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U.S. Department of Health and Human Services

Drugs

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Approvals - December 2004

  ANDA Number Generic Drug Name Applicant Approval Date
1 76-608 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG AND 20 MG/12.5 MG   ANDRX PHARMACEUTICALS,LLC 12/3/2004 
2 76-624 MOMETASONE FUROATE OINTMENT, USP 0.1%   TARO PHARMACEUTICALS USA, INC. 12/3/2004 
3 76-711 BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP 200 MG   IMPAX LABORATORIES, INC. 12/3/2004 
4 77-167 DIDANOSINE DELAYED-RELEASE CAPSULES 200 MG, 250 MG, AND 400 MG   BARR LABORATORIES, INC. 12/3/2004 
5 77-030 CILOSTAZOL TABLETS 50 MG AND 100 MG   APOTEX , INC. 12/10/2004 
6 65-171 DEMECLOCYCLINE HYDROCHLORIDE TABLETS, USP 150 MG AND 300 MG   BARR LABORATORIES, INC. 12/13/2004 
7 76-990 FLUOXETINE CAPSULES, USP 40 MG   RANBAXY LABORATORIES LIMITED 12/13/2004 
8 77-043 CITALOPRAM HYDROBROMIDE ORAL SOLUTION 10 MG (BASE)/ 5 ML   ROXANE LABORATORIES, INC. 12/13/2004 
9 76-223 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG   SANDOZ INC. 12/14/2004 
10 76-706 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG   APOTEX INC. 12/14/2004 
11 76-818 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG   COBALT PHARMACEUTICALS, INC. 12/14/2004 
12 76-873 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG   EON LABS, INC. 12/14/2004 
13 75-827 GABAPENTIN TABLETS 600 MG AND 800 MG   TEVA PHARMACEUTICALS USA 12/15/2004 
14 76-607 QUINAPRIL TABLETS, USP 5 MG, 10 MG, 20 MG, AND 40 MG   RANBAXY LABORATORIES LIMITED 12/15/2004 
15 40-569 PROPOXYPHENE HYDROCHLORIDE CAPSULES, USP 65 MG   MYLAN PHARMACEUTICALS, INC. 12/16/2004 
16 76-831 FLAVOXATE HYDROCHLORIDE TABLETS 100 MG   PADDOCK LABORATORIES, INC. 12/16/2004 
17 76-872 HALOBETASOL PROPIONATE OINTMENT 0.05%   AGIS INDUSTRIES (1983) LTD. 12/16/2004 
18 76-903 HALOBETASOL PROPIONATE OINTMENT 0.05%   ALTANA INC. 12/16/2004 
19 76-922 FLUOXETINE CAPSULES, USP 10 MG, 20 MG, AND 40 MG   PAR PHARMACEUTICAL, INC. 12/16/2004 
20 76-994 HALOBETASOL PROPIONATE OINTMENT 0.05%   TARO PHARMACEUTICALS USA, INC. 12/16/2004 
21 77-001 HALOBETASOL PROPIONATE CREAM 0.05%   ALTANA INC. 12/16/2004 
22 77-123 HALOBETASOL PROPIONATE CREAM 0.05%   AGIS INDUSTRIES (1983) LTD. 12/16/2004 
23 65-175 NYSTATIN TOPICAL POWDER, USP 100,000 UNITS/GRAM   X-GEN PHARMACEUTICALS, INC. 12/17/2004 
24 76-574 ECONAZOLE NITRATE CREAM 1%   HEALTHPOINT, LTD. 12/17/2004 
25 76-739 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG AND 20 MG/12.5 MG   RANBAXY LABORATORIES LIMITED 12/17/2004 
26 75-317 TERAZOSIN HYDROCHLORIDE CAPSULES 1 MG (BASE), 2 MG (BASE), 5 MG (BASE), AND 10 MG (BASE)   TRIGEN LABORATORIES, INC. 12/20/2004 
27 40-581 PREDNISONE TABLETS, USP 2.5 MG   VINTAGE PHARMACEUTICALS, INC. 12/21/2004 
28 40-584 PREDNISONE TABLETS, USP 1 MG   VINTAGE PHARMACEUTICALS, INC. 12/21/2004 
29 76-679 MOMETASONE FUROATE CREAM, USP 0.1%   TARO PHARMACEUTICALS U.S.A., INC. 12/21/2004 
30 40-568 GLYCOPYRROLATE TABLETS, USP 1 MG AND 2 MG   COREPHARMA LLC 12/22/2004 
31 76-459 QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   AMIDE PHARMACEUTICAL, INC. 12/22/2004 
32 76-963 PILOCARPINE HYDROCHLORIDE TABLETS 5 MG   ROXANE LABORATORIES, INC. 12/22/2004 
33 76-694 QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   MYLAN PHARMACEUTICALS, INC. 12/23/2004 
34 76-855 HYDROMORPHONE HYDROCHLORIDE TABLETS, USP 8 MG   MALLINCKRODT, INC. 12/23/2004 
35 76-987 FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG AND 40 MG   WATSON LABORATORIES, INC. 12/23/2004 
36 65-139 CLINDAMYCIN PHOSPHATE VAGINAL CREAM, USP 2% (BASE)   ALTANA INC. 12/27/2004 
37 76-842 HYDROCORTISONE BUTYRATE OINTMENT, USP 0.1%   TARO PHARMACEUTICAL INDUSTRIES LTD. 12/27/2004 
38 40-600 HYDROXYZINE HYDROCHLORIDE TABLETS, USP 10 MG   AMIDE PHARMACEUTICAL, INC. 12/28/2004 
39 40-602 HYDROXYZINE HYDROCHLORIDE TABLETS, USP 25 MG   AMIDE PHARMACEUTICAL, INC. 12/28/2004 
40 40-604 HYDROXYZINE HYDROCHLORIDE TABLETS, USP 50 MG   AMIDE PHARMACEUTICAL, INC. 12/28/2004 
41 76-682 OXYBUTYNIN CHLORIDE SYRUP, USP 5 MG/5 ML   VINTAGE PHARMACEUTICALS, LLC 12/28/2004 
42 76-435 CICLOPIROX OLAMINE CREAM, USP 0.77%   ALTANA INC. 12/29/2004 
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