LUPIN LTD FDA Approval ANDA 204964

ANDA 204964

LUPIN LTD

FDA Drug Application

Application #204964

Documents

Letter2022-09-08

Application Sponsors

ANDA 204964LUPIN LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL100MG0RUFINAMIDERUFINAMIDE
002TABLET;ORAL200MG0RUFINAMIDERUFINAMIDE
003TABLET;ORAL400MG0RUFINAMIDERUFINAMIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-17STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

002PrescriptionAB
003PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204964
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RUFINAMIDE","activeIngredients":"RUFINAMIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"RUFINAMIDE","activeIngredients":"RUFINAMIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RUFINAMIDE","activeIngredients":"RUFINAMIDE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/17\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-17
        )

)

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