NDA 21074, held by Solventum. Alcohol; Chlorhexidine Gluconate.
As of Nov 15, 2026, NDA 21074 (Avagard), held by Solventum, was first approved by FDA on Jun 7, 2001, with 7 approved supplements and 0 published complete response letters.
Uses surgical hand antiseptic: significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care healthcare personnel hand antiseptic: hand rub to help reduce bacteria that potentially can cause disease recommended for repeated use
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 7, 2001 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Avagard61%;1% · solution;topical | Alcohol; Chlorhexidine Gluconate | OTCReference drug |
| Sep 6, 2017 | Supplement 12Labeling · Standard review | Approved | |
| Nov 4, 2016 | Supplement 11Labeling · Standard review | Approved | |
| Nov 12, 2015 | Supplement 10Labeling · Standard review | Approved | |
| Feb 15, 2013 | Supplement 9Labeling · Standard review | Approved | |
| Jun 7, 2012 | Supplement 8Labeling | Approved | |
| May 17, 2012 | Supplement 7Labeling · Standard review | Approved | |
| Jul 23, 2002 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jun 7, 2001 | 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
