BIONPHARMA INC FDA Approval ANDA 210920

ANDA 210920

BIONPHARMA INC

FDA Drug Application

Application #210920

Application Sponsors

ANDA 210920BIONPHARMA INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET, FOR SUSPENSION;ORAL125MG0DEFERASIROXDEFERASIROX
002TABLET, FOR SUSPENSION;ORAL250MG0DEFERASIROXDEFERASIROX
003TABLET, FOR SUSPENSION;ORAL500MG0DEFERASIROXDEFERASIROX

FDA Submissions

UNKNOWN; ORIG1AP2019-11-20STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

BIONPHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210920
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"125MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"250MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"500MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-20
        )

)

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