药品名称LOTENSIN HCT
申请号020033产品号003
活性成分BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格20MG;25MG
治疗等效代码AB参比药物
批准日期1992/05/19申请机构US PHARMACEUTICALS HOLDINGS I LLC
化学类型New combination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
020033052APLabel2015/08/26下载
020033052APLetter2015/08/27下载
020033050APLetter2014/12/15下载
020033050APLabel2014/12/16下载
020033047APLabel2012/09/25下载
020033046APLetter2012/07/30下载
020033046APLabel2012/07/30下载
020033045APLabel2012/01/23下载
020033045APLetter2012/02/06下载
020033043APLetter2012/02/17下载
020033043APLabel2012/02/17下载
020033041APLetter2011/06/16下载
020033041APLabel2011/06/16下载
020033040APLetter2011/03/21下载
020033040APLabel2011/03/21下载
020033038APLabel2009/11/12下载
020033038APLetter2010/01/19下载
020033037APLetter2009/01/26下载
020033036APLetter2008/06/02下载
020033033APLetter2007/02/12下载
020033025APLetter2003/11/05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
020033058AP2016/10/14Manufacturing Change or Addition
020033057AP2016/10/14Manufacturing Change or Addition
020033056AP2016/09/23Manufacturing Change or Addition
020033055AP2016/05/05Manufacturing Change or Addition
020033054AP2016/06/03Manufacturing Change or Addition
020033053AP2016/02/12Manufacturing Change or Addition
020033052AP2015/08/25Labeling Revision
020033051AP2015/07/07Manufacturing Change or Addition
020033050AP2014/12/12Labeling Revision
020033049AP2014/08/14Manufacturing Change or Addition
020033048AP2014/07/22Manufacturing Change or Addition
020033047AP2012/09/21Labeling Revision
020033046AP2012/07/26Labeling Revision
020033045AP2012/01/19Labeling Revision
020033043AP2012/02/16Labeling Revision
020033041AP2011/06/14Labeling Revision
020033040AP2011/03/17Labeling Revision
020033038AP2009/11/10Labeling Revision
020033037AP2009/01/22Labeling Revision
020033036AP2008/05/29Labeling Revision
020033033AP2007/02/02Labeling Revision
020033025AP2003/10/29Labeling Revision
020033023AP2002/10/25Control Supplement
020033022AP2002/09/20Manufacturing Change or Addition
020033021AP2002/04/29Manufacturing Change or Addition
020033020AP2001/11/30Control Supplement
020033019AP2001/08/13Package Change
020033018AP2001/12/14Labeling Revision
020033017AP2000/05/10Manufacturing Change or Addition
020033016AP2001/10/16Manufacturing Change or Addition
020033014AP1999/04/28Package Change
020033013AP1998/07/29Labeling Revision
020033012AP1997/04/09Labeling Revision
020033011AP1997/01/13Expiration Date Change
020033010AP1995/11/02Manufacturing Change or Addition
020033009AP1996/04/02Labeling Revision
020033008AP1995/05/05Labeling Revision
020033007AP1993/12/20Labeling Revision
020033006AP1993/06/30Control Supplement
020033005AP1993/10/21Labeling Revision
020033004AP1992/11/25Labeling Revision
020033003AP1993/01/07Package Change
020033002AP1992/06/23Control Supplement
020033001AP1992/06/23Package Change
020033000AP1992/05/19Approval