AXUNIO FDA Approval ANDA 213497

ANDA 213497

AXUNIO

FDA Drug Application

Application #213497

Application Sponsors

ANDA 213497AXUNIO

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL10MG0LEFLUNOMIDELEFLUNOMIDE
002TABLET;ORAL20MG0LEFLUNOMIDELEFLUNOMIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-05-10STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

AXUNIO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213497
            [companyName] => AXUNIO
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEFLUNOMIDE","activeIngredients":"LEFLUNOMIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEFLUNOMIDE","activeIngredients":"LEFLUNOMIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/10\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-10
        )

)

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