Lamotrigine

Treats bipolar I disorder. ANDA 90170, held by Unichem Labs Ltd. Lamotrigine.

As of Nov 14, 2026, ANDA 90170 (Lamotrigine), held by Unichem Labs Ltd, was first approved by FDA on Oct 6, 2011, with 13 approved supplements and 0 published complete response letters.

First approved: Oct 6, 2011
Supplements approved: 13
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 14 submissions below

Date	Submission	Status	Documents
Oct 6, 2011	Original application	Approved	Label Review

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 14 submissions, including labeling and manufacturing supplements


Apr 9, 2026	Supplement 42Labeling · Standard review	Approved	None posted
Aug 6, 2025	Supplement 39Labeling · Standard review	Approved	None posted
Jun 8, 2023	Supplement 34Labeling · Standard review	Approved	None posted
Jun 8, 2023	Supplement 30Labeling · Standard review	Approved	None posted
Jun 8, 2023	Supplement 29Labeling · Standard review	Approved	None posted
Jan 17, 2020	Supplement 25Labeling · Standard review	Approved	None posted
Jan 17, 2020	Supplement 23Labeling · Standard review	Approved	None posted
Jan 17, 2020	Supplement 21Labeling · Standard review	Approved	None posted
Jan 17, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Dec 10, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Dec 10, 2014	Supplement 6Labeling · Standard review	Approved	None posted
May 21, 2012	Supplement 2Labeling	Approved	None posted
Mar 27, 2012	Supplement 1Labeling	Approved	None posted
Oct 6, 2011	Original application	Approved	Label Review

Identifiers

Application: ANDA 90170
Drugs@FDA: Overview at FDA
Company: Unichem 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