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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - January 2003

175-823CALCITRIOL INJECTION 0.001 MG/ML AND 0.002 MG/ML; 1 ML FILL IN 2 ML SINGLE-DOSE VIALSGENSIA SICOR PHARMACEUTICALS, INC.1/2/03
276-162CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG SINGLE-DOSE VIALSPHARMACHEMIE B.V.1/14/03
376-196NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MGROXANE LABORATORIES, INC.1/14/03
476-270MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MGROXANE LABORATORIES, INC.1/14/03
576-215BETAMETHASONE DIPROPIONATE CREAM, USP (AUGMENTED) 0.05% (BASE)ALTANA INC.1/15/03
675-746CALCITRIOL INJECTION 0.001 MG/ML AND 0.002 MG'ML; PACKAGED IN 1 ML AMPULESLUITPOLD PHARMACEUTICALS, INC.1/21/03
776-401VINCRISTINE SULFATE INJECTION, USP 1 MG/ML; PACKAGED IN 5 MG/5 ML MULTIPLE- DOSE VIALSAMERICAN PHARMACEUTICAL PARTNERS, INC.1/24/03
875-360GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MGTORPHARM1/29/03
976-072NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MGGENEVA PHARMACEUTICALS, INC.1/30/03
1076-279PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, 40 MG, AND 80 MGGENEVA PHARMACEUTICALS TECHNOLOGY CORP.1/30/03