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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - September 2005

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
177-268ZIDOVUDINE ORAL SOLUTION, USP 50 MG/5 ML  AUROBINDO PHARMA LIMITED9/7/2005 
277-351FAMOTIDINE TABLETS USP, 20 MG (OTC)  PERRIGO R&D COMPANY9/9/2005 
377-100DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP, 125 MG, 250 MG, AND 500 MG  ZYDUS PHARMACEUTICALS USA, INC.9/9/2005 
477-143DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, 250 MG  RANBAXY LABORATORIES LIMITED9/12/2005 
577-261GABAPENTIN CAPSULES, 100 MG, 300 MG, AND 400 MG  TARO PHARMACEUTICALS USA, INC.9/13/2005 
677-018METRONIDAZOLE TOPICAL GEL USP, 0.75%  ALTANA INC.9/13/2005 
776-953TOLTERODINE TARTRATE TABLETS, 1 MG AND 2 MG  RANBAXY LABORATORIES LIMITED9/15/2005 
877-053RIBAVIRIN TABLETS, 200 MG  TEVA PHARMACEUTICALS USA9/15/2005 
977-206SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)  AUROBINDO PHARMA LIMITED9/16/2005 
1077-138CIPROFLOXACIN AND DEXTROSE (5%) INJECTION USP, 2 MG/ML; 100 ML AND 200 ML PLASTIC CONTAINERS  SICOR PHARMACEUTICALS, INC.9/21/2005 
1177-274GLIMEPIRIDE TABLETS, 1 MG, 2 MG, AND 4 MG  COREPHARMA, LLC9/21/2005 
1277-094RIBAVIRIN TABLETS, 200 MG  ZYDUS PHARMACEUTICALS USA, INC.9/30/2005