APPLICATION
ANDA078127
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-25
LATEST ACTION
2026-04-03
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ONDANSETRON HYDROCHLORIDEPrescription
ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML · SOLUTION · ORAL
Approval history
2026-04-03Manufacturing (CMC) · Supplement 14 · unknownAP
2025-09-17Labeling · Supplement 12 · standardAP
2025-09-17Labeling · Supplement 11 · standardAP
2018-03-07Labeling · Supplement 10 · standardAP
2017-03-27Labeling · Supplement 8 · standardAP
2017-03-27Labeling · Supplement 9 · standardAP
2015-01-15Labeling · Supplement 6 · standardAP
2015-01-15Labeling · Supplement 7 · standardAP
2015-01-15Labeling · Supplement 5 · standardAP
2013-06-29Labeling · Supplement 4 · 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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