TEVA PHARMS USA FDA Approval ANDA 210726

ANDA 210726

TEVA PHARMS USA

FDA Drug Application

Application #210726

Application Sponsors

ANDA 210726TEVA PHARMS USA

Marketing Status

Prescription001

Application Products

001TABLET;ORAL500MG0ABIRATERONE ACETATEABIRATERONE ACETATE

FDA Submissions

UNKNOWN; ORIG1AP2023-01-26STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

TEVA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210726
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABIRATERONE ACETATE","activeIngredients":"ABIRATERONE ACETATE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/26\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-26
        )

)

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