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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - February 2004

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
175-896FELODIPINE EXTENDED-RELEASE TABLETS 2.5 MG, 5 MG, AND 10 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.2/6/2004 
276-593CIPROFLOXACIN TABLETS, USP 100 MG, 250 MG, 500 MG, AND 750 MG  EON LABS, INC.2/10/2004 
375-821FAMOTIDINE TABLETS (CHEWABLE) 10 MG  TEVA PHARMACEUTICALS USA2/12/2004 
475-566PAROXETINE HYDROCHLORIDE TABLETS 10 MG (BASE), 20 MG (BASE), 30 MG (BASE), AND 40 MG (BASE)  SANDOZ, INC.2/18/2004 
576-595MODAFINIL TABLETS 100 MG 200 MG  RANBAXY PHARMACEUTICALS, INC.2/18/2004 
676-484CIPROFLOXACIN 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 
776-611MITOXANTRONE 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 LABORATORIES2/19/2004 
876-695ONDANSETRON INJECTION, USP 2 MG/ML; PACKAGED IN 40 MG/20 ML MULTIPLE-DOSE VIALS  MAYNE PHARMA (USA) INC.2/26/2004 
976-483FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG  EON LABS, INC.2/26/2004 
1076-696ONDANSETRON INJECTION, USP (PRESERVATIVE-FREE) 2 MG/ML, PACKAGED IN 4 MG/2 ML SINGLE-DOSE VIALS  MAYNE PHARMA (USA), INC.2/26/2004 
1176-298FEXOFENADINE HCL & PSEUDOEPHEDRINE HCL EXTENDED-RELEASE TABL 60 MG/120 MG  IMPAX LABORATORIES, INC.2/27/2004