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GUIDANCE DOCUMENT

Labeling OTC Human Drug Products -- Questions and Answers January 2009

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2004-D-0437
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 who have questions about the standardized labeling content and format requirements set forth in 21 CFR 201.66.
 

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2004-D-0437.

 
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