药品名称ZESTRIL
申请号019777产品号001
活性成分LISINOPRIL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1988/05/19申请机构ALVOGEN MALTA OPERATIONS LTD
化学类型New formulation or new manufacturer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
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
PED2006/11/29
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
019777074APLetter2016/04/22下载
019777074APLabel2016/04/29下载
019777073APLabel2015/08/26下载
019777073APLetter2015/08/27下载
019777064APLetter2014/12/30下载
019777064APLabel2015/01/09下载
019777063APLetter2013/11/07下载
019777063APLabel2013/11/21下载
019777062APLabel2012/08/15下载
019777062APLetter2012/08/16下载
019777061APLabel2012/11/02下载
019777061APLetter2012/11/05下载
019777060APLabel2012/03/29下载
019777060APLetter2012/04/02下载
019777059APLetter2012/05/04下载
019777059APLabel2012/05/07下载
019777058APLetter2011/08/09下载
019777058APLabel2011/08/12下载
019777057APLetter2014/06/27下载
019777057APLabel2014/06/30下载
019777056APLabel2009/11/19下载
019777056APLetter2010/01/07下载
019777054APLabel2009/05/25下载
019777054APLetter2009/05/26下载
019777053APLetter2007/10/10下载
019777052APLetter2007/07/24下载
019777050APLetter2006/06/20下载
019777049APLetter2005/05/25下载
019777044APReview2004/09/08下载
019777044APLabel2004/01/02下载
019777044APLetter2003/07/06下载
019777043APLetter2004/04/07下载
019777042APReview2004/09/08下载
019777042APLetter2003/07/06下载
019777042APLabel2003/07/08下载
019777037APLetter2000/02/07下载
019777037APReview2005/12/16下载
019777035APReview1999/01/20下载
019777034APReview1998/11/06下载
019777033APReview1998/05/01下载
019777032APReview1997/01/08下载
019777031APReview2003/08/08下载
019777030APReview2003/08/08下载
019777027APReview2003/08/08下载
019777026APReview2003/08/05下载
019777024APReview2003/08/05下载
019777018APReview2001/09/18下载
019777017APReview2003/08/05下载
019777015APReview2003/08/05下载
019777013APReview2003/08/05下载
019777012APReview2003/08/05下载
019777011APReview2003/08/05下载
019777009APReview2001/09/18下载
019777008APReview2003/08/05下载
019777006APReview2003/08/05下载
019777004APReview2001/09/18下载
019777003APReview2001/09/18下载
019777002APReview2003/08/05下载
019777001APReview2001/09/18下载
019777000APOther 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
019777074AP2016/04/21Labeling Revision
019777073AP2015/08/25Labeling Revision
019777064AP2014/12/24Labeling Revision
019777063AP2013/11/05Labeling Revision
019777062AP2012/08/13Labeling Revision
019777061AP2012/10/31Labeling Revision
019777060AP2012/03/29Labeling Revision
019777059AP2012/05/02Labeling Revision
019777058AP2011/08/04Labeling Revision
019777057AP2014/06/26Labeling Revision
019777056AP2009/11/06Labeling Revision
019777054AP2009/05/20Labeling Revision
019777053AP2007/10/04Labeling Revision
019777052AP2007/07/16Labeling Revision
019777050AP2006/06/16Labeling Revision
019777049AP2005/05/24Labeling Revision
019777044AP2003/07/01Patient Population Altered
019777043AP2004/03/30Labeling Revision
019777042AP2003/07/01Approval
019777041AP2000/12/15Manufacturing Change or Addition
019777040AP2000/12/19Manufacturing Change or Addition
019777039AP2000/07/27Manufacturing Change or Addition
019777038AP1999/11/18Control Supplement
019777037AP2000/02/07New or Modified Indication
019777036AP1999/02/24Manufacturing Change or Addition
019777035AP1999/01/20Manufacturing Change or Addition
019777034AP1998/11/06Manufacturing Change or Addition
019777033AP1998/05/01Labeling Revision
019777032AP1997/01/08Labeling Revision
019777031AP1996/10/11Package Change
019777030AP1995/11/15Labeling Revision
019777028AP1995/10/26Manufacturing Change or Addition
019777027AP1995/07/11Package Change
019777026AP1995/07/11Control Supplement
019777025AP1995/03/31Labeling Revision
019777024AP1995/06/05Manufacturing Change or Addition
019777023AP1995/11/24New or Modified Indication
019777022AP1994/05/17Manufacturing Change or Addition
019777021AP1994/08/05Labeling Revision
019777020AP1995/06/13Labeling Revision
019777019AP1993/09/23Labeling Revision
019777018AP1993/03/31Labeling Revision
019777017AP1993/05/26Manufacturing Change or Addition
019777016AP1993/04/29Formulation Revision
019777015AP1992/11/18Manufacturing Change or Addition
019777014AP1992/06/25Labeling Revision
019777013AP1992/02/12Control Supplement
019777012AP1991/12/11Manufacturing Change or Addition
019777011AP1991/07/29Control Supplement
019777010AP1991/04/11Labeling Revision
019777009AP1990/10/17Labeling Revision
019777008AP1990/11/08Control Supplement
019777007AP1993/06/09New or Modified Indication
019777006AP1989/09/05Control Supplement
019777005AP1989/07/20Labeling Revision
019777004AP1989/04/11Labeling Revision
019777003AP1989/01/18Control Supplement
019777002AP1988/09/20Package Change
019777001AP1988/06/30Labeling Revision
019777000AP1988/05/19Approval