DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER-美国FDA药品数据库-药物在线

产品信息

产品号	商品名	活性成分	剂型/给药途径	规格/剂量	参比药物(RLD)	生物等效参考标准(RS)	治疗等效代码	该申请号批准日期	该产品号批准日期	市场状态
001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	2.5GM/100ML;110MG/100ML	No	No	None	1988/02/24	1988/02/24	Prescription
002	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	2.5GM/100ML;200MG/100ML	No	No	None		1988/02/24	Prescription
003	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	2.5GM/100ML;330MG/100ML	No	No	None		1988/02/24	Prescription
004	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	2.5GM/100ML;450MG/100ML	No	No	AP		1988/02/24	Prescription
005	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	2.5GM/100ML;900MG/100ML	No	No	None		1988/02/24	Prescription
006	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;110MG/100ML	No	No	None		1988/02/24	Prescription
007	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;200MG/100ML	No	No	AP		1988/02/24	Prescription
008	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;330MG/100ML	No	No	AP		1988/02/24	Prescription
009	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;450MG/100ML	No	No	AP		1988/02/24	Prescription
010	DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;900MG/100ML	No	No	AP		1988/02/24	Prescription
011	DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	10GM/100ML;110MG/100ML	No	No	None		1988/02/24	Prescription
012	DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	10GM/100ML;200MG/100ML	No	No	None		1988/02/24	Prescription
013	DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	10GM/100ML;330MG/100ML	No	No	None		1988/02/24	Prescription
014	DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	10GM/100ML;450MG/100ML	No	No	None		1988/02/24	Prescription
015	DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	10GM/100ML;900MG/100ML	No	No	None		1988/02/24	Prescription
016	DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	3.3GM/100ML;300MG/100ML	No	No	None		1990/01/19	Prescription

批准日期，申请提交历史，通知信，药品说明书，审评文件等信息

提交状态日期	提交号	审批结论	申请内容分类	审评优先级；罕用药状态	通知信、审评文件、说明书、包装标签
2014/08/22	SUPPL-31（补充）	Approval	Manufacturing (CMC)	STANDARD
2014/01/24	SUPPL-34（补充）	Approval	Manufacturing (CMC)	STANDARD
2004/09/27	SUPPL-23（补充）	Approval	Labeling	STANDARD	Label Letter
2002/07/23	SUPPL-22（补充）	Approval	Manufacturing (CMC)	STANDARD
2002/03/08	SUPPL-20（补充）	Approval	Manufacturing (CMC)	STANDARD
2001/03/12	SUPPL-19（补充）	Approval	Manufacturing (CMC)	STANDARD
2000/04/11	SUPPL-18（补充）	Approval	Manufacturing (CMC)	STANDARD
1998/09/25	SUPPL-17（补充）	Approval	Manufacturing (CMC)	STANDARD
1995/03/17	SUPPL-16（补充）	Approval	Manufacturing (CMC)	STANDARD
1994/12/19	SUPPL-15（补充）	Approval	Manufacturing (CMC)	STANDARD
1993/07/21	SUPPL-14（补充）	Approval	Manufacturing (CMC)	STANDARD
1992/12/29	SUPPL-13（补充）	Approval	Manufacturing (CMC)	STANDARD
1991/08/29	SUPPL-11（补充）	Approval	Manufacturing (CMC)	STANDARD
1990/09/18	SUPPL-10（补充）	Approval	Manufacturing (CMC)	STANDARD
1990/04/13	SUPPL-8（补充）	Approval	Manufacturing (CMC)	STANDARD
1990/01/19	SUPPL-9（补充）	Approval	Labeling
1990/01/19	SUPPL-6（补充）	Approval	Manufacturing (CMC)	STANDARD
1989/11/21	SUPPL-4（补充）	Approval	Manufacturing (CMC)	STANDARD
1989/07/26	SUPPL-7（补充）	Approval	Manufacturing (CMC)	STANDARD
1989/05/05	SUPPL-5（补充）	Approval	Manufacturing (CMC)	STANDARD
1988/12/21	SUPPL-3（补充）	Approval	Manufacturing (CMC)	STANDARD
1988/08/25	SUPPL-2（补充）	Approval	Manufacturing (CMC)	STANDARD
1988/03/25	SUPPL-1（补充）	Approval	Labeling
1988/02/24	ORIG-1（原始申请）	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD

