TECHNELITE(TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR)

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	是
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
无
历史专利信息
无

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
017771	039	AP	2015/08/27	Manufacturing Change or Addition
017771	038	AP	2016/02/12	Manufacturing Change or Addition
017771	036	AP	2015/02/09	Manufacturing Change or Addition
017771	035	AP	2014/02/12	Labeling Revision
017771	034	AP	2012/11/16	Manufacturing Change or Addition
017771	025	AP	2009/03/25	Manufacturing Change or Addition
017771	024	AP	2007/12/07	Formulation Revision
017771	023	AP	2004/09/02	Control Supplement
017771	022	AP	2001/12/05	Control Supplement
017771	021	AP	2000/12/06	Manufacturing Change or Addition
017771	020	AP	2000/02/29	Manufacturing Change or Addition
017771	019	AP	2000/08/11	Labeling Revision
017771	018	AP	1998/02/04	Manufacturing Change or Addition
017771	017	AP	1997/12/15	Manufacturing Change or Addition
017771	016	AP	1997/11/05	Manufacturing Change or Addition
017771	015	AP	1996/04/05	Control Supplement
017771	014	AP	1996/01/24	Control Supplement
017771	013	AP	1996/01/11	Control Supplement
017771	012	AP	1995/05/23	Package Change
017771	011	AP	1993/08/12	Control Supplement
017771	010	AP	1993/01/12	Control Supplement
017771	009	AP	1985/04/29	Labeling Revision
017771	008	AP	1983/05/13	Control Supplement
017771	007	AP	1983/04/18	Control Supplement
017771	005	AP	1978/11/21	Labeling Revision
017771	002	AP	1978/06/07	Control Supplement
017771	001	AP	1978/10/11	Manufacturing Change or Addition
017771	000	AP	1976/11/16	Approval