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FDA NDA · NDA220201

FAVLYXA

fluorouracil

Sponsor: AVYXA HOLDINGS

APPLICATION
NDA220201
TYPE
NDA
ORIGINAL APPROVAL
2026-02-20
LATEST ACTION
2026-02-20
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

FAVLYXA · ReferencePrescription
FLUOROURACIL 2.5GM/100ML (25MG/ML) · SOLUTION · INTRAVENOUS
FAVLYXA · ReferencePrescription
FLUOROURACIL 250MG/10ML (25MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-02-20Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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