DANYELZA
Active substance: naxitamab
INJECTION · NAXITAMAB 40 mg/10mL
United StatesActive
Marketing holder: BTG International Inc.
Verified 2026-10-09 · openFDA NDC
- Source: openFDA NDC
- Countries with the substance registered: 1
Composition
- NAXITAMAB · 40 mg/10mL
Import and control
Control by country
- United Statesprescription only
Source: openFDA NDC · record 01a1208e-61f5-7506-b7c2-2b73466361b6;count=1 · valid from 2026-10-09 · verified 2026-10-09
Registration
- Registration number
- 50633-230
- Registration status
- Active
- Dispensing
- Prescription only
- Route
- INTRAVENOUS
Sources
- product · openFDA NDC · 50633-230 · Verified 2026-10-09 · open in source
- registration_status · openFDA NDC · 50633-230 · Verified 2026-10-09 · open in source
- ingredients.0 · openFDA NDC · 50633-230 · Verified 2026-10-09 · open in source