Product Details for: Plegridy
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
125MCG/0.5ML
Autoinjector
351(a)
Plegridy
Rx
002
Injection
Subcutaneous
63MCG/0.5ML
Autoinjector
351(a)
Plegridy
Rx
003
Injection
Subcutaneous
94MCG/0.5ML
Autoinjector
351(a)
Plegridy
Rx
004
Injection
Subcutaneous, Intramuscular
125MCG/0.5ML
Pre-Filled Syringe
351(a)
Plegridy
Rx
005
Injection
Subcutaneous
63MCG/0.5ML
Pre-Filled Syringe
351(a)
Plegridy
Rx
006
Injection
Subcutaneous
94MCG/0.5ML
Pre-Filled Syringe
351(a)
Plegridy
Rx
Proper Name
peginterferon beta-1a
peginterferon beta-1a
BLA Number
125499
125499
Applicant
Biogen Inc.
Biogen Inc.
Original Approval Date
August 15, 2014
August 15, 2014
Date of First Licensure