Ethosuximide

Controls absence (petit mal) epilepsy. ANDA 40253, held by Pharm Assoc. Ethosuximide.

As of Nov 13, 2026, ANDA 40253 (Ethosuximide), held by Pharm Assoc, was first approved by FDA on Nov 22, 2000, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 22, 2000
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
Nov 22, 2000	Original application	Approved	Label Review Letter

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Aug 1, 2025	Supplement 10Labeling · Standard review	Approved	None posted
Aug 1, 2025	Supplement 5Labeling · Standard review	Approved	None posted
May 5, 2017	Supplement 4Labeling · Standard review	Approved	None posted
Jan 15, 2014	Supplement 3Labeling	Approved	None posted
Jan 4, 2010	Supplement 2Labeling	Approved	None posted
Nov 22, 2000	Original application	Approved	Label Review Letter

Identifiers

Application: ANDA 40253
Drugs@FDA: Overview at FDA
Company: Pharmaceutical Associates

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