Zofran Odt

NDA 20781, held by Sandoz. Ondansetron.

As of Nov 13, 2026, NDA 20781 (Zofran Odt), held by Sandoz, was first approved by FDA on Jan 27, 1999, with 16 approved supplements and 0 published complete response letters.

First approved: Jan 27, 1999
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Jan 27, 1999	Original applicationNew active ingredient · Standard review	Approved	Label Letter Review

Products

2 strengths and forms


Zofran Odt4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, orally disintegrating;oral	Ondansetron	DiscontinuedReference drug
Zofran Odt8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, orally disintegrating;oral	Ondansetron	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements


Jun 2, 2025	Supplement 23Labeling · Standard review	Approved	Label Letter
Oct 20, 2021	Supplement 22Labeling · Standard review	Approved	Letter Label
Apr 29, 2021	Supplement 21Labeling · Standard review	Approved	Letter Label
Oct 5, 2017	Supplement 20Labeling · Standard review	Approved	Label Letter
Nov 9, 2016	Supplement 19Labeling · Standard review	Approved	Label Letter
Sep 28, 2016	Supplement 17Labeling · Standard review	Approved	Review Letter
Sep 18, 2014	Supplement 18Labeling	Approved	Letter Label
Dec 10, 2013	Supplement 15Labeling · Standard review	Approved	Letter Label
Sep 14, 2011	Supplement 14Labeling · Standard review	Approved	Letter Label
Sep 22, 2010	Supplement 13Labeling	Approved	Label Letter
Aug 22, 2006	Supplement 10Labeling · Standard review	Approved	Letter Label
Dec 27, 2005	Supplement 8Labeling · Standard review	Approved	Letter
Nov 24, 2004	Supplement 7Labeling · Standard review	Approved	Label Letter
Jan 31, 2003	Supplement 3Labeling · Standard review	Approved	Letter
Dec 13, 2000	Supplement 2Labeling · Standard review	Approved	None posted
Apr 11, 2000	Supplement 1Labeling · Standard review	Approved	Review
Jan 27, 1999	Original applicationNew active ingredient · Standard review	Approved	Label Letter Review

Identifiers

Application: NDA 20781
Drugs@FDA: Overview at FDA
Company: Sandoz

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