LUPIN LTD FDA Approval ANDA 201513

ANDA 201513

LUPIN LTD

FDA Drug Application

Application #201513

Application Sponsors

ANDA 201513LUPIN LTD

Marketing Status

Prescription001
Prescription002

Application Products

001FOR SUSPENSION;ORAL800MG/PACKET0SEVELAMER CARBONATESEVELAMER CARBONATE
002FOR SUSPENSION;ORAL2.4GM/PACKET0SEVELAMER CARBONATESEVELAMER CARBONATE

FDA Submissions

N/A; Not ApplicableORIG1AP2021-12-23

Submissions Property Types

ORIG1Null19

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201513
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEVELAMER CARBONATE","activeIngredients":"SEVELAMER CARBONATE","strength":"800MG\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SEVELAMER CARBONATE","activeIngredients":"SEVELAMER CARBONATE","strength":"2.4GM\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-23
        )

)

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