QILU FDA Approval ANDA 212826

ANDA 212826

QILU

FDA Drug Application

Application #212826

Application Sponsors

ANDA 212826QILU

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUS50MG/VIAL0DECITABINEDECITABINE

FDA Submissions

UNKNOWN; ORIG1AP2021-04-12STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

QILU
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212826
            [companyName] => QILU
            [docInserts] => ["",""]
            [products] => [{"drugName":"DECITABINE","activeIngredients":"DECITABINE","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/12\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-12
        )

)

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