APPLICATION
ANDA076780
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-26
LATEST ACTION
2026-04-08
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2026-04-08Labeling · Supplement 20 · standardAP
2023-04-26Labeling · Supplement 19 · standardAP
2023-04-26Labeling · Supplement 17 · standardAP
2014-12-20Labeling · Supplement 16 · standardAP
2014-12-20Labeling · Supplement 15 · standardAP
2013-09-19Labeling · Supplement 14 · standardAP
2012-04-30Labeling · Supplement 13AP
2011-01-31Labeling · Supplement 11AP
2006-12-26OriginalAP
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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