Drug Approval Package
-
Gabitril (Tiagabine HCl)
Company: Cephalon
Application No.: 20646
Approval Date: 9/30/1997
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Medical Review(s) (PDF)
- Bioequivalence Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Statistical Review(s) (PDF)
- Administrative Document(s) (PDF)
Date created: January 7, 2010
Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-