METHOTREXATE SODIUM(METHOTREXATE SODIUM) - 美国FDA药品数据库

药品名称	METHOTREXATE SODIUM
申请号	011719	产品号	010
活性成分	METHOTREXATE SODIUM	市场状态	处方药
剂型或给药途径	INJECTABLE;INJECTION	规格	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
治疗等效代码	AP	参比药物	是
批准日期	2004/12/15	申请机构	HOSPIRA INC
化学类型	New active ingredient	审评分类	Standard review drug
罕用药/孤儿药	是

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

与本品相关的市场独占权保护信息
独占权代码	失效日期
无
历史市场独占权保护信息
无

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
011719	122	AP	Letter	2015/11/23	下载
011719	122	AP	Label	2015/11/25	下载
011719	117	AP	Letter	2011/11/03	下载
011719	117	AP	Label	2011/11/04	下载
011719	108	AP	Letter	2005/04/19	下载
011719	107	AP	Letter	2004/12/30	下载
011719	106	AP	Letter	2004/02/02	下载
011719	106	AP	Label	2004/02/03	下载
011719	105	AP	Letter	2003/08/06	下载
011719	104	AP	Letter	2003/01/03	下载
011719	103	AP	Letter	2002/02/20	下载
011719	102	AP	Letter	2002/02/20	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
011719	124	AP	2016/02/03	Manufacturing Change or Addition
011719	122	AP	2015/11/20	Labeling Revision
011719	121	AP	2015/08/14	Manufacturing Change or Addition
011719	117	AP	2011/11/01	Labeling Revision
011719	108	AP	2005/04/13	Manufacturing Change or Addition
011719	107	AP	2004/12/15	Manufacturing Change or Addition
011719	106	AP	2004/01/27	Labeling Revision
011719	105	AP	2003/07/30	Labeling Revision
011719	104	AP	2003/01/03	Labeling Revision
011719	103	AP	2002/02/20	Labeling Revision
011719	102	AP	2002/02/20	Labeling Revision
011719	100	AP	2001/05/08	Labeling Revision
011719	099	AP	1999/10/29	Labeling Revision
011719	098	AP	1999/02/12	Control Supplement
011719	097	AP	1998/06/22	Manufacturing Change or Addition
011719	096	AP	2000/11/08	Labeling Revision
011719	095	AP	1997/05/20	Labeling Revision
011719	094	AP	1995/04/25	Control Supplement
011719	089	AP	1992/01/23	Manufacturing Change or Addition
011719	086	AP	1991/11/05	Package Change
011719	085	AP	1990/10/24	Control Supplement
011719	083	AP	1991/02/20	Control Supplement
011719	081	AP	1989/03/01	Control Supplement
011719	079	AP	1988/04/21	Formulation Revision
011719	078	AP	1988/04/07	Control Supplement
011719	077	AP	1988/04/07	New or Modified Indication
011719	076	AP	1990/01/18	Labeling Revision
011719	075	AP	1986/12/08	Manufacturing Change or Addition
011719	074	AP	1987/08/18	Manufacturing Change or Addition
011719	073	AP	1986/09/16	Labeling Revision
011719	071	AP	1986/09/16	Manufacturing Change or Addition
011719	070	AP	1987/03/19	Manufacturing Change or Addition
011719	063	AP	1983/04/08	Control Supplement
011719	062	AP	1982/08/24	Labeling Revision
011719	059	AP	1983/04/08	Manufacturing Change or Addition
011719	058	AP	1982/03/31	Control Supplement
011719	057	AP	1982/03/31	Labeling Revision
011719	056	AP	1981/12/07	Manufacturing Change or Addition
011719	054	AP	1981/05/11	Manufacturing Change or Addition
011719	053	AP	1980/12/03	Expiration Date Change
011719	052	AP	1980/02/29	Control Supplement
011719	051	AP	1979/10/15	Manufacturing Change or Addition
011719	050	AP	1980/06/11	Manufacturing Change or Addition
011719	049	AP	1979/02/15	Control Supplement
011719	047	AP	1978/12/14	Control Supplement
011719	046	AP	1978/08/08	Manufacturing Change or Addition
011719	043	AP	1979/01/02	Control Supplement
011719	039	AP	1978/08/22	Control Supplement
011719	038	AP	1977/07/14	Manufacturing Change or Addition
011719	037	AP	1977/03/18	Control Supplement
011719	036	AP	1977/03/28	Manufacturing Change or Addition
011719	035	AP	1977/08/02	Manufacturing Change or Addition
011719	033	AP	1976/09/14	Control Supplement
011719	032	AP	1976/09/14	Control Supplement
011719	031	AP	1976/09/07	Control Supplement
011719	030	AP	1976/09/07	Manufacturing Change or Addition
011719	029	AP	1976/09/07	Control Supplement
011719	028	AP	1976/06/29	Control Supplement
011719	027	AP	1976/08/03	Manufacturing Change or Addition
011719	026	AP	1976/06/29	Labeling Revision
011719	025	AP	1976/06/29	Manufacturing Change or Addition
011719	024	AP	1975/12/05	Labeling Revision
011719	023	AP	1975/11/03	Labeling Revision
011719	022	AP	1975/11/03	Final Printed Labeling - MarkIV
011719	021	AP	1975/07/22	Control Supplement
011719	000	AP	1959/08/10	Approval

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