QUAGEN FDA Approval ANDA 213559

ANDA 213559

QUAGEN

FDA Drug Application

Application #213559

Application Sponsors

ANDA 213559QUAGEN

Marketing Status

Prescription001
Prescription002

Application Products

001LOTION;TOPICAL0.025%0TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE
002LOTION;TOPICAL0.1%0TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-07-01STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAT
002PrescriptionAT

CDER Filings

QUAGEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213559
            [companyName] => QUAGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.025%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.1%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-01
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.