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Approvals - January 2006

  ANDA Number Generic Drug Name Applicant Approval Date
1 77-317 ISRADIPINE CAPSULES USP, 2.5 MG AND 5 MG   ABRIKA PHARMACEUTICALS 1/5/2006 
2 77-552 DESOXIMETASONE GEL USP, 0.05%   CLAY-PARK LABS, INC. 1/9/2006 
3 76-143 BUPROPION HYDROCHLORIDE TABLETS USP, 75 MG AND 100 MG   APOTEX INC. 1/17/2006 
4 40-655 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 5 MG/325 MG   VINTAGE PHARMACEUTICALS, LLC 1/19/2006 
5 40-656 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 7.5 MG/325 MG   VINTAGE PHARMACEUTICALS, LLC 1/19/2006 
6 40-658 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 5 MG/300 MG   MIKART, INC. 1/19/2006 
7 65-278 CEFADROXIL FOR ORAL SUSPENSION USP, 250 MG/5 ML AND 500 MG/5 ML   TEVA PHARMACEUTICALS USA 1/20/2006 
8 65-282 CEFADROXIL CAPSULES USP, 500 MG   TEVA PHARMACEUTICALS USA 1/20/2006 
9 76-274 CLOPIDOGREL BISULFATE TABLETS, 75 MG   APOTEX CORPORATION 1/20/2006 
10 65-313 CEFOXITIN FOR INJECTION USP, 1 G/VIAL AND 2 G/VIAL   ORCHID HEALTHCARE 1/23/2006 
11 65-215 CEPHALEXIN CAPSULES USP, 250 MG AND 500 MG   HIKMA PHARMACEUTICALS 1/24/2006 
12 75-428 GABAPENTIN CAPSULES, 100 MG, 300 MG, AND 400 MG   SANDOZ INC. 1/24/2006 
13 77-182 DESOGESTREL AND ETHINYL ESTRADIOL TABLETS, 0.1 MG/0.025 MG, 0.125 MG/0.025 MG AND 0.15 MG/0.025 MG   WATSON LABORATORIES, INC. 1/24/2006 
14 77-122 DESMOPRESSIN ACETATE TABLETS, 0.1 MG AND 0.2 MG   TEVAPHARMACEUTICALS USA 1/25/2006 
15 77-253 FLUCONAZOLE TABLETS, 50 MG, 100 MG, 150 MG, AND 200 MG   GLENMARK PHARMACEUTICALS LIMITED 1/25/2006 
16 76-240 QUINAPRIL TABLETS USP, 5 MG, 10 MG, 20 MG, AND 40 MG   APOTEX INC. 1/26/2006 
17 77-391 ALPRAZOLAM EXTENDED-RELEASE TABLETS, 0.5 MG, 1 MG, 2 MG, AND 3 MG   MYLAN PHARMACEUTICALS, INC. 1/26/2006 
18 76-120 GABAPENTIN TABLETS, 600 MG AND 800 MG   SANDOZ INC. 1/27/2006 
19 76-737 TESTOSTERONE GEL, 1%   WATSON LABORATORIES, INC. 1/27/2006 
20 77-383 CARBOPLATIN FOR INJECTION USP, 50 MG, 150 MG, AND 450 MG   WATSON LABORATORIES, INC. 1/27/2006 
21 77-651 ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG   GLENMARK PHARMACEUTICALS LIMITED 1/30/2006 
22 40-650 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP USP, 6.25 MG/5 ML AND 10 MG/5 ML   VINTAGE PHARMACEUTICALS, LLC 1/31/2006 
23 65-106 NEOMYCIN & POLYMYXIN B SULFATES SOLUTION FOR IRRIGATION USP, 40 MG (BASE)/ML AND 200,000 U/ML; PACKAGED IN SINGLE-DOSE AMPULES   X-GEN PHARMACEUTICALS, INC. 1/31/2006 
24 65-108 NEOMYCIN & POLYMYXIN B SULFATES SOLUTION FOR IRRIGATION USP, 40 MG (BASE)/ML AND 200,000 UNITS/ML; PACKAGED IN MULTIPLE-DOSE VIALS   X-GEN PHARMACEUTICALS, INC. 1/31/2006 
25 77-007 NICOTINE POLACRILEX LOZENGES, 2 MG AND 4 MG   PERRIGO R&D COMPANY 1/31/2006 

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Date created: February 9, 2006

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