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FDA NDA · NDA203214

XELJANZ

tofacitinib

Sponsor: PF PRISM CV

APPLICATION
NDA203214
TYPE
NDA
ORIGINAL APPROVAL
2012-11-06
LATEST ACTION
2026-06-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

XELJANZ · ReferencePrescription
TOFACITINIB CITRATE EQ 10MG BASE · TABLET · ORAL
XELJANZ · ReferencePrescription
TOFACITINIB CITRATE EQ 5MG BASE · TABLET · ORAL

Approval history

2026-06-30Labeling · Supplement 43 · standard — Letter ↗AP
2026-03-06Efficacy · Supplement 41 · standard — Letter ↗AP
2025-10-16Efficacy · Supplement 39 · standard — Letter ↗AP
2025-02-21Efficacy · Supplement 38 · standard — Label ↗AP
2024-09-27Labeling · Supplement 36 · standard — Label ↗AP
2024-05-14Labeling · Supplement 34 · standard — Label ↗AP
2021-12-14Efficacy · Supplement 28 · standard — Label ↗AP
2021-12-02Labeling · Supplement 31 · standard — Label ↗AP
2020-09-25Efficacy · Supplement 26 · priority — Letter ↗AP
2019-12-12Labeling · Supplement 25 · standard — Label ↗AP
2019-08-30Labeling · Supplement 23 · standard — Letter ↗AP
2019-07-25Labeling · Supplement 24 · standard — Letter ↗AP
2018-10-18Labeling · Supplement 20 · standard — Label ↗AP
2018-08-17Labeling · Supplement 21 · standard — Letter ↗AP
2018-05-30Efficacy · Supplement 18 · standard — Label ↗AP
2017-12-14Efficacy · Supplement 17 · standard — Label ↗AP
2017-08-22Efficacy · Supplement 14 · standard — Label ↗AP
2017-08-22Labeling · Supplement 16 · standard — Label ↗AP
2016-02-08REMS · Supplement 13 — Review ↗AP
2015-12-22Labeling · Supplement 11 · standard — Label ↗AP
2015-06-19Labeling · Supplement 10 · standard — Label ↗AP
2015-02-11REMS · Supplement 8 — Review ↗AP
2014-05-07Labeling · Supplement 7 · standard — Letter ↗AP
2014-03-26Labeling · Supplement 5 · standard — Letter ↗AP
2014-02-21Efficacy · Supplement 4 · standard — Review ↗AP
2013-11-18Efficacy · Supplement 2 · standard — Label ↗AP
2013-11-08REMS · Supplement 6 — Letter ↗AP
2013-05-03Manufacturing (CMC) · Supplement 1 · standardAP
2012-11-06Type 1 - New Molecular Entity · 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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