ANDA 211199

ALKEM LABS LTD

FDA Drug Application

Application #211199

Application Sponsors

ANDA 211199

ALKEM LABS LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	200MG	0	ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE
002	TABLET;ORAL	400MG	0	ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE
003	TABLET;ORAL	600MG	0	ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE
004	TABLET;ORAL	800MG	0	ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-01-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211199
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESLICARBAZEPINE ACETATE","activeIngredients":"ESLICARBAZEPINE ACETATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ESLICARBAZEPINE ACETATE","activeIngredients":"ESLICARBAZEPINE ACETATE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ESLICARBAZEPINE ACETATE","activeIngredients":"ESLICARBAZEPINE ACETATE","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ESLICARBAZEPINE ACETATE","activeIngredients":"ESLICARBAZEPINE ACETATE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/28\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-28
        )

)