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 |
|---|
| 2023/10/06 |
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:ESLICARBAZEPINE ACETATE 剂型/给药途径:TABLET;ORAL 规格:200MG 治疗等效代码:AB
| 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 |
|---|
| 022416 |
001 |
NDA |
APTIOM |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
200MG |
Prescription |
Yes |
No |
AB |
2013/11/08
|
SUMITOMO PHARMA AM |
| 211238 |
001 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2021/06/29
|
DR REDDYS |
| 211186 |
001 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2023/08/03
|
HETERO LABS LTD V |
| 211199 |
001 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2023/10/06
|
ALKEM LABS LTD |
| 211236 |
001 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
200MG |
Discontinued |
No |
No |
AB |
2023/12/07
|
APOTEX |
| 211227 |
001 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
200MG |
Discontinued |
No |
No |
AB |
2024/02/27
|
TORRENT |
| 211246 |
001 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
200MG |
Discontinued |
No |
No |
AB |
2024/03/27
|
LUPIN LTD |
活性成分:ESLICARBAZEPINE ACETATE 剂型/给药途径:TABLET;ORAL 规格:400MG 治疗等效代码:AB
| 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 |
|---|
| 022416 |
002 |
NDA |
APTIOM |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
400MG |
Prescription |
Yes |
No |
AB |
2013/11/08
|
SUMITOMO PHARMA AM |
| 211238 |
002 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
400MG |
Prescription |
No |
No |
AB |
2021/06/29
|
DR REDDYS |
| 211186 |
002 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
400MG |
Prescription |
No |
No |
AB |
2023/08/03
|
HETERO LABS LTD V |
| 211199 |
002 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
400MG |
Prescription |
No |
No |
AB |
2023/10/06
|
ALKEM LABS LTD |
| 211236 |
002 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
400MG |
Discontinued |
No |
No |
AB |
2023/12/07
|
APOTEX |
| 211227 |
002 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
400MG |
Discontinued |
No |
No |
AB |
2024/02/27
|
TORRENT |
| 211246 |
002 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
400MG |
Discontinued |
No |
No |
AB |
2024/03/27
|
LUPIN LTD |
活性成分:ESLICARBAZEPINE ACETATE 剂型/给药途径:TABLET;ORAL 规格:600MG 治疗等效代码:AB
| 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 |
|---|
| 022416 |
003 |
NDA |
APTIOM |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
600MG |
Prescription |
Yes |
No |
AB |
2013/11/08
|
SUMITOMO PHARMA AM |
| 211238 |
003 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB |
2021/06/29
|
DR REDDYS |
| 211186 |
003 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB |
2023/08/03
|
HETERO LABS LTD V |
| 211199 |
003 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB |
2023/10/06
|
ALKEM LABS LTD |
| 211236 |
003 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
600MG |
Discontinued |
No |
No |
AB |
2023/12/07
|
APOTEX |
| 211227 |
003 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
600MG |
Discontinued |
No |
No |
AB |
2024/02/27
|
TORRENT |
| 211246 |
003 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
600MG |
Discontinued |
No |
No |
AB |
2024/03/27
|
LUPIN LTD |
活性成分:ESLICARBAZEPINE ACETATE 剂型/给药途径:TABLET;ORAL 规格:800MG 治疗等效代码:AB
| 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 |
|---|
| 022416 |
004 |
NDA |
APTIOM |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
800MG |
Prescription |
Yes |
Yes |
AB |
2013/11/08
|
SUMITOMO PHARMA AM |
| 211238 |
004 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
800MG |
Prescription |
No |
No |
AB |
2021/06/29
|
DR REDDYS |
| 211186 |
004 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
800MG |
Prescription |
No |
No |
AB |
2023/08/03
|
HETERO LABS LTD V |
| 211199 |
004 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
800MG |
Prescription |
No |
No |
AB |
2023/10/06
|
ALKEM LABS LTD |
| 211236 |
004 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
800MG |
Discontinued |
No |
No |
AB |
2023/12/07
|
APOTEX |
| 211227 |
004 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
800MG |
Discontinued |
No |
No |
AB |
2024/02/27
|
TORRENT |
| 211246 |
004 |
ANDA |
ESLICARBAZEPINE ACETATE |
ESLICARBAZEPINE ACETATE |
TABLET;ORAL |
800MG |
Discontinued |
No |
No |
AB |
2024/03/27
|
LUPIN LTD |