Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761398
Company: FRESENIUS KABI USA LLC
Company: FRESENIUS KABI USA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BOMYNTRA | DENOSUMAB-BNHT | 120MG/1.7ML (70 MG/ML) | INJECTION | Prescription | None | No | No |
| CONEXXENCE | DENOSUMAB-BNHT | 60MG/ML | INJECTION | Prescription | None | No | No |
| DENOSUMAB-BNHT | DENOSUMAB-BNHT | 120MG/1.7ML (70 MG/ML) | INJECTION | Prescription | None | No | No |
| DENOSUMAB-BNHT | DENOSUMAB-BNHT | 60MG/ML | INJECTION | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/25/2025 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761398Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761398Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/25/2025 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761398Orig1s000lbl.pdf |