APPLICATION
ANDA076960
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-26
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 11 · standardAP
2022-06-23Labeling · Supplement 9 · standardAP
2022-06-23Labeling · Supplement 8 · standardAP
2018-05-14Labeling · Supplement 7 · standardAP
2018-05-14Labeling · Supplement 6 · standardAP
2015-03-02Labeling · Supplement 4 · standardAP
2012-02-17Labeling · Supplement 3AP
2011-10-13Labeling · Supplement 2AP
2010-11-30Labeling · Supplement 1AP
2006-12-26OriginalAP
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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