ENCUBE FDA Approval ANDA 212385

ANDA 212385

ENCUBE

FDA Drug Application

Application #212385

Application Sponsors

ANDA 212385ENCUBE

Marketing Status

Over-the-counter001

Application Products

001CREAM;TOPICAL10%0DOCOSANOLDOCOSANOL

FDA Submissions

UNKNOWN; ORIG1AP2022-10-07STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

ENCUBE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212385
            [companyName] => ENCUBE
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOCOSANOL","activeIngredients":"DOCOSANOL","strength":"10%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-07
        )

)

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