Drug Approval Package: GOPRELTO (cocaine hydrochloride)

Company: Genus Lifesciences, Inc.
Application Number: 209963
Approval Date: 12/14/2017

Drugs@FDA information available about GOPRELTO

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FDA Approval Letter and Labeling

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)

FDA Application Review Files

• Summary Review (PDF)
• Officer/Employee List (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Statistical Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: April 30, 2018

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