Drug Approval Package: NEXLIZET
Company: Esperion Therapeutics, Inc
Application Number: 211617
Approval Date: 02/26/2020
Application Number: 211617
Approval Date: 02/26/2020
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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)
- Integrated Review (PDF)
- Proprietary Name Review(s) (PDF)
- Officer/Employee List (PDF)
- Other Review(s) (PDF)
- Risk Assessment and Risk Mitigation Review(s) (PDF)
- Administrative and Correspondence Documents (PDF)
Date created: April 17, 2020
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