Application 761424
- Type
- BLA
- Sponsor
- ACCORD BIOPHARMA INC.
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761424 | Osvyrti | denosumab-desu | 351(k) Interchangeable | Rx | 2026-07-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OSVYRTI | denosumab-desu | INJECTABLE;SUBCUTANEOUS | 60MG/ML | No | No |
| 002 | JUBEREQ | denosumab-desu | INJECTABLE;SUBCUTANEOUS | 120MG/1.7ML | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| JUBEREQ | DENOSUMAB-DESU | Accord BioPharma Inc. | e15dfe74-1575-4a2a-895e-323c05613362 | 2026-07-14 | Warnings, Adverse reactions | BLA761424 |
| OSVYRTI | DENOSUMAB-DESU | Accord BioPharma Inc. | 5f3be096-5100-4d0e-b765-481bbb2672e1 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | BLA761424 |