Lamotrigine

Treats bipolar I disorder. ANDA 79132, held by Jubilant Cadista. Lamotrigine.

As of Nov 14, 2026, ANDA 79132 (Lamotrigine), held by Jubilant Cadista, 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)

1. 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 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


Jul 18, 2022	Supplement 28Labeling · Standard review	Approved	None posted
Jul 18, 2022	Supplement 27Labeling · Standard review	Approved	None posted
Dec 6, 2019	Supplement 23Labeling · Standard review	Approved	None posted
Dec 6, 2019	Supplement 20Labeling · Standard review	Approved	None posted
Sep 2, 2016	Supplement 16Labeling · Standard review	Approved	None posted
Sep 2, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Sep 2, 2016	Supplement 13Labeling · Standard review	Approved	None posted
Dec 10, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Dec 10, 2014	Supplement 11Labeling · Standard review	Approved	None posted
Dec 10, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Dec 10, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Nov 4, 2010	Supplement 2REMS	Approved	None posted
Jan 27, 2009	Original application	Approved	Letter

Identifiers

Application: ANDA 79132
Drugs@FDA: Overview at FDA
Company: Jubilant Cadista 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