GRANULES FDA Approval ANDA 212750

ANDA 212750

GRANULES

FDA Drug Application

Application #212750

Application Sponsors

ANDA 212750GRANULES

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2021-10-14STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

GRANULES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212750
            [companyName] => GRANULES
            [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":"10\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-14
        )

)

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