Drug Approval Package: DYANAVEL XR
Company: Tris Pharma, Inc.
Application Number: 210526
Approval Date: 11/4/2021
Application Number: 210526
Approval Date: 11/4/2021
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
- Product Quality Review(s) (PDF)
- Other Action Letters (PDF)
- Multi-Discipline Review (PDF)
- Proprietary Name Review(s) (PDF)
- Officer/Employee List (PDF)
- Other Review(s) (PDF)
- Administrative and Correspondence Documents (PDF)
Date created: March 21, 2022
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®.