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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - April 2002

 ANDA NumberDrug NameApplicantTentative Approval Date
175-753FENOFIBRATE CAPSULES (MICRONIZED) 67 MGNOVOPHARM LIMITED4/9/02
276-108AMIODARONE HYDROCHLORIDE INJECTION 50 MG/MLFAULDING PHARMACEUTICAL CO.4/12/02
376-172METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MGANDRX PHARMACEUTICALS, INC.4/18/02
476-184ALENDRONATE SODIUM TABLETS 35 MG AND 70 MGBARR LABORATORIES, INC.4/23/02
576-062ZOLPIDEM TARTRATE TABLETS 5 MG, AND 10 MGPAR PHARMACEUTICAL, INC.4/26/02
675-660MILRINONE LACTATE INJECTION 1 MG (BASE)/ML PACKAGED IN 10 ML, 20 ML, AND 50 ML SINGLE-DOSE VIALSBEDFORD LABORATORIES4/30/02