APPLICATION
ANDA203711
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-08
LATEST ACTION
2025-09-16
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ONDANSETRON HYDROCHLORIDEPrescription
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2025-09-16Labeling · Supplement 17 · standardAP
2022-02-28Labeling · Supplement 13 · standardAP
2021-09-01Labeling · Supplement 2 · standardAP
2021-09-01Labeling · Supplement 10 · standardAP
2015-04-03Labeling · Supplement 1 · standardAP
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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