ANDA 77428, held by Natco Pharma. Lamotrigine.
As of Nov 14, 2026, ANDA 77428 (Lamotrigine), held by Natco Pharma, was first approved by FDA on Jan 27, 2009, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 27, 2009 | Original application | Approved |
| Lamotrigine25MG · tablet;oral | Lamotrigine | Discontinued |
| Lamotrigine100MG · tablet;oral | Lamotrigine | Discontinued |
| Lamotrigine150MG · tablet;oral | Lamotrigine | Discontinued |
| Lamotrigine200MG · tablet;oral | Lamotrigine | Discontinued |
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
