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Simponi
golimumab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Simponi
Proper name
golimumab
Licence type
351(a)
BLA number
125289
Applicant
Janssen Biotech, Inc.
Center
CDER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100MG/ML | Injection | Subcutaneous | Autoinjector | Rx | May 15, 2013 |
| 100MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | May 15, 2013 |
| 50MG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | April 24, 2009 |
| 50MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | April 24, 2009 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | October 7, 1932 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |