ANDA 202498, held by Sciegen Pharms. Lamotrigine.
As of Nov 14, 2026, ANDA 202498 (Lamotrigine), held by Sciegen Pharms, was first approved by FDA on Jan 4, 2013, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 4, 2013 | Original application | Approved | None posted |
| Lamotrigine25MG · tablet, extended release;oral | Lamotrigine | Rx |
| Lamotrigine50MG · tablet, extended release;oral | Lamotrigine | Rx |
| Lamotrigine100MG · tablet, extended release;oral | Lamotrigine | Rx |
| Lamotrigine200MG · tablet, extended release;oral | Lamotrigine | Rx |
| Lamotrigine300MG · 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
