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 |
|---|
| 2024/11/05 |
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: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 |
| 215638 |
001 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB2 |
2024/11/05
|
XIAMEN LP PHARM CO |
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 |
| 215638 |
002 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
No |
No |
AB2 |
2024/11/05
|
XIAMEN LP PHARM CO |
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 |
| 215638 |
003 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB2 |
2024/11/05
|
XIAMEN LP PHARM CO |
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 |
| 215638 |
004 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
150MG |
Prescription |
No |
No |
AB2 |
2024/11/05
|
XIAMEN LP PHARM CO |
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 |
| 215638 |
005 |
ANDA |
TOPIRAMATE |
TOPIRAMATE |
CAPSULE, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB2 |
2024/11/05
|
XIAMEN LP PHARM CO |