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 |
2024/03/28 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/12/02 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/02/04 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/02/18 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/02/14 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/02/21 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/03/29 |
SUPPL-5(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2017/03/29 |
SUPPL-3(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2015/06/16 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/03/30 |
SUPPL-1(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2014/03/11 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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:AB2
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 |
205122 |
001 |
NDA |
QUDEXY XR |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
Yes |
No |
AB2 |
2014/03/11
|
UPSHER SMITH LABS |
210278 |
001 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB2 |
2021/02/01
|
GLENMARK PHARMS LTD |
208949 |
001 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB2 |
2022/11/29
|
ZYDUS |
活性成分:TOPIRAMATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:50MG 治疗等效代码:AB2
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 |
205122 |
002 |
NDA |
QUDEXY XR |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
Yes |
No |
AB2 |
2014/03/11
|
UPSHER SMITH LABS |
210278 |
002 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
No |
No |
AB2 |
2021/02/01
|
GLENMARK PHARMS LTD |
208949 |
002 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
No |
No |
AB2 |
2022/11/29
|
ZYDUS |
活性成分:TOPIRAMATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:100MG 治疗等效代码:AB2
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 |
205122 |
003 |
NDA |
QUDEXY XR |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
Yes |
No |
AB2 |
2014/03/11
|
UPSHER SMITH LABS |
210278 |
003 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB2 |
2021/02/01
|
GLENMARK PHARMS LTD |
208949 |
003 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB2 |
2022/11/29
|
ZYDUS |
活性成分:TOPIRAMATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:150MG 治疗等效代码:AB2
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 |
205122 |
004 |
NDA |
QUDEXY XR |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
150MG |
Prescription |
Yes |
No |
AB2 |
2014/03/11
|
UPSHER SMITH LABS |
210278 |
004 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
150MG |
Prescription |
No |
No |
AB2 |
2021/02/01
|
GLENMARK PHARMS LTD |
208949 |
004 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
150MG |
Prescription |
No |
No |
AB2 |
2022/11/29
|
ZYDUS |
活性成分:TOPIRAMATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:200MG 治疗等效代码:AB2
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 |
205122 |
005 |
NDA |
QUDEXY XR |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
Yes |
Yes |
AB2 |
2014/03/11
|
UPSHER SMITH LABS |
210278 |
005 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB2 |
2021/02/01
|
GLENMARK PHARMS LTD |
208949 |
005 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB2 |
2022/11/29
|
ZYDUS |