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This article was originally published in The Tan Sheet

Executive Summary

Private labeler receives tentative approval of its ANDA (75-598) for minoxidil 5% topical solution for men. Pharmacia's marketing exclusivity for Rogaine Extra Strength expires Nov. 14, after which Perrigo, Copley Pharmaceutical and Alpharma will join the fray (1"The Tan Sheet" Jan. 31, In Brief)

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Private label minoxidil

FDA tentatively approves Copley Pharmaceutical ANDA 75-619 for minoxidil 5% on Jan. 18. The reference drug, Pharmacia & Upjohn's Rogaine Extra Strength for Men, loses market exclusivity Nov. 14, 2000. The ANDA is the second for 5% minoxidil to be tentatively cleared by the agency; Alpharma received tentative approval on July 22. Perrigo also has filed an ANDA for the product

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