General MedicationsINJECTIONStandard
TREMFYA
GUSELKUMAB
Standard Dose
100MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview TREMFYA is listed in Drugs@FDA under application 761061 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient GUSELKUMAB Form and strength INJECTABLE;INJECTION - 100MG/ML Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2025-09-26 00:00:00.
Structured Monograph
Clinical summary
Approval overview TREMFYA is listed in Drugs@FDA under application 761061 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient GUSELKUMAB Form and strength INJECTABLE;INJECTION - 100MG/ML Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2025-09-26 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.