Drug Approval Package: XENLENTA

Company: NABRIVA THERAPEUTICS
Application Number: 211672, 211673
Approval Date: 08/19/2019

Drugs@FDA information available about XENLENTA (211672)
Drugs@FDA information available about XENLENTA (211673)

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

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)
• Administrative and Correspondence Documents (PDF)

Date created: September 26, 2019

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