Drug Approval Package
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Welchol (colesevelam HCL) for Oral Suspension
Company: Daiichi Sankyo, Inc.
Application No.: 022362
Approval Date: 10/2/2009
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)
- Printed Labeling (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Environmental Assessment (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: March 31, 2010
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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