NDA 215344, held by Azurity. Magnesium Sulfate; Polyethylene Glycol 3350; Potassium Chloride; Sodium Chloride; Sodium Sulfate.
As of Nov 13, 2026, NDA 215344 (Suflave), held by Azurity, was first approved by FDA on Jun 15, 2023, with 0 approved supplements and 1 published complete response letter.
SUFLAVE is indicated for the cleansing of the colon as a preparation for colonoscopy in adults. SUFLAVE is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 15, 2023 | Original applicationNew combination · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jun 6, 2022 | NDA 215344Product Quality/ Facility Inspection Deficiencies | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Suflave0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT · for solution;oral | Magnesium Sulfate; Polyethylene Glycol 3350; Potassium Chloride; Sodium Chloride; Sodium Sulfate | RxReference drug |
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
