Drug Approval Package: FABRAZYME (AGALSIDASE BETA)
Company: Genzyme Corp
Application No.: 103979
Approval Date: 4/24/2003
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- Printed Labeling (PDF)
- Statistical - 4/24/2003 (PDF)
- Clinical - 4/23/2003 (PDF)
- CMC - 8/4/2000 (PDF)
- CMC - 12/12/2000 (PDF)
- Clinical - 4/21/2003 (PDF)
- Clinical - 4/22/2003 (PDF)
Date created: March 15, 2004, Updated August 22, 2017
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