NOVITIUM PHARMA FDA Approval ANDA 215246

ANDA 215246

NOVITIUM PHARMA

FDA Drug Application

Application #215246

Application Sponsors

ANDA 215246NOVITIUM PHARMA

Marketing Status

Prescription001

Application Products

001TABLET;ORAL1MG0PREDNISONEPREDNISONE

FDA Submissions

UNKNOWN; ORIG1AP2021-07-06STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

NOVITIUM PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215246
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/06\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-06
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.