APPLICATION
ANDA077365
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-26
LATEST ACTION
2021-08-16
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ONDANSETRON HYDROCHLORIDEPrescription
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2021-08-16Labeling · Supplement 10 · standardAP
2021-08-16Labeling · Supplement 13 · standardAP
2014-12-10Labeling · Supplement 7 · standardAP
2014-12-10Labeling · Supplement 8 · standardAP
2013-03-19Labeling · Supplement 5 · standardAP
2013-03-19Labeling · Supplement 6 · standardAP
2010-11-30Labeling · Supplement 4AP
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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