APR 9, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Lamotrigine (Labeling)
U.S. Food and Drug Administration
FDA supplemental approval of labeling changes for lamotrigine tablets; this is a regulatory action record, not a clinical trial, and does not report efficacy or safety trial data.
Reported
Approval date2026-04-09
Application numberANDA090170
Submission typeSupplemental—Labeling