General MedicationsINJECTIONStandard
BOMYNTRA
DENOSUMAB-BNHT
Standard Dose
120MG/1.7ML (70 MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview BOMYNTRA is listed in Drugs@FDA under application 761398 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DENOSUMAB-BNHT Form and strength INJECTION - 120MG/1.7ML (70 MG/ML) Sponsor FRESENIUS KABI USA LLC Submission history Latest submission status date: 2025-10-29 00:00:00.
Structured Monograph
Clinical summary
Approval overview BOMYNTRA is listed in Drugs@FDA under application 761398 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient DENOSUMAB-BNHT Form and strength INJECTION - 120MG/1.7ML (70 MG/ML) Sponsor FRESENIUS KABI USA LLC Submission history Latest submission status date: 2025-10-29 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.