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 |
|---|
| 2020/10/19 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/10/19 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/10/19 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/10/19 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/10/19 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2011/02/25 |
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, DELAYED 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 |
|---|
| 018723 |
002 |
NDA |
DEPAKOTE |
DIVALPROEX SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
Yes |
Yes |
AB |
1983/03/10
|
ABBVIE |
| 077615 |
001 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2008/07/29
|
APOTEX |
| 078182 |
003 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2008/07/29
|
UPSHER SMITH LABS |
| 078290 |
001 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2008/07/29
|
INVATECH |
| 078597 |
003 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2008/07/29
|
SUN PHARM INDS |
| 078755 |
003 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2008/07/29
|
DR REDDYS LABS LTD |
| 078790 |
003 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2008/07/29
|
LUPIN |
| 077296 |
003 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2008/07/31
|
CHARTWELL RX |
| 078853 |
003 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2008/11/25
|
ORBION PHARMS |
| 077100 |
003 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2009/03/05
|
ZYDUS PHARMS USA INC |
| 090210 |
003 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2009/11/30
|
PRINSTON INC |
| 079080 |
001 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Discontinued |
No |
No |
AB |
2011/02/25
|
ACTAVIS LABS FL INC |
| 079163 |
003 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2011/04/05
|
UNICHEM LABS LTD |
| 090554 |
003 |
ANDA |
DIVALPROEX SODIUM |
DIVALPROEX SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 500MG VALPROIC ACID |
Prescription |
No |
No |
AB |
2011/04/21
|
AUROBINDO PHARMA LTD |