Ethosuximide

Controls absence (petit mal) epilepsy. ANDA 200892, held by Heritage Pharms Inc. Ethosuximide.

As of Nov 13, 2026, ANDA 200892 (Ethosuximide), held by Heritage Pharms Inc, was first approved by FDA on Sep 25, 2012, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 25, 2012
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Ethosuximide capsule 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 3 submissions below

Date	Submission	Status	Documents
Sep 25, 2012	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ethosuximide250MG · capsule;oral	Ethosuximide	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Feb 22, 2022	Supplement 14Labeling · Standard review	Approved	None posted
Mar 16, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Sep 25, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 200892
Drugs@FDA: Overview at FDA
Company: Heritage Pharmaceuticals

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