15.7.2009114. Milnacipran 100mg (additional Strength)same as approved16.7.2009115. Rifaximin 400mg (additional Indication)For the treatment of hepatic encephalopathy18.7.2009116. Nevirapine tablet 50 mg for oral suspension mgFor the treatment of HIV infection in combination with other anti retro viral agents18.7.2009117. Desvenlafaxine (as Succinate) ER Tablets 50mg/100mgFor the treatment of major depressive disorder (MDD)18.7.2009118. Posaconazole Oral Suspension 40mg/mlFor the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole. For prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severly immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. 18.7.2009119. Caffeine Citrate 20mg / ml (equivalent to 10mg of Caffeine base) Oral Solution (Addl. Dosage form)same as approved18.7.2009120. Amphotericin B Emulsion 5mg/ml (Addl. Indication)Febrile Neutropenia in cancer patients18.7.2009121. Hydroxy ethyl starch 10% Solution for infusionFor the treatment of imminent or manifest hypovolemia and shock.18.7.2009122. Naratriptan (as HCl) Tablets 1/ 2.5mgFor the acute treatment of migraine with or without aura in adults.18.7.2009123. Colistimethate Sodium powder for solution for injection/infusion 500000IU and 2000000IU (additional Strength)same as approved20.7.2009124.Simvastatin 20 mg + Ramipril 5mg + Atenolol 50 mg + HCTZ 12.5 mg + Aspirin 100 mg (EC Pellets) Capsules For secondary prevention of coronory heart disease/stroke in patients where use of such combination is appropriate21.7.2009125. Colistimethate Sodium powder for solution for inhalation 500000IU/1000000IU/2000000IU Treatment by inhalation of Pseudomonas aeruginosa lung infection in patients with cystic fibrosis28.7.2009126. Ramipril MR capsule 10mgFor the treatment of hypertension/ cardiac failure and myocardial infarction30.7.2009 127. Abacavir Sulfate Tablet 60mg For the treatment of HIV-1 infection in combination with other antiretroviral agents 1.08.2009  128. Zoledronic Acid Solution for Infusion Addl. Indication Prevention of clinical fractures after hip fracture in men and women 1.08.2009  129. Sumatriptan 85 mg + Naproxen 500 mg Tablets Additional Strength for the treatment of migraine 3.08.2009  130. Aceclofenac(100mg) + Thiocolchicoside ( 8 mg) tablets For the treatment of acute inflammation conditions associated with spasm in adults only 3.08.2009  131. Oxcarbazepine 150/300/600mg Tablet (Addl. Indication Treatment of generalized tonic-clonic seizures in adults and children 13.08.2009  132. Ofloxacin 2mg + Ornidazole 5 mg per ml Infusion for the treatment of diarrhoea of mixed infection in adult patients 17.08.2009 133. Clozapine Tablet200mg (Addl. Strength) Indicated in the management of Schizophrenic patients 19.08.2009  134. Oxymetazoline Hydrochloride Nasal Spray50mcg/0.05%w/w Is indicated for the relief of stuffy,running nose associated with colds and influenza, also post nasal drip, sinusitis. 19.08.2009  135. Enoxaparin Sodium Injection (Addl.Indication) Treatment of acute ST-segment elevation myocardial infarction including patients to be managed medically or with subsequent percuaneous coronary intervention (PCI) 19.08.2009  136. Fluvoxamine Maleate100/150mg ER Tablets For the treatment of obsessive compulsive disorder (OCD)and depression 19.08.2009  137. Lidocaine Lozenges 200/300mg (Addl. Indication) For single agent anesthesia in procedure involving the introduction of instrument & tubes into respiratory tract. 19.08.2009  138. Risperidone long acting injection (Addl. Indication) Indicated as monotherapy or as adjunctive therapy in lithium or valproate for the maintenance treatment of Bipolar-1 disorder. 29.08.2009  139. Exemestane 25mg Tablet (Addl. Indication) Indicated for adjuvant treatment of Post Menopausal Women with estrogen receptor positive early breast cancer who have received two-three year of tamoxifen and are switched to exemestane for completion of total of five years of adjuvant hormonal therapy. 29.08.2009  140 Artesunate (25/50/100mg) + Amodiaquine (67.5 mg/135/270mg) bilayerd Tablets For the treatment of uncomplicated malaria due to plasmodium falciparum strain in various age groups 01.09.2009 141 Ezetimibe 10 mg + Fenofibrate 145 mg Film coated tablets For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function 01.09.2009 142 Buprenorphine Transdermal Patch Each Transdermal Patch having an area of 6.25cm, 12.5cm, and 25cmcontains: Buprenorphine5mg/10mg/20mg having release rate of 5mcg, 10mcg, 20mcg Buprenorphine per hour respectively(over a period of 7 days). For the treatment of severe opioid responsive painconditions which are not adequately responding to non-opioid analgesics.For Hospital supply only. 03.09.09 143 Trospium Chloride ER Capsules 60 mg For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency and urinary frequency. 04.09.2009 144 Metoclopramide (as HCl) 200mg / 400mg per ml Intranasal Solution For the treatment of nausea and vomiting. 09.09.09 145 Isosorbibe 20 mg + Hydralazine 37.5 mg tablets For the treatment of heart failure as an adjunct to standard therapy in patients to improve survival, to prolong time to hospitalization for heart failure and to improve patients reported functional status. 18.09.2009 146 Cefixime 200 mg + Dicloxacillin ER 500 mg Tablets For the treatment of adult patients with Upper and Lower respiratory tract infections, skin and soft tissue infections 22.09.2009 147 Chlorthalidone Tablet 6.25mg For the treatment of mild to moderate hypetension. 03.10.09 148 Cefovecin( as sodium) 80mg/ ml Lyophilised powder for injection (Veterinary) For the treatment of skin bacterial infections in dogs and cats. 03.10.09 149 Imidacloprid 10% + Moxidectin 1.0% & 2.5% Topical solution (Veterinary) Each pippette contains: (a) 0.4ml, 1.0ml, 2.5ml, 4ml of 10% Imidacloprid and 1.0% moxidectin (b) 0.4ml, 0.8ml of 10% Imidacloprid and 2.5% moxidectin For the treatment and prevention of flea infestations, prevention of heartworm disease and treatment of infections with gastrointestinal nematodes in dogs and cats. 03.10.09 150 Isoflupredone AcetateSuspension for Injection (2mg per ml) ( For Veterinary) For the glucocorticoid, anti-inflammatory or supportive therapy to cattle suffering from conditions such as: (1) Overwhelming infections with severe toxicity. (2) Bovine ketosis. (3) Musculoskeletal conditions. (4) Shock. (5) Parturient paresis (supportive stress therapy for milk fever). 03.10.09 151 Saxagliptin (as HCl) 2.5mg/ 5mg Tablets As an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. (It should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. 24.10.09 152 Calcipotriol Gel 0.005% (additional dosage form) For the treatment of moderate plaque psoriasis in adults 3.10.2009 153 Lamotrigine MR Tablets 150mg (Addl. Strength) same as approved 3.10.2009 154 Metoprolol Tartrate ER Tablet 75mg (additional strength) same as approved 3.10.2009 155 Valganciclovir Powder for Oral Solution 50mg/ml For the treatment of cytomegalovirus (CMV) retinitis in AIDS patients and for prevention of CMV disease in solid organ transplant patients at high risk 9.10.2009 156 Dexketoprofen Trometamol Gel 12.5mg/gm For the painful and inflammatory conditions associated with joints, tendons, ligaments and muscle 13.10.2009 157 Donepezil Hydrochloride Orodispersible Tablet 5mg/10mg For the treatment of mild to moderate severe Alzheimer's Dementia 15.10.2009 158 Dexketoprofen Trometamol Injection 50mg/2ml Symptomatic treatment of acute pain of moderate to severe intensity, when oral administration is not appropriate such as post-operative pain, renal colic and low back pain. 22.10.2009 159 Bromocriptine Mesylate Tablet IP 0.8mg, (additional Indication) Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 22.10.2009 160 Levosulpride ER Tablet 100/150/200mg For the treatment of depression and schizophrenia in adults 27.10.2009 161 Ambroxol 30 mg+ Terbutaline 2.5 mg + Guaiphenesin 100mg + Menthol 2.5 mg per 5 ml syrup Additional strength 27.10.2009 162 Propofol 10 mg+ Lignocaine 2.5 mg per ml injection Additional strength 27.10.2009 163 Mecobalamin 750 mg + Pyridoxine Hydrochloride1.5 mg + Nicotinamide 45 mg tablets For the treatment of diabetic neuropathy 27.10.2009 164 Olmesartan (20/40mg )+ Atorvastatin 5/10/20mg film coated tablets For the treatment of co-existing essential hypertension and hyperlipidemia in adult patients 27.10.2009  165 Deltamethrin (0.50% m/v) and Piperonyl Butoxide (2.0% m/v) per ml PourOn Solution Ready to use pour-on for cattle, sheep and goats. 1. For use in Cattle to control ticks, stable flies, horn flies, cattle louse flies and nuisance flies e.g. house flies, to kill lice and protection against blackflies. 2. For use in sheep and goats for controlling Karoo paralysis, bont- legged and red-legged ticks 29.10.2009 166 Glucosamine sulphate potassium chloride 500 mg + Ibuprofen IP 200mg film coated Tablets For the treatment of adult patients with osteoarthritis of knee and/or hip joints 03.11.2009 167 Methylcobalamin 1500 mcg + Gabapentin SR 600 mg film coated tablets Additional strength 4.11.2009 168 Propofol 1% for injection (Additional Indication) 1. For conscious sedation for surgical and diagnostic procedures 2. for sedation of ventilated patients receiving intensive care 5.11.2009 169 Rupatadine 10 mg + Montelukast 10 mg Tablets For the management of seasonal allergic rhinitis (SAR) 10.11.2009 170 Eperisone 50 mg + Paracetamol 500 mg Tablets For improvement of mytonic conditions caused by neck shoulder arm syndrome , scapulhumeral periarthritis and low back pain in adult patients only 10.11.2009 171 Lafutidine Tablets ....5mg/10mg. For the treatment of: gastric ulcers, duodenal ulcers and stromal ulcers gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis and acute exacerbation of chronic gastritis. 