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Generic Drug Revised Labeling Mock-Ups Available On FDA Web Site

This article was originally published in The Tan Sheet

Executive Summary

Private label firms will be able to reference labeling examples for seven OTC drug categories when revising product labeling to conform to the provisions of the OTC labeling final reg, FDA asserts in a draft guidance for industry published in the Feb. 22 Federal Register.

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

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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