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 |
|---|
| 2020/08/25 |
SUPPL-17（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/08/25 |
SUPPL-15（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/08/25 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/01/20 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/01/20 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/01/19 |
SUPPL-5（补充） |
Approval |
REMS |
|
|
|
| 2011/12/28 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 2010/06/29 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 2007/10/09 |
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:OXCARBAZEPINE 剂型/给药途径:TABLET;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 |
|---|
| 021014 |
001 |
NDA |
TRILEPTAL |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Prescription |
Yes |
No |
AB |
2000/01/14
|
NOVARTIS |
| 077794 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2007/10/09
|
SUN PHARM INDS |
| 077802 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2007/10/09
|
GLENMARK PHARMS LTD |
| 077801 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2007/11/15
|
TARO |
| 078069 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2008/01/11
|
BRECKENRIDGE PHARM |
| 077747 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2008/04/09
|
RUBICON |
| 215939 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2022/01/11
|
ANNORA PHARMA |
| 211747 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Discontinued |
No |
No |
AB |
2023/07/03
|
ZYDUS |
| 207717 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2024/03/05
|
RUBICON |
活性成分:OXCARBAZEPINE 剂型/给药途径:TABLET;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 |
|---|
| 021014 |
002 |
NDA |
TRILEPTAL |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Prescription |
Yes |
No |
AB |
2000/01/14
|
NOVARTIS |
| 077794 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2007/10/09
|
SUN PHARM INDS |
| 077802 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2007/10/09
|
GLENMARK PHARMS LTD |
| 077801 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2007/11/15
|
TARO |
| 078069 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2008/01/11
|
BRECKENRIDGE PHARM |
| 077747 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2008/04/09
|
RUBICON |
| 215939 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2022/01/11
|
ANNORA PHARMA |
| 211747 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Discontinued |
No |
No |
AB |
2023/07/03
|
ZYDUS |
| 207717 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2024/03/05
|
RUBICON |
活性成分:OXCARBAZEPINE 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 |
|---|
| 021014 |
003 |
NDA |
TRILEPTAL |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Prescription |
Yes |
Yes |
AB |
2000/01/14
|
NOVARTIS |
| 077794 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB |
2007/10/09
|
SUN PHARM INDS |
| 077802 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB |
2007/10/09
|
GLENMARK PHARMS LTD |
| 077801 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB |
2007/11/15
|
TARO |
| 078069 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB |
2008/01/11
|
BRECKENRIDGE PHARM |
| 077747 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB |
2008/04/09
|
RUBICON |
| 215939 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB |
2022/01/11
|
ANNORA PHARMA |
| 211747 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Discontinued |
No |
No |
AB |
2023/07/03
|
ZYDUS |
| 207717 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB |
2024/03/05
|
RUBICON |
