ANDA 211505

TEVA PHARMS USA

FDA Drug Application

Application #211505

Application Sponsors

ANDA 211505

TEVA PHARMS USA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, DELAYED REL PELLETS;ORAL

EQ 125MG VALPROIC ACID

0

DIVALPROEX SODIUM

DIVALPROEX SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-11-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211505
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIVALPROEX SODIUM","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 125MG VALPROIC ACID","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-17
        )

)