Lamotrigine

Treats bipolar I disorder. ANDA 78625, held by Rubicon Research. Lamotrigine.

As of Nov 14, 2026, ANDA 78625 (Lamotrigine), held by Rubicon Research, was first approved by FDA on Jan 27, 2009, with 12 approved supplements and 0 published complete response letters.

First approved: Jan 27, 2009
Supplements approved: 12
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 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 13 submissions below

Date	Submission	Status	Documents
Jan 27, 2009	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 13 submissions, including labeling and manufacturing supplements


May 12, 2026	Supplement 17Labeling · Standard review	Approved	None posted
Oct 29, 2021	Supplement 14Labeling · Standard review	Approved	None posted
Jan 29, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Jan 29, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Jan 29, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Dec 23, 2015	Supplement 1Labeling	Approved	None posted
Dec 23, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Dec 23, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Dec 23, 2015	Supplement 9Labeling · Standard review	Approved	None posted
Feb 18, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Feb 18, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Feb 18, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Jan 27, 2009	Original application	Approved	Letter

Identifiers

Application: ANDA 78625
Drugs@FDA: Overview at FDA
Company: Rubicon Research

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