Drug Approval Package
-
Enablex (Darifenacin Hydrobromide)
Extended Release Tablets
Company: Novartis Pharmaceutical Corp.
Application No.: 021513
Approval Date: 12/22/2004
-
Approval Letter(s) (PDF)
-
Printed Labeling (PDF)
-
Medical Review(s) (PDF)
-
Chemistry Review(s) (PDF)
-
Pharmacology Review(s) (PDF)
-
Statistical Review(s) (PDF)
Date created: February 08, 2005
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-