UNICHEM FDA Approval ANDA 214643

ANDA 214643

UNICHEM

FDA Drug Application

Application #214643

Application Sponsors

ANDA 214643UNICHEM

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 250MG VALPROIC ACID0DIVALPROEX SODIUMDIVALPROEX SODIUM
002TABLET, EXTENDED RELEASE;ORALEQ 500MG VALPROIC ACID0DIVALPROEX SODIUMDIVALPROEX SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2022-02-25STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

UNICHEM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214643
            [companyName] => UNICHEM
            [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":"02\/25\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-25
        )

)

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