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U.S. Department of Health and Human Services

Drugs

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Approvals - April 2006

 ANDA NumberGeneric Drug NameApplicantApproval Date
177-569ALBUTEROL SULFATE INHALATION SOLUTION, 0.083% (BASE); PACKAGED IN 2.5 MG (BASE)/3 ML UNIT-DOSE VIALS  RxELITE4/4/2006 
240-666HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION USP, 100 MG (BASE)/2 ML SINGLE-DOSE VIAL  HOSPIRA INC.4/6/2006 
376-502FEXOFENADINE HYDROCHLORIDE TABLETS 30 MG 60 MG 180 MG  DR REDDY'S LABORATORIES INC.4/11/2006 
476-611MITOXANTRONE INJECTION USP, (CONCENTRATE) 2 MG/ML; PACKAGED IN 20 MG/10 ML, 25 MG/12.5 ML, AND 30 MG/15 ML MULTIPLE-DOSE VIALS  BEDFORD LABORATORIES4/11/2006 
576-871MITOXANTRONE INJECTION USP, (CONCENTRATE) 2 MG/ML; PACKAGED IN 20 MG/10 ML, 25 MG/12.5 ML, AND 30 MG/15 ML MULTIPLE-DOSE VIALS  MAYNE PHARMA (USA) INC.4/11/2006 
677-356MITOXANTRONE INJECTION, USP (CONCENTRATE) 2 MG/ML; PACKAGED IN 20 MG/10 ML, 25 MG/12.5 ML, AND 30 MG/15 ML MULTIPLE-DOSE VIALS  SICOR PHARMACEUTICALS, INC.4/11/2006 
777-496MITOXANTRONE INJECTION, USP (CONCENTRATE) 2 MG/ML; PACKAGED IN 20 MG/10 ML, 25 MG/12.5 ML, AND 30 MG/15 ML MULTIPLE-DOSE VIALS  AMERICAN PHARMACEUTICAL PARTNERS, INC.4/11/2006 
877-520LOVASTATIN TABLETS USP, 10 MG, 20 MG, AND 40 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.4/14/2006 
940-578BENZPHETAMINE HCL TABLETS 50 MG  PADDOCK LABORATORIES INC.4/17/2006 
1040-676OXYCODONE AND ACETAMINOPHEN TABLETS USP, 10 MG/650 MG  MIKART INC.4/19/2006 
1177-563CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP, 5 MG AND 10 MG  JUBILANT PHARMACEUTICALS, INC.4/19/2006 
1277-323CILOSTAZOL TABLETS 50 MG AND 100 MG  MYLAN PHARMACEUTICALS, INC.4/20/2006 
1377-650ZONISAMIDE CAPSULES 25 MG, 50 MG, AND 100 MG  WATSON LABORATORIES, INC.4/20/2006 
1440-542DIPYRIDAMOLE TABLETS USP, 25 MG, 50 MG, AND 75 MG  AMIDE PHARMACEUTICAL, INC.4/21/2006 
1540-560THEOPHYLLINE EXTENDED-RELEASE TABLETS 600 MG  NOSTRUM PHARMACEUTICALS, INC.4/21/2006 
1640-595THEOPHYLLINE EXTENDED-RELEASE TABLETS 400 MG  NOSTRUM PHARMACEUTICALS, INC.4/21/2006 
1776-056PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, AND 40 MG  TEVA PHARMACEUTICALS USA4/24/2006 
1877-169ISRADIPINE CAPSULES USP, 2.5 MG AND 5 MG  AMIDE PHARMACEUTICAL, INC.4/24/2006 
1940-643PROMETHAZINE HYDROCHLORIDE SYRUP USP, 6.25 MG/5 ML  VINTAGE PHARMACEUTICALS, LLC4/26/2006 
2040-687OXYCODONE AND ACETAMINOPHEN TABLETS USP, 5 MG/400 MG  MIKART INC.4/27/2006 
2140-692OXYCODONE AND ACETAMINOPHEN TABLETS USP, 10 MG/400 MG  MIKART INC.4/27/2006 
2240-698OXYCODONE AND ACETAMINOPHEN TABLETS USP, 7.5 MG/400 MG  MIKART INC.4/27/2006