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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213716
Company: AURINIA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUPKYNIS VOCLOSPORIN 7.9MG CAPSULE;ORAL Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/22/2021 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213716s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213716Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000TOC.html
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/08/2025 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213716s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213716Orig1s008ltr.pdf
04/29/2024 SUPPL-4 Labeling-Medication Guide, Efficacy-Labeling Change With Clinical Data, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213716s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213716Orig1s004ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/08/2025 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213716s008lbl.pdf
10/08/2025 SUPPL-8 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213716s008lbl.pdf
04/29/2024 SUPPL-4 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213716s004lbl.pdf
04/29/2024 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213716s004lbl.pdf
04/29/2024 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213716s004lbl.pdf
01/22/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213716s000lbl.pdf
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