QUAGEN FDA Approval ANDA 213761

ANDA 213761

QUAGEN

FDA Drug Application

Application #213761

Application Sponsors

ANDA 213761QUAGEN

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION;ORAL5MG/5ML0OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
002SOLUTION;ORAL100MG/5ML0OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-06-02STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA
002PrescriptionAA

CDER Filings

QUAGEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213761
            [companyName] => QUAGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"100MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-02
        )

)

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