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Simponi Aria
golimumab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Simponi Aria
Proper name
golimumab
Licence type
351(a)
BLA number
125433
Applicant
Janssen Biotech, Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 50MG/4ML (12.5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | July 18, 2013 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | September 29, 2027 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |