APPLICATION
ANDA090424
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-16
LATEST ACTION
2023-04-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-04-19Labeling · Supplement 19 · standardAP
2021-08-18Labeling · Supplement 16 · standardAP
2021-08-18Labeling · Supplement 18 · standardAP
2015-01-15Labeling · Supplement 5 · standardAP
2015-01-15Labeling · Supplement 8 · standardAP
2015-01-15Labeling · Supplement 4 · standardAP
2015-01-15Labeling · Supplement 2 · standardAP
2010-04-16OriginalAP
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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