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U.S. Department of Health and Human Services


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Peginterferon alfa-2b Product Approval Information - Licensing Action

Proper name: Peginterferon alfa-2b
Tradename: PEG-Intron
Manufacturer: Schering Corp, Kenilworth, NJ, License #0994
Indication for Use: Combination therapy with Ribavirin, USP (Rebetol), for the treatment of chronic hepatitis C
Approval Date: 8/7/2001
Type of submission: Biologics license application supplement


Approval Letter (PDF)

Label (PDF)

Medication Guide (PDF)