药品名称ESIDRIX
申请号011793产品号008
活性成分HYDROCHLOROTHIAZIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格50MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构NOVARTIS PHARMACEUTICALS CORP
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
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
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
011793070AP2002/04/29Manufacturing Change or Addition
011793069AP1999/04/28Package Change
011793068AP1997/07/21Control Supplement
011793067AP1996/06/20Control Supplement
011793066AP1996/02/27Manufacturing Change or Addition
011793065AP1995/07/31Control Supplement
011793064AP1994/12/01Labeling Revision
011793062AP1993/03/10Labeling Revision
011793061AP1991/06/05Labeling Revision
011793060AP1992/07/30Labeling Revision
011793059AP1990/11/09Formulation Revision
011793058AP1988/09/23Labeling Revision
011793057AP1986/10/02Labeling Revision
011793056AP1985/03/19Control Supplement
011793055AP1982/12/08Control Supplement
011793054AP1982/08/23Package Change
011793053AP1982/06/04Package Change
011793051AP1986/04/10Practioner Draft Labeling
011793050AP1981/02/02Package Change
011793049AP1980/01/30Package Change
011793048AP1980/01/17Package Change
011793047AP1979/06/29Package Change
011793046AP1979/06/29Package Change
011793045AP1979/06/29Package Change
011793044AP1978/01/10Formulation Revision
011793043AP1977/06/16Control Supplement
011793042AP1977/04/12Package Change
011793041AP1978/02/22Labeling Revision
011793040AP1977/02/09Labeling Revision
011793039AP1976/08/31Control Supplement
011793038AP1977/02/09Labeling Revision
011793037AP1976/08/18Formulation Revision
011793036AP1976/05/20Formulation Revision
011793035AP1976/03/24Manufacturing Change or Addition
011793034AP1975/10/09Labeling Revision
011793033AP1976/03/24Control Supplement
011793032AP1975/07/02Control Supplement
011793030AP1975/04/02Package Change
011793029AP1975/04/02Package Change
011793000AP1959/02/12Approval