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FDA NDA · NDA211675

RINVOQ

upadacitinib

Sponsor: ABBVIE

APPLICATION
NDA211675
TYPE
NDA
ORIGINAL APPROVAL
2019-08-16
LATEST ACTION
2026-06-30
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

RINVOQ · ReferencePrescription
UPADACITINIB 30MG · TABLET, EXTENDED RELEASE · ORAL
RINVOQ · ReferencePrescription
UPADACITINIB 45MG · TABLET, EXTENDED RELEASE · ORAL
RINVOQ · ReferencePrescription
UPADACITINIB 15MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-06-30Labeling · Supplement 34 · standard — Letter ↗AP
2025-10-10Efficacy · Supplement 28 · standard — Label ↗AP
2025-08-12Manufacturing (CMC) · Supplement 29 — Label ↗AP
2025-04-28Efficacy · Supplement 25 · standard — Label ↗AP
2025-03-26Labeling · Supplement 27 · standard — Label ↗AP
2024-04-26Efficacy · Supplement 22 · standard — Label ↗AP
2024-04-26Efficacy · Supplement 21 · standard — Label ↗AP
2023-11-14Labeling · Supplement 19 · standard — Letter ↗AP
2023-06-22Efficacy · Supplement 17 · standard — Letter ↗AP
2023-05-18Efficacy · Supplement 15 · standard — Label ↗AP
2023-04-10Labeling · Supplement 12 · standard — Label ↗AP
2022-10-21Efficacy · Supplement 10 · standard — Letter ↗AP
2022-04-29Efficacy · Supplement 3 · standard — Label ↗AP
2022-03-16Efficacy · Supplement 7 · priority — Letter ↗AP
2022-01-14Efficacy · Supplement 4 · priority — Letter ↗AP
2021-12-14Efficacy · Supplement 2 · standard — Label ↗AP
2021-12-14Labeling · Supplement 5 · standard — Label ↗AP
2021-12-02Labeling · Supplement 8 · standard — Letter ↗AP
2020-07-10Labeling · Supplement 1 · standard — Label ↗AP
2019-08-16Type 1 - New Molecular Entity · Original · priority — Label ↗AP
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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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