QUAGEN FDA Approval ANDA 213560

ANDA 213560

QUAGEN

FDA Drug Application

Application #213560

Application Sponsors

ANDA 213560QUAGEN

Marketing Status

Prescription001

Application Products

001OINTMENT;TOPICAL0.05%0HALOBETASOL PROPIONATEHALOBETASOL PROPIONATE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-06STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

QUAGEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213560
            [companyName] => QUAGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"HALOBETASOL PROPIONATE","activeIngredients":"HALOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-06
        )

)

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