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General MedicationsSUBCUTANEOUSStandard

DENOSUMAB-DSSB

DENOSUMAB-DSSB

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

Approval overview DENOSUMAB-DSSB is listed in Drugs@FDA under application 761392 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DENOSUMAB-DSSB Form and strength INJECTABLE;SUBCUTANEOUS - 70MG/ML Sponsor SAMSUNG BIOEPIS CO LTD Submission history Latest submission status date: 2025-10-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview DENOSUMAB-DSSB is listed in Drugs@FDA under application 761392 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient DENOSUMAB-DSSB Form and strength INJECTABLE;SUBCUTANEOUS - 70MG/ML Sponsor SAMSUNG BIOEPIS CO LTD 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.