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 |
2022/10/18 |
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 |