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Drug Approval Package: BAQSIMI

Company: Eli Lilly and Company
Application Number: 210134
Approval Date: 7/24/2019

Drugs@FDA information available about BAQSIMI

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)
Statistical Review(s) (PDF)
Summary Review (PDF)
Administrative and Correspondence Documents (PDF)

Date created: November 25, 2019

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®.

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