Ethosuximide

Controls absence (petit mal) epilepsy. ANDA 40506, held by Chartwell Rx. Ethosuximide.

As of Nov 13, 2026, ANDA 40506 (Ethosuximide), held by Chartwell Rx, was first approved by FDA on Dec 22, 2003, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 22, 2003
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Ethosuximide is 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 6 submissions below

Date	Submission	Status	Documents
Dec 22, 2003	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ethosuximide250MG/5ML · syrup;oral	Ethosuximide	Rx

All 6 submissions, including labeling and manufacturing supplements


Sep 11, 2026	Supplement 5Labeling · Standard review	Approved	None posted
Sep 11, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Jan 10, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Dec 10, 2009	Supplement 3Labeling	Approved	None posted
Aug 15, 2008	Supplement 2Labeling	Approved	None posted
Dec 22, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 40506
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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