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ANDA filings

This article was originally published in The Tan Sheet

Executive Summary

Extended-release acetaminophen (Tylenol Arthritis), ibuprofen with pseudoephedrine (Advil Cold & Sinus) and ibuprofen oral suspensions and oral drops (Children's Motrin) among recent ANDA filings, according to CDER's Web site. An ANDA also has been filed for acetaminophen/aspirin/caffeine; Bristol-Myers Squibb's exclusivity for Excedrin Migraine expires Jan. 14, 2001. In addition, ANDAs for famotidine, ranitidine, ketoprofen and smoking cessation products were filed. FDA announced in May it will update the listings on its Web site monthly, but will not post the date ANDAs were received or the name of the filing company (1"The Tan Sheet" May 22, p. 2)
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