APPLICATION
ANDA090469
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-12
LATEST ACTION
2025-11-24
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
ONDANSETRONPrescription
ONDANSETRON 4MG · TABLET, ORALLY DISINTEGRATING · ORAL
ONDANSETRONPrescription
ONDANSETRON 8MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2025-11-24Labeling · Supplement 23 · standardAP
2024-01-31Labeling · Supplement 18 · standardAP
2024-01-31Labeling · Supplement 19 · standardAP
2018-03-07Labeling · Supplement 14 · standardAP
2017-03-27Labeling · Supplement 12 · standardAP
2017-03-27Labeling · Supplement 11 · standardAP
2014-12-21Labeling · Supplement 7 · standardAP
2014-12-21Labeling · Supplement 8 · standardAP
2012-02-16Labeling · Supplement 3AP
2010-12-08Labeling · Supplement 1AP
2010-04-12OriginalAP
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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