DEXTROSE 2.5% 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% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	2.5GM/100ML	No	No	None	1988/02/02	1988/02/02	Discontinued
002	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	5GM/100ML	Yes	Yes	AP		1988/02/02	Prescription
003	DEXTROSE 7.7% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	7.7GM/100ML	No	No	None		1988/02/02	Discontinued
004	DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	10GM/100ML	Yes	Yes	AP		1988/02/02	Prescription
005	DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	70GM/100ML	Yes	Yes	AP		2015/02/18	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

>>>原始批准或临时批准<<<

审批日期	提交号	审批结论	提交分类	审评优先级；罕用药状态	通知信、审评文件、说明书、包装标签	备注
1988/02/02	ORIG-1（原始申请）	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD

>>>补充申请<<<

审批日期	提交号	审批结论	补充类别或审批类型	审评优先级；罕用药状态	通知信、审评文件、说明书、包装标签
2015/11/20	SUPPL-31（补充）	Approval	Manufacturing (CMC)	STANDARD
2015/02/18	SUPPL-30（补充）	Approval	Manufacturing (CMC)	STANDARD	Label
2014/08/22	SUPPL-27（补充）	Approval	Manufacturing (CMC)	STANDARD
2004/02/13	SUPPL-19（补充）	Approval	Manufacturing (CMC)-Control	STANDARD	Label Letter
2002/07/23	SUPPL-18（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
2002/03/08	SUPPL-16（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
2001/03/12	SUPPL-15（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
2000/04/11	SUPPL-14（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1998/09/25	SUPPL-13（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1993/07/21	SUPPL-10（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1993/06/01	SUPPL-12（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1993/04/26	SUPPL-11（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1991/08/29	SUPPL-8（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1990/09/18	SUPPL-7（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1990/04/13	SUPPL-6（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1989/11/21	SUPPL-3（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1989/07/26	SUPPL-5（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1989/05/05	SUPPL-4（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1988/12/21	SUPPL-2（补充）	Approval	Manufacturing (CMC)	STANDARD
1988/03/16	SUPPL-1（补充）	Approval	Labeling

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; 剂型/给药途径:INJECTABLE;INJECTION; 规格:5GM/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
016673	001	NDA	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	5GM/100ML	Prescription	Yes	Yes	AP	Approved Prior to Jan 1, 1982	BAXTER HLTHCARE
016730	001	NDA	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	5GM/100ML	Prescription	Yes	Yes	AP	Approved Prior to Jan 1, 1982	B BRAUN
019466	001	NDA	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	5GM/100ML	Prescription	Yes	Yes	AP	1985/07/15	HOSPIRA
019479	001	NDA	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	5GM/100ML	Prescription	Yes	Yes	AP	1985/09/17	HOSPIRA
019626	002	NDA	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	5GM/100ML	Prescription	Yes	Yes	AP	1988/02/02	B BRAUN
020179	001	NDA	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	5GM/100ML	Prescription	Yes	Yes	AP	1992/12/07	BAXTER HLTHCARE

>>>活性成分:DEXTROSE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:10GM/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
016694	001	NDA	DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	10GM/100ML	Prescription	Yes	Yes	AP	Approved Prior to Jan 1, 1982	BAXTER HLTHCARE
018080	001	NDA	DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	10GM/100ML	Prescription	Yes	Yes	AP	Approved Prior to Jan 1, 1982	OTSUKA ICU MEDCL
019626	004	NDA	DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	10GM/100ML	Prescription	Yes	Yes	AP	1988/02/02	B BRAUN
209448	001	ANDA	DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	10GM/100ML	Prescription	No	No	AP	2018/07/16	FRESENIUS KABI USA

>>>活性成分:DEXTROSE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:70GM/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
018561	001	NDA	DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	70GM/100ML	Prescription	Yes	Yes	AP	1982/03/23	OTSUKA ICU MEDCL
019893	001	NDA	DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	70GM/100ML	Prescription	Yes	Yes	AP	1989/12/26	OTSUKA ICU MEDCL
020047	003	NDA	DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	70GM/100ML	Prescription	Yes	Yes	AP	1991/07/02	BAXTER HLTHCARE
019626	005	NDA	DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	70GM/100ML	Prescription	Yes	Yes	AP	2015/02/18	B BRAUN