APPLICATION
ANDA205467
TYPE
ANDA
ORIGINAL APPROVAL
2019-07-01
LATEST ACTION
2023-08-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FEBUXOSTATPrescription
FEBUXOSTAT 80MG · TABLET · ORAL
FEBUXOSTATPrescription
FEBUXOSTAT 40MG · TABLET · ORAL
Approval history
2023-08-09Labeling · Supplement 7 · standardAP
2019-07-01UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.