Drug Approval Package: Byvalson (nebivolol/valsartan)

Company:  Foreset Laboratories, LLC
Application No.:  206302
Approval Date: June 3, 2016

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• Approval Letter(s) (PDF)
• Other Action Letters (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)
• Microbiology Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative and Correspondence Document(s) (PDF)

Date created: September 12, 2016

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