FDA Approves Levetiracetam Oral Solution (ANDA078976)

The U.S. Food and Drug Administration (FDA) has granted approval for Abbreviated New Drug Application (ANDA) number 078976 covering Levetiracetam oral solution. The product is marketed as a prescription human drug by Actavis Pharma, Inc. Levetiracetam is supplied as an oral solution (100 MG/ML) with the package NDC 0472-0235-16 and route of administration listed as oral. It is classified pharmacologically under decreased central nervous system disorganized electrical activity. The approval follows an original submission (submission 1) that received an approval letter on 15 January 2009. Since then, multiple labeling supplements have been filed and approved (submissions 3, 4, 9, 11, 13, 15, 16, 17, and 22), with the most recent labeling approval dated 4 March 2025. A REMS supplement (submission 3) was also approved on 16 February 2010. All listed submissions carry an "AP" (approved) status, indicating the product meets FDA regulatory requirements for marketing as a prescription medication.