FDA Approves Zydus Lifesciences’ Generic Leflunomide Tablets (ANDA212308)

The U.S. Food and Drug Administration has approved an Abbreviated New Drug Application (ANDA) numbered 212308 for generic leflunomide tablets submitted by Zydus Lifesciences Limited and Zydus Pharmaceuticals (USA) Inc. The approved products are oral tablets available in two strengths: 10 mg and 20 mg. Both strengths are classified as prescription‑only human drugs and are listed under the National Drug Code (NDC) series 70771‑1491 and 70771‑1492, as well as 70710‑1157 and 70710‑1158. The original submission was filed as an “ORIG” type on April 26, 2019, with the FDA issuing an approval letter on April 24, 2019. A supplemental labeling submission (type “SUPPL”) received approval status on September 26, 2024. Leflunomide is classified as an antirheumatic agent and the generic product is marketed under the brand name “LEFLUNOMIDE.”