NDA 207964, held by Medline Industries. Chlorhexidine Gluconate.
As of Nov 13, 2026, NDA 207964 (Readyprep Chg), held by Medline Industries, was first approved by FDA on Nov 20, 2018, with 1 approved supplement and 0 published complete response letters.
Uses helps reduce bacteria that can potentially cause skin infection for preparation of skin prior to surgery
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 20, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Readyprep Chg2% · cloth;topical | Chlorhexidine Gluconate | OTCReference drug |
| May 24, 2023 | Supplement 3Manufacturing | Approved | |
| Nov 20, 2018 | Original applicationNew formulation or manufacturer · 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
