Drug Approval Package: RECARBRIO

Company: Merck Sharp & Dohme Corp.
Application Number: 212819
Approval Date: 07/16/2019

Drugs@FDA information available about RECARBRIO

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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)
• Multi-Discipline Review (PDF)
• Propietary Name Review(s) (PDF)
• Employee/Officer List (PDF)
• Other Review(s) (PDF)
• Administrative and Correspondence Documents (PDF)

Date created: July 22, 2019

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