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Tentative Approvals - August 2002

  ANDA Number Drug Name Applicant Tentative Approval Date
1 76-227 CARBOPLATIN INJECTION 10 MG/ML GENSIA SICOR PHARMACEUTICALS, INC. 8/12/02
2 76-126 CIPROFLOXACIN TABLETS, USP 250 MG (BASE), 500 MG (BASE), AND 750 MG (BASE) CARLSBAD TECHNOLOGY, INC. 8/14/02
3 75-593 CIPROFLOXACIN TABLETS, USP 100 MG, 250 MG, 500 MG, AND 750 MG DR. REDDY'S LABORATORIES, INC. 8/22/02
4 75-740 TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE), AND 20 MG (BASE) IVAX PHARMACEUTICALS, INC. 8/30/02

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FDA/Center for Drug Evaluation and Research
Last Updated: April 25, 2006
Originator: OGC
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