Application 216490
- Type
- NDA
- Sponsor
- ASCENDIS PHARMA BONE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | YORVIPATH | PALOPEGTERIPARATIDE | SOLUTION;SUBCUTANEOUS | EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML) | Yes | Yes |
| 002 | YORVIPATH | PALOPEGTERIPARATIDE | SOLUTION;SUBCUTANEOUS | EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML) | Yes | No |
| 003 | YORVIPATH | PALOPEGTERIPARATIDE | SOLUTION;SUBCUTANEOUS | EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML) | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83846 | SUPPL | 2025-10-21 |
| 83804 | SUPPL | 2025-10-20 |
| 83803 | SUPPL | 2025-10-20 |
| 79565 | ORIG | 2024-10-15 |
| 79375 | ORIG | 2024-08-12 |
| 79370 | ORIG | 2024-08-12 |