Application 761184
- Type
- BLA
- Sponsor
- PFIZER IRELAND PHARMACEUTICALS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NGENLA | SOMATROGON-GHLA | INJECTABLE;INJECTION | 24MG | No | No |
| 002 | NGENLA | SOMATROGON-GHLA | INJECTABLE;INJECTION | 60MG | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85796 | SUPPL | 2026-05-01 |
| 85795 | SUPPL | 2026-05-01 |
| 82809 | SUPPL | 2025-07-11 |
| 82780 | SUPPL | 2025-07-11 |
| 77213 | SUPPL | 2024-01-16 |
| 74918 | ORIG | 2023-07-28 |
| 74676 | ORIG | 2023-06-30 |
| 74669 | ORIG | 2023-06-30 |