Bylvay
Active substance: odevixibat
CAPSULE, COATED PELLETS · ODEVIXIBAT 600 ug/1
United StatesActive
Marketing holder: Ipsen Biopharmaceuticals, Inc.
Verified 2026-10-09 · openFDA NDC
Analogues in other countries- Source: openFDA NDC
- Countries with the substance registered: 2
Composition
- ODEVIXIBAT · 600 ug/1
Analogues by country
Products with the same active substance registered in other countries.
| Country | Products |
|---|---|
| EU 1 |
|
Import and control
Control by country
- United Statesprescription only
Source: openFDA NDC · record 01a1208e-060c-79f2-9cbe-3a73b846d1e3,01a12091-6df8-7907-b239-751d22791422,01a12091-6df9-7bd7-8cad-14f53d5b6915,01a12093-44bf-7387-8e7b-b72879d868d5;count=4 · valid from 2026-10-09 · verified 2026-10-09
Registration
- Registration number
- 15054-3303
- Registration status
- Active
- Dispensing
- Prescription only
- Route
- ORAL
Sources
- product · openFDA NDC · 15054-3303 · Verified 2026-10-09 · open in source
- registration_status · openFDA NDC · 15054-3303 · Verified 2026-10-09 · open in source
- ingredients.0 · openFDA NDC · 15054-3303 · Verified 2026-10-09 · open in source