Drug Approval Package: SAPHNELO
Company: AstraZeneca AB
Application Number: 761123
Approval Date: 7/30/2021
Application Number: 761123
Approval Date: 7/30/2021
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FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
- Product Quality Review(s) (PDF)
- Multi-Discipline Review (PDF)
- Proprietary Name Review(s) (PDF)
- Officer/Employee List (PDF)
- Other Review(s) (PDF)
- Risk Assessment and Risk Mitigation Review(s) (PDF)
Date created: August 17, 2021
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