Lamotrigine

Treats bipolar I disorder. ANDA 77633, held by Zydus Pharms USA. Lamotrigine.

As of Nov 14, 2026, ANDA 77633 (Lamotrigine), held by Zydus Pharms USA, was first approved by FDA on Jan 27, 2009, with 22 approved supplements and 0 published complete response letters.

First approved: Jan 27, 2009
Supplements approved: 22
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 23 submissions below

Date	Submission	Status	Documents
Jan 27, 2009	Original application	Approved	Review

Products

6 strengths and forms


Lamotrigine25MG · tablet;oral	Lamotrigine	Rx
Lamotrigine50MG · tablet;oral	Lamotrigine	Rx
Lamotrigine100MG · tablet;oral	Lamotrigine	Rx
Lamotrigine150MG · tablet;oral	Lamotrigine	Rx
Lamotrigine200MG · tablet;oral	Lamotrigine	Rx
Lamotrigine250MG · tablet;oral	Lamotrigine	Rx

All 23 submissions, including labeling and manufacturing supplements


Sep 29, 2025	Supplement 41Labeling · Standard review	Approved	None posted
Jun 10, 2022	Supplement 37Labeling · Standard review	Approved	None posted
Jun 10, 2022	Supplement 35Labeling · Standard review	Approved	None posted
Oct 29, 2019	Supplement 32Labeling · Standard review	Approved	None posted
Oct 29, 2019	Supplement 31Labeling · Standard review	Approved	None posted
Oct 29, 2019	Supplement 30Labeling · Standard review	Approved	None posted
Oct 29, 2019	Supplement 29Labeling · Standard review	Approved	None posted
Oct 29, 2019	Supplement 28Labeling · Standard review	Approved	None posted
Dec 11, 2015	Supplement 24Labeling · Standard review	Approved	None posted
Dec 11, 2015	Supplement 20Labeling · 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
Sep 26, 2014	Supplement 16Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Feb 28, 2012	Supplement 6REMS	Approved	None posted
Feb 27, 2012	Supplement 8Labeling	Approved	None posted
Feb 27, 2012	Supplement 7Labeling	Approved	None posted
Sep 29, 2011	Supplement 5Labeling	Approved	None posted
Apr 25, 2011	Supplement 4Labeling	Approved	None posted
Feb 23, 2010	Supplement 2Labeling	Approved	None posted
Feb 23, 2010	Supplement 1Labeling	Approved	None posted
Jan 27, 2009	Original application	Approved	Review

Identifiers

Application: ANDA 77633
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