Details for New Drug Application (NDA): 220200
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NDA 220200 describes AVOPEF, 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 AVOPEF profile page.
The generic ingredient in AVOPEF is etoposide. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the etoposide profile page.
The generic ingredient in AVOPEF is etoposide. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the etoposide profile page.
Summary for 220200
| Tradename: | AVOPEF |
| Applicant: | Avyxa Holdings |
| Ingredient: | etoposide |
| Patents: | 0 |
Pharmacology for NDA: 220200
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 220200
Suppliers and Packaging for NDA: 220200
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AVOPEF | etoposide | SOLUTION;INTRAVENOUS | 220200 | NDA | Avyxa Pharma, LLC | 83831-144 | 83831-144-05 | 1 VIAL in 1 CARTON (83831-144-05) / 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MG/5ML (20MG/ML) | ||||
| Approval Date: | Feb 13, 2026 | TE: | RLD: | Yes | |||||
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