ANDA 209738, held by Micro Labs. Tofacitinib Citrate.
As of Nov 15, 2026, ANDA 209738 (Tofacitinib Citrate), held by Micro Labs, was first approved by FDA on Jun 3, 2026, with 1 approved supplement 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 3, 2026 | Original application | Approved | None posted |
| Mar 13, 2023 | Original application | Approved |
| Tofacitinib CitrateEQ 5MG BASE · tablet;oral | Tofacitinib Citrate | Rx |
| Tofacitinib CitrateEQ 10MG BASE · tablet;oral | Tofacitinib Citrate | Rx |
| Jun 3, 2026 | Original application | Approved | None posted |
| Jul 21, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 13, 2023 | 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
