MANKIND PHARMA FDA Approval ANDA 213864

ANDA 213864

MANKIND PHARMA

FDA Drug Application

Application #213864

Application Sponsors

ANDA 213864MANKIND PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL54MG0FENOFIBRATEFENOFIBRATE
002TABLET;ORAL160MG0FENOFIBRATEFENOFIBRATE

FDA Submissions

UNKNOWN; ORIG1AP2020-06-12STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

MANKIND PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213864
            [companyName] => MANKIND PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"54MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/12\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-12
        )

)

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