Documents
Application Sponsors
NDA 213716 | AURINIA PHARMACEUTICALS, INC. | |
Marketing Status
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
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
)
)