药品名称DIABETA
申请号017532产品号002
活性成分GLYBURIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格2.5MG
治疗等效代码AB2参比药物
批准日期1984/05/01申请机构SANOFI AVENTIS US LLC
化学类型New formulation or new manufacturer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
017532034APLetter2013/10/16下载
017532034APLabel2013/10/21下载
017532030APLetter2009/07/15下载
017532030APLabel2009/07/23下载
017532028APLetter2009/03/10下载
017532028APLabel2009/03/17下载
017532027APLetter2009/03/10下载
017532027APLabel2009/03/17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
017532036AP2014/08/25Manufacturing Change or Addition
017532035AP2013/08/16Manufacturing Change or Addition
017532034AP2013/10/15Labeling Revision
017532030AP2009/07/09Labeling Revision
017532028AP2009/03/05Labeling Revision
017532027AP2009/03/05Labeling Revision
017532023AP1999/12/29Labeling Revision
017532022AP1997/10/08Manufacturing Change or Addition
017532021AP1997/02/20Control Supplement
017532020AP1996/03/29Package Change
017532019AP1996/11/22Control Supplement
017532018AP1995/02/01Control Supplement
017532017AP1994/08/11Labeling Revision
017532016AP1994/05/20Package Change
017532015AP1993/07/27Labeling Revision
017532014AP1993/01/21Labeling Revision
017532013AP1993/03/26Package Change
017532012AP1992/08/06Labeling Revision
017532011AP1992/06/19Labeling Revision
017532010AP1993/03/26Control Supplement
017532009AP1988/04/27Labeling Revision
017532008AP1988/04/27Manufacturing Change or Addition
017532007AP1987/08/27Labeling Revision
017532006AP1987/10/20Control Supplement
017532005AP1987/10/20Control Supplement
017532004AP1986/07/01Labeling Revision
017532003AP1985/01/04Package Change
017532002AP1985/03/27Formulation Revision
017532001AP1985/03/27Labeling Revision
017532000AP1984/05/01Approval