FDA Application
-
Naltrexone Hydrochloride Tablets
Company: Barr Laboratories, Inc.
Application No.: ANDA 74-918
Approval Date: 5/08/98
-
Approval Letter, Final Printed Labeling, Chemistry Review(s), Bioequivalence Review(s), and Administrative Documents (PDF) (2.1 MB)
-
Correspondence (PDF) (3 MB)
Last update: June 30, 2005
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-