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Consumer OTC Drugs

Perrigo

This article was originally published in The Tan Sheet

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Executive Summary

Receives FDA approval for private label pseudoephedrine extended-release tablets, 120 mg (ANDA 75-153) on Feb. 26. The product is Perrigo's first ANDA approval for an extended-release delivery system. The reference drug is Warner-Lambert's Sudafed 12 Hour Extended-release caplets. FDA indicated ANDA suitability in an Oct. 29, 1997 Federal Register notice ("The Tan Sheet" Nov. 3, 1997, p. 18). Eurand America filed a citizen petition in June 1997 requesting clearance to file an application for the product

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