Lamotrigine

Treats bipolar I disorder. ANDA 200828, held by Impax Labs Inc. Lamotrigine.

As of Nov 14, 2026, ANDA 200828 (Lamotrigine), held by Impax Labs Inc, was first approved by FDA on Jul 15, 2013, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 15, 2013
Supplements approved: 7
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 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 AED. 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 8 submissions below

Date	Submission	Status	Documents
Jul 15, 2013	Original application	Approved	Letter

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

All 8 submissions, including labeling and manufacturing supplements


Oct 15, 2026	Supplement 14Labeling · Standard review	Approved	None posted
Oct 15, 2026	Supplement 13Labeling · Standard review	Approved	None posted
Oct 15, 2026	Supplement 10Labeling · Standard review	Approved	None posted
Oct 15, 2026	Supplement 9Labeling · Standard review	Approved	None posted
Jan 29, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Jan 29, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Jan 29, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Jul 15, 2013	Original application	Approved	Letter

Identifiers

Application: ANDA 200828
Drugs@FDA: Overview at FDA
Company: Impax 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