APPLICATION
ANDA090648
TYPE
ANDA
ORIGINAL APPROVAL
2012-06-15
LATEST ACTION
2025-11-17
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ONDANSETRON HYDROCHLORIDEPrescription
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2025-11-17Labeling · Supplement 17 · standardAP
2022-03-11Labeling · Supplement 14 · standardAP
2021-08-18Labeling · Supplement 13 · standardAP
2021-08-18Labeling · Supplement 8 · standardAP
2015-01-09Labeling · Supplement 6 · standardAP
2015-01-09Labeling · Supplement 4 · standardAP
2013-06-30Labeling · Supplement 3 · standardAP
2013-06-30Labeling · 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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