Active ingredient
Golimumab
3 finished FDA listings contain Golimumab as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- GOLIMUMAB
- Dosage forms
- Injection, Solution, Solution
- Routes
- Intravenous, Subcutaneous
- Manufacturers / labelers
- 1
- Strengths listed
- 100 mg/ml · 50 mg/.5ml · 50 mg/4ml
- Brand names in FDA listings
- Simponi, Simponi Aria
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 819300
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| BLA 125289 | CENTOCOR ORTHO BIOTECH INC | 2009-04-24 | 2 |
| BLA 125433 | JANSSEN BIOTECH | 2013-07-18 | 1 |
Official labeling on DailyMed
- SIMPONI ARIA (GOLIMUMAB) SOLUTION [JANSSEN BIOTECH, INC.] · version 28 · 2025-09-11
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.