药品名称MODURETIC 5-50
申请号018201产品号001
活性成分AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格EQ 5MG ANHYDROUS;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MERCK RESEARCH LABORATORIES DIV MERCK CO INC
化学类型New combination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
018201040APLetter2003/03/10下载
018201037APLetter2002/03/21下载
018201037APLabel2002/03/21下载
018201037APReview2002/05/30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
018201040AP2003/02/25Labeling Revision
018201039AP2002/06/24Manufacturing Change or Addition
018201038AP2002/04/05Manufacturing Change or Addition
018201037AP2002/03/21Labeling Revision
018201036AP2001/09/18Labeling Revision
018201035AP1998/02/12Control Supplement
018201034AP1998/08/24Labeling Revision
018201033AP1995/11/29Manufacturing Change or Addition
018201032AP1993/12/09Labeling Revision
018201031AP1992/10/01Labeling Revision
018201030AP1992/09/17Labeling Revision
018201029AP1992/03/26Control Supplement
018201026AP1991/05/14Control Supplement
018201025AP1989/04/12Labeling Revision
018201024AP1988/03/29Manufacturing Change or Addition
018201023AP1988/04/21Manufacturing Change or Addition
018201022AP1987/07/10Package Change
018201021AP1987/06/01Manufacturing Change or Addition
018201020AP1987/03/09Control Supplement
018201019AP1987/08/26Labeling Revision
018201018AP1988/08/15Control Supplement
018201017AP1986/01/21Labeling Revision
018201016AP1985/11/01Labeling Revision
018201015AP1988/05/05Labeling Revision
018201014AP1985/09/10Control Supplement
018201013AP1985/06/14Labeling Revision
018201012AP1986/07/16Labeling Revision
018201011AP1985/02/07Labeling Revision
018201010AP1984/08/28Labeling Revision
018201009AP1984/04/19Labeling Revision
018201007AP1984/01/04Formulation Revision
018201006AP1983/12/23Manufacturing Change or Addition
018201005AP1983/03/01Package Change
018201004AP1982/07/08Package Change
018201003AP1982/06/04Control Supplement
018201002AP1982/03/03Manufacturing Change or Addition
018201001AP1982/02/08Control Supplement
018201000AP1981/10/05Approval