EPIPEN E Z PEN(EPINEPHRINE) - 美国FDA药品数据库

药品名称	EPIPEN E Z PEN
申请号	019430	产品号	003
活性成分	EPINEPHRINE	市场状态	停止上市
剂型或给药途径	INJECTABLE;INTRAMUSCULAR	规格	0.3MG/DELIVERY
治疗等效代码		参比药物	否
批准日期	1995/08/03	申请机构	MYLAN SPECIALTY LP
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
019430	062	AP	2016/08/15	Manufacturing Change or Addition
019430	061	AP	2016/05/18	Labeling Revision
019430	060	AP	2016/03/03	Manufacturing Change or Addition
019430	059	AP	2014/04/30	Labeling Revision
019430	058	AP	2014/07/17	Labeling Revision
019430	057	AP	2013/12/13	Manufacturing Change or Addition
019430	056	AP	2013/11/08	Manufacturing Change or Addition
019430	055	AP	2013/09/16	Manufacturing Change or Addition
019430	054	AP	2013/07/23	Manufacturing Change or Addition
019430	053	AP	2012/08/20	Labeling Revision
019430	047	AP	2009/05/19	Labeling Revision
019430	044	AP	2008/09/26	Labeling Revision
019430	025	AP	2003/12/17	Labeling Revision
019430	018	AP	2002/12/19	Control Supplement
019430	017	AP	2002/08/21	Control Supplement
019430	016	AP	2002/06/28	Manufacturing Change or Addition
019430	015	AP	2002/04/16	Expiration Date Change
019430	014	AP	2002/02/20	Control Supplement
019430	012	AP	2001/08/27	Labeling Revision
019430	011	AP	2001/01/11	Control Supplement
019430	010	AP	2000/05/11	Manufacturing Change or Addition
019430	009	AP	1999/11/05	Manufacturing Change or Addition
019430	008	AP	1999/12/15	Manufacturing Change or Addition
019430	007	AP	1999/05/25	Manufacturing Change or Addition
019430	006	AP	1997/01/24	Manufacturing Change or Addition
019430	005	AP	1996/07/25	Control Supplement
019430	004	AP	1995/08/03	Control Supplement
019430	001	AP	1989/03/02	Labeling Revision
019430	000	AP	1987/12/22	Approval