On this page
Cimzia
certolizumab pegol
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Cimzia
Proper name
certolizumab pegol
Licence type
351(a)
BLA number
125160
Applicant
UCB, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 200MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | April 22, 2008 |
| 200MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | March 28, 2019 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |