Lamotrigine

Treats bipolar I disorder. ANDA 200694, held by Alkem Labs Ltd. Lamotrigine.

As of Nov 14, 2026, ANDA 200694 (Lamotrigine), held by Alkem Labs Ltd, was first approved by FDA on Jun 14, 2013, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 14, 2013
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lamotrigine tablets are indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older:

partial-onset seizures.
primary generalized tonic-clonic (PGTC) seizures.
generalized seizures of Lennox-Gastaut syndrome. Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Jun 14, 2013	Original application	Approved	None posted

Products

4 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Oct 9, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Dec 6, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Dec 6, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Jun 14, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 200694
Drugs@FDA: Overview at FDA
Company: Alkem Laboratories

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