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AGAMREE

Active substance: vamorolone

KIT · vamorolone

United StatesActive

Marketing holder: Catalyst 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
EU 1
  • Agamree
    vamorolone
    EMEA/H/C/005679
    Santhera Pharmaceuticals (Deutschland) GmbH
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-afb9-707d-8f95-6047af8d11b1;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
69616-264
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 69616-264 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 69616-264 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 69616-264 · Verified 2026-10-09 · open in source