11.11.2009 172 Ramosetron Hydrochloride Tablets 2.5mcg, 5mcg, 0.1mg & Injecton 0.3mg /2ml 1. Tablets 0.1mg & Injection 0.3-- for the prevention and treatment of gastrointestinal symptoms (nausea and vomiting) associated with emetogenic cancer chemotherapy. 2. Tablets 2.5mcg & 5mcg--- for the treatment of diarrhoea predominant irritable bowel syndrome. 11.11.2009 173 Tadalafil tablet 20 mg (Additional Indication) For the treatment of pulmonary arterial hypertension 14.11.2009 174 Flurbiprofen Sodium 0.03% Ophthalmic solution USP for the reduction of post-operative inflammatory condition 14.11.2009 175 Dexmedetomidine HCl Injection (Additional Indication) Sedation of non-intubated patients prior to and/or during surgical and other procedure 14.11.2009 176 Paliperidone ER tablet 12 mg (Additional Strength) Same as approved 14.11.2009 177 1) Triticum Vulgare Topical Cream Each 100gm of cream contains: Aqueous extract of Triticum Vulgare (dry residue 200mg / 100ml) ..... 15gm 2-phenoxyethanol Eur. Ph.....1gm 2) Triticum Vulgare Vaginal Pessary Each 3.5gm of vaginal pessary contains: Aqueous extract of Triticum Vulgare (dry residue 200mg/ 100ml) .....0.60gm 2-phenoxyethanol Eur. Ph.....0.04gm 1) Triticum Vulgare Cream is indicated for the treatment of ulcers and bed sores. 2) Triticum Vulgare Vaginal Pessary is indicated for the treatment of phlogistic and dystrophic disorders of the female genital tract.14.11.2009 178 Febuxostat Tablets 80mg / 120mg For treatment of chronic hyperuricemia in conditions where urate depression has already occured (including a history, or presence of tophus and /or gouty arthritis). 14.11.2009 179 Euphorbia Prostrata Dry Extract :100mg tablet (addl. Indication) For the treatment of 3 and 4 haemorrhoids (Addl. Indication). 14.11.2009 180 Euphorbia Prostrata dry extract ethanolic 80%v/v[(35-70):1] cream 1% w/w For the treatment of 1 and 2 internal haemorrhoids. 14.11.2009 181 Lactobacillus Rhammnosus 1 billion cells + Saccharomyces Boulardi 125 mg + Zinc Enriched yeast 20 mg sachets & capsules For the treatment of acute diarrhoea in children 4.11.2009 182 Nimesulide 1.0% w/w + Ethanol 31% w/w topical solution For the local application in relieving pain in acute low backache, tendonitis, tenosinovitis and sprains 17.11.2009 183 Diacerein Modified Release Capsule 100mg Symptomatic treatment of osteoarthritis of knee & hip 20.11.2009 184 Amlodipine 5mg/10mg/5mg/10mg/10mg + Valsartan 160mg/160mg/160mg/160mg/320mg + Hydrochlorothizide 12.5mg/12.5mg/25mg/25mg/25mg Tablets For the treatment of essential hypertension 24.11.2009 185 Maraviroc Tablets 150mg/300mg. For the treatment of patients infected with CCR5- trophic HIV-1. 25.11.2009 186 S (+) Etodolac 150/200/300mg + Paracetamol 500/500/500mg Tablets For the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis 25.11.2009 187 Tacrolimus Granules for oral suspension 0.2/1 mg per sachet Prophylaxis of transplant rejection in kidney, liver or heart allograft recipient 26.11.2009 188 Rifaximin Dispersible Tablet 200mg For infections diarrhoea in adults 26.11.2009 189 Prednisolone Sodium Phosphate Orally Disintegrating Tablet 10/15/30mg Indicating for condition required Glucocorticoids activity including collagen disease, allergic disease and hypersensitive reaction 26.11.2009 190 Cinitapride Hydrogen Tartrate ER Tablet 3mg For the treatment of gastroesophageal reflux disease (GERD) and functional inconveniences of the gastrointestinal motility 26.11.2009 191 Sevelamer Carbonate (Additional Indication) for control of serum phosphorus in patients with chronic kidney disease on haemodialysis or peritoneal dialysis and patients with CKD not on dialysis with serum phosphate > 5.5 mg/dl 26.11.2009 192 Oxcarbazepine Tablets (Additional Indication)150/300/600 mg Monotherapy in the treatment of partial seizures in children ages 4-16 26.11.2009 193 Ketoprofen plaster 30 mg (7cm X 10 cm) for the relief of musculoskeletal pain & inflammation 11.12.2009 194 Acipimox Capsules 250mg. As adjunctive therapy to diet and weight loss in the treatment of type IIa, IIb and IV lipid disorders.26.11.2009 195 Amisulpiride SR Tablet 100 mg Same as approved 27.11.2009 196 Mycophenolate Sodium Enteric coated tablet 540 mg (Additional Strength) Same as approved 29.10.2009 197 Loteprednol etabonate 0.5% w/v + Moxifloxacin 0.5% w/v opthalmic Suspension For the treatement of post operative steriod responsive inflammatory ocular infections or risk of bacterial ocular infections exists 1.12.2009 198 Ropinirole ER tablet 2/4/8mg for the treatment of signs & symptoms of idiopathic Parkinson's disease 3.12.2009 199 Diclofenac Diethyl amine transdermal patch 100 mg/37.5 sq cm (Additional Strength) same as approved 4.12.2009 200 Lornoxicam ER Tablet 8 mg (Additional Strength) same as approved 11.12.2009 201 Flurbiprofen plaster 20 mg (7cm X 10cm) for the relief of pain & inflammation due to rheumatoid arthritis , osteoarthritis and allied disorder 11.12.2009 202 Carvedilol Phosphate ER tablet 10/20/40/80mg 1. Mild to severe chronic heart failure. 2. Left ventricular dysfunction following myocardial infarction in clinically stable patients 3. hypertension 11.12.2009 203 Halometasone monohydrate 0.05% w/w + Fusidic acid 2.00% w/w cream For the treatment of acute and chronic infected eczematous dermatitis 15.12.2009 204 Glimepiride 1/2 mg + Metformin 500 mg + Atorvastatin 10 mg tablets For the treatment of type II diabetes mellitus associated with dyslipidemia 17.12.2009 205 Betahistine Di hydrochloride CR capsule 24/32/48mg indicated in the treatment of Menier's syndrome, characterized by unilateral or bilateral tinnitus, vertigo, sensorineural hearing loss 17.12.2009 206 Gefitinib tab 250mg (Additional Indication) Indicated for the first line treatment of patients with locally advanced or metastatic non small cell lung cancer (NSLC) who have activating mutationof the EGFRTK". 18.12.2009 207 Midazolam Hcl Syrup 2mg/ml For selection,anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedure or before induction of anesthesia. 18.12.2009 208 Guaiphenasin Syrup 133mg/5ml For the treatment of productive cough accompanied by phlegm 18.12.2009 209 Balofloxacin Tablet 100mg for the treatment of uncomplicated urinary tract infectins (such as cystitis and urethritis) 22.12.2009 210 Xylometazoline 0.5 mg + Ipratropium 0.6 mg Nasal spray For symptomatic treatment of nasal congestion with running nose (rhinorrhea) 23.12.2009 211 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 23.12.2009 212 Ribavirin Capsules 200mg (Addl. Strength) Indicated in combination with peg interferon alpha-2b for the treatment of nave adult patients with chronic hepatitis C with clinically stable HIV co-infection. 24.12.2009 213 Formoterol 6 mcg + Mometasone furoate 100/200/400mcg Metered dose Inhaler & Dry Powder Inhalation For the treatment of patients with bronchial asthma and COPD, where the use of combination is found appropriate 30.12.2009 214 Chlorohexidine Gluconate Gel 0.2% For the prevention of Plaque and treatment of gengivitis. 30.12.2009 215 Chlorohexidine Gluconate Mouth wash 0.1% For the prevention of Plaque and treatment of gengivitis. 30.12.2009  216 Levodropropizine Eur. Ph. 30mg + Chlorpheniramine maleate IP 2mg per 5 ml Syrup For the treatment of non-productive cough 06.07.09 LIST OF APPROVED DRUG FROM 01.01.2010 TO 31.12.2010S.NOPRODUCT NAME DATE OF APPROVAL1Ferrous ascorbate 100mg + Folic acid 1.1 mg tablet and Omega-3-fatty acid 200mg capsules combikitFor iron, folic acid & omega-3-fatty acid deficiency08/01/20102Sphaeranthus Indicus Extract Tablets 700mgFor the management of psoriasis.08/01/20103Febuxostat 40mg Additional StrengthSame As approved16/01/20104Dexamethasone Intravitreal Implant 0.7mg (in solid polymer drug delivery system)For the treatment of macular edema following branch retinal vein occlusion (CRVO)16/01/20105Buclizine Hcl 25mg Tablet (Additional Indication)For the Symptomatic treatment of various allergic conditions (rhinitis, conjunctivitis and urticaria) and for prevention and treatment of motion sickness16/01/20106Pemetrexed Disodium 500mg/100mg Powder for Injection (additional indication)Indicated as a monotherapy for the maintenance treatment of locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.First line treatment should be a platinum doublet with gemcitabine, paclitaxel or docetaxel.16/01/20107Levobetaxolol HCl Opthalmic Suspension 0.5%For lowering of intraoccular pressure in patients with chronic open-angle glaucoma or occular hypertension.16/01/20108Sarpogrelate Hydrochloride film coated Tablets 100mgFor the improvement of ischemic symptoms including ulcer, associated with chronic arterial occlusion.16/01/20109Propanol 1-ol 18gm + Ethanol 100% 45gm/100ml solutionFor hygenic and surgical hand disinfection18/01/201010Aliskiren 150/160mg + Valsartan300/320mg tabletsFor the treatment of hypertension19/01/201011Piroxicam 20mg tab& Paracetamol 500mg tab combikitFor treatment of fever and pain associated with acute upper respiratory tract inflammation, acute musculoskeletal disorders, pain after operative intervetion and following trauma, chronic condition like rheumatoid arthritis, osteoarthritis etc for short term management of acute painful episodes.19/01/201012Soybean oil 60gm + Triglycerides (medium chain) 50gm + olive oilpurified fish oil 30gm + dl-alpha-tocopherol 163-225mg + glycerol (anhydrous) 25gm + Egg lecithin 12gm + sodium hydroxide (to approx pH 8) + sodium pleate 0.3mg emulsion for infusion in 100ml.Total parenteral nutrition following major abdominal, major thoracic or major urological surgery19/01/201013Raltegravir (as Potassium) film coated Tablets 400mgIn combination with other anti retroviral agents forthe treatment of human immunodeficiency virus (HIV-1) infection in treatment experienced patients with evidence of HIV-1 replication