ANNORA PHARMA FDA Approval ANDA 213519

ANDA 213519

ANNORA PHARMA

FDA Drug Application

Application #213519

Application Sponsors

ANDA 213519ANNORA PHARMA

Marketing Status

Prescription001

Application Products

001FOR SOLUTION;ORAL500MG/PACKET0VIGABATRINVIGABATRIN

FDA Submissions

UNKNOWN; ORIG1AP2021-01-26STANDARD
REMS; REMSSUPPL2AP2022-10-12

Submissions Property Types

ORIG1Null7
SUPPL2Null15

TE Codes

001PrescriptionAA

CDER Filings

ANNORA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213519
            [companyName] => ANNORA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIGABATRIN","activeIngredients":"VIGABATRIN","strength":"500MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-26
        )

)

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