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Xospata

Active substance: gilteritinib

TABLET · GILTERITINIB FUMARATE 40 mg/1

United StatesActive

Marketing holder: Astellas Pharma US, Inc.

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
  • Xospata
    gilteritinib fumarate
    EMEA/H/C/004752
    Astellas Pharma Europe B.V.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-2765-7b61-9194-b32170c63a06;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
0469-1425
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 0469-1425 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 0469-1425 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 0469-1425 · Verified 2026-10-09 · open in source