FDA Approves Mylan Generic Levetiracetam Tablets (ANDA 076919)

The U.S. Food and Drug Administration has approved the Abbreviated New Drug Application (ANDA) 076919 submitted by Mylan Pharmaceuticals Inc. for generic levetiracetam tablets. The approval covers oral tablets in three strengths – 250 mg (listed as discontinued), 500 mg, and 750 mg – all intended for prescription use. FDA labeling submissions (numbers 13, 15, 17, 19, 21, 25, 31) were all approved on 10 February 2025, confirming the product’s labeling and marketing status. The products are identified under NDC codes 0378‑5615‑05, 0378‑5615‑78, 0378‑5617‑05, 0378‑5617‑78, and 0378‑5619‑91.