Lamotrigine

Treats bipolar I disorder. ANDA 206382, held by Sciegen Pharms. Lamotrigine.

As of Nov 14, 2026, ANDA 206382 (Lamotrigine), held by Sciegen Pharms, was first approved by FDA on Jun 17, 2016, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 17, 2016
Review: Standard
Supplements approved: 7
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 8 submissions below

Date	Submission	Status	Documents
Jun 17, 2016	Original application	Approved	None posted

Products

4 strengths and forms


Lamotrigine25MG · tablet, orally disintegrating;oral	Lamotrigine	Rx
Lamotrigine50MG · tablet, orally disintegrating;oral	Lamotrigine	Rx
Lamotrigine100MG · tablet, orally disintegrating;oral	Lamotrigine	Rx
Lamotrigine200MG · tablet, orally disintegrating;oral	Lamotrigine	Rx

All 8 submissions, including labeling and manufacturing supplements


Jul 27, 2026	Supplement 21Labeling · Standard review	Approved	None posted
Jul 28, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Jul 28, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Jul 28, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Jan 29, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Jan 29, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Jan 29, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Jun 17, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 206382
Drugs@FDA: Overview at FDA
Company: ScieGen 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