药品名称TOPROL-XL
申请号019962产品号002
活性成分METOPROLOL SUCCINATE市场状态处方药
剂型或给药途径TABLET, EXTENDED RELEASE;ORAL规格EQ 100MG TARTRATE
治疗等效代码AB参比药物
批准日期1992/01/10申请机构ASTRAZENECA PHARMACEUTICALS LP
化学类型New active ingredient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
49276402007/05/22YPDF格式
4927640*PED2007/11/22PDF格式
49577452007/09/18YU-107PDF格式
4957745*PED2008/03/18PDF格式
50011612007/09/18YPDF格式
5001161*PED2008/03/18PDF格式
50811542007/09/18YPDF格式
5081154*PED2008/03/18PDF格式
52467142010/09/21PDF格式
5246714*PED2011/03/21PDF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
D-952008/02/15
M-612010/07/18
PED2008/08/15
PED2011/01/18
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
019962044APLetter2014/05/08下载
019962044APLabel2014/05/12下载
019962043APLabel2012/11/02下载
019962043APLetter2012/11/05下载
019962042APLabel2010/01/20下载
019962042APLetter2010/01/26下载
019962041APLetter2010/03/24下载
019962041APLabel2010/03/26下载
019962038APLetter2009/03/02下载
019962038APLabel2009/03/02下载
019962036APLetter2008/02/19下载
019962036APLabel2008/02/25下载
019962034APLetter2007/03/23下载
019962033APLetter2007/07/24下载
019962033APLabel2007/07/24下载
019962032APLabel2006/08/04下载
019962032APLetter2006/08/04下载
019962031APLetter2006/05/05下载
019962028APLetter2005/04/12下载
019962027APLetter2005/02/17下载
019962027APLabel2005/02/17下载
019962024APLetter2003/01/30下载
019962022APLetter2002/03/05下载
019962022APReview2002/05/30下载
019962013APLetter2000/07/10下载
019962013APLabel2000/07/10下载
019962013APReview2000/07/20下载
019962004APReview2005/07/15下载
019962003APReview2005/07/15下载
019962002APReview2005/07/15下载
019962001APReview2005/07/15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
019962045AP2014/05/12Manufacturing Change or Addition
019962044AP2014/05/06Labeling Revision
019962043AP2012/10/31Labeling Revision
019962042AP2010/01/19Labeling Revision
019962041AP2010/03/19Approval
019962038AP2009/02/12Labeling Revision
019962036AP2008/02/15Control Supplement
019962034AP2007/03/14Labeling Revision
019962033AP2007/07/18Patient Population Altered
019962032AP2006/07/27Control Supplement
019962031AP2006/05/04Labeling Revision
019962028AP2005/04/05Labeling Revision
019962027AP2005/02/15New Dosage Regimen
019962024AP2003/01/27Labeling Revision
019962022AP2002/03/05Labeling Revision
019962021AP2001/10/25Package Change
019962020AP2001/08/22Manufacturing Change or Addition
019962019AP2001/06/12Package Change
019962018AP2001/09/26Manufacturing Change or Addition
019962017AP2001/02/02Manufacturing Change or Addition
019962016AP2000/11/22Manufacturing Change or Addition
019962015AP2000/09/28Manufacturing Change or Addition
019962014AP2000/10/13Manufacturing Change or Addition
019962013AP2001/02/05New or Modified Indication
019962011AP1999/03/05Control Supplement
019962010AP1999/01/14Manufacturing Change or Addition
019962009AP1996/06/25Labeling Revision
019962008AP1996/03/11Control Supplement
019962007AP1996/03/12Labeling Revision
019962006AP1995/06/13Formulation Revision
019962005AP1995/02/07Control Supplement
019962004AP1994/10/27Labeling Revision
019962003AP1994/03/04Control Supplement
019962002AP1992/06/24Labeling Revision
019962001AP1992/02/27Labeling Revision
019962000AP1992/01/10Approval