sodium sulfate anhydrous, potassium sulfate, and magnesium sulfate

FDA Drug Profile — Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep kit

Drug Details

Generic Name
sodium sulfate anhydrous, potassium sulfate, and magnesium sulfate
Brand Names
Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep kit
Application Number
ANDA206431
Sponsor
Sun Pharmaceutical Industries, Inc.
NDC Codes
1
Dosage Forms
SOLUTION
Routes
ORAL
Active Ingredients
MAGNESIUM SULFATE, UNSPECIFIED FORM, POTASSIUM SULFATE, SODIUM SULFATE ANHYDROUS

Indications and Usage

1 INDICATIONS AND USAGE Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult patients. Pediatric use information is approved for Braintree Laboratories, Inc.'s SUPREPP® BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adult patients. ( 1 )