ENCUBE FDA Approval ANDA 212443

ANDA 212443

ENCUBE

FDA Drug Application

Application #212443

Application Sponsors

ANDA 212443ENCUBE

Marketing Status

Prescription001

Application Products

001CREAM;TOPICAL2%0KETOCONAZOLEKETOCONAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2021-05-20STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

ENCUBE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212443
            [companyName] => ENCUBE
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOCONAZOLE","activeIngredients":"KETOCONAZOLE","strength":"2%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/20\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-20
        )

)

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