APPLICATION
ANDA077729
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-28
LATEST ACTION
2026-02-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 24MG BASE · TABLET · ORAL
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 4MG BASE · TABLET · ORAL
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 8MG BASE · TABLET · ORAL
Approval history
2026-02-26Labeling · Supplement 5 · standardAP
2026-02-26Labeling · Supplement 4 · standardAP
2015-01-15Labeling · Supplement 3 · standardAP
2015-01-15Labeling · Supplement 2 · standardAP
2013-12-30Labeling · Supplement 1 · standardAP
2011-03-28OriginalAP
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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