Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsINJECTIONStandard

SIMPONI

GOLIMUMAB

Standard Dose
50MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SIMPONI is listed in Drugs@FDA under application 125289 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient GOLIMUMAB Form and strength INJECTABLE; INJECTION - 50MG Sponsor CENTOCOR ORTHO BIOTECH INC Submission history Latest submission status date: 2025-10-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview SIMPONI is listed in Drugs@FDA under application 125289 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient GOLIMUMAB Form and strength INJECTABLE; INJECTION - 50MG Sponsor CENTOCOR ORTHO BIOTECH INC Submission history Latest submission status date: 2025-10-22 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.