ANDA 219542, held by Ajanta Pharma Ltd. Tofacitinib Citrate.
As of Nov 15, 2026, ANDA 219542 (Tofacitinib Citrate), held by Ajanta Pharma Ltd, was first approved by FDA on Oct 19, 2026, with 2 approved supplements and 0 published complete response letters.
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. Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers.
| Oct 19, 2026 | Original application | Approved | None posted |
| Aug 19, 2025 | Original application | Approved | None posted |
| Tofacitinib CitrateEQ 11MG BASE · tablet, extended release;oral | Tofacitinib Citrate | Rx |
| Tofacitinib CitrateEQ 22MG BASE · tablet, extended release;oral | Tofacitinib Citrate | Rx |
| Oct 19, 2026 | Original application | Approved | None posted |
| Oct 8, 2026 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 8, 2026 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 19, 2025 | Original application | Approved | None posted |
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
