MYLAN PHARMS INC FDA Approval ANDA 202579

ANDA 202579

MYLAN PHARMS INC

FDA Drug Application

Application #202579

Application Sponsors

ANDA 202579MYLAN PHARMS INC

Marketing Status

Discontinued001
Discontinued002

Application Products

001CAPSULE;ORAL43MG0FENOFIBRATE (MICRONIZED)FENOFIBRATE
002CAPSULE;ORAL130MG0FENOFIBRATE (MICRONIZED)FENOFIBRATE

FDA Submissions

UNKNOWN; ORIG1AP2013-01-10
LABELING; LabelingSUPPL7AP2022-01-04STANDARD

Submissions Property Types

ORIG1Null7
SUPPL7Null7

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202579
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"43MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"130MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/10\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-01-10
        )

)

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