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General MedicationsINJECTIONStandard

BILPREVDA

DENOSUMAB-NXXP

Standard Dose
120MG/1.7ML(70MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

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

Review priority: STANDARD Marketing status: Prescription Active ingredient DENOSUMAB-NXXP Form and strength INJECTABLE;INJECTION - 120MG/1.7ML(70MG/ML) Sponsor SHANGHAI HENLIUS BIOTECH Submission history Latest submission status date: 2025-10-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview BILPREVDA is listed in Drugs@FDA under application 761444 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient DENOSUMAB-NXXP Form and strength INJECTABLE;INJECTION - 120MG/1.7ML(70MG/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.