ANDA 77420, held by Rising. Lamotrigine.
As of Nov 14, 2026, ANDA 77420 (Lamotrigine), held by Rising, was first approved by FDA on Jan 27, 2009, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 27, 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 |
| May 15, 2026 | Supplement 21Labeling · Standard review | Approved | None posted |
| Aug 26, 2025 | Supplement 20Labeling · Standard review | Approved | None posted |
| Nov 20, 2019 | Supplement 18Labeling · Standard review | Approved | None posted |
| Nov 20, 2019 | Supplement 17Labeling · Standard review | Approved | None posted |
| Apr 13, 2017 | Supplement 16Labeling · Standard review | Approved | None posted |
| Apr 13, 2017 | Supplement 15Labeling · Standard review | Approved | None posted |
| Apr 13, 2017 | Supplement 13Labeling · Standard review | Approved | None posted |
| Apr 13, 2017 | Supplement 12Labeling · Standard review | Approved | None posted |
| Mar 16, 2012 | Supplement 11Labeling | Approved | None posted |
| Jan 10, 2011 | Supplement 8Labeling | Approved | None posted |
| Oct 30, 2010 | Supplement 5Labeling | Approved | None posted |
| Nov 25, 2009 | Supplement 1Labeling | Approved | None posted |
| Jan 27, 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
