APPLICATION
ANDA076930
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-25
LATEST ACTION
2026-02-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval), Discontinued
Products
ONDANSETRON HYDROCHLORIDENone (Tentative Approval)
ONDANSETRON HYDROCHLORIDE EQ 16MG · TABLET · ORAL
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 4MG BASE · TABLET · ORAL
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 24MG BASE · TABLET · ORAL
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 8MG BASE · TABLET · ORAL
Approval history
2026-02-25Labeling · Supplement 12 · standardAP
2024-05-31Labeling · Supplement 11 · standardAP
2018-03-07Labeling · Supplement 8 · standardAP
2018-03-07Labeling · Supplement 9 · standardAP
2015-03-18Labeling · Supplement 7 · standardAP
2013-09-19Labeling · Supplement 6 · standardAP
2007-06-25OriginalAP
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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