ANDA 216151

NOVITIUM PHARMA

FDA Drug Application

Application #216151

Application Sponsors

ANDA 216151

NOVITIUM PHARMA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

10MG/ML

0

LACOSAMIDE

LACOSAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

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
        )

)