Zofran, Zofran Preservative Free

NDA 20007, held by Sandoz. Ondansetron Hydrochloride.

As of Nov 14, 2026, NDA 20007 (Zofran, Zofran Preservative Free), held by Sandoz, was first approved by FDA on Jan 4, 1991, with 43 approved supplements and 0 published complete response letters.

First approved: Jan 4, 1991
Review: Priority
Supplements approved: 43
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 44 submissions below


Mar 25, 2005	Supplement 35Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Statistical Review
Oct 31, 1997	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Review
May 16, 1996	Supplement 20Efficacy (new indication or use) · Standard review	Approved	None posted
Aug 13, 1993	Supplement 5Efficacy (new indication or use)	Approved	None posted
Feb 2, 1993	Supplement 3Efficacy (new indication or use)	Approved	None posted
Jan 4, 1991	Original applicationNew molecular entity · Priority review	Approved	Other

Products

2 strengths and forms


ZofranEQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Ondansetron Hydrochloride	DiscontinuedReference drug
Zofran Preservative FreeEQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Ondansetron Hydrochloride	DiscontinuedReference drug

All 44 submissions, including labeling and manufacturing supplements


Jun 2, 2025	Supplement 50Labeling · Standard review	Approved	Label Letter
Oct 20, 2021	Supplement 49Labeling · Standard review	Approved	Letter Label
Apr 29, 2021	Supplement 48Labeling · Standard review	Approved	Letter Label
Mar 8, 2017	Supplement 47Labeling · Standard review	Approved	Letter Label
Sep 18, 2014	Supplement 46Labeling	Approved	Letter Label
Dec 10, 2013	Supplement 44Labeling · Standard review	Approved	Letter Label
Nov 14, 2012	Supplement 43Labeling · Standard review	Approved	Letter Label
Sep 14, 2011	Supplement 42Labeling · Standard review	Approved	Letter Label
Jul 7, 2011	Supplement 41Labeling	Approved	Review Letter
Sep 22, 2010	Supplement 40Labeling	Approved	Label Letter
Aug 22, 2006	Supplement 39Labeling · Standard review	Approved	Letter Label
Dec 27, 2005	Supplement 37Labeling · Standard review	Approved	Review Label
Mar 25, 2005	Supplement 35Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Statistical Review
Nov 24, 2004	Supplement 34Labeling · Standard review	Approved	Label Letter
Dec 8, 2000	Supplement 32Labeling · Standard review	Approved	None posted
Dec 8, 2000	Supplement 31Labeling · Standard review	Approved	None posted
Apr 11, 2000	Supplement 30Labeling · Standard review	Approved	Review
May 14, 1999	Supplement 29Manufacturing · Priority review	Approved	None posted
Mar 10, 1999	Supplement 27Labeling · Standard review	Approved	None posted
Feb 17, 1999	Supplement 28Labeling · Standard review	Approved	None posted
Oct 31, 1997	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Review
Aug 12, 1997	Supplement 24Manufacturing · Priority review	Approved	None posted
Apr 2, 1997	Supplement 23Labeling · Standard review	Approved	None posted
Jul 29, 1996	Supplement 19Manufacturing · Priority review	Approved	None posted
May 16, 1996	Supplement 20Efficacy (new indication or use) · Standard review	Approved	None posted
Mar 12, 1996	Supplement 21Labeling · Standard review	Approved	None posted
Feb 14, 1995	Supplement 18Manufacturing · Priority review	Approved	None posted
Jan 31, 1995	Supplement 14Manufacturing · Priority review	Approved	None posted
Apr 27, 1994	Supplement 16Labeling · Standard review	Approved	None posted
Mar 31, 1994	Supplement 15Manufacturing · Priority review	Approved	None posted
Dec 10, 1993	Supplement 9Manufacturing · Priority review	Approved	None posted
Aug 13, 1993	Supplement 5Efficacy (new indication or use)	Approved	None posted
Apr 28, 1993	Supplement 13Labeling · Standard review	Approved	None posted
Mar 24, 1993	Supplement 11Manufacturing · Priority review	Approved	None posted
Feb 9, 1993	Supplement 12Manufacturing · Priority review	Approved	None posted
Feb 2, 1993	Supplement 8Labeling	Approved	None posted
Feb 2, 1993	Supplement 7Labeling	Approved	None posted
Feb 2, 1993	Supplement 4Labeling	Approved	None posted
Feb 2, 1993	Supplement 3Efficacy (new indication or use)	Approved	None posted
Feb 2, 1993	Supplement 2Labeling	Approved	None posted
Feb 2, 1993	Supplement 1Labeling	Approved	None posted
Jan 22, 1993	Supplement 10Manufacturing · Priority review	Approved	None posted
Aug 18, 1992	Supplement 6Manufacturing · Priority review	Approved	None posted
Jan 4, 1991	Original applicationNew molecular entity · Priority review	Approved	Other

Identifiers

Application: NDA 20007
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