NDA 21669, held by Sage Prods. Chlorhexidine Gluconate.
As of Nov 14, 2026, NDA 21669 (Chlorhexidine Gluconate), held by Sage Prods, was first approved by FDA on Apr 25, 2005, with 13 approved supplements 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 |
|---|---|---|---|
| Apr 25, 2005 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Chlorhexidine Gluconate2% · cloth;topical | Chlorhexidine Gluconate | OTCReference drug |
| Sep 6, 2017 | Supplement 23Labeling · Standard review | Approved | |
| Jun 7, 2016 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Mar 16, 2015 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jun 24, 2014 | Supplement 19Labeling · Standard review | Approved | |
| Nov 22, 2013 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Aug 30, 2013 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Dec 26, 2012 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| May 20, 2012 | Supplement 14Labeling · Standard review | Approved | |
| Feb 1, 2007 | Supplement 6 | Approved | |
| Aug 17, 2006 | Supplement 3Labeling · Standard review | Approved | |
| Jul 24, 2006 | Supplement 4 | Approved | None posted |
| Feb 17, 2006 | Supplement 1 | Approved | None posted |
| Jan 13, 2006 | Supplement 2Labeling · Standard review | Approved | |
| Apr 25, 2005 | Original applicationNew dosage form · 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
