[Skip navigation]FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Drug Evaluation and Research
  HHS Logo links to Department of Health and Human Services website

FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER

horizonal rule
CDER Home About CDER Drug Information Regulatory Guidance CDER Calendar Specific Audiences CDER Archives
 
Powered by Google
 

 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), (Text)

Label (PDF), (Text)

Medication Guide (PDF)


Last Updated: 9/24/2001

 

Back to Top     Back to Index

Updated: September 25, 2003

horizonal rule