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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - December 2002

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
175-710ALENDRONATE SODIUM TABLETS 5 MG (BASE), 10 MG (BASE), 35 MG (BASE), 40 MG (BASE), AND 70 MG (BASE)TEVA PHARMACEUTICALS USA12/27/02
265-105TOBRAMYCIN SOLUTION FOR INHALATION 300 MG/5 ML VIALROXANE LABORATORIES, INC.12/31/02
375-816CALCITRIOL INJECTION 0.001 MG/ML AND 0.002 MG/ML PACKAGED IN SINGLE-DOSE AMPULESFAULDING PHARMACEUTICAL COMPANY12/31/02