Application 220406
- Type
- NDA
- Sponsor
- AVYXA HOLDINGS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VYKOURA | LEUCOVORIN CALCIUM | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | EQ 50MG BASE/5ML (EQ 10MG BASE/ML) | Yes | Yes |
| 002 | VYKOURA | LEUCOVORIN CALCIUM | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | EQ 350MG BASE/35ML (EQ 10MG BASE/ML) | Yes | Yes |
| 003 | VYKOURA | LEUCOVORIN CALCIUM | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | EQ 500MG BASE/50ML (EQ 10MG BASE/ML) | Yes | Yes |