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
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2022-11-16UNKNOWN

Submissions Property Types

ORIG1Null15
SUPPL2Null7

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
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.