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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2024/02/22 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2024/11/21 |
SUPPL-1（补充） |
Approval |
Labeling-Package Insert |
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:OXCARBAZEPINE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:150MG; 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 |
|---|
| 202810 |
001 |
NDA |
OXTELLAR XR |
OXCARBAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
150MG |
Prescription |
Yes |
No |
AB |
2012/10/19
|
SUPERNUS PHARMS |
| 213369 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
150MG |
Prescription |
No |
No |
AB |
2023/07/13
|
APOTEX |
| 217659 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
150MG |
Prescription |
No |
No |
AB |
2024/02/22
|
AJANTA PHARMA LTD |
| 215796 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
150MG |
Prescription |
No |
No |
AB |
2024/11/22
|
RICONPHARMA LLC |
| 219241 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
150MG |
Discontinued |
No |
No |
AB |
2025/04/30
|
AUROBINDO PHARMA LTD |
>>>活性成分:OXCARBAZEPINE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:300MG; 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 |
|---|
| 202810 |
002 |
NDA |
OXTELLAR XR |
OXCARBAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
Yes |
No |
AB |
2012/10/19
|
SUPERNUS PHARMS |
| 213369 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2023/07/13
|
APOTEX |
| 217659 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2024/02/22
|
AJANTA PHARMA LTD |
| 215796 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2024/11/22
|
RICONPHARMA LLC |
| 219241 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Discontinued |
No |
No |
AB |
2025/04/30
|
AUROBINDO PHARMA LTD |
>>>活性成分:OXCARBAZEPINE; 剂型/给药途径:TABLET, EXTENDED RELEASE;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 |
|---|
| 202810 |
003 |
NDA |
OXTELLAR XR |
OXCARBAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
600MG |
Prescription |
Yes |
Yes |
AB |
2012/10/19
|
SUPERNUS PHARMS |
| 213369 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
600MG |
Prescription |
No |
No |
AB |
2023/07/13
|
APOTEX |
| 217659 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
600MG |
Prescription |
No |
No |
AB |
2024/02/22
|
AJANTA PHARMA LTD |
| 215796 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
600MG |
Prescription |
No |
No |
AB |
2024/11/22
|
RICONPHARMA LLC |
| 219241 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
600MG |
Discontinued |
No |
No |
AB |
2025/04/30
|
AUROBINDO PHARMA LTD |