FDA
Denosumab-DSSB
The FDA lists this product in 2 strengths and forms.
Composition
- Active ingredients
- DENOSUMAB-DSSB 60MG/ML
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- DENOSUMAB-DSSB 60MG/ML · InjectableThis page
- DENOSUMAB-DSSB 70MG/ML · InjectableBLA761392-004 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application BLA761392.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Denosumab-DSSB
- Route
- Subcutaneous
- Dosage form
- Injectable
- Applicant
- Samsung Bioepis Co LTD
- Status
- Prescription
- FDA approval
- 29 Oct 2025
- Application
- BLA761392-003