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Drug Approval Package: Lokelma (sodium zirconium cyclosilicate)

Company: AstraZeneca Pharmaceuticals LP
Application Number: 207078
Approval Date: 05/18/2018

Drugs@FDA information available about Lokelma

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)
Medical Review(s) (PDF)
Chemistry Review(s) (PDF)
Pharmacology Review(s) (PDF)
Statistical Review(s) (PDF)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Risk Assessment and Risk Mitigation Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Other Review(s) (PDF)

Date created: June 08, 2018

Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.

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