Tofacitinib Citrate

ANDA 218900, held by Saptalis Pharms. Tofacitinib Citrate.

As of Nov 15, 2026, ANDA 218900 (Tofacitinib Citrate), held by Saptalis Pharms, was first approved by FDA on Jun 9, 2026, with 0 approved supplements and 0 published complete response letters.

First approved: Jun 9, 2026
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Tofacitinib oral solution is a Janus kinase (JAK) inhibitor. Tofacitinib oral solution is indicated for the treatment of pediatric patients 2 years of age and older with:

Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.
Active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use:
Use of tofacitinib oral solution for PsA or pcJIA in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.2, 1.4) 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Jun 9, 2026	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tofacitinib CitrateEQ 1MG BASE/ML · solution;oral	Tofacitinib Citrate	Rx

Identifiers

Application: ANDA 218900
Drugs@FDA: Overview at FDA
Company: Saptalis Pharmaceuticals

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