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OGSIVEO

Active substance: nirogacestat

TABLET, FILM COATED · NIROGACESTAT 100 mg/1

United StatesActive

Marketing holder: SpringWorks 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
  • Ogsiveo
    nirogacestat hydrobromide
    EMEA/H/C/006071
    Merck Europe B.V.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-36cc-730f-85f6-d8c622a7c45f,01a12091-15cb-7cb0-8fbe-45f2b536f0d0;count=2 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
82448-100
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 82448-100 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 82448-100 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 82448-100 · Verified 2026-10-09 · open in source