Lamotrigine

Treats bipolar I disorder. ANDA 204158, held by Ph Health. Lamotrigine.

As of Nov 14, 2026, ANDA 204158 (Lamotrigine), held by Ph Health, was first approved by FDA on Oct 27, 2015, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 27, 2015
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lamotrigine orally disintegrating tablets are 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
Oct 27, 2015	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


Jun 26, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Jun 26, 2026	Supplement 8Labeling · Standard review	Approved	None posted
Jun 26, 2026	Supplement 11Labeling · Standard review	Approved	None posted
Jun 26, 2026	Supplement 13Labeling · Standard review	Approved	None posted
Feb 12, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Feb 12, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Feb 12, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Oct 27, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 204158
Drugs@FDA: Overview at FDA
Company: PH Health

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