Drug Approval Package: RAYALDEE (Calcifediol)

Company:  OPKO Ireland Global Holdings Ltd.
Application No.:  208010Orig1
Approval Date: June 17, 2016

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• Approval Letter(s) (PDF)
• Other Action Letters (PDF)
• Printed Labeling (PDF)
• Summary Review (PDF)
• Officer/Employee List (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: January 03, 2017

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