Application 761062
- Type
- BLA
- Sponsor
- AMGEN INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761062 | Evenity | romosozumab-aqqg | 351(a) | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EVENITY | ROMOSOZUMAB-AQQG | INJECTABLE;INJECTION | 105MG/1.17ML | 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 |
|---|---|---|---|---|---|---|
| Evenity | ROMOSOZUMAB-AQQG | Amgen, Inc | 471baba2-7154-4488-9891-0db2f46791e7 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | BLA761062 55513-880 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55513-880 | Evenity | romosozumab-aqqg | Amgen Inc | BLA | Current |
| 55513-880 | Evenity | romosozumab-aqqg | Amgen Inc | BLA | Current |
| 55513-880 | Evenity | romosozumab-aqqg | Amgen Inc | BLA | Current |
| 55513-880 | Evenity | romosozumab-aqqg | Amgen Inc | BLA | Current |
| 55513-880 | Evenity | romosozumab-aqqg | Amgen Inc | BLA | Current |