APPLICATION
ANDA077545
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-06
LATEST ACTION
2023-05-15
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
2023-05-15Labeling · Supplement 13 · standardAP
2023-05-15Labeling · Supplement 14 · standardAP
2018-02-21Labeling · Supplement 11 · standardAP
2018-02-21Labeling · Supplement 12 · standardAP
2015-01-15Labeling · Supplement 8 · standardAP
2013-02-27Labeling · Supplement 3AP
2013-02-27Labeling · Supplement 4AP
2013-02-27Labeling · Supplement 7AP
2008-04-11Labeling · Supplement 2AP
2007-09-06OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.