Drug Approval Package: Pretomanid

Company: The Global Alliance for TB Drug Development, Inc. (TB Alliance)
Application Number: 212862
Approval Date: 08/14/2019

Drugs@FDA information available about Pretomanid

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-Disclipine Review (PDF)
• Other Review(s) (PDF)
• Officer/Employee List (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Administrative and Correspondence Documents (PDF)

Date created: September 12, 2019

Updated: September 13, 2019

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