Application Sponsors
| ANDA 070631 | UPSHER SMITH LABS | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 250MG | 0 | VALPROIC ACID | VALPROIC ACID |
FDA Submissions
| ORIG | 1 | AP | 1987-06-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1989-10-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1989-10-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1989-10-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1990-11-16 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1991-01-25 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1992-02-12 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1993-02-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1993-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1993-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1993-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1993-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1993-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1995-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1995-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1997-12-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1997-12-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1997-12-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1997-12-15 | |
| LABELING; Labeling | SUPPL | 23 | AP | 1997-12-15 | |
| LABELING; Labeling | SUPPL | 24 | AP | 2001-02-28 | |
Submissions Property Types
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
CDER Filings
UPSHER SMITH LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 70631
[companyName] => UPSHER SMITH LABS
[docInserts] => ["",""]
[products] => [{"drugName":"VALPROIC ACID","activeIngredients":"VALPROIC ACID","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"VALPROIC ACID","submission":"VALPROIC ACID","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)