药品名称LOTREL
申请号020364产品号003
活性成分AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE市场状态处方药
剂型或给药途径CAPSULE;ORAL规格EQ 5MG BASE;10MG
治疗等效代码AB参比药物
批准日期1995/03/03申请机构NOVARTIS PHARMACEUTICALS CORP
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
61628022017/12/19U-367PDF格式
历史专利信息
45729092006/07/31PDF格式
48793032007/03/25PDF格式
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
020364061APLetter2015/05/19下载
020364061APLabel2015/05/21下载
020364060APLetter2015/04/23下载
020364060APLabel2015/04/24下载
020364058APLetter2014/12/30下载
020364058APLabel2015/01/05下载
020364057APLetter2012/10/10下载
020364057APLabel2012/10/09下载
020364056APLetter2012/10/10下载
020364056APLabel2012/10/09下载
020364055APLetter2012/01/23下载
020364055APLabel2012/01/23下载
020364054APLetter2011/10/31下载
020364054APLabel2011/11/01下载
020364052APLetter2011/06/29下载
020364052APLabel2011/07/07下载
020364050APLabel2011/01/05下载
020364050APLetter2011/01/07下载
020364048APLabel2010/01/04下载
020364048APLetter2010/01/05下载
020364047APLetter2010/04/02下载
020364047APLabel2010/04/04下载
020364046APLabel2009/10/30下载
020364046APLetter2009/11/19下载
020364039APLabel2007/09/04下载
020364039APLetter2007/09/06下载
020364036APLetter2007/03/06下载
020364028APLetter2004/08/12下载
020364024APLetter2004/07/06下载
020364024APLabel2004/07/07下载
020364023APLabel2006/04/12下载
020364023APLetter2006/04/13下载
020364016APLetter2002/06/20下载
020364016APLabel2002/06/20下载
020364016APReview2002/11/22下载
020364014APLetter2003/09/09下载
020364008APReview2001/08/21下载
020364008APLetter1999/06/16下载
020364008APLabel1999/06/16下载
020364007APReview1997/03/14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
020364063AP2016/10/14Manufacturing Change or Addition
020364062AP2016/02/08Manufacturing Change or Addition
020364061AP2015/05/18Labeling Revision
020364060AP2015/04/22Labeling Revision
020364059AP2015/06/16Manufacturing Change or Addition
020364058AP2014/12/31Labeling Revision
020364057AP2012/10/05Labeling Revision
020364056AP2012/10/05Labeling Revision
020364055AP2012/01/19Labeling Revision
020364054AP2011/10/28Labeling Revision
020364052AP2011/06/20Labeling Revision
020364050AP2011/01/04Labeling Revision
020364048AP2009/12/22Manufacturing Change or Addition
020364047AP2010/03/29Labeling Revision
020364046AP2009/10/28Labeling Revision
020364039AP2007/08/31Control Supplement
020364036AP2007/02/23Labeling Revision
020364028AP2004/08/11Labeling Revision
020364024AP2004/07/02Labeling Revision
020364023AP2006/04/11New Dosage Regimen
020364020AP2002/10/25Control Supplement
020364019AP2002/09/20Manufacturing Change or Addition
020364018AP2002/04/29Manufacturing Change or Addition
020364017AP2001/12/12Control Supplement
020364016AP2002/06/20Efficacy Supplement with Clinical Data to Support
020364015AP2001/11/30Control Supplement
020364014AP2003/08/29Labeling Revision
020364013AP2000/11/02Manufacturing Change or Addition
020364012AP2000/05/10Manufacturing Change or Addition
020364011AP1999/04/28Package Change
020364010AP1999/02/18Manufacturing Change or Addition
020364009AP1998/07/21Manufacturing Change or Addition
020364008AP1999/06/16Labeling Revision
020364007AP1997/03/14Labeling Revision
020364006AP1995/11/06Control Supplement
020364005AP1995/11/17Expiration Date Change
020364004AP1995/11/02Manufacturing Change or Addition
020364003AP1995/08/15Control Supplement
020364002AP1996/04/29Labeling Revision
020364001AP1995/07/06Package Change
020364000AP1995/03/03Approval