药品名称UNIVASC
申请号020312产品号002
活性成分MOEXIPRIL HYDROCHLORIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格15MG
治疗等效代码参比药物
批准日期1995/04/19申请机构UCB INC
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
47434502007/02/24PDF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
020312035APLetter2012/09/18下载
020312035APLabel2012/09/18下载
020312034APLetter2012/01/23下载
020312034APLabel2012/01/23下载
020312033APLetter2011/08/26下载
020312033APLabel2011/09/02下载
020312031APLetter2010/01/15下载
020312031APLabel2010/01/29下载
020312024APLetter2003/11/25下载
020312016APLetter2001/04/11下载
020312000APReview2002/09/13下载
020312000APOther 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
020312035AP2012/09/14Labeling Revision
020312034AP2012/01/19Labeling Revision
020312033AP2011/08/23Labeling Revision
020312031AP2010/01/13Labeling Revision
020312024AP2003/10/29Labeling Revision
020312019AP2002/12/09Package Change
020312018AP2001/10/02Control Supplement
020312017AP2001/09/24Control Supplement
020312016AP2001/04/11Labeling Revision
020312015AP2001/03/28Package Change
020312014AP2000/02/02Labeling Revision
020312013AP2000/07/18Manufacturing Change or Addition
020312012AP1999/10/29Manufacturing Change or Addition
020312011AP1999/02/11Manufacturing Change or Addition
020312010AP1998/04/08Labeling Revision
020312009AP1998/09/03Manufacturing Change or Addition
020312008AP1996/11/08Control Supplement
020312007AP1996/09/03Package Change
020312006AP1996/07/09Control Supplement
020312005AP1996/01/17Manufacturing Change or Addition
020312004AP1995/10/18Package Change
020312002AP1995/10/18Manufacturing Change or Addition
020312001AP1995/10/18Control Supplement
020312000AP1995/04/19Approval