FDA Application
-
Amiodarone Hydrochloride
Company: Apotex
Application No.: 076394
Approval Date: 04/25/2003
-
Approval Letter(s) (PDF)
-
Printed Labeling (PDF)
-
Chemistry Review(s) (PDF)
-
Microbiology Review(s) (PDF)
-
Bioequivalence Review(s) (PDF)
-
Correspondence (PDF)
Date created: December 24, 2003
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-