FDA Approves Multiple Labeling Updates for Levetiracetam Oral Solution

The FDA’s drug approval database lists an oral solution of Levetiracetam (100 mg/mL) under product number 001. The product is marked as discontinued and is not a reference drug. Since the original approval (submission 1, ORIG) on 17 Oct 2011, the agency has approved a series of labeling supplement (SUPPL) submissions for this product. Approved submissions include numbers 1 (03 Nov 2014), 3 (12 Mar 2013), 6 (03 Nov 2014), 9 (24 Dec 2015), 10 (24 Dec 2015), 13 (16 Mar 2023), 14 (16 Mar 2023), 15 (date incomplete), 18 (16 Mar 2023), 20 (16 Mar 2023), 22 (24 Oct 2023), and 23 (22 Nov 2024). All listed submissions have a status of AP (Approved) and pertain to labeling updates.