HIKMA FDA Approval ANDA 213104

ANDA 213104

HIKMA

FDA Drug Application

Application #213104

Application Sponsors

ANDA 213104HIKMA

Marketing Status

Prescription001

Application Products

001TABLET;ORAL500MG0VIGABATRINVIGABATRIN

FDA Submissions

UNKNOWN; ORIG1AP2022-08-29STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213104
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIGABATRIN","activeIngredients":"VIGABATRIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/29\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-29
        )

)

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