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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - April 2003

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-042 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG GENPHARM INC. 4/10/2003 
2 76-145 FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE VIALS. AMERICAN PHARMACEUTICAL PARTNERS, INC. 4/15/2003 
3 76-473 CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG PACKAGED IN SINGLE- DOSE VIALS FAULDING PHARMACEUTICAL COMPANY 4/16/2003 
4 76-409 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG RANBAXY LABORATORIES LIMITED 4/17/2003 
5 76-404 ADENOSINE INJECTION, USP 3 MG/ML PACKAGED IN 6 MG/2 ML AND 12 MG/4 ML SINGLE-DOSE VIALS BEDFORD LABORATORIES 4/18/2003 
6 76-246 FLUCONAZOLE FOR ORAL SUSPENSION 10 MG/ML AND 40 MG/ML ROXANE LABORATORIES, INC. 4/18/2003 
7 76-314 TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG MYLAN PHARMACEUTICALS, INC. 4/23/2003 
8 76-094 PERGOLIDE MESYLATE TABLETS, USP 0.05 MG (BASE), 0.25 MG (BASE), AND 1 MG (BASE) IVAX PHARMACEUTICALS s.r.o. 4/24/2003 

 

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