BIONPHARMA INC FDA Approval ANDA 208625

ANDA 208625

BIONPHARMA INC

FDA Drug Application

Application #208625

Application Sponsors

ANDA 208625BIONPHARMA INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2018-04-10STANDARD
LABELING; LabelingSUPPL4AP2022-11-28STANDARD

Submissions Property Types

ORIG1Null7
SUPPL4Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

BIONPHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208625
            [companyName] => BIONPHARMA INC
            [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":"04\/10\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-04-10
        )

)

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