药品名称AN-DTPA
申请号017714产品号001
活性成分TECHNETIUM TC-99M PENTETATE KIT市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格N/A
治疗等效代码AP参比药物
批准日期Approved Prior to Jan 1, 1982申请机构JUBILANT DRAXIMAGE INC
化学类型New formulation or new manufacturer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
017714021APLetter2002/03/20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
017714022AP2002/12/12Control Supplement
017714021AP2002/03/20Labeling Revision
017714020AP1997/05/27Control Supplement
017714019AP1993/02/23Control Supplement
017714018AP1986/04/02Manufacturing Change or Addition
017714017AP1986/01/27Manufacturing Change or Addition
017714016AP1985/08/02Manufacturing Change or Addition
017714015AP1985/04/29Manufacturing Change or Addition
017714012AP1984/03/23Control Supplement
017714011AP1983/06/03Control Supplement
017714008AP1982/06/30Manufacturing Change or Addition
017714005AP1979/03/07Manufacturing Change or Addition
017714004AP1979/03/07Manufacturing Change or Addition
017714001AP1979/03/07Labeling Revision
017714000AP1976/11/16Approval