despite ongoing retroviral therapy.27/01/201014Deflazacort Tablet 18mg (Additional Strength)Same as approved30/01/201015Pregabalin SR Tablet 75mg (Additional Strength)Same as approved30/01/201016Rivaroxaban film coated Tablets 10mgFor the prevention of venous thromboembolism in patients (VTE) in adult patients undergoing hip or knee replacement surgery.30/01/201017Cinnarizine 20mg + Dimenhydrinate 40mg tabletsFor the treatment of vertigo03/02/201018Lipid Based Amphotericin-BGel 0.1%Indicated in the treatment of cutaneous and mucocutaneous mycotic infections caused by candida (Monilia) species.05/02/201019Sodium Hyaluronate Injectable Gel 14mg/ml, 18mg/ml, 25.5mg/ml (Additional Strength)Same as approved06/02/201020Milnacipran Hcl 12.5mg (Addl. Strength)Same as approved06/02/201021Ropinirole 6mg ER Tablets (Addl. Strength)Same as approved06/02/201022Coseal Surgical Sealent 2/4/8ml (Addl. Indication)(1)Enforcement of suture and staple lines in lung resection procedures. (2)Patients undergoing cardiac surgery to prevent or reduce the incidence, severity and extend of post surgical adhesion formation. (3)Patients undergoing laparotomy or laproscopic abdomino-pelvic surgery as an adjunct to good surgical technique intended to reduce the incidence, severity and extent of post surgical adhesion formation.06/02/201023Pregabalin SR 75/150/300mg + Methylcobalamin 1500mcg tabletsFor the treatment of adult patients with peripheral neuropathy09/02/201024Ivabradine Hcl Tablets 5/7.5mg (Additional Indication)For Symptomatic Treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm, indicated in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is >60bpm.10/02/201025Paracetamol Solution for Infusion (10mg/ml) in 50ml (Additional Packsize)Same as approved10/02/201026Ketorolac Tromethamine Ophthalmic Solution 0.45%Indicated for the treatment of pain and inflammation following cataract surgery.10/02/201027Cytarabine Injection 100mg Additional Packsize (20ml)In combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children.It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia.Intrathecal administration of cytarabine is indicated in the prophylaxis and treatment of meningal leukemia.10/02/201028Olopatadine Hcl Nasal Spray 0.6% w/w (Additional Indication)For the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older.10/02/201029Sodium chloride 6.80gm + Potassium chloride 0.30 gm + Calcium chloride dihydrate 0.37gm+ Magnesium chloridehexahydrate 0.20gm + Sodium acetate trihydrate 3.27gm + L-malic acid 0.67gm in 1000ml solution for infusionReplacement of extracellular fluid losses in case of isotonic dehydration, especially if acidosis is being imminent or present11/02/201030Chemically Modified Sodium Hyaluronate andCaboxymethylcellulose Absorbable Adhesion Barrier.As an adjunct in abdominal or pelvic surgery for reducing the incidence, extent and severity of postoperative adhesions at the site of placement.11/02/201031Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tabletsFor the treatment of patients with acute painful musculoskeletal conditions12/02/201032Cefixime 100mg/200mg + Cloxacillin 500mg/500mg tabletsFor the treatment of adult patients with upper & lower respiratory tract infections, skin and soft tissue infections12/02/201033Celecoxib Mouth Dissolving Tablet 50/100/200 mgFor the Treatment of Osteoarthritis and Rheumatoid Arthritis25/02/201034Propofol 2% w/v Injection (additionalStrength)Same as Approved27/02/201035Spironolactone 25mg + Furosemide 20mg tabletsFor treatment of resistant oedema associated with secondary hyperaldosteronism; resistant hypertension, chronic cardic failure and hepatic cirrhosis05/03/201036Olopatadine5mg + Ambroxol30mg tabletsFor the management of cough in adult patients only05/03/201037Methylcobalamin750mcg + Pregabalin75/150mg + Vitamin B61.5mg + Folic acid0.75mg + Benfothiamine7.5mg capsulesFor the treaetment of painful diabetic neuropathy in adults only05/03/201038Calcium acetate 435mg + Magnesium carbonate 235mg tabletsFor the management of hyperphosphatemia in adults patients with renal failure being treated with dialysis (hemodialysis or peritoneal dialysis05/03/201039Dicyclomine2.5mg + Dried Aluminimum Hydroxide200mg + Light Magnesium Oxide100mg + Simethicone 20mg per 5ml suspension.For the treatment of the symptoms of functional gastrointestinal disorders like irratible bowel syndrome, functional dyspepsia, peptic ulcers., GERD which includes smooth muscle spasm, flatulence, abdominal distension, hyperacdity, gastric distress, bloting etc.05/03/201040Sertaconazole 2% w/v+ Zinc Pyrithione 1% w/v ShampooFor the treatment in adults patients with dandruff/seborrheic dermatitis of the scalp05/03/201041Faropenam Sodium Extended Release Tablet 225/300/450 mgFor the Treatment of respiratory tract infections, urinary tract infection, skin and skin structure infections and gynaecological infections08/03/201042Amlodipine5mg + Ramipril10mg/5mg Tablets (additional strength)For the treatment of hypertension only10/03/201043Doxofylline MR Tablet 650 mgFor the treatment of Bronchial Asthma and COPD in Adults11/03/201044Lidocaine7.5mg + Prilocaine2.5mg per acutation sprayFor the treatment of adult male patients with premature ejaculation12/03/201045Pramipexole Di HCl monohydrate ER Tablet 0.375/0.75/1.5/3/4.5 mgFor the treatment of the sign and symptoms of idiopathic parkinsons disease13/03/201046Drosperinone 3mg + Ethinyl Estradiol0.02mg tabletsFor the treatment of symptoms of premenstrual dysphoric disorders (PMDD) in women (additional indication)16/03/201047Miglitol 25 mg + Metformin 500mg tabletsAdditional Strength16/03/201048Propranolol 40mg (SR Pellets) + Fluarizine 5mg/10mg capsulesFor the prophylaxis of migraine16/03/201049Citicholine 500mg + Piracetam 400mg TabletsFor the treatment of acute stroke16/03/201050Diclofenac 50mg + Chlorzoxazone500mg TabletsFor the treatment of acute inflammation conditions associated with spasm in adults only16/03/201051Mecobalamin 750 mcg + Pyridoxine 1.5mg + Nicotinamide 45 mg + Benfotiamine 150mg TabletsFor the treatment of diabetic neuropathy in adults16/03/201052Etoricoxib 1%+ Menthol 5% SprayFor the topical treatment of acute musculoskeletal pain16/03/201053Pantoprazole 40mg + Cinitapride (ER) 3mg CapsulesFor the treatment of patients suffering from non-ulcer dyspepsia (NUD) or gasteroesophageal reflux disease (GERD)17/03/201054Atorvastatin 20mg + Ramipril 2.5mg/5mg CapsulesAdditional higher strength17/03/201055Lamotrigine Orodispersible Tablet 12.5 mg(additional strength)Same as Approved20/03/201056Trabectedin powder for Conc. solution for infusion (Additional Indication)In combination with pegylated liposomal doxorubicin, it is indicated for the treatment of patients with relapsed platinum- sensitive ovarian cancer20/03/201057Lornoxicam 8mg/8mg + Thiocolchicoside 4mg/8mg TabletsAdditional higher strength23/03/201058Diclofenac sodium SR Tablet 150 mgFor the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondilytis,gout,painful post perative pain following dental surgery etc.26/03/201059Magnesium Valproate CR Tablet 200/ 300/400/ 500 mg (additonal strength)Same as Approved26/03/201060Lidocaine 2.5% w/w+Prilocaine 2.5% w/w GelAdditional higher Strength26/03/201061Nicotinic Acid and Laropiprant Modified Release Tablets: Nicotinic Acid.........1000 mgLaropiprant...........20mg1. For the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDl-cholesterol) and in patients with primary hypercholesterolemia (heterozygous familial and non-familial).2. In combination with HMG-CoA reductase inhibitors (statins), when cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated. Diet or other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy.26/03/201062Pantoprazole Mouth Dissolving Tablet 20/40 mgFor the treatment of gastric ulcer, duodenal ulcer & gastroesophageal reflux disease (GERD).30/03/201063Praziquntel 175mg + Pyrantel 504mg + Febental 525mg TabletsFor the treatment of mixed infections with roundworms and tapeworms in dogs30/03/201064Difluprednate Opthalmic Emulsion 0.05% w/vFor the treatment of inflammation and painassociated with ocular surgery.30/03/201065Tolperisone Hcl SR 450mg TabletsFor the relief of painful muscle spasms of the skeletal muscualture.30/03/201066S(-)Metoprolol 25mg/50mg (ER) + Atorvastatin (IR)10mg tabletsFor the treatment of patients with both essential hypertension and hypercholesterolemia04/01/201067Atorvastatin10mg + Ramipril 5mg + Aspirin (EC pellets) 75mg/150mg + Metoprolol (ER tablets) 25mg CapsulesFor secondary prophylaxis of ischemic heart disease in patients where use of such combinations in appropriate05/04/201068Lamotrigine 25mg Modified Release Tablet (Addl. Strength)Same as Approved05/04/201069Imatinib Mesylate 100/400mg Tablets (Addl. Indication)Adjuvant treatment of adult patients following resection of gastro-intestinal stromal tumours (GIST)05/04/201070Azithromycin SR Granules for Oral Suspension 1gm (Addl. Strength)Same as Approved05/04/201071Gemfibrozil Capsule USP & Gemfibrozil Tablet USP 200mg/600mg (Addl. Indication)For the treatment of other dyslipidemias: (a) Fredrickson Types III and V.(b) Associated with diabetes.(C) Associated with xanthomata.05/04/201072Ibuprofen 400mg + Chlorzoxazone 500mg TabletsFor the short term treatment of musculoskeletal pain associated with inflammation and spasm in adults only07/04/201073Doxophylline (SR) 400mg/800mg + Montelukast 10mg/10mg TabletsFor the treatment of bronchial asthma in adults07/04/201074Dronedarone( as Hydrochloride) film coated tablet .... 400 mg.To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age > 70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter > 50mm or left ventricular ejection fraction [LVEF] < 40%), who are in sinus rhythm or who will be cardioverted.08/04/201075Dosulepin Hcl Tablet 25mg/75mg (Additional Indication)For the treatment of chronic pain.08/04/201076Prasugrel (as Hydrochloride) film coated tablet ....5 mg / 10mg.To reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows: Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI). Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.13/04/201077Tofisopam uncoated tablet JP... 50/100mgFor the treatment of anxiety and depression.13/04/201078Zotepine tablet ....25/50/100mgFor the treatment of schizophrenia15/04/201079Armodafinil uncoated tablet ..50/150/250mgTo improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder (SWD) or narcolepsy.23/04/201080Indacaterol ( as Maleate ) Inhalation Powder Hard Capsules .. ...150/300mcgFor maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).24/04/201081Ranolazine ER Tablets 750mg (Additional Strength)Same as Approved24/04/201082Tacrolimus Capsules 3mg (Additional Strength)Same as approved24/04/201083Cefixime 100mg/200mg + Ofloxacin 100mg/200mg TabletsFor the treatment of patients with typhoid fever and urinary tract infection in adults26/04/201084Liquid paraffin 6% + White soft paraffin 15%w/v CreamFor symptomatic relief of dermatological condition associated with dry skin including atopic dermatitis, eczema, pruritus, ichthyosis, xerosis, psoriasis29/04/201085Levosimendan Injection 2.5mg / mlFor the short term treatment of acutely decompensated chronic heart failure (ADHF) in situations where conventional therapy is not sufficient and in cases where ionotropic support is considered appropriate.30/04/201086Thiocholchicoside SR Tablet 16 mgAs an adjuvant treatment in painful spasms associated with degenerative vertebral disorders and vertebral static problems, torticollis dorsal pain, low back pain, traumatological and neurological disorders.31/04/201087Telmisartan 40/80 mg+ Indapamide SR 1.5/1.5 mg tabletFor the treatment essential hypertension05/04/201088one strip of 3 uncoated tablets of artesunate 150mg & one strip of 2 uncoated tablets of FDC of Sulphadoxine IP 500mg + Pyrimethamine IP 25mgAdditional strength05/04/201089Lapatinib Ditosylate Tablets 250mg (addl. Indication)In combination with letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated.10/05/201090Pentosan polysulfate Sodium Cpasules100mgFor the relief of bladder pain or discomfort associated with interstitial cystitis.11/05/201091Indapamide (SR) 1.5mg/1.5mg +Nebivolol 2.5mg/5mg tabletFor the treatment of hypertension not controlled with monotherapy12/05/201092Cinitapride (ER) 3mg + Omeprazole (EC) 20mg CapsulesFor the treatment of gastirc ulcer,gastroesophageal reflux disease(GERD) & Dyspepsia not responding to omeprazole alone12/05/201093Timolol Maleate Long Acting Ophthalamic Solution 5mg/mlFor the treatment of elevated intraocular pressure in patient with ocular hypertension or open angle glaucoma.14/05/201094Telmisartan tablet 20/40/80 mg(Additional indication)For the prevention of cardiovascular morbidity and mortality in patient 55 years older at high risk of cardiovascular disease14/05/201095Dexketoprofen Trometamol 25mg + Thiocolchicoside 4mg tabletsFor the treatment of acute low back pain and other musculoskeletal painful & inflammatory conditions in adult patients20/05/201096Troxipidefilm coated Tablets 50mg /100mgFor the treatment of Gastric ulcers and for amelioration of gastric mucosal lesions (erosion, hemorrhage, redness and edema) in the diseases such as acute gastritis, acute exacerbation stage of chronic gastritis.20/05/201097Ambrisentan film coated Tablets 5 mg / 10mgFor the treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening.24/05/201098Rosuvastatin Calcium Tablet(Additional Indication)Risk reduction of MI stroke and arterial evascularisation procedure in patients without clinically evident CHD but with multiple risk factor24/05/201099Paracetamol SR 1000mg Bilayered tabletFor symptomatic treatment of pain and fever24/05/2010100Tacrolimus PR Caps 0.5/1/5 mgFor Prophylaxis of transplant rejection in adult kidney or liver allograft rejection24/05/2010101Rizatriptan Benzoate orally disintegrating tablet 10 mg(Additional Dosage Form)Same as Already approved24/05/2010102Ramipril 1.25/ 2.5/5/10 mg(Additional Indication)For the treatment ofnon-diabetic overt glomerular or incipient nephropathy24/05/2010103Exenatide Inj. (Additional Indication)Use in patients with type-2 diabetes mellitus who are using a thiazolidinedione alone or in combination with metformibn but have not achieved adequate glycemic control24/05/2010104Temozolomide lyophilised powder 100mg / vialFor the treatment of "Adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment." Children from the age of three years, adolescents and Adult patients with malignant giloma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.24/05/2010105Fluticasone Propionate 50mcg/125mcg/250mcg + Salmeterol xinafoate 25mcg/25mcg/25mcg Powder for inhalationFor the maintenance treatment of asthma and for the treatment of COPD associated with chronic bronchitis25/05/2010106Cross linked Hyaluronic Acid 24mg + Lidocaine 3mg Pre-filled syringsFor filling any medium sized depression of the skin via mid dermis injection as well as for lip definition. The presence of lidocaine is meant to reduce the patients pain during the treatment28/05/2010107Aceclofenac 1% w/w + Menthol 5% SprayFor the treatment of acute painful inflammatory conditions in adults only28/05/2010108Metformin SR 500mg/500mg + GliclazideSR 60mg/30mg + Pioglitazone 15mg/15mg tabletsAs 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control28/05/20101093 tablets of artesunate 100mg + 3 tablets of Artesuante 50mg & 2 tablets of FDC of Pyrimethamine 25mg + Sulphadoxine 500mg combipackAdditional strength28/05/2010110Calcium carbonate 600mg +Simethicone 80mg Chewable tabletTo relive the uncomfortable symptoms of acid indigestion, heart burn, gas or sour stomach28/05/2010111Activated Dimethicone 50mg + Magnesium Hydroxide 250mg+ Dried Aluminium Hydroxide250 mg + Sorbitol (70%)1.25 gm /5ml SolutionFor treatment of symptoms of hyperacidity (e.g. heartburn, epigastric discomfort, or their equivalents) that are often associated with dyspepsia, peptic ulcers, gastritis, peptic esophagitis and indicated for relief of flatulence28/05/2010112Aspirin 75mg + Simvastatin 10mg/20mg + Lisinopril 5mg/10mg + Atenolol 25mg/50mg TabletsFor secondary prevention of coronory heart disease/stroke in patients where use of such combination is appropriate01/06/2010113Irsogladine Maleate Tablet2mg /4mgFor gastric ulcers, improvement of gastric mucosal lesion (erosion, hemorrhage, redness and edema) caused by acute gastritis and acute exacerbation stage of chronic gastritis.05/06/2010114Lacosamide film coated tablet 50mg /100mg /150mg /200mgAs an adjunctive treatment of partial onset seizures in patients > 17 years of age.10/06/2010115Carmustine for inj. 100 mgIndicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: 1.Brain tumorsglioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors.2.Multiple myelomain combination with prednisone. 3.Hodgkins Diseaseas secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. 4.Non-Hodgkins lymphomasas secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.10/06/2010116Monteleukast Sodium Tablet 10mg; Monteleukast Sodium 4/5mg Chewable Tablet; Monteleukast Sodium Oral granule(Additional Indication)For the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older.12/06/2010117Ramosetron Dispersible Tablet 0.1 mgFor the prevention and treatment of gastrointestinal symptoms(nausea and vomitting) associated with ematogenic cancer chemotherapy12/06/2010118Amitraz 2%w/v pour on solutionFor the control of ticks on cattle and ostriches12/06/2010119Flupirtine Maleate Capsules 100mgFor treatmentof acute and chronic pain,i.e, for painful increased muscle tone of the posture and motor muscles, primary headache,tumor pain, dysmenorrhea and pain after traumatologic / orthopaedic operations and injuries.12/06/2010120Lidocaine Patch 350mg (Additional Pack Size)For the relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.17/06/2010121Oseltamivir Phosphate (Additional indication)In the treatment of children 6 to 12 months of age during a pandemic influenza outbreak.19/06/2010122Methylcobalamin 1500mcg +Folic acid 0.7mg +Niacinamide 12mg injectionFor the treatment of diabetic neuropathy in adults23/06/2010123Methylcobalamin 1500mcg +Pyridoxine 100mg +Nicotinamide 100mg injectionFor the treatment of diabetic neuropathy in adults23/06/20101241 tablet of Tenofovir disoproxil 300mg + Lamivudine 300mg& 2 tablet of Nevirapine 200mg combipackFor the treatment of HIV infection in adults23/06/2010125Vitamin A (oily form) as palmiate 2000IU + Vitamin B1 1mg + Vitamin B2 1mg + Vitamin B6 1.34mg + Vitamin B12 1mcg + Ascorbic acid 33.3mg+ Vitamin D3 200IU + Folic acid 0.3mg + Calcium pantothenate 1mg + Niacinamide 15mg + Dibasic calcium phosphate 100mg + Phosphorus 77mg+ Ferrous fumarate 50mg + Copper 0.01mg+ Potassium iodide 0.0015mg + Heavy magnesium oxide 1mg + Manganse sulphate 0.01mg + Potassium sulphate 1mg + Zinc sulphate 0.15mg CapsuleFor the treatment of vitamin deficiency states in adults23/06/2010126Ramipril MR Capsules 2.5/5 mg (Additional Strength)Same As Approved03/07/10127Sitagliptin Phosphate 25/50/100 mg Tablet (Additional Indication)(i) Use of Sitagliptin Phosphate in combination with Metformin and a PPAR agonist as an adjunct to diet & exercise in adult patients with type-2 Diabetes mellitus who are inadequately controlled on combination therapy with Metformin and a PPAR agonist. (ii) Use of Sitagliptin Phosphate in combination with insulin, alone or in combination with Metformin.03/07/10128Erlotinib HCl 25/100 mg Tablet (Additional Indication)As monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with stable disease after 4 cycles of standard