← FDA DRUG APPROVALS

FDA NDA · NDA220406

VYKOURA

leucovorin calcium

Sponsor: AVYXA HOLDINGS

APPLICATION
NDA220406
TYPE
NDA
ORIGINAL APPROVAL
2026-02-03
LATEST ACTION
2026-02-03
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

VYKOURA · ReferencePrescription
LEUCOVORIN CALCIUM EQ 500MG BASE/50ML (EQ 10MG BASE/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS
VYKOURA · ReferencePrescription
LEUCOVORIN CALCIUM EQ 50MG BASE/5ML (EQ 10MG BASE/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS
VYKOURA · ReferencePrescription
LEUCOVORIN CALCIUM EQ 350MG BASE/35ML (EQ 10MG BASE/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS

Approval history

2026-02-03Type 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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