DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER(CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE)

药品名称	DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
申请号	018379	产品号	001
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;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
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	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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