TEVA PHARMS USA FDA Approval ANDA 207124

ANDA 207124

TEVA PHARMS USA

FDA Drug Application

Application #207124

Application Sponsors

ANDA 207124TEVA PHARMS USA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2022-09-23STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

TEVA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207124
            [companyName] => TEVA PHARMS USA
            [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":"09\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-23
        )

)

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