Details for New Drug Application (NDA): 220201
✉ Email this page to a colleague
NDA 220201 describes FAVLYXA, which is a drug marketed by Avyxa Holdings and is included in one NDA. It is available from one supplier. Additional details are available on the FAVLYXA profile page.
The generic ingredient in FAVLYXA is fluorouracil. There are fifteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
The generic ingredient in FAVLYXA is fluorouracil. There are fifteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 220201
| Tradename: | FAVLYXA |
| Applicant: | Avyxa Holdings |
| Ingredient: | fluorouracil |
| Patents: | 0 |
Pharmacology for NDA: 220201
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 220201
Suppliers and Packaging for NDA: 220201
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FAVLYXA | fluorouracil | SOLUTION;INTRAVENOUS | 220201 | NDA | Avyxa Pharma, LLC | 83831-143 | 83831-143-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83831-143-01) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 250MG/10ML (25MG/ML) | ||||
| Approval Date: | Feb 20, 2026 | TE: | RLD: | Yes | |||||
Complete Access Available with Subscription
