Tresiba (degludec) and Ryzodeg

Company:  Novo Nordisk, Inc.
Application No.:  203313Orig1 and 203314Orig1
Approval Date: September 25, 2015

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

• Approval Letter(s) NDA 203313) (PDF)
• Approval Letter(s) NDA 203314 (PDF)
• Other Action Letter (PDF)
• Printed Labeling NDA 203313 (PDF)
• Printed Labeleing NDA 203314 (PDF)
• Summary Review (PDF)
• Officer/Employee List NDA 203313 (PDF)
• Officer/Employee List NDA 203314 (PDF)
• Office Director Memo (PDF)
• Cross Discipline Review (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Microbiology Review (PDF)
• Pharmacology Review(s) (PDF)
• Statistical Review (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

 

Date created: November 25, 2015

Back to Top    Drugs@FDA

Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.

Note: Documents in PDF format require the Adobe Acrobat Reader®.