药品名称ULTRA-TECHNEKOW FM
申请号017243产品号002
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;INTRAVENOUS规格0.25-3 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
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
017243046APLetter2015/05/05下载
017243046APLabel2015/05/06下载
017243044APLetter2013/12/24下载
017243044APLabel2014/01/13下载
017243043APLetter2014/02/19下载
017243043APLabel2014/02/19下载
017243028APLetter2006/04/05下载
017243025APLetter2004/10/22下载
017243025APLabel2004/10/22下载
017243022APLetter2004/06/29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
017243046AP2015/05/04Labeling Revision
017243045AP2015/02/16Manufacturing Change or Addition
017243044AP2013/12/20Labeling Revision
017243043AP2014/02/18Labeling Revision
017243041AP2013/11/18Manufacturing Change or Addition
017243040AP2013/06/11Manufacturing Change or Addition
017243039AP2013/03/15Manufacturing Change or Addition
017243038AP2013/05/10Manufacturing Change or Addition
017243037AP2013/05/13Manufacturing Change or Addition
017243036AP2013/06/21Manufacturing Change or Addition
017243028AP2006/03/27Labeling Revision
017243025AP2004/10/15Control Supplement
017243022AP2003/01/16Control Supplement
017243021AP2002/04/19Manufacturing Change or Addition
017243020AP2002/03/04Control Supplement
017243019AP1999/12/29Formulation Revision
017243018AP1999/04/14Control Supplement
017243017AP1998/11/20Manufacturing Change or Addition
017243016AP1998/02/18Labeling Revision
017243015AP1997/06/18Manufacturing Change or Addition
017243014AP1996/08/20Control Supplement
017243013AP1997/03/21Control Supplement
017243012AP1996/07/16Control Supplement
017243010AP1984/03/26Practioner Draft Labeling
017243009AP1982/06/30Package Change
017243008AP1982/05/07Control Supplement
017243006AP1979/07/24Package Change
017243005AP1977/08/23Manufacturing Change or Addition
017243004AP1977/07/27Manufacturing Change or Addition
017243003AP1976/10/08Package Change
017243000AP1973/11/23Approval