NDA 22372, held by Azurity. Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate.
As of Nov 14, 2026, NDA 22372 (Suprep Bowel Prep Kit), held by Azurity, was first approved by FDA on Aug 5, 2010, with 5 approved supplements and 0 published complete response letters.
SUPREP Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. SUPREP Bowel Prep Kit is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adult and pediatric patients 12 years of age and older.
| Aug 5, 2020 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Aug 5, 2010 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Suprep Bowel Prep Kit1.6GM/BOT;3.13GM/BOT;17.5GM/BOT · solution;oral | Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate | RxReference drug |
| Nov 18, 2025 | Supplement 16Labeling · Standard review | Approved | |
| Aug 5, 2020 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Nov 6, 2012 | Supplement 4Labeling · Standard review | Approved | |
| Jul 24, 2012 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jul 6, 2011 | Supplement 3REMS | Approved | |
| Aug 5, 2010 | Original applicationNew combination · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
