APPLICATION
ANDA077050
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-25
LATEST ACTION
2022-11-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 8MG BASE · TABLET · ORAL
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 4MG BASE · TABLET · ORAL
Approval history
2022-11-09Labeling · Supplement 19 · standardAP
2022-11-09Labeling · Supplement 20 · standardAP
2018-03-14Labeling · Supplement 11 · standardAP
2017-03-24Labeling · Supplement 9 · standardAP
2017-03-24Labeling · Supplement 10 · standardAP
2015-03-18Labeling · Supplement 7 · standardAP
2013-12-19Labeling · Supplement 5 · standardAP
2007-06-25OriginalAP
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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