BYLVAY is a Oral Capsule, Coated Pellets in the Human Prescription Drug category. It is labeled and distributed by Albireo Pharma, Inc.. The primary component is Odevixibat.
| Product ID | 74528-020_16dd4a78-9875-4c90-9dee-8f4d6af2e710 |
| NDC | 74528-020 |
| Product Type | Human Prescription Drug |
| Proprietary Name | BYLVAY |
| Generic Name | Odevixibat |
| Dosage Form | Capsule, Coated Pellets |
| Route of Administration | ORAL |
| Marketing Start Date | 2021-07-20 |
| Marketing Category | NDA / |
| Application Number | NDA215498 |
| Labeler Name | Albireo Pharma, Inc. |
| Substance Name | ODEVIXIBAT |
| Active Ingredient Strength | 200 ug/1 |
| Pharm Classes | Ileal Bile Acid Transporter Inhibitor [EPC], Ileal Bile Acid Transporter Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2021-07-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 74528-020 | BYLVAY | odevixibat |
| 74528-040 | BYLVAY | odevixibat |
| 74528-060 | BYLVAY | odevixibat |
| 74528-120 | BYLVAY | odevixibat |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BYLVAY 88932949 not registered Live/Pending |
Albireo AB 2020-05-26 |