药品名称TENORMIN
申请号018240产品号002
活性成分ATENOLOL市场状态处方药
剂型或给药途径TABLET;ORAL规格100MG
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ALVOGEN MALTA OPERATIONS LTD
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
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
018240032APLetter2012/11/05下载
018240032APLabel2012/11/06下载
018240031APLetter2011/08/18下载
018240031APLabel2011/08/24下载
018240030APLetter2008/05/05下载
018240029APLetter2005/02/11下载
018240028APLetter2003/11/13下载
018240027APLetter2003/01/09下载
018240026APReview2001/06/04下载
018240025APReview2001/06/04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
018240039AP2015/09/10Manufacturing Change or Addition
018240038AP2015/09/03Manufacturing Change or Addition
018240037AP2015/08/27Manufacturing Change or Addition
018240035AP2015/07/16Manufacturing Change or Addition
018240034AP2015/07/15Manufacturing Change or Addition
018240033AP2015/07/09Manufacturing Change or Addition
018240032AP2012/10/31Labeling Revision
018240031AP2011/08/17Labeling Revision
018240030AP2008/04/29Labeling Revision
018240029AP2005/02/09Labeling Revision
018240028AP2003/11/06Labeling Revision
018240027AP2003/01/09Labeling Revision
018240026AP1999/07/21Labeling Revision
018240025AP2000/04/04Labeling Revision
018240024AP1996/10/11Package Change
018240023AP1996/02/09Labeling Revision
018240021AP1994/05/04Labeling Revision
018240020AP1993/04/29Labeling Revision
018240019AP1992/08/05Labeling Revision
018240018AP1992/08/05Labeling Revision
018240017AP1991/09/18Labeling Revision
018240016AP1991/02/21Labeling Revision
018240015AP1991/02/21Labeling Revision
018240014AP1991/02/21Labeling Revision
018240013AP1990/04/09New Dosage Regimen
018240011AP1987/02/13Package Change
018240009AP1985/09/18Labeling Revision
018240008AP1984/11/19Control Supplement
018240007AP1984/07/12Manufacturing Change or Addition
018240006AP1983/12/15Control Supplement
018240005AP1989/09/13New or Modified Indication
018240004AP1983/09/27Package Change
018240003AP1983/04/07Formulation Revision
018240002AP1985/09/04New or Modified Indication
018240001AP1981/09/23Labeling Revision
018240000AP1981/08/19Approval