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Exondys 51

Active substance: eteplirsen

INJECTION · ETEPLIRSEN 50 mg/mL

United StatesActive

Marketing holder: Sarepta 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 1
  • Exondys
    eteplirsen
    EMEA/H/C/004355
    AVI Biopharma International Ltd
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208d-5891-729b-90fd-87aa11428487,01a1208f-8219-7939-94d9-2819b76167e3,01a12092-09b9-72a2-8bae-69484981eef4,01a12095-6afc-7cfb-9550-dfc3cc855bf6;count=4 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
60923-363
Registration status
Active
Dispensing
Prescription only
Route
INTRAVENOUS
Sources
  • product · openFDA NDC · 60923-363 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 60923-363 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 60923-363 · Verified 2026-10-09 · open in source