platinum based first line chemotherapy.03/07/10129Gemcitabine HCl injection 2gm/vial (Additional Strength)Same as Approved03/07/10130Etizolam 0.25 mg tablet (Additional Strength)Same As Approved03/07/10131Dexketoprofen1.25% w/w +Linseed Oil 3.0%w/w +Menthol 5%w/w +Methyl Salicylate 10%w/w (12.5mg)For the topical treatment of acute musculoskeletal pain06/07/10132Cefuroxime Sodium 750/1500mg +Sulbactam Sodium 375/750mgFor the treatment of mild to moderate lower respiratory tract infection06/07/10133HPMC 0.3% +Dextran 0.1% + Glycerin 0.2%For the temporary relief of burning and irritation due to dryness of the eye and for use as a protection against further irritation. For the temporary relief of discomfort due to minorirritations of the eyes or to exposure to wind or sun06/07/10134Cyanocobalamin 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 mgFor Mineral & Vitamins deficiency states in adult patients06/07/10135Methylparaben 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.For short term treatment of chronic wounds including stage III & IV pressure sores, leg ulcers06/07/10136Clonazepam IR 0.5mg/0.5mg+ Paroxetine CR 12.5/25mgFor the treatment of patients with co-morbid depression and axiety08/07/10137Nilotinib Capsules 200mgFor the treatment of chronic and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant to or intolerant to prior therapy that included imatinib.10/07/10138Imipenem 50mg + Clistatin 50mgTreatment of infection caused by susceptible bacteria for the following indication as in neonates and infants (below 3 months of age) 1. Lower respiratory tract infections 2. Urinary tract infections 3. Intra-abdominal infections 4. Bacterial septicemia 5. bone and joint infections 6. Skin and Skin structure infections 7. Bacterial endocarditis14/07/10139Lidocaine Lozenges 100mg (Additional Strength)Same as Approved15/07/10140Metoprolol succinate ER 25/50 mg+Telmisartan 20/40mgFor the treatment of essential hypertension16/07/10141Etodolac 300/300mg +Thiocolchicoside 4/8mgFor the treatment of patients with acute painful musculoskeletal conditions19/07/10142Celecoxib 100/200mg +Diacerein 50/50mgFor the treatment of adult patients with osteoarthritis of knee and/or hip joints19/07/10143Metoprolol succinate ER 25mg+50mg + Olmesartan 20/20mgFor the treatment of essential hypertension19/07/101441 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 ofTenofovir Disoproxil Fumarate 300mg + Lamivudine 300mg)For the treatment of HIV infections in adults19/07/10145Gliclazide 40/80mg+Metformin 500mg+Pioglitazone15mgAdditional strength19/07/10146Lidocaine HCl Ophthalmic Sterile Gel 35 mg/mlIndicated for ocular surface anaesthesia during ophthalmologic procedures.30/07/10147Naftopidil Tablets 25/50/75mgFor the treatment of dysuria associated with benign prostratic hyperplasia.30/07/10148Metformin 500/850/1000mg+Sitagliptin Phosphate 50/50/50mg (Additional Indication)A) FDC is indicated as triple combination therapy with a PPARy agonist (i.e a thiazolidinedione) as an adjunct to diet and exercise in patients inadequtely controlled on their maximal tolerated dose of metfomin and a PPARy agonist. B) FDC is also indicated as add-on to insulin(i.e triple combination therapy) as an adjucnjt to diet and exercise to improve glycemic contrl in patients when stable dosage of insulin and metformin alone do not provide adequte control.02/08/10149Bimatoprost Eye Drps 0.1mg/mlfor the treatment of hypotrichosis of the eye-lashes by increasing their growth including length, thickness & darkness.05/08/10150S(+) Etodolac 5/10%w/w + Camphor 4%w/w+ Menthol 10%w/w + Methyl salicylate 5%w/w + Linseed oil 3%w/wFor the painful & inflammatory conditions associated with joint, tendons, ligaments and muscles05/08/10151Cefpodoxime 100/200mg+Dicloxacillin ER 500/500mgFor the treatment of lower RI, Skin and soft tissue, bone and joint infections and ENT infections in adult patients prone to antibiotic induced diarrhoea06/08/10152Voglibose0.3 + Metformin (SR) 500mgAdditional higher strength06/08/10153Amoxycillin Oral Suspension 200/400 mg per 5mlin the treatment of infections due to susceptible strains of the designated micro-organisms in the condition of E.N.T infection, skin & skin structure infection, lower respiratory tract infection, genito-urinary tract infection, gonorrhea, acute uncomplicated (anogenital & urethral) infections.09/08/10154Olmesartan 40mg + Amlodipine 5mg (Additional Strength)Additional indication: 1. For the treatmenmt of hypertension alone or with other antihypertensive agents 2. To use as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals09/08/10155Doripenem 500 mg powder for injection (Additional Indication)Complicated intra-abdominal infections and complicated urinary tract infections, including complicated and uncomplicated pyelonephritis and cases with concurrent bacteremia10/08/10156Nadolol tablet USP 20/40/80 mgin the treatment of angina-pectoris, cardiac arrythmias & essential hypertension.20/08/10157Fluconazole For Oral suspension 50/200 mg per 5ml (Pack Size : 35ml)for the treatment of systemic candidiasis, mucosal candidiasis, prevention of fungal infections in patients with malignancy.20/08/10158Metformin 500/500mg + Repaglinide 1/2mgIndicated as an adjunct to diet and excersice to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide & metformin or who have inadequte glycemic control on a meglotinide alone or metformin20/08/10159Hydroxyzine Hydrochloride SR Tablets 25/50/75mgFor management of pruritus due to allergic conditions such as chronic urticaria and atopic contact dermatoses, and in histamine - mediated pruritus.20/08/10160Rosuvastatin 5/10/20mg+Fenofibrate 67/145/160mgFor the treatment of combined hyperlipidemia in patients with normal hepatic and renal function23/08/10161Fexofenadine 120mg + Montelukast 10mgFor treatment of allergic rhinitis in adults only31/08/10162Irinotecan HCl Trihydrate Injection 20 mg/ml (Pack Size 25ml)for the treatment of metastatic colorectal cancer .31.08.10163Cefixime SR 200mg/400mg + Ofloxacin SR 200mg/400mg TabletAdditional strength31.08.10164Ademetionine enteric coated Tablets ..200mg/400mgFor the management of intrahepatic cholestasis and liver disease.01.09.10165Memantine HCl ER Tablet 28mgin the treatment of moderate to severe Alzheimer's disease.06.09.10166Buserelin Acetate injection 1mg/ml (Additional Indication)indicated for the palliative (initial & maintenance treatment) of patients with hormone-dependent advanced carcinoma of the Prostate gland (Stage D).08.09.10167Etodolac 400mg/400mg + Thiocolchicoside 4mg/8mg tabletAdditional higher strength09.09.10168Montelukast Sodium 10 mg Tablet, Montelukast Sodium 4/5 mg Chewable Tablet and Montelukast Sodium Oral Granules (Additional Indication).For The relief of perennial allergic rhinitis in adults & pediatrics patients 6 months of age and older.11.09.10169Acyclovir SR Tablet 1200 mgFor the treatment of uncomplicated Herbis Zoster in immunocompetent patients.11.09.10170Lornoxicam 4mg + Eperisone 50mg tabletFor the improvement of myotonic conditions caused by neck shoulder arm syndrome, scapulumeral periarthiritis and low back pain in adult patients only13.09.10171Pirfenidone film coated tablet ...200mgFor the treatment of idiopathic pulmonary fibrosis.14.09.10172Beclomethasone Dipropionate IP0.025% w/w + Neomycin sulphate IP 0.5% w/wcreamAdditional lower strenth15.09.10173Amlodipine 5mg/2.5mg + Valsartan 320mg/80mg + HCTZ 12.5mg/12.5mg tabletAdditional strength21.09.10174Paracetamol 500mg/500mg +Thioclchicoside 4mg/8mg tabletFor the treatment of acute inflammation conditions associated with spasm in adults only21.09.10175Ketorolac Tromethamine 0.4% w/v +Moxifloxacin 0.5% w/v Opthalmic solutionAdditional lower strenth21.09.10176Nilotinib Capsules 150 mg.Treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase.29/09/10177Levocloperastine ( as Fendizoate) Suspension eq. to Levocloperastine Hcl20mg / 5ml.For the treatment of non productive cough in adult patients29.09.10178Zileuton uncoated bilayered extended release tablet ...600mgFor the prophylaxis and chronic treatment of asthma in adults.30.09.10179Etodolac 400mg + Paracetamol IP 500mg tabletAdditional higher strength01.10.10180Dried Aluminium Hydroxide Gel IP 600mg +Magnesium Hydroxide IP 300mg +Simethicone IP 25mg +Oxetacaine BP 10mg per 5ml syrupFor the treatment of symptoms of functional gastrointestinal disorders like irritable bowel syndrome, functional dyspepsia, peptic ulcer, gasteroesophagal reflux disease which include smooth muscle spasms, flatulence, abdominal distension, hyperacidity, gastric distress, bloting etc.05.10.10181S(-) Metoprolol Succinate ER Eq. toS (-) Metoprolol tartarate 25mg/50mg + Clopidogrel (IR) 75mg/75mg tabletFor the treatment of essential hypertension who need antiplatelet therapy especially for prophylaxis of atherombotic event.07.10.10182Exenatide Injection (Additional indication)Exenatide is a glucagon like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus.09.10.10183Bimatoprost Ophthalmic Solution 0.01% w/v (Additional Strength)Same as approved.09.10.10184Drosperinone + Ethinylestradiol tabletsSame as approvedFor the treatment of moderate acne vulgaris in adult females, who have no known contraindications to oral contraceptive therapy, and have achieved menarche. It should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.09.10.10185Etodolac USP 400mg +Tolperisone HCL150mg tabletFor the treatment of acute inflammation conditions associated with spasm in adults only11.10.10186Citicoline 500mg +Piracetam 400mg per 5 ml syrupAdditional dosage form11.10.10187Thiocolchicoside 0.25% +Methyl salicylate IP 100mg +Menthol IP 50mg +Absolute alchol IP 50mg per gm gelFor the topical treatment of painful muscles spasms of skeletal musculature11.10.10188Amlodipine Besylate IP