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Tentative Approvals - January 2003

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 75-823 CALCITRIOL INJECTION 0.001 MG/ML AND 0.002 MG/ML; 1 ML FILL IN 2 ML SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC. 1/2/03
2 76-162 CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG SINGLE-DOSE VIALS PHARMACHEMIE B.V. 1/14/03
3 76-196 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG ROXANE LABORATORIES, INC. 1/14/03
4 76-270 MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG ROXANE LABORATORIES, INC. 1/14/03
5 76-215 BETAMETHASONE DIPROPIONATE CREAM, USP (AUGMENTED) 0.05% (BASE) ALTANA INC. 1/15/03
6 75-746 CALCITRIOL INJECTION 0.001 MG/ML AND 0.002 MG'ML; PACKAGED IN 1 ML AMPULES LUITPOLD PHARMACEUTICALS, INC. 1/21/03
7 76-401 VINCRISTINE SULFATE INJECTION, USP 1 MG/ML; PACKAGED IN 5 MG/5 ML MULTIPLE- DOSE VIALS AMERICAN PHARMACEUTICAL PARTNERS, INC. 1/24/03
8 75-360 GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG TORPHARM 1/29/03
9 76-072 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG GENEVA PHARMACEUTICALS, INC. 1/30/03
10 76-279 PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, 40 MG, AND 80 MG GENEVA PHARMACEUTICALS TECHNOLOGY CORP. 1/30/03

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Last Updated: January 2, 2003
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