ENCUBE FDA Approval ANDA 212984

ANDA 212984

ENCUBE

FDA Drug Application

Application #212984

Application Sponsors

ANDA 212984ENCUBE

Marketing Status

Prescription001

Application Products

001GEL;TRANSDERMAL50MG/5GM PACKET0TESTOSTERONETESTOSTERONE

FDA Submissions

UNKNOWN; ORIG1AP2021-11-09STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB1

CDER Filings

ENCUBE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212984
            [companyName] => ENCUBE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESTOSTERONE","activeIngredients":"TESTOSTERONE","strength":"50MG\/5GM PACKET","dosageForm":"GEL;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/09\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-09
        )

)

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