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 |
2021/01/06 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/05/20 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
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:SOLIFENACIN SUCCINATE 剂型/给药途径:TABLET;ORAL 规格:5MG 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 |
021518 |
001 |
NDA |
VESICARE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Prescription |
Yes |
No |
AB |
2004/11/19
|
ASTELLAS |
091464 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2014/04/02
|
TEVA PHARMS USA |
202551 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2019/05/20
|
WATSON LABS INC |
211657 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2019/05/20
|
SCIEGEN PHARMS INC |
209239 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2019/05/20
|
GLENMARK SPECLT |
209333 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2019/05/20
|
QILU |
209839 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Discontinued |
No |
No |
AB |
2019/05/20
|
CIPLA |
210224 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2019/05/20
|
ALKEM LABS LTD |
210281 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2019/05/20
|
AUSTARPHARMA |
210582 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2019/05/20
|
CHARTWELL RX |
210688 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2019/05/20
|
MSN |
205575 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2019/05/20
|
ALEMBIC |
211701 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2019/08/27
|
UNICHEM |
212214 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2019/09/26
|
STRIDES PHARMA |
211423 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2019/12/11
|
RISING |
207477 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Discontinued |
No |
No |
AB |
2022/01/04
|
ACCORD HLTHCARE |
215761 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2022/06/15
|
ANNORA PHARMA |
206817 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2022/12/27
|
AUROBINDO PHARMA |
211622 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Discontinued |
No |
No |
AB |
2023/06/06
|
LANNETT CO INC |
204374 |
001 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2024/02/20
|
MACLEODS PHARMS LTD |
活性成分:SOLIFENACIN SUCCINATE 剂型/给药途径:TABLET;ORAL 规格:10MG 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 |
021518 |
002 |
NDA |
VESICARE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Prescription |
Yes |
Yes |
AB |
2004/11/19
|
ASTELLAS |
091464 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2014/04/02
|
TEVA PHARMS USA |
202551 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2019/05/20
|
WATSON LABS INC |
211657 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2019/05/20
|
SCIEGEN PHARMS INC |
209239 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2019/05/20
|
GLENMARK SPECLT |
209333 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2019/05/20
|
QILU |
209839 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Discontinued |
No |
No |
AB |
2019/05/20
|
CIPLA |
210224 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2019/05/20
|
ALKEM LABS LTD |
210281 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2019/05/20
|
AUSTARPHARMA |
210582 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2019/05/20
|
CHARTWELL RX |
210688 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2019/05/20
|
MSN |
205575 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2019/05/20
|
ALEMBIC |
211701 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2019/08/27
|
UNICHEM |
212214 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2019/09/26
|
STRIDES PHARMA |
211423 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2019/12/11
|
RISING |
207477 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Discontinued |
No |
No |
AB |
2022/01/04
|
ACCORD HLTHCARE |
215761 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2022/06/15
|
ANNORA PHARMA |
206817 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2022/12/27
|
AUROBINDO PHARMA |
211622 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Discontinued |
No |
No |
AB |
2023/06/06
|
LANNETT CO INC |
204374 |
002 |
ANDA |
SOLIFENACIN SUCCINATE |
SOLIFENACIN SUCCINATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2024/02/20
|
MACLEODS PHARMS LTD |