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U.S. Department of Health and Human Services

Drugs

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Approvals - January 2005

 ANDA NumberGeneric Drug NameApplicantApproval Date
165-167CYCLOSPORINE ORAL SOLUTION USP (MODIFIED) 100 MG/ML  NOVEX PHARMA1/5/2005 
276-813ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS 60 MG  WEST-WARD PHARMACEUTICAL CORP.1/7/2005 
377-218POTASSIUM IODIDE ORAL SOLUTION, USP 65 MG/ML  FLEMING & COMPANY, PHARMACEUTICALS1/12/2005 
476-837FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE FLEXIBLE PLASTIC CONTAINERS  SICOR PHARMACEUTICALS, INC.1/13/2005 
576-049QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  ANDRX PHARMACEUTICALS, INC.1/14/2005 
677-095METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 G  AUROBINDO PHARMA LIMITED1/14/2005 
776-043TERCONAZOLE VAGINAL CREAM 0.4%  TARO PHARMACEUTICALS USA, INC.1/19/2005 
876-673CIPROFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%  HI-TECH PHARMACAL CO., INC.1/21/2005 
965-191AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, U 200 MG/28.5 MG(BASE) PER 5 ML AND 400 MG/57 MG (BASE) PER 5 ML  HIKMA PHARMACEUTICALS1/25/2005 
1065-210CLARITHROMYCIN EXTENDED-RELEASE TABLETS 1000 MG  RANBAXY LABORATORIES LIMITED1/26/2005 
1176-144MIDAZOLAM HYDROCHLORIDE INJECTION 1 MG/ML (SYRINGE) AND 5 MG/ML (SYRINGE)  INTERNATIONAL MEDICATION SYSTEMS, LTD.1/26/2005 
1276-361LEVOFLOXACIN TABLETS 750 MG  TEVA PHARMACEUTICALS USA1/26/2005 
1376-703DESMOPRESSIN ACETATE NASAL SOLUTION 0.01% (NASAL SPRAY)  APOTEX INC.1/27/2005 
1476-821GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS 1.25 MG/250 MG, 2.5 MG/500 MG, AND 5 MG/500 MG  TEVA PHARMACEUTICALS USA1/27/2005 
1576-899SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS, USP 400 MG/80 MG AND 800 MG/160 MG (DOUBLE STRENGTH)  INTERPHARM, INC.1/27/2005 
1676-036QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  PAR PHARMACEUTICAL, INC.1/28/2005 
1776-258FENTANYL TRANSDERMAL SYSTEMS 25 MCG/HOUR, 50 MCG/HOUR, 75 MCG/HOUR, AND 100 MCG/HOUR  MYLAN TECHNOLOGIES, INC.1/28/2005 
1876-900ATENOLOL TABLETS, USP 25 MG, 50 MG, AND 100 MG  ZYDUS PHARMACEUTICALS USA, INC.1/28/2005 
1940-530TESTOSTERONE CYPIONATE INJECTION, USP 200 MG/ML; PACKAGED IN 1 ML AND 10 ML MULTIPLE-DOSE VIALS  PADDOCK LABORATORIES1/31/2005 
2065-217CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 75 MG (BASE), 150 MG (BASE), AND 300 MG (BASE)  ZYDUS PHARMACEUTICALS USA, INC.1/31/2005