APPLICATION
ANDA078539
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-31
LATEST ACTION
2026-03-02
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
2026-03-02Labeling · Supplement 16 · standardAP
2018-03-07Labeling · Supplement 8 · standardAP
2018-03-07Labeling · Supplement 9 · standardAP
2015-01-15Labeling · Supplement 6 · standardAP
2015-01-15Labeling · Supplement 7 · standardAP
2011-10-17Labeling · Supplement 4AP
2011-01-04Labeling · Supplement 2AP
2007-07-31OriginalAP
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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