ANDA 209829, held by Zydus Pharms. Tofacitinib Citrate.
As of Nov 15, 2026, ANDA 209829 (Tofacitinib Citrate), held by Zydus Pharms, was first approved by FDA on Jun 5, 2026, with 0 approved supplements and 0 published complete response letters.
Tofacitinib tablets are Janus kinase (JAK) inhibitors. Tofacitinib 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.
| Jun 5, 2026 | Original application | Approved | None posted |
| Mar 14, 2023 | Original application | Approved |
| Tofacitinib CitrateEQ 5MG BASE · tablet;oral | Tofacitinib Citrate | Rx |
| Tofacitinib CitrateEQ 10MG BASE · tablet;oral | Tofacitinib Citrate | Rx |
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
