Drug Approval Package: Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution)

Company: Altaire Pharmaceuticals, Inc.
Application Number: 208582
Approval Date: 12/14/2017

Drugs@FDA information available about Altafluor Benox

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FDA Approval Letter and Labeling

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

FDA Application Review Files

• Other Action Letters (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Cross Discipline Team Leader Review (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 9, 2018

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