NAPROSYN(NAPROXEN) - 美国FDA药品数据库

药品名称	NAPROSYN
申请号	017581	产品号	003
活性成分	NAPROXEN	市场状态	处方药
剂型或给药途径	TABLET;ORAL	规格	375MG
治疗等效代码	AB	参比药物	否
批准日期	Approved Prior to Jan 1, 1982	申请机构	ATNAHS PHARMA US LTD
化学类型	New molecular entity (NME)	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

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
017581	112	AP	Letter	2016/05/11	下载
017581	112	AP	Label	2016/05/11	下载
017581	111	AP	Label	2013/03/26	下载
017581	111	AP	Letter	2013/03/26	下载
017581	110	AP	Label	2008/07/29	下载
017581	110	AP	Letter	2008/07/30	下载
017581	108	AP	Letter	2007/09/25	下载
017581	108	AP	Label	2007/09/26	下载
017581	107	AP	Letter	2007/04/25	下载
017581	106	AP	Label	2006/01/25	下载
017581	106	AP	Letter	2006/01/30	下载
017581	105	AP	Label	2006/03/14	下载
017581	105	AP	Letter	2006/03/23	下载
017581	100	AP	Letter	2004/11/16	下载
017581	100	AP	Label	2004/11/16	下载
017581	099	AP	Label	2004/11/16	下载
017581	099	AP	Letter	2004/11/16	下载
017581	098	AP	Letter	2003/05/29	下载
017581	004	AP	Review	2007/04/11	下载
017581	000	AP	Medication Guide	2009/11/19	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
017581	112	AP	2016/05/09	Labeling Revision
017581	111	AP	2013/03/22	Labeling Revision
017581	110	AP	2008/07/25	Labeling Revision
017581	108	AP	2007/09/20	Labeling Revision
017581	107	AP	2007/04/19	Labeling Revision
017581	106	AP	2006/01/24	Labeling Revision
017581	105	AP	2006/03/10	Labeling Revision
017581	103	AP	2002/02/22	Manufacturing Change or Addition
017581	102	AP	2001/11/09	Package Change
017581	101	AP	2000/12/08	Manufacturing Change or Addition
017581	100	AP	2004/11/10	Labeling Revision
017581	099	AP	2004/11/10	Labeling Revision
017581	098	AP	2003/04/14	Labeling Revision
017581	097	AP	1994/12/08	Manufacturing Change or Addition
017581	096	AP	1994/03/28	Package Change
017581	095	AP	1994/09/12	Control Supplement
017581	093	AP	1992/08/12	Manufacturing Change or Addition
017581	089	AP	1992/05/08	Package Change
017581	088	AP	1991/09/16	Package Change
017581	087	AP	1994/04/21	Package Change
017581	086	AP	1991/10/30	Control Supplement
017581	080	AP	1989/04/21	Formulation Revision
017581	073	AP	1987/03/23	New or Modified Indication
017581	072	AP	1986/12/16	Labeling Revision
017581	069	AP	1985/09/24	Labeling Revision
017581	068	AP	1986/06/10	Package Change
017581	067	AP	1986/07/17	Control Supplement
017581	065	AP	1987/03/23	New Dosage Regimen
017581	064	AP	1985/04/23	Manufacturing Change or Addition
017581	063	AP	1986/12/16	Formulation Revision
017581	062	AP	1985/04/23	Manufacturing Change or Addition
017581	060	AP	1985/04/29	Manufacturing Change or Addition
017581	054	AP	1983/09/09	Labeling Revision
017581	053	AP	1985/04/23	Control Supplement
017581	051	AP	1988/02/18	Manufacturing Change or Addition
017581	050	AP	1982/12/03	Labeling Revision
017581	049	AP	1982/12/03	Labeling Revision
017581	048	AP	1983/01/13	Control Supplement
017581	046	AP	1983/09/09	Labeling Revision
017581	045	AP	1982/03/31	Manufacturing Change or Addition
017581	044	AP	1982/03/31	Manufacturing Change or Addition
017581	043	AP	1981/12/21	Package Change
017581	042	AP	1982/01/07	Package Change
017581	041	AP	1981/10/13	Control Supplement
017581	040	AP	1981/10/13	Control Supplement
017581	039	AP	1981/10/13	Control Supplement
017581	038	AP	1982/01/08	Package Change
017581	037	AP	1981/04/02	Control Supplement
017581	036	AP	1981/10/13	Formulation Revision
017581	034	AP	1981/04/13	Labeling Revision
017581	033	AP	1981/10/13	Labeling Revision
017581	031	AP	1982/04/15	Labeling Revision
017581	030	AP	1980/09/12	Labeling Revision
017581	027	AP	1980/05/13	Labeling Revision
017581	026	AP	1980/03/21	Control Supplement
017581	024	AP	1980/04/14	Formulation Revision
017581	020	AP	1979/07/09	Control Supplement
017581	019	AP	1979/07/09	Package Change
017581	018	AP	1979/09/06	Manufacturing Change or Addition
017581	017	AP	1979/07/17	Control Supplement
017581	015	AP	1979/02/15	Control Supplement
017581	013	AP	1979/02/15	Control Supplement
017581	012	AP	1979/06/07	Manufacturing Change or Addition
017581	011	AP	1978/05/02	Manufacturing Change or Addition
017581	010	AP	1979/05/24	Control Supplement
017581	009	AP	1978/11/27	Control Supplement
017581	007	AP	1978/08/04	Control Supplement
017581	006	AP	1979/05/02	Package Change
017581	005	AP	1979/05/02	Package Change
017581	004	AP	1980/07/15	Manufacturing Change or Addition
017581	003	AP	1976/11/29	Manufacturing Change or Addition
017581	002	AP	1976/05/13	Labeling Revision
017581	001	AP	1980/07/15	General Efficacy (MarkIV)
017581	000	AP	1976/03/11	Approval

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