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Drixoral NDA

This article was originally published in The Tan Sheet

Executive Summary

Supplemental NDA 19-453 S/014 covering voluntary labeling changes for acetaminophen approved by FDA March 28. Novartis submitted mock-color labeling for Drixoral Cold & Flu and Allergy Sinus extended release tablets to agency "for revisions to the Drug Facts labeling, including changes to the active ingredients and warnings section"...
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