Drug Approval Package
Pepcid
AC Coated Tablets
Company: Merch Research Laboratories
Application No.: 020902
Approval Date: 08/05/1999
-
Approval Letter(s) (PDF) (301 KB)
-
Final Printed Labeling (PDF) (915 KB)
-
Medical Review(s) (PDF) (781 KB)
-
Chemistry Review(s)
Part 1 (PDF) (1.2 MB)
Part 2 (PDF) (3 MB)
Part 3 (PDF) (2.2 MB)
Part 4 (PDF) (3 MB) -
Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF) ( MB)
Part 2 (PDF) ( MB) -
Administrative Document(s)/Correspondence
Part 1 (PDF) (2.7 MB) Part 9 (PDF) (3 MB) Part 17 (PDF) (3 MB) Part 2 (PDF) (3 MB) Part 10 (PDF) (3 MB) Part 18 (PDF) (2.9 MB) Part 3 (PDF) (3 MB) Part 11 (PDF) (3 MB) Part 19 (PDF) (3 MB) Part 4 (PDF) (3 MB) Part 12 (PDF) (3 MB) Part 20 (PDF) (1.4 MB) Part 5 (PDF) (2.2 MB) Part 13 (PDF) (3 MB) Part 21 (PDF) (3 MB) Part 6 (PDF) (3 MB) Part14 (PDF) (3 MB) Part 22 (PDF) (3 MB) Part 7 (PDF) (3 MB) Part 15 (PDF) (3 MB) Part 23 (PDF) (3 MB) Part 8 (PDF) (2.2 MB) Part 16 (PDF) (3 MB)
Date created: March 30, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.