Treats active rheumatoid arthritis (RA). ANDA 212453, held by Abhai LLC. Leflunomide.
As of Nov 14, 2026, ANDA 212453 (Leflunomide), held by Abhai LLC, was first approved by FDA on Jun 3, 2019, with 0 approved supplements and 0 published complete response letters.
Leflunomide tablets are indicated for the treatment of adults with active rheumatoid arthritis (RA).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 3, 2019 | Original application | Approved | None posted |
| Leflunomide10MG · tablet;oral | Leflunomide | Rx |
| Leflunomide20MG · tablet;oral | Leflunomide | 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
