SUN PHARM FDA Approval ANDA 211922

ANDA 211922

SUN PHARM

FDA Drug Application

Application #211922

Application Sponsors

ANDA 211922SUN PHARM

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001SUSPENSION;INHALATION0.25MG/2ML0BUDESONIDEBUDESONIDE
002SUSPENSION;INHALATION0.5MG/2ML0BUDESONIDEBUDESONIDE
003SUSPENSION;INHALATION1MG/2ML0BUDESONIDEBUDESONIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-04-14STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAN
002PrescriptionAN
003PrescriptionAN

CDER Filings

SUN PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211922
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"0.25MG\/2ML","dosageForm":"SUSPENSION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"0.5MG\/2ML","dosageForm":"SUSPENSION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"1MG\/2ML","dosageForm":"SUSPENSION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-14
        )

)

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