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Asenapine

Active substance: asenapine

TABLET · ASENAPINE 5 mg/1

United StatesActive

Marketing holder: Alembic Pharmaceuticals 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
RU 1
  • Сафрис®
    таблетки подъязычные, 10 мг (original in Russian, GRLS)
    ЛП-001526
    Н.В. Органон
EU 1
  • Sycrest
    asenapine maleate
    EMEA/H/C/001177
    Organon N.V.
Import and control

Control by country

  • Russiaprescription only

    Source: GRLS (Russian state register) · record 01a120c5-076b-73b4-a005-16c52ea5b47e;count=1 · valid from 2026-10-09 · verified 2026-10-09

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-aa2e-76a9-8159-5e55ab7a34b7,01a1208d-3afe-78f9-819e-d066afad24c7,01a1208e-9c03-7889-9bf2-a8f7bfb81873,01a1208e-cc2c-71ff-b740-af5be8aed378,01a12090-1dff-7b63-a6dd-85ddcf8cefd0;count=24 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
62332-198
Registration status
Active
Dispensing
Prescription only
Route
SUBLINGUAL
Sources
  • product · openFDA NDC · 62332-198 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 62332-198 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 62332-198 · Verified 2026-10-09 · open in source