Eq. to Amlodipine 10mg/5mg/2.5mg +Telmisartan 80mg/40mg/20mg + HCTZ 25mg/12.5mg/12.5mg tabletFor the treatment of essential hypertension12.10.10189Pregabalin 150mg/75mg +Methylcobalamin 750mcg +Alpha lipoic acid 100mg +Pyridoxine 3mg +Folic acid 1.5mg capsuleFor the treatment of painful diabetic neuropathy in adults only12.10.10190Ferrous bisglycinate 60mg + Zinc sulphate monohydrate Eq. to Zinc 14mg + Copper as copper sulphate 1 mg + Selenium as selenomethionine 70mcg + Vitamin B6 IP 10mg+ Methylcobalamin 1500mcg + Folic acid 5mg + Fish oil 10/40 (DHA 200mg) 500mg capsule.For Vitamin and mineral deficiency13.10.10191Combipack of 21 tablets of FDC ofEthinylestradiol IP 0.03 mg + Levonorgestrel IP 0.15 mg and 7 tablets of Ferrous Fumarate IP 75mg (Eq. to 24.375 mg of Ferrous iron)As contraceptive pill for women13.10.10192Amitriptyline Hydrochloride IP 4%w/w + Ketamine HCL eq. to Ketamine 2% w/w per gm cream.For the treatment of patients suffering from neuralgia13.10.10193Paracetamol IP 500mg + Phenylephrine HCL IP 5mg +Caffeine (anhydrous) IP 30mg + Diphenhydramine HCL IP 25mg tablet.For the treatment of fever associated with cold, nasal congestion in adults13.10.10194Levocetirizine dihydrochloride 2.5mg +Montelukast 5mg dispersible tabletAdditional strength13.10.10195Calcium citrate maleate Eq. to elemental calcium 250mg +Vitamin D3 IP 200 IU tabletFor the treatment of calcium and Vitamin D deficiency states13.10.10196Levonorgesterel 100mcg +Ethniyl estradiol IP 20mcg tablet(Additional indication) For the treatment of moderate acne vulgaris in women more than 18 years of age who have no therapy contraindications to oral contraceptive therapy, desire contraceptiopn, and have achieved menarche13.10.10197Eberconazole 1% w/w + Mometasone Furate USP 0.1% w/w creamFor the treatment of mild to moderate inflammed cutaneous mycoses13.10.10198Lubiprostone Soft Gelatin Capsules ..8mcg /24mcg1. For the treatment of chronic constipation in adults. 2. For the treatment of irritable bowel syndrome with constipation (IBS-C) in women > 18 years old.16.10.10199Pazopanib (as Hydrochloride) film coated Tablets200mg / 400mgFor the treatment of patients with advanced renal cell carcinoma.16.10.10200Eltrombopag (as Olamine) Tablets ...25mg / 50mgfor the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. (It should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. It should not be used in an attempt to normalize platelet counts).16.10.10201Tolperisone HCL 150mg + Paracetamol IP 500mg tabletFor the treatment of patients with acute painful musculoskeletal conditions21.10.10202Zaltoprofen film coated tablet 80mg JPFor anti inflammatory and analgesic activity in rheumatoid arthritis, osteoarthritis, low back pain, periarthritis of shoulder, cervicobrachial syndrome, postoperative, post trauma, and post dental extraction.31.10.10203Hyoscine Butylbromide 20 mg tablet (Additional Strength)Same as Approved.04.11.10204Cerebroprotein Hydrolysateinjection (Lyophilised) ..1050mg / 2100mg (approx)equivalent to nitrogen.30mg / 60mg respectively.For amelioration of cranial injury, cerebrovascular pathological sequelae and aprosexia in dementia.04.11.10205Clebopride (as Malate) (1)Tablets...0.5 mg Ph. Eur. (2.) Syrup...0.1 mg / ml Ph. Eur. (3.) Injection...1 mg / 2mlPh. Eur.For the treatment of various disorders associated with altered gastrointestinal motility like non-ulcer dyspepsia (NUD) and / or chronic gastritis, gastroesophageal reflux disease (GERD), nausea and vomiting of organic or functional origin.04.11.10206Tolperisone HCl Mouth Dissolving tablet 50/100 mg (Additional Dosage Form)Same as Approved.04.11.10207Oxybutynin Gel 100 mgFor the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency and urinary frequency.04.11.10208Dapoxetine ( asHydrochloride) Tablets 30mg/60mgFor the treatment of premature ejaculation(PE) in men 18 to 64 years of age.13.11.10209Opipramol dihydrochloride Tablet 50mg/100mg.For the Treatment of generalised anxiety disorder(GAD) and somatic disturbances.13.11.10.210Ondansetron Rapid Film Oral Strip 4/8 mgFor chemotherapeutic induced nausea and vomiting.16.11.10211Acebrophylline SR Tablet 200 mgFor the treatment of adult patients with chronic obstructive pulmonary disease (COPD) and bronchial asthma.23.11.10212Ammonium Lactate Cream 12% w/wIndicated For the treatment of Dry,scaly skin(xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these condition.03.12.2010213Rabeprazole Sodium Powder oral suspension( sachet of 20 mg) (Additional dasage form)Same as approved03.12.2010214Temsirolimus Concentrate for Infusion for Injection 25mg/mlFor the treatment of advanced renal cell carcinoma11.12.2010215Acetyl Cysteine Eye Drops 5% w/vIndicated the relief of Dry eye symptoms associated with defecient tear secretion, impaired or abnormal mucus Production.14.12.2010216Clindamycin Palmitate Hcl For Oral Solution 75mg/5ml.Indicated for the Prophylaxis against alpha-hemolytic(viridans group) sreptococci before dental, oral and upper respiratory tract surgery.14.12.2010217Deferasirox Tablet for Oral Suspension(Additional Sosage Form)Same as approved14.12.2010218Ramelteon film coated tablets 8mgFor the treatment of insomnia characterized by difficulty with sleep onset.15.12.2010219Memantine ER Tablet 7mg/14mg/21mg.(Additional Strength)Same as approved17.12.2010220Solution for haemofiltration and haemodialysis (Each unit contains two compartments A & B. Before reconstitution: 1000ml of electrolyte solution in Compartment A contains: Calcium Chloride. 2H2O .....5.145gm Magnesium Chloride. 2H2O.... 2.033gm Lactic Acid....5.4gm 1000ml of buffer solution in Compartment B contains: Sodium Chloride....6.45gm Sodium Bicarbonate....3.090gm )For treatment of acute kidney disease (renal failure),as substitution solution in continuous haemofiltration and haemodiafiltration and as a dialysis solution in continuous haemodialysis.23.12.2010221Pyridoxine HCL IP 3mg + Nicotinamide IP 100mg + Cyanocobalamin IP 15mcg + Folic acid IP 500mcg+ Chromium Picolinate USP 250mcg TabletFor Mineral & Vitamins deficiency states in adult patients23.12.2010222Rosuvastatin Calcium IP 5mg/10mg + Fenofibrate BP 160mg/160mg tabletAdditional strength29.12.2010223Chlorhexidine gluconate IP 1%w/v+ Ethyl Alcohol IP 61%w/v SolutionSurgical hand scrub & healthcare personnel hand wash29.12.2010224Streptococcus faecalis T-110 JPC 30 million + Clostridium butyricum TO-A2 million + Bacillus mesentericus TO-A JPC 1 million + Lactic acid bacillus (lactobacillus sporogenes) 50 million CapsulesFor restoration of intestinal microflora15-03-2010 LIST OF APPROVED DRUG FROM 01-01-2011 to 31-12-2011 S.NoName Of DrugIndicationDate of issueAlpha 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 CapsuleFor the treatment of diabetic neuropathy03.01.11Ropinirole ER Tablet 1 mg. (Additional Strength)Same as approved04.01.11Erlotinib HCl Tablet 150 mg (Additional Indication)Monotherapy for the Maintenance Treatment of Patients with locally advanced metastatic non-small lung cancer whose disease has not progressed after four cycles of Platinum based First Line Chemotherapy.04.01.11Moxifloxacin HCl BP 0.5% w/v + Bromfenac Sodium 0.09% w/v Eye dropFor the reduction of post operative inflammatory conditions of the eye05.01.11Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Cyanocobalamin IP 15mcg + Zinc Sulphate Monohydrate Eq. to Elemental Zinc 22.5mg TabletFor the treatment of iron deficiency anaemia05.01.11S (+) Etodolac 300mg +Thiocolchicoside 8mg TabletFor the treatment of patients with acute painful musculoskeletal conditions05.01.11Beclomethasone Dipropionate IP 100mcg + Formoterol Fumarate Dihydrate BP Eq. to Formoterol Fumarate 6 mcg Metered Dose InhalerFor the treatment of bronchial asthma where use of inhaled corticosteroid therapy found appropriate05.01.11Amlodipine Besilate IP Eq. to Amlodipine 5mg + Indapamide USP SR 1.5mg TabletFor the treatment of mild to moderate hypertension05.01.11Metformin HCl IP 500mg + Alpha Lipoic Acid USP 200mg TabletFor the treatment of patients with diabetic polyneuropathy05.01.11Spironolactone IP 25mg + Furosemide IP 40mg TabletAdditional strength05.01.11Bicalutamide Tablet 150 mg.(Additional Strength and Indication)Indicated either alone or as adjuvant to radical Prostatetomy or radiotherapy in Patients with Locally advanced Prostate cancer at High risk for disease Progression.05.01.11Paracetamol Chewable Tablet 500 mg. ( Additional Dosage Form)Same as approved05.01.11Methylcobalamin 500mcg + Folic Acid IP 1.5mg + Zinc Sulphate IP 25mg + Chromium Polynicotinate 200mcg + Selenium as Sodium Selenite USP 65 mcg + Inositol 100mg + Alpha Lipoic Acid 50mg + Streptococcus faecalis 30 Millions (30 lakh) + Clostridium butyricum 2 Million (20 lakh) + Bacillus mesentericus 1 Million (10 lakh) + Lactic acid bacillus 50 Million (500lakh) CapsuleFor Vitamins and Minerals deficiency states in adult patients11.01.11Dextromethorphan Extended Release Oral Suspension 30 mg per 5 mlFor the Relief of Persistent Dry irritating cough in adult patients Only.17.01.11Hydroquinone USP 2% w/w + Tretinoin USP 0.025% w/w + Allantoin USP 1%w/w GelFor treatment of hyper pigmentry disorders31.01.11Paracetamol Fast Release Tablet 500mg (Additional Dosage Form)Same as approved10.02.11Each bowel preparatory kit contains: One enteric coated tablet Biscodyl IP 5mg & One sachet of powder for reconstitution contains: Polyethylene glycol 3350NF: 210gm + Sodium Bicarbonate IP 2.86gm + Sodium Chloride IP 5.6gm + Potassium Chloride IP 0.74gmFor bowel cleansing prior to colonoscopy in adult patients only11.02.11Ferric Carboxymaltose equivalent to elemental Iron50mg/ml InjectionFor the treatment of iron deficiency in adults when oral iron preparations are ineffective or cannot be used.11.02.11Pidotimod Tablet 400 mg/800 mg & Oral Solution 400 mg/800 mg per 7mlFor infections of the respiratory system in secondary and primary immunodeficiency with alteration in maturation of T cells in adults only.11.02.11Ursodeoxycholic Acid Suspension 125mg/5ml and 250 mg /5ml.For the treatment of patients with chronic cholestatic liver disease.11.02.11Iloperidone Tablets 1mg/2mg/4mg/6mg/8mg /10mg/12mgFor the acute treatment of adults with schizophrenia.17.02.11Calf lung surfactant Intratracheal Suspension containing Phospholipids.... 