Drug Approval Package
-
Reminyl
(Galantamine Hydrobromide) Tablets
Company: Janssen Research Foundation
Application No.: 21-169
Approval Date: 2/28/2001
-
Approval Letter(s) (PDF)
-
Printed Labeling (PDF)
-
Medical Review(s)
Part 1 (PDF) Part 4 (PDF) Part 7 (PDF) Part 2 (PDF) Part 5 (PDF) Part 8 (PDF) Part 3 (PDF) Part 6 (PDF) Part 9 (PDF) -
Chemistry Review(s) (PDF)
-
Statistical Review(s) (PDF)
-
Correspondence (PDF)
Date created: November 20, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-