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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - November 2001

 ANDA NumberDrug NameApplicantTentative Approval Date
175-830MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; 10 ML, 20 ML, AND 50 ML VIALSFAULDING PHARMACEUTICAL COMPANY11/9/01
276-182OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MGTEVA PHARMACEUTICALS USA11/23/01
375-594PAMIDRONATE DISODIUM FOR INJECTION 30 MG/VIAL AND 90 MG/VIALAESGEN, INC.11/28/01
475-863DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL TABLETS 0.15 MG/0.02 MG AND 0.01 MG 28-DAY CYCLEDURAMED PHARMACEUTICALS, INC.11/29/01