XYLOCAINE(LIDOCAINE HYDROCHLORIDE) - 美国FDA药品数据库

药品名称	XYLOCAINE
申请号	006488	产品号	010
活性成分	LIDOCAINE HYDROCHLORIDE	市场状态	处方药
剂型或给药途径	INJECTABLE;INJECTION	规格	1.5%
治疗等效代码	AP	参比药物	是
批准日期	Approved Prior to Jan 1, 1982	申请机构	FRESENIUS KABI USA LLC
化学类型		审评分类

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
006488	074	AP	Label	2010/02/25	下载
006488	074	AP	Letter	2010/03/18	下载
006488	019	AP	Review	2012/01/27	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
006488	091	AP	2016/03/17	Manufacturing Change or Addition
006488	089	AP	2015/03/03	Manufacturing Change or Addition
006488	088	AP	2013/12/26	Manufacturing Change or Addition
006488	087	AP	2013/07/22	Manufacturing Change or Addition
006488	086	AP	2013/02/20	Manufacturing Change or Addition
006488	085	AP	2013/02/13	Manufacturing Change or Addition
006488	084	AP	2013/03/28	Labeling Revision
006488	083	AP	2013/02/16	Manufacturing Change or Addition
006488	079	AP	2013/10/29	Manufacturing Change or Addition
006488	078	AP	2013/04/09	Manufacturing Change or Addition
006488	076	AP	2013/06/11	Manufacturing Change or Addition
006488	074	AP	2010/02/19	Labeling Revision
006488	066	AP	2002/07/17	Control Supplement
006488	065	AP	2000/12/08	Control Supplement
006488	064	AP	2000/12/14	Control Supplement
006488	062	AP	1998/03/06	Manufacturing Change or Addition
006488	061	AP	1999/05/26	Labeling Revision
006488	060	AP	1996/05/02	Control Supplement
006488	059	AP	1996/05/31	Manufacturing Change or Addition
006488	058	AP	1996/01/03	Manufacturing Change or Addition
006488	057	AP	1997/12/08	Package Change
006488	056	AP	1995/07/18	Expiration Date Change
006488	055	AP	1995/07/11	Control Supplement
006488	054	AP	1994/11/21	Manufacturing Change or Addition
006488	053	AP	1993/04/13	Control Supplement
006488	052	AP	1993/02/18	Manufacturing Change or Addition
006488	051	AP	1993/10/20	Expiration Date Change
006488	050	AP	1990/10/02	Control Supplement
006488	049	AP	1989/07/11	Package Change
006488	048	AP	1988/12/02	Labeling Revision
006488	047	AP	1988/12/02	Package Change
006488	046	AP	1987/09/11	Labeling Revision
006488	045	AP	1987/09/11	Control Supplement
006488	044	AP	1987/03/18	Labeling Revision
006488	043	AP	1987/09/16	Manufacturing Change or Addition
006488	042	AP	1986/05/19	Labeling Revision
006488	041	AP	1986/02/27	Labeling Revision
006488	040	AP	1986/08/29	Labeling Revision
006488	039	AP	1986/08/29	Control Supplement
006488	038	AP	1986/11/13	Labeling Revision
006488	037	AP	1986/11/13	Control Supplement
006488	036	AP	1991/03/21	Labeling Revision
006488	035	AP	1991/03/21	Control Supplement
006488	034	AP	1985/03/22	Labeling Revision
006488	033	AP	1985/03/22	Control Supplement
006488	032	AP	1984/12/03	Labeling Revision
006488	031	AP	1982/06/28	Manufacturing Change or Addition
006488	030	AP	1982/03/25	Control Supplement
006488	029	AP	1986/02/22	Labeling Revision
006488	028	AP	1986/02/22	Control Supplement
006488	027	AP	1984/12/12	Practioner Draft Labeling
006488	026	AP	1981/10/01	Labeling Revision
006488	025	AP	1982/07/26	Labeling Revision
006488	024	AP	1982/07/26	Control Supplement
006488	023	AP	1981/10/01	Control Supplement
006488	022	AP	1980/04/17	Control Supplement
006488	021	AP	1979/08/29	Labeling Revision
006488	020	AP	1980/12/31	Labeling Revision
006488	019	AP	1979/02/27	Control Supplement
006488	018	AP	1979/04/09	Labeling Revision
006488	017	AP	1979/04/09	Control Supplement
006488	016	AP	1979/03/26	Control Supplement
006488	015	AP	1978/05/17	Labeling Revision
006488	013	AP	1976/02/02	Manufacturing Change or Addition
006488	011	AP	1975/10/09	Labeling Revision
006488	010	AP	1975/07/16	Control Supplement
006488	009	AP	1975/08/28	Control Supplement
006488	008	AP	1975/08/28	Labeling Revision
006488	006	AP	1974/06/24	Supplement
006488	005	AP	1974/05/20	Control Supplement
006488	002	AP	1972/12/04	Labeling Revision
006488	000	AP	1948/11/19	Approval

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