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Unituxin

Active substance: dinutuximab

INJECTION · DINUTUXIMAB 3.5 mg/mL

United StatesActive

Marketing holder: United Therapeutics Corporation

Verified 2026-10-09 · openFDA NDC

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
EU 1
  • Unituxin
    dinutuximab
    EMEA/H/C/002800
    United Therapeutics Europe Ltd
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12096-e9ff-70d4-8791-e3fa5a1cb41e;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
66302-014
Registration status
Active
Dispensing
Prescription only
Route
INTRAVENOUS
Sources
  • product · openFDA NDC · 66302-014 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 66302-014 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 66302-014 · Verified 2026-10-09 · open in source