← FDA DRUG APPROVALS

FDA NDA · NDA020103

ZOFRAN

Sponsor: SANDOZ

APPLICATION
NDA020103
TYPE
NDA
ORIGINAL APPROVAL
1992-12-31
LATEST ACTION
2025-06-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ZOFRAN · ReferenceDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ZOFRAN · ReferenceDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ZOFRAN · ReferenceDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2025-06-02Labeling · Supplement 39 · standard — Letter ↗AP
2021-10-20Labeling · Supplement 38 · standard — Label ↗AP
2021-04-29Labeling · Supplement 37 · standard — Letter ↗AP
2017-10-05Labeling · Supplement 36 · standard — Label ↗AP
2016-11-09Labeling · Supplement 35 · standard — Label ↗AP
2016-09-28Labeling · Supplement 33 · standard — Letter ↗AP
2014-09-18Labeling · Supplement 34 · 901 required — Label ↗AP
2013-12-10Labeling · Supplement 31 · standard — Letter ↗AP
2011-09-14Labeling · Supplement 30 · standard — Label ↗AP
2010-09-22Labeling · Supplement 29 · unknown — Label ↗AP
2006-08-22Labeling · Supplement 27 · standard — Label ↗AP
2005-12-27Labeling · Supplement 25 · standard — Review ↗AP
2005-02-18Manufacturing (CMC) · Supplement 24 · priority — Letter ↗AP
2004-11-24Labeling · Supplement 23 · standard — Letter ↗AP
2003-01-31Labeling · Supplement 21 · standard — Letter ↗AP
2001-10-24Manufacturing (CMC) · Supplement 19 · priorityAP
2001-10-24Manufacturing (CMC) · Supplement 20 · priorityAP
2000-12-13Labeling · Supplement 18 · standard — Label ↗AP
2000-04-11Labeling · Supplement 17 · standard — Review ↗AP
1999-08-27Efficacy · Supplement 15 · standard — Review ↗AP
1999-08-27Manufacturing (CMC) · Supplement 16 · priority — Review ↗AP
1997-04-15Labeling · Supplement 13 · standardAP
1995-11-16Labeling · Supplement 11 · standardAP
1995-05-17Manufacturing (CMC) · Supplement 10 · priorityAP
1995-04-19Efficacy · Supplement 5 · standardAP
1995-04-10Efficacy · Supplement 8 · unknown — Label ↗AP
1995-02-14Manufacturing (CMC) · Supplement 9 · priorityAP
1994-09-26Efficacy · Supplement 4 · priorityAP
1994-04-27Labeling · Supplement 7 · standardAP
1994-04-15Manufacturing (CMC) · Supplement 6 · priorityAP
1994-04-04Labeling · Supplement 3 · standardAP
1993-09-28Manufacturing (CMC) · Supplement 2 · priorityAP
1993-02-22Labeling · Supplement 1 · standardAP
1992-12-31Type 3 - New Dosage Form · Original · priority — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →