药品名称PYROLITE
申请号017684产品号001
活性成分TECHNETIUM TC-99M PYRO/TRIMETA PHOSPHATES KIT市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格N/A
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构PHARMALUCENCE 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
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
017684019AP2000/05/02Manufacturing Change or Addition
017684018AP2000/02/07Manufacturing Change or Addition
017684017AP1998/12/17Control Supplement
017684016AP1998/03/23Manufacturing Change or Addition
017684015AP1997/06/13Control Supplement
017684014AP1989/06/26Labeling Revision
017684013AP1989/05/02Manufacturing Change or Addition
017684009AP1986/06/10New or Modified Indication
017684008AP1983/11/17Package Change
017684007AP1983/05/31Control Supplement
017684006AP1982/02/04Practioner Draft Labeling
017684005AP1980/08/11Package Change
017684001AP1983/03/02General Efficacy (MarkIV)
017684000AP1976/11/19Approval