Marksans Pharma Inc. receives USFDA approval for Loperamide Hydrochloride Tablets
Drug Approval

Marksans Pharma Inc. receives USFDA approval for Loperamide Hydrochloride Tablets

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

  • By IPP Bureau | November 24, 2025

Marksans Pharma Limited announces the 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 diarrhoea.

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