Lamotrigine

Treats bipolar I disorder. ANDA 217278, held by Alembic. Lamotrigine.

As of Nov 14, 2026, ANDA 217278 (Lamotrigine), held by Alembic, was first approved by FDA on Feb 25, 2026, with 0 approved supplements and 0 published complete response letters.

First approved: Feb 25, 2026
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lamotrigine orally disintegrating 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

Date	Submission	Status	Documents
Feb 25, 2026	Original application	Approved	None posted

Products

4 strengths and forms


Lamotrigine25MG · tablet, orally disintegrating;oral	Lamotrigine	Rx
Lamotrigine50MG · tablet, orally disintegrating;oral	Lamotrigine	Rx
Lamotrigine100MG · tablet, orally disintegrating;oral	Lamotrigine	Rx
Lamotrigine200MG · tablet, orally disintegrating;oral	Lamotrigine	Rx

Identifiers

Application: ANDA 217278
Drugs@FDA: Overview at FDA
Company: Alembic, LLC

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