Drug Approval Package
-
Evamist (estradiol transdermal spray)
Company: VIVUS, Inc.
NDA: 022014
Approval Date: 7/27/2007
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)
- Cross Discipline Team Leader Review (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Statistical Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Other Review(s) (PDF)
Date created: April 22, 2009
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-