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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - April 2003

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-042FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MGGENPHARM INC.4/10/2003 
276-145FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE VIALS.AMERICAN PHARMACEUTICAL PARTNERS, INC.4/15/2003 
376-473CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG PACKAGED IN SINGLE- DOSE VIALSFAULDING PHARMACEUTICAL COMPANY4/16/2003 
476-409NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MGRANBAXY LABORATORIES LIMITED4/17/2003 
576-404ADENOSINE INJECTION, USP 3 MG/ML PACKAGED IN 6 MG/2 ML AND 12 MG/4 ML SINGLE-DOSE VIALSBEDFORD LABORATORIES4/18/2003 
676-246FLUCONAZOLE FOR ORAL SUSPENSION 10 MG/ML AND 40 MG/MLROXANE LABORATORIES, INC.4/18/2003 
776-314TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MGMYLAN PHARMACEUTICALS, INC.4/23/2003 
876-094PERGOLIDE MESYLATE TABLETS, USP 0.05 MG (BASE), 0.25 MG (BASE), AND 1 MG (BASE)IVAX PHARMACEUTICALS s.r.o.4/24/2003