VGYAAN FDA Approval ANDA 215323

ANDA 215323

VGYAAN

FDA Drug Application

Application #215323

Application Sponsors

ANDA 215323VGYAAN

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2022-04-14STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

VGYAAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215323
            [companyName] => VGYAAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOFETILIDE","activeIngredients":"DOFETILIDE","strength":"0.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOFETILIDE","activeIngredients":"DOFETILIDE","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOFETILIDE","activeIngredients":"DOFETILIDE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/14\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-14
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.