NARCAN(NALOXONE HYDROCHLORIDE) - 美国FDA药品数据库

药品名称	NARCAN
申请号	016636	产品号	001
活性成分	NALOXONE HYDROCHLORIDE	市场状态	停止上市
剂型或给药途径	INJECTABLE;INJECTION	规格	0.4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
治疗等效代码		参比药物	否
批准日期	Approved Prior to Jan 1, 1982	申请机构	ADAPT PHARMA OPERATIONS LTD
化学类型	New molecular entity (NME)	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

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
016636	054	AP	Letter	2002/02/11	下载
016636	054	AP	Label	2015/03/02	下载
016636	052	AP	Letter	2002/02/11	下载
016636	052	AP	Label	2015/03/02	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
016636	057	AP	2002/10/25	Control Supplement
016636	056	AP	2002/01/15	Control Supplement
016636	055	AP	2002/04/16	Manufacturing Change or Addition
016636	054	AP	2002/02/11	Labeling Revision
016636	053	AP	1996/09/06	Control Supplement
016636	052	AP	2002/02/11	Labeling Revision
016636	051	AP	1995/03/20	Control Supplement
016636	050	AP	1995/06/15	Control Supplement
016636	049	AP	1987/12/07	Control Supplement
016636	048	AP	1987/10/20	Control Supplement
016636	047	AP	1987/02/26	Control Supplement
016636	046	AP	1986/06/04	Final Printed Labeling - MarkIV
016636	043	AP	1986/06/04	Control Supplement
016636	042	AP	1986/06/04	Control Supplement
016636	041	AP	1986/06/04	Control Supplement
016636	039	AP	1984/09/17	Formulation Revision
016636	038	AP	1984/09/17	Formulation Revision
016636	036	AP	1984/09/25	Manufacturing Change or Addition
016636	035	AP	1984/10/15	Control Supplement
016636	034	AP	1985/07/23	Labeling Revision
016636	033	AP	1983/11/17	Manufacturing Change or Addition
016636	032	AP	1983/11/17	Manufacturing Change or Addition
016636	031	AP	1992/05/29	New or Modified Indication
016636	030	AP	1983/06/23	Package Change
016636	028	AP	1982/06/14	Package Change
016636	027	AP	1982/07/23	Labeling Revision
016636	026	AP	1982/05/19	Package Change
016636	024	AP	1981/05/14	Package Change
016636	023	AP	1981/05/14	Manufacturing Change or Addition
016636	022	AP	1981/09/30	Labeling Revision
016636	021	AP	1981/04/01	Manufacturing Change or Addition
016636	020	AP	1981/06/23	Manufacturing Change or Addition
016636	019	AP	1980/06/17	Manufacturing Change or Addition
016636	018	AP	1979/11/30	Manufacturing Change or Addition
016636	017	AP	1979/03/23	Labeling Revision
016636	016	AP	1978/10/20	Control Supplement
016636	015	AP	1976/04/06	Labeling Revision
016636	014	AP	1976/04/08	Labeling Revision
016636	013	AP	1975/09/24	Labeling Revision
016636	011	AP	1975/06/06	Labeling Revision
016636	009	AP	1974/12/09	Distributor
016636	008	AP	1975/06/05	Labeling Revision
016636	007	AP	1975/01/16	Labeling Revision
016636	005	AP	1975/04/04	Control Supplement
016636	004	AP	1975/04/04	Control Supplement
016636	000	AP	1971/04/13	Approval

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