美国FDA药品数据库（U.S. FDA Drugs Database）
检索条件:" 药品名称=OPANA"
符合检索条件的记录共 18 条
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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
OPANA 011707 001 NDA OXYMORPHONE HYDROCHLORIDE INJECTABLE;INJECTION 1.5MG/ML No No 1959/04/02 Approved Prior to Jan 1, 1982 ENDO PHARMS Discontinued
OPANA 011707 002 NDA OXYMORPHONE HYDROCHLORIDE INJECTABLE;INJECTION 1MG/ML Yes No 1959/04/02 Approved Prior to Jan 1, 1982 ENDO PHARMS Discontinued
OPANA ER 021610 001 NDA OXYMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2006/06/22 2006/06/22 ENDO OPERATIONS Discontinued
OPANA ER 021610 002 NDA OXYMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2006/06/22 2006/06/22 ENDO OPERATIONS Discontinued
OPANA ER 021610 003 NDA OXYMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2006/06/22 2006/06/22 ENDO OPERATIONS Discontinued
OPANA ER 021610 004 NDA OXYMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2006/06/22 2006/06/22 ENDO OPERATIONS Discontinued
OPANA ER 021610 005 NDA OXYMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2006/06/22 2008/02/29 ENDO OPERATIONS Discontinued
OPANA ER 021610 006 NDA OXYMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2006/06/22 2008/02/29 ENDO OPERATIONS Discontinued
OPANA ER 021610 007 NDA OXYMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2006/06/22 2008/02/29 ENDO OPERATIONS Discontinued
OPANA 021611 001 NDA OXYMORPHONE HYDROCHLORIDE TABLET;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2006/06/22 2006/06/22 ENDO PHARMS Discontinued
OPANA 021611 002 NDA OXYMORPHONE HYDROCHLORIDE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2006/06/22 2006/06/22 ENDO PHARMS Discontinued
OPANA ER 201655 001 NDA OXYMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG Yes No 2011/12/09 2011/12/09 ENDO PHARMS Discontinued
OPANA ER 201655 002 NDA OXYMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 7.5MG Yes No 2011/12/09 2011/12/09 ENDO PHARMS Discontinued
OPANA ER 201655 003 NDA OXYMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG Yes No 2011/12/09 2011/12/09 ENDO PHARMS Discontinued
OPANA ER 201655 004 NDA OXYMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MG Yes No 2011/12/09 2011/12/09 ENDO PHARMS Discontinued
OPANA ER 201655 005 NDA OXYMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MG Yes No 2011/12/09 2011/12/09 ENDO PHARMS Discontinued
OPANA ER 201655 006 NDA OXYMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 30MG Yes No 2011/12/09 2011/12/09 ENDO PHARMS Discontinued
OPANA ER 201655 007 NDA OXYMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 40MG Yes No 2011/12/09 2011/12/09 ENDO PHARMS Discontinued
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