MYLAN FDA Approval ANDA 212088

ANDA 212088

MYLAN

FDA Drug Application

Application #212088

Application Sponsors

ANDA 212088MYLAN

Marketing Status

Over-the-counter001

Application Products

001TABLET, DELAYED RELEASE;ORALEQ 20MG BASE0ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM

FDA Submissions

UNKNOWN; ORIG1AP2020-06-25STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

MYLAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212088
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 20MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/25\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-25
        )

)

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