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 |
2019/11/28 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2016/06/17 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/06/25 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2015/02/12 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/06/06 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2011/06/10 |
SUPPL-8(补充) |
Approval |
REMS |
N/A
|
|
|
2011/03/03 |
SUPPL-7(补充) |
Approval |
REMS |
N/A
|
|
|
2010/11/08 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/10/16 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/11/14 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
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: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 |
021911 |
002 |
NDA |
BANZEL |
RUFINAMIDE |
TABLET;ORAL |
200MG |
Prescription |
Yes |
No |
AB |
2008/11/14
|
EISAI INC |
204988 |
001 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2016/05/16
|
HIKMA |
205075 |
001 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2016/05/16
|
GLENMARK PHARMS LTD |
205095 |
001 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2016/05/16
|
MYLAN |
204993 |
001 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2021/05/11
|
HETERO LABS LTD III |
204964 |
002 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2022/08/17
|
LUPIN LTD |
216688 |
001 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2023/05/15
|
MICRO LABS |
217230 |
001 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2023/06/16
|
AUROBINDO PHARMA |
活性成分:RUFINAMIDE 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 |
021911 |
003 |
NDA |
BANZEL |
RUFINAMIDE |
TABLET;ORAL |
400MG |
Prescription |
Yes |
Yes |
AB |
2008/11/14
|
EISAI INC |
204988 |
002 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
TABLET;ORAL |
400MG |
Prescription |
No |
No |
AB |
2016/05/16
|
HIKMA |
205075 |
002 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
TABLET;ORAL |
400MG |
Prescription |
No |
No |
AB |
2016/05/16
|
GLENMARK PHARMS LTD |
205095 |
002 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
TABLET;ORAL |
400MG |
Prescription |
No |
No |
AB |
2016/05/16
|
MYLAN |
204993 |
002 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
TABLET;ORAL |
400MG |
Prescription |
No |
No |
AB |
2021/05/11
|
HETERO LABS LTD III |
204964 |
003 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
TABLET;ORAL |
400MG |
Prescription |
No |
No |
AB |
2022/08/17
|
LUPIN LTD |
216688 |
002 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
TABLET;ORAL |
400MG |
Prescription |
No |
No |
AB |
2023/05/15
|
MICRO LABS |
217230 |
002 |
ANDA |
RUFINAMIDE |
RUFINAMIDE |
TABLET;ORAL |
400MG |
Prescription |
No |
No |
AB |
2023/06/16
|
AUROBINDO PHARMA |