FdaApplication
NDA 220406
Identifiers
- fda_app_no: NDA220406
Properties
| Property | Value |
|---|---|
| applicant_name | AVYXA HOLDINGS LLC |
| application_type | NDA |
| approval_date | 2026-02-03 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| VYKOURA | LEUCOVORIN CALCIUM | EQ 500MG BASE/50ML (EQ 10MG BASE/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS |
| VYKOURA | LEUCOVORIN CALCIUM | EQ 50MG BASE/5ML (EQ 10MG BASE/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS |
| VYKOURA | LEUCOVORIN CALCIUM | EQ 350MG BASE/35ML (EQ 10MG BASE/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS |
3 products