药品名称AMARYL
申请号020496产品号003
活性成分GLIMEPIRIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格4MG
治疗等效代码AB参比药物
批准日期1995/11/30申请机构SANOFI AVENTIS US 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-542008/11/28
PED2009/05/28
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
020496027APLetter2013/10/18下载
020496027APLabel2013/10/22下载
020496026APLetter2013/08/05下载
020496026APLabel2013/08/09下载
020496022APLabel2012/02/06下载
020496022APLetter2012/02/08下载
020496021APLabel2009/06/04下载
020496021APLetter2009/06/16下载
020496019APLabel2009/02/04下载
020496019APLetter2009/02/13下载
020496018APLetter2009/02/13下载
020496018APLabel2009/02/04下载
020496016APLabel2005/09/22下载
020496016APLetter2005/09/22下载
020496015APLabel2005/12/05下载
020496015APLetter2005/12/06下载
020496013APLetter2004/08/25下载
020496007APLetter2002/04/15下载
020496005APReview2004/05/27下载
020496002APLetter1999/02/24下载
020496002APReview1999/02/24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
020496027AP2013/10/15Labeling Revision
020496026AP2013/08/01Labeling Revision
020496025AP2013/04/19Manufacturing Change or Addition
020496024AP2013/03/14Manufacturing Change or Addition
020496022AP2012/02/03Labeling Revision
020496021AP2009/06/04Labeling Revision
020496019AP2009/02/03Labeling Revision
020496018AP2009/02/03Labeling Revision
020496016AP2005/09/19Labeling Revision
020496015AP2005/11/28Patient Population Altered
020496013AP2004/08/16Labeling Revision
020496011AP2001/07/21Manufacturing Change or Addition
020496010AP2000/12/05Control Supplement
020496009AP2000/08/29Control Supplement
020496007AP2002/04/15Labeling Revision
020496006AP2000/01/06Manufacturing Change or Addition
020496005AP2000/09/27Efficacy Supplement with Clinical Data to Support
020496004AP1998/09/16Package Change
020496003AP1998/09/16Package Change
020496002AP1999/02/24New or Modified Indication
020496001AP1997/07/28Manufacturing Change or Addition
020496000AP1995/11/30Approval