ANDA 214695

ALKEM LABS LTD

FDA Drug Application

Application #214695

Application Sponsors

ANDA 214695

ALKEM LABS LTD

Marketing Status

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

Application Products

001	UNKNOWN	UNKNOWN	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

2021-03-25

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214695
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/25\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-25
        )

)