药品名称CAPOTEN
申请号018343产品号005
活性成分CAPTOPRIL市场状态停止上市
剂型或给药途径TABLET;ORAL规格12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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1985/01/17申请机构PAR PHARMACEUTICAL INC
化学类型New molecular entity (NME)审评分类Priority 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
52389242010/08/24U-92PDF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
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
018343086APLetter2015/06/22下载
018343086APLabel2015/06/22下载
018343085APLetter2014/12/30下载
018343085APLabel2015/01/09下载
018343084APLabel2012/08/28下载
018343084APLetter2012/08/29下载
018343083APLabel2011/12/14下载
018343083APLetter2011/12/15下载
018343082APLabel2011/05/23下载
018343082APLetter2011/05/24下载
018343081APLetter2008/09/29下载
018343075APLetter2004/05/07下载
018343000APOther Important Information from FDA2006/06/09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
018343086AP2015/06/19Labeling Revision
018343085AP2014/12/24Labeling Revision
018343084AP2012/08/27Labeling Revision
018343083AP2011/12/14Labeling Revision
018343082AP2011/05/19Labeling Revision
018343081AP2008/09/25Labeling Revision
018343075AP2004/05/07Labeling Revision
018343073AP1999/04/20Labeling Revision
018343072AP1998/01/09Control Supplement
018343071AP1997/08/21Control Supplement
018343070AP1996/06/25Manufacturing Change or Addition
018343069AP1996/03/01Control Supplement
018343068AP1996/07/31Labeling Revision
018343067AP1995/03/06Control Supplement
018343066AP1995/06/13Formulation Revision
018343065AP1993/11/04Labeling Revision
018343064AP1994/01/28New or Modified Indication
018343063AP1994/03/31Labeling Revision
018343062AP1993/05/12Package Change
018343061AP1992/06/25Labeling Revision
018343060AP1992/09/03Labeling Revision
018343059AP1992/12/21Control Supplement
018343058AP1992/01/14Control Supplement
018343057AP1995/06/19Control Supplement
018343056AP1992/05/07Formulation Revision
018343055AP1991/10/07Manufacturing Change or Addition
018343054AP1991/01/31Package Change
018343053AP1991/04/12Manufacturing Change or Addition
018343052AP1990/11/05Package Change
018343051AP1991/03/21Labeling Revision
018343050AP1990/09/27Labeling Revision
018343049AP1990/05/10Manufacturing Change or Addition
018343048AP1993/09/23New or Modified Indication
018343047AP1989/05/03Labeling Revision
018343046AP1989/10/19Labeling Revision
018343045AP1988/05/13Control Supplement
018343044AP1988/02/19Labeling Revision
018343041AP1987/06/26Expiration Date Change
018343040AP1988/05/13New or Modified Indication
018343039AP1987/01/06Package Change
018343038AP1987/01/21Control Supplement
018343037AP1987/02/13Control Supplement
018343036AP1987/04/02Manufacturing Change or Addition
018343035AP1986/08/14Manufacturing Change or Addition
018343033AP1986/07/24Control Supplement
018343032AP1990/03/23Control Supplement
018343031AP1986/03/04Control Supplement
018343030AP1986/09/17Control Supplement
018343029AP1986/05/27Control Supplement
018343028AP1986/02/27Expiration Date Change
018343027AP1986/01/17Labeling Revision
018343026AP1985/12/18Package Change
018343025AP1985/04/16Control Supplement
018343024AP1985/06/12Manufacturing Change or Addition
018343023AP1985/04/16Control Supplement
018343022AP1984/11/19Control Supplement
018343021AP1984/10/12Labeling Revision
018343020AP1984/07/12Package Change
018343018AP1985/01/17General Efficacy (MarkIV)
018343017AP1984/09/18Control Supplement
018343016AP1984/06/08Package Change
018343015AP1984/06/08Package Change
018343014AP1984/08/28General Efficacy (MarkIV)
018343013AP1983/10/14Package Change
018343012AP1984/02/07Expiration Date Change
018343011AP1983/10/14Formulation Revision
018343010AP1983/05/18Control Supplement
018343009AP1985/07/10Labeling Revision
018343008AP1984/02/07Manufacturing Change or Addition
018343007AP1982/03/09Control Supplement
018343006AP1982/02/25Control Supplement
018343005AP1982/10/25General Efficacy (MarkIV)
018343004AP1981/11/30Formulation Revision
018343003AP1981/10/27Control Supplement
018343002AP1982/10/07Control Supplement
018343001AP1981/06/12Package Change
018343000AP1981/04/06Approval