Drug Approval Package: POSLUMA
Company: Blue Earth Diaganostics Ltd.
Application Number: 216023
Approval Date: 5/23/2023
Application Number: 216023
Approval Date: 5/23/2023
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: June 09, 2023
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®.