TEVA PHARMS USA FDA Approval ANDA 212206

ANDA 212206

TEVA PHARMS USA

FDA Drug Application

Application #212206

Documents

Letter2022-08-01

Application Sponsors

ANDA 212206TEVA PHARMS USA

Marketing Status

Prescription001

Application Products

001TABLET;ORAL125MG0ABIRATERONE ACETATEABIRATERONE ACETATE

FDA Submissions

UNKNOWN; ORIG1AP2022-06-24STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

TEVA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212206
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABIRATERONE ACETATE","activeIngredients":"ABIRATERONE ACETATE","strength":"125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ABIRATERONE ACETATE","submission":"ABIRATERONE ACETATE","actionType":"125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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