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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - September 2006

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-314TOPIRAMATE TABLETS 50 MGMYLAN PHARMACEUTICALS, INC.9/11/2006
277-535ONDANSETRON HYDROCHLORIDE TABLETS 4 MG (BASE), 8 MG (BASE), AND 24 MG (BASE)GLENMARK PHARMACEUTICALS LIMITED9/12/2006
377-411LAMIVUDINE AND ZIDOVUDINE TABLETS 150 MG/300 MGCIPLA LIMITED9/13/2006
477-900RAMIPRIL CAPSULES 1.25 MG, 2.5 MG, 5 MG, AND 10 MGROXANE LABORATORIES, INC.9/13/2006
577-884ZOLPIDEM TARTRATE TABLETS 5 MG AND 10 MGAPOTEX INC.9/15/2006
678-158FOSPHENYTOIN SODIUM INJECTION USP, 75 MG/ML (50 MG PE/ML), PACKAGED IN 100 MG PE/2 ML AND 500 MG PE/10 ML SINGLE-DOSE VIALS (PE=PHENYTOIN SODIUM EQUIVALENTS)HOSPIRA INC.9/21/2006
776-882SERTRALINE HYDROCHLORIDE TABLETS 125 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)APOTEX INC.9/27/2006
877-687CICLOPIROX TOPICAL SOLUTION 8% (NAIL LACQUER)QLT USA, INC.9/27/2006
977-643TOPIRAMATE TABLETS 25 MG, 50 MG, 100 MG, AND 200 MGCOBALT PHARMACEUTICALS INC.9/29/2006
1077-993OLANZAPINE TABLETS 5 MGROXANE LABORATORIES, INC.9/29/2006
1177-623CICLOPIROX TOPICAL SOLUTION 8% (NAIL LACQUER)PERRIGO COMPANY9/29/2006