Amneal wins two labeling supplement approvals for extended-release Lamotrigine ANDA
FDA approved two labeling supplements for Amneal's generic extended-release Lamotrigine tablets, both dated August 5, 2026.
Amneal Pharmaceuticals received back-to-back FDA labeling approvals this week for its extended-release Lamotrigine tablets under ANDA207497.
- Supplement number 23 for LAMOTRIGINE (ANDA207497), a labeling submission covering extended-release tablets in strengths of 25MG, 50MG, 100MG, 200MG, 250MG and 300MG, was approved with a status date of 2026-08-05.1
- Supplement number 25 for the same ANDA207497 extended-release Lamotrigine tablet line, also a labeling submission spanning the 25MG through 300MG strengths, was likewise approved effective 2026-08-05.2
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