Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsINJECTIONStandard

BILDYOS

DENOSUMAB-NXXP

Standard Dose
60MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview BILDYOS is listed in Drugs@FDA under application 761444 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DENOSUMAB-NXXP Form and strength INJECTABLE;INJECTION - 60MG/ML Sponsor SHANGHAI HENLIUS BIOTECH Submission history Latest submission status date: 2025-10-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview BILDYOS is listed in Drugs@FDA under application 761444 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient DENOSUMAB-NXXP Form and strength INJECTABLE;INJECTION - 60MG/ML Sponsor SHANGHAI HENLIUS BIOTECH 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.