Drug Approval Package
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Drug Name: Cymbalta (duloxetine hydrochloride)
Company: Eli Lilly and Company
NDA: 22148
Approval Date: 6/13/2008
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s)(PDF)
- Printed Labeling(PDF) [note for vision impaired users]
- Summary Review(PDF)
- Officer/Employee List (PDF)
- Cross Discipline Team Leader Review(PDF)
- Medical Review(s)
- Chemistry Review(s)(PDF)
- Environmental Assessment(PDF)
- Pharmacology Review(s) (PDF)
- Statistical Review(s)(PDF)
- Clinical Pharmacology Biopharmaceutics Review(s)(PDF)
- Administrative Document(s) and Correspondence(PDF)
Date created: September 5, 2008
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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