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 |
|---|
| 2023/03/28 |
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 |
|---|
| 2025/07/23 |
SUPPL-6（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2025/03/13 |
SUPPL-4（补充） |
Approval |
Labeling-Package Insert |
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:GABAPENTIN; 剂型/给药途径:TABLET;ORAL; 规格:600MG; 治疗等效代码:AB1<<<
| 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 |
|---|
| 020882 |
001 |
NDA |
NEURONTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
Yes |
No |
AB1 |
1998/10/09
|
VIATRIS |
| 075694 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Discontinued |
No |
No |
AB1 |
2004/10/21
|
ACTAVIS ELIZABETH |
| 077662 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB1 |
2006/08/18
|
GLENMARK PHARMS LTD |
| 077525 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Discontinued |
No |
No |
AB1 |
2006/08/24
|
SUN PHARM INDS LTD |
| 077661 |
004 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB1 |
2006/09/13
|
RUBICON RESEARCH |
| 078926 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB1 |
2011/02/11
|
ZYDUS PHARMS USA INC |
| 200651 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB1 |
2011/10/06
|
AUROBINDO PHARMA LTD |
| 202764 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Discontinued |
No |
No |
AB1 |
2012/10/16
|
INVAGEN PHARMS |
| 203244 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB1 |
2013/07/12
|
STRIDES PHARMA |
| 206402 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB1 |
2015/12/23
|
ALKEM LABS LTD |
| 205101 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB1 |
2016/02/04
|
SCIEGEN PHARMS INC |
| 207057 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB1 |
2017/10/26
|
CSPC OUYI |
| 214957 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB1 |
2021/10/01
|
ASCENT PHARMS INC |
| 217116 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB1 |
2023/03/28
|
GRANULES |
| 217995 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB1 |
2023/07/19
|
RISING |
| 211313 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB1 |
2024/03/04
|
STRIDES PHARMA |
| 217965 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB1 |
2024/04/08
|
LAURUS |
| 209855 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Discontinued |
No |
No |
AB1 |
2024/05/29
|
IPCA LABS LTD |
>>>活性成分:GABAPENTIN; 剂型/给药途径:TABLET;ORAL; 规格:800MG; 治疗等效代码:AB1<<<
| 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 |
|---|
| 020882 |
002 |
NDA |
NEURONTIN |
GABAPENTIN |
TABLET;ORAL |
800MG |
Prescription |
Yes |
Yes |
AB1 |
1998/10/09
|
VIATRIS |
| 075694 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
800MG |
Discontinued |
No |
No |
AB1 |
2004/10/21
|
ACTAVIS ELIZABETH |
| 077662 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
800MG |
Prescription |
No |
No |
AB1 |
2006/08/18
|
GLENMARK PHARMS LTD |
| 077525 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
800MG |
Discontinued |
No |
No |
AB1 |
2006/08/24
|
SUN PHARM INDS LTD |
| 077661 |
005 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
800MG |
Prescription |
No |
No |
AB1 |
2006/09/13
|
RUBICON RESEARCH |
| 078926 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
800MG |
Prescription |
No |
No |
AB1 |
2011/02/11
|
ZYDUS PHARMS USA INC |
| 200651 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
800MG |
Prescription |
No |
No |
AB1 |
2011/10/06
|
AUROBINDO PHARMA LTD |
| 202764 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
800MG |
Discontinued |
No |
No |
AB1 |
2012/10/16
|
INVAGEN PHARMS |
| 203244 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
800MG |
Prescription |
No |
No |
AB1 |
2013/07/12
|
STRIDES PHARMA |
| 206402 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
800MG |
Prescription |
No |
No |
AB1 |
2015/12/23
|
ALKEM LABS LTD |
| 205101 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
800MG |
Prescription |
No |
No |
AB1 |
2016/02/04
|
SCIEGEN PHARMS INC |
| 207057 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
800MG |
Prescription |
No |
No |
AB1 |
2017/10/26
|
CSPC OUYI |
| 214957 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
800MG |
Prescription |
No |
No |
AB1 |
2021/10/01
|
ASCENT PHARMS INC |
| 217116 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
800MG |
Prescription |
No |
No |
AB1 |
2023/03/28
|
GRANULES |
| 217995 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
800MG |
Prescription |
No |
No |
AB1 |
2023/07/19
|
RISING |
| 211313 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
800MG |
Prescription |
No |
No |
AB1 |
2024/03/04
|
STRIDES PHARMA |
| 217965 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
800MG |
Prescription |
No |
No |
AB1 |
2024/04/08
|
LAURUS |
| 209855 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
800MG |
Discontinued |
No |
No |
AB1 |
2024/05/29
|
IPCA LABS LTD |