On this page
Eylea HD
aflibercept
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Eylea HD
Proper name
aflibercept
Licence type
351(a)
BLA number
761355
Applicant
Regeneron Pharmaceuticals, Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 8MG/0.07ML | Injection | Intravitreal | Single-Dose Vial | Rx | August 18, 2023 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |