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FDA NDA · NDA020605

ZOFRAN

Sponsor: SANDOZ

APPLICATION
NDA020605
TYPE
NDA
ORIGINAL APPROVAL
1997-01-24
LATEST ACTION
2025-06-02
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

ZOFRAN · ReferenceDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2025-06-02Labeling · Supplement 23 · standard — Letter ↗AP
2021-10-20Labeling · Supplement 22 · standard — Label ↗AP
2021-04-29Labeling · Supplement 21 · standard — Letter ↗AP
2017-10-05Labeling · Supplement 20 · standard — Label ↗AP
2016-11-09Labeling · Supplement 19 · standard — Label ↗AP
2016-09-28Labeling · Supplement 17 · standard — Letter ↗AP
2014-09-18Labeling · Supplement 18 · 901 required — Letter ↗AP
2013-12-10Labeling · Supplement 15 · standard — Label ↗AP
2011-09-14Labeling · Supplement 14 · standard — Label ↗AP
2010-09-22Labeling · Supplement 13 · unknown — Label ↗AP
2006-08-22Labeling · Supplement 10 · standard — Label ↗AP
2005-12-27Labeling · Supplement 8 · standard — Review ↗AP
2004-11-24Labeling · Supplement 7 · standard — Label ↗AP
2000-12-13Labeling · Supplement 5 · standard — Label ↗AP
2000-04-11Labeling · Supplement 4 · standard — Review ↗AP
1999-01-26Manufacturing (CMC) · Supplement 3 · standardAP
1997-04-15Labeling · Supplement 1 · standardAP
1997-01-24Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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