ANDA 211238

DR REDDYS LABS LTD

FDA Drug Application

Application #211238

Documents

• Letter: 2020-10-30

Application Sponsors

ANDA 211238

DR REDDYS LABS LTD

Marketing Status

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

2020-09-29

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

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

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211238
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESLICARBAZEPINE ACETATE","activeIngredients":"ESLICARBAZEPINE ACETATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/29\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-29
        )

)