APOTEX FDA Approval ANDA 209645

ANDA 209645

APOTEX

FDA Drug Application

Application #209645

Application Sponsors

ANDA 209645APOTEX

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL40MG0ENZALUTAMIDEENZALUTAMIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-04-22STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

APOTEX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209645
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENZALUTAMIDE","activeIngredients":"ENZALUTAMIDE","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/22\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-22
        )

)

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