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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - September 2002

  ANDA Number Generic Drug Name APPLICANT Tentative Approval Date
1 76-138 CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG TECHNILAB PHARMA, INC. 9/11/02
2 76-028 VINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML PACKAGED IN 10 MG/1 ML AND 50 MG/5 ML SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC. 9/17/02
3 76-308 MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG PUREPAC PHARMACEUTICAL CO. 9/17/02
4 76-099 CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG SINGLE-DOSE VIALS BEDFORD LABORATORIES 9/18/02

 

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