Food and Drug Administration
Joint Meeting of the Nonprescription Drug Advisory Committee and the Gastrointestinal Drug Advisory Committee
June 21, 2002
Briefing Information
Omeprazole Magnesium Tablets, NDA No. 21-229, Procter & Gamble doc htm pdf
Memo from OTC Omeprazole Magnesium Review Team doc htm pdf
OTC Medical Officer's Review doc htm pdf
Label Comprehension Study 12179 doc htm pdf
Proposed Carton Label pdf
Current Label pdf
OTC Omeprazole Magnesium Review Team Summary pdf
Preliminary Efficacy Assessment pdf
Executive Summary of Safety Profile for Omeprazole-Mg pdf
Application for Omeprazole-Magnesium MUPS Tablets to be marketed OTC pdf
A Multi-Center, Open-Label, Actual Use Study pdf
Statistical Consult for NDA 21-229 pdf
Study 3358 Label Comprehension pdf
Pharmacodoynamic Aspects of H2-Blockers versus Proton Pump Inhibitors pdf
NDA 22-229: Prilosec 1 (omeprazole magnesium) for OTC Use pdf
Nonprescription Drugs and Gastrointestinal Drugs Advisory Committees Transcript pages 1-100 pages 101-200 pages 201-300 pages 301-362