LUPIN LTD FDA Approval ANDA 201354

ANDA 201354

LUPIN LTD

FDA Drug Application

Application #201354

Application Sponsors

ANDA 201354LUPIN LTD

Marketing Status

Prescription001

Application Products

001TABLET;ORAL625MG0COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDE

FDA Submissions

N/A; Not ApplicableORIG1AP2020-12-17

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201354
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLESEVELAM HYDROCHLORIDE","activeIngredients":"COLESEVELAM HYDROCHLORIDE","strength":"625MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-17
        )

)

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