ACEPHEN(ACETAMINOPHEN) - 美国FDA药品数据库

药品名称	ACEPHEN
申请号	018060	产品号	003
活性成分	ACETAMINOPHEN	市场状态	非处方药
剂型或给药途径	SUPPOSITORY;RECTAL	规格	325MG
治疗等效代码		参比药物	否
批准日期	1986/12/18	申请机构	G AND W LABORATORIES INC
化学类型	New formulation or new manufacturer	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
018060	066	AP	Letter	2014/03/27	下载
018060	066	AP	Label	2014/04/16	下载
018060	065	AP	Letter	2011/11/03	下载
018060	063	AP	Letter	2010/05/03	下载
018060	055	AP	Review	2003/09/11	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
018060	067	AP	2014/12/02	Manufacturing Change or Addition
018060	066	AP	2014/03/25	Labeling Revision
018060	065	AP	2011/11/01	Labeling Revision
018060	064	AP	2010/04/01	Labeling Revision
018060	063	AP	2010/04/28	Labeling Revision
018060	059	AP	2002/02/15	Manufacturing Change or Addition
018060	058	AP	1999/03/24	Control Supplement
018060	056	AP	1996/07/29	Manufacturing Change or Addition
018060	055	AP	1997/03/31	Labeling Revision
018060	053	AP	1987/08/26	Labeling Revision
018060	052	AP	1987/10/20	Labeling Revision
018060	051	AP	1985/01/22	Control Supplement
018060	050	AP	1986/12/17	Formulation Revision
018060	049	AP	1983/05/11	Expiration Date Change
018060	048	AP	1981/04/22	Distributor
018060	046	AP	1980/12/18	Manufacturing Change or Addition
018060	045	AP	1980/11/21	Control Supplement
018060	044	AP	1980/11/25	Formulation Revision
018060	043	AP	1980/11/19	Distributor
018060	042	AP	1980/08/12	Labeling Revision
018060	039	AP	1980/02/21	Labeling Revision
018060	038	AP	1980/02/13	Labeling Revision
018060	037	AP	1980/02/13	Labeling Revision
018060	036	AP	1980/02/13	Labeling Revision
018060	034	AP	1980/02/20	Manufacturing Change or Addition
018060	033	AP	1979/09/11	Labeling Revision
018060	032	AP	1979/11/06	Package Change
018060	031	AP	1979/11/05	Labeling Revision
018060	030	AP	1979/11/05	Package Change
018060	029	AP	1979/10/22	Labeling Revision
018060	027	AP	1979/09/12	Package Change
018060	025	AP	1979/11/06	Manufacturing Change or Addition
018060	024	AP	1979/10/24	Package Change
018060	023	AP	1979/09/27	Package Change
018060	022	AP	1979/09/14	Package Change
018060	021	AP	1979/04/13	Distributor
018060	020	AP	1980/03/06	Package Change
018060	019	AP	1979/09/17	Manufacturing Change or Addition
018060	018	AP	1979/03/15	Manufacturing Change or Addition
018060	017	AP	1978/10/05	Distributor
018060	016	AP	1978/08/31	Distributor
018060	015	AP	1978/10/06	Distributor
018060	014	AP	1978/10/06	Distributor
018060	013	AP	1978/10/06	Distributor
018060	012	AP	1978/10/06	Distributor
018060	011	AP	1978/10/05	Distributor
018060	010	AP	1978/10/05	Distributor
018060	009	AP	1978/10/05	Distributor
018060	008	AP	1978/10/05	Distributor
018060	007	AP	1978/10/06	Distributor
018060	006	AP	1978/10/05	Distributor
018060	005	AP	1978/10/06	Distributor
018060	004	AP	1978/10/05	Distributor
018060	003	AP	1978/10/06	Distributor
018060	002	AP	1978/10/06	Distributor
018060	001	AP	1978/05/03	Labeling Revision
018060	000	AP	1978/02/09	Approval

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