PRINSTON INC FDA Approval ANDA 211080

ANDA 211080

PRINSTON INC

FDA Drug Application

Application #211080

Application Sponsors

ANDA 211080PRINSTON INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL48MG0FENOFIBRATEFENOFIBRATE
002TABLET;ORAL145MG0FENOFIBRATEFENOFIBRATE

FDA Submissions

UNKNOWN; ORIG1AP2018-08-28STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211080
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"48MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"145MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/28\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-08-28
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.