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 |
2023/04/18 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
N/A
;Orphan
|
|
|
2021/09/16 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2020/04/02 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/03/06 |
SUPPL-24(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2017/01/09 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/09/09 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/07/31 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/06/10 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/04/09 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/03/28 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/03/27 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/03/25 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/02/13 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/01/31 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2012/11/30 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2012/08/08 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/01/31 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/06/28 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/04/28 |
SUPPL-3(补充) |
Approval |
REMS |
N/A
|
|
|
2011/01/28 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
STANDARD
;Orphan
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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:300MG 治疗等效代码:AB2
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 |
022544 |
001 |
NDA |
GRALISE |
GABAPENTIN |
TABLET;ORAL |
300MG |
Prescription |
Yes |
Yes |
AB2 |
2011/01/28
|
ALMATICA |
203934 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB2 |
2024/01/24
|
ZYDUS PHARMS |
216252 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB2 |
2024/02/26
|
HUMANWELL |
218075 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB2 |
2024/02/26
|
ANNORA PHARMA |
活性成分:GABAPENTIN 剂型/给药途径:TABLET;ORAL 规格:600MG 治疗等效代码:AB2
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 |
022544 |
002 |
NDA |
GRALISE |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
Yes |
No |
AB2 |
2011/01/28
|
ALMATICA |
203934 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB2 |
2024/01/24
|
ZYDUS PHARMS |
216252 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB2 |
2024/02/26
|
HUMANWELL |
218075 |
002 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB2 |
2024/02/26
|
ANNORA PHARMA |
203643 |
001 |
ANDA |
GABAPENTIN |
GABAPENTIN |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB2 |
2024/09/09
|
ABON PHARMS LLC |