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Perrigo Loratadine 10 Mg 505(b)(2) Should Be Denied – Genpharm Petition

This article was originally published in The Tan Sheet

Executive Summary

FDA should "send a prompt letter ruling" to Perrigo denying approval of the firm's 505(b)(2) application for 10 mg loratadine tablets, according to an April 15 citizen petition submitted to the agency by Genpharm

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