LUPIN LTD FDA Approval ANDA 213457

ANDA 213457

LUPIN LTD

FDA Drug Application

Application #213457

Application Sponsors

ANDA 213457LUPIN LTD

Marketing Status

Prescription001

Application Products

001SUSPENSION;ORAL40MG/ML0RUFINAMIDERUFINAMIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-12-18STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213457
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RUFINAMIDE","activeIngredients":"RUFINAMIDE","strength":"40MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-18
        )

)

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