Drug Approval Package
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Interferon beta-1a
Company: Biogen Inc.
Application No.: 103628s5021
Approval Date: 5/28/2003
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Summary Basis for Approval (PDF)
- Chemistry, Manufacture and Control Review Part 1 (PDF)
- Chemistry, Manufacture and Control Review Part 2 (PDF)
- Printed Labeling (PDF)
- Medication Guide (PDF)
- Clinical Review(s) (PDF)
- Licensing Action (PDF)
- Review of Assay Validation (PDF)
- Immunogenicity Review(s) (PDF)
- Pharmacology Toxicology Review(s) (PDF)
- Toxicologist Review(s) (PDF)
Date created: February 8, 2011
Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.
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