Tofacitinib Citrate

ANDA 216001, held by Sinotherapeutics Inc. Tofacitinib Citrate.

As of Nov 15, 2026, ANDA 216001 (Tofacitinib Citrate), held by Sinotherapeutics Inc, was first approved by FDA on Sep 30, 2025, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 30, 2025
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Tofacitinib extended-release tablets are Janus kinase (JAK) inhibitors. Tofacitinib extended-release tablets 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 4 submissions below


Sep 30, 2025	Original application	Approved	None posted
Sep 30, 2025	Original application	Tentative approval	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tofacitinib CitrateEQ 11MG BASE · tablet, extended release;oral	Tofacitinib Citrate	Rx

All 4 submissions, including labeling and manufacturing supplements


Oct 14, 2026	Supplement 2Labeling · Standard review	Approved	None posted
Oct 14, 2026	Supplement 3Labeling · Standard review	Approved	None posted
Sep 30, 2025	Original application	Approved	None posted
Sep 30, 2025	Original application	Tentative approval	None posted

Identifiers

Application: ANDA 216001
Drugs@FDA: Overview at FDA
Company: Sinotherapeutics

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