Application Sponsors
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | EQ 250MG VALPROIC ACID | 0 | DIVALPROEX SODIUM | DIVALPROEX SODIUM |
002 | TABLET, EXTENDED RELEASE;ORAL | EQ 500MG VALPROIC ACID | 0 | DIVALPROEX SODIUM | DIVALPROEX SODIUM |
FDA Submissions
| ORIG | 1 | AP | 2009-02-26 | |
S; Supplement | SUPPL | 2 | AP | 2009-08-04 | |
S; Supplement | SUPPL | 3 | AP | 2009-08-04 | |
LABELING; Labeling | SUPPL | 4 | AP | 2009-08-04 | |
LABELING; Labeling | SUPPL | 5 | AP | 2014-10-26 | |
LABELING; Labeling | SUPPL | 9 | AP | 2014-10-26 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2014-10-26 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2014-10-26 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 2016-02-28 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 2016-02-28 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2016-02-28 | STANDARD |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 7 |
SUPPL | 5 | Null | 7 |
SUPPL | 9 | Null | 7 |
SUPPL | 10 | Null | 15 |
SUPPL | 12 | Null | 15 |
SUPPL | 14 | Null | 15 |
SUPPL | 15 | Null | 7 |
SUPPL | 16 | Null | 7 |
CDER Filings
ANCHEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 78445
[companyName] => ANCHEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"DIVALPROEX SODIUM","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 250MG VALPROIC ACID","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DIVALPROEX SODIUM","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 500MG VALPROIC ACID","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DIVALPROEX SODIUM","submission":"DIVALPROEX SODIUM","actionType":"EQ 250MG VALPROIC ACID","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DIVALPROEX SODIUM","submission":"DIVALPROEX SODIUM","actionType":"EQ 500MG VALPROIC ACID","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)