DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER(DEXTROSE; SODIUM CHLORIDE)

药品名称	DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
申请号	016678	产品号	001
活性成分	DEXTROSE; SODIUM CHLORIDE	市场状态	处方药
剂型或给药途径	INJECTABLE;INJECTION	规格	5GM/100ML;900MG/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
016678	105	AP	Label	2013/09/11	下载
016678	105	AP	Letter	2013/09/12	下载
016678	098	AP	Letter	2004/06/07	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
016678	108	AP	2015/12/23	Manufacturing Change or Addition
016678	106	AP	2015/01/12	Manufacturing Change or Addition
016678	105	AP	2013/09/10	Labeling Revision
016678	098	AP	2004/06/02	Labeling Revision
016678	096	AP	2001/08/14	Manufacturing Change or Addition
016678	095	AP	1999/11/24	Manufacturing Change or Addition
016678	094	AP	2000/11/29	Labeling Revision
016678	093	AP	1997/04/29	Package Change
016678	092	AP	1996/10/11	Package Change
016678	091	AP	1994/02/18	Control Supplement
016678	090	AP	1994/09/30	Control Supplement
016678	087	AP	1991/04/29	Control Supplement
016678	086	AP	1991/03/26	Control Supplement
016678	085	AP	1991/02/15	Control Supplement
016678	084	AP	1989/07/26	Control Supplement
016678	083	AP	1989/01/12	Control Supplement
016678	082	AP	1987/07/25	Package Change
016678	081	AP	1987/05/28	Control Supplement
016678	078	AP	1986/02/27	Package Change
016678	077	AP	1985/04/15	Control Supplement
016678	076	AP	1985/07/03	Labeling Revision
016678	074	AP	1985/06/13	Control Supplement
016678	073	AP	1984/09/22	Control Supplement
016678	072	AP	1984/02/28	Control Supplement
016678	070	AP	1985/08/28	Control Supplement
016678	069	AP	1985/08/28	Control Supplement
016678	068	AP	1984/03/16	Control Supplement
016678	067	AP	1985/01/24	Control Supplement
016678	065	AP	1982/02/16	Control Supplement
016678	064	AP	1983/07/11	Practioner Draft Labeling
016678	063	AP	1981/11/20	Control Supplement
016678	061	AP	1982/06/03	Control Supplement
016678	060	AP	1981/11/09	Control Supplement
016678	059	AP	1982/04/16	Control Supplement
016678	058	AP	1981/08/26	Labeling Revision
016678	057	AP	1981/12/21	Control Supplement
016678	056	AP	1981/05/08	Control Supplement
016678	054	AP	1981/06/29	Control Supplement
016678	053	AP	1981/01/21	Control Supplement
016678	052	AP	1980/07/31	Control Supplement
016678	051	AP	1980/08/06	Control Supplement
016678	050	AP	1981/04/16	Control Supplement
016678	048	AP	1980/06/18	Control Supplement
016678	047	AP	1980/05/30	Control Supplement
016678	046	AP	1980/02/22	Control Supplement
016678	045	AP	1980/08/07	Control Supplement
016678	043	AP	1980/06/28	Control Supplement
016678	042	AP	1979/08/02	Control Supplement
016678	040	AP	1978/10/12	Control Supplement
016678	039	AP	1978/10/20	Control Supplement
016678	038	AP	1978/08/07	Control Supplement
016678	037	AP	1978/08/02	Control Supplement
016678	036	AP	1978/11/03	Control Supplement
016678	035	AP	1978/04/25	Labeling Revision
016678	034	AP	1978/03/22	Control Supplement
016678	033	AP	1980/02/25	Control Supplement
016678	032	AP	1978/06/20	Control Supplement
016678	031	AP	1978/03/24	Control Supplement
016678	030	AP	1978/02/28	Control Supplement
016678	029	AP	1977/12/14	Control Supplement
016678	028	AP	1977/06/06	Control Supplement
016678	027	AP	1977/02/07	Package Change
016678	026	AP	1976/10/13	Labeling Revision
016678	025	AP	1976/07/13	Final Printed Labeling - MarkIV
016678	024	AP	1976/06/17	Control Supplement
016678	022	AP	1976/01/02	Labeling Revision
016678	021	AP	1976/07/01	Control Supplement
016678	020	AP	1976/01/05	Control Supplement
016678	019	AP	1976/11/29	Labeling Revision
016678	018	AP	1975/09/23	Control Supplement
016678	017	AP	1976/05/11	Labeling Revision
016678	016	AP	1975/09/17	Control Supplement
016678	015	AP	1975/09/25	Control Supplement
016678	013	AP	1975/07/10	Control Supplement
016678	000	AP	1970/12/09	Approval

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