Skip to contentApplication 219164
- Type
- NDA
- Sponsor
- ASCENDIS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | YUVIWEL | NAVEPEGRITIDE | POWDER;SUBCUTANEOUS | 1.3MG/VIAL | Yes | Yes |
| 002 | YUVIWEL | NAVEPEGRITIDE | POWDER;SUBCUTANEOUS | 2.8MG/VIAL | Yes | Yes |
| 003 | YUVIWEL | NAVEPEGRITIDE | POWDER;SUBCUTANEOUS | 5.5MG/VIAL | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85921 | ORIG | 2026-03-30 |
| 85266 | ORIG | 2026-03-04 |
| 85219 | ORIG | 2026-03-03 |