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U.S. Department of Health and Human Services

Drugs

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Approvals - September 2005

 ANDA NumberGeneric Drug NameApplicantApproval Date
176-447FEXOFENADINE HYDROCHLORIDE TABLETS, 30 MG, 60 MG, AND 180 MG  TEVA PHARMACEUTICALS, USA9/1/2005 
277-113METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 750 MG  MYLAN PHARMACEUTICALS, INC.9/8/2005 
377-353ALLOPURINOL TABLETS USP, 100 MG AND 300 MG  APOTEX INC.9/8/2005 
477-483BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS, 5 MG/6.25 MG, 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG  RANBAXY LABORATORIES LIMITED9/8/2005 
577-115MIDAZOLAM HYDROCHLORIDE SYRUP, 2 MG (BASE)/ML  APOTEX INC.9/9/2005 
677-321LISINOPRIL TABLETS USP, 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG  LUPIN LIMITED9/9/2005 
776-650METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 500 MG  MYLAN PHARMACEUTICALS, INC.9/13/2005 
876-985METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 750 MG  IMPAX LABORATORIES, INC.9/13/2005 
977-083LEFLUNOMIDE TABLETS, 10 MG AND 20 MG  BARR LABORATORIES, INC.9/13/2005 
1077-084LEFLUNOMIDE TABLETS, 10 MG AND 20 MG  TEVA PHARMACEUTICALS USA9/13/2005 
1177-085LEFLUNOMIDE TABLETS, 10 MG AND 20 MG  SANDOZ, INC.9/13/2005 
1277-086LEFLUNOMIDE TABLETS, 10 MG AND 20 MG  KALI LABORATORIES, INC.9/13/2005 
1377-087LEFLUNOMIDE TABLETS, 10 MG AND 20 MG  SANDOZ, INC.9/13/2005 
1477-090LEFLUNOMIDE TABLETS, 10 MG AND 20 MG  APOTEX, INC.9/13/2005 
1576-605GABAPENTIN TABLETS, 60O MG AND 800 MG  RANBAXY LABORATORIES LIMITED9/14/2005 
1676-498TRETINOIN CREAM USP (EMOLLIENT), 0.05%  SPEAR PHARMACEUTICALS9/15/2005 
1776-587ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%  TARO PHARMACEUTICALS USA, INC.9/15/2005 
1877-314NIZATIDINE CAPSULES USP, 150 MG AND 300 MG  DR. REDDY'S LABORATORIES LIMITED9/15/2005 
1940-590ERGOTAMINE TARTRATE AND CAFFEINE TABLETS USP, 1 MG/100 MG  MIKART, INC.9/16/2005 
2076-844ZIDOVUDINE TABLETS USP, 300 MG  ROXANE LABORATORIES, INC.9/19/2005 
2177-267ZIDOVUDINE TABLETS USP, 300 MG  AUROBINDO PHARMA LIMITED9/19/2005 
2277-268ZIDOVUDINE ORAL SOLUTION USP, 50 MG/5 ML  AUROBINDO PHARMA LIMITED9/19/2005 
2377-327ZIDOVUDINE TABLETS USP, 300 MG  RANBAXY LABORATORIES LIMITED9/19/2005 
2477-139CARBOPLATIN INJECTION, 10 MG/ML; 5 ML, 15 ML, 45 ML, AND 60 ML VIALS  SICOR PHARMACEUTICALS, INC.9/21/2005 
2565-170MUPIROCIN OINTMENT USP, 2 %  TARO PHARMACEUTICALS U.S.A., INC.9/23/2005 
2675-677ACYCLOVIR CAPSULES USP, 200 MG  APOTEX INC.9/28/2005 
2776-957FLUCONAZOLE TABLETS, 50 MG, 100 MG, AND 200 MG  UNIQUE PHARMACEUTICAL LABORATORIES9/28/2005 
2876-961FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS, 10 MG/12.5 MG AND 20 MG/12.5 MG  SANDOZ INC.9/28/2005 
2977-246DANAZOL CAPSULES USP, 200 MG  LANNETT HOLDINGS, INC.9/28/2005 
3077-442PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, 120 MG  RANBAXY LABORATORIES LIMITED9/28/2005 
3140-626PRIMIDONE TABLETS USP, 50 MG AND 250 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.9/29/2005 
3277-309ACYCLOVIR TABLETS USP, 400 MG AND 800 MG  APOTEX INC.9/29/2005