药品名称ALDACTONE
申请号012151产品号010
活性成分SPIRONOLACTONE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1983/12/30申请机构GD SEARLE LLC
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
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
012151072APLabel2014/10/24下载
012151071APLetter2013/06/13下载
012151071APLabel2013/06/18下载
012151068APLabel2012/09/17下载
012151068APLetter2012/09/20下载
012151067APLetter2011/09/26下载
012151062APLetter2008/11/26下载
012151062APLabel2009/01/02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
012151074AP2016/04/11Manufacturing Change or Addition
012151073AP2015/05/01Manufacturing Change or Addition
012151072AP2014/10/22Labeling Revision
012151071AP2013/06/12Labeling Revision
012151068AP2012/09/17Approval
012151067AP2011/09/22Labeling Revision
012151062AP2008/11/25Labeling Revision
012151061AP2002/11/26Control Supplement
012151060AP1999/03/26Labeling Revision
012151059AP1999/01/13Labeling Revision
012151058AP1996/05/14Manufacturing Change or Addition
012151057AP1995/05/31Package Change
012151056AP1997/07/30Labeling Revision
012151055AP1992/05/07Labeling Revision
012151054AP1990/01/23Manufacturing Change or Addition
012151053AP1990/03/15Labeling Revision
012151052AP1989/10/30Labeling Revision
012151050AP1988/11/09Labeling Revision
012151049AP1987/06/15Control Supplement
012151048AP1987/11/23Expiration Date Change
012151047AP1986/01/13Labeling Revision
012151046AP1985/09/26Labeling Revision
012151045AP1985/08/15Manufacturing Change or Addition
012151044AP1984/11/05Labeling Revision
012151043AP1984/03/22Labeling Revision
012151042AP1983/12/20Labeling Revision
012151041AP1983/07/29Labeling Revision
012151040AP1983/04/07Formulation Revision
012151038AP1982/12/30Formulation Revision
012151037AP1982/05/03Labeling Revision
012151036AP1983/11/29Formulation Revision
012151035AP1997/07/30Practioner Draft Labeling
012151034AP1981/06/22Manufacturing Change or Addition
012151033AP1983/11/29Formulation Revision
012151031AP1981/03/04Package Change
012151030AP1981/06/30General Efficacy (MarkIV)
012151022AP1976/11/10Labeling Revision
012151000AP1960/01/21Approval