APPLICATION
ANDA077535
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-25
LATEST ACTION
2025-09-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription
Products
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 24MG BASE · TABLET · ORAL
ONDANSETRON HYDROCHLORIDEPrescription
ONDANSETRON HYDROCHLORIDE EQ 4MG BASE · TABLET · ORAL
ONDANSETRON HYDROCHLORIDEPrescription
ONDANSETRON HYDROCHLORIDE EQ 8MG BASE · TABLET · ORAL
Approval history
2025-09-09Labeling · Supplement 21 · standardAP
2018-02-13Labeling · Supplement 15 · standardAP
2017-03-30Labeling · Supplement 14 · standardAP
2014-12-08Labeling · Supplement 12 · standardAP
2014-12-08Labeling · Supplement 13 · standardAP
2011-09-30Labeling · Supplement 9AP
2011-09-30Labeling · Supplement 8AP
2011-07-25Labeling · Supplement 7AP
2008-10-23Labeling · Supplement 5AP
2008-08-18Labeling · Supplement 4AP
2008-08-18Labeling · Supplement 2AP
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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