Lamotrigine

Treats bipolar I disorder. ANDA 201168, held by Alembic. Lamotrigine.

As of Nov 14, 2026, ANDA 201168 (Lamotrigine), held by Alembic, was first approved by FDA on Jun 12, 2014, with 11 approved supplements and 0 published complete response letters.

First approved: Jun 12, 2014
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lamotrigine is 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 12 submissions below

Date	Submission	Status	Documents
Jun 12, 2014	Original application	Approved	None posted

Products

2 strengths and forms


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

All 12 submissions, including labeling and manufacturing supplements


Jan 30, 2026	Supplement 29Labeling · Standard review	Approved	None posted
Jan 30, 2026	Supplement 27Labeling · Standard review	Approved	None posted
Jan 30, 2026	Supplement 21Labeling · Standard review	Approved	None posted
Jan 30, 2026	Supplement 19Labeling · Standard review	Approved	None posted
Jan 30, 2026	Supplement 18Labeling · Standard review	Approved	None posted
Dec 17, 2019	Supplement 14Labeling · Standard review	Approved	None posted
Dec 17, 2019	Supplement 13Labeling · Standard review	Approved	None posted
Dec 17, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Dec 29, 2017	Supplement 4Labeling · Standard review	Approved	None posted
Dec 29, 2017	Supplement 3Labeling · Standard review	Approved	None posted
Dec 29, 2017	Supplement 1Labeling · Standard review	Approved	None posted
Jun 12, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 201168
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