ANDA 214264, held by Zydus Pharms. Tofacitinib Citrate.
As of Nov 15, 2026, ANDA 214264 (Tofacitinib Citrate), held by Zydus Pharms, was first approved by FDA on Aug 19, 2021, with 0 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 19, 2021 | 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 |
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
