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 |
|---|
| 2023/04/06 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/06/28 |
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 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 |
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
|
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 |
No |
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 HLTHCARE UK |
| 215516 |
002 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AP |
2022/05/24
|
PIRAMAL CRITICAL |
| 203078 |
001 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AP |
2022/06/28
|
HIKMA |
| 217725 |
002 |
ANDA |
CISATRACURIUM BESYLATE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AP |
2023/06/09
|
CAPLIN |