ANDA 206355

APOTEX INC

FDA Drug Application

Application #206355

Application Sponsors

ANDA 206355

APOTEX INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;ORAL

10MG/ML

0

LACOSAMIDE

LACOSAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-08-16

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AA

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206355
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"10MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/16\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-08-16
        )

)