Application 761398
- Type
- BLA
- Sponsor
- FRESENIUS KABI USA LLC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761398 | Conexxence | denosumab-bnht | 351(k) Interchangeable | Rx | 2026-07-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BOMYNTRA | DENOSUMAB-BNHT | INJECTION | 120MG/1.7ML (70 MG/ML) | No | No |
| 002 | CONEXXENCE | DENOSUMAB-BNHT | INJECTION | 60MG/ML | 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 |
|---|---|---|---|---|---|---|
| CONEXXENCE | DENOSUMAB | Fresenius Kabi USA, LLC | 39a0a789-778f-4695-b3a9-61643e6396cd | 2025-12-15 | Boxed warning, Warnings, Adverse reactions | BLA761398 |
| BOMYNTRA | DENOSUMAB | Fresenius Kabi USA, LLC | 49d25732-e05d-47e4-98cb-67df04796d4b | 2025-03-31 | Warnings, Adverse reactions | BLA761398 |