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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - September 2005

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 77-268 ZIDOVUDINE ORAL SOLUTION, USP 50 MG/5 ML   AUROBINDO PHARMA LIMITED 9/7/2005 
2 77-351 FAMOTIDINE TABLETS USP, 20 MG (OTC)   PERRIGO R&D COMPANY 9/9/2005 
3 77-100 DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP, 125 MG, 250 MG, AND 500 MG   ZYDUS PHARMACEUTICALS USA, INC. 9/9/2005 
4 77-143 DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, 250 MG   RANBAXY LABORATORIES LIMITED 9/12/2005 
5 77-261 GABAPENTIN CAPSULES, 100 MG, 300 MG, AND 400 MG   TARO PHARMACEUTICALS USA, INC. 9/13/2005 
6 77-018 METRONIDAZOLE TOPICAL GEL USP, 0.75%   ALTANA INC. 9/13/2005 
7 76-953 TOLTERODINE TARTRATE TABLETS, 1 MG AND 2 MG   RANBAXY LABORATORIES LIMITED 9/15/2005 
8 77-053 RIBAVIRIN TABLETS, 200 MG   TEVA PHARMACEUTICALS USA 9/15/2005 
9 77-206 SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)   AUROBINDO PHARMA LIMITED 9/16/2005 
10 77-138 CIPROFLOXACIN AND DEXTROSE (5%) INJECTION USP, 2 MG/ML; 100 ML AND 200 ML PLASTIC CONTAINERS   SICOR PHARMACEUTICALS, INC. 9/21/2005 
11 77-274 GLIMEPIRIDE TABLETS, 1 MG, 2 MG, AND 4 MG   COREPHARMA, LLC 9/21/2005 
12 77-094 RIBAVIRIN TABLETS, 200 MG   ZYDUS PHARMACEUTICALS USA, INC. 9/30/2005 
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