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FDA "Drug Facts" Templates Supersede Reference Listed Drug Labeling - FDA

This article was originally published in The Tan Sheet

Executive Summary

Generic drugs approved under ANDAs may conform to "Drug Facts" labeling as it appears in templates posted on FDA's Web site without having to wait for the reference listed drug's labeling to be approved.

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FDA OTC Labeling Guidance Allows Flexible Approach To Template Use

OTC drug manufacturers that choose to employ FDA's "Drug Facts" labeling templates do not have to follow them verbatim, the agency says in a guidance published in the Oct. 18 Federal Register

FDA OTC Labeling Guidance Allows Flexible Approach To Template Use

OTC drug manufacturers that choose to employ FDA's "Drug Facts" labeling templates do not have to follow them verbatim, the agency says in a guidance published in the Oct. 18 Federal Register

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