golimumab Injection
- Brand(s)
- Simponi
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Janssen Biotech, Inc. (2015-08-10)
- Oldest Current Product
- 2013-07-19
- License(s)
- BLA
- RxNORM
- INJECTION\GOLIMUMAB
- SPL Active
- INTRAVENOUS\SOLUTION\GOLIMUMAB
- SPL Moiety
- INTRAVENOUS\SOLUTION\GOLIMUMAB
product(s) by strength(s)
4 ml golimumab 12.5 mg/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 578940350 | Simponi | BLA | Janssen Biotech, Inc. | 2013-07-19 | GOLIMUMAB | INTRAVENOUS | SOLUTION | 125433 | 9e260a47-55af-4c92-8d88-a86ccc767fff |
application(s)
| # | id | title | approved | tradenames | fda division |
|---|---|---|---|---|---|
| 1 | 125433 | golimumab injection, for IV use Application | 2013-07-18 | Simponi Aria | CDER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 9e260a47-55af-4c92-8d88-a86ccc767fff (view SPL) | These highlights do not include all the information needed to use SIMPONI ARIA safely and effectively. See full prescribing information for SIMPONI ARIA. SIMPONI ARIA (golimumab) injection, for intravenous use Initial U.S. Approval: 2009 | prescription | Human Prescription | Janssen Biotech, Inc. | ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK | 2015-08-10 | 6 | 578940350 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII