Lamotrigine

For partial-onset seizures. ANDA 207497, held by Amneal Pharms. Lamotrigine.

As of Nov 14, 2026, ANDA 207497 (Lamotrigine), held by Amneal Pharms, was first approved by FDA on Nov 30, 2018, with 6 approved supplements and 0 published complete response letters.

First approved: Nov 30, 2018
Review: Standard
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lamotrigine extended-release tablets are indicated for: adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Nov 30, 2018	Original application	Approved	None posted

Products

6 strengths and forms


Lamotrigine25MG · tablet, extended release;oral	Lamotrigine	Rx
Lamotrigine50MG · tablet, extended release;oral	Lamotrigine	Rx
Lamotrigine100MG · tablet, extended release;oral	Lamotrigine	Rx
Lamotrigine200MG · tablet, extended release;oral	Lamotrigine	Rx
Lamotrigine250MG · tablet, extended release;oral	Lamotrigine	Rx
Lamotrigine300MG · tablet, extended release;oral	Lamotrigine	Rx

All 7 submissions, including labeling and manufacturing supplements


Aug 5, 2026	Supplement 23Labeling · Standard review	Approved	None posted
Aug 5, 2026	Supplement 25Labeling · Standard review	Approved	None posted
Dec 26, 2024	Supplement 14Labeling · Standard review	Approved	None posted
Feb 11, 2021	Supplement 11Labeling · Standard review	Approved	None posted
Jun 9, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Jun 9, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Nov 30, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 207497
Drugs@FDA: Overview at FDA
Company: Amneal 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