NOVITIUM PHARMA FDA Approval ANDA 213479

ANDA 213479

NOVITIUM PHARMA

FDA Drug Application

Application #213479

Application Sponsors

ANDA 213479NOVITIUM PHARMA

Marketing Status

Prescription001

Application Products

001TABLET;ORAL2MG0LEVORPHANOL TARTRATELEVORPHANOL TARTRATE

FDA Submissions

UNKNOWN; ORIG1AP2020-07-01STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

NOVITIUM PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213479
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVORPHANOL TARTRATE","activeIngredients":"LEVORPHANOL TARTRATE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-01
        )

)

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