APPLICATION
ANDA078257
TYPE
ANDA
ORIGINAL APPROVAL
2008-04-23
LATEST ACTION
2026-04-15
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2026-04-15Labeling · Supplement 10 · standardAP
2023-05-01Labeling · Supplement 8 · standardAP
2023-05-01Labeling · Supplement 6 · standardAP
2015-10-26Labeling · Supplement 4 · standardAP
2013-12-10Labeling · Supplement 3 · standardAP
2008-04-23OriginalAP
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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