QUAGEN FDA Approval ANDA 213890

ANDA 213890

QUAGEN

FDA Drug Application

Application #213890

Application Sponsors

ANDA 213890QUAGEN

Marketing Status

Prescription001

Application Products

001SYRUP;ORAL6.25MG/5ML0PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-07-12STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

CDER Filings

QUAGEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213890
            [companyName] => QUAGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"6.25MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/12\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-12
        )

)

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