NDA 208288, held by Solventum. Chlorhexidine Gluconate; Isopropyl Alcohol.
As of Nov 13, 2026, NDA 208288 (Soluprep S), held by Solventum, was first approved by FDA on Aug 8, 2018, with 1 approved supplement and 2 published complete response letters.
Uses patient preoperative skin preparation: for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infection
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 20, 2023 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Aug 8, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Sep 1, 2017 | NDA 208288Nonclinical, Chemistry, Manufacturing And Controls | Approved |
| May 6, 2016 | SoluPrepClinical, Clinical Pharmacology, Nonclinical | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Soluprep S2%;70% · solution;topical | Chlorhexidine Gluconate; Isopropyl Alcohol | OTCReference 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
