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Aleve Sinus & Headache NDA

This article was originally published in The Tan Sheet

Executive Summary

Labeling supplement (NDA 21-076/S7) for naproxen sodium 220 mg/extended-release pseudoephedrine 120 mg combination approved by FDA July 31. Bayer says agency asked it to file formal supplement to add the Sinus & Headache sub-brand under previously approved NDA for Aleve Cold & Sinus; both products contain the same formulation. Sinus & Headache began shipping in July 2001 (1"The Tan Sheet" July 9, 2001, p. 3)...

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