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This article was originally published in The Tan Sheet

Executive Summary

Receives tentative ANDA approval for OTC ranitidine 75 mg Jan. 29. Exclusivity for the branded product, Warner-Lambert's Zantac 75, expires June 19. Other firms with tentative approvals include Chelsea, Ranbaxy, Novopharm and Zenith Goldline. Novopharm was awarded 180-day generic exclusivity for being the first to submit an application. Marketing exclusivity for Zantac 75 originally was to expire Dec. 19 but was extended an additional six months due to Warner-Lambert's submission of pediatric use data for the molecule

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