MYLAN PHARMS INC FDA Approval ANDA 200913

ANDA 200913

MYLAN PHARMS INC

FDA Drug Application

Application #200913

Documents

Letter2013-03-28

Application Sponsors

ANDA 200913MYLAN PHARMS INC

Marketing Status

Discontinued001
Discontinued002

Application Products

001CAPSULE, DELAYED RELEASE;ORALEQ 45MG FENOFIBRIC ACID0FENOFIBRIC ACIDCHOLINE FENOFIBRATE
002CAPSULE, DELAYED RELEASE;ORALEQ 135MG FENOFIBRIC ACID0FENOFIBRIC ACIDCHOLINE FENOFIBRATE

FDA Submissions

N/A; Not ApplicableORIG1AP2013-03-25
LABELING; LabelingSUPPL2AP2015-07-06STANDARD
LABELING; LabelingSUPPL5AP2019-09-19STANDARD
LABELING; LabelingSUPPL6AP2019-09-19STANDARD
LABELING; LabelingSUPPL7AP2021-11-16STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null7
SUPPL5Null15
SUPPL6Null7
SUPPL7Null7

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200913
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRIC ACID","activeIngredients":"CHOLINE FENOFIBRATE","strength":"EQ 45MG FENOFIBRIC ACID","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FENOFIBRIC ACID","activeIngredients":"CHOLINE FENOFIBRATE","strength":"EQ 135MG FENOFIBRIC ACID","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/25\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/200913Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/19\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/19\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/06\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-19
        )

)

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