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 |
|---|
| 2023/03/28 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/05/03 |
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:LACOSAMIDE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:200MG/20ML (10MG/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 |
|---|
| 218464 |
001 |
ANDA |
LACOSAMIDE |
LACOSAMIDE |
SOLUTION;INTRAVENOUS |
200MG/20ML (10MG/ML) |
Prescription |
No |
No |
AP |
--
|
ACELLA |
| 022254 |
001 |
NDA |
VIMPAT |
LACOSAMIDE |
SOLUTION;INTRAVENOUS |
200MG/20ML (10MG/ML) |
Prescription |
Yes |
Yes |
AP |
2008/10/28
|
UCB INC |
| 214301 |
001 |
ANDA |
LACOSAMIDE |
LACOSAMIDE |
SOLUTION;INTRAVENOUS |
200MG/20ML (10MG/ML) |
Prescription |
No |
No |
AP |
2022/04/07
|
INDOCO |
| 214677 |
001 |
ANDA |
LACOSAMIDE |
LACOSAMIDE |
SOLUTION;INTRAVENOUS |
200MG/20ML (10MG/ML) |
Prescription |
No |
No |
AP |
2022/05/03
|
FRESENIUS KABI USA |
| 209465 |
001 |
ANDA |
LACOSAMIDE |
LACOSAMIDE |
SOLUTION;INTRAVENOUS |
200MG/20ML (10MG/ML) |
Prescription |
No |
No |
AP |
2022/06/29
|
ZYDUS PHARMS |
| 216335 |
001 |
ANDA |
LACOSAMIDE |
LACOSAMIDE |
SOLUTION;INTRAVENOUS |
200MG/20ML (10MG/ML) |
Prescription |
No |
No |
AP |
2022/09/14
|
ASPIRO |
| 215628 |
001 |
ANDA |
LACOSAMIDE |
LACOSAMIDE |
SOLUTION;INTRAVENOUS |
200MG/20ML (10MG/ML) |
Prescription |
No |
No |
AP |
2022/09/19
|
GLAND PHARMA LTD |
| 215979 |
001 |
ANDA |
LACOSAMIDE |
LACOSAMIDE |
SOLUTION;INTRAVENOUS |
200MG/20ML (10MG/ML) |
Prescription |
No |
No |
AP |
2023/02/09
|
MSN |
| 216670 |
001 |
ANDA |
LACOSAMIDE |
LACOSAMIDE |
SOLUTION;INTRAVENOUS |
200MG/20ML (10MG/ML) |
Prescription |
No |
No |
AP |
2023/11/13
|
APOTEX |
| 217311 |
001 |
ANDA |
LACOSAMIDE |
LACOSAMIDE |
SOLUTION;INTRAVENOUS |
200MG/20ML (10MG/ML) |
Prescription |
No |
No |
AP |
2024/02/13
|
HAINAN POLY |
| 217718 |
001 |
ANDA |
LACOSAMIDE |
LACOSAMIDE |
SOLUTION;INTRAVENOUS |
200MG/20ML (10MG/ML) |
Prescription |
No |
No |
AP |
2024/03/25
|
DR REDDYS |
| 216806 |
001 |
ANDA |
LACOSAMIDE |
LACOSAMIDE |
SOLUTION;INTRAVENOUS |
200MG/20ML (10MG/ML) |
Prescription |
No |
No |
AP |
2024/04/05
|
HIKMA |
| 214960 |
001 |
ANDA |
LACOSAMIDE |
LACOSAMIDE |
SOLUTION;INTRAVENOUS |
200MG/20ML (10MG/ML) |
Prescription |
No |
No |
AP |
2024/10/09
|
SOMERSET THERAPS LLC |