Lacosamide

ANDA 206355, held by Apotex. Lacosamide.

As of Nov 14, 2026, ANDA 206355 (Lacosamide), held by Apotex, was first approved by FDA on Sep 26, 2022, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 26, 2022
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 26, 2022	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lacosamide10MG/ML · solution;oral	Lacosamide	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Apr 5, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Apr 5, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Apr 5, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Sep 26, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 206355
Drugs@FDA: Overview at FDA
Company: Apotex

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