Xeljanz

NDA 213082, held by Pfizer. Tofacitinib Citrate.

As of Nov 14, 2026, NDA 213082 (Xeljanz), held by Pfizer, was first approved by FDA on Sep 25, 2020, with 9 approved supplements and 0 published complete response letters.

First approved: Sep 25, 2020
Review: Priority
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

XELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) are Janus kinase (JAK) inhibitors. XELJANZ tablets and XELJANZ XR are indicated for the treatment of adult patients with:

Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers.
Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.
Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below


Mar 6, 2026	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 16, 2025	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 21, 2025	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 25, 2020	Original applicationNew dosage form · Priority review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
XeljanzEQ 1MG BASE/ML · solution;oral	Tofacitinib Citrate	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


Sep 16, 2026	Supplement 15Labeling · Standard review	Approved	Label Medication Guide Letter
Jun 30, 2026	Supplement 16Labeling · Standard review	Approved	Label Letter
Mar 6, 2026	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 16, 2025	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 21, 2025	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 27, 2024	Supplement 8Labeling · Standard review	Approved	Label Letter Letter
May 14, 2024	Supplement 6Labeling · Standard review	Approved	Letter Label
Dec 14, 2021	Supplement 3Labeling · Standard review	Approved	Letter Label
Dec 2, 2021	Supplement 4Labeling · Standard review	Approved	Letter Label
Sep 25, 2020	Original applicationNew dosage form · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 213082
Drugs@FDA: Overview at FDA
Company: Pfizer

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters