APPLICATION
ANDA078139
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-25
LATEST ACTION
2023-01-31
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued
Products
ONDANSETRONDiscontinued
ONDANSETRON 8MG · TABLET, ORALLY DISINTEGRATING · ORAL
ONDANSETRONDiscontinued
ONDANSETRON 4MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2023-01-31Labeling · Supplement 17 · standardAP
2023-01-31Labeling · Supplement 15 · standardAP
2018-03-07Labeling · Supplement 8 · standardAP
2017-03-31Labeling · Supplement 7 · standardAP
2015-12-07Labeling · Supplement 5 · standardAP
2013-08-27Labeling · Supplement 4 · 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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