FDA Application
-
Selegiline Hydrochloride Tablets USP
Company: Stason Industrial Corporation
Application No.: ANDA 74-912
Approval Date: 4/30/98
-
Approval Letter, Final Printed Labeling, and Chemistry Review(s) (PDF) (972 KB)
-
Bioequivalence Review(s) Part 1 of 2 (PDF) (3 MB)
-
Bioequivalence Review(s) Part 2 of 2 (PDF) (2.7 MB)
-
Administrative Documents and Correspondence Part 1 of 2 (PDF) (2.4 MB)
-
Correspondence Part 2 of 2 (PDF) (2.5 MB)
Last update: June 30, 2005
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-