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 |
|---|
| 2022/01/04 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>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 |
|---|
| 无 |
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:SILODOSIN; 剂型/给药途径:CAPSULE;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 |
|---|
| 022206 |
001 |
NDA |
RAPAFLO |
SILODOSIN |
CAPSULE;ORAL |
4MG |
Discontinued |
Yes |
No |
AB |
2008/10/08
|
ABBVIE |
| 204726 |
001 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2017/03/31
|
CHARTWELL RX |
| 206541 |
001 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
4MG |
Prescription |
No |
Yes |
AB |
2018/12/03
|
LUPIN LTD |
| 209745 |
001 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2018/12/03
|
AMNEAL PHARMS CO |
| 210687 |
001 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2018/12/03
|
MSN |
| 211060 |
001 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2018/12/03
|
AJANTA PHARMA LTD |
| 211166 |
001 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2018/12/03
|
MACLEODS PHARMS LTD |
| 210626 |
001 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2018/12/10
|
AUROBINDO PHARMA LTD |
| 204793 |
001 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2020/02/14
|
HETERO LABS LTD V |
| 213230 |
001 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2022/01/03
|
CREEKWOOD PHARMS |
| 209029 |
001 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
4MG |
Prescription |
No |
No |
AB |
2022/01/04
|
PRINSTON INC |
| 204816 |
001 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
4MG |
Discontinued |
No |
No |
AB |
2022/12/08
|
ZYDUS PHARMS |
| 210396 |
001 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
4MG |
Discontinued |
No |
No |
AB |
2025/02/10
|
TORRENT |
>>>活性成分:SILODOSIN; 剂型/给药途径:CAPSULE;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 |
|---|
| 022206 |
002 |
NDA |
RAPAFLO |
SILODOSIN |
CAPSULE;ORAL |
8MG |
Discontinued |
Yes |
No |
AB |
2008/10/08
|
ABBVIE |
| 204726 |
002 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2017/03/31
|
CHARTWELL RX |
| 206541 |
002 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2018/12/03
|
LUPIN LTD |
| 209745 |
002 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2018/12/03
|
AMNEAL PHARMS CO |
| 210687 |
002 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2018/12/03
|
MSN |
| 211060 |
002 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2018/12/03
|
AJANTA PHARMA LTD |
| 211166 |
002 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2018/12/03
|
MACLEODS PHARMS LTD |
| 210626 |
002 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2018/12/10
|
AUROBINDO PHARMA LTD |
| 204793 |
002 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2020/02/14
|
HETERO LABS LTD V |
| 213230 |
002 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2022/01/03
|
CREEKWOOD PHARMS |
| 209029 |
002 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2022/01/04
|
PRINSTON INC |
| 204816 |
002 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
8MG |
Discontinued |
No |
No |
AB |
2022/12/08
|
ZYDUS PHARMS |
| 210396 |
002 |
ANDA |
SILODOSIN |
SILODOSIN |
CAPSULE;ORAL |
8MG |
Discontinued |
No |
No |
AB |
2025/02/10
|
TORRENT |