AMNEAL FDA Approval ANDA 212570

ANDA 212570

AMNEAL

FDA Drug Application

Application #212570

Application Sponsors

ANDA 212570AMNEAL

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL267MG0PIRFENIDONEPIRFENIDONE
002TABLET;ORAL801MG0PIRFENIDONEPIRFENIDONE

FDA Submissions

UNKNOWN; ORIG1TA2020-05-20STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

AMNEAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212570
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"267MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"801MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/25\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-25
        )

)

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