On this page
Enbrel Mini
etanercept
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Enbrel Mini
Proper name
etanercept
Licence type
351(a)
BLA number
103795
Applicant
Immunex Corporation
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 50MG/ML | Injection | Subcutaneous | Single-Dose Cartridge | Rx | September 14, 2017 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | May 27, 2006 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |