Zonegran

Treats partial seizures. NDA 20789, held by Advanz Pharma. Zonisamide.

As of Nov 13, 2026, NDA 20789 (Zonegran), held by Advanz Pharma, was first approved by FDA on Mar 27, 2000, with 21 approved supplements and 0 published complete response letters.

First approved: Mar 27, 2000
Review: Standard
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE ZONEGRAN is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Mar 27, 2000	Original applicationNew molecular entity · Standard review	Approved	Label Letter Review

Products

3 strengths and forms


Zonegran100MG · capsule;oral	Zonisamide	RxReference drug
Zonegran50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Zonisamide	DiscontinuedReference drug
Zonegran25MG · capsule;oral	Zonisamide	RxReference drug

All 22 submissions, including labeling and manufacturing supplements


Apr 13, 2020	Supplement 36Labeling	Approved	Label Medication Guide Letter
Apr 6, 2016	Supplement 34Labeling · Standard review	Approved	Letter Label
Nov 12, 2015	Supplement 33Manufacturing · Standard review	Approved	None posted
Jun 19, 2015	Supplement 21Labeling · Standard review	Approved	Label Letter
Oct 11, 2013	Supplement 32Manufacturing · Standard review	Approved	None posted
Jan 26, 2012	Supplement 12Labeling · Standard review	Approved	Label Letter
Sep 23, 2011	Supplement 30Labeling	Approved	Label Letter
May 27, 2011	Supplement 29REMS	Approved	Letter
Apr 19, 2010	Supplement 26Labeling · Standard review	Approved	Letter Label
Apr 19, 2010	Supplement 24Labeling · Standard review	Approved	Letter Label
Apr 23, 2009	Supplement 25Labeling · Standard review	Approved	Label Letter
Apr 23, 2009	Supplement 22REMS	Approved	Label Letter
Nov 20, 2006	Supplement 19Labeling · Standard review	Approved	Letter Label
Aug 22, 2003	Supplement 1Manufacturing · Standard review	Approved	Letter Label
Oct 7, 2002	Supplement 5Labeling · Standard review	Approved	Letter Label
Jun 13, 2002	Supplement 8Manufacturing · Standard review	Approved	None posted
May 15, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 1, 2002	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 6, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 28, 2001	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 4, 2000	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 27, 2000	Original applicationNew molecular entity · Standard review	Approved	Label Letter Review

Identifiers

Application: NDA 20789
Drugs@FDA: Overview at FDA
Company: ADVANZ PHARMA

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