35mg (containing 26 mg phosphatidylcholine of which 16mg is disaturated phosphatidylcholine) Proteins....0.65mg (including 0.26mg of surfactant associated proteins B) per ml(a). As a prophylaxis therapy for premature infants <29 weeks of gestational age at significant risk for Respiratory Distress Syndrome (RDS). (b). For the treatment of infants <72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotrachteal intubation.17.02.11Baclofen ER Capsule 10 mg/50 mg. (Additional Strength)Same as approved17.02.11Dexketoprofen Trometamol ER Tablet 50 mg (Additional Strength)Same as approved21.02.11Gatifloxacin Eye drop 5 mg/mlFor the treatment of bacterial conjunctivitis caused by susceptible strains21.02.11Paclitaxel Injection 30mg/100 mg/300 mg (additional Indication)Advanced squmous cell carcinoma of Head and Neck SCCHN: 1. Diagnosed but unrectable locally advanced SCCHN 2. Recurrent SCCHN, if surgery or radiation is not feasible. 3. Palliative treatment of metastatic SCCHN.24.02.11Eslicarbazepine Acetate Tablets 200mg/400mg/600mg/800mgAs an adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.07.03.11Ketoprofen Plaster ( Size - 7cm x 10 cm)For the Relief of Musculoskeletal pain and Inflammation.09.03.11Meropenem IP 1000mg + Sulbactam sodium USP 500mg injectionFor the treatment of lower respiratory tract infection caused by gram negative bacteria in adults only15.03.11Dasatinib 20mg/50mg/70mg (Additional Indication)Treatment of newly Diagnosed Adults with Chronic Myeloid Leukaemia (CML) in Chronic Phase.16.03.11Adenosylcobalamin 15mcg + Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Zinc Sulphate USP Eq. to Elemental Zinc 22.5mg tabletFor the treatment of iron deficiency anaemia in adults only21.03.11Tioconazole Vaginal Gel 65mg per gmFor the local treatment of vulvo vaginal candidiasis in adult patients.22.03.11Aspirin (EC Tablets) 75mg/75mg/150mg +Rosuvastatin (Granules) 5mg/10mg/10mg CapsulesFor the treatment of dyslipidemia associated with arthersclerotic arterial disease with risk of Myocardial infarction, stroke or peripheral vascular disease.30.03.11Ilaprazole Tablets 5mg/10mgFor the treatment of duodenal ulcer in adults only.05.04.11Asenapine Maleate Sublingual Tablets 5mg/10mgFor acute treatment of schizophrenia in adults only.07.04.11Cefpodoxime IP 100mg/100mg/200mg/200mg +Ofloxacin IP 100mg/200mg/100mg/200mg TabletsFor the Treatment of Lower and upper respiratory tract infection and Typhoid fever in adults only16.04.11Tapentadol Hydrochloride Tablets 50mg/75mg/100mgFor relief of moderate to severe acute pain in adults 18 years of age or older.18.04.11Cefixime Trihydrate IP Eq. to Anhydrous Cefixime 100mg/200mg + Ofloxacin IP 100mg/200mg Dispersible Tablet (Additional dosage form )Same as approved20.04.11S-Bupivacaine Hydrochloride Injection 2.5mg/5mg/7.5mg per mlFor surgical anaesthesia in adults for epidural (including caesarean section), intrathecal, peripheral nerve block.28.04.11Dexketoprofen 50mg + Dicyclomine 20mg per 2ml InjectionFor the treatment of acute colicky pain in adult patients28.04.11Gatifloxacin 0.3% + Loteprednol Etabonate 0.5% + Benzalkonium Chloride 0.01% w/v Opthalmic suspensionFor Post-Operative Steroid repulsive inflammatory Ocular conditions when Ocular bacterial infections or a risk of bacterial infection exists19.05.11Diclofenac Colestyramine 145.6 mg corresponding to 75mg Diclofenac Sodium Capsules.For the treatment of acute arthritis (including attacks of gout), chronic arthritis especially rheumatoid arthritis (chronic polyarthritis), ankylosing spondylitis (Morbus Bechterew) and other inflammatory, rheumatoid syndromes of vertebral column.19.05.11Brinzolamide Ophthalmic Suspension 1%w/vFor the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.26.05.11Besifloxacin Ophthalmic Suspension 0.6% w/vFor the treatment of bacterial conjunctivitis.31.05.11Diclofenac (as EC Tablets) 25mg + Paracetamol 325 mg Capsule (Additional Strength)Same as approved31.05.11Amlodipine 10mg/10mg+ Telmisartan 40mg/80mg Tablets (Additional Strength)Same as approved31.05.111. PROBIO : Each sachet (1g) contains: Total Probiotic.... Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) 2. PROBIO & PREBIO (F)s Each sachet (1g) contains: Probio (CMP 5) Total Probiotic...Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) Fructo Oligo Saccharides . 100mg 3. PROBIO & PREBIO (D) Each sachet (1.3g) contains: Probio (CMP 5) Total probiotic... not less than 1.25 billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) Fructo Oligo Saccharides...1000mg For the treatment of rotavirus diarrhoea.09.06.11Paracetamol 325mg + Tramadol Hydrochloride 37.5 mg TabletsAdditional indication. (For Symptomatic Treatment of Moderate To Severe Pain.)21.06.11Silodosin Capsules2mg/4mg/8mgFor the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in adults only.23.06.11Tiapride Hydrochloride Tablets 25mg/50mg/100mgFor the treatment of agitation and aggressiveness in adult patients with cognitive impairment.23.06.11 Fexofenadine 120mg + Montelukast 10mg Chewable tablet Additional dosage form 07.07.11Each Combipack of 21 tablets contains : A) FDC of Norgestrel & Ethinyl estradiol tablets IP Each sugar coated white tablet contains: Norgestrel 0.30mg & Ethinyl estradiol 0.03mg B) 7 tablets of Ferrous Fumarate: Each sugar coated tablet contains : - Ferrous Fumarate 75mg eq. to 24.375mg of ferrous ironAs contraceptive pill for women27.07.11Cefixime (SR) 400mg +Moxifloxacin (SR) 400 mg TabletsFor the treatment of lower respiratory tract infections in adults only08.08.11Alpha Lipoic acid 100mg + Folic acid 1.5mg + Methylcobalamin 1500mcg + Pyridoxine Hydrochloride 3mg + Vitamin D3 1000 IU TabletsFor the treatment of Diabetic neuropathy10.08.11Levosulpride (SR) 75mg + Rabeprazole sodium IP (EC Pellets) 20mg CapsuleFor the treatment of Gastro-oesophageal Reflux Disease (GERD)19.08.11Each 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 100mgFor the treatment of HIV infection in adults.23.08.11Diclofenac sodium (SR) 100mg + Eperisone Hydrochloride (SR) 150mg CapsulesFor the treatment of patient with acute musculoskeletal spasm associated with low back pain.24.08.11Rosuvastatin Calcium eq. to Rosuvastatin 20mg/20mg + Fenofibrate BP 67.5mg/145mg TabletsAdditional Strength24.08.11Eletriptan Hydrobromide Tablets 20mg/40mgFor the treatments of Migraine with or without aura in adults 25.08.11Acyclovir 50g + Hydrocortisone 10mg CreamFor the early treatment of recurrent cold sores in adult patients to reduce likelihood of ulcerative cold sores and to shorten the lesion healing time30.08.11Clindamycin Phosphate eq. to Clindamycin 1% w/w + Hydrous Benzoyl Peroxide eq. to Anhydrous Benzoyl peroxide 2.5% w/w topical gelFor topical treatment of inflammatory acne vulgaris (Additional lower strength)30.08.11Polyethylene glycol 0.4% w/v + Propylene Glycol 0.3% w/v Eye DropsFor temporary relief of burning and irritation due to dryness of the eye13.09.11Glutathione for Injection 600mgFor the treatment of alcoholic liver diseases like alcoholic fatty liver, alcoholic liver fibrosis, alcoholic liver cirrhosis, and hepatitis14.09.11Udenafil Tablet 100mg/200mgFor the treatment of erectile dysfunction15.09.11Metformin (ER )1000mg/500mg +Saxagliptin 2.5 mg/5mg TabletsAs an Adjunct to diet and exercise to improve glycemic control in adults patients with type 2 diabetes mellitus when treatment with both Saxagliptin and Metformin is appropriate19.09.11Ceftriaxone Sodium eq. to Ceftriaxone Sodium 1000mg/2000mg + Sulbactam Sodium eq. Sulbactam 500mg/500mg.injectionAdditional Indication - For the treatment of urinary tract infections and lower respiratory tract infections, various bacteria21.09.11Difluprednate 0.05% w/v + Moxifloxacin 0.5% w/v Eye DropsFor steroid responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists22.09.11S(-) Amlodipine 2.5mg/5mg + Clopidogrel 75mg/75mg Tablets For the treatment of high risk hypertensives who need anti-platelet therapy especially for prophylaxis of artherothrombotic events in patients with a history of recent stroke or established peripheral arterial disease22.09.11Acrivastine Capsules 8mgFor the symptomatic relief of allergic rhinitis.26.09.11Tacalcitol ointment 4mcgFor the treatment of psoriasis vulgaris in adults only.26.09.11Each Combipack contains: - A) One tablet of Risedronate Sodium - Each film coated tablet contains: Risedronate Sodium (as Risedronate Sodium Hemi-Pentahydrate) - 35 mg B) Six Capsules of FDC of Calcitriol +Calcium carbonate + Zinc Each soft gelatin capsule contains : - Calcitriol IP - 0.25mcg Calcium Carbonate IP - 500mg (eq. to elemental calcium 200mg) Zinc (as Zinc Sulphate USP) 7.5 mgFor the treatment of Osteoporosis in post menopausal women 30.09.11Akiskiren Hemifumarate eq. to Aliskiren 150mg/150mg/300mg/300mg +Amlodipine Besilate IP eq. to Amlodipine 5mg/10mg/5mg/10mg TabletsFor the treatment of hypertension: a) As initial therapy in the patient likely to need multiple drugs to achieve blood pressure control. B) In the patients whose blood pressure is not adequately controlled with the Aliskiren alone or Amlodipine (or another di-hydropyridine calcium channel blocker) alone. C) As replacement therapy in patients already receiving Aliskiren and Amlodipine from separate tablets at the same dose level. 