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 |
|---|
| 2025/08/07 |
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:PRUCALOPRIDE SUCCINATE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 1MG BASE; 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 |
|---|
| 210166 |
001 |
NDA |
MOTEGRITY |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
Yes |
No |
AB |
2018/12/14
|
TAKEDA PHARMS USA |
| 218492 |
001 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2024/12/26
|
NOVITIUM PHARMA |
| 218778 |
001 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 1MG BASE |
Discontinued |
No |
No |
AB |
2025/06/24
|
TORRENT |
| 218795 |
001 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
ZENARA |
| 218812 |
001 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
AMNEAL |
| 218847 |
001 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
LUPIN LTD |
| 218963 |
001 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
APPCO |
| 218977 |
001 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
APOTEX |
| 219078 |
001 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
SOMERSET THERAP |
| 219160 |
001 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
ANNORA PHARMA |
| 219193 |
001 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
SPECGX LLC |
| 219216 |
001 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
H2-PHARMA |
| 217662 |
001 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
HIKMA |
| 218177 |
001 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
MSN |
| 218295 |
001 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
ALKEM LABS LTD |
| 218056 |
001 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2025/08/07
|
ZYDUS LIFESCIENCES |
>>>活性成分:PRUCALOPRIDE SUCCINATE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 2MG BASE; 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 |
|---|
| 210166 |
002 |
NDA |
MOTEGRITY |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
Yes |
Yes |
AB |
2018/12/14
|
TAKEDA PHARMS USA |
| 218492 |
002 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2024/12/26
|
NOVITIUM PHARMA |
| 218778 |
002 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 2MG BASE |
Discontinued |
No |
No |
AB |
2025/06/24
|
TORRENT |
| 218795 |
002 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
ZENARA |
| 218812 |
002 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
AMNEAL |
| 218847 |
002 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
LUPIN LTD |
| 218963 |
002 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
APPCO |
| 218977 |
002 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
APOTEX |
| 219078 |
002 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
SOMERSET THERAP |
| 219160 |
002 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
ANNORA PHARMA |
| 219193 |
002 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
SPECGX LLC |
| 219216 |
002 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
H2-PHARMA |
| 217662 |
002 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
HIKMA |
| 218177 |
002 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
MSN |
| 218295 |
002 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2025/06/24
|
ALKEM LABS LTD |
| 218056 |
002 |
ANDA |
PRUCALOPRIDE SUCCINATE |
PRUCALOPRIDE SUCCINATE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2025/08/07
|
ZYDUS LIFESCIENCES |