ANDA 214918

LUPIN LTD

FDA Drug Application

Application #214918

Documents

• Letter: 2021-09-02

Application Sponsors

ANDA 214918

LUPIN LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004
• None (Tentative Approval): 005

Application Products

001	TABLET;ORAL	10MG	0	BRIVARACETAM	BRIVARACETAM
002	TABLET;ORAL	25MG	0	BRIVARACETAM	BRIVARACETAM
003	TABLET;ORAL	50MG	0	BRIVARACETAM	BRIVARACETAM
004	TABLET;ORAL	75MG	0	BRIVARACETAM	BRIVARACETAM
005	TABLET;ORAL	100MG	0	BRIVARACETAM	BRIVARACETAM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-08-13

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

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

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214918
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/13\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-13
        )

)