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Motrin Sinus/Headache

This article was originally published in The Tan Sheet

Executive Summary

Supplemental NDA covering revised labeling of 20- and 40-count cartons to comply with content, format requirements of OTC labeling final reg approved by FDA Sept. 9. McNeil Consumer & Specialty Pharmaceuticals submitted NDA 19-899/S-012 for the ibuprofen/pseudoephedrine HCl caplets on April 5, 2000...

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