Lamotrigine

ANDA 78134, held by Hikma Pharms. Lamotrigine.

As of Nov 14, 2026, ANDA 78134 (Lamotrigine), held by Hikma Pharms, was first approved by FDA on Apr 19, 2011, with 9 approved supplements and 0 published complete response letters.

First approved: Apr 19, 2011
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Apr 19, 2011	Original application	Approved	Letter

Products

4 strengths and forms


Lamotrigine25MG · tablet;oral	Lamotrigine	Discontinued
Lamotrigine100MG · tablet;oral	Lamotrigine	Discontinued
Lamotrigine150MG · tablet;oral	Lamotrigine	Discontinued
Lamotrigine200MG · tablet;oral	Lamotrigine	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Jun 15, 2022	Supplement 10Labeling · Standard review	Approved	None posted
Jun 15, 2022	Supplement 11Labeling · Standard review	Approved	None posted
Nov 21, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Nov 21, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Dec 14, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Dec 14, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Dec 14, 2014	Supplement 7Labeling · Standard review	Approved	None posted
May 17, 2012	Supplement 4Labeling	Approved	None posted
Sep 29, 2011	Supplement 2Labeling	Approved	None posted
Apr 19, 2011	Original application	Approved	Letter

Identifiers

Application: ANDA 78134
Drugs@FDA: Overview at FDA
Company: Hikma Pharmaceuticals

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