MYLAN FDA Approval ANDA 201069

ANDA 201069

MYLAN

FDA Drug Application

Application #201069

Application Sponsors

ANDA 201069MYLAN

Marketing Status

Prescription001

Application Products

001TABLET;ORAL800MG0SEVELAMER CARBONATESEVELAMER CARBONATE

FDA Submissions

N/A; Not ApplicableORIG1AP2020-08-05

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

MYLAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201069
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEVELAMER CARBONATE","activeIngredients":"SEVELAMER CARBONATE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/05\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-05
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.