Drug Approval Package: BREZTRI AEROSPHERE
Company: AstraZeneca
Application Number: 212122
Approval Date: 7/23/2020
Application Number: 212122
Approval Date: 7/23/2020
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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)
- Administrative and Correspondence Documents (PDF)
Date created: July 01, 2021
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