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U.S. Department of Health and Human Services

Drugs

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Approvals - December 2005

 ANDA NumberGeneric Drug NameApplicantApproval Date
177-053RIBAVIRIN TABLETS, 200 MG  TEVA PHARMACEUTICALS, INC.12/5/2005 
277-094RIBAVIRIN TABLETS, 200 MG  ZYDUS PHARMACEUTICALS USA, INC.12/5/2005 
377-456RIBAVIRIN TABLETS, 200 MG, 400 MG, AND 600 MG  THREE RIVERS PHARMACEUTICALS, LLC12/5/2005 
465-208CEFPROZIL TABLETS USP, 250 MG AND 500 MG  TEVA PHARMACEUTICALS USA12/6/2005 
576-446OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 10 MG, 20 MG, AND 40 MG  IMPAX LABORATORIES, INC.12/6/2005 
676-610OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 10 MG, 20 MG, AND 40 MG  TEVA PHARMACEUTICALS, USA12/6/2005 
777-272CARBAMAZEPINE TABLETS USP, 100 MG, 200 MG, 300 MG, AND 400 MG  CARACO PHARMACEUTICAL LABORATORIES, LTD.12/7/2005 
865-236CEFPROZIL FOR ORAL SUSPENSION USP, 125 MG/5 ML AND 250 MG/5 ML  TEVA PHARMACEUTICALS USA12/8/2005 
965-257CEFPROZIL FOR ORAL SUSPENSION USP, 125 MG/5 ML AND 250 MG/5 ML  SANDOZ INC.12/8/2005 
1065-276CEFPROZIL TABLETS USP, 250 MG AND 500 MG  LUPIN LIMITED12/8/2005 
1165-285DOXYCYCLINE TABLETS, 50 MG AND 100 MG  LANNETT HOLDINGS, INC.12/8/2005 
1277-290OXYCODONE HYDROCHLORIDE TABLETS USP, 5 MG, 10 MG, 15 MG, 20 MG, AND 30 MG  KV PHARMACEUTICAL COMPANY12/8/2005 
1377-376MIRTAZAPINE ORALLY DISINTEGRATING TABLETS, 15 MG AND 30 MG  AUROBINDO PHARMA LIMITED12/8/2005 
1465-179AZITHROMYCIN FOR INJECTION, 500 MG/VIAL  AMERICAN PHARMACEUTICAL PARTNERS, INC.12/13/2005 
1575-831BISOPROLOL FUMARATE TABLETS, 5 MG AND 10 MG  MYLAN PHARMACEUTICALS, INC.12/14/2005 
1676-809CLOZAPINE TABLETS USP, 50 MG, 100 MG, AND 200 MG  GOLDLINE LABORATORIES, INC.12/16/2005 
1777-184TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, 37.5 MG/325 MG  CARACO PHARMACEUTICAL LABORATORIES LTD.12/16/2005 
1865-261CEFPROZIL FOR ORAL SUSPENSION USP, 125 MG/5 ML AND 250 MG/5 ML  LUPIN LIMITED12/19/2005 
1965-267CEFPROZIL TABLETS USP, 250 MG AND 500 MG  ORCHID HEALTHCARE12/19/2005 
2077-426RANITIDINE TABLETS USP, 150 MG AND 300 MG  COBALT PHARMACEUTICALS, INC.12/19/2005 
2140-664METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION USP, 40 MG (BASE)/FLIPTOP VIAL  HOSPIRA INC.12/20/2005 
2240-665METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION USP, 125 MG (BASE)/FLIPTOP VIAL  HOSPIRA INC.12/20/2005 
2377-241BACLOFEN TABLETS USP, 20 MG  LANNETT HOLDINGS, INC.12/20/2005 
2465-281DOXYCYCLINE HYCLATE DELAYED-RELEASE CAPSULES USP, 75 MG (BASE) AND 100 MG (BASE)  SANDOZ INC.12/21/2005 
2577-124METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 500 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.12/21/2005 
2677-635ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.12/22/2005 
2777-636ZONISAMIDE CAPSULES, 100 MG  WOCKHARDT LIMITED12/22/2005 
2877-637ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG  MYLAN PHARMACEUTICALS, INC.12/22/2005 
2977-639ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG  BARR LABORATORIES, INC.12/22/2005 
3077-641ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG  TEVA PHARMACEUTICALS USA12/22/2005 
3177-642ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG  APOTEX INC.12/22/2005 
3277-644ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG  SANDOZ INC.12/22/2005 
3377-645ZONISAMIDE CAPSULES, 100 MG  DR. REDDY'S LABORATORIES LIMITED12/22/2005 
3477-647ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG  ALPHAPHARM PTY LTD12/22/2005 
3577-648ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG  ROXANE LABORATORIES, INC.12/22/2005 
3677-370GLIMEPIRIDE TABLETS, 1 MG, 2 MG, 4 MG, AND 8 MG  PAR PHARMACEUTICAL INC.12/23/2005 
3776-310CABERGOLINE TABLETS, 0.5 MG  PAR PHARMACEUTICAL, INC.12/29/2005 
3876-520FENOFIBRATE TABLETS, 107 MG  PAR PHARMACEUTICAL, INC.12/29/2005 
3940-608OXYCODONE AND ACETAMINOPHEN TABLETS USP, 2.5 MG/300 MG, 5 MG/300 MG, 7.5 MG/300 MG, AND 10 MG/300 MG  MIKART INC.12/30/2005 
4065-284CEFPROZIL FOR ORAL SUSPENSION USP, 125 MG/5 ML AND 250 MG/5 ML  ORCHID HEALTHCARE12/30/2005