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Private label ranitidine

This article was originally published in The Tan Sheet

Executive Summary

Abbreviated NDAs for 75 mg ranitidine tablets (Warner-Lambert's Zantac 75) submitted by Ranbaxy Pharmaceuticals (ANDAs 75-254, 75-132), Genpharm (75-497), Zenith Goldline Pharmaceuticals (75-296) and Chelsea Laboratories (75-212) were approved by FDA Jan. 14. The companies may begin shipping the product now. Granutec launched its generic ranitidine July 19 with six months of private label marketing exclusivity. Watson Pharmaceuticals, which plans to launch a private label nicotine polacrilex gum soon, also has plans to launch private label ranitidine. The product will be manufactured by Aventis. Watson said final ANDA approval is pending
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