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U.S. Department of Health and Human Services

Drugs

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Approvals - November 2004

  ANDA Number Generic Drug Name Applicant Approval Date
1 76-721 MEGESTROL ACETATE ORAL SUSPENSION, USP 40 MG/ML   MORTON GROVE PHARMACEUTICALS, INC. 11/1/2004 
2 76-762 LOXAPINE CAPSULES, USP 5 MG, 10 MG, 25 MG, AND 50 MG   MYLAN PHARMACEUTICALS, INC. 11/1/2004 
3 75-896 FELODIPINE EXTENDED-RELEASE TABLETS, USP 2.5 MG, 5 MG, AND 10 MG   MUTUAL PHARMACEUTICAL COMPANY, INC. 11/2/2004 
4 76-725 MIDODRINE HYDROCHLORIDE TABLETS 2.5 MG, 5 MG, AND 10 MG   UPSHER-SMITH LABORATORIES 11/3/2004 
5 76-896 CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG   APOTEX INC. 11/4/2004 
6 77-037 CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   ALPHAPHARM PTY LTD. 11/5/2004 
7 77-042 CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   KALI LABORATORIES, INC. 11/5/2004 
8 77-044 CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   WATSON LABORATORIES, INC. 11/5/2004 
9 40-541 SODIUM 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 
10 75-436 PACLITAXEL 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 
11 77-032 CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   CARACO PHARMACEUTICAL LABORATORIES, LTD. 11/12/2004 
12 76-150 LORAZEPAM INJECTION, USP 2 MG/ML   INTERNATIONAL MEDICATION SYSTEMS, LTD. 11/15/2004 
13 76-602 CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG SINGLE-DOSE VIALS   PLIVA - LACHEMA A.S. 11/16/2004 
14 76-609 PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/650 MG   ANDRX PHARMACEUTICALS, LLC 11/16/2004 
15 76-746 PILOCARPINE HYDROCHLORIDE TABLETS 5 MG   COREPHARMA, LLC 11/16/2004 
16 77-048 CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   IVAX PHARMACEUTICALS, INC. 11/16/2004 
17 76-625 LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.1 MG/0.02 MG (28-DAY REGIMEN)   WATSON LABORATORIES, INC. 11/18/2004 
18 74-764 RANITIDINE INJECTION, USP 25 MG (BASE)/ML; PACKAGED IN 50 MG (BASE)/2 ML AND 150 MG (BASE)/6 ML MULTIPLE DOSE VIALS   BEDFORD LABORATORIES 11/19/2004 
19 76-731 GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS 1.25 MG/250 MG, 2.5 MG/500 MG, AND 5 MG/500 MG   COREPHARMA LLC 11/19/2004 
20 76-795 LITHIUM CARBONATE CAPSULES, USP 300 MG   APOTEX INC. 11/22/2004 
21 77-019 CILOSTAZOL TABLETS 50 MG AND 100 MG   ALPHAPHARM PTY, LTD. 11/23/2004 
22 77-021 CILOSTAZOL TABLETS 100 MG   EON LABS, INC. 11/23/2004 
23 77-022 CILOSTAZOL TABLETS 100 MG   COREPHARMA, LLC 11/23/2004 
24 77-041 CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   ROXANE LABORATORIES, INC. 11/23/2004 
25 77-059 CARBOPLATIN INJECTION 10 MG/ML; PACKAGED IN 600 MG/60 ML SINGLE-DOSE VIALS   MAYNE PHARMA (USA) INC. 11/23/2004 
26 77-027 CILOSTAZOL TABLETS 50 MG AND 100 MG   TEVA PHARMACEUTICALS USA 11/24/2004 
27 77-046 CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   APOTEX INC. 11/24/2004 
28 77-028 CILOSTAZOL TABLETS 100 MG   AMIDE PHARMACEUTICAL, INC. 11/26/2004 
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