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 |
|---|
| 2024/05/24 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/04/13 |
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:PREGABALIN 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:82.5MG 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 |
|---|
| 209501 |
001 |
NDA |
LYRICA CR |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
82.5MG |
Prescription |
Yes |
No |
AB |
2017/10/11
|
UPJOHN |
| 211593 |
001 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
82.5MG |
Prescription |
No |
No |
AB |
2021/04/13
|
ALVOGEN |
| 211889 |
001 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
82.5MG |
Prescription |
No |
No |
AB |
2021/04/13
|
SUN PHARM |
| 213226 |
001 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
82.5MG |
Prescription |
No |
No |
AB |
2021/04/13
|
MSN |
| 215249 |
001 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
82.5MG |
Prescription |
No |
No |
AB |
2022/03/22
|
RUBICON |
| 215577 |
001 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
82.5MG |
Discontinued |
No |
No |
AB |
2022/08/26
|
ZYDUS PHARMS |
| 215675 |
001 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
82.5MG |
Discontinued |
No |
No |
AB |
2022/09/14
|
SCIEGEN PHARMS INC |
| 214496 |
001 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
82.5MG |
Prescription |
No |
No |
AB |
2023/06/01
|
EPIC PHARMA LLC |
活性成分:PREGABALIN 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:165MG 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 |
|---|
| 209501 |
002 |
NDA |
LYRICA CR |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
165MG |
Prescription |
Yes |
No |
AB |
2017/10/11
|
UPJOHN |
| 211593 |
002 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
165MG |
Prescription |
No |
No |
AB |
2021/04/13
|
ALVOGEN |
| 211889 |
002 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
165MG |
Prescription |
No |
No |
AB |
2021/04/13
|
SUN PHARM |
| 213226 |
002 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
165MG |
Prescription |
No |
No |
AB |
2021/04/13
|
MSN |
| 213313 |
001 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
165MG |
Prescription |
No |
No |
AB |
2021/04/13
|
APOTEX |
| 215249 |
002 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
165MG |
Prescription |
No |
No |
AB |
2022/03/22
|
RUBICON |
| 215577 |
002 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
165MG |
Discontinued |
No |
No |
AB |
2022/08/26
|
ZYDUS PHARMS |
| 215675 |
002 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
165MG |
Discontinued |
No |
No |
AB |
2022/09/14
|
SCIEGEN PHARMS INC |
| 214496 |
002 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
165MG |
Prescription |
No |
No |
AB |
2023/06/01
|
EPIC PHARMA LLC |
活性成分:PREGABALIN 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:330MG 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 |
|---|
| 209501 |
003 |
NDA |
LYRICA CR |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
330MG |
Prescription |
Yes |
Yes |
AB |
2017/10/11
|
UPJOHN |
| 211593 |
003 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
330MG |
Prescription |
No |
No |
AB |
2021/04/13
|
ALVOGEN |
| 211889 |
003 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
330MG |
Prescription |
No |
No |
AB |
2021/04/13
|
SUN PHARM |
| 213226 |
003 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
330MG |
Prescription |
No |
No |
AB |
2021/04/13
|
MSN |
| 213313 |
002 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
330MG |
Prescription |
No |
No |
AB |
2021/04/13
|
APOTEX |
| 215249 |
003 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
330MG |
Prescription |
No |
No |
AB |
2022/03/22
|
RUBICON |
| 215577 |
003 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
330MG |
Discontinued |
No |
No |
AB |
2022/08/26
|
ZYDUS PHARMS |
| 215675 |
003 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
330MG |
Discontinued |
No |
No |
AB |
2022/09/14
|
SCIEGEN PHARMS INC |
| 214496 |
003 |
ANDA |
PREGABALIN |
PREGABALIN |
TABLET, EXTENDED RELEASE;ORAL |
330MG |
Prescription |
No |
No |
AB |
2023/06/01
|
EPIC PHARMA LLC |