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Private label famotidine

This article was originally published in The Tan Sheet

Executive Summary

Danbury Pharmacal ANDA for OTC famotidine 10 mg tablets (the active in J&J/Merck's leading H2 antagonist Pepcid AC) "tentatively" approved by FDA June 4. Marketing exclusivity for the branded product is set to expire in October 2000. An ANDA suitability petition for effervescent famotidine (Pepcid AC) was approved by the agency Nov. 30 ("The Tan Sheet" Dec. 21, 1998, In Brief)
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