ANNORA PHARMA FDA Approval ANDA 214341

ANDA 214341

ANNORA PHARMA

FDA Drug Application

Application #214341

Application Sponsors

ANDA 214341ANNORA PHARMA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2021-05-14STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ANNORA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214341
            [companyName] => ANNORA PHARMA
            [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\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-14
        )

)

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