ANDA 76388, held by Teva. Lamotrigine.
As of Nov 14, 2026, ANDA 76388 (Lamotrigine), held by Teva, was first approved by FDA on Aug 30, 2006, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 30, 2006 | Original application | Approved |
| Lamotrigine25MG · tablet;oral | Lamotrigine | Discontinued |
| Lamotrigine100MG · tablet;oral | Lamotrigine | Discontinued |
| Lamotrigine150MG · tablet;oral | Lamotrigine | Discontinued |
| Lamotrigine200MG · tablet;oral | Lamotrigine | Discontinued |
| Sep 30, 2016 | Supplement 26Labeling · Standard review | Approved | None posted |
| Sep 30, 2016 | Supplement 27Labeling · Standard review | Approved | None posted |
| Sep 30, 2016 | Supplement 28Labeling · Standard review | Approved | None posted |
| Sep 26, 2014 | Supplement 21Labeling · Standard review | Approved | None posted |
| Sep 26, 2014 | Supplement 23Labeling · Standard review | Approved | None posted |
| Sep 26, 2014 | Supplement 24Labeling · Standard review | Approved | None posted |
| Apr 30, 2012 | Supplement 19Labeling | Approved | None posted |
| Apr 30, 2012 | Supplement 20Labeling | Approved | None posted |
| Sep 29, 2011 | Supplement 17Labeling | Approved | None posted |
| Apr 28, 2010 | Supplement 13Labeling | Approved | None posted |
| Apr 28, 2010 | Supplement 14Labeling | Approved | None posted |
| Dec 20, 2009 | Supplement 12Labeling | Approved | None posted |
| Mar 14, 2008 | Supplement 6Labeling | Approved | None posted |
| Oct 31, 2007 | Supplement 1Labeling | Approved | None posted |
| Aug 30, 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
