ATROPEN(ATROPINE) - 美国FDA药品数据库

药品名称	ATROPEN
申请号	017106	产品号	003
活性成分	ATROPINE	市场状态	处方药
剂型或给药途径	INJECTABLE;INJECTION	规格	EQ 0.5MG SULFATE/0.7ML
治疗等效代码		参比药物	是
批准日期	2003/06/19	申请机构	MERIDIAN MEDICAL TECHNOLOGIES INC
化学类型	New formulation or new manufacturer	审评分类	Priority 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
017106	051	AP	2015/08/10	Manufacturing Change or Addition
017106	049	AP	2016/05/27	Manufacturing Change or Addition
017106	045	AP	2013/11/14	Manufacturing Change or Addition
017106	032	AP	2004/09/17	Formulation Revision
017106	028	AP	2003/06/19	Patient Population Altered
017106	027	AP	2002/06/28	Control Supplement
017106	026	AP	2002/01/07	Control Supplement
017106	025	AP	2002/03/04	Manufacturing Change or Addition
017106	024	AP	2001/06/08	Manufacturing Change or Addition
017106	023	AP	2001/02/13	Package Change
017106	022	AP	2001/01/31	Package Change
017106	021	AP	2000/10/19	Control Supplement
017106	020	AP	2000/08/16	Manufacturing Change or Addition
017106	019	AP	2000/08/18	Manufacturing Change or Addition
017106	018	AP	1999/10/28	Manufacturing Change or Addition
017106	017	AP	1999/04/26	Control Supplement
017106	016	AP	1999/03/16	Manufacturing Change or Addition
017106	015	AP	1998/08/25	Manufacturing Change or Addition
017106	014	AP	1998/04/21	Labeling Revision
017106	013	AP	1997/03/06	Control Supplement
017106	012	AP	1996/12/17	Control Supplement
017106	011	AP	1991/03/05	Manufacturing Change or Addition
017106	010	AP	1990/08/17	Package Change
017106	009	AP	1989/04/04	Control Supplement
017106	008	AP	1987/08/19	Package Change
017106	007	AP	1986/10/06	Package Change
017106	006	AP	1985/01/14	Control Supplement
017106	005	AP	1984/06/06	Labeling Revision
017106	004	AP	1979/12/27	Expiration Date Change
017106	003	AP	1979/05/10	Control Supplement
017106	001	AP	1978/07/27	Manufacturing Change or Addition
017106	000	AP	1973/05/15	Approval