Lupin Limited (Lupin) has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g.
Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g is bioequivalent to the reference listed drug (RLD), Sutab® Tablets, 1.479 g/0.225 g/0.188 g of Azurity Pharmaceuticals, Inc. Lupin is the exclusive first-to-file for this product and is eligible for 180-day generic drug exclusivity. This product will be manufactured at Lupin’s Nagpur facility in India.
Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets are indicated for the cleansing of the colon as a preparation for colonoscopy in adults.
Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets (RLD Sutab®) had an estimated annual sale of USD 132.8 million in the U.S. (IQVIA MAT March 2026).
