Zarontin

Controls absence (petit mal) epilepsy. NDA 12380, held by Parke Davis. Ethosuximide.

As of Nov 13, 2026, NDA 12380 (Zarontin), held by Parke Davis, was first approved by FDA on Nov 2, 1960, with 24 approved supplements and 0 published complete response letters.

First approved: Nov 2, 1960
Review: Priority
Supplements approved: 24
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Zarontin 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 25 submissions below

Date	Submission	Status	Documents
Nov 2, 1960	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Zarontin250MG · capsule;oral	Ethosuximide	RxReference drug

All 25 submissions, including labeling and manufacturing supplements


Oct 28, 2021	Supplement 37Labeling · Standard review	Approved	Letter Label
May 17, 2016	Supplement 36Labeling · Standard review	Approved	Letter Label
May 3, 2012	Supplement 34Labeling	Approved	Letter Label Medication Guide
Jun 15, 2011	Supplement 33REMS	Approved	Letter
Sep 14, 2010	Supplement 32Labeling · Standard review	Approved	Letter Label
Apr 23, 2009	Supplement 31Labeling	Approved	Letter Label
Sep 1, 2006	Supplement 30Labeling · Standard review	Approved	Letter
Apr 19, 2002	Supplement 29Labeling · Standard review	Approved	Letter
Apr 9, 2001	Supplement 25Labeling · Standard review	Approved	Letter
Apr 9, 2001	Supplement 23Labeling	Approved	Letter
Apr 9, 2001	Supplement 22Labeling	Approved	Letter
Sep 22, 2000	Supplement 28Manufacturing · Priority review	Approved	None posted
Jun 28, 2000	Supplement 27Manufacturing · Priority review	Approved	None posted
Feb 22, 1996	Supplement 24Manufacturing · Priority review	Approved	None posted
Jan 8, 1991	Supplement 21Manufacturing · Priority review	Approved	None posted
Jul 31, 1984	Supplement 20Manufacturing · Priority review	Approved	None posted
Nov 8, 1983	Supplement 19Manufacturing · Priority review	Approved	None posted
Sep 3, 1982	Supplement 18Manufacturing · Priority review	Approved	None posted
Dec 9, 1981	Supplement 17Manufacturing · Priority review	Approved	None posted
May 28, 1981	Supplement 16Manufacturing · Priority review	Approved	None posted
May 28, 1981	Supplement 15Manufacturing · Priority review	Approved	None posted
Feb 3, 1981	Supplement 14Manufacturing · Priority review	Approved	None posted
Dec 11, 1980	Supplement 12Manufacturing · Priority review	Approved	None posted
Jun 2, 1980	Supplement 11Manufacturing · Priority review	Approved	None posted
Nov 2, 1960	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 12380
Drugs@FDA: Overview at FDA
Company: Parke-Davis

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