Lamotrigine

Treats bipolar I disorder. ANDA 90607, held by Alembic Pharms Ltd. Lamotrigine.

As of Nov 14, 2026, ANDA 90607 (Lamotrigine), held by Alembic Pharms Ltd, was first approved by FDA on Jan 13, 2011, with 19 approved supplements and 0 published complete response letters.

First approved: Jan 13, 2011
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. 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 20 submissions below

Date	Submission	Status	Documents
Jan 13, 2011	Original application	Approved	Letter

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 20 submissions, including labeling and manufacturing supplements


Apr 13, 2026	Supplement 41Labeling · Standard review	Approved	None posted
Apr 13, 2026	Supplement 38Labeling · Standard review	Approved	None posted
Jul 27, 2022	Supplement 29Labeling · Standard review	Approved	None posted
Jul 27, 2022	Supplement 28Labeling · Standard review	Approved	None posted
Jul 27, 2022	Supplement 26Labeling · Standard review	Approved	None posted
Jan 15, 2020	Supplement 20Labeling · Standard review	Approved	None posted
Jan 15, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Jan 15, 2020	Supplement 17Labeling · Standard review	Approved	None posted
Sep 2, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Sep 2, 2016	Supplement 10Labeling · Standard review	Approved	None posted
Sep 2, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Sep 2, 2016	Supplement 8Labeling · Standard review	Approved	None posted
Dec 12, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Dec 12, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Dec 12, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Dec 12, 2014	Supplement 4Labeling · Standard review	Approved	None posted
May 18, 2012	Supplement 3Labeling	Approved	None posted
Mar 15, 2012	Supplement 2Labeling	Approved	None posted
Mar 15, 2012	Supplement 1Labeling	Approved	None posted
Jan 13, 2011	Original application	Approved	Letter

Identifiers

Application: ANDA 90607
Drugs@FDA: Overview at FDA
Company: Alembic 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