药品名称OPANA
申请号011707产品号002
活性成分OXYMORPHONE HYDROCHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格1MG/ML
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ENDO PHARMACEUTICALS INC
化学类型New dosage form审评分类Standard review drug
罕用药/孤儿药
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
011707031APLabel2006/10/18下载
011707031APLetter2006/10/23下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
011707031AP2006/10/16Labeling Revision
011707029AP2002/10/25Control Supplement
011707028AP2002/01/15Control Supplement
011707027AP2002/04/16Manufacturing Change or Addition
011707026AP1997/10/29Labeling Revision
011707025AP1997/08/06Control Supplement
011707024AP2000/09/25Control Supplement
011707023AP1996/10/15Labeling Revision
011707022AP1994/08/11Package Change
011707021AP1994/05/11Control Supplement
011707020AP1987/12/08Control Supplement
011707017AP1993/08/24Control Supplement
011707016AP1983/08/31Manufacturing Change or Addition
011707015AP1983/08/31Manufacturing Change or Addition
011707013AP1981/11/09Manufacturing Change or Addition
011707011AP1981/04/01Manufacturing Change or Addition
011707008AP1976/03/26Labeling Revision
011707000AP1959/04/02Approval