Lamotrigine

ANDA 78645, held by Aiping Pharm Inc. Lamotrigine.

As of Nov 14, 2026, ANDA 78645 (Lamotrigine), held by Aiping Pharm Inc, was first approved by FDA on Jan 27, 2009, with 5 approved supplements and 0 published complete response letters.

First approved: Jan 27, 2009
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

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

Products

4 strengths and forms


Lamotrigine25MG · tablet;oral	Lamotrigine	Discontinued
Lamotrigine100MG · tablet;oral	Lamotrigine	Discontinued
Lamotrigine150MG · tablet;oral	Lamotrigine	Discontinued
Lamotrigine200MG · tablet;oral	Lamotrigine	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jan 18, 2022	Supplement 10Labeling · Standard review	Approved	None posted
Jan 18, 2022	Supplement 11Labeling · Standard review	Approved	None posted
Jan 18, 2022	Supplement 12Labeling · Standard review	Approved	None posted
Feb 18, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Sep 29, 2011	Supplement 1Labeling	Approved	None posted
Jan 27, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78645
Drugs@FDA: Overview at FDA
Company: Aiping Pharmaceutical

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