MYLAN PHARMS INC FDA Approval ANDA 202676

ANDA 202676

MYLAN PHARMS INC

FDA Drug Application

Application #202676

Application Sponsors

ANDA 202676MYLAN PHARMS INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL67MG0FENOFIBRATE (MICRONIZED)FENOFIBRATE
002CAPSULE;ORAL134MG0FENOFIBRATE (MICRONIZED)FENOFIBRATE
003CAPSULE;ORAL200MG0FENOFIBRATE (MICRONIZED)FENOFIBRATE

FDA Submissions

UNKNOWN; ORIG1AP2012-10-23
LABELING; LabelingSUPPL4AP2018-05-18STANDARD
LABELING; LabelingSUPPL5AP2019-05-15STANDARD
LABELING; LabelingSUPPL9AP2021-06-03STANDARD

Submissions Property Types

ORIG1Null7
SUPPL4Null7
SUPPL5Null7
SUPPL9Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202676
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"67MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"134MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/23\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/15\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/18\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-05-15
        )

)

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