药品名称STENDRA
申请号202276产品号001
活性成分AVANAFIL市场状态处方药
剂型或给药途径TABLET;ORAL规格50MG
治疗等效代码参比药物
批准日期2012/04/27申请机构METUCHEN PHARMACEUTICALS LLC
化学类型New molecular entity (NME)审评分类Standard review drug
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
66569352025/04/27YYU-155PDF格式
75014092023/05/05YPDF格式
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
NCE2017/04/27
D-1402017/09/17
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
202276013APLetter2015/09/17下载
202276013APLabel2015/09/23下载
202276010APLetter2015/05/19下载
202276010APLabel2015/06/05下载
202276006APLetter2014/04/30下载
202276006APLabel2014/05/02下载
202276005APLetter2014/09/18下载
202276005APLabel2014/09/19下载
202276001APLetter2012/11/06下载
202276001APLabel2012/11/06下载
202276000APLetter2012/04/27下载
202276000APLabel2012/04/27下载
202276000APReview2012/06/04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
202276014AP2016/06/15Manufacturing Change or Addition
202276013AP2015/09/16Labeling Revision
202276012AP2015/11/02Manufacturing Change or Addition
202276011AP2015/03/03Manufacturing Change or Addition
202276010AP2015/05/13Labeling Revision
202276009AP2015/02/09Manufacturing Change or Addition
202276007AP2014/11/20Manufacturing Change or Addition
202276006AP2014/04/29Labeling Revision
202276005AP2014/09/17Efficacy Supplement with Clinical Data to Support
202276004AP2013/07/10Manufacturing Change or Addition
202276003AP2013/08/06Manufacturing Change or Addition
202276001AP2012/10/31Labeling Revision
202276000AP2012/04/27Approval