BRECKENRIDGE FDA Approval ANDA 209583

ANDA 209583

BRECKENRIDGE

FDA Drug Application

Application #209583

Application Sponsors

ANDA 209583BRECKENRIDGE

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL7MG0TERIFLUNOMIDETERIFLUNOMIDE
002TABLET;ORAL14MG0TERIFLUNOMIDETERIFLUNOMIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-09-24STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

BRECKENRIDGE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209583
            [companyName] => BRECKENRIDGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TERIFLUNOMIDE","activeIngredients":"TERIFLUNOMIDE","strength":"7MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TERIFLUNOMIDE","activeIngredients":"TERIFLUNOMIDE","strength":"14MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/24\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-24
        )

)

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