ANDA 76420, held by Teva. Lamotrigine.
As of Nov 14, 2026, ANDA 76420 (Lamotrigine), held by Teva, was first approved by FDA on Jun 21, 2006, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 21, 2006 | Original application | Approved |
| Lamotrigine5MG · tablet, for suspension;oral | Lamotrigine | Discontinued |
| Lamotrigine25MG · tablet, for suspension;oral | Lamotrigine | Discontinued |
| Sep 20, 2016 | Supplement 18Labeling · Standard review | Approved | None posted |
| Sep 20, 2016 | Supplement 17Labeling · Standard review | Approved | None posted |
| Sep 20, 2016 | Supplement 16Labeling · Standard review | Approved | None posted |
| Sep 26, 2014 | Supplement 15Labeling · Standard review | Approved | None posted |
| Sep 26, 2014 | Supplement 14Labeling · Standard review | Approved | None posted |
| Sep 26, 2014 | Supplement 12Labeling · Standard review | Approved | None posted |
| Apr 28, 2012 | Supplement 11Labeling | Approved | None posted |
| Apr 28, 2012 | Supplement 10Labeling | Approved | None posted |
| Apr 28, 2012 | Supplement 9Labeling | Approved | None posted |
| Nov 2, 2010 | Supplement 8Labeling | Approved | None posted |
| Jul 28, 2010 | Supplement 6Labeling | Approved | None posted |
| Apr 28, 2010 | Supplement 7Labeling | Approved | None posted |
| Oct 31, 2007 | Supplement 3Labeling | Approved | None posted |
| Mar 12, 2007 | Supplement 1Labeling | Approved | None posted |
| Jun 21, 2006 | Original application | Approved |
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
