Details for New Drug Application (NDA): 220406
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NDA 220406 describes VYKOURA, which is a drug marketed by Avyxa Holdings and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the VYKOURA profile page.
The generic ingredient in VYKOURA is leucovorin calcium. There are nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.
The generic ingredient in VYKOURA is leucovorin calcium. There are nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.
Summary for 220406
| Tradename: | VYKOURA |
| Applicant: | Avyxa Holdings |
| Ingredient: | leucovorin calcium |
| Patents: | 1 |
Suppliers and Packaging for NDA: 220406
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VYKOURA | leucovorin calcium | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 220406 | NDA | Avyxa Pharma, LLC | 83831-147 | 83831-147-05 | 1 VIAL, SINGLE-USE in 1 CARTON (83831-147-05) / 5 mL in 1 VIAL, SINGLE-USE |
| VYKOURA | leucovorin calcium | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 220406 | NDA | Avyxa Pharma, LLC | 83831-148 | 83831-148-35 | 1 VIAL, SINGLE-USE in 1 CARTON (83831-148-35) / 35 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 50MG BASE/5ML (EQ 10MG BASE/ML) | ||||
| Approval Date: | Feb 3, 2026 | TE: | RLD: | Yes | |||||
| Patent: | 12,564,592 | Patent Expiration: | Dec 23, 2044 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 350MG BASE/35ML (EQ 10MG BASE/ML) | ||||
| Approval Date: | Feb 3, 2026 | TE: | RLD: | Yes | |||||
| Patent: | 12,564,592 | Patent Expiration: | Dec 23, 2044 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 500MG BASE/50ML (EQ 10MG BASE/ML) | ||||
| Approval Date: | Feb 3, 2026 | TE: | RLD: | Yes | |||||
| Patent: | 12,564,592 | Patent Expiration: | Dec 23, 2044 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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