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 |
|---|
| 2023/05/23 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/11/20 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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:ZOLMITRIPTAN 剂型/给药途径:TABLET;ORAL 规格:2.5MG 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 |
|---|
| 020768 |
001 |
NDA |
ZOMIG |
ZOLMITRIPTAN |
TABLET;ORAL |
2.5MG |
Discontinued |
Yes |
No |
AB |
1997/11/25
|
IPR |
| 201779 |
001 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2013/05/14
|
GLENMARK PHARMS LTD |
| 204284 |
001 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
2.5MG |
Discontinued |
No |
No |
AB |
2014/04/09
|
INVAGEN PHARMS |
| 202279 |
001 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2014/11/20
|
JUBILANT GENERICS |
| 204232 |
001 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2015/09/30
|
ALEMBIC |
| 207021 |
001 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2016/05/11
|
AUROBINDO PHARMA |
| 204041 |
001 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2016/05/20
|
AJANTA PHARMA LTD |
| 207867 |
001 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2017/02/27
|
PLD ACQUISITIONS LLC |
| 206973 |
001 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2017/06/30
|
SOMERSET THERAPS LLC |
| 203019 |
001 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2018/07/11
|
ZYDUS PHARMS |
| 203726 |
001 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2019/10/21
|
ORBION PHARMS |
活性成分:ZOLMITRIPTAN 剂型/给药途径:TABLET;ORAL 规格:5MG 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 |
|---|
| 020768 |
002 |
NDA |
ZOMIG |
ZOLMITRIPTAN |
TABLET;ORAL |
5MG |
Discontinued |
Yes |
No |
AB |
1997/11/25
|
IPR |
| 201779 |
002 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2013/05/14
|
GLENMARK PHARMS LTD |
| 204284 |
002 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
5MG |
Discontinued |
No |
No |
AB |
2014/04/09
|
INVAGEN PHARMS |
| 202279 |
002 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2014/11/20
|
JUBILANT GENERICS |
| 204232 |
002 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2015/09/30
|
ALEMBIC |
| 207021 |
002 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2016/05/11
|
AUROBINDO PHARMA |
| 204041 |
002 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
5MG |
Prescription |
No |
Yes |
AB |
2016/05/20
|
AJANTA PHARMA LTD |
| 207867 |
002 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2017/02/27
|
PLD ACQUISITIONS LLC |
| 206973 |
002 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2017/06/30
|
SOMERSET THERAPS LLC |
| 203019 |
002 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2018/07/11
|
ZYDUS PHARMS |
| 203726 |
002 |
ANDA |
ZOLMITRIPTAN |
ZOLMITRIPTAN |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2019/10/21
|
ORBION PHARMS |