Product Details for: Pegasys
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
180MCG/ML
Single-Dose Vial
351(a)
Pegasys
Rx
002
Injection
Subcutaneous
180MCG/0.5ML
Pre-Filled Syringe
351(a)
Pegasys
Rx
003
Injection
Subcutaneous
180MCG/0.5ML
Autoinjector
351(a)
Pegasys
Disc
004
Injection
Subcutaneous
135MCG/0.5ML
Autoinjector
351(a)
Pegasys
Disc
Proper Name
peginterferon alfa-2a
peginterferon alfa-2a
BLA Number
103964
103964
Applicant
pharmaand GmbH
pharmaand GmbH
Original Approval Date
October 16, 2002
October 16, 2002
Date of First Licensure