Lamotrigine

ANDA 76630, held by Pharmobedient. Lamotrigine.

As of Nov 14, 2026, ANDA 76630 (Lamotrigine), held by Pharmobedient, was first approved by FDA on Jan 22, 2009, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 22, 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
Jan 22, 2009	Original application	Approved	None posted

Products

2 strengths and forms


Lamotrigine5MG · tablet, for suspension;oral	Lamotrigine	Discontinued
Lamotrigine25MG · tablet, for suspension;oral	Lamotrigine	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Mar 19, 2012	Supplement 5Labeling	Approved	None posted
Apr 25, 2011	Supplement 4Labeling	Approved	None posted
Apr 27, 2010	Supplement 1Labeling	Approved	None posted
Jan 22, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 76630
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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