ANDA 214961

ELITE LABS INC

FDA Drug Application

Application #214961

Application Sponsors

ANDA 214961

ELITE LABS INC

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

500MG/PACKET

0

VIGABATRIN

VIGABATRIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-06-24

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

ELITE LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214961
            [companyName] => ELITE LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIGABATRIN","activeIngredients":"VIGABATRIN","strength":"500MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VIGABATRIN","submission":"VIGABATRIN","actionType":"500MG\/PACKET","submissionClassification":"FOR SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)