IMPAX FDA Approval ANDA 211316

ANDA 211316

IMPAX

FDA Drug Application

Application #211316

Application Sponsors

ANDA 211316IMPAX

Marketing Status

Prescription001
Prescription002

Application Products

001FOR SUSPENSION;ORAL800MG/PACKET0SEVELAMER CARBONATESEVELAMER CARBONATE
002FOR SUSPENSION;ORAL2.4GM/PACKET0SEVELAMER CARBONATESEVELAMER CARBONATE

FDA Submissions

UNKNOWN; ORIG1AP2020-11-20STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

IMPAX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211316
            [companyName] => IMPAX
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEVELAMER CARBONATE","activeIngredients":"SEVELAMER CARBONATE","strength":"800MG\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SEVELAMER CARBONATE","activeIngredients":"SEVELAMER CARBONATE","strength":"2.4GM\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-20
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.