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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - November 2001

  ANDA Number Drug Name Applicant Tentative Approval Date
1 75-830 MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; 10 ML, 20 ML, AND 50 ML VIALS FAULDING PHARMACEUTICAL COMPANY 11/9/01
2 76-182 OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG TEVA PHARMACEUTICALS USA 11/23/01
3 75-594 PAMIDRONATE DISODIUM FOR INJECTION 30 MG/VIAL AND 90 MG/VIAL AESGEN, INC. 11/28/01
4 75-863 DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL TABLETS 0.15 MG/0.02 MG AND 0.01 MG 28-DAY CYCLE DURAMED PHARMACEUTICALS, INC. 11/29/01
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