APPLICATION
ANDA209389
TYPE
ANDA
ORIGINAL APPROVAL
2023-10-30
LATEST ACTION
2025-11-13
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
2025-11-13Labeling · Supplement 4 · standardAP
2023-10-30UNKNOWN · Original · standardAP
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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