LUPIN LTD FDA Approval ANDA 205930

ANDA 205930

LUPIN LTD

FDA Drug Application

Application #205930

Application Sponsors

ANDA 205930LUPIN LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 5MG BASE0PRASUGREL HYDROCHLORIDEPRASUGREL
002TABLET;ORALEQ 10MG BASE0PRASUGREL HYDROCHLORIDEPRASUGREL

FDA Submissions

UNKNOWN; ORIG1AP2023-01-09STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205930
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRASUGREL HYDROCHLORIDE","activeIngredients":"PRASUGREL","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRASUGREL HYDROCHLORIDE","activeIngredients":"PRASUGREL","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/09\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-09
        )

)

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