APPLICATION
ANDA077577
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-26
LATEST ACTION
2023-04-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ONDANSETRON HYDROCHLORIDEPrescription
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-04-19Labeling · Supplement 4 · standardAP
2023-04-19Labeling · Supplement 5 · standardAP
2015-03-09Labeling · Supplement 3 · standardAP
2013-12-14Labeling · Supplement 1 · 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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