Drug Approval Package: Yosprala (aspirin 81 mg/omeprazole 40 mg, and aspirin 325 mg/omeprazole 40 mg)

Company: Aralez Pharmaceuticals R&D Inc.
Application Number: 205103
Approval Date: 09/14/2016

Drugs@FDA information available about Yosprala

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

• Other Action Letters (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Cross Discipline Team Leader Review (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Statistical Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: April 9, 2018

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®.