ANDA 209301

HETERO LABS UNIT III

FDA Drug Application

Application #209301

Application Sponsors

ANDA 209301

HETERO LABS UNIT III

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;ORAL

10MG/ML

0

LACOSAMIDE

LACOSAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-05-09

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AA

CDER Filings

HETERO LABS UNIT III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209301
            [companyName] => HETERO LABS UNIT III
            [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":"05\/09\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-09
        )

)