药品名称TECHNETIUM TC 99M GENERATOR
申请号017693产品号002
活性成分TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR市场状态处方药
剂型或给药途径SOLUTION;INTRAVENOUS, ORAL规格68-2703mCi/GENERATOR
治疗等效代码参比药物
批准日期2013/12/13申请机构GE HEALTHCARE
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
017693029APLetter2015/08/11下载
017693029APLabel2015/09/09下载
017693026APLabel2014/10/15下载
017693026APLetter2014/10/15下载
017693025APOther2013/12/17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
017693029AP2015/08/07Labeling Revision
017693027AP2015/01/05Manufacturing Change or Addition
017693026AP2014/10/14Labeling Revision
017693025AP2013/12/13Manufacturing Change or Addition
017693024AP1998/07/28Manufacturing Change or Addition
017693023AP1997/03/24Manufacturing Change or Addition
017693022AP1993/06/11Manufacturing Change or Addition
017693021AP1995/04/27Manufacturing Change or Addition
017693020AP1995/04/17Manufacturing Change or Addition
017693019AP1990/11/16Control Supplement
017693017AP1989/02/17Control Supplement
017693015AP1987/06/30Manufacturing Change or Addition
017693014AP1986/01/31Manufacturing Change or Addition
017693013AP1987/06/08Labeling Revision
017693011AP1988/06/01Control Supplement
017693010AP1984/01/10Labeling Revision
017693009AP1983/02/09General Efficacy (MarkIV)
017693008AP1982/06/07Labeling Revision
017693007AP1979/12/28Manufacturing Change or Addition
017693006AP1978/10/20Manufacturing Change or Addition
017693005AP1979/01/31Labeling Revision
017693003AP1978/02/13Labeling Revision
017693002AP1978/01/19Manufacturing Change or Addition
017693001AP1978/07/19Control Supplement
017693000AP1976/11/15Approval