Marksans Pharma Limited announced that its wholly owned subsidiary, Marksans Pharma Inc., has received final USFDA approval for its ANDA for Loperamide Hydrochloride Tablets USP, 2 mg (OTC).

The approved product is bioequivalent to Imodium A-D Tablets, 2 mg, the reference listed drug (RLD) of Kenvue Brands LLC (NDA 019860).

Loperamide Hydrochloride is an anti-diarrheal medication indicated for the management of acute and chronic diarrhea.