General MedicationsINTRAMUSCULAR, INTRAVENOUSStandard

VYKOURA

LEUCOVORIN CALCIUM

Standard Dose

EQ 350MG BASE/35ML (EQ 10MG BASE/ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview VYKOURA is listed in Drugs@FDA under application 220406 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient LEUCOVORIN CALCIUM Form and strength SOLUTION;INTRAMUSCULAR, INTRAVENOUS - EQ 350MG BASE/35ML (EQ 10MG BASE/ML) Sponsor AVYXA HOLDINGS Submission history Latest submission status date: 2026-02-03 00:00:00.

Structured Monograph

Clinical summary

Approval overview VYKOURA is listed in Drugs@FDA under application 220406 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LEUCOVORIN CALCIUM Form and strength SOLUTION;INTRAMUSCULAR, INTRAVENOUS - EQ 350MG BASE/35ML (EQ 10MG BASE/ML) Sponsor AVYXA HOLDINGS Submission history Latest submission status date: 2026-02-03 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.