药品名称PROSCAR
申请号020180产品号001
活性成分FINASTERIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格5MG
治疗等效代码AB参比药物
批准日期1992/06/19申请机构MERCK AND CO INC
化学类型New molecular entity (NME)审评分类Priority 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
59425192018/10/23U-280PDF格式
历史专利信息
58861842012/11/19YPDF格式
60461832011/03/20YU-577PDF格式
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
020180044APLetter2014/03/13下载
020180044APLabel2014/03/13下载
020180043APLetter2013/01/22下载
020180043APLabel2013/01/22下载
020180042APLabel2012/04/11下载
020180042APLetter2012/04/12下载
020180041APLabel2012/04/11下载
020180041APLetter2012/04/12下载
020180040APLetter2012/04/12下载
020180040APLabel2012/04/11下载
020180039APLetter2011/06/10下载
020180039APLabel2011/06/10下载
020180037APLabel2010/10/04下载
020180037APLetter2010/10/07下载
020180035APLetter2011/06/17下载
020180033APLabel2010/03/26下载
020180033APLetter2010/03/29下载
020180029APReview2007/07/24下载
020180029APLetter2004/04/29下载
020180029APLabel2004/05/04下载
020180027APReview2006/05/08下载
020180027APLetter2003/09/25下载
020180027APLabel2003/09/25下载
020180026APLabel2004/04/14下载
020180026APLetter2004/04/20下载
020180026APReview2007/07/24下载
020180025APReview2007/07/06下载
020180025APLetter2003/07/06下载
020180024APReview2007/07/24下载
020180023APReview2007/07/24下载
020180022APReview2008/08/04下载
020180020APLetter2003/09/30下载
020180020APReview2007/07/06下载
020180019APReview2008/08/04下载
020180018APReview2008/08/08下载
020180017APReview1997/12/19下载
020180016APReview1998/03/20下载
020180015APReview1998/03/20下载
020180014APReview2006/05/10下载
020180013APReview1997/05/12下载
020180011APReview2003/08/07下载
020180010APReview2006/05/10下载
020180000APOther Important Information from FDA2011/12/20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
020180045AP2015/07/06Manufacturing Change or Addition
020180044AP2014/03/11Labeling Revision
020180043AP2013/01/16Labeling Revision
020180042AP2012/04/11Labeling Revision
020180041AP2012/04/11Labeling Revision
020180040AP2012/04/11Labeling Revision
020180039AP2011/06/09Labeling Revision
020180037AP2010/10/04Labeling Revision
020180035AP2011/06/10Labeling Revision
020180033AP2010/03/23Labeling Revision
020180029AP2004/04/23Labeling Revision
020180027AP2003/09/09Labeling Revision
020180026AP2004/04/12Efficacy Supplement with Clinical Data to Support
020180025AP2003/06/26Labeling Revision
020180024AP2002/11/26Control Supplement
020180023AP2002/10/28Control Supplement
020180022AP2001/01/30Labeling Revision
020180020AP2003/09/23Labeling Revision
020180019AP2001/01/17Labeling Revision
020180018AP1999/08/02Labeling Revision
020180017AP1997/12/19Labeling Revision
020180016AP1998/03/20New or Modified Indication
020180015AP1998/03/20Patient Population Altered
020180014AP1997/05/16Control Supplement
020180013AP1997/05/12Manufacturing Change or Addition
020180011AP1996/08/28Labeling Revision
020180010AP1996/07/24Manufacturing Change or Addition
020180009AP1994/12/30Labeling Revision
020180008AP1994/05/18Labeling Revision
020180007AP1994/05/18Labeling Revision
020180006AP1993/09/16Package Change
020180005AP1993/09/01Manufacturing Change or Addition
020180004AP1993/04/05Package Change
020180003AP1992/12/22Labeling Revision
020180002AP1992/12/22Manufacturing Change or Addition
020180001AP1992/08/20Labeling Revision
020180000AP1992/06/19Approval