ANDA 214875

APOTEX INC

FDA Drug Application

Application #214875

Documents

• Letter: 2022-08-30

Application Sponsors

ANDA 214875

APOTEX INC

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

2022-07-12

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214875
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/12\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-12
        )

)