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FDA NDA · NDA020403

ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

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APPLICATION
NDA020403
TYPE
NDA
ORIGINAL APPROVAL
1995-01-31
LATEST ACTION
2011-09-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER · ReferenceDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 0.64MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2011-09-14Labeling · Supplement 20 · standard — Label ↗AP
2011-07-07Labeling · Supplement 19 · standard — Letter ↗AP
2010-09-22Labeling · Supplement 18 · standard — Label ↗AP
2006-08-22Labeling · Supplement 16 · standard — Label ↗AP
2005-12-27Labeling · Supplement 14 · standard — Review ↗AP
2004-11-24Labeling · Supplement 13 · standard — Label ↗AP
2000-12-08Labeling · Supplement 10 · standardAP
2000-12-08Labeling · Supplement 11 · standardAP
2000-11-15Manufacturing (CMC) · Supplement 12 · standardAP
2000-04-11Labeling · Supplement 9 · standard — Review ↗AP
1999-03-10Labeling · Supplement 7 · standardAP
1999-02-17Labeling · Supplement 8 · standardAP
1997-10-31Labeling · Supplement 5 · standard — Review ↗AP
1997-04-02Labeling · Supplement 4 · standardAP
1996-07-26Manufacturing (CMC) · Supplement 2 · standardAP
1996-05-24Labeling · Supplement 1 · standardAP
1996-03-12Labeling · Supplement 3 · standardAP
1995-01-31Type 3 - New Dosage Form · Original · standardAP
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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