Drug Approval Package
-
Gleevec
(Imatinib Mesylate) Capsules
Company: Novartis Pharmaceuticals Corporation
Application No.: 21-335
Approval Date: 5/10/2001
-
Approval Letter(s) (PDF)
-
Printed Labeling (PDF)
-
Chemistry Review(s) (PDF)
-
Statistical Review(s) (PDF)
-
Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF)
Date created: October 17, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-