FdaApplication
NDA 215498
Identifiers
- fda_app_no: NDA215498
Properties
| Property | Value |
|---|---|
| applicant_name | IPSEN BIOPHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2021-07-20 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| BYLVAY | ODEVIXIBAT | 0.2MG | CAPSULE, PELLETS;ORAL |
| BYLVAY | ODEVIXIBAT | 0.4MG | CAPSULE;ORAL |
| BYLVAY | ODEVIXIBAT | 0.6MG | CAPSULE, PELLETS;ORAL |
| BYLVAY | ODEVIXIBAT | 1.2MG | CAPSULE;ORAL |
4 products