Product Details for: Dupixent
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
300MG/2ML
Pre-Filled Syringe
351(a)
Dupixent
Rx
002
Injection
Subcutaneous
300MG/2ML
Pre-Filled Syringe
351(a)
Dupixent
Disc
003
Injection
Subcutaneous
200MG/1.14ML
Pre-Filled Syringe
351(a)
Dupixent
Rx
004
Injection
Subcutaneous
300MG/2ML
Autoinjector
351(a)
Dupixent
Rx
005
Injection
Subcutaneous
200MG/1.14ML
Autoinjector
351(a)
Dupixent
Rx
006
Injection
Subcutaneous
100MG/0.67ML
Pre-Filled Syringe
351(a)
Dupixent
Disc
Proper Name
dupilumab
dupilumab
BLA Number
761055
761055
Applicant
Regeneron Pharmaceuticals, Inc.
Regeneron Pharmaceuticals, Inc.
Original Approval Date
March 28, 2017
March 28, 2017
Date of First Licensure