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Marksans Pharma receives USFDA approval for Loperamide Hydrochloride tablets
Nov 19,2025

Marksans Pharma announced USFDA final approval of the Company's wholly owned subsidiary Marksans Pharma Inc.'s Abbreviated New Drug Application (ANDA) for Loperamide Hydrochloride Tablets USP, 2 mg (OTC). This product is bioequivalent to the reference listed drug (RLD), Imodium A-D Tablets, 2mg, of Kenvue Brands LLC (Kenvue) NDA - 019860.

 Loperamide Hydrochloride is an anti-diarrheal medication used to control symptoms of acute and chronic diarrhea.