药品名称VASOTEC
申请号018998产品号002
活性成分ENALAPRIL MALEATE市场状态处方药
剂型或给药途径TABLET;ORAL规格10MG
治疗等效代码AB参比药物
批准日期1985/12/24申请机构VALEANT PHARMACEUTICALS NORTH AMERICA LLC
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
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
018998080APLabel2015/08/26下载
018998080APLetter2015/08/27下载
018998079APLetter2014/12/30下载
018998079APLabel2015/01/09下载
018998077APLabel2012/09/14下载
018998077APLetter2012/09/17下载
018998076APLabel2012/02/22下载
018998076APLetter2012/02/23下载
018998071APLetter2008/09/29下载
018998071APLabel2010/05/18下载
018998070APLetter2007/11/08下载
018998064APReview2006/10/26下载
018998063APLetter2002/08/30下载
018998062APReview2006/10/25下载
018998061APReview2006/10/25下载
018998059APReview2001/02/13下载
018998059APLetter2001/02/13下载
018998059APLabel2001/02/13下载
018998058APReview2001/11/27下载
018998058APLetter2001/11/27下载
018998058APLabel2001/11/27下载
018998057APReview2001/06/22下载
018998053APReview1997/06/11下载
018998052APReview2007/04/09下载
018998051APReview2007/04/09下载
018998050APReview2007/07/06下载
018998046APReview2007/07/06下载
018998045APReview2007/06/12下载
018998044APReview2011/02/15下载
018998043APReview2011/02/15下载
018998042APReview2007/06/12下载
018998041APReview2007/06/12下载
018998040APReview2011/01/04下载
018998039APReview2011/01/04下载
018998038APReview2011/01/04下载
018998034APReview2007/07/06下载
018998025APReview2007/09/14下载
018998024APReview2007/09/14下载
018998023APReview2007/07/20下载
018998022APReview2007/07/20下载
018998021APReview2007/07/20下载
018998020APReview2007/07/06下载
018998018APReview2007/07/06下载
018998017APReview2007/09/14下载
018998016APReview2007/11/19下载
018998015APReview2007/07/06下载
018998013APReview2007/11/19下载
018998011APReview2007/11/19下载
018998009APReview2006/10/26下载
018998006APReview2006/10/26下载
018998005APReview2006/10/26下载
018998000APReview2005/04/27下载
018998000APOther Important Information from FDA2006/06/09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
018998080AP2015/08/25Labeling Revision
018998079AP2014/12/24Labeling Revision
018998077AP2012/09/13Labeling Revision
018998076AP2012/02/17Labeling Revision
018998071AP2008/09/25Labeling Revision
018998070AP2007/10/31Labeling Revision
018998064AP2002/10/10Manufacturing Change or Addition
018998063AP2002/08/30Manufacturing Change or Addition
018998062AP2002/04/03Control Supplement
018998061AP2002/02/04Manufacturing Change or Addition
018998059AP2001/02/13Efficacy Supplement with Clinical Data to Support
018998058AP2001/11/27Labeling Revision
018998057AP1999/02/17Labeling Revision
018998056AP1997/12/10Control Supplement
018998055AP1997/07/21Manufacturing Change or Addition
018998054AP1997/07/23Package Change
018998053AP1997/06/11Labeling Revision
018998052AP1997/02/03Manufacturing Change or Addition
018998051AP1997/01/09Manufacturing Change or Addition
018998050AP1996/03/22Manufacturing Change or Addition
018998049AP1995/09/19Control Supplement
018998048AP1995/09/19Control Supplement
018998047AP1995/09/19Control Supplement
018998046AP1995/09/28Labeling Revision
018998045AP1994/07/25Labeling Revision
018998044AP1994/05/16Labeling Revision
018998043AP1994/02/18Labeling Revision
018998042AP1994/07/15Control Supplement
018998041AP1994/12/12Manufacturing Change or Addition
018998040AP1993/10/21Labeling Revision
018998039AP1994/01/14Labeling Revision
018998038AP1994/05/11Labeling Revision
018998037AP1993/07/01Labeling Revision
018998036AP1993/02/24Labeling Revision
018998035AP1993/07/26Manufacturing Change or Addition
018998034AP1996/07/31Labeling Revision
018998033AP1992/09/30Labeling Revision
018998032AP1993/11/04New or Modified Indication
018998031AP1992/05/07Labeling Revision
018998030AP1992/05/13Labeling Revision
018998029AP1992/09/30Package Change
018998027AP1992/04/08Patient Population Altered
018998026AP1991/08/02Package Change
018998025AP1991/02/06Labeling Revision
018998024AP1990/11/28Labeling Revision
018998023AP1990/07/19Package Change
018998022AP1990/06/12New or Modified Indication
018998021AP1990/03/09Labeling Revision
018998020AP1989/11/30Labeling Revision
018998018AP1989/04/18Labeling Revision
018998017AP1991/02/20Manufacturing Change or Addition
018998016AP1989/01/10Labeling Revision
018998015AP1989/03/29Labeling Revision
018998013AP1988/08/03Manufacturing Change or Addition
018998012AP1988/07/26Formulation Revision
018998011AP1988/04/25Labeling Revision
018998009AP1987/07/10Package Change
018998007AP1988/06/24New or Modified Indication
018998006AP1987/01/28Labeling Revision
018998005AP1987/05/14Labeling Revision
018998004AP1986/10/03Labeling Revision
018998003AP1986/11/07Control Supplement
018998002AP1986/10/27Control Supplement
018998000AP1985/12/24Approval