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ERLOTINIB HYDROCHLORIDE

Active substance: erlotinib

TABLET, FILM COATED · ERLOTINIB HYDROCHLORIDE 25 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 2
  • Erlotinib Accord
    erlotinib
    EMEA/H/C/005071
    Accord Healthcare S.L.U.
  • Tarceva
    erlotinib
    EMEA/H/C/000618
    Cheplapharm Registration GmbH
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-626f-76f7-8600-fb09a3a48015,01a1208c-a68f-7cd0-b6af-f37da7ef915d,01a1208d-0122-77e8-bd41-1d23da3e09ab,01a1208d-05a4-7d1b-9fb9-511eeb14e392,01a1208d-66bc-7acb-8c25-0e9036be72db;count=30 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
46708-565
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 46708-565 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 46708-565 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 46708-565 · Verified 2026-10-09 · open in source