药品名称MIDAMOR
申请号018200产品号001
活性成分AMILORIDE HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格5MG
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构PADDOCK LABORATORIES LLC
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
018200026APLetter2003/03/10下载
018200024APLetter2002/03/21下载
018200024APLabel2002/03/21下载
018200024APReview2002/05/30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
018200026AP2003/02/25Labeling Revision
018200025AP2002/06/24Manufacturing Change or Addition
018200024AP2002/03/21Labeling Revision
018200023AP2001/09/18Labeling Revision
018200022AP2000/11/21Manufacturing Change or Addition
018200021AP1998/02/12Control Supplement
018200020AP1992/09/16Labeling Revision
018200019AP1992/03/26Control Supplement
018200018AP1991/05/14Control Supplement
018200017AP1989/04/12Labeling Revision
018200016AP1988/03/29Manufacturing Change or Addition
018200015AP1987/06/01Manufacturing Change or Addition
018200014AP1987/03/09Control Supplement
018200013AP1988/06/22Control Supplement
018200012AP1986/01/21Labeling Revision
018200011AP1985/11/01Labeling Revision
018200010AP1988/05/05Labeling Revision
018200009AP1985/09/10Control Supplement
018200008AP1985/06/14Labeling Revision
018200007AP1985/02/07Labeling Revision
018200006AP1984/01/04Formulation Revision
018200005AP1983/12/23Manufacturing Change or Addition
018200004AP1983/03/01Package Change
018200003AP1982/07/08Package Change
018200002AP1982/03/03Manufacturing Change or Addition
018200001AP1982/02/08Control Supplement
018200000AP1981/10/05Approval