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 |
|---|
| 2024/05/30 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/08/15 |
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:TOPIRAMATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:25MG 治疗等效代码:AB1
| 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 |
|---|
| 201635 |
001 |
NDA |
TROKENDI XR |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
Yes |
No |
AB1 |
2013/08/16
|
SUPERNUS PHARMS |
| 207382 |
001 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB1 |
2017/11/24
|
ZYDUS |
| 206210 |
001 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB1 |
2023/03/10
|
ACTAVIS LABS FL |
| 205976 |
002 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB1 |
2023/05/04
|
ENDO OPERATIONS |
| 217248 |
001 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB1 |
2023/06/20
|
ALKEM LABS LTD |
| 215663 |
001 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Discontinued |
No |
No |
AB1 |
2023/08/15
|
AJANTA PHARMA LTD |
| 217231 |
001 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB1 |
2023/11/17
|
DR REDDYS |
| 215561 |
001 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB1 |
2024/07/11
|
LUPIN LTD |
活性成分:TOPIRAMATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:50MG 治疗等效代码:AB1
| 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 |
|---|
| 201635 |
002 |
NDA |
TROKENDI XR |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
Yes |
No |
AB1 |
2013/08/16
|
SUPERNUS PHARMS |
| 207382 |
002 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
No |
No |
AB1 |
2017/11/24
|
ZYDUS |
| 206210 |
002 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
No |
No |
AB1 |
2023/03/10
|
ACTAVIS LABS FL |
| 205976 |
003 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
No |
No |
AB1 |
2023/05/04
|
ENDO OPERATIONS |
| 217248 |
002 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
No |
No |
AB1 |
2023/06/20
|
ALKEM LABS LTD |
| 215663 |
002 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
50MG |
Discontinued |
No |
No |
AB1 |
2023/08/15
|
AJANTA PHARMA LTD |
| 217231 |
002 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
No |
No |
AB1 |
2023/11/17
|
DR REDDYS |
| 215561 |
002 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
No |
No |
AB1 |
2024/07/11
|
LUPIN LTD |
活性成分:TOPIRAMATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:100MG 治疗等效代码:AB1
| 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 |
|---|
| 201635 |
003 |
NDA |
TROKENDI XR |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
Yes |
No |
AB1 |
2013/08/16
|
SUPERNUS PHARMS |
| 207382 |
003 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB1 |
2017/11/24
|
ZYDUS |
| 206210 |
003 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB1 |
2023/03/10
|
ACTAVIS LABS FL |
| 205976 |
004 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB1 |
2023/05/04
|
ENDO OPERATIONS |
| 217248 |
003 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB1 |
2023/06/20
|
ALKEM LABS LTD |
| 215663 |
003 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
100MG |
Discontinued |
No |
No |
AB1 |
2023/08/15
|
AJANTA PHARMA LTD |
| 217231 |
003 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB1 |
2023/11/17
|
DR REDDYS |
| 215561 |
003 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB1 |
2024/07/11
|
LUPIN LTD |
活性成分:TOPIRAMATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:200MG 治疗等效代码:AB1
| 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 |
|---|
| 201635 |
004 |
NDA |
TROKENDI XR |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
Yes |
Yes |
AB1 |
2013/08/16
|
SUPERNUS PHARMS |
| 216167 |
001 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
200MG |
Discontinued |
No |
No |
AB1 |
2023/02/09
|
ZYDUS PHARMS |
| 205976 |
001 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB1 |
2023/03/01
|
ENDO OPERATIONS |
| 206210 |
004 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB1 |
2023/03/10
|
ACTAVIS LABS FL |
| 217248 |
004 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB1 |
2023/06/20
|
ALKEM LABS LTD |
| 215663 |
004 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
200MG |
Discontinued |
No |
No |
AB1 |
2023/08/15
|
AJANTA PHARMA LTD |
| 207382 |
004 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB1 |
2023/10/30
|
ZYDUS |
| 217231 |
004 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB1 |
2023/11/17
|
DR REDDYS |
| 215561 |
004 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB1 |
2024/07/11
|
LUPIN LTD |