ANDA 214992

DEXCEL PHARMA

FDA Drug Application

Application #214992

Application Sponsors

ANDA 214992

DEXCEL PHARMA

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

500MG/PACKET

0

VIGABATRIN

VIGABATRIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2021-05-13	STANDARD
REMS; REMS	SUPPL	2	AP	2022-10-12

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

AA

CDER Filings

DEXCEL PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214992
            [companyName] => DEXCEL PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIGABATRIN","activeIngredients":"VIGABATRIN","strength":"500MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-13
        )

)