approval · primary record
GOLIMUMAB
2 approval events · latest 2025-10-22
| Agency | FDA |
|---|---|
| Submission type | BLA |
| Latest action | 2025-10-22 |
| Approval events | 2 |
| Brand | SIMPONI |
| Sponsor | CENTOCOR ORTHO BIOTECH INC |
| Route | INJECTION |
Approval history
2 actions on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2025-10-22 | FDA | BLA | SIMPONI | CENTOCOR ORTHO BIOTECH INC | INJECTION |
| 2025-04-18 | FDA | BLA | SIMPONI ARIA | JANSSEN BIOTECH | INJECTION |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:28:46.534Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:golimumab
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Golimumab · compound