Lamotrigine

ANDA 78310, held by Zennova. Lamotrigine.

As of Nov 14, 2026, ANDA 78310 (Lamotrigine), held by Zennova, was first approved by FDA on Feb 4, 2009, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 4, 2009
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Feb 4, 2009	Original application	Approved	None posted

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 4 submissions, including labeling and manufacturing supplements


Dec 7, 2014	Supplement 3Labeling · Standard review	Approved	None posted
May 21, 2012	Supplement 2Labeling · Standard review	Approved	None posted
Sep 29, 2011	Supplement 1Labeling	Approved	None posted
Feb 4, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78310
Drugs@FDA: Overview at FDA
Company: Zennova

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