Application 215498
- Type
- NDA
- Sponsor
- ALBIREO PHARMA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BYLVAY | ODEVIXIBAT | CAPSULE;ORAL | 400MCG | No | No |
| 002 | BYLVAY | ODEVIXIBAT | CAPSULE;ORAL | 1200MCG | No | No |
| 003 | BYLVAY | ODEVIXIBAT | PELLETS;ORAL | 200MCG | No | No |
| 004 | BYLVAY | ODEVIXIBAT | PELLETS;ORAL | 600MCG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 74528-020 | BYLVAY | odevixibat | Albireo Pharma, Inc. | NDA | Current |
| 74528-020 | BYLVAY | odevixibat | Albireo Pharma, Inc. | NDA | Current |
| 74528-020 | BYLVAY | odevixibat | Albireo Pharma, Inc. | NDA | Current |
| 74528-040 | BYLVAY | odevixibat | Albireo Pharma, Inc. | NDA | Current |
| 74528-040 | BYLVAY | odevixibat | Albireo Pharma, Inc. | NDA | Current |
| 74528-040 | BYLVAY | odevixibat | Albireo Pharma, Inc. | NDA | Current |
| 74528-060 | BYLVAY | odevixibat | Albireo Pharma, Inc. | NDA | Current |
| 74528-060 | BYLVAY | odevixibat | Albireo Pharma, Inc. | NDA | Current |
| 74528-060 | BYLVAY | odevixibat | Albireo Pharma, Inc. | NDA | Current |
| 74528-120 | BYLVAY | odevixibat | Albireo Pharma, Inc. | NDA | Current |
| 74528-120 | BYLVAY | odevixibat | Albireo Pharma, Inc. | NDA | Current |
| 74528-120 | BYLVAY | odevixibat | Albireo Pharma, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84513 | SUPPL | 2025-12-23 |
| 84506 | SUPPL | 2025-12-23 |
| 81673 | SUPPL | 2025-03-21 |
| 81672 | SUPPL | 2025-03-21 |
| 74493 | SUPPL | 2023-06-15 |
| 74489 | SUPPL | 2023-06-14 |
| 74196 | SUPPL | 2023-05-09 |
| 74193 | SUPPL | 2023-05-09 |
| 72468 | SUPPL | 2022-10-26 |
| 72452 | SUPPL | 2022-10-24 |
| 68404 | ORIG | 2021-08-18 |
| 68148 | ORIG | 2021-07-21 |
| 68140 | ORIG | 2021-07-21 |