12.10.1173.Ferrous Ascorbate eq. to elemental iron 100mg + Folic acid IP 1.1mg + Methylcobalamin 1.5mg +Zinc Sulphate monohydrate IP eq to elemental Zinc 22.5mg Tablets. (Additional strength) For the treatment of Iron deficiency anaemia19.10.1174.Arterolane Maleate 150mg + Piperaquine Phosphate 750mg TabletTreatment of acute uncomplicated malaria infection due to Plasmodium falciparum in adults.19.10.1175.Tafluprost Eye Drops 0.0015% w/vFor the reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension.21.10.1176.Gatifloxacin IP eq. to Gatifloxacin (Anhydrous) 3.0mg + Difluprednate 0.5mg + Benzalkonium Chloride IP (As preservative) 0.01% w/v Eye DropsFor the treatment in the patients with inflammatory occular conditions where bacterial infection or a risk of bacterial occular infection exists24.10.1177.Diazinon Flea Drops Spot on Dogs 30.0% w/wFor dogs infected with fleas.11.11.1178.Diclofenac Sodium IP (as sustained release Pellets) 100mg + Thiocolchicoside (as sustained release pellets) 16mg Capsule. (New Dosage Form)For the treatment of acute inflammation conditions associated with spasm in adults only.15.11.1179.Epalrestat 50mg + Methylcobalamin 500mcg TabletsFor the treatment of Diabetic Neuropathy16.11.1180.Cabazitaxel Injection 60mg / 1.5mlIn combination with prednisone for treatment of patients with hormone-refractory metastatic prostrate cancer previously treated with a docetaxel-containing treatment regimen.16.11.1181.Ketorolac Tromethamine IP 4.00mg + Olopatadine Hcl eq. to Olopatadine 1.00mg + Benzalkonium Chloride IP 0.05mg Ophthalmic solutionFor the treatment of seasonal allergic conjunctivitis in adults only21.11.1182.Tramadol Hcl IP (As Immediate Release Layer) 50mg + Diclofenac Sodium IP (As Sustained Release Layer) 75mg TabletsFor the symptomatic treatment of moderate to severe pain in adult patients21.11.1183.Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension. (Additional Strength)For the treatment of asthma where the use of corticosteroid and long acting beta agonist in combination is appropriate21.11.1184.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 TabletFor the treatment of essential hypertension23.11.1185.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 hypertension and as an adjunct to diet in patients to reduce elevated total cholesterol and triglyceride levels hypertension and dyslipidemia. The polypack should be used in patients for whom treatment with all of the three i.e Ramipril, Amlodipine and Atorvastatin is appropriate.28.11.1186.Rosuvastatin Calcium IP eq to Rosuvastatin 5mg + Ezetimibe 10mg. (Additional Strength)For the treatment of patients with primary hypercholesterolemia.05.12.1187.Tolperisone Hcl IP 150mg + Diclofenac IP 50mg TabletsFor the treatment of Patients with acute muscle/musculoskeletal spasm in adult07.12.1188.Paracetamol IP 325mg + Pamabrom USP 25mg TabletsFor the treatment of patient with pre-menstrual syndrome in adults only07.12.1190.Dosulepine Hcl 50mg/75mg + Methylcobalamin 1500mcg/1500mcg TabletsFor the treatment of neuropathic pain.08.12.1191.Trifluridine Eye Drops 1% w/v For the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex viruses type 1 and 2. 08.12.11 92.Dabigatran Etexilate( as Mesilate) hard gelatin Capsules 75mg/110mg/150mg For prevention of stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation.12.12.11 93.Montelukast Sodium IP eq.to Montelukast 10mg +Olopatadine Hcl 5mg TabletsFor the treatment of relief of symptoms of allergic rhinitis16.12.1194.Fosaprepitant (as Dimeglumine) for Injection 150mg. 1. Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults. 2. Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.16.12.11 95.Abiraterone Acetate Tablets 250mg In combination with prednisone for the treatment of patients with metastatic castration-resistant prostrate cancer who have received prior chemotherapy containing docetaxel.16.12.11 96.Crizotinib hard gelatin Capsules 200mg/250mg For the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as detected by an FDA-approved test.16.12.11 97.Amlodipine Besilate IP eq. to Amlodipine 5mg + Perindopril Erbumine BP 8mg Tablets. (Additional Strength).For the treatment of mild to moderate hypertension in adults only and or treatment of stable coronary artery disease in patients already controlled with Perindopril & Amlodipine given concurrently at same dose level20.12.1198.Iron Amino Acid Chelate as Ferrous Bisglycinate (75mg) eq. to Elemental Iron 15mg + Folic acid IP 0.25mg + Vitamin B 12 IP 3.75mcg +Zinc Picolinate (26mg) eq. to Elemental Zinc 5.5mg SyrupFor the treatment of Iron Deficiency Anaemia22.12.11 LIST OF APPROVED DRUG FROM 01-01-2012 to Till Date S.No Name Of DrugIndicationDate of issueOrnidazole IP 1 % w/w + Povidone Iodine IP (0.5% w/w available Iodine) 5% w/w OintmentFor the prevention and treatment of surgical wound infections in adult patients undergoing surgery03.01.12Aceclofenac IP (Sustained released pellets) 200mg/200mg + Thiocolchicoside IP (Sustained released pellets) 8mg/16mg Capsules. (New Dosage Form)For the treatment of acute inflammation conditions associated with spasm in adults only04.01.12 3.Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension. (Additional Indication)In the regular treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with frequent symptoms and a history of exacerbations. 04.01.12 4.Diclofenac Sodium IP (Enteric coated granules) 50mg + Eperisone Hcl IP (Tablet) 50mg Hard Gelatin Capsules. (New Dosage Form)For the treatment of Patients with acute musculoskeletal spasm associated with low back pain06.01.125Degarelix for Injection 80mg / 120mg per vialFor the treatment of adult patients with advanced hormone dependent prostate cancer. 19.01.126Linagliptin film coated Tablet 5mg As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important limitations of use: 1. Should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. 2. Has not been studied in combination with insulin. 23.01.127Eribulin mesylate solution for injection 0.88mg / 2ml vial For the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.27.01.128Plerixafor Injection 20mg/mlIn combination with Granulocyte Colony Stimulating Factor (G-CSF) to enhance mobilisation of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous hematopoeitic stem cells transplantation in patients with non-Hodgkins lymphoma and multiple myeloma whose cells mobilise poorly.31.01.129Cephalexin IP (as monohydrate) 200mg + Kanamycin IP (as monosulphate) 100,000 IU Suspension per 10 gm Intramammary SuspensionFor the treatment of clinical mastitis in lactating dairy cows for bacteria susceptible to the combination of cephalexin and kanamycin such as Staphylococcus aureus, Streptococcus dysgalactiae, Streptococcus uberis and Escheria coli.07.03.12 $%&+,-9:XYijklmxy%&'()ӛӛӛӇӇӐӇӐӐӇӐӐӇӐӐCJOJPJQJCJOJPJQJaJ#5B*CJOJPJQJ\aJph'5B*CJOJPJQJ\^JaJph#5B*CJOJPJQJ\^JphCJOJPJQJaJ#5B*CJOJPJQJ\aJphB*CJOJPJQJaJph5%&-:Yjddd$If[$\$H$$IfI)fg'    @ t g'622 l4a$ddd$If[$\$a$ ddd[$\$^jkmysccsddd$If[$\$$ddd$If[$\$a$x$$If\g$)fK f f f  tg'622 l4akXHHXddd$If[$\$$ddd$If[$\$a$$$Ifg\g$)fK f f f   t(g'622 l4apsccsddd$If[$\$$ddd$If[$\$a$x$$Ifg\g$)fK f f f  tg'622 l4a&kXHHXddd$If[$\$$ddd$If[$\$a$$$Ifg\g$)fK f f f   t(g'622 l4a&')<S\sccsddd$If[$\$$ddd$If[$\$a$x$$Ifo\g$)fK f f f  tg'622 l4a);<RS[\]^_ipq#$,-./0:;@AIJKMNVWhiqrsuvCJOJPJQJaJCJOJPJQJaJCJOJPJQJY\]_qk8XHHXddd$If[$\$$ddd$If[$\$a$$$Ifg\g$)fK f f f   t(g'622 l4asccsddd$If[$\$$ddd$If[$\$a$x$$IfI\g$)fK f f f  tg'622 l4a$-kPXHHXddd$If[$\$$ddd$If[$\$a$$$Ifg\g$)fK f f f   t(g'622 l4a-.0;AJtsccsddd$If[$\$$ddd$If[$\$a$x$$Ifg\g$)fK f f f  tg'622 l4aJKNWirkXHHXddd$If[$\$$ddd$If[$\$a$$$Ifg\g$)fK f f f   t(g'622 l4arsvsccsddd$If[$\$$ddd$If[$\$a$x$$Ifg\g$)fK f f f  tg'622 l4akXHHXddd$If[$\$$ddd$If[$\$a$$$Ifg\g$)fK f f f   t(g'622 l4asccsddd$If[$\$$ddd$If[$\$a$x$$Ifg\g$)fK f f f  tg'622 l4a#*+67HIQRSUVcdstu ()12356?@MNVWXZ[eftu}~CJOJPJQJCJOJPJQJaJCJOJPJQJaJY+IRkXHHXddd$If[$\$$ddd$If[$\$a$$$Ifg\g$)fK f f f   t(g'622 l4aRSVusccsddd$If[$\$$ddd$If[$\$a$x$$Ifg\g$)fK f f f  tg'622 l4akXHHXddd$If[$\$$ddd$If[$\$a$$$Ifg\g$)fK f f f   t(g'622 l4asccsddd$If[$\$$ddd$If[$\$a$x$$Ifg\g$)fK f f f  tg'622 l4a)2k,XHHXddd$If[$\$$ddd$If[$\$a$$$Ifg\g$)fK f f f   t(g'622 l4a236@NWsccsddd$If[$\$$ddd$If[$\$a$x$$If#\g$)fK f f f  tg'622 l4aWX[fu~kXHHXddd$If[$\$$ddd$If[$\$a$$$Ifg\g$)fK f f f   t(g'622 l4a~sccsddd$If[$\$$ddd$If[$\$a$x$$Ifg\g$)fK f f f  tg'622 l4akXHHXddd$If[$\$$ddd$If[$\$a$$$Ifg\g$)fK f f f   t(g'622 l4a   5 6 7 < = > J K i j z { | ~   #5B*CJOJPJQJ\aJph'5B*CJOJPJQJ\^JaJph#5B*CJOJPJQJ\^Jph#5B*CJOJPJQJ\aJphCJOJPJQJCJOJPJQJaJCJOJPJQJaJ; sccsddd$If[$\$$ddd$If[$\$a$x$$Ifg\g$)fK f f f  tg'622 l4a       6 kiiiiiiV$ddd$If[$\$a$$$Ifg\g$)fK f f f   t(g'622 l4a6 7 > K j { ddd$If[$\$$ddd$If[$\$a$H$$If0*f(    @ t (622 l4a{ |  qaaqddd$If[$\$$ddd$If[$\$a${$$If\:#0*f f&f{f{ t(622 l4a qaaqddd$If[$\$$ddd$If[$\$a${$$If9\:#0*f f&f{f{ t(622 l4a iVFFVddd$If[$\$$ddd$If[$\$a$$$If9\:#0*f f&f{f{  t((622 l4a  & qaaqddd$If[$\$$ddd$If[$\$a${$$If9\:#0*f f&f{f{ t(622 l4a  % & ' ) * 3 4 9 : D E F H I S T \ ] g h i k l w x      " # ( ) 3 4 5 7 8 B C S T ^ _ ` b c x y CJOJPJQJCJOJPJQJaJCJOJPJQJaJY& ' * 4 : E i|VFFVddd$If[$\$$ddd$If[$\$a$$$If9\:#0*f f&f{f{  t((622 l4aE F I T ] h qaaqddd$If[$\$$ddd$If[$\$a${$$If9\:#0*f f&f{f{ t(622 l4ah i l x iVFFVddd$If[$\$$ddd$If[$\$a$$$If9\:#0*f f&f{f{  t((622 l4a qaaqddd$If[$\$$ddd$If[$\$a${$$If9\:#0*f f&f{f{ t(622 l4a iVFFVddd$If[$\$$ddd$If[$\$a$$$If9\:#0*f f&f{f{  t((622 l4a  qaaqddd$If[$\$$ddd$If[$\$a${$$If9\:#0*f f&f{f{ t(622 l4a   # ) 4 i|VFFVddd$If[$\$$ddd$If[$\$a$$$If9\:#0*f f&f{f{  t((622 l4a4 5 8 C T _ qaaqddd$If[$\$$ddd$If[$\$a${$$If9\:#0*f f&f{f{ t(622 l4a_ ` c y iVFFVddd$If[$\$$ddd$If[$\$a$$$If9\:#0*f f&f{f{  t((622 l4a qaaqddd$If[$\$$ddd$If[$\$a${$$If9\:#0*f f&f{f{ t(622 l4a    ' ( 2 3 4 6 7 B C Q R \ ] ^ ` a l m } ~       " # / 0 > ? 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