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[交流]
FDA4月份药品批准信息
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Approvals - April 2006 ANDA Number Generic Drug Name Applicant Approval Date 1 77-569 ALBUTEROL SULFATE INHALATION SOLUTION, 0.083% (BASE); PACKAGED IN 2.5 MG (BASE)/3 ML UNIT-DOSE VIALS RxELITE 4/4/2006 2 40-666 HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION USP, 100 MG (BASE)/2 ML SINGLE-DOSE VIAL HOSPIRA INC. 4/6/2006 3 76-502 FEXOFENADINE HYDROCHLORIDE TABLETS 30 MG 60 MG 180 MG DR REDDY'S LABORATORIES INC. 4/11/2006 4 76-611 MITOXANTRONE 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 LABORATORIES 4/11/2006 5 76-871 MITOXANTRONE 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 6 77-356 MITOXANTRONE 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 7 77-496 MITOXANTRONE 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 8 77-520 LOVASTATIN TABLETS USP, 10 MG, 20 MG, AND 40 MG MUTUAL PHARMACEUTICAL COMPANY, INC. 4/14/2006 9 40-578 BENZPHETAMINE HCL TABLETS 50 MG PADDOCK LABORATORIES INC. 4/17/2006 10 40-676 OXYCODONE AND ACETAMINOPHEN TABLETS USP, 10 MG/650 MG MIKART INC. 4/19/2006 11 77-563 CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP, 5 MG AND 10 MG JUBILANT PHARMACEUTICALS, INC. 4/19/2006 12 77-323 CILOSTAZOL TABLETS 50 MG AND 100 MG MYLAN PHARMACEUTICALS, INC. 4/20/2006 13 77-650 ZONISAMIDE CAPSULES 25 MG, 50 MG, AND 100 MG WATSON LABORATORIES, INC. 4/20/2006 14 40-542 DIPYRIDAMOLE TABLETS USP, 25 MG, 50 MG, AND 75 MG AMIDE PHARMACEUTICAL, INC. 4/21/2006 15 40-560 THEOPHYLLINE EXTENDED-RELEASE TABLETS 600 MG NOSTRUM PHARMACEUTICALS, INC. 4/21/2006 16 40-595 THEOPHYLLINE EXTENDED-RELEASE TABLETS 400 MG NOSTRUM PHARMACEUTICALS, INC. 4/21/2006 17 76-056 PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, AND 40 MG TEVA PHARMACEUTICALS USA 4/24/2006 18 77-169 ISRADIPINE CAPSULES USP, 2.5 MG AND 5 MG AMIDE PHARMACEUTICAL, INC. 4/24/2006 19 40-643 PROMETHAZINE HYDROCHLORIDE SYRUP USP, 6.25 MG/5 ML VINTAGE PHARMACEUTICALS, LLC 4/26/2006 20 40-687 OXYCODONE AND ACETAMINOPHEN TABLETS USP, 5 MG/400 MG MIKART INC. 4/27/2006 21 40-692 OXYCODONE AND ACETAMINOPHEN TABLETS USP, 10 MG/400 MG MIKART INC. 4/27/2006 22 40-698 OXYCODONE AND ACETAMINOPHEN TABLETS USP, 7.5 MG/400 MG MIKART INC. 4/27/2006 |
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