ANDA 214677

FRESENIUS KABI USA

FDA Drug Application

Application #214677

Application Sponsors

ANDA 214677

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

200MG/20ML (10MG/ML)

0

LACOSAMIDE

LACOSAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-05-03

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214677
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"200MG\/20ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/03\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-03
        )

)