Zofran

NDA 20605, held by Sandoz. Ondansetron Hydrochloride.

As of Nov 13, 2026, NDA 20605 (Zofran), held by Sandoz, was first approved by FDA on Jan 24, 1997, with 17 approved supplements and 0 published complete response letters.

First approved: Jan 24, 1997
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jan 24, 1997	Original applicationNew formulation or manufacturer · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
ZofranEQ 4MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;oral	Ondansetron Hydrochloride	DiscontinuedReference drug

All 18 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	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	Label Letter
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	Review Letter Label
Nov 24, 2004	Supplement 7Labeling · Standard review	Approved	Label Letter
Dec 13, 2000	Supplement 5Labeling · Standard review	Approved	Letter Label
Apr 11, 2000	Supplement 4Labeling · Standard review	Approved	Review
Jan 26, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 15, 1997	Supplement 1Labeling · Standard review	Approved	None posted
Jan 24, 1997	Original applicationNew formulation or manufacturer · Standard review	Approved	Review

Identifiers

Application: NDA 20605
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