Ethosuximide

ANDA 40686, held by Epic Pharma LLC. Ethosuximide.

As of Nov 13, 2026, ANDA 40686 (Ethosuximide), held by Epic Pharma LLC, was first approved by FDA on May 28, 2008, with 5 approved supplements and 0 published complete response letters.

First approved: May 28, 2008
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
May 28, 2008	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ethosuximide250MG · capsule;oral	Ethosuximide	Rx

All 6 submissions, including labeling and manufacturing supplements


Nov 10, 2022	Supplement 13Labeling · Standard review	Approved	None posted
Aug 18, 2021	Supplement 12Labeling · Standard review	Approved	None posted
Mar 17, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Jan 14, 2014	Supplement 3Labeling	Approved	None posted
Dec 10, 2009	Supplement 2Labeling	Approved	None posted
May 28, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 40686
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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