ANDA 214748

SUNSHINE

FDA Drug Application

Application #214748

Documents

• Letter: 2022-08-01

Application Sponsors

ANDA 214748

SUNSHINE

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 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

AP

2022-06-09

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

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

CDER Filings

SUNSHINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214748
            [companyName] => SUNSHINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/09\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-09
        )

)