Pepcid AC gelcaps
This article was originally published in The Tan Sheet
Executive Summary
FDA approves Merck's NDA (20-902) for 10 mg famotidine "gelatin coated, capsule shaped tablets" Aug. 5. The new dosage form, which would be marketed by J&J/Merck, will carry the indications: "Treatment of heartburn associated with acid indigestion and sour stomach" and "Prevention of meal-induced heartburn." The dosage form had been deemed "approvable" by FDA Sept. 30 and again on June 21 (1"The Tan Sheet" July 5, In Brief)
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