Drug Approval Package: ELYXYB

Company: Dr. Reddy's Laboratories Limited
Application Number: 212157
Approval Date: 05/05/2020

Drugs@FDA information available about ELYXYB

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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)
• Clinical Pharmacology and Biopharmaceutics Review(s) (PDF)
• Clinical Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Officer/Employee List (PDF)
• Other Review(s) (PDF)
• Statistical Review(s) (PDF)
• Summary Review (PDF)
• Administrative and Correspondence Documents (PDF)

Date created: July 28, 2020

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