LUPIN LTD FDA Approval ANDA 211790

ANDA 211790

LUPIN LTD

FDA Drug Application

Application #211790

Application Sponsors

ANDA 211790LUPIN LTD

Marketing Status

Prescription001

Application Products

001FOR SOLUTION;ORAL500MG/PACKET0VIGABATRINVIGABATRIN

FDA Submissions

UNKNOWN; ORIG1AP2022-03-10STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211790
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIGABATRIN","activeIngredients":"VIGABATRIN","strength":"500MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/10\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-10
        )

)

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