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Perrigo’s Loratadine 505(b)(2) NDA Was Properly Submitted, Firm Maintains

This article was originally published in The Tan Sheet

Executive Summary

Perrigo chose to file a 505(b)(2) NDA for its generic loratadine 10 mg tablet because at the time it submitted the application, reference listed drug Claritin still was a prescription product, the firm states in recent comments to FDA

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