General MedicationsINJECTIONStandard
TEPEZZA
TEPROTUMUMAB-TRBW
Standard Dose
500MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview TEPEZZA is listed in Drugs@FDA under application 761143 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient TEPROTUMUMAB-TRBW Form and strength INJECTABLE;INJECTION - 500MG Sponsor HORIZON THERAPEUTICS IRELAND Submission history Latest submission status date: 2025-11-24 00:00:00.
Structured Monograph
Clinical summary
Approval overview TEPEZZA is listed in Drugs@FDA under application 761143 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient TEPROTUMUMAB-TRBW Form and strength INJECTABLE;INJECTION - 500MG Sponsor HORIZON THERAPEUTICS IRELAND Submission history Latest submission status date: 2025-11-24 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.