ANDA 218668, held by Dexcel. Tofacitinib Citrate.
As of Nov 15, 2026, ANDA 218668 (Tofacitinib Citrate), held by Dexcel, was first approved by FDA on Nov 10, 2026, with 3 approved supplements and 0 published complete response letters.
Tofacitinib is a Janus kinase (JAK) inhibitor: 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. Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers.
| Nov 10, 2026 | Original application | Approved | |
| Dec 16, 2024 | Original application | Approved |
| Tofacitinib CitrateEQ 11MG BASE · tablet, extended release;oral | Tofacitinib Citrate | Rx |
| Tofacitinib CitrateEQ 22MG BASE · tablet, extended release;oral | Tofacitinib Citrate | Rx |
| Nov 10, 2026 | Original application | Approved | |
| Oct 26, 2026 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 26, 2026 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 26, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Dec 16, 2024 | Original application | Approved |
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
