ANDA 214672

ALKEM LABS LTD

FDA Drug Application

Application #214672

Documents

• Letter: 2022-08-25

Application Sponsors

ANDA 214672

ALKEM LABS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

UNKNOWN

UNKNOWN

0

LACOSAMIDE

LACOSAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-03-12

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AA

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214672
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/12\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-12
        )

)