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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - December 2002

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 75-710 ALENDRONATE SODIUM TABLETS 5 MG (BASE), 10 MG (BASE), 35 MG (BASE), 40 MG (BASE), AND 70 MG (BASE) TEVA PHARMACEUTICALS USA 12/27/02
2 65-105 TOBRAMYCIN SOLUTION FOR INHALATION 300 MG/5 ML VIAL ROXANE LABORATORIES, INC. 12/31/02
3 75-816 CALCITRIOL INJECTION 0.001 MG/ML AND 0.002 MG/ML PACKAGED IN SINGLE-DOSE AMPULES FAULDING PHARMACEUTICAL COMPANY 12/31/02
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