NDA 213716

AURINIA PHARMACEUTICALS, INC.

FDA Drug Application

Application #213716

Documents

• Letter: 2021-01-25
• Label: 2021-01-27
• Medication Guide: 2021-01-27
• Review: 2021-02-24

Application Sponsors

NDA 213716

AURINIA PHARMACEUTICALS, INC.

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE; ORAL

7.9MG

0

LUPKYNIS

VOCLOSPORIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-01-22

PRIORITY

Submissions Property Types

ORIG

1

Null

2

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
        )

)