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 |
|---|
| 2023/01/05 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/01/05 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/04/07 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/08/13 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/11/29 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/11/15 |
ORIG-1（原始申请） |
Approval |
|
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:TERIFLUNOMIDE 剂型/给药途径:TABLET;ORAL 规格:7MG 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 |
|---|
| 202992 |
001 |
NDA |
AUBAGIO |
TERIFLUNOMIDE |
TABLET;ORAL |
7MG |
Prescription |
Yes |
No |
AB |
2012/09/12
|
SANOFI AVENTIS US |
| 209700 |
001 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
7MG |
Prescription |
No |
No |
AB |
2018/09/04
|
TEVA PHARMS USA |
| 209613 |
001 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
7MG |
Discontinued |
No |
No |
AB |
2018/09/28
|
AMNEAL PHARMS CO |
| 209638 |
001 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
7MG |
Prescription |
No |
No |
AB |
2018/10/26
|
AUROBINDO PHARMA |
| 209601 |
001 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
7MG |
Prescription |
No |
No |
AB |
2018/11/02
|
APOTEX |
| 209663 |
001 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
7MG |
Prescription |
No |
No |
AB |
2018/11/15
|
GLENMARK SPECLT |
| 209668 |
001 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
7MG |
Prescription |
No |
No |
AB |
2018/11/30
|
ZYDUS PHARMS |
| 209710 |
001 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
7MG |
Prescription |
No |
No |
AB |
2019/01/03
|
SANDOZ |
| 209690 |
001 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
7MG |
Prescription |
No |
No |
AB |
2019/01/07
|
ACCORD HLTHCARE |
| 209572 |
001 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
7MG |
Prescription |
No |
No |
AB |
2019/04/19
|
ALEMBIC |
| 209623 |
001 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
7MG |
Prescription |
No |
No |
AB |
2019/04/24
|
MSN |
| 209702 |
001 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
7MG |
Discontinued |
No |
No |
AB |
2020/02/28
|
MYLAN |
| 209639 |
001 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
7MG |
Prescription |
No |
No |
AB |
2023/03/13
|
BIOCON PHARMA |
| 209598 |
001 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
7MG |
Prescription |
No |
No |
AB |
2023/03/13
|
HETERO LABS LTD V |
| 209555 |
001 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
7MG |
Prescription |
No |
No |
AB |
2023/05/15
|
NATCO |
| 209677 |
002 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
7MG |
Prescription |
No |
No |
AB |
2023/09/28
|
SOLA PHARMS |
| 209697 |
001 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
7MG |
Discontinued |
No |
No |
AB |
2024/04/04
|
TORRENT |
活性成分:TERIFLUNOMIDE 剂型/给药途径:TABLET;ORAL 规格:14MG 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 |
|---|
| 202992 |
002 |
NDA |
AUBAGIO |
TERIFLUNOMIDE |
TABLET;ORAL |
14MG |
Prescription |
Yes |
Yes |
AB |
2012/09/12
|
SANOFI AVENTIS US |
| 209700 |
002 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
14MG |
Prescription |
No |
No |
AB |
2018/09/04
|
TEVA PHARMS USA |
| 209613 |
002 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
14MG |
Discontinued |
No |
No |
AB |
2018/09/28
|
AMNEAL PHARMS CO |
| 209638 |
002 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
14MG |
Prescription |
No |
No |
AB |
2018/10/26
|
AUROBINDO PHARMA |
| 209601 |
002 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
14MG |
Prescription |
No |
No |
AB |
2018/11/02
|
APOTEX |
| 209663 |
002 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
14MG |
Prescription |
No |
No |
AB |
2018/11/15
|
GLENMARK SPECLT |
| 209668 |
002 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
14MG |
Prescription |
No |
No |
AB |
2018/11/30
|
ZYDUS PHARMS |
| 209710 |
002 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
14MG |
Prescription |
No |
No |
AB |
2019/01/03
|
SANDOZ |
| 209690 |
002 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
14MG |
Prescription |
No |
No |
AB |
2019/01/07
|
ACCORD HLTHCARE |
| 209572 |
002 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
14MG |
Prescription |
No |
No |
AB |
2019/04/19
|
ALEMBIC |
| 209623 |
002 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
14MG |
Prescription |
No |
No |
AB |
2019/04/24
|
MSN |
| 209702 |
002 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
14MG |
Discontinued |
No |
No |
AB |
2020/02/28
|
MYLAN |
| 209677 |
001 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
14MG |
Prescription |
No |
No |
AB |
2020/06/17
|
SOLA PHARMS |
| 209639 |
002 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
14MG |
Prescription |
No |
No |
AB |
2023/03/13
|
BIOCON PHARMA |
| 209598 |
002 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
14MG |
Prescription |
No |
No |
AB |
2023/03/13
|
HETERO LABS LTD V |
| 209555 |
002 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
14MG |
Prescription |
No |
No |
AB |
2023/05/15
|
NATCO |
| 209697 |
002 |
ANDA |
TERIFLUNOMIDE |
TERIFLUNOMIDE |
TABLET;ORAL |
14MG |
Discontinued |
No |
No |
AB |
2024/04/04
|
TORRENT |