NDA 22509, held by Smithkline Beecham. Lamotrigine.
As of Nov 15, 2026, NDA 22509 (Lamictal Xr), held by Smithkline Beecham, was first approved by FDA on Jan 29, 2010, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 29, 2010 | Original applicationNew dosage form · Standard review | Approved |
| Lamictal Xr25MG · tablet, extended release; oral | Lamotrigine | Rx |
| Lamictal Xr50MG · tablet, extended release; oral | Lamotrigine | Rx |
| Lamictal Xr100MG · tablet, extended release; oral | Lamotrigine | Rx |
| Lamictal Xr200MG · tablet, extended release; oral | Lamotrigine | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
