LUPIN LTD FDA Approval ANDA 211636

ANDA 211636

LUPIN LTD

FDA Drug Application

Application #211636

Application Sponsors

ANDA 211636LUPIN LTD

Marketing Status

Prescription001

Application Products

001TABLET;ORAL200MG0ALBENDAZOLEALBENDAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2020-06-10STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211636
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBENDAZOLE","activeIngredients":"ALBENDAZOLE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-10
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.