← FDA DRUG APPROVALS

FDA NDA · NDA218347

RINVOQ

upadacitinib

Sponsor: ABBVIE

APPLICATION
NDA218347
TYPE
NDA
ORIGINAL APPROVAL
2024-04-26
LATEST ACTION
2026-06-30
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

RINVOQ LQ · ReferencePrescription
UPADACITINIB 1MG/ML · SOLUTION · ORAL

Approval history

2026-06-30Labeling · Supplement 8 · standard — Letter ↗AP
2025-10-10Labeling · Supplement 5 · standard — Label ↗AP
2025-08-19Manufacturing (CMC) · Supplement 3 · standard — Letter ↗AP
2025-03-26Labeling · Supplement 2 · standard — Label ↗AP
2024-04-26Type 3 - New Dosage Form · Original · standard — Label ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →