Lamotrigine

Treats bipolar I disorder. ANDA 78947, held by Torrent Pharms. Lamotrigine.

As of Nov 14, 2026, ANDA 78947 (Lamotrigine), held by Torrent Pharms, was first approved by FDA on Jan 27, 2009, with 21 approved supplements and 0 published complete response letters.

First approved: Jan 27, 2009
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lamotrigine, USP 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 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 22 submissions below

Date	Submission	Status	Documents
Jan 27, 2009	Original application	Approved	None posted

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 22 submissions, including labeling and manufacturing supplements


Apr 10, 2026	Supplement 43Labeling · Standard review	Approved	None posted
Apr 10, 2026	Supplement 42Labeling · Standard review	Approved	None posted
Apr 10, 2026	Supplement 41Labeling · Standard review	Approved	None posted
Apr 10, 2026	Supplement 40Labeling · Standard review	Approved	None posted
Jun 30, 2022	Supplement 38Labeling · Standard review	Approved	None posted
Jun 30, 2022	Supplement 37Labeling · Standard review	Approved	None posted
Dec 6, 2019	Supplement 34Labeling · Standard review	Approved	None posted
Dec 6, 2019	Supplement 33Labeling · Standard review	Approved	None posted
Dec 6, 2019	Supplement 32Labeling · Standard review	Approved	None posted
Jan 29, 2018	Supplement 26Labeling · Standard review	Approved	None posted
Jun 16, 2017	Supplement 23Labeling · Standard review	Approved	None posted
Jun 16, 2017	Supplement 22Labeling · Standard review	Approved	None posted
Dec 10, 2014	Supplement 21Labeling · Standard review	Approved	None posted
Dec 10, 2014	Supplement 18Labeling · Standard review	Approved	None posted
Mar 14, 2012	Supplement 15Labeling	Approved	None posted
Jan 31, 2012	Supplement 14Labeling	Approved	None posted
Sep 29, 2011	Supplement 11Labeling	Approved	None posted
Jul 28, 2010	Supplement 9Labeling	Approved	None posted
Jan 21, 2010	Supplement 8REMS	Approved	None posted
Sep 21, 2009	Supplement 6Labeling	Approved	None posted
Sep 21, 2009	Supplement 5Labeling	Approved	None posted
Jan 27, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78947
Drugs@FDA: Overview at FDA
Company: Torrent Pharmaceuticals

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