QUAGEN FDA Approval ANDA 214582

ANDA 214582

QUAGEN

FDA Drug Application

Application #214582

Application Sponsors

ANDA 214582QUAGEN

Marketing Status

Prescription001

Application Products

001PASTE;DENTAL0.1%0TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-12-09STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAT

CDER Filings

QUAGEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214582
            [companyName] => QUAGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.1%","dosageForm":"PASTE;DENTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/09\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-09
        )

)

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