Drug Approval Package
Topamax
(Topiramate) Tablets
Company: R.W. Johnson Pharmaceutical Research Institute
Application No.: 20505/S001
Approval Date: 7/23/1999
-
Approval Letter(s) & Final Printed Labeling (PDF) (2 MB)
-
Medical Review(s)
Part 1 (PDF) (2.7 MB)
Part 2 (PDF) (2.3 MB)
Part 3 (PDF) (2.7 MB)
Part 4 (PDF) (2.1 MB) -
Chemistry Review(s) & Statistical Review(s) (PDF) (2.7 MB)
-
Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.7 MB)
-
Administrative Document(s)/Correspondence (PDF) (3 MB)
Date created: March 30, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.