General MedicationsINJECTIONStandard
STELARA
USTEKINUMAB
Standard Dose
45MG/0.5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview STELARA is listed in Drugs@FDA under application 125261 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient USTEKINUMAB Form and strength INJECTABLE; INJECTION - 45MG/0.5ML Sponsor CENTOCOR ORTHO BIOTECH INC Submission history Latest submission status date: 2025-11-03 00:00:00.
Structured Monograph
Clinical summary
Approval overview STELARA is listed in Drugs@FDA under application 125261 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient USTEKINUMAB Form and strength INJECTABLE; INJECTION - 45MG/0.5ML Sponsor CENTOCOR ORTHO BIOTECH INC Submission history Latest submission status date: 2025-11-03 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.