Drug Approval Package: ULTOMIRIS
Company: Alexion Pharmaceuticals Inc.
Application Number: 761108
Approval Date: 12/21/2018
Application Number: 761108
Approval Date: 12/21/2018
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FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
- REMS (PDF)
- Officer/Employee List (PDF)
- Multi-Discipline Review (PDF)
- Chemistry Review(s) (PDF)
- Risk Assessment and Risk Mitigation Review(s)
- Proprietary Name Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: January 18, 2019
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