Documents
Application Sponsors
ANDA 078597 | SUN PHARM INDS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET, DELAYED RELEASE;ORAL | EQ 125MG VALPROIC ACID | 0 | DIVALPROEX SODIUM | DIVALPROEX SODIUM |
002 | TABLET, DELAYED RELEASE;ORAL | EQ 250MG VALPROIC ACID | 0 | DIVALPROEX SODIUM | DIVALPROEX SODIUM |
003 | TABLET, DELAYED RELEASE;ORAL | EQ 500MG VALPROIC ACID | 0 | DIVALPROEX SODIUM | DIVALPROEX SODIUM |
FDA Submissions
| ORIG | 1 | AP | 2008-07-29 | |
LABELING; Labeling | SUPPL | 3 | AP | 2010-01-12 | |
LABELING; Labeling | SUPPL | 7 | AP | 2014-03-20 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2014-03-20 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2014-11-08 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2014-11-08 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 2020-01-30 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 2020-01-30 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2020-01-30 | STANDARD |
LABELING; Labeling | SUPPL | 18 | AP | 2020-01-30 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 2020-01-30 | STANDARD |
LABELING; Labeling | SUPPL | 20 | AP | 2020-01-30 | STANDARD |
LABELING; Labeling | SUPPL | 22 | AP | 2020-01-30 | STANDARD |
LABELING; Labeling | SUPPL | 25 | AP | 2020-01-30 | STANDARD |
LABELING; Labeling | SUPPL | 28 | AP | 2020-01-30 | STANDARD |
Submissions Property Types
SUPPL | 3 | Null | 7 |
SUPPL | 7 | Null | 15 |
SUPPL | 8 | Null | 15 |
SUPPL | 12 | Null | 15 |
SUPPL | 13 | Null | 15 |
SUPPL | 14 | Null | 7 |
SUPPL | 15 | Null | 7 |
SUPPL | 16 | Null | 7 |
SUPPL | 18 | Null | 7 |
SUPPL | 19 | Null | 7 |
SUPPL | 20 | Null | 15 |
SUPPL | 22 | Null | 15 |
SUPPL | 25 | Null | 7 |
SUPPL | 28 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
SUN PHARM INDS
cder:Array
(
[0] => Array
(
[ApplNo] => 78597
[companyName] => SUN PHARM INDS
[docInserts] => ["",""]
[products] => [{"drugName":"DIVALPROEX SODIUM","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 125MG VALPROIC ACID","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIVALPROEX SODIUM","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 250MG VALPROIC ACID","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIVALPROEX SODIUM","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 500MG VALPROIC ACID","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DIVALPROEX SODIUM","submission":"DIVALPROEX SODIUM","actionType":"EQ 125MG VALPROIC ACID","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DIVALPROEX SODIUM","submission":"DIVALPROEX SODIUM","actionType":"EQ 250MG VALPROIC ACID","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DIVALPROEX SODIUM","submission":"DIVALPROEX SODIUM","actionType":"EQ 500MG VALPROIC ACID","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)