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Miglustat

Active substance: miglustat

CAPSULE · MIGLUSTAT 100 mg/1

United StatesActive

Marketing holder: CoTherix, 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 5
  • Miglustat Dipharma
    miglustat
    EMEA/H/C/004904
    Dipharma Arzneimittel GmbH
  • Miglustat Gen.Orph
    miglustat
    EMEA/H/C/004366
    Gen.Orph
  • Opfolda
    miglustat
    EMEA/H/C/005695
    Amicus Therapeutics Europe Limited
  • Yargesa
    miglustat
    EMEA/H/C/004016
    Piramal Critical Care B.V.
  • Zavesca
    miglustat
    EMEA/H/C/000435
    Advanz Pharma Limited
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208d-8f56-7499-bcc9-7c3478e16e36,01a12092-53b2-729f-a642-f7c102d974de,01a12093-3da4-7828-b5f4-d91247ba8bd2,01a12097-33eb-75b5-a605-c2c4603331b5,01a12098-8235-7238-87f6-dc9bdf25ca6b;count=7 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
10148-201
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 10148-201 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 10148-201 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 10148-201 · Verified 2026-10-09 · open in source