UNICHEM FDA Approval ANDA 214492

ANDA 214492

UNICHEM

FDA Drug Application

Application #214492

Application Sponsors

ANDA 214492UNICHEM

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL25MG0ZONISAMIDEZONISAMIDE
002CAPSULE;ORAL50MG0ZONISAMIDEZONISAMIDE
003CAPSULE;ORAL100MG0ZONISAMIDEZONISAMIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-01-26STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

UNICHEM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214492
            [companyName] => UNICHEM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZONISAMIDE","activeIngredients":"ZONISAMIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZONISAMIDE","activeIngredients":"ZONISAMIDE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZONISAMIDE","activeIngredients":"ZONISAMIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-26
        )

)

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