APPLICATION
ANDA077306
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-25
LATEST ACTION
2018-02-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 4MG BASE · TABLET · ORAL
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 8MG BASE · TABLET · ORAL
Approval history
2018-02-26Labeling · Supplement 12 · standardAP
2018-02-26Labeling · Supplement 10 · standardAP
2018-02-26Labeling · Supplement 11 · standardAP
2014-12-19Labeling · Supplement 9 · standardAP
2014-12-19Labeling · Supplement 7 · standardAP
2014-12-19Labeling · Supplement 8 · standardAP
2014-12-19Labeling · Supplement 6 · standardAP
2014-01-27Labeling · 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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