Drug Approval Package
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Silenor (doxepin hydrochloride), 3 and 6 mg Oral Tablets
Company: Somaxon Pharmaceuticals, Inc.
Application No.: 022036
Approval Date: 03/17/2010
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)
- Pharmacology Review(s) (PDF)
- Statistical Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Risk Assessment and Risk Mitigation Review(s) (PDF)
- Risk Evaluation and Mitigation Stategy (PDF)
- Proprietary Name Review(s) (PDF)
- Other Action Letters (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: February 11, 2011
Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.
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