NOVITIUM PHARMA FDA Approval ANDA 216151

ANDA 216151

NOVITIUM PHARMA

FDA Drug Application

Application #216151

Application Sponsors

ANDA 216151NOVITIUM PHARMA

Marketing Status

Prescription001

Application Products

001SOLUTION;ORAL10MG/ML0LACOSAMIDELACOSAMIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-26STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

CDER Filings

NOVITIUM PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216151
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"10MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-26
        )

)

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