LUPIN LTD FDA Approval ANDA 213145

ANDA 213145

LUPIN LTD

FDA Drug Application

Application #213145

Application Sponsors

ANDA 213145LUPIN LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL400MG0SEVELAMER HYDROCHLORIDESEVELAMER HYDROCHLORIDE
002TABLET;ORAL800MG0SEVELAMER HYDROCHLORIDESEVELAMER HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-06-16STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213145
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEVELAMER HYDROCHLORIDE","activeIngredients":"SEVELAMER HYDROCHLORIDE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SEVELAMER HYDROCHLORIDE","activeIngredients":"SEVELAMER HYDROCHLORIDE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/16\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-16
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.