OSMITROL 5% IN WATER(MANNITOL) - 美国FDA药品数据库

药品名称	OSMITROL 5% IN WATER
申请号	013684	产品号	001
活性成分	MANNITOL	市场状态	处方药
剂型或给药途径	INJECTABLE;INJECTION	规格	5GM/100ML
治疗等效代码	AP	参比药物	否
批准日期	Approved Prior to Jan 1, 1982	申请机构	BAXTER HEALTHCARE CORP
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
013684	092	AP	Label	2005/09/07	下载
013684	092	AP	Letter	2005/09/07	下载
013684	091	AP	Letter	2005/06/14	下载
013684	091	AP	Label	2005/06/14	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
013684	101	AP	2015/12/23	Manufacturing Change or Addition
013684	100	AP	2015/07/15	Manufacturing Change or Addition
013684	099	AP	2015/04/08	Manufacturing Change or Addition
013684	097	AP	2013/07/19	Manufacturing Change or Addition
013684	092	AP	2005/08/26	Supplement
013684	091	AP	2005/06/09	Labeling Revision
013684	087	AP	2002/01/16	Control Supplement
013684	086	AP	2001/08/14	Manufacturing Change or Addition
013684	085	AP	1999/11/24	Manufacturing Change or Addition
013684	084	AP	1997/04/29	Package Change
013684	083	AP	1994/02/18	Control Supplement
013684	082	AP	1994/09/30	Control Supplement
013684	081	AP	1994/06/01	Control Supplement
013684	079	AP	1991/04/29	Control Supplement
013684	078	AP	1991/03/26	Control Supplement
013684	077	AP	1991/02/15	Control Supplement
013684	076	AP	1989/07/26	Control Supplement
013684	075	AP	1987/07/25	Package Change
013684	074	AP	1987/05/28	Control Supplement
013684	071	AP	1985/04/15	Control Supplement
013684	070	AP	1985/06/13	Control Supplement
013684	069	AP	1984/09/22	Control Supplement
013684	068	AP	1984/02/28	Control Supplement
013684	067	AP	1983/07/11	Labeling Revision
013684	065	AP	1985/08/28	Control Supplement
013684	064	AP	1985/08/28	Control Supplement
013684	063	AP	1984/03/16	Control Supplement
013684	062	AP	1985/01/24	Control Supplement
013684	060	AP	1982/04/08	Labeling Revision
013684	059	AP	1982/02/16	Control Supplement
013684	058	AP	1981/11/20	Control Supplement
013684	056	AP	1982/06/03	Control Supplement
013684	055	AP	1982/11/22	Practioner Draft Labeling
013684	054	AP	1982/04/16	Control Supplement
013684	053	AP	1981/08/26	Labeling Revision
013684	051	AP	1982/11/22	Labeling Revision
013684	050	AP	1982/11/22	Control Supplement
013684	049	AP	1981/06/29	Control Supplement
013684	048	AP	1981/01/21	Control Supplement
013684	047	AP	1980/07/31	Control Supplement
013684	046	AP	1981/09/08	Labeling Revision
013684	045	AP	1981/09/08	Control Supplement
013684	044	AP	1981/09/08	Labeling Revision
013684	043	AP	1981/09/08	Control Supplement
013684	042	AP	1981/04/16	Control Supplement
013684	041	AP	1980/06/18	Control Supplement
013684	040	AP	1980/05/30	Control Supplement
013684	039	AP	1980/08/07	Control Supplement
013684	037	AP	1980/06/28	Control Supplement
013684	036	AP	1979/08/02	Control Supplement
013684	034	AP	1978/10/20	Control Supplement
013684	033	AP	1978/08/07	Control Supplement
013684	031	AP	1978/03/22	Control Supplement
013684	030	AP	1980/02/25	Control Supplement
013684	029	AP	1978/06/20	Control Supplement
013684	028	AP	1978/03/24	Control Supplement
013684	027	AP	1978/02/28	Control Supplement
013684	026	AP	1977/12/14	Control Supplement
013684	025	AP	1979/08/07	Labeling Revision
013684	024	AP	1979/04/25	Manufacturing Change or Addition
013684	023	AP	1977/08/30	Labeling Revision
013684	022	AP	1977/02/07	Package Change
013684	021	AP	1976/10/07	Control Supplement
013684	020	AP	1976/07/13	Final Printed Labeling - MarkIV
013684	018	AP	1977/04/08	Control Supplement
013684	017	AP	1976/06/17	Control Supplement
013684	015	AP	1976/07/01	Control Supplement
013684	014	AP	1976/01/05	Control Supplement
013684	013	AP	1975/07/29	Control Supplement
013684	012	AP	1975/09/17	Control Supplement
013684	011	AP	1975/06/16	Control Supplement
013684	010	AP	1975/09/25	Control Supplement
013684	009	AP	1975/07/10	Control Supplement
013684	008	AP	1974/11/11	Supplement
013684	000	AP	1964/06/08	Approval

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