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 |
|---|
| 2024/08/27 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/08/27 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/08/13 |
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:FESOTERODINE FUMARATE 剂型/给药途径:TABLET, 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 |
|---|
| 022030 |
001 |
NDA |
TOVIAZ |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
4MG |
Prescription |
Yes |
No |
AB |
2008/10/31
|
PFIZER |
| 204827 |
001 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2015/12/10
|
ALKEM LABS LTD |
| 205007 |
001 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2017/02/17
|
AUROBINDO PHARMA |
| 204946 |
001 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2017/10/03
|
ZYDUS PHARMS |
| 204975 |
001 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2019/08/13
|
DR REDDYS |
| 204973 |
001 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2023/01/04
|
ALEMBIC |
| 204868 |
001 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
4MG |
Discontinued |
No |
No |
AB |
2023/01/04
|
ACTAVIS LABS FL INC |
| 204504 |
001 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
4MG |
Discontinued |
No |
No |
AB |
2023/01/04
|
ANI PHARMS |
| 205012 |
001 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
4MG |
Discontinued |
No |
No |
AB |
2023/01/04
|
ACCORD HLTHCARE |
| 205002 |
001 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2023/01/04
|
AMNEAL PHARMS NY |
| 204983 |
001 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
4MG |
Discontinued |
No |
No |
AB |
2023/01/05
|
CHARTWELL RX |
| 204792 |
001 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2024/01/09
|
HETERO LABS LTD V |
活性成分:FESOTERODINE FUMARATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:8MG 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 |
|---|
| 022030 |
002 |
NDA |
TOVIAZ |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
8MG |
Prescription |
Yes |
Yes |
AB |
2008/10/31
|
PFIZER |
| 204827 |
002 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2015/12/10
|
ALKEM LABS LTD |
| 205007 |
002 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2017/02/17
|
AUROBINDO PHARMA |
| 204946 |
002 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2017/10/03
|
ZYDUS PHARMS |
| 204975 |
002 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2019/08/13
|
DR REDDYS |
| 204973 |
002 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2023/01/04
|
ALEMBIC |
| 204868 |
002 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
8MG |
Discontinued |
No |
No |
AB |
2023/01/04
|
ACTAVIS LABS FL INC |
| 204504 |
002 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
8MG |
Discontinued |
No |
No |
AB |
2023/01/04
|
ANI PHARMS |
| 205012 |
002 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
8MG |
Discontinued |
No |
No |
AB |
2023/01/04
|
ACCORD HLTHCARE |
| 205002 |
002 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2023/01/04
|
AMNEAL PHARMS NY |
| 204983 |
002 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
8MG |
Discontinued |
No |
No |
AB |
2023/01/05
|
CHARTWELL RX |
| 204792 |
002 |
ANDA |
FESOTERODINE FUMARATE |
FESOTERODINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2024/01/09
|
HETERO LABS LTD V |