DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER(CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE)

药品名称	DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
申请号	018379	产品号	008
活性成分	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	市场状态	停止上市
剂型或给药途径	SOLUTION;INTRAPERITONEAL	规格	25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
治疗等效代码		参比药物	否
批准日期	1988/06/24	申请机构	FRESENIUS MEDICAL CARE NORTH AMERICA
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
无

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
018379	096	AP	1999/09/27	Manufacturing Change or Addition
018379	095	AP	2001/11/09	Formulation Revision
018379	094	AP	1997/08/14	Manufacturing Change or Addition
018379	093	AP	1996/07/03	Control Supplement
018379	092	AP	1996/11/01	Control Supplement
018379	091	AP	1996/02/07	Manufacturing Change or Addition
018379	089	AP	1996/01/23	Control Supplement
018379	085	AP	1991/08/30	Package Change
018379	084	AP	1992/01/28	Package Change
018379	083	AP	1991/09/10	Control Supplement
018379	081	AP	1990/01/11	Manufacturing Change or Addition
018379	080	AP	1990/08/01	Expiration Date Change
018379	079	AP	1990/02/22	Manufacturing Change or Addition
018379	078	AP	1989/06/14	Control Supplement
018379	077	AP	1988/02/24	Formulation Revision
018379	076	AP	1988/02/02	Formulation Revision
018379	074	AP	1988/06/24	Labeling Revision
018379	073	AP	1988/06/24	Manufacturing Change or Addition
018379	072	AP	1988/06/24	Labeling Revision
018379	071	AP	1988/06/24	Manufacturing Change or Addition
018379	069	AP	1987/07/30	Control Supplement
018379	068	AP	1986/11/26	Control Supplement
018379	067	AP	1986/08/08	Control Supplement
018379	066	AP	1987/02/11	Control Supplement
018379	065	AP	1987/02/11	Control Supplement
018379	064	AP	1987/04/28	Labeling Revision
018379	063	AP	1987/04/28	Control Supplement
018379	062	AP	1987/02/27	Labeling Revision
018379	061	AP	1987/02/27	Control Supplement
018379	060	AP	1986/02/21	Control Supplement
018379	059	AP	1985/12/06	Control Supplement
018379	058	AP	1986/02/26	Control Supplement
018379	057	AP	1986/02/26	Control Supplement
018379	056	AP	1986/01/18	Labeling Revision
018379	055	AP	1986/01/18	Package Change
018379	054	AP	1986/01/18	Labeling Revision
018379	053	AP	1986/01/18	Package Change
018379	052	AP	1986/01/31	Control Supplement
018379	051	AP	1985/10/02	Labeling Revision
018379	050	AP	1985/10/02	Control Supplement
018379	049	AP	1985/10/24	Labeling Revision
018379	048	AP	1985/10/24	Control Supplement
018379	047	AP	1985/10/02	Control Supplement
018379	046	AP	1985/09/06	Control Supplement
018379	045	AP	1985/10/02	Manufacturing Change or Addition
018379	044	AP	1985/10/02	Labeling Revision
018379	043	AP	1985/10/02	Control Supplement
018379	042	AP	1985/12/10	Labeling Revision
018379	041	AP	1985/12/10	Control Supplement
018379	040	AP	1984/10/22	Control Supplement
018379	039	AP	1985/09/26	Package Change
018379	037	AP	1985/05/01	Control Supplement
018379	036	AP	1985/10/29	Package Change
018379	035	AP	1984/11/28	Control Supplement
018379	034	AP	1984/09/08	Control Supplement
018379	033	AP	1984/06/08	Control Supplement
018379	032	AP	1989/06/22	Control Supplement
018379	031	AP	1984/10/17	Control Supplement
018379	030	AP	1984/03/21	Control Supplement
018379	029	AP	1985/03/15	Control Supplement
018379	028	AP	1984/01/25	Package Change
018379	027	AP	1984/01/25	Control Supplement
018379	026	AP	1984/02/17	Control Supplement
018379	025	AP	1982/07/26	Control Supplement
018379	024	AP	1982/07/21	Control Supplement
018379	023	AP	1984/03/01	Control Supplement
018379	022	AP	1984/10/10	Labeling Revision
018379	021	AP	1984/10/10	Package Change
018379	020	AP	1983/07/05	Control Supplement
018379	019	AP	1982/07/04	Labeling Revision
018379	018	AP	1982/07/04	Formulation Revision
018379	017	AP	1982/06/09	Expiration Date Change
018379	016	AP	1982/07/07	Labeling Revision
018379	015	AP	1982/07/07	Control Supplement
018379	014	AP	1982/08/05	Labeling Revision
018379	013	AP	1982/08/05	Control Supplement
018379	012	AP	1982/02/01	Control Supplement
018379	011	AP	1982/01/08	Control Supplement
018379	010	AP	1982/03/11	Labeling Revision
018379	009	AP	1982/03/11	Formulation Revision
018379	008	AP	1982/06/09	Control Supplement
018379	007	AP	1981/10/01	Labeling Revision
018379	005	AP	1981/04/23	Control Supplement
018379	004	AP	1981/09/16	Control Supplement
018379	003	AP	1982/04/09	Practioner Draft Labeling
018379	002	AP	1981/01/19	Control Supplement
018379	001	AP	1980/10/31	Control Supplement
018379	000	AP	1980/09/03	Approval

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