TEVA PHARMS USA INC FDA Approval ANDA 212759

ANDA 212759

TEVA PHARMS USA INC

FDA Drug Application

Application #212759

Documents

Letter2020-09-18
Letter2022-03-18

Application Sponsors

ANDA 212759TEVA PHARMS USA INC

Marketing Status

None (Tentative Approval)001
Prescription002

Application Products

001TABLET;ORAL267MG0PIRFENIDONEPIRFENIDONE
002TABLET;ORAL801MG0PIRFENIDONEPIRFENIDONE

FDA Submissions

UNKNOWN; ORIG1TA2020-08-14STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

TEVA PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212759
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/14\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-14
        )

)

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