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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2016/11/22 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2025/06/17 |
SUPPL-14（补充） |
Approval |
Labeling-Package Insert,Labeling-Patient Package Insert,Labeling-Container/Carton Labels |
STANDARD
|
|
|
| 2020/03/09 |
SUPPL-1（补充） |
Approval |
Labeling-Package Insert,Labeling-Patient Package Insert |
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:TOLTERODINE TARTRATE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:2MG; 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 |
|---|
| 021228 |
001 |
NDA |
DETROL LA |
TOLTERODINE TARTRATE |
CAPSULE, EXTENDED RELEASE;ORAL |
2MG |
Prescription |
Yes |
No |
AB |
2000/12/22
|
UPJOHN |
| 203016 |
001 |
ANDA |
TOLTERODINE TARTRATE |
TOLTERODINE TARTRATE |
CAPSULE, EXTENDED RELEASE;ORAL |
2MG |
Prescription |
No |
No |
AB |
2015/08/11
|
TORRENT |
| 079141 |
001 |
ANDA |
TOLTERODINE TARTRATE |
TOLTERODINE TARTRATE |
CAPSULE, EXTENDED RELEASE;ORAL |
2MG |
Prescription |
No |
No |
AB |
2016/11/22
|
TEVA PHARMS USA |
| 206419 |
001 |
ANDA |
TOLTERODINE TARTRATE |
TOLTERODINE TARTRATE |
CAPSULE, EXTENDED RELEASE;ORAL |
2MG |
Prescription |
No |
No |
AB |
2017/12/12
|
HETERO LABS LTD III |
| 204562 |
001 |
ANDA |
TOLTERODINE TARTRATE |
TOLTERODINE TARTRATE |
CAPSULE, EXTENDED RELEASE;ORAL |
2MG |
Prescription |
No |
No |
AB |
2019/08/19
|
INVENTIA HLTHCARE |
| 213397 |
001 |
ANDA |
TOLTERODINE TARTRATE |
TOLTERODINE TARTRATE |
CAPSULE, EXTENDED RELEASE;ORAL |
2MG |
Prescription |
No |
No |
AB |
2020/05/19
|
AJANTA PHARMA LTD |
| 213858 |
001 |
ANDA |
TOLTERODINE TARTRATE |
TOLTERODINE TARTRATE |
CAPSULE, EXTENDED RELEASE;ORAL |
2MG |
Prescription |
No |
No |
AB |
2021/02/02
|
UTOPIC PHARMS |
| 216917 |
001 |
ANDA |
TOLTERODINE TARTRATE |
TOLTERODINE TARTRATE |
CAPSULE, EXTENDED RELEASE;ORAL |
2MG |
Prescription |
No |
No |
AB |
2024/08/27
|
UNICHEM |
>>>活性成分:TOLTERODINE TARTRATE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:4MG; 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 |
|---|
| 021228 |
002 |
NDA |
DETROL LA |
TOLTERODINE TARTRATE |
CAPSULE, EXTENDED RELEASE;ORAL |
4MG |
Prescription |
Yes |
Yes |
AB |
2000/12/22
|
UPJOHN |
| 203016 |
002 |
ANDA |
TOLTERODINE TARTRATE |
TOLTERODINE TARTRATE |
CAPSULE, EXTENDED RELEASE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2015/08/11
|
TORRENT |
| 079141 |
002 |
ANDA |
TOLTERODINE TARTRATE |
TOLTERODINE TARTRATE |
CAPSULE, EXTENDED RELEASE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2016/11/22
|
TEVA PHARMS USA |
| 206419 |
002 |
ANDA |
TOLTERODINE TARTRATE |
TOLTERODINE TARTRATE |
CAPSULE, EXTENDED RELEASE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2017/12/12
|
HETERO LABS LTD III |
| 204562 |
002 |
ANDA |
TOLTERODINE TARTRATE |
TOLTERODINE TARTRATE |
CAPSULE, EXTENDED RELEASE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2019/08/19
|
INVENTIA HLTHCARE |
| 213397 |
002 |
ANDA |
TOLTERODINE TARTRATE |
TOLTERODINE TARTRATE |
CAPSULE, EXTENDED RELEASE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2020/05/19
|
AJANTA PHARMA LTD |
| 213858 |
002 |
ANDA |
TOLTERODINE TARTRATE |
TOLTERODINE TARTRATE |
CAPSULE, EXTENDED RELEASE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2021/02/02
|
UTOPIC PHARMS |
| 216917 |
002 |
ANDA |
TOLTERODINE TARTRATE |
TOLTERODINE TARTRATE |
CAPSULE, EXTENDED RELEASE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2024/08/27
|
UNICHEM |