ANDA 218462, held by Aurobindo Pharma Ltd. Tofacitinib Citrate.
As of Nov 15, 2026, ANDA 218462 (Tofacitinib Citrate), held by Aurobindo Pharma Ltd, was first approved by FDA on Jun 3, 2024, 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 3, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tofacitinib CitrateEQ 11MG BASE · tablet, extended release;oral | Tofacitinib Citrate | Rx |
| Jul 18, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 14, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 3, 2024 | 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
