Drug application

LUPKYNIS (VOCLOSPORIN)

Drugs@FDA NDA 213716 · AURINIA

Key facts

Drug name LUPKYNIS
Active ingredients VOCLOSPORIN
Application type NDA
Application number 213716
Company AURINIA
Dosage forms CAPSULE, ORAL
Strength 7.9MG
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Jan 22, 2021

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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