Issue Date: October 18, 2002
Issued by: Center for Drug Evaluation and Research
Topic(s): Over-the-Counter Drugs
Status: Final
Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs
This guidance is intended to assist manufacturers, packers, and distributors of over-the-counter (OTC) drug products marketed under abbreviated new drug applications (ANDAs) and the manufacturers of corresponding reference listed drugs (RLDs) implement the Agency’s regulation on standardized content and format requirements for the labeling of OTC drug products. The guidance contains recommendations on how RLD and ANDA holders can update their labeling in a timely manner consistent with the regulation on OTC drug product labeling (21 CFR 201.66).
Download the Guidance Document
