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 |
|---|
| 2024/09/12 |
SUPPL-1（补充） |
Approval |
REMS |
|
|
|
| 2023/03/02 |
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:VIGABATRIN 剂型/给药途径:FOR SOLUTION;ORAL 规格:500MG/PACKET 治疗等效代码:AA
| 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 |
|---|
| 022006 |
001 |
NDA |
SABRIL |
VIGABATRIN |
FOR SOLUTION;ORAL |
500MG/PACKET |
Prescription |
Yes |
Yes |
AA |
2009/08/21
|
LUNDBECK PHARMS LLC |
| 208218 |
001 |
ANDA |
VIGABATRIN |
VIGABATRIN |
FOR SOLUTION;ORAL |
500MG/PACKET |
Prescription |
No |
No |
AA |
2017/04/27
|
ENDO OPERATIONS |
| 210155 |
001 |
ANDA |
VIGABATRIN |
VIGABATRIN |
FOR SOLUTION;ORAL |
500MG/PACKET |
Prescription |
No |
No |
AA |
2018/03/13
|
AMNEAL PHARMS |
| 209824 |
001 |
ANDA |
VIGABATRIN |
VIGABATRIN |
FOR SOLUTION;ORAL |
500MG/PACKET |
Prescription |
No |
No |
AA |
2018/04/23
|
TEVA PHARMS USA |
| 210196 |
001 |
ANDA |
VIGADRONE |
VIGABATRIN |
FOR SOLUTION;ORAL |
500MG/PACKET |
Prescription |
No |
No |
AA |
2018/06/21
|
AUCTA |
| 211481 |
001 |
ANDA |
VIGABATRIN |
VIGABATRIN |
FOR SOLUTION;ORAL |
500MG/PACKET |
Prescription |
No |
No |
AA |
2018/11/20
|
DR REDDYS |
| 211592 |
001 |
ANDA |
VIGABATRIN |
VIGABATRIN |
FOR SOLUTION;ORAL |
500MG/PACKET |
Prescription |
No |
No |
AA |
2019/12/03
|
INVAGEN PHARMS |
| 213469 |
001 |
ANDA |
VIGABATRIN |
VIGABATRIN |
FOR SOLUTION;ORAL |
500MG/PACKET |
Discontinued |
No |
No |
AA |
2020/04/24
|
GRANULES |
| 214425 |
001 |
ANDA |
VIGABATRIN |
VIGABATRIN |
FOR SOLUTION;ORAL |
500MG/PACKET |
Discontinued |
No |
No |
AA |
2020/11/13
|
ACCORD HLTHCARE |
| 213375 |
001 |
ANDA |
VIGABATRIN |
VIGABATRIN |
FOR SOLUTION;ORAL |
500MG/PACKET |
Prescription |
No |
No |
AA |
2020/12/02
|
ALKEM LABS LTD |
| 213519 |
001 |
ANDA |
VIGABATRIN |
VIGABATRIN |
FOR SOLUTION;ORAL |
500MG/PACKET |
Prescription |
No |
No |
AA |
2021/01/26
|
ANNORA PHARMA |
| 214992 |
001 |
ANDA |
VIGABATRIN |
VIGABATRIN |
FOR SOLUTION;ORAL |
500MG/PACKET |
Prescription |
No |
No |
AA |
2021/05/13
|
DEXCEL |
| 213390 |
001 |
ANDA |
VIGABATRIN |
VIGABATRIN |
FOR SOLUTION;ORAL |
500MG/PACKET |
Discontinued |
No |
No |
AA |
2021/07/29
|
PROPEL PHARMA |
| 213899 |
001 |
ANDA |
VIGABATRIN |
VIGABATRIN |
FOR SOLUTION;ORAL |
500MG/PACKET |
Prescription |
No |
No |
AA |
2021/09/29
|
AUROBINDO PHARMA LTD |
| 211790 |
001 |
ANDA |
VIGABATRIN |
VIGABATRIN |
FOR SOLUTION;ORAL |
500MG/PACKET |
Discontinued |
No |
No |
AA |
2022/03/10
|
CHARTWELL RX |
| 214961 |
001 |
ANDA |
VIGPODER |
VIGABATRIN |
FOR SOLUTION;ORAL |
500MG/PACKET |
Prescription |
No |
No |
AA |
2022/06/24
|
PYROS PHARMS |
| 215363 |
001 |
ANDA |
VIGABATRIN |
VIGABATRIN |
FOR SOLUTION;ORAL |
500MG/PACKET |
Prescription |
No |
No |
AA |
2022/09/07
|
MSN |
| 214671 |
001 |
ANDA |
VIGABATRIN |
VIGABATRIN |
FOR SOLUTION;ORAL |
500MG/PACKET |
Discontinued |
No |
No |
AA |
2023/03/02
|
ZYDUS LIFESCIENCES |