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Ranitidine 75 mg applicants not entitled to 180-day exclusivity -- Torpharm petition.

This article was originally published in The Tan Sheet

Executive Summary

NOVOPHARM 75 MG RANITIDINE INELIGIBLE FOR 180-DAY EXCLUSIVITY, TORPHARM argues in a recent citizen petition to FDA. Neither Novopharm nor any other ANDA applicant for private label versions of Warner-Lambert's Zantac 75 is entitled to 180 days of generic exclusivity because the period already has expired, the petition asserts.

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