Marksans Pharma receives USFDA approval for Loperamide Hydrochloride tablets

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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.
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First Published: Nov 19 2025 | 11:32 AM IST