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U.S. Department of Health and Human Services

Drugs

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Approvals - January 2005

  ANDA Number Generic Drug Name Applicant Approval Date
1 65-167 CYCLOSPORINE ORAL SOLUTION USP (MODIFIED) 100 MG/ML   NOVEX PHARMA 1/5/2005 
2 76-813 ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS 60 MG   WEST-WARD PHARMACEUTICAL CORP. 1/7/2005 
3 77-218 POTASSIUM IODIDE ORAL SOLUTION, USP 65 MG/ML   FLEMING & COMPANY, PHARMACEUTICALS 1/12/2005 
4 76-837 FLUCONAZOLE 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 
5 76-049 QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   ANDRX PHARMACEUTICALS, INC. 1/14/2005 
6 77-095 METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 G   AUROBINDO PHARMA LIMITED 1/14/2005 
7 76-043 TERCONAZOLE VAGINAL CREAM 0.4%   TARO PHARMACEUTICALS USA, INC. 1/19/2005 
8 76-673 CIPROFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%   HI-TECH PHARMACAL CO., INC. 1/21/2005 
9 65-191 AMOXICILLIN 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 PHARMACEUTICALS 1/25/2005 
10 65-210 CLARITHROMYCIN EXTENDED-RELEASE TABLETS 1000 MG   RANBAXY LABORATORIES LIMITED 1/26/2005 
11 76-144 MIDAZOLAM HYDROCHLORIDE INJECTION 1 MG/ML (SYRINGE) AND 5 MG/ML (SYRINGE)   INTERNATIONAL MEDICATION SYSTEMS, LTD. 1/26/2005 
12 76-361 LEVOFLOXACIN TABLETS 750 MG   TEVA PHARMACEUTICALS USA 1/26/2005 
13 76-703 DESMOPRESSIN ACETATE NASAL SOLUTION 0.01% (NASAL SPRAY)   APOTEX INC. 1/27/2005 
14 76-821 GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS 1.25 MG/250 MG, 2.5 MG/500 MG, AND 5 MG/500 MG   TEVA PHARMACEUTICALS USA 1/27/2005 
15 76-899 SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS, USP 400 MG/80 MG AND 800 MG/160 MG (DOUBLE STRENGTH)   INTERPHARM, INC. 1/27/2005 
16 76-036 QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   PAR PHARMACEUTICAL, INC. 1/28/2005 
17 76-258 FENTANYL TRANSDERMAL SYSTEMS 25 MCG/HOUR, 50 MCG/HOUR, 75 MCG/HOUR, AND 100 MCG/HOUR   MYLAN TECHNOLOGIES, INC. 1/28/2005 
18 76-900 ATENOLOL TABLETS, USP 25 MG, 50 MG, AND 100 MG   ZYDUS PHARMACEUTICALS USA, INC. 1/28/2005 
19 40-530 TESTOSTERONE CYPIONATE INJECTION, USP 200 MG/ML; PACKAGED IN 1 ML AND 10 ML MULTIPLE-DOSE VIALS   PADDOCK LABORATORIES 1/31/2005 
20 65-217 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 75 MG (BASE), 150 MG (BASE), AND 300 MG (BASE)   ZYDUS PHARMACEUTICALS USA, INC. 1/31/2005 

 

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