Drug Approval Package
-
Baraclude (Entecavir) Film
Coated Tablets & Oral Solution
Company: Bristol-Myers Squibb Pharmaceutical Co.
Application No.: 021797 & 021798
Approval Date: 03/29/2005
-
Approval Letter(s) (PDF)
-
Printed Labeling (PDF)
-
Medical Review(s) (PDF)
-
Chemistry Review(s) (PDF)
-
Pharmacology Review(s) (PDF)
-
Statistical Review(s) (PDF)
-
Microbiology Review(s) (PDF)
Date created: July 12, 2005: Updated December 28, 2011
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-