Celontin

Controls absence (petit mal) seizures. NDA 10596, held by Parke Davis. Methsuximide.

As of Nov 14, 2026, NDA 10596 (Celontin), held by Parke Davis, was first approved by FDA on Feb 8, 1957, with 15 approved supplements and 0 published complete response letters.

First approved: Feb 8, 1957
Review: Priority
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Celontin is indicated for the control of absence (petit mal) seizures that are refractory to other drugs.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Feb 8, 1957	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


Celontin150MG · capsule;oral	Methsuximide	DiscontinuedReference drug
Celontin300MG · capsule;oral	Methsuximide	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


Jun 15, 2011	Supplement 23REMS	Approved	Letter
Oct 11, 2010	Supplement 22Labeling · Standard review	Approved	Letter Label
Apr 23, 2009	Supplement 21Labeling	Approved	Letter Label
Apr 17, 2002	Supplement 17Labeling · Standard review	Approved	Letter
Apr 9, 2001	Supplement 9Labeling	Approved	Letter
Apr 9, 2001	Supplement 12Labeling · Standard review	Approved	Letter
Apr 11, 2000	Supplement 16Manufacturing · Priority review	Approved	None posted
Apr 12, 1999	Supplement 15Manufacturing · Priority review	Approved	None posted
Oct 20, 1997	Supplement 13Manufacturing · Priority review	Approved	None posted
Dec 11, 1995	Supplement 11Manufacturing · Priority review	Approved	None posted
Jan 24, 1990	Supplement 10Labeling	Approved	None posted
Aug 20, 1987	Supplement 8Manufacturing · Priority review	Approved	None posted
Jan 27, 1981	Supplement 6Manufacturing · Priority review	Approved	None posted
Jan 27, 1981	Supplement 7Manufacturing · Priority review	Approved	None posted
May 23, 1977	Supplement 4Labeling	Approved	None posted
Feb 8, 1957	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 10596
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