药品名称TECHNESCAN PYP KIT
申请号017538产品号001
活性成分TECHNETIUM TC-99M PYROPHOSPHATE 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MALLINCKRODT NUCLEAR MEDICINE LLC
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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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
017538018AP2013/11/25Manufacturing Change or Addition
017538014AP1998/04/08Manufacturing Change or Addition
017538013AP1998/03/23Manufacturing Change or Addition
017538012AP1988/02/22Labeling Revision
017538011AP1989/01/30New Route of Administration
017538010AP1984/05/21Practioner Draft Labeling
017538009AP1982/05/07Control Supplement
017538008AP1978/11/09Labeling Revision
017538007AP1978/11/09Labeling Revision
017538006AP1977/08/23Manufacturing Change or Addition
017538005AP1977/07/27Manufacturing Change or Addition
017538004AP1977/01/11Labeling Revision
017538002AP1976/01/13Control Supplement
017538000AP1974/05/28Approval