Product Details for: Eylea
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravitreal
2MG/0.05ML
Single-Dose Vial
351(a)
Eylea
Rx
002
Injection
Intravitreal
2MG/0.05ML
Pre-Filled Syringe
351(a)
Eylea
Rx
Proper Name
aflibercept
aflibercept
BLA Number
125387
125387
Applicant
Regeneron Pharmaceuticals, Inc.
Regeneron Pharmaceuticals, Inc.
Original Approval Date
November 18, 2011
November 18, 2011
Date of First Licensure
11/18/2011
11/18/2011