APPLICATION
ANDA078050
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-13
LATEST ACTION
2025-11-17
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
ONDANSETRONPrescription
ONDANSETRON 8MG · TABLET, ORALLY DISINTEGRATING · ORAL
ONDANSETRONPrescription
ONDANSETRON 4MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2025-11-17Labeling · Supplement 19 · standardAP
2024-05-31Labeling · Supplement 18 · standardAP
2024-05-31Labeling · Supplement 17 · standardAP
2018-05-14Labeling · Supplement 16 · standardAP
2017-03-24Labeling · Supplement 15 · standardAP
2014-12-10Labeling · Supplement 12 · standardAP
2014-12-10Labeling · Supplement 13 · standardAP
2012-02-16Labeling · Supplement 5AP
2011-10-18Labeling · Supplement 4AP
2011-03-31Labeling · Supplement 2AP
2010-10-29Labeling · Supplement 1AP
2007-08-13OriginalAP
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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