NOVITIUM PHARMA FDA Approval ANDA 210799

ANDA 210799

NOVITIUM PHARMA

FDA Drug Application

Application #210799

Application Sponsors

ANDA 210799NOVITIUM PHARMA

Marketing Status

Prescription001

Application Products

001SUSPENSION;ORAL50MG/ML0DIAZOXIDEDIAZOXIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-07-08STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

NOVITIUM PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210799
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIAZOXIDE","activeIngredients":"DIAZOXIDE","strength":"50MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/08\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-08
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.