AURINIA PHARMACEUTICALS, INC. FDA Approval NDA 213716

NDA 213716

AURINIA PHARMACEUTICALS, INC.

FDA Drug Application

Application #213716

Documents

Letter2021-01-25
Label2021-01-27
Medication Guide2021-01-27
Review2021-02-24

Application Sponsors

NDA 213716AURINIA PHARMACEUTICALS, INC.

Marketing Status

Prescription001

Application Products

001CAPSULE; ORAL7.9MG0LUPKYNISVOCLOSPORIN

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-01-22PRIORITY

Submissions Property Types

ORIG1Null2

CDER Filings

AURINIA PHARMACEUTICALS, INC.
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213716
            [companyName] => AURINIA PHARMACEUTICALS, INC.
            [docInserts] => ["",""]
            [products] => [{"drugName":"LUPKYNIS","activeIngredients":"VOCLOSPORIN","strength":"7.9MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213716Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-22
        )

)

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