Drug Approval Package: Arikayce
Company: Insmed Incorporated
Application Number: 207356
Approval Date: 09/28/2018
Application Number: 207356
Approval Date: 09/28/2018
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
Date created: February 7, 2019
Updated: May 28, 2019
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®.