Drug Approval Package
Salagen
(pilocarpine HCL) Tablets
Company: MGI Pharma, Inc.
Application No.: 02237/S007
Approval Date: 2/11/1998
-
Approval Letter(s) (PDF) (678 KB)
-
Medical Review(s)
Part 1 (PDF) (2.3 MB)
Part 2 (PDF) (2.4 MB)
Part 3 (PDF) (2.7 MB)
Part 4 (PDF) (2.8 MB)
Part 5 (PDF) (2.7 MB)
Part 6 (PDF) (2.5 MB) -
Chemistry Review(s) (PDF) (830 KB)
-
Pharmacology Review(s) (PDF) (2.7 MB)
-
Statistical Review(s) & Bioequivalence Review(s) (PDF) (2.4 MB)
-
Administrative Document(s) (PDF) (842 KB)
Date created: September 10, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.