MOTRIN(IBUPROFEN) - 美国FDA药品数据库

药品名称	MOTRIN
申请号	017463	产品号	003
活性成分	IBUPROFEN	市场状态	停止上市
剂型或给药途径	TABLET;ORAL	规格	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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	MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
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
017463	105	AP	Label	2007/09/11	下载
017463	105	AP	Letter	2007/09/11	下载
017463	104	AP	Label	2006/01/25	下载
017463	104	AP	Letter	2006/01/30	下载
017463	000	AP	Medication Guide	2009/12/04	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
017463	105	AP	2007/09/10	Labeling Revision
017463	104	AP	2006/01/24	Labeling Revision
017463	103	AP	2001/05/14	Control Supplement
017463	102	AP	2001/06/20	Manufacturing Change or Addition
017463	101	AP	1999/11/29	Control Supplement
017463	099	AP	1999/07/20	Manufacturing Change or Addition
017463	098	AP	1995/11/20	Control Supplement
017463	097	AP	1995/11/15	Control Supplement
017463	095	AP	1995/03/23	Control Supplement
017463	091	AP	1992/10/19	Manufacturing Change or Addition
017463	089	AP	1990/12/26	Control Supplement
017463	087	AP	1989/07/25	Manufacturing Change or Addition
017463	085	AP	1994/06/22	Control Supplement
017463	082	AP	1990/10/02	Control Supplement
017463	079	AP	1988/02/16	Labeling Revision
017463	078	AP	1988/02/16	Labeling Revision
017463	077	AP	1988/02/16	Labeling Revision
017463	075	AP	1987/11/27	Labeling Revision
017463	074	AP	1986/12/16	Manufacturing Change or Addition
017463	072	AP	1986/10/10	Labeling Revision
017463	071	AP	1986/10/10	Labeling Revision
017463	070	AP	1986/10/10	Package Change
017463	069	AP	1985/11/06	Labeling Revision
017463	068	AP	1990/10/31	Formulation Revision
017463	065	AP	1986/12/22	Formulation Revision
017463	063	AP	1985/05/22	Labeling Revision
017463	062	AP	1984/05/29	Control Supplement
017463	057	AP	1983/04/09	Labeling Revision
017463	053	AP	1985/05/22	Labeling Revision
017463	052	AP	1982/03/01	Labeling Revision
017463	051	AP	1981/07/02	Expiration Date Change
017463	050	AP	1981/07/02	Expiration Date Change
017463	049	AP	1982/03/01	Labeling Revision
017463	048	AP	1981/03/31	Labeling Revision
017463	047	AP	1980/09/12	Expiration Date Change
017463	046	AP	1982/03/01	Labeling Revision
017463	045	AP	1979/12/21	Control Supplement
017463	044	AP	1980/01/31	Control Supplement
017463	042	AP	1979/06/20	Manufacturing Change or Addition
017463	041	AP	1979/04/16	Manufacturing Change or Addition
017463	040	AP	1979/08/21	General Efficacy (MarkIV)
017463	039	AP	1979/03/22	Package Change
017463	038	AP	1979/02/27	Expiration Date Change
017463	035	AP	1978/09/12	Package Change
017463	034	AP	1979/02/09	Control Supplement
017463	032	AP	1978/08/08	Manufacturing Change or Addition
017463	031	AP	1978/02/23	Control Supplement
017463	030	AP	1978/04/21	Manufacturing Change or Addition
017463	029	AP	1978/02/03	Expiration Date Change
017463	028	AP	1977/04/07	Supplement
017463	024	AP	1979/08/21	Labeling Revision
017463	022	AP	1976/12/14	Distributor
017463	019	AP	1976/09/08	Manufacturing Change or Addition
017463	018	AP	1976/08/27	Labeling Revision
017463	017	AP	1976/05/03
017463	016	AP	1976/03/01	Labeling Revision
017463	013	AP	1975/11/12	Labeling Revision
017463	012	AP	1975/11/12	Control Supplement
017463	011	AP	1975/11/12	Labeling Revision
017463	010	AP	1976/05/03	Control Supplement
017463	008	AP	1975/11/11	Control Supplement
017463	000	AP	1974/09/19	Approval

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