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FDA NDA · NDA213716

LUPKYNIS

Sponsor: AURINIA

APPLICATION
NDA213716
TYPE
NDA
ORIGINAL APPROVAL
2021-01-22
LATEST ACTION
2025-10-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

LUPKYNIS · ReferencePrescription
VOCLOSPORIN 7.9MG · CAPSULE · ORAL

Approval history

2025-10-08Labeling · Supplement 8 · standard — Label ↗AP
2024-04-29Efficacy · Supplement 4 · standard — Letter ↗AP
2021-01-22Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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