USFDA19 Nov 2025, 11:16 am
Marksans Pharma Inc Receives US FDA Approval for Loperamide Hydrochloride Tablets
AI Summary
Marksans Pharma Limited's wholly owned subsidiary, Marksans Pharma Inc, has received US FDA approval 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.
Key Highlights
- Marksans Pharma Inc receives US FDA approval for Loperamide Hydrochloride Tablets USP, 2 mg (OTC)
- The product is bioequivalent to the reference listed drug (RLD), Imodium A-D Tablets, 2mg, of Kenvue Brands LLC
- Loperamide Hydrochloride is an anti-diarrheal medication used to control symptoms of acute and chronic diarrhea