MYLAN FDA Approval ANDA 208851

ANDA 208851

MYLAN

FDA Drug Application

Application #208851

Application Sponsors

ANDA 208851MYLAN

Marketing Status

Prescription001

Application Products

001TABLET, EXTENDED RELEASE;ORAL9MG0BUDESONIDEBUDESONIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-17STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

MYLAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208851
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"9MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-17
        )

)

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