NIMBEX-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	NIMBEX	CISATRACURIUM BESYLATE	INJECTABLE;INJECTION	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	AP	1995/12/15	1995/12/15	Discontinued
002	NIMBEX PRESERVATIVE FREE	CISATRACURIUM BESYLATE	INJECTABLE;INJECTION	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	AP		1995/12/15	Discontinued
003	NIMBEX PRESERVATIVE FREE	CISATRACURIUM BESYLATE	INJECTABLE;INJECTION	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	AP		1995/12/15	Discontinued

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
1995/12/15	ORIG-1（原始申请）	Approval	Type 2 - New Active Ingredient	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
2022/10/14	SUPPL-28（补充）	Approval	Labeling-Package Insert	STANDARD	Letter Label
2022/10/07	SUPPL-29（补充）	Approval	Labeling-Package Insert	STANDARD
2018/07/26	SUPPL-26（补充）	Approval	Labeling-Container/Carton Labels	STANDARD	Label Letter
2018/07/26	SUPPL-20（补充）	Approval	Labeling-Package Insert	STANDARD	Label Letter
2013/04/01	SUPPL-23（补充）	Approval	Manufacturing (CMC)	STANDARD
2010/11/22	SUPPL-19（补充）	Approval	Labeling	901 REQUIRED	Letter Label
2010/06/02	SUPPL-17（补充）	Approval	Labeling-Container/Carton Labels	STANDARD	Letter
2003/07/18	SUPPL-9（补充）	Approval	Efficacy-Labeling Change With Clinical Data	STANDARD	Letter
2002/10/15	SUPPL-11（补充）	Approval	Manufacturing (CMC)	STANDARD
2002/06/04	SUPPL-10（补充）	Approval	Manufacturing (CMC)	STANDARD	Letter
2000/02/25	SUPPL-8（补充）	Approval	Labeling	STANDARD
2000/02/25	SUPPL-7（补充）	Approval	Labeling	STANDARD
1999/05/21	SUPPL-5（补充）	Approval	Labeling	STANDARD
1999/05/21	SUPPL-4（补充）	Approval	Labeling	STANDARD
1999/03/26	SUPPL-6（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1998/10/15	SUPPL-3（补充）	Approval	Efficacy-Labeling Change With Clinical Data	STANDARD
1998/06/19	SUPPL-2（补充）	Approval	Labeling	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	专利用途代码	专利下载	备注
001	5453510	2012/09/26	U-127	PDF格式	本条是由Drugfuture回溯的历史信息
002	5453510	2012/09/26	U-127	PDF格式	本条是由Drugfuture回溯的历史信息
003	5453510	2012/09/26	U-127	PDF格式	本条是由Drugfuture回溯的历史信息

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:CISATRACURIUM BESYLATE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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
020551	001	NDA	NIMBEX	CISATRACURIUM BESYLATE	INJECTABLE;INJECTION	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	Yes	No	AP	1995/12/15	ABBVIE
020551	003	NDA	NIMBEX PRESERVATIVE FREE	CISATRACURIUM BESYLATE	INJECTABLE;INJECTION	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	Yes	No	AP	1995/12/15	ABBVIE

>>>活性成分:CISATRACURIUM BESYLATE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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
020551	002	NDA	NIMBEX PRESERVATIVE FREE	CISATRACURIUM BESYLATE	INJECTABLE;INJECTION	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	Yes	No	AP	1995/12/15	ABBVIE

>>>活性成分:CISATRACURIUM BESYLATE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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
020551	001	NDA	NIMBEX	CISATRACURIUM BESYLATE	INJECTABLE;INJECTION	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	Yes	No	AP	1995/12/15	ABBVIE
020551	003	NDA	NIMBEX PRESERVATIVE FREE	CISATRACURIUM BESYLATE	INJECTABLE;INJECTION	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	Yes	No	AP	1995/12/15	ABBVIE