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Leiner Store Brand Loratadine To Begin Retail Shipments In July

This article was originally published in The Tan Sheet

Executive Summary

Leiner Health Products plans to begin shipping private label OTC loratadine immediate-release 10 mg tablets "on or around" July 21, according to the firm

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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

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

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

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

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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