Lamotrigine

ANDA 201791, held by Ph Health. Lamotrigine.

As of Nov 14, 2026, ANDA 201791 (Lamotrigine), held by Ph Health, was first approved by FDA on Jan 18, 2013, with 7 approved supplements and 0 published complete response letters.

First approved: Jan 18, 2013
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jan 18, 2013	Original application	Approved	None posted

Products

6 strengths and forms


Lamotrigine25MG · tablet, extended release;oral	Lamotrigine	Discontinued
Lamotrigine50MG · tablet, extended release;oral	Lamotrigine	Discontinued
Lamotrigine100MG · tablet, extended release;oral	Lamotrigine	Discontinued
Lamotrigine200MG · tablet, extended release;oral	Lamotrigine	Discontinued
Lamotrigine250MG · tablet, extended release;oral	Lamotrigine	Discontinued
Lamotrigine300MG · tablet, extended release;oral	Lamotrigine	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Nov 9, 2021	Supplement 8Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Jun 19, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Jun 19, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Jun 19, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Apr 24, 2014	Supplement 1Labeling · Standard review	Approved	None posted
Jan 18, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 201791
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