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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - September 2006

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-314 TOPIRAMATE TABLETS 50 MG MYLAN PHARMACEUTICALS, INC. 9/11/2006
2 77-535 ONDANSETRON HYDROCHLORIDE TABLETS 4 MG (BASE), 8 MG (BASE), AND 24 MG (BASE) GLENMARK PHARMACEUTICALS LIMITED 9/12/2006
3 77-411 LAMIVUDINE AND ZIDOVUDINE TABLETS 150 MG/300 MG CIPLA LIMITED 9/13/2006
4 77-900 RAMIPRIL CAPSULES 1.25 MG, 2.5 MG, 5 MG, AND 10 MG ROXANE LABORATORIES, INC. 9/13/2006
5 77-884 ZOLPIDEM TARTRATE TABLETS 5 MG AND 10 MG APOTEX INC. 9/15/2006
6 78-158 FOSPHENYTOIN 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
7 76-882 SERTRALINE HYDROCHLORIDE TABLETS 125 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) APOTEX INC. 9/27/2006
8 77-687 CICLOPIROX TOPICAL SOLUTION 8% (NAIL LACQUER) QLT USA, INC. 9/27/2006
9 77-643 TOPIRAMATE TABLETS 25 MG, 50 MG, 100 MG, AND 200 MG COBALT PHARMACEUTICALS INC. 9/29/2006
10 77-993 OLANZAPINE TABLETS 5 MG ROXANE LABORATORIES, INC. 9/29/2006
11 77-623 CICLOPIROX TOPICAL SOLUTION 8% (NAIL LACQUER) PERRIGO COMPANY 9/29/2006
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