Application 220200
- Type
- NDA
- Sponsor
- AVYXA HOLDINGS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AVOPEF | ETOPOSIDE | SOLUTION;INTRAVENOUS | 100MG/5ML (20MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N220200-001 | AVOPEF | ETOPOSIDE | 100MG/5ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2026-02-13 | |
| N220200-002 | AVOPEF | ETOPOSIDE | 500MG/25ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2026-06-24 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N220200-001 | AVOPEF | 100MG/5ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2026-02-13 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N220200-002 | AVOPEF | 500MG/25ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2026-06-24 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Avopef | ETOPOSIDE | Avyxa Pharma, LLC | acc1e443-ef7b-486f-a638-710a20e81059 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 220200 NDA220200 |