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KOSELUGO

Active substance: selumetinib

CAPSULE · SELUMETINIB 10 mg/1

United StatesActive

Marketing holder: AstraZeneca Pharmaceuticals LP

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
  • Koselugo
    selumetinib sulfate
    EMEA/H/C/005244
    AstraZeneca AB
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12090-7816-7a21-b07c-09b75477ec00,01a1209b-8aa7-736f-9742-963ede98a03f,01a1209d-d791-7f32-a262-1e290369aa5a,01a1209d-d797-7184-a836-7e1785046ec1;count=4 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
0310-0610
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 0310-0610 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 0310-0610 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 0310-0610 · Verified 2026-10-09 · open in source