QUAGEN FDA Approval ANDA 212695

ANDA 212695

QUAGEN

FDA Drug Application

Application #212695

Application Sponsors

ANDA 212695QUAGEN

Marketing Status

Prescription001

Application Products

001OINTMENT;TOPICAL5%0LIDOCAINELIDOCAINE

FDA Submissions

UNKNOWN; ORIG1AP2021-04-20STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAT

CDER Filings

QUAGEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212695
            [companyName] => QUAGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE","activeIngredients":"LIDOCAINE","strength":"5%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/20\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-20
        )

)

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