MOTRIN(IBUPROFEN) - 美国FDA药品数据库

药品名称	MOTRIN
申请号	017463	产品号	005
活性成分	IBUPROFEN	市场状态	停止上市
剂型或给药途径	TABLET;ORAL	规格	800MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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	1985/05/22	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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