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 |
|---|
| 2023/02/22 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/03/31 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/03/31 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/11/24 |
ORIG-1（原始申请） |
Approval |
|
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 |
|---|
| 无 |
与本品治疗等效的药品
活性成分:SUCCINYLCHOLINE CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:20MG/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 |
|---|
| 008453 |
002 |
NDA |
ANECTINE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
SANDOZ |
| 008845 |
006 |
NDA |
QUELICIN |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
HOSPIRA |
| 209467 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
Yes |
AP |
2018/05/04
|
ZYDUS PHARMS |
| 210231 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2018/06/04
|
AMRING PHARMS |
| 211432 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2018/11/16
|
AMNEAL |
| 210698 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2019/08/02
|
DR REDDYS |
| 212638 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Discontinued |
No |
No |
AP |
2019/10/09
|
BRECKENRIDGE |
| 211589 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2020/01/15
|
SOMERSET THERAPS LLC |
| 213810 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2020/05/04
|
ASPIRO |
| 211625 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2020/05/19
|
UMEDICA |
| 213705 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Discontinued |
No |
No |
AP |
2020/05/20
|
ACCORD HLTHCARE |
| 214308 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2020/05/22
|
ADAPTIS |
| 213229 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2020/06/12
|
HIKMA |
| 214246 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2020/06/16
|
GLAND PHARMA LTD |
| 213552 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Discontinued |
No |
No |
AP |
2020/10/27
|
NEXUS |
| 211346 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2020/11/20
|
FRESENIUS KABI USA |
| 214879 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2020/11/24
|
MICRO LABS |
| 214491 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2020/12/21
|
DEVA HOLDING AS |
| 215022 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2021/03/29
|
SAGENT PHARMS INC |
| 214514 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2021/10/19
|
MEITHEAL |
| 216003 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2022/02/07
|
BE PHARMS |
| 216127 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Discontinued |
No |
No |
AP |
2023/02/02
|
MANKIND PHARMA |
| 217808 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Discontinued |
No |
No |
AP |
2023/10/16
|
EUGIA PHARMA |
| 218878 |
001 |
ANDA |
SUCCINYLCHOLINE CHLORIDE |
SUCCINYLCHOLINE CHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2024/09/24
|
BAXTER HLTHCARE CORP |