TEVA PHARMS USA FDA Approval ANDA 210018

ANDA 210018

TEVA PHARMS USA

FDA Drug Application

Application #210018

Application Sponsors

ANDA 210018TEVA PHARMS USA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL0.125MG0DOFETILIDEDOFETILIDE
002CAPSULE;ORAL0.25MG0DOFETILIDEDOFETILIDE
003CAPSULE;ORAL0.5MG0DOFETILIDEDOFETILIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-04-15STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

TEVA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210018
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOFETILIDE","activeIngredients":"DOFETILIDE","strength":"0.125MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOFETILIDE","activeIngredients":"DOFETILIDE","strength":"0.25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOFETILIDE","activeIngredients":"DOFETILIDE","strength":"0.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOFETILIDE","submission":"DOFETILIDE","actionType":"0.125MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOFETILIDE","submission":"DOFETILIDE","actionType":"0.25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOFETILIDE","submission":"DOFETILIDE","actionType":"0.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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