药品名称INDERIDE-80/25
申请号018031产品号002
活性成分HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格25MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构WYETH PHARMACEUTICALS 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
018031038APLabel2011/03/21下载
018031038APLetter2011/03/23下载
018031037APLetter2011/03/23下载
018031037APLabel2011/03/21下载
018031036APLabel2010/03/05下载
018031036APLetter2010/03/08下载
018031035APLabel2008/01/08下载
018031035APLetter2008/01/09下载
018031034APLetter2007/03/06下载
018031033APLetter2007/01/08下载
018031032APLetter2004/06/10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
018031038AP2011/03/17Labeling Revision
018031037AP2011/03/17Labeling Revision
018031036AP2010/03/04Labeling Revision
018031035AP2008/01/02Labeling Revision
018031034AP2007/02/21Labeling Revision
018031033AP2006/12/29Labeling Revision
018031032AP2004/06/09Labeling Revision
018031031AP2001/05/03Labeling Revision
018031030AP2001/11/01Labeling Revision
018031029AP1997/11/07Labeling Revision
018031028AP1994/06/14Manufacturing Change or Addition
018031027AP1989/08/09Package Change
018031026AP1989/04/12Package Change
018031025AP1989/07/10Control Supplement
018031024AP1988/11/07Labeling Revision
018031023AP1988/05/25Package Change
018031022AP1986/12/30Expiration Date Change
018031021AP1986/10/08Formulation Revision
018031021AP1987/01/20Package Change
018031019AP1986/07/24Control Supplement
018031018AP1990/02/08New Dosage Regimen
018031017AP1990/02/08Practioner Draft Labeling
018031016AP1985/02/22Manufacturing Change or Addition
018031015AP1983/08/11Control Supplement
018031013AP1982/08/23Formulation Revision
018031012AP1982/06/09Control Supplement
018031011AP1982/04/28Labeling Revision
018031010AP1982/01/26Manufacturing Change or Addition
018031009AP1982/03/03Manufacturing Change or Addition
018031008AP1980/09/19Formulation Revision
018031007AP1982/04/12Control Supplement
018031006AP1981/01/27Control Supplement
018031005AP1980/10/03Control Supplement
018031004AP1980/03/27Expiration Date Change
018031003AP1980/05/28Control Supplement
018031002AP1981/12/10Control Supplement
018031001AP1979/07/31Package Change
018031000AP1979/06/15Approval