Drug Approval Package: NEXLETOL

Company: Esperion Therapeutics, Inc
Application Number: 211616
Approval Date: 03/01/2020

Drugs@FDA information available about NEXLETOL

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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)
• Administrative and Correspondence Documents (PDF)

Date created: March 24, 2020

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