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Drug Approval Package: epinephrine inhalation aerosal

Company: Armstrong Pharmaceuticals, Inc
Application Number: 205920
Approval Date: 11/07/2018

Drugs@FDA information available about Hydrocodone

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)
Cross Discipline Team Leader Review (PDF)
Clinical Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Officer/Employee List (PDF)
Other Action Letters (PDF)
Other Review(s) (PDF)
Non-Clinical Review(s) (PDF)
Statistical Review(s) (PDF)
Summary Review(s) (PDF)
Administrative Document(s) & Correspondence (PDF)

Date created: February 7, 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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