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 |
|---|
| 2023/05/30 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2019/11/28 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
| 2015/10/06 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2015/06/25 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
| 2015/02/12 |
SUPPL-3（补充） |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
| 2015/01/05 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2011/06/10 |
SUPPL-1（补充） |
Approval |
REMS |
N/A
;Orphan
|
|
|
| 2011/03/03 |
ORIG-1（原始申请） |
Approval |
Type 3 - New Dosage Form |
STANDARD
;Orphan
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
与本品治疗等效的药品
活性成分:RUFINAMIDE 剂型/给药途径:SUSPENSION;ORAL 规格:40MG/ML 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 |
|---|
| 201367 |
001 |
NDA |
BANZEL |
RUFINAMIDE |
SUSPENSION;ORAL |
40MG/ML |
Prescription |
Yes |
Yes |
AB |
2011/03/03
|
EISAI INC |
| 207363 |
001 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
SUSPENSION;ORAL |
40MG/ML |
Prescription |
No |
No |
AB |
2019/04/23
|
HIKMA |
| 211388 |
001 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
SUSPENSION;ORAL |
40MG/ML |
Prescription |
No |
No |
AB |
2019/04/23
|
BIONPHARMA |
| 213457 |
001 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
SUSPENSION;ORAL |
40MG/ML |
Prescription |
No |
No |
AB |
2020/12/18
|
LUPIN LTD |
| 213410 |
001 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
SUSPENSION;ORAL |
40MG/ML |
Prescription |
No |
No |
AB |
2021/02/23
|
ALKEM LABS LTD |
| 216549 |
001 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
SUSPENSION;ORAL |
40MG/ML |
Prescription |
No |
No |
AB |
2022/10/26
|
AUROBINDO PHARMA |
| 214009 |
001 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
SUSPENSION;ORAL |
40MG/ML |
Prescription |
No |
No |
AB |
2022/11/07
|
CHARTWELL RX |
| 216841 |
001 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
SUSPENSION;ORAL |
40MG/ML |
Prescription |
No |
No |
AB |
2023/12/05
|
HETERO LABS LTD III |
