ANDA 204999

TEVA PHARMS USA

FDA Drug Application

Application #204999

Application Sponsors

ANDA 204999

TEVA PHARMS USA

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004

Application Products

001	TABLET;ORAL	50MG	0	LACOSAMIDE	LACOSAMIDE
002	TABLET;ORAL	100MG	0	LACOSAMIDE	LACOSAMIDE
003	TABLET;ORAL	150MG	0	LACOSAMIDE	LACOSAMIDE
004	TABLET;ORAL	200MG	0	LACOSAMIDE	LACOSAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-02-28

STANDARD

Submissions Property Types

ORIG

1

Null

1

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204999
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/28\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-02-28
        )

)