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