ELITE LABS INC FDA Approval ANDA 214961

ANDA 214961

ELITE LABS INC

FDA Drug Application

Application #214961

Application Sponsors

ANDA 214961ELITE LABS INC

Marketing Status

Prescription001

Application Products

001FOR SOLUTION;ORAL500MG/PACKET0VIGABATRINVIGABATRIN

FDA Submissions

UNKNOWN; ORIG1AP2022-06-24STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

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
        )

)

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