Lamotrigine

Treats bipolar I disorder. ANDA 90401, held by Aurobindo Pharma. Lamotrigine.

As of Nov 14, 2026, ANDA 90401 (Lamotrigine), held by Aurobindo Pharma, was first approved by FDA on Nov 4, 2009, with 18 approved supplements and 0 published complete response letters.

First approved: Nov 4, 2009
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lamotrigine tablets for oral suspension 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 19 submissions below

Date	Submission	Status	Documents
Nov 4, 2009	Original application	Approved	None posted

Products

3 strengths and forms


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

All 19 submissions, including labeling and manufacturing supplements


Dec 31, 2025	Supplement 34Labeling · Standard review	Approved	None posted
Dec 31, 2025	Supplement 33Labeling · Standard review	Approved	None posted
Dec 31, 2025	Supplement 27Labeling · Standard review	Approved	None posted
Dec 31, 2025	Supplement 26Labeling · Standard review	Approved	None posted
Dec 6, 2019	Supplement 24Labeling · Standard review	Approved	None posted
Dec 6, 2019	Supplement 23Labeling · Standard review	Approved	None posted
Dec 6, 2019	Supplement 19Labeling · Standard review	Approved	None posted
Dec 6, 2019	Supplement 16Labeling · Standard review	Approved	None posted
Apr 18, 2017	Supplement 14Labeling · Standard review	Approved	None posted
Apr 18, 2017	Supplement 13Labeling · Standard review	Approved	None posted
Apr 18, 2017	Supplement 11Labeling · Standard review	Approved	None posted
Dec 5, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Dec 5, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Dec 5, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Dec 5, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Apr 25, 2012	Supplement 5Labeling	Approved	None posted
Sep 29, 2011	Supplement 3Labeling	Approved	None posted
Aug 13, 2010	Supplement 2Labeling	Approved	None posted
Nov 4, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 90401
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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