Application 761457
- Type
- BLA
- Sponsor
- AMNEAL PHARMS LLC
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761457 | Oziltus | denosumab-mobz | 351(k) Interchangeable | Rx | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OZILTUS | DENOSUMAB-MOBZ | INJECTABLE;SUBCUTANEOUS | 120MG/1.7ML (70MG/ML) | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84691 | ORIG | 2026-01-06 |
| 84519 | ORIG | 2025-12-23 |