Lamotrigine

Treats bipolar I disorder. ANDA 76708, held by Dr Reddys Labs Ltd. Lamotrigine.

As of Nov 14, 2026, ANDA 76708 (Lamotrigine), held by Dr Reddys Labs Ltd, was first approved by FDA on Jan 27, 2009, with 8 approved supplements and 0 published complete response letters.

First approved: Jan 27, 2009
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lamotrigine tablet 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 9 submissions below

Date	Submission	Status	Documents
Jan 27, 2009	Original application	Approved	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 9 submissions, including labeling and manufacturing supplements


Sep 26, 2016	Supplement 8Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Mar 15, 2012	Supplement 6Labeling	Approved	None posted
Mar 15, 2012	Supplement 5Labeling	Approved	None posted
Sep 29, 2011	Supplement 4Labeling	Approved	None posted
Feb 24, 2010	Supplement 3Labeling	Approved	None posted
Sep 21, 2009	Supplement 2Labeling	Approved	None posted
Sep 21, 2009	Supplement 1Labeling	Approved	None posted
Jan 27, 2009	Original application	Approved	Review

Identifiers

Application: ANDA 76708
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's 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