药品名称MAXZIDE-25
申请号019129产品号003
活性成分HYDROCHLOROTHIAZIDE; TRIAMTERENE市场状态处方药
剂型或给药途径TABLET;ORAL规格25MG;37.5MG
治疗等效代码AB参比药物
批准日期1988/05/13申请机构MYLAN PHARMACEUTICALS INC
化学类型New dosage form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
019129043APLetter2011/03/24下载
019129043APLabel2011/03/28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
019129047AP2016/10/13Manufacturing Change or Addition
019129045AP2015/05/11Manufacturing Change or Addition
019129043AP2011/03/20Labeling Revision
019129030AP2001/02/02Control Supplement
019129029AP1999/07/16Package Change
019129028AP1997/01/10Labeling Revision
019129027AP1996/09/12Manufacturing Change or Addition
019129026AP1992/07/01Labeling Revision
019129025AP1991/06/06Package Change
019129024AP1989/02/06Labeling Revision
019129023AP1988/07/21Control Supplement
019129022AP1988/06/29Labeling Revision
019129021AP1988/05/13Manufacturing Change or Addition
019129020AP1988/02/25Control Supplement
019129019AP1987/10/28Manufacturing Change or Addition
019129018AP1987/11/13Manufacturing Change or Addition
019129016AP1987/08/04Manufacturing Change or Addition
019129015AP1987/07/29Expiration Date Change
019129014AP1990/02/09Labeling Revision
019129013AP1987/04/14Expiration Date Change
019129011AP1986/07/08Labeling Revision
019129010AP1986/01/27Control Supplement
019129008AP1988/05/13New Dosage Regimen
019129007AP1985/10/08Expiration Date Change
019129006AP1985/08/16Labeling Revision
019129005AP1985/05/10Control Supplement
019129004AP1985/04/26Formulation Revision
019129003AP1985/04/01Package Change
019129001AP1985/05/03Labeling Revision
019129000AP1984/10/22Approval