药品名称ZESTORETIC
申请号019888产品号001
活性成分HYDROCHLOROTHIAZIDE; LISINOPRIL市场状态处方药
剂型或给药途径TABLET;ORAL规格12.5MG;20MG
治疗等效代码AB参比药物
批准日期1990/09/20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
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
019888065APLabel2015/08/26下载
019888065APLetter2015/08/27下载
019888056APLetter2014/12/30下载
019888056APLabel2015/01/09下载
019888055APLabel2013/11/08下载
019888055APLetter2013/11/08下载
019888054APLabel2012/08/15下载
019888054APLetter2012/08/16下载
019888053APLabel2012/11/02下载
019888053APLetter2012/11/05下载
019888052APLabel2012/03/29下载
019888052APLetter2012/04/02下载
019888051APLetter2012/05/04下载
019888051APLabel2012/05/07下载
019888050APLetter2011/08/05下载
019888050APLabel2011/08/05下载
019888049APLabel2011/03/11下载
019888049APLetter2011/03/16下载
019888047APLabel2009/11/19下载
019888047APLetter2010/01/07下载
019888045APLabel2009/05/25下载
019888045APLetter2009/05/26下载
019888044APLetter2007/10/10下载
019888043APLetter2007/07/24下载
019888041APLetter2006/06/20下载
019888040APLetter2005/05/25下载
019888035APLetter2003/05/29下载
019888020APReview2003/08/08下载
019888012APReview2001/09/18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
019888065AP2015/08/25Labeling Revision
019888056AP2014/12/24Labeling Revision
019888055AP2013/11/05Labeling Revision
019888054AP2012/08/13Labeling Revision
019888053AP2012/10/31Labeling Revision
019888052AP2012/03/29Labeling Revision
019888051AP2012/05/02Labeling Revision
019888050AP2011/08/04Labeling Revision
019888049AP2011/03/11Labeling Revision
019888047AP2009/11/06Labeling Revision
019888045AP2009/05/20Labeling Revision
019888044AP2007/10/04Labeling Revision
019888043AP2007/07/16Labeling Revision
019888041AP2006/06/16Labeling Revision
019888040AP2005/05/24Labeling Revision
019888035AP2003/04/17Labeling Revision
019888034AP2001/12/18Labeling Revision
019888033AP2000/12/19Manufacturing Change or Addition
019888032AP2000/12/15Manufacturing Change or Addition
019888031AP2000/07/27Manufacturing Change or Addition
019888030AP1999/11/18Control Supplement
019888029AP1998/05/08Labeling Revision
019888028AP1997/01/14Manufacturing Change or Addition
019888027AP1996/10/11Package Change
019888026AP1996/01/05Labeling Revision
019888025AP1995/12/14Manufacturing Change or Addition
019888024AP1996/01/05Labeling Revision
019888023AP1995/07/11Manufacturing Change or Addition
019888022AP1995/10/26Control Supplement
019888021AP1995/03/31Labeling Revision
019888020AP1995/06/13Labeling Revision
019888019AP1994/09/15Labeling Revision
019888018AP1994/08/05Labeling Revision
019888017AP1994/08/05Labeling Revision
019888016AP1993/12/09Labeling Revision
019888015AP1995/06/13Labeling Revision
019888014AP1993/09/23Labeling Revision
019888013AP1994/08/05Labeling Revision
019888012AP1993/03/31Labeling Revision
019888011AP1993/11/18New Dosage Regimen
019888010AP1992/11/18Manufacturing Change or Addition
019888009AP1992/06/25Labeling Revision
019888008AP1991/12/11Manufacturing Change or Addition
019888007AP1991/04/11Labeling Revision
019888006AP1991/04/08Control Supplement
019888005AP1991/02/21Labeling Revision
019888004AP1990/12/21Manufacturing Change or Addition
019888003AP1990/11/08Labeling Revision
019888002AP1990/09/20Formulation Revision
019888001AP1989/10/13Control Supplement
019888000AP1989/07/20Approval