MYLAN PHARMS INC FDA Approval ANDA 200579

ANDA 200579

MYLAN PHARMS INC

FDA Drug Application

Application #200579

Application Sponsors

ANDA 200579MYLAN PHARMS INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

001CAPSULE; ORAL43MG0FENOFIBRATEFENOFIBRATE
002CAPSULE; ORAL130MG0FENOFIBRATEFENOFIBRATE

FDA Submissions

ORIG1TA2012-11-29

Submissions Property Types

ORIG1Null0

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200579
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"43MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"130MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/29\/2012","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-11-29
        )

)

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