Treats active rheumatoid arthritis (RA). ANDA 213652, held by Aurobindo Pharma. Leflunomide.
As of Nov 14, 2026, ANDA 213652 (Leflunomide), held by Aurobindo Pharma, was first approved by FDA on Mar 29, 2021, 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 |
|---|---|---|---|
| Mar 29, 2021 | Original application | Approved | None posted |
| Leflunomide10MG · tablet;oral | Leflunomide | Rx |
| Leflunomide20MG · tablet;oral | Leflunomide | Rx |
| Sep 26, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 29, 2021 | 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
