DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER(CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE)

药品名称	DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
申请号	017512	产品号	003
活性成分	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	市场状态	处方药
剂型或给药途径	SOLUTION;INTRAPERITONEAL	规格	25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
治疗等效代码	AT	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
017512	123	AP	Label	2016/08/17	下载
017512	123	AP	Letter	2016/08/18	下载
017512	122	AP	Letter	2015/09/04	下载
017512	122	AP	Label	2015/09/04	下载
017512	121	AP	Label	2015/07/30	下载
017512	121	AP	Letter	2015/07/31	下载
017512	120	AP	Label	2015/07/30	下载
017512	120	AP	Letter	2015/07/31	下载
017512	118	AP	Letter	2015/02/10	下载
017512	118	AP	Label	2015/02/10	下载
017512	113	AP	Label	2013/04/23	下载
017512	113	AP	Letter	2013/04/24	下载
017512	108	AP	Letter	2008/12/24	下载
017512	108	AP	Label	2009/01/02	下载
017512	106	AP	Letter	2005/08/11	下载
017512	104	AP	Letter	2005/08/11	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
017512	124	AP	2016/08/01	Manufacturing Change or Addition
017512	123	AP	2016/08/16	Labeling Revision
017512	122	AP	2015/09/01	Labeling Revision
017512	121	AP	2015/07/29	Manufacturing Change or Addition
017512	120	AP	2015/07/29	Manufacturing Change or Addition
017512	119	AP	2015/05/22	Manufacturing Change or Addition
017512	118	AP	2015/02/09	Labeling Revision
017512	117	AP	2014/09/30	Manufacturing Change or Addition
017512	116	AP	2013/04/26	Manufacturing Change or Addition
017512	113	AP	2013/04/19	Labeling Revision
017512	108	AP	2008/12/19	Labeling Revision
017512	106	AP	2005/08/09	Labeling Revision
017512	104	AP	2005/08/09	Labeling Revision
017512	099	AP	2002/09/20	Package Change
017512	098	AP	2001/08/22	Control Supplement
017512	097	AP	2000/09/20	Package Change
017512	096	AP	1997/04/29	Package Change
017512	095	AP	1997/01/17	Package Change
017512	094	AP	1996/07/02	Package Change
017512	093	AP	1994/02/18	Control Supplement
017512	092	AP	1994/09/30	Control Supplement
017512	091	AP	1994/07/01	Control Supplement
017512	089	AP	1995/07/21	Package Change
017512	088	AP	1992/11/23	Control Supplement
017512	086	AP	1991/04/29	Control Supplement
017512	085	AP	1993/06/14	Manufacturing Change or Addition
017512	084	AP	1992/06/12	Manufacturing Change or Addition
017512	083	AP	1990/11/28	Labeling Revision
017512	082	AP	1991/02/15	Control Supplement
017512	081	AP	1990/07/11	Labeling Revision
017512	080	AP	1990/07/11	Formulation Revision
017512	079	AP	1989/07/26	Control Supplement
017512	078	AP	1989/01/12	Control Supplement
017512	077	AP	1989/01/10	Labeling Revision
017512	076	AP	1989/01/10	Formulation Revision
017512	075	AP	1987/07/25	Package Change
017512	074	AP	1987/01/14	Control Supplement
017512	073	AP	1989/10/16	Labeling Revision
017512	072	AP	1989/10/16	Control Supplement
017512	071	AP	1987/05/28	Control Supplement
017512	070	AP	1986/05/27	Manufacturing Change or Addition
017512	069	AP	1986/09/04	Package Change
017512	068	AP	1985/11/18	Labeling Revision
017512	067	AP	1985/11/18	Package Change
017512	066	AP	1986/02/27	Package Change
017512	065	AP	1985/04/15	Control Supplement
017512	064	AP	1985/07/16	Labeling Revision
017512	063	AP	1985/07/16	Control Supplement
017512	062	AP	1985/08/29	Practioner Draft Labeling
017512	061	AP	1985/08/29	Practioner Draft Labeling
017512	058	AP	1985/04/10	Labeling Revision
017512	055	AP	1985/06/13	Control Supplement
017512	054	AP	1984/09/22	Control Supplement
017512	053	AP	1984/07/09	Labeling Revision
017512	052	AP	1984/07/09	Package Change
017512	050	AP	1984/02/28	Control Supplement
017512	049	AP	1983/11/07	Labeling Revision
017512	048	AP	1983/11/07	Control Supplement
017512	046	AP	1985/08/28	Control Supplement
017512	045	AP	1985/08/28	Control Supplement
017512	044	AP	1984/03/16	Control Supplement
017512	043	AP	1985/01/24	Control Supplement
017512	041	AP	1982/12/08	Labeling Revision
017512	040	AP	1982/12/08	Control Supplement
017512	039	AP	1982/12/08	Labeling Revision
017512	038	AP	1982/12/08	Control Supplement
017512	037	AP	1982/12/03	Labeling Revision
017512	036	AP	1982/02/16	Control Supplement
017512	035	AP	1981/12/15	Control Supplement
017512	034	AP	1981/11/20	Control Supplement
017512	032	AP	1982/04/09	Labeling Revision
017512	031	AP	1982/04/09	Control Supplement
017512	030	AP	1982/06/03	Control Supplement
017512	029	AP	1982/04/16	Control Supplement
017512	028	AP	1981/08/26	Labeling Revision
017512	027	AP	1981/12/21	Control Supplement
017512	026	AP	1981/11/13	Control Supplement
017512	025	AP	1981/10/05	Labeling Revision
017512	024	AP	1981/10/05	Formulation Revision
017512	022	AP	1981/06/29	Control Supplement
017512	021	AP	1981/01/21	Control Supplement
017512	019	AP	1980/07/31	Control Supplement
017512	018	AP	1985/07/16	Labeling Revision
017512	017	AP	1985/07/16	Control Supplement
017512	016	AP	1980/08/06	Control Supplement
017512	015	AP	1981/04/16	Control Supplement
017512	014	AP	1980/06/18	Control Supplement
017512	013	AP	1980/06/02	Labeling Revision
017512	012	AP	1980/06/02	Labeling Revision
017512	011	AP	1980/06/02	Control Supplement
017512	010	AP	1980/05/30	Control Supplement
017512	009	AP	1980/06/02	Package Change
017512	008	AP	1980/06/02	Labeling Revision
017512	007	AP	1980/06/02	Control Supplement
017512	006	AP	1980/08/07	Control Supplement
017512	004	AP	1980/06/28	Control Supplement
017512	003	AP	1979/02/27	Labeling Revision
017512	002	AP	1979/08/02	Control Supplement
017512	001	AP	1978/11/21	Formulation Revision
017512	000	AP	1978/09/27	Approval

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