MYLAN FDA Approval ANDA 210531

ANDA 210531

MYLAN

FDA Drug Application

Application #210531

Application Sponsors

ANDA 210531MYLAN

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE, DELAYED RELEASE;ORAL120MG0DIMETHYL FUMARATEDIMETHYL FUMARATE
002CAPSULE, DELAYED RELEASE;ORAL240MG0DIMETHYL FUMARATEDIMETHYL FUMARATE

FDA Submissions

UNKNOWN; ORIG1AP2020-08-17STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

MYLAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210531
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIMETHYL FUMARATE","activeIngredients":"DIMETHYL FUMARATE","strength":"120MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIMETHYL FUMARATE","activeIngredients":"DIMETHYL FUMARATE","strength":"240MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-17
        )

)

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