药品名称MINITEC
申请号017339产品号001
活性成分TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR市场状态停止上市
剂型或给药途径SOLUTION;INJECTION, ORAL规格0.22-2.22 CI/GENERATOR
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构BRACCO DIAGNOSTICS 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
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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
017339029AP1985/09/30Manufacturing Change or Addition
017339028AP1985/05/30Package Change
017339024AP1981/05/05Manufacturing Change or Addition
017339023AP1980/02/08Labeling Revision
017339022AP1981/10/22Control Supplement
017339021AP1981/11/18Manufacturing Change or Addition
017339019AP1979/10/11Manufacturing Change or Addition
017339018AP1983/05/27General Efficacy (MarkIV)
017339017AP1979/04/05Labeling Revision
017339015AP1979/05/18Control Supplement
017339013AP1978/03/20Labeling Revision
017339012AP1977/02/11Control Supplement
017339011AP1977/06/15Manufacturing Change or Addition
017339010AP1976/10/21Labeling Revision
017339009AP1976/02/05Labeling Revision
017339008AP1975/12/22Control Supplement
017339007AP1975/09/02Labeling Revision
017339000AP1974/06/03Approval