Drug Approval Package

Betaseron Interferon BETA-1B Subcutaneous
Company: Chiron Corporation
Application No.:  103471
Approval Date: 07/23/1993

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3400 for assistance.

• Approval Letter(s) (PDF) 

• Approvable Letter (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)

• Environmental Assessment (PDF)

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF) 

• Microbiology Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: June 11, 2007

Back to Top    Drugs@FDA

Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3400 for assistance.

Note: Documents in PDF format require the Adobe Acrobat Reader®.