Drug Approval Package
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Epiduo (adapalene and benzoyl peroxide) Gel 0.1% and 2.5%
Company: Galderma Laboratories, L.P.
Application No.: 022320
Approval Date: 12/8/2008
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Cross Discipline Team Leader Review (PDF)
- Printed Labeling (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)
- Administrative Document(s) & Correspondence (PDF)
Date created: January 13, 2010
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