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 | 备注 |
2023/02/06 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/02/06 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/07/31 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/01/27 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
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 | 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 |
Discontinued |
Yes |
No |
AP |
1995/12/15
|
ABBVIE |
020551 |
003 |
NDA |
NIMBEX PRESERVATIVE FREE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML |
Discontinued |
Yes |
No |
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
|
HENGRUI PHARMA |
209334 |
001 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML |
Prescription |
No |
No |
AP |
2017/08/30
|
HENGRUI PHARMA |
203236 |
001 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML |
Prescription |
No |
No |
AP |
2018/03/30
|
HOSPIRA |
203238 |
001 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML |
Prescription |
No |
No |
AP |
2018/03/30
|
HOSPIRA |
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 |
Yes |
AP |
2019/04/25
|
MEITHEAL |
211669 |
001 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML |
Prescription |
No |
Yes |
AP |
2019/04/25
|
MEITHEAL |
212171 |
001 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML |
Prescription |
No |
No |
AP |
2019/11/04
|
ZYDUS PHARMS |
209144 |
001 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML |
Prescription |
No |
No |
AP |
2020/05/08
|
EUGIA PHARMA |
209665 |
001 |
ANDA |
CISATRACURIUM BESYLATE PRESERVATIVE FREE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML |
Prescription |
No |
No |
AP |
2020/10/27
|
EUGIA PHARMA |
201836 |
001 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML |
Prescription |
No |
No |
AP |
2020/11/06
|
SAGENT PHARMS INC |
201851 |
001 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML |
Prescription |
No |
No |
AP |
2020/11/06
|
SAGENT PHARMS INC |
212432 |
001 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML |
Discontinued |
No |
No |
AP |
2022/03/11
|
PIRAMAL |
215516 |
001 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML |
Prescription |
No |
No |
AP |
2022/05/24
|
PIRAMAL CRITICAL |
203078 |
001 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML |
Prescription |
No |
No |
AP |
2022/06/28
|
HIKMA |
215516 |
003 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML |
Prescription |
No |
No |
AP |
2022/12/14
|
PIRAMAL CRITICAL |
203079 |
001 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML |
Prescription |
No |
No |
AP |
2023/04/19
|
HIKMA |
217725 |
001 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML |
Prescription |
No |
No |
AP |
2023/06/09
|
CAPLIN |
216538 |
001 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML |
Prescription |
No |
No |
AP |
2024/03/08
|
HAINAN POLY |
216539 |
001 |
ANDA |
CISATRACURIUM BESYLATE PRESERVATIVE FREE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML |
Prescription |
No |
No |
AP |
2024/08/27
|
HAINAN POLY |
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 | 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 |
Discontinued |
Yes |
No |
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
|
HENGRUI PHARMA |
203236 |
002 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AP |
2018/03/30
|
HOSPIRA |
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 |
Yes |
AP |
2019/04/25
|
MEITHEAL |
212171 |
002 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AP |
2019/11/04
|
ZYDUS PHARMS |
201836 |
002 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AP |
2020/11/06
|
SAGENT PHARMS INC |
212432 |
002 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 10MG BASE/ML |
Discontinued |
No |
No |
AP |
2022/03/11
|
PIRAMAL |
215516 |
002 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AP |
2022/05/24
|
PIRAMAL CRITICAL |
217725 |
002 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AP |
2023/06/09
|
CAPLIN |
203078 |
002 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AP |
2023/12/18
|
HIKMA |
216539 |
002 |
ANDA |
CISATRACURIUM BESYLATE PRESERVATIVE FREE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AP |
2024/08/27
|
HAINAN POLY |