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 |
|---|
| 2012/10/03 |
ORIG-1（原始申请） |
Approval |
Not Applicable |
|
|
|
>>>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 |
|---|
| 2025/04/03 |
SUPPL-9（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2020/10/28 |
SUPPL-5（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2020/10/28 |
SUPPL-4（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2015/07/24 |
SUPPL-3（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2015/07/24 |
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:SUSPENSION;ORAL; 规格:300MG/5ML; 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 |
|---|
| 021285 |
001 |
NDA |
TRILEPTAL |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
Yes |
Yes |
AB |
2001/05/25
|
NOVARTIS |
| 078734 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2009/06/26
|
SUN PHARM INDS LTD |
| 202961 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2012/09/17
|
AMNEAL PHARMS |
| 201193 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Discontinued |
No |
No |
AB |
2012/10/03
|
HIKMA |
| 212428 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2021/06/21
|
CHARTWELL RX |
| 211420 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Discontinued |
No |
No |
AB |
2021/07/09
|
PAI HOLDINGS |
| 215726 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2022/08/30
|
RUBICON RESEARCH |
| 209652 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2022/11/04
|
BIONPHARMA |
| 215332 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2022/11/30
|
AUCTA |
| 213183 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2023/03/18
|
ALKEM LABS LTD |
| 216749 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2023/10/20
|
HETERO LABS LTD III |
| 217782 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2024/02/14
|
KANCHAN HLTHCARE |
| 218278 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2024/03/01
|
BIOCON PHARMA |
| 207300 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2025/07/11
|
MACLEODS PHARMS LTD |