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Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol

Bevespi Aerosphere

Company: Pearl Therapeutics, Inc.
Application No.: 208294
Approval Date: 04/25/2016

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Approval Letter(s) (PDF)
Printed Labeling (PDF)
Summary Review (PDF)
Officer/Employee List (PDF)
Cross Discipline Team Leader Review (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: February 16, 2018

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