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U.S. Department of Health and Human Services

Drugs

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Approvals - November 2004

 ANDA NumberGeneric Drug NameApplicantApproval Date
176-721MEGESTROL ACETATE ORAL SUSPENSION, USP 40 MG/ML  MORTON GROVE PHARMACEUTICALS, INC.11/1/2004 
276-762LOXAPINE CAPSULES, USP 5 MG, 10 MG, 25 MG, AND 50 MG  MYLAN PHARMACEUTICALS, INC.11/1/2004 
375-896FELODIPINE EXTENDED-RELEASE TABLETS, USP 2.5 MG, 5 MG, AND 10 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.11/2/2004 
476-725MIDODRINE HYDROCHLORIDE TABLETS 2.5 MG, 5 MG, AND 10 MG  UPSHER-SMITH LABORATORIES11/3/2004 
576-896CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG  APOTEX INC.11/4/2004 
677-037CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  ALPHAPHARM PTY LTD.11/5/2004 
777-042CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  KALI LABORATORIES, INC.11/5/2004 
877-044CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  WATSON LABORATORIES, INC.11/5/2004 
940-541SODIUM TETRADECYL SULFATE INJECTION 1% (10 MG/ML) AND 3% (30 MG/ML) PACKAGED IN 2 ML VIALS  BIONICHE PHARMA U.S.A., INC.11/12/2004 
1075-436PACLITAXEL INJECTION, USP 6 MG/ML; PACKAGED IN 30 MG/5 ML AND 100 MG/16.7 ML MULTIPLE-DOSE VIALS  SUPERGEN, INC.11/12/2004 
1177-032CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  CARACO PHARMACEUTICAL LABORATORIES, LTD.11/12/2004 
1276-150LORAZEPAM INJECTION, USP 2 MG/ML  INTERNATIONAL MEDICATION SYSTEMS, LTD.11/15/2004 
1376-602CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG SINGLE-DOSE VIALS  PLIVA - LACHEMA A.S.11/16/2004 
1476-609PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/650 MG  ANDRX PHARMACEUTICALS, LLC11/16/2004 
1576-746PILOCARPINE HYDROCHLORIDE TABLETS 5 MG  COREPHARMA, LLC11/16/2004 
1677-048CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  IVAX PHARMACEUTICALS, INC.11/16/2004 
1776-625LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.1 MG/0.02 MG (28-DAY REGIMEN)  WATSON LABORATORIES, INC.11/18/2004 
1874-764RANITIDINE INJECTION, USP 25 MG (BASE)/ML; PACKAGED IN 50 MG (BASE)/2 ML AND 150 MG (BASE)/6 ML MULTIPLE DOSE VIALS  BEDFORD LABORATORIES11/19/2004 
1976-731GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS 1.25 MG/250 MG, 2.5 MG/500 MG, AND 5 MG/500 MG  COREPHARMA LLC11/19/2004 
2076-795LITHIUM CARBONATE CAPSULES, USP 300 MG  APOTEX INC.11/22/2004 
2177-019CILOSTAZOL TABLETS 50 MG AND 100 MG  ALPHAPHARM PTY, LTD.11/23/2004 
2277-021CILOSTAZOL TABLETS 100 MG  EON LABS, INC.11/23/2004 
2377-022CILOSTAZOL TABLETS 100 MG  COREPHARMA, LLC11/23/2004 
2477-041CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  ROXANE LABORATORIES, INC.11/23/2004 
2577-059CARBOPLATIN INJECTION 10 MG/ML; PACKAGED IN 600 MG/60 ML SINGLE-DOSE VIALS  MAYNE PHARMA (USA) INC.11/23/2004 
2677-027CILOSTAZOL TABLETS 50 MG AND 100 MG  TEVA PHARMACEUTICALS USA11/24/2004 
2777-046CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  APOTEX INC.11/24/2004 
2877-028CILOSTAZOL TABLETS 100 MG  AMIDE PHARMACEUTICAL, INC.11/26/2004