ANDA 78443, held by Pharmobedient. Lamotrigine.
As of Nov 14, 2026, ANDA 78443 (Lamotrigine), held by Pharmobedient, was first approved by FDA on Feb 11, 2009, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 11, 2009 | Original application | Approved | None posted |
| Lamotrigine25MG · tablet;oral | Lamotrigine | Discontinued |
| Lamotrigine100MG · tablet;oral | Lamotrigine | Discontinued |
| Lamotrigine150MG · tablet;oral | Lamotrigine | Discontinued |
| Lamotrigine200MG · tablet;oral | Lamotrigine | Discontinued |
| Jun 23, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 12, 2016 | Supplement 1Labeling | Approved | None posted |
| Feb 11, 2009 | Original application | Approved | None posted |
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
