Drug Approval Package: REBLOZYL (luspatercept-aamt)
Company: Celgene Corporation
Application Number: 761136
Approval Date: 11/08/2019
Application Number: 761136
Approval Date: 11/08/2019
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FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
- Officer/Employee List (PDF)
- Multi-Discipline Review (PDF)
- Proprietary Name Review (PDF)
- Chemistry Review(s) (PDF)
- Risk Assessment Review(s) (PDF)
- Administrative and Correspondence Review(s) (PDF)
- Other Review(s) (PDF)
Date created: December 19, 2019
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