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Xultophy 100/3.6 (insulin degludec and liraglutide) Injection

Xultophy

Company: Novo Nordisk Inc.
Application No.: 208583
Approval Date: 11/21/2016

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

Approval Letter(s) (PDF)
Printed Labeling (PDF)
REMS (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)
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 27, 2017

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