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 | 74528-120_16dd4a78-9875-4c90-9dee-8f4d6af2e710 |
NDC | 74528-120 |
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 | 1200 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 |