美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=EMBEDA"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
EMBEDA 022321 001 NDA MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2009/08/13 2009/08/13 ALPHARMA PHARMS Discontinued
EMBEDA 022321 002 NDA MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2009/08/13 2009/08/13 ALPHARMA PHARMS Discontinued
EMBEDA 022321 003 NDA MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2009/08/13 2009/08/13 ALPHARMA PHARMS Discontinued
EMBEDA 022321 004 NDA MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2009/08/13 2009/08/13 ALPHARMA PHARMS Discontinued
EMBEDA 022321 005 NDA MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2009/08/13 2009/08/13 ALPHARMA PHARMS Discontinued
EMBEDA 022321 006 NDA MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2009/08/13 2009/08/13 ALPHARMA PHARMS Discontinued
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