On this page
Humira
adalimumab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Humira
Proper name
adalimumab
Licence type
351(a)
BLA number
125057
Applicant
AbbVie Inc.
Center
CDER
Presentations
11
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10MG/0.1ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | April 28, 2017 |
| 10MG/0.2ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc* | September 23, 2014 |
| 20MG/0.2ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | April 28, 2017 |
| 20MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc* | February 21, 2008 |
| 40MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | November 23, 2015 |
| 40MG/0.4ML | Injection | Subcutaneous | Autoinjector | Rx | March 9, 2016 |
| 40MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | December 31, 2002 |
| 40MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | December 31, 2002 |
| 40MG/0.8ML | Injection | Subcutaneous | Single-Dose Vial | Disc* | April 24, 2013 |
| 80MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | October 17, 2016 |
| 80MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | April 21, 2017 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | February 24, 2028 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |