Drug Approval Package: HEMADY

Company: Dexcel Pharma Technologies Ltd
Application Number: 211379
Approval Date: 10/03/2019

Drugs@FDA information available about HEMADY

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)
• Clinical Pharmacology and Biopharmaceutics Review(s) (PDF)
• Clinical Review(s) (PDF)
• Non-Clinical Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Officer/Employee List (PDF)
• Other Review(s) (PDF)
• Summary Review (PDF)
• Administrative and Correspondence Documents (PDF)

Date created: December 27, 2019

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