CELLTRION FDA Approval ANDA 212669

ANDA 212669

CELLTRION

FDA Drug Application

Application #212669

Application Sponsors

ANDA 212669CELLTRION

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL90MG0DEFERASIROXDEFERASIROX
002TABLET;ORAL180MG0DEFERASIROXDEFERASIROX
003TABLET;ORAL360MG0DEFERASIROXDEFERASIROX

FDA Submissions

UNKNOWN; ORIG1AP2021-05-27STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

CELLTRION
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212669
            [companyName] => CELLTRION
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"90MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"180MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"360MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/27\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-27
        )

)

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