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 |
2014/11/08 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/11/08 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/08/05 |
SUPPL-4(补充) |
Approval |
Labeling |
|
|
|
2009/08/04 |
SUPPL-3(补充) |
Approval |
Labeling |
|
|
|
2009/08/04 |
SUPPL-2(补充) |
Approval |
Supplement |
|
|
|
2009/08/04 |
SUPPL-1(补充) |
Approval |
Supplement |
|
|
|
2009/02/10 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
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:DIVALPROEX SODIUM 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 500MG VALPROIC ACID 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 |
021168 |
001 |
NDA |
DEPAKOTE ER |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
Yes |
No |
AB |
2000/08/04
|
ABBVIE |
077567 |
002 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2009/01/29
|
MYLAN |
078239 |
002 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2009/08/04
|
ZYDUS PHARMS USA INC |
078705 |
001 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2009/08/04
|
WOCKHARDT |
090070 |
001 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2012/03/12
|
REDDYS |
202419 |
002 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2014/06/02
|
AUROBINDO PHARMA LTD |
203730 |
002 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
Yes |
AB |
2015/05/29
|
AMNEAL PHARMS |
209286 |
002 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2019/10/18
|
LUPIN LTD |
214643 |
002 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2022/02/25
|
UNICHEM |
215527 |
002 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2023/09/26
|
ANNORA PHARMA |
活性成分:DIVALPROEX SODIUM 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 250MG VALPROIC ACID 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 |
021168 |
002 |
NDA |
DEPAKOTE ER |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 250MG VALPROIC ACID |
Prescription |
Yes |
No |
AB |
2002/05/31
|
ABBVIE |
077567 |
001 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 250MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2009/01/29
|
MYLAN |
078705 |
002 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 250MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2009/02/10
|
WOCKHARDT |
078239 |
001 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 250MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2009/02/27
|
ZYDUS PHARMS USA INC |
090161 |
001 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 250MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2012/03/15
|
DR REDDYS LABS LTD |
202419 |
001 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 250MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2014/06/02
|
AUROBINDO PHARMA LTD |
203730 |
001 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 250MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2015/05/29
|
AMNEAL PHARMS |
209286 |
001 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 250MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2019/10/18
|
LUPIN LTD |
214643 |
001 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 250MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2022/02/25
|
UNICHEM |
215527 |
001 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 250MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2023/09/26
|
ANNORA PHARMA |