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FDA NDA · NDA020007

ZOFRAN

Sponsor: SANDOZ

APPLICATION
NDA020007
TYPE
NDA
ORIGINAL APPROVAL
1991-01-04
LATEST ACTION
2025-06-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ZOFRAN · ReferenceDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ZOFRAN PRESERVATIVE FREE · ReferenceDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2025-06-02Labeling · Supplement 50 · standard — Letter ↗AP
2021-10-20Labeling · Supplement 49 · standard — Label ↗AP
2021-04-29Labeling · Supplement 48 · standard — Letter ↗AP
2017-03-08Labeling · Supplement 47 · standard — Label ↗AP
2014-09-18Labeling · Supplement 46 · 901 required — Label ↗AP
2013-12-10Labeling · Supplement 44 · standard — Letter ↗AP
2012-11-14Labeling · Supplement 43 · standard — Label ↗AP
2011-09-14Labeling · Supplement 42 · standard — Label ↗AP
2011-07-07Labeling · Supplement 41 · unknown — Review ↗AP
2010-09-22Labeling · Supplement 40 · unknown — Label ↗AP
2006-08-22Labeling · Supplement 39 · standard — Letter ↗AP
2005-12-27Labeling · Supplement 37 · standard — Label ↗AP
2005-03-25Efficacy · Supplement 35 · priority — Pediatric Medical Review ↗AP
2004-11-24Labeling · Supplement 34 · standard — Label ↗AP
2000-12-08Labeling · Supplement 32 · standardAP
2000-12-08Labeling · Supplement 31 · standardAP
2000-04-11Labeling · Supplement 30 · standard — Review ↗AP
1999-05-14Manufacturing (CMC) · Supplement 29 · priorityAP
1999-03-10Labeling · Supplement 27 · standardAP
1999-02-17Labeling · Supplement 28 · standardAP
1997-10-31Efficacy · Supplement 22 · standard — Review ↗AP
1997-08-12Manufacturing (CMC) · Supplement 24 · priorityAP
1997-04-02Labeling · Supplement 23 · standardAP
1996-07-29Manufacturing (CMC) · Supplement 19 · priorityAP
1996-05-16Efficacy · Supplement 20 · standardAP
1996-03-12Labeling · Supplement 21 · standardAP
1995-02-14Manufacturing (CMC) · Supplement 18 · priorityAP
1995-01-31Manufacturing (CMC) · Supplement 14 · priorityAP
1994-04-27Labeling · Supplement 16 · standardAP
1994-03-31Manufacturing (CMC) · Supplement 15 · priorityAP
1993-12-10Manufacturing (CMC) · Supplement 9 · priorityAP
1993-08-13Efficacy · Supplement 5AP
1993-04-28Labeling · Supplement 13 · standardAP
1993-03-24Manufacturing (CMC) · Supplement 11 · priorityAP
1993-02-09Manufacturing (CMC) · Supplement 12 · priorityAP
1993-02-02Efficacy · Supplement 3AP
1993-02-02Labeling · Supplement 1AP
1993-02-02Labeling · Supplement 8AP
1993-02-02Labeling · Supplement 4AP
1993-02-02Labeling · Supplement 2AP
VIEW ON DRUGS@FDA ↗

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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.

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