Drug Approval Package
-
Focalin
(Dexmethylphenidate HCI) Tabelts
Company: Celgene Corporation
Application No.: 21-278
Approval Date: 11/13/01
-
Approval Letter(s) (PDF)
-
Printed Labeling (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®.
-