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Bosutinib

Active substance: bosutinib

TABLET, FILM COATED · BOSUTINIB 100 mg/1

United StatesActive

Marketing holder: Alembic Pharmaceuticals Limited

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
  • Bosulif
    bosutinib (as monohydrate)
    EMEA/H/C/002373
    Pfizer Europe MA EEIG
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-3ddf-765e-92c1-65eba9d8a1a8,01a1208c-8a1a-7571-8caa-ceb7bfde7374,01a1208c-900f-7e49-99b0-1b5fffd8825b,01a1208f-b7e4-72da-b11a-f5ceda45b1ac,01a1208f-b7e6-7f72-9b38-7423a2d8ca1d;count=11 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
46708-311
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 46708-311 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 46708-311 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 46708-311 · Verified 2026-10-09 · open in source