ANDA 209645

APOTEX

FDA Drug Application

Application #209645

Application Sponsors

ANDA 209645

APOTEX

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

40MG

0

ENZALUTAMIDE

ENZALUTAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-04-22

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

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
        )

)