药品名称AVALIDE
申请号020758产品号001
活性成分HYDROCHLOROTHIAZIDE; IRBESARTAN市场状态停止上市
剂型或给药途径TABLET;ORAL规格12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期1997/09/30申请机构SANOFI AVENTIS US 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
5994348*PED2015/12/07PDF格式
历史专利信息
52703172011/09/30PDF格式
5270317*PED2012/03/30PDF格式
59943482015/06/07PDF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
I-5492010/11/16
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
020758070APLetter2016/02/09下载
020758070APLabel2016/02/18下载
020758067APLabel2014/05/30下载
020758067APLetter2014/06/02下载
020758064APLabel2012/10/26下载
020758064APLetter2012/10/29下载
020758062APLetter2012/01/23下载
020758062APLabel2012/01/23下载
020758060APLetter2012/02/13下载
020758060APLabel2012/02/17下载
020758059APLabel2011/06/06下载
020758059APLetter2011/06/09下载
020758058APLetter2011/06/09下载
020758058APLabel2011/06/06下载
020758050APLetter2010/09/09下载
020758050APLabel2010/09/10下载
020758037APLabel2007/11/19下载
020758037APLetter2007/11/19下载
020758036APLabel2006/04/25下载
020758036APLetter2006/04/25下载
020758035APLetter2005/11/30下载
020758032APLetter2005/03/18下载
020758031APReview2005/04/27下载
020758030APReview2005/04/27下载
020758029APReview2005/05/03下载
020758028APReview2005/05/03下载
020758028APOther2005/05/03下载
020758023APOther2005/05/05下载
020758023APReview2005/05/05下载
020758016APReview2004/05/27下载
020758003APReview1998/08/31下载
020758000APReview2009/09/01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
020758070AP2016/02/05Labeling Revision
020758067AP2014/05/28Labeling Revision
020758064AP2012/10/26Labeling Revision
020758062AP2012/01/18Labeling Revision
020758060AP2012/02/09Labeling Revision
020758059AP2011/06/06Labeling Revision
020758058AP2011/06/06Labeling Revision
020758050AP2010/09/07Labeling Revision
020758037AP2007/11/16New or Modified Indication
020758036AP2006/04/21Labeling Revision
020758035AP2005/11/21Labeling Revision
020758032AP2005/03/15Formulation Revision
020758031AP2004/10/29Supplement
020758030AP2004/07/21Supplement
020758029AP2004/01/02Supplement
020758028AP2003/10/10Supplement
020758023AP2003/05/01Supplement
020758021AP2001/06/07Manufacturing Change or Addition
020758020AP2001/03/06Manufacturing Change or Addition
020758019AP2001/02/21Control Supplement
020758018AP2000/09/20Labeling Revision
020758017AP2000/05/10Manufacturing Change or Addition
020758016AP2000/05/09Labeling Revision
020758015AP2000/08/01Control Supplement
020758014AP2000/04/28Control Supplement
020758013AP2001/09/26Labeling Revision
020758012AP2000/08/23Control Supplement
020758011AP1999/04/20Labeling Revision
020758010AP1999/03/16Manufacturing Change or Addition
020758009AP1999/03/16Manufacturing Change or Addition
020758008AP1999/01/21Manufacturing Change or Addition
020758007AP1998/07/14Labeling Revision
020758006AP1998/07/15Formulation Revision
020758005AP1998/09/03Manufacturing Change or Addition
020758004AP1998/04/06Manufacturing Change or Addition
020758003AP1998/08/31Formulation Revision
020758002AP1998/01/30Control Supplement
020758001AP1998/01/30Control Supplement
020758000AP1997/09/30Approval