NDA 21586, held by Solventum. Iodine Povacrylex; Isopropyl Alcohol.
As of Nov 14, 2026, NDA 21586 (Duraprep), held by Solventum, was first approved by FDA on Sep 29, 2006, with 4 approved supplements and 0 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 |
|---|---|---|---|
| Sep 29, 2006 | Original applicationNew combination · Standard review | Approved |
| DuraprepEQ 0.7% IODINE;74% (6ML) · sponge;topical | Iodine Povacrylex; Isopropyl Alcohol | OTCReference drug |
| DuraprepEQ 0.7% IODINE;74% (26ML) · sponge;topical | Iodine Povacrylex; Isopropyl Alcohol | OTCReference drug |
| Jun 8, 2015 | Supplement 5Labeling · Standard review | Approved | |
| Jul 10, 2013 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Feb 20, 2013 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Mar 11, 2010 | Supplement 2Labeling | Approved | |
| Sep 29, 2006 | 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
