Drug Approval Package
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Cymbalta (duloxetine hydrochloride), 20, 30, and 60 mg Capsules
Company: Eli Lilly and Company
Application No.: 022516
Approval Date: 11/04/2010
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Approvable Letter(s) (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Cross Discipline Team Leader Review (PDF)
- Environmental Assessment (PDF)
- Printed Labeling (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Risk Assessment and Risk Mitigation Review(s) (PDF)
- Statistical Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: September 16, 2011
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