Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761392
Company: SAMSUNG BIOEPIS CO LTD
Company: SAMSUNG BIOEPIS CO LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DENOSUMAB-DSSB | DENOSUMAB-DSSB | 60MG/ML | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |
| DENOSUMAB-DSSB | DENOSUMAB-DSSB | 70MG/ML | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |
| OSPOMYV | DENOSUMAB-DSSB | 60MG/ML | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |
| XBRYK | DENOSUMAB-DSSB | 70MG/ML | INJECTABLE;SUBCUTANEOUS | 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 |
|---|---|---|---|---|---|---|---|
| 02/13/2025 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761392Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761392Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/13/2025 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761392Orig1s000lbl.pdf |