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 |
|---|
| 2024/02/08 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/02/08 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/02/08 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/02/08 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/02/08 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/10/06 |
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:DIMETHYL FUMARATE 剂型/给药途径:CAPSULE, DELAYED RELEASE;ORAL 规格:120MG 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 |
|---|
| 204063 |
001 |
NDA |
TECFIDERA |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
120MG |
Prescription |
Yes |
No |
AB |
2013/03/27
|
BIOGEN INC |
| 210531 |
001 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2020/08/17
|
MYLAN |
| 210440 |
001 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2020/09/24
|
ALKEM LABS LTD |
| 210460 |
001 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2020/09/24
|
MSN |
| 210499 |
001 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2020/09/24
|
ACCORD HLTHCARE |
| 210500 |
001 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2020/09/24
|
HETERO LABS LTD III |
| 210305 |
001 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2020/09/24
|
CIPLA |
| 210402 |
001 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2020/09/24
|
AMNEAL |
| 210226 |
001 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2020/10/05
|
LUPIN |
| 210309 |
001 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2020/10/06
|
GLENMARK PHARMS LTD |
| 210382 |
001 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2020/10/14
|
TWI PHARMS |
| 210436 |
001 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2021/03/26
|
SOLA PHARMS |
| 210285 |
001 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
120MG |
Discontinued |
No |
No |
AB |
2021/12/21
|
SAWAI USA |
| 210414 |
001 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2022/10/18
|
PRINSTON INC |
| 210385 |
001 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2022/12/22
|
AUROBINDO PHARMA |
| 210377 |
001 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2024/06/26
|
MACLEODS PHARMS LTD |
活性成分:DIMETHYL FUMARATE 剂型/给药途径:CAPSULE, DELAYED RELEASE;ORAL 规格:240MG 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 |
|---|
| 204063 |
002 |
NDA |
TECFIDERA |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
240MG |
Prescription |
Yes |
Yes |
AB |
2013/03/27
|
BIOGEN INC |
| 210531 |
002 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB |
2020/08/17
|
MYLAN |
| 210440 |
002 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB |
2020/09/24
|
ALKEM LABS LTD |
| 210460 |
002 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB |
2020/09/24
|
MSN |
| 210499 |
002 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB |
2020/09/24
|
ACCORD HLTHCARE |
| 210500 |
002 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB |
2020/09/24
|
HETERO LABS LTD III |
| 210305 |
002 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB |
2020/09/24
|
CIPLA |
| 210402 |
002 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB |
2020/09/24
|
AMNEAL |
| 210226 |
002 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB |
2020/10/05
|
LUPIN |
| 210309 |
002 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB |
2020/10/06
|
GLENMARK PHARMS LTD |
| 210382 |
002 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB |
2020/10/14
|
TWI PHARMS |
| 210436 |
002 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB |
2021/03/26
|
SOLA PHARMS |
| 210285 |
002 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
240MG |
Discontinued |
No |
No |
AB |
2021/12/21
|
SAWAI USA |
| 210414 |
002 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB |
2022/10/18
|
PRINSTON INC |
| 210385 |
002 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB |
2022/12/22
|
AUROBINDO PHARMA |
| 210377 |
002 |
ANDA |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB |
2024/06/26
|
MACLEODS PHARMS LTD |
