NDA 221109, held by Azurity. Lamotrigine Hemifumarate.
As of Nov 13, 2026, NDA 221109 (Lamlique), held by Azurity, was first approved by FDA on Sep 25, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 25, 2026 | Original applicationNew active ingredient · Standard review | Approved |
| LamliqueEQ 5MG BASE/ML · suspension;oral | Lamotrigine Hemifumarate | RxReference drug |
| LamliqueEQ 25MG BASE/ML · suspension;oral | Lamotrigine Hemifumarate | RxReference drug |
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
