药品名称ACTIGALL
申请号019594产品号001
活性成分URSODIOL市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格150MG
治疗等效代码参比药物
批准日期1987/12/31申请机构ALLERGAN SALES LLC
化学类型New molecular entity (NME)审评分类Priority review drug
罕用药/孤儿药
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
019594021APLetter2002/08/14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
019594035AP2016/06/27Manufacturing Change or Addition
019594034AP2015/10/30Manufacturing Change or Addition
019594021AP2002/08/14Labeling Revision
019594020AP1999/04/22Package Change
019594019AP1999/04/19Manufacturing Change or Addition
019594018AP1996/06/05Manufacturing Change or Addition
019594017AP1995/09/15Manufacturing Change or Addition
019594016AP1996/03/29New or Modified Indication
019594013AP2002/03/15Expiration Date Change
019594011AP1992/04/24Labeling Revision
019594010AP1990/10/05Labeling Revision
019594009AP1991/10/04Control Supplement
019594008AP1989/05/19Labeling Revision
019594007AP1989/08/02Control Supplement
019594006AP1989/04/19Package Change
019594005AP1988/09/30Package Change
019594004AP1988/10/26Formulation Revision
019594003AP1988/07/08Labeling Revision
019594002AP1988/07/08Package Change
019594001AP1989/02/14Manufacturing Change or Addition
019594000AP1987/12/31Approval