DEXCEL PHARMA FDA Approval ANDA 214992

ANDA 214992

DEXCEL PHARMA

FDA Drug Application

Application #214992

Application Sponsors

ANDA 214992DEXCEL PHARMA

Marketing Status

Prescription001

Application Products

001FOR SOLUTION;ORAL500MG/PACKET0VIGABATRINVIGABATRIN

FDA Submissions

UNKNOWN; ORIG1AP2021-05-13STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

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
        )

)

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