与本品相关的专利信息（来自FDA橙皮书Orange Book）

关联产品号	专利号	专利过期日	是否物质专利	是否产品专利	专利用途代码	撤销请求	提交日期	专利下载	备注
无

与本品相关的市场独占权保护信息

关联产品号	独占权代码	失效日期	备注
无

与本品治疗等效的药品

活性成分:DEXTROSE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:2.5GM/100ML;450MG/100ML 治疗等效代码:AP

申请号	产品号	申请类型	商品名	活性成分	剂型/给药途径	规格	市场状态	RLD	RS	TE Code	产品号批准日期	申请人
016697	001	NDA	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	2.5GM/100ML;450MG/100ML	Prescription	Yes	Yes	AP	Approved Prior to Jan 1, 1982	BAXTER HLTHCARE
019631	004	NDA	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	2.5GM/100ML;450MG/100ML	Prescription	No	No	AP	1988/02/24	B BRAUN
211190	001	ANDA	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	2.5GM/100ML;450MG/100ML	Prescription	No	No	AP	2019/12/20	FRESENIUS KABI USA

活性成分:DEXTROSE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;200MG/100ML 治疗等效代码:AP

申请号	产品号	申请类型	商品名	活性成分	剂型/给药途径	规格	市场状态	RLD	RS	TE Code	产品号批准日期	申请人
016689	001	NDA	DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;200MG/100ML	Prescription	No	No	AP	Approved Prior to Jan 1, 1982	BAXTER HLTHCARE
019631	007	NDA	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;200MG/100ML	Prescription	No	No	AP	1988/02/24	B BRAUN

活性成分:DEXTROSE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;330MG/100ML 治疗等效代码:AP

申请号	产品号	申请类型	商品名	活性成分	剂型/给药途径	规格	市场状态	RLD	RS	TE Code	产品号批准日期	申请人
016687	001	NDA	DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;330MG/100ML	Prescription	No	No	AP	Approved Prior to Jan 1, 1982	BAXTER HLTHCARE
019631	008	NDA	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;330MG/100ML	Prescription	No	No	AP	1988/02/24	B BRAUN

活性成分:DEXTROSE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;450MG/100ML 治疗等效代码:AP

申请号	产品号	申请类型	商品名	活性成分	剂型/给药途径	规格	市场状态	RLD	RS	TE Code	产品号批准日期	申请人
016683	001	NDA	DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;450MG/100ML	Prescription	No	No	AP	Approved Prior to Jan 1, 1982	BAXTER HLTHCARE
017607	001	NDA	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;450MG/100ML	Prescription	Yes	No	AP	Approved Prior to Jan 1, 1982	ICU MEDICAL INC
019631	009	NDA	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;450MG/100ML	Prescription	No	No	AP	1988/02/24	B BRAUN
211276	001	ANDA	DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;450MG/100ML	Prescription	No	No	AP	2020/09/15	FRESENIUS KABI USA

活性成分:DEXTROSE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;900MG/100ML 治疗等效代码:AP

申请号	产品号	申请类型	商品名	活性成分	剂型/给药途径	规格	市场状态	RLD	RS	TE Code	产品号批准日期	申请人
016678	001	NDA	DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;900MG/100ML	Prescription	No	No	AP	Approved Prior to Jan 1, 1982	BAXTER HLTHCARE
017585	001	NDA	DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;900MG/100ML	Prescription	Yes	Yes	AP	Approved Prior to Jan 1, 1982	ICU MEDICAL INC
019631	010	NDA	DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;900MG/100ML	Prescription	No	No	AP	1988/02/24	B BRAUN
211211	001	ANDA	DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;900MG/100ML	Prescription	No	No	AP	2020/09/14	FRESENIUS KABI USA