AUSTARPHARMA FDA Approval ANDA 208476

ANDA 208476

AUSTARPHARMA

FDA Drug Application

Application #208476

Application Sponsors

ANDA 208476AUSTARPHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL48MG0FENOFIBRATEFENOFIBRATE
002TABLET;ORAL145MG0FENOFIBRATEFENOFIBRATE

FDA Submissions

UNKNOWN; ORIG1AP2021-02-10STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

AUSTARPHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208476
            [companyName] => AUSTARPHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"48MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"145MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/10\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-10
        )

)

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