药品名称SALUTENSIN
申请号012359产品号003
活性成分HYDROFLUMETHIAZIDE; RESERPINE市场状态停止上市
剂型或给药途径TABLET;ORAL规格50MG;0.125MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构SHIRE DEVELOPMENT 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
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
012359032AP1996/06/24Manufacturing Change or Addition
012359031AP1992/10/07Manufacturing Change or Addition
012359030AP1990/07/09Manufacturing Change or Addition
012359029AP1988/06/22Labeling Revision
012359028AP1986/10/24Control Supplement
012359027AP1986/06/27Manufacturing Change or Addition
012359026AP1985/08/01Control Supplement
012359025AP1985/07/29Labeling Revision
012359024AP1984/06/08Package Change
012359023AP1983/08/23Labeling Revision
012359022AP1984/05/10Formulation Revision
012359021AP1982/03/03Control Supplement
012359020AP1982/03/03Package Change
012359019AP1981/08/03Labeling Revision
012359018AP1985/07/29Practioner Draft Labeling
012359017AP1982/06/10Package Change
012359016AP1979/07/31Labeling Revision
012359015AP1980/10/03Control Supplement
012359014AP1980/10/03Control Supplement
012359013AP1978/05/15Final Printed Labeling - MarkIV
012359012AP1978/05/15Package Change
012359011AP1978/04/27Control Supplement
012359010AP1978/05/15Control Supplement
012359009AP1978/05/15Formulation Revision
012359006AP1977/06/23Labeling Revision
012359005AP1977/12/13Other Amendment
012359003AP1977/06/23Formulation Revision
012359000AP1960/06/20Approval