Drug Approval Package
Panretin (Alitretinoin) Gel
Company: Ligand Pharmaceuticals
Application No.: 20-886
Approval Date: 2/2/1999
-
Approval Letter (PDF) (734 KB)
-
Medical Review(s)
Part 1 (PDF) (2.4 MB) Part 5 (PDF) (2.3 MB) Part 9 (PDF) (2.8 MB) Part 2 (PDF) (2.3 MB) Part 6 (PDF) (2.8 MB) Part 10 (PDF) (2.9 MB) Part 3 (PDF) (2.9 MB) Part 7 (PDF) (2.7 MB) Part 11 (PDF) (2.8 MB) Part 4 (PDF) (2.7 MB) Part 8 (PDF) (2.5 MB) Part 12 (PDF) (3 MB) -
Chemistry Review(s) (PDF) (1.3 MB)
-
Pharmacology Review(s)
Part 1 (PDF) (2.3 MB)
Part 2 (PDF) (2 MB) -
Statistical Review(s)
Part 1 (PDF) (2.3 MB)
Part 2 (PDF) (1.9 MB)
Part 3 (PDF) (2.6 MB)
Part 4 (PDF) (2.2 MB) -
Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF) (1.5 MB)
Part 2 (PDF) (1.9 MB)
Part 3 (PDF) (2.5 MB)
Part 4 (PDF) (2.8 MB) -
Administrative Document(s)/Correspondence (PDF) (2.3 MB)
Date created: March 30, 2001; last update: July 5, 2005
Note: Documents in PDF format require the Adobe Acrobat Reader®.