Treats active rheumatoid arthritis (RA). ANDA 212308, held by Zydus Lifesciences. Leflunomide.
As of Nov 14, 2026, ANDA 212308 (Leflunomide), held by Zydus Lifesciences, was first approved by FDA on Apr 24, 2019, with 1 approved supplement and 0 published complete response letters.
Leflunomide tablets are indicated for the treatment of adults with active rheumatoid arthritis (RA).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 24, 2019 | Original application | Approved |
| Leflunomide10MG · tablet;oral | Leflunomide | Rx |
| Leflunomide20MG · tablet;oral | Leflunomide | Rx |
| Sep 26, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 24, 2019 | 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
