药品注册申请号:020551
申请类型:NDA (新药申请)
申请人:ABBVIE
申请人全名:ABBVIE INC
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 Yes Yes AP 1995/12/15 1995/12/15 Prescription
002 NIMBEX PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Yes Yes AP 1995/12/15 Prescription
003 NIMBEX PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Yes Yes AP 1995/12/15 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2018/07/26 SUPPL 26 Approval Labeling STANDARD
2018/07/26 SUPPL 20 Approval Labeling STANDARD
2013/04/01 SUPPL 23 Approval Manufacturing (CMC) STANDARD
2010/11/22 SUPPL 19 Approval Labeling 901 REQUIRED
2010/06/02 SUPPL 17 Approval Labeling STANDARD
2003/07/18 SUPPL 9 Approval Efficacy STANDARD
2002/10/15 SUPPL 11 Approval Manufacturing (CMC) STANDARD
2002/06/04 SUPPL 10 Approval Manufacturing (CMC) STANDARD
2000/02/25 SUPPL 8 Approval Labeling STANDARD
2000/02/25 SUPPL 7 Approval Labeling STANDARD
1999/05/21 SUPPL 5 Approval Labeling STANDARD
1999/05/21 SUPPL 4 Approval Labeling STANDARD
1999/03/26 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1998/10/15 SUPPL 3 Approval Efficacy STANDARD
1998/06/19 SUPPL 2 Approval Labeling STANDARD
1995/12/15 ORIG 1 Approval Type 2 - New Active Ingredient 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
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
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 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RLDRSTE Code产品号批准日期申请人
020551 001 NDA NIMBEX CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription Yes Yes AP 1995/12/15 ABBVIE
020551 003 NDA NIMBEX PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription Yes Yes AP 1995/12/15 ABBVIE
200154 001 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2012/02/03 SANDOZ INC
200159 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2012/02/03 SANDOZ INC
203182 001 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2015/02/26 FRESENIUS KABI USA
203183 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2015/02/26 FRESENIUS KABI USA
204960 001 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2017/01/27 JIANGSU HENGRUI MED
209334 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2017/08/30 JIANGSU HENGRUI MED
206791 001 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2019/02/20 SOMERSET THERAPS LLC
209132 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2019/04/24 SOMERSET
211668 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2019/04/25 NANJING KING-FRIEND
211669 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2019/04/25 NANJING KING-FRIEND
212171 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2019/11/04 ZYDUS PHARMS
活性成分:CISATRACURIUM BESYLATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 10MG BASE/ML 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RLDRSTE 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 Prescription Yes Yes AP 1995/12/15 ABBVIE
200154 002 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2012/02/03 SANDOZ INC
203182 002 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2015/02/26 FRESENIUS KABI USA
204960 002 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2017/09/19 JIANGSU HENGRUI MED
206791 002 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2019/02/20 SOMERSET THERAPS LLC
211668 002 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2019/04/25 NANJING KING-FRIEND
212171 002 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2019/11/04 ZYDUS PHARMS
活性成分:CISATRACURIUM BESYLATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 2MG BASE/ML 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RLDRSTE Code产品号批准日期申请人
020551 001 NDA NIMBEX CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription Yes Yes AP 1995/12/15 ABBVIE
020551 003 NDA NIMBEX PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription Yes Yes AP 1995/12/15 ABBVIE
200154 001 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2012/02/03 SANDOZ INC
200159 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2012/02/03 SANDOZ INC
203182 001 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2015/02/26 FRESENIUS KABI USA
203183 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2015/02/26 FRESENIUS KABI USA
204960 001 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2017/01/27 JIANGSU HENGRUI MED
209334 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2017/08/30 JIANGSU HENGRUI MED
206791 001 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2019/02/20 SOMERSET THERAPS LLC
209132 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2019/04/24 SOMERSET
211668 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2019/04/25 NANJING KING-FRIEND
211669 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2019/04/25 NANJING KING-FRIEND
212171 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2019/11/04 ZYDUS PHARMS
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