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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - July 2004

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-706 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG   APOTEX INC. 7/1/2004 
2 76-236 FEXOFENADINE HCL & PSEUDOEPHEDRINE HCL EXTENDED-RELEASE TABL 60 MG/120 MG   BARR LABORATORIES, INC. 7/1/2004 
3 76-591 MOMETASONE FUROATE CREAM, USP 0.1%   ATRIX LABORATORIES, INC. 7/13/2004 
4 76-540 SERTRALINE HYDROCHLORIDE TABLETS 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)   GENPHARM INC. 7/14/2004 
5 76-651 QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   MUTUAL PHARMACEUTICAL COMPANY, INC. 7/15/2004 
6 76-665 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG   APOTEX INC. 7/20/2004 
7 76-573 ESMOLOL HYDROCHLORIDE INJECTION 10 MG/ML; PACKAGED IN 100 MG/10 ML SINGLE-DOSE VIALS   AMERICAN PHARMACEUTICAL PARTNERS, INC. 7/20/2004 
8 76-871 MITOXANTRONE INJECTION, USP (CONCENTRATE) 2 MG/ML; PACKAGED IN 20 MG/10 ML, 25 MG/12.5 ML, AND 30 MG/15 ML MULTIPLE-DOSE VIALS   MAYNE PHARMA (USA) INC. 7/23/2004 
9 76-731 GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS 1.25 MG/250 MG, 2.5 MG/500 MG, AND 5 MG/500 MG   COREPHARMA LLC 7/30/2004 

 

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