药品名称TECHNELITE
申请号017771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规格1-20 CI/GENERATOR
治疗等效代码参比药物
批准日期2014/02/12申请机构LANTHEUS MEDICAL IMAGING 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
017771035APLabel2014/02/12下载
017771035APLetter2014/02/13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
017771039AP2015/08/27Manufacturing Change or Addition
017771038AP2016/02/12Manufacturing Change or Addition
017771036AP2015/02/09Manufacturing Change or Addition
017771035AP2014/02/12Labeling Revision
017771034AP2012/11/16Manufacturing Change or Addition
017771025AP2009/03/25Manufacturing Change or Addition
017771024AP2007/12/07Formulation Revision
017771023AP2004/09/02Control Supplement
017771022AP2001/12/05Control Supplement
017771021AP2000/12/06Manufacturing Change or Addition
017771020AP2000/02/29Manufacturing Change or Addition
017771019AP2000/08/11Labeling Revision
017771018AP1998/02/04Manufacturing Change or Addition
017771017AP1997/12/15Manufacturing Change or Addition
017771016AP1997/11/05Manufacturing Change or Addition
017771015AP1996/04/05Control Supplement
017771014AP1996/01/24Control Supplement
017771013AP1996/01/11Control Supplement
017771012AP1995/05/23Package Change
017771011AP1993/08/12Control Supplement
017771010AP1993/01/12Control Supplement
017771009AP1985/04/29Labeling Revision
017771008AP1983/05/13Control Supplement
017771007AP1983/04/18Control Supplement
017771005AP1978/11/21Labeling Revision
017771002AP1978/06/07Control Supplement
017771001AP1978/10/11Manufacturing Change or Addition
017771000AP1976/11/16Approval