APPLICATION
ANDA091483
TYPE
ANDA
ORIGINAL APPROVAL
2011-01-31
LATEST ACTION
2025-09-15
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ONDANSETRON HYDROCHLORIDEPrescription
ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML · SOLUTION · ORAL
Approval history
2025-09-15Labeling · Supplement 17 · standardAP
2022-06-14Labeling · Supplement 11 · standardAP
2021-10-01Labeling · Supplement 7 · standardAP
2018-03-07Labeling · Supplement 5 · standardAP
2017-02-07Labeling · Supplement 3 · standardAP
2017-02-07Labeling · Supplement 4 · standardAP
2012-04-27Labeling · Supplement 2AP
2011-01-31Not Applicable · OriginalAP
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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