Ethosuximide

Controls absence (petit mal) epilepsy. ANDA 40430, held by Bionpharma. Ethosuximide.

As of Nov 13, 2026, ANDA 40430 (Ethosuximide), held by Bionpharma, was first approved by FDA on Oct 28, 2002, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 28, 2002
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Ethosuximide capsules are indicated for the control of absence (petit mal) epilepsy.

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 28, 2002	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ethosuximide250MG · capsule;oral	Ethosuximide	Rx

All 8 submissions, including labeling and manufacturing supplements


Feb 16, 2022	Supplement 19Labeling · Standard review	Approved	None posted
Apr 1, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Jan 7, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Oct 19, 2012	Supplement 7REMS	Approved	None posted
Dec 27, 2011	Supplement 6Labeling	Approved	None posted
Dec 10, 2009	Supplement 5Labeling	Approved	None posted
Mar 3, 2008	Supplement 4Labeling	Approved	None posted
Oct 28, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 40430
Drugs@FDA: Overview at FDA
Company: Bionpharma

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