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KOVANAZE (tetracaine HCl and oxymetazoline HCl) Nasal Spray

KOVANAZE

Company: St. Renatus, LLC
Application No.: 208032
Approval Date: 06/29/2016

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Approval Letter(s) (PDF)
Printed Labeling (PDF)
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: November 28, 2017

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