NDAC/PADAC Joint Meeting

5/10/01


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Table of Contents

NDAC/PADAC Joint Meeting

Prescription Availability

Durham-Humphrey Amendment

OTC Availability

NDA Process Rx-to-OTC

NDA Process Rx-to-OTC

NDA Process Rx-to-OTC

OTC Drug Monograph Process

Advisory Review Panel

Advanced Notice of Proposed Rulemaking - 1976

Advisory Panel Report

Advisory Panel Report

Tentative Final Monograph

Final Monograph - 1992 (OTC Antihistamines)

OTC Monograph Antihistamines 21 CFR 341.12

OTC NDA/ANDA Antihistamines

Nonmonograph Ingredients

OTC Antihistamines

PPT Slide

Summary

Author: CDER User