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U.S. Department of Health and Human Services

Drugs

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Approvals - January 2006

 ANDA NumberGeneric Drug NameApplicantApproval Date
177-317ISRADIPINE CAPSULES USP, 2.5 MG AND 5 MG  ABRIKA PHARMACEUTICALS1/5/2006 
277-552DESOXIMETASONE GEL USP, 0.05%  CLAY-PARK LABS, INC.1/9/2006 
376-143BUPROPION HYDROCHLORIDE TABLETS USP, 75 MG AND 100 MG  APOTEX INC.1/17/2006 
440-655HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 5 MG/325 MG  VINTAGE PHARMACEUTICALS, LLC1/19/2006 
540-656HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 7.5 MG/325 MG  VINTAGE PHARMACEUTICALS, LLC1/19/2006 
640-658HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 5 MG/300 MG  MIKART, INC.1/19/2006 
765-278CEFADROXIL FOR ORAL SUSPENSION USP, 250 MG/5 ML AND 500 MG/5 ML  TEVA PHARMACEUTICALS USA1/20/2006 
865-282CEFADROXIL CAPSULES USP, 500 MG  TEVA PHARMACEUTICALS USA1/20/2006 
976-274CLOPIDOGREL BISULFATE TABLETS, 75 MG  APOTEX CORPORATION1/20/2006 
1065-313CEFOXITIN FOR INJECTION USP, 1 G/VIAL AND 2 G/VIAL  ORCHID HEALTHCARE1/23/2006 
1165-215CEPHALEXIN CAPSULES USP, 250 MG AND 500 MG  HIKMA PHARMACEUTICALS1/24/2006 
1275-428GABAPENTIN CAPSULES, 100 MG, 300 MG, AND 400 MG  SANDOZ INC.1/24/2006 
1377-182DESOGESTREL 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 
1477-122DESMOPRESSIN ACETATE TABLETS, 0.1 MG AND 0.2 MG  TEVAPHARMACEUTICALS USA1/25/2006 
1577-253FLUCONAZOLE TABLETS, 50 MG, 100 MG, 150 MG, AND 200 MG  GLENMARK PHARMACEUTICALS LIMITED1/25/2006 
1676-240QUINAPRIL TABLETS USP, 5 MG, 10 MG, 20 MG, AND 40 MG  APOTEX INC.1/26/2006 
1777-391ALPRAZOLAM EXTENDED-RELEASE TABLETS, 0.5 MG, 1 MG, 2 MG, AND 3 MG  MYLAN PHARMACEUTICALS, INC.1/26/2006 
1876-120GABAPENTIN TABLETS, 600 MG AND 800 MG  SANDOZ INC.1/27/2006 
1976-737TESTOSTERONE GEL, 1%  WATSON LABORATORIES, INC.1/27/2006 
2077-383CARBOPLATIN FOR INJECTION USP, 50 MG, 150 MG, AND 450 MG  WATSON LABORATORIES, INC.1/27/2006 
2177-651ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG  GLENMARK PHARMACEUTICALS LIMITED1/30/2006 
2240-650PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP USP, 6.25 MG/5 ML AND 10 MG/5 ML  VINTAGE PHARMACEUTICALS, LLC1/31/2006 
2365-106NEOMYCIN & 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 
2465-108NEOMYCIN & 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 
2577-007NICOTINE POLACRILEX LOZENGES, 2 MG AND 4 MG  PERRIGO R&D COMPANY1/31/2006