APPLICATION
ANDA077548
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-26
LATEST ACTION
2025-11-18
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEPrescription
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2025-11-18Labeling · Supplement 22 · standardAP
2022-03-15Labeling · Supplement 15 · standardAP
2021-09-01Labeling · Supplement 14 · standardAP
2021-09-01Labeling · Supplement 11 · standardAP
2015-01-20Labeling · Supplement 9 · standardAP
2013-12-24Labeling · Supplement 7 · standardAP
2013-12-24Labeling · Supplement 8 · standardAP
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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