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	018883	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;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
治疗等效代码	AT	参比药物	否
批准日期	1984/11/30	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
018883	057	AP	Letter	2015/01/09	下载
018883	057	AP	Label	2015/01/12	下载
018883	051	AP	Letter	2014/04/25	下载
018883	051	AP	Label	2014/04/28	下载
018883	048	AP	Label	2013/04/19	下载
018883	044	AP	Label	2013/02/01	下载
018883	044	AP	Letter	2013/02/04	下载
018883	033	AP	Letter	2009/11/13	下载
018883	028	AP	Letter	2003/12/02	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
018883	061	AP	2016/07/18	Manufacturing Change or Addition
018883	060	AP	2016/10/17	Manufacturing Change or Addition
018883	058	AP	2015/12/28	Manufacturing Change or Addition
018883	057	AP	2015/01/08	Labeling Revision
018883	056	AP	2014/12/08	Manufacturing Change or Addition
018883	055	AP	2014/08/07	Manufacturing Change or Addition
018883	054	AP	2014/04/23	Manufacturing Change or Addition
018883	053	AP	2014/01/24	Manufacturing Change or Addition
018883	052	AP	2014/01/13	Manufacturing Change or Addition
018883	051	AP	2014/04/24	Labeling Revision
018883	050	AP	2013/07/26	Manufacturing Change or Addition
018883	049	AP	2013/08/15	Manufacturing Change or Addition
018883	048	AP	2013/04/18	Manufacturing Change or Addition
018883	047	AP	2013/02/22	Manufacturing Change or Addition
018883	044	AP	2013/01/30	Labeling Revision
018883	033	AP	2009/09/14	Labeling Revision
018883	028	AP	2003/11/26	Control Supplement
018883	026	AP	2001/09/26	Package Change
018883	025	AP	1999/05/18	Package Change
018883	024	AP	1997/02/24	Control Supplement
018883	023	AP	1996/06/14	Control Supplement
018883	022	AP	1996/02/22	Control Supplement
018883	021	AP	1996/01/19	Control Supplement
018883	020	AP	1993/07/07	Manufacturing Change or Addition
018883	019	AP	1993/07/07	Labeling Revision
018883	018	AP	1993/07/07	Manufacturing Change or Addition
018883	016	AP	1990/07/11	Control Supplement
018883	015	AP	1989/01/10	Control Supplement
018883	013	AP	1988/02/05	Control Supplement
018883	012	AP	1990/01/24	Labeling Revision
018883	011	AP	1990/01/24	Control Supplement
018883	010	AP	1990/01/24	Labeling Revision
018883	009	AP	1990/01/24	Control Supplement
018883	008	AP	1987/04/08	Control Supplement
018883	007	AP	1987/01/14	Labeling Revision
018883	006	AP	1987/07/21	Control Supplement
018883	005	AP	1987/10/27	Labeling Revision
018883	004	AP	1987/10/27	Control Supplement
018883	003	AP	1986/06/16	Labeling Revision
018883	002	AP	1986/06/16	Manufacturing Change or Addition
018883	001	AP	1985/09/05	Expiration Date Change
018883	000	AP	1984/11/30	Approval

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