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MIPLYFFA

Active substance: Arimoclomol

CAPSULE · ARIMOCLOMOL CITRATE 124 mg/1

United StatesActive

Marketing holder: Acer Therapeutics 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 2
  • Meplyffa
    arimoclomol citrate
    EMEA/H/C/006736
    Zevra Denmark A/S
  • Miplyffa
    arimoclomol citrate
    EMEA/H/C/005203
    Orphazyme A/S
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12090-e34d-7389-8859-8f2ec7ce67eb,01a12090-e351-7768-a0dc-875303a9814b,01a12092-ab70-774f-ba77-cc85b688f0c2,01a12095-17e7-72b7-a9be-4f26690b687a;count=4 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
72542-124
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 72542-124 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 72542-124 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 72542-124 · Verified 2026-10-09 · open in source