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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - February 2004

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 75-896 FELODIPINE EXTENDED-RELEASE TABLETS 2.5 MG, 5 MG, AND 10 MG   MUTUAL PHARMACEUTICAL COMPANY, INC. 2/6/2004 
2 76-593 CIPROFLOXACIN TABLETS, USP 100 MG, 250 MG, 500 MG, AND 750 MG   EON LABS, INC. 2/10/2004 
3 75-821 FAMOTIDINE TABLETS (CHEWABLE) 10 MG   TEVA PHARMACEUTICALS USA 2/12/2004 
4 75-566 PAROXETINE HYDROCHLORIDE TABLETS 10 MG (BASE), 20 MG (BASE), 30 MG (BASE), AND 40 MG (BASE)   SANDOZ, INC. 2/18/2004 
5 76-595 MODAFINIL TABLETS 100 MG 200 MG   RANBAXY PHARMACEUTICALS, INC. 2/18/2004 
6 76-484 CIPROFLOXACIN INJECTION, USP 10 MG/ML; PACKAGED IN 200 MG/20 ML AND 400 MG/40 ML SINGLE-DOSE VIALS   AMERICAN PHARMACEUTICAL PARTNERS, INC. 2/19/2004 
7 76-611 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   BEDFORD LABORATORIES 2/19/2004 
8 76-695 ONDANSETRON INJECTION, USP 2 MG/ML; PACKAGED IN 40 MG/20 ML MULTIPLE-DOSE VIALS   MAYNE PHARMA (USA) INC. 2/26/2004 
9 76-483 FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG   EON LABS, INC. 2/26/2004 
10 76-696 ONDANSETRON INJECTION, USP (PRESERVATIVE-FREE) 2 MG/ML, PACKAGED IN 4 MG/2 ML SINGLE-DOSE VIALS   MAYNE PHARMA (USA), INC. 2/26/2004 
11 76-298 FEXOFENADINE HCL & PSEUDOEPHEDRINE HCL EXTENDED-RELEASE TABL 60 MG/120 MG   IMPAX LABORATORIES, INC. 2/27/2004 

 

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