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GUIDANCE DOCUMENT

Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs October 2002

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2001-D-0135
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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).
 

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All written comments should be identified with this document's docket number: FDA-2001-D-0135.

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