APPLICATION
ANDA090116
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-14
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 8 · standardAP
2023-04-19Labeling · Supplement 9 · standardAP
2016-09-02Labeling · Supplement 6 · standardAP
2016-09-02Labeling · Supplement 7 · standardAP
2015-01-16Labeling · Supplement 5 · standardAP
2013-08-08Labeling · Supplement 4 · standardAP
2012-02-10Labeling · Supplement 3AP
2011-09-30Labeling · Supplement 2AP
2011-07-22Labeling · Supplement 1AP
2010-04-14OriginalAP
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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