Drug Approval Package
-
Taclonex Scalp (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension
Company: Parexel Consulting for LEO Pharmaceuticals Products, Ltd.
NDA: 022185
Approval Date: 5/9/2008
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
- Summary Review (PDF)
- Medical Review(s)
[note for vision impaired users]
- 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)
- Proprietary Name Review(s) (PDF)
Date created: April 14, 2009
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-