药品名称LOTENSIN
申请号019851产品号001
活性成分BENAZEPRIL HYDROCHLORIDE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1991/06/25申请机构US PHARMACEUTICALS HOLDINGS I LLC
化学类型New molecular entity (NME)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
M-302007/03/02
PED2007/09/02
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
019851049APLetter2015/07/23下载
019851049APLabel2015/07/24下载
019851047APLetter2015/01/27下载
019851047APLabel2015/01/30下载
019851046APLetter2014/12/15下载
019851046APLabel2014/12/16下载
019851045APLetter2015/07/23下载
019851045APLabel2015/07/24下载
019851044APLabel2012/09/25下载
019851043APLabel2012/01/23下载
019851043APLetter2012/02/06下载
019851042APLetter2012/05/21下载
019851042APLabel2012/05/22下载
019851040APLetter2011/06/16下载
019851040APLabel2011/06/16下载
019851038APLabel2009/11/16下载
019851038APLetter2010/01/07下载
019851037APLetter2009/01/26下载
019851036APLetter2008/06/02下载
019851034APLetter2007/02/12下载
019851029APLetter2003/11/05下载
019851028APLetter2004/03/03下载
019851028APLabel2004/04/05下载
019851000APOther 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
019851050AP2015/12/17Manufacturing Change or Addition
019851049AP2015/07/22Labeling Revision
019851048AP2015/07/14Manufacturing Change or Addition
019851047AP2015/01/26Labeling Revision
019851046AP2014/12/12Labeling Revision
019851045AP2015/07/22Labeling Revision
019851044AP2012/09/21Labeling Revision
019851043AP2012/01/19Labeling Revision
019851042AP2012/05/17Labeling Revision
019851040AP2011/06/14Labeling Revision
019851038AP2009/11/10Labeling Revision
019851037AP2009/01/22Labeling Revision
019851036AP2008/05/29Labeling Revision
019851034AP2007/02/02Labeling Revision
019851029AP2003/10/29Labeling Revision
019851028AP2004/03/02Patient Population Altered
019851026AP2002/10/25Control Supplement
019851025AP2002/09/20Manufacturing Change or Addition
019851024AP2002/04/29Manufacturing Change or Addition
019851023AP2001/11/30Control Supplement
019851022AP2001/08/13Package Change
019851021AP2001/12/14Labeling Revision
019851020AP2000/11/02Manufacturing Change or Addition
019851019AP2000/05/10Manufacturing Change or Addition
019851018AP1999/04/28Package Change
019851017AP1998/07/20Control Supplement
019851016AP1998/07/29Labeling Revision
019851015AP1997/08/13Package Change
019851014AP1997/04/18Package Change
019851013AP1997/01/13Expiration Date Change
019851012AP1996/06/25Package Change
019851011AP1995/11/02Manufacturing Change or Addition
019851010AP1995/07/07Control Supplement
019851009AP1995/11/22Labeling Revision
019851008AP1995/02/08Control Supplement
019851007AP1995/05/05Labeling Revision
019851006AP1994/03/15Control Supplement
019851005AP1993/10/21Labeling Revision
019851004AP1992/11/20Labeling Revision
019851003AP1992/06/25Labeling Revision
019851002AP1992/03/13Package Change
019851001AP1992/01/09Labeling Revision
019851000AP1991/06/25Approval