Lamotrigine

Treats bipolar I disorder. ANDA 78009, held by Zydus Pharms USA Inc. Lamotrigine.

As of Nov 14, 2026, ANDA 78009 (Lamotrigine), held by Zydus Pharms USA Inc, was first approved by FDA on Jan 22, 2009, with 23 approved supplements and 0 published complete response letters.

First approved: Jan 22, 2009
Supplements approved: 23
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 (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 24 submissions below

Date	Submission	Status	Documents
Jan 22, 2009	Original application	Approved	Review

Products

3 strengths and forms


Lamotrigine2MG · tablet, chewable; oral	Lamotrigine	Rx
Lamotrigine5MG · tablet, for suspension;oral	Lamotrigine	Rx
Lamotrigine25MG · tablet, for suspension;oral	Lamotrigine	Rx

All 24 submissions, including labeling and manufacturing supplements


Sep 29, 2025	Supplement 30Labeling · Standard review	Approved	None posted
Jun 10, 2022	Supplement 29Labeling · Standard review	Approved	None posted
Jun 10, 2022	Supplement 28Labeling · Standard review	Approved	None posted
Oct 29, 2019	Supplement 27Labeling · Standard review	Approved	None posted
Oct 29, 2019	Supplement 26Labeling · Standard review	Approved	None posted
Oct 29, 2019	Supplement 25Labeling · Standard review	Approved	None posted
Oct 29, 2019	Supplement 24Labeling · Standard review	Approved	None posted
Oct 29, 2019	Supplement 23Labeling · Standard review	Approved	None posted
Dec 11, 2015	Supplement 19Labeling · Standard review	Approved	None posted
Dec 11, 2015	Supplement 18Labeling · Standard review	Approved	None posted
Dec 11, 2015	Supplement 17Labeling · Standard review	Approved	None posted
Dec 11, 2015	Supplement 16Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 15Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Mar 14, 2012	Supplement 9Labeling	Approved	None posted
Mar 14, 2012	Supplement 8Labeling	Approved	None posted
Mar 7, 2012	Supplement 7REMS	Approved	None posted
Sep 29, 2011	Supplement 6Labeling	Approved	None posted
Apr 25, 2011	Supplement 5Labeling	Approved	None posted
Jun 23, 2010	Supplement 4Labeling	Approved	None posted
Jun 23, 2010	Supplement 3Labeling	Approved	None posted
Jun 23, 2010	Supplement 1Labeling	Approved	None posted
Jan 22, 2009	Original application	Approved	Review

Identifiers

Application: ANDA 78009
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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