ANDA 214462

AMTA

FDA Drug Application

Application #214462

Application Sponsors

ANDA 214462

AMTA

Marketing Status

• Prescription: 001
• Prescription: 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

UNKNOWN;

ORIG

1

AP

2021-03-15

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AMTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214462
            [companyName] => AMTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIVALPROEX SODIUM","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 250MG VALPROIC ACID","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIVALPROEX SODIUM","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 500MG VALPROIC ACID","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/15\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-15
        )

)