General MedicationsSUBCUTANEOUSStandard
OZILTUS
DENOSUMAB-MOBZ
Standard Dose
120MG/1.7ML (70MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview OZILTUS is listed in Drugs@FDA under application 761457 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DENOSUMAB-MOBZ Form and strength INJECTABLE;SUBCUTANEOUS - 120MG/1.7ML (70MG/ML) Sponsor AMNEAL PHARMS LLC Submission history Latest submission status date: 2025-12-19 00:00:00.
Structured Monograph
Clinical summary
Approval overview OZILTUS is listed in Drugs@FDA under application 761457 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient DENOSUMAB-MOBZ Form and strength INJECTABLE;SUBCUTANEOUS - 120MG/1.7ML (70MG/ML) Sponsor AMNEAL PHARMS LLC Submission history Latest submission status date: 2025-12-19 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.