← FDA DRUG APPROVALS

FDA NDA · NDA208246

XELJANZ XR

tofacitinib

Sponsor: PFIZER

APPLICATION
NDA208246
TYPE
NDA
ORIGINAL APPROVAL
2016-02-23
LATEST ACTION
2026-06-30
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

XELJANZ XR · ReferencePrescription
TOFACITINIB CITRATE EQ 11MG BASE · TABLET, EXTENDED RELEASE · ORAL
XELJANZ XR · ReferencePrescription
TOFACITINIB CITRATE EQ 22MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-06-30Labeling · Supplement 29 · standard — Letter ↗AP
2026-03-06Efficacy · Supplement 27 · standard — Letter ↗AP
2025-02-21Efficacy · Supplement 25 · standard — Label ↗AP
2024-09-27Labeling · Supplement 23 · standard — Label ↗AP
2024-05-14Labeling · Supplement 21 · standard — Label ↗AP
2021-12-14Efficacy · Supplement 13 · standard — Label ↗AP
2021-12-02Labeling · Supplement 17 · standard — Label ↗AP
2019-12-12Efficacy · Supplement 9 · standard — Letter ↗AP
2019-08-30Labeling · Supplement 11 · standard — Letter ↗AP
2019-07-25Labeling · Supplement 10 · standard — Letter ↗AP
2018-10-18Labeling · Supplement 6 · standard — Label ↗AP
2018-08-17Labeling · Supplement 7 · standard — Letter ↗AP
2017-12-14Efficacy · Supplement 3 · standard — Label ↗AP
2017-08-22Labeling · Supplement 2 · standard — Label ↗AP
2017-08-22Efficacy · Supplement 1 · standard — Label ↗AP
2016-02-23Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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