AKORN FDA Approval ANDA 211420

ANDA 211420

AKORN

FDA Drug Application

Application #211420

Application Sponsors

ANDA 211420AKORN

Marketing Status

Prescription001

Application Products

001SUSPENSION;ORAL300MG/5ML0OXCARBAZEPINEOXCARBAZEPINE

FDA Submissions

UNKNOWN; ORIG1AP2021-07-09STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

AKORN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211420
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"300MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/09\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-09
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.