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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - September 2002

 ANDA NumberGeneric Drug NameAPPLICANTTentative Approval Date
176-138CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MGTECHNILAB PHARMA, INC.9/11/02
276-028VINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML PACKAGED IN 10 MG/1 ML AND 50 MG/5 ML SINGLE-DOSE VIALSGENSIA SICOR PHARMACEUTICALS, INC.9/17/02
376-308MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MGPUREPAC PHARMACEUTICAL CO.9/17/02
476-099CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG SINGLE-DOSE VIALSBEDFORD LABORATORIES9/18/02