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U.S. Department of Health and Human Services

Drugs

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Approvals - July 2006

  ANDA Number Generic Drug Name Applicant Approval Date
1 77-052 CITALOPRAM HYDROBROMIDE TABLETS, 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   MUTUAL PHARMACEUTICAL COMPANY, INC. 7/3/2006 
2 40-616 WARFARIN SODIUM TABLETS USP, 1 MG, 2 MG, 2.5 MG, 3 MG, 4 MG, 5 MG, 6 MG, 7.5 MG, AND 10 MG   PLIVA INC. 7/5/2006 
3 65-246 AZITHROMYCIN FOR ORAL SUSPENSION USP, 100 MG/5 ML AND 200 MG/5 ML   PLIVA, INC. 7/5/2006 
4 76-232 AMIODARONE HYDROCHLORIDE INJECTION, 50 MG/ML; 3 ML AMPULES   AKORN INC. 7/5/2006 
5 76-945 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, 10 MG/12.5 MG AND 20 MG/12.5 MG   TEVA PHARMACEUTICALS USA 7/5/2006 
6 76-877 GABAPENTIN TABLETS, 600 MG AND 800 MG   SANDOZ INC. 7/6/2006 
7 65-326 CEPHALEXIN FOR ORAL SUSPENSION USP, 125 MG/5 ML AND 250 MG/5 ML   ORCHID HEALTHCARE 7/10/2006 
8 77-820 GLIPIZIDE TABLETS USP, 5 MG AND 10 MG   CARACO PHARMACEUTICAL LABORATORIES, LTD. 7/11/2006 
9 76-850 TERCONAZOLE VAGINAL SUPPOSITORIES, 80 MG   ALTANA INC. 7/12/2006 
10 77-547 METRONIDAZOLE TOPICAL GEL USP, 0.75%   QLT USA, INC. 7/13/2006 
11 40-622 PROMETHAZINE HYDROCHLORIDE TABLETS USP, 12.5 MG, 25 MG, AND 50 MG   VINTAGE PHARMACEUTICALS, LLC 7/18/2006 
12 77-819 METRONIDAZOLE TOPICAL GEL USP, 0.75%   TARO PHARMACEUTICAL INDUSTRIES LTD. 7/18/2006 
13 77-920 MELOXICAM TABLETS, 7.5 MG AND 15 MG   BRECKENRIDGE PHARMACEUTICAL, INC. 7/19/2006 
14 77-921 MELOXICAM TABLETS, 7.5 MG AND 15 MG   ZYDUS PHARMACEUTICALS USA, INC. 7/19/2006 
15 77-923 MELOXICAM TABLETS, 7.5 MG AND 15 MG   MYLAN PHARMACEUTICALS, INC. 7/19/2006 
16 77-925 MELOXICAM TABLETS, 7.5 MG AND 15 MG   ROXANE LABORATORIES, INC. 7/19/2006 
17 77-929 MELOXICAM TABLETS, 7.5 MG AND 15 MG   WATSON LABORATORIES, INC. 7/19/2006 
18 77-930 MELOXICAM TABLETS, 7.5 MG AND 15 MG   COREPHARMA LLC 7/19/2006 
19 77-932 MELOXICAM TABLETS, 7.5 MG AND 15 MG   GLENMARK PHARMACEUTICALS LTD. 7/19/2006 
20 77-933 MELOXICAM TABLETS, 7.5 MG AND 15 MG   PAR PHARMACEUTICAL 7/19/2006 
21 77-935 MELOXICAM TABLETS, 7.5 MG AND 15 MG   MUTUAL PHARMACEUTICAL COMPANY, INC. 7/19/2006 
22 77-936 MELOXICAM TABLETS, 7.5 MG AND 15 MG   TEVA PHARMACEUTICALS, USA 7/19/2006 
23 77-937 MELOXICAM TABLETS, 7.5 MG AND 15 MG   CARACO PHARMACEUTICAL LABORATORIES, LTD. 7/19/2006 
24 77-938 MELOXICAM TABLETS, 7.5 MG AND 15 MG   ACTAVIS TOTOWA LLC 7/19/2006 
25 77-944 MELOXICAM TABLETS, 7.5 MG AND 15 MG   LUPIN LIMITED 7/19/2006 
26 77-882 MELOXICAM TABLETS, 7.5 MG AND 15 MG   APOTEX INC. 7/20/2006 
27 77-934 MELOXICAM TABLETS, 7.5 MG AND 15 MG   GENPHARM INC. 7/20/2006 
28 65-240 AMPICILLIN AND SULBACTAM FOR INJECTION USP, 10 G(BASE) AND 5 G(BASE), RESPECTIVELY, (PHARMACY BULK PACKAGE)   SANDOZ INC. 7/25/2006 
29 65-241 AMPICILLIN AND SULBACTAM FOR INJECTION USP, 1.5 G AND 3 MG; PACKAGED IN VIALS   SANDOZ INC. 7/25/2006 
30 65-310 AMPICILLIN AND SULBACTAM FOR INJECTION USP, 1.5 G AND 3 G; PACKAGED IN ADD-VANTAGE VIALS   SANDOZ INC. 7/25/2006 
31 65-320 ERYTHROMYCIN PLEDGETS USP, 2%   ALTANA INC. 7/25/2006 
32 77-931 MELOXICAM TABLETS, 7.5 MG AND 15 MG   DR. REDDY'S LABORATORIES LIMITED 7/25/2006 
33 76-756 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 500 MG   SYNOVICS LABORATORIES, INC. 7/26/2006 
34 76-914 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, 37.5 MG/325 MG   BARR LABORATORIES, INC. 7/26/2006 
35 40-667 PRIMIDONE TABLETS USP, 50 MG AND 250 MG   WEST-WARD PHARMACEUTICAL CORP. 7/27/2006 
36 77-836 GEMFIBROZIL TABLETS USP, 600 MG   INVAGEN PHARMACEUTICALS, INC. 7/27/2006 
37 77-895 URSODIOL CAPSULES USP, 300 MG   COREPHARMA LLC 7/27/2006 
38 65-220 NEOMYCIN SULFATE TABLETS USP, 500 MG [350 MG (BASE)]   X-GEN PHARMACEUTICALS, INC. 7/28/2006 
39 76-436 FINASTERIDE TABLETS USP, 1 MG   DR. REDDY'S LABORATORIES LIMITED 7/28/2006 
40 77-853 METFORMIN HYDROCHLORIDE TABLETS USP, 500 MG, 850 MG, AND 1000 MG   AMNEAL PHARMACEUTICALS LLC 7/28/2006 
41 40-712 PROMETHAZINE HYDROCHLORIDE TABLETS USP, 25 MG   KVK-TECH, INC. 7/31/2006 
42 40-713 PROMETHAZINE HYDROCHLORIDE TABLETS USP, 50 MG   KVK-TECH, INC. 7/31/2006 
43 76-969 METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS, USP 25 MG   SANDOZ INC. 7/31/2006 
44 77-725 ALPRAZOLAM EXTENDED-RELEASE TABLETS 0.5 MG, 1 MG, 2 MG, AND 3 MG   BARR LABORATORIES, INC. 7/31/2006 
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