Product Details for: Pegintron

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
50MCG/0.5ML
Single-Dose Vial
351(a)
Pegintron
Disc
002
For Injection
Subcutaneous
200MCG
Single-Dose Vial
351(a)
Sylatron
Disc
003
For Injection
Subcutaneous
300MCG
Single-Dose Vial
351(a)
Sylatron
Disc
004
For Injection
Subcutaneous
600MCG
Single-Dose Vial
351(a)
Sylatron
Disc
005
Injection
Subcutaneous
50MCG/0.5ML
Autoinjector
351(a)
Pegintron
Disc
006
Injection
Subcutaneous
80MCG/0.5ML
Autoinjector
351(a)
Pegintron
Disc
007
Injection
Subcutaneous
80MCG/0.5ML
Single-Dose Vial
351(a)
Pegintron
Disc
008
Injection
Subcutaneous
120MCG/0.5ML
Autoinjector
351(a)
Pegintron
Disc
009
Injection
Subcutaneous
120MCG/0.5ML
Single-Dose Vial
351(a)
Pegintron
Disc
010
Injection
Subcutaneous
150MCG/0.5ML
Autoinjector
351(a)
Pegintron
Disc
011
Injection
Subcutaneous
150MCG/0.5ML
Single-Dose Vial
351(a)
Pegintron
Disc
Proper Name
peginterferon alfa-2b
BLA Number
103949
Applicant
Merck Sharp & Dohme LLC
Original Approval Date
January 19, 2001
Date of First Licensure
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