NDA 20832, held by Becton Dickinson Co. Chlorhexidine Gluconate; Isopropyl Alcohol.
As of Nov 13, 2026, NDA 20832 (Chloraprep One-Step, Chloraprep With Tint, Chloraprep One-Step Frepp), held by Becton Dickinson Co, was first approved by FDA on Jul 14, 2000, with 29 approved supplements and 0 published complete response letters.
Use for the preparation of the patient’s skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 14, 2000 | Original applicationNew combination · Standard review | Approved |
| Chloraprep One-Step2%;70% (3ML) · sponge;topical | Chlorhexidine Gluconate; Isopropyl Alcohol | OTCReference drug |
| Chloraprep With Tint2%;70% (26ML) · sponge;topical | Chlorhexidine Gluconate; Isopropyl Alcohol | OTCReference drug |
| Chloraprep One-Step Frepp2%;70% (1.5ML) · sponge;topical | Chlorhexidine Gluconate; Isopropyl Alcohol | OTCReference drug |
| Chloraprep One-Step2%;70% (10.5ML) · sponge;topical | Chlorhexidine Gluconate; Isopropyl Alcohol | OTCReference drug |
| Chloraprep With Tint2%;70% (10.5ML) · sponge;topical | Chlorhexidine Gluconate; Isopropyl Alcohol | OTCReference drug |
| Chloraprep One-Step2%;70% (26ML) · sponge;topical | Chlorhexidine Gluconate; Isopropyl Alcohol | OTCReference drug |
| Chloraprep With Tint2%;70% (3ML) · sponge;topical | Chlorhexidine Gluconate; Isopropyl Alcohol | OTCReference drug |
| Chloraprep One-Step2%;70% (1ML) · sponge;topical | Chlorhexidine Gluconate; Isopropyl Alcohol | OTCReference drug |
| Apr 3, 2019 | Supplement 38Manufacturing | Approved | None posted |
| Apr 3, 2019 | Supplement 36Manufacturing | Approved | |
| Sep 12, 2017 | Supplement 42Labeling · Standard review | Approved | |
| Jun 7, 2016 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Jun 9, 2015 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Jun 30, 2014 | Supplement 34Labeling · Standard review | Approved | |
| Feb 12, 2014 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Oct 10, 2013 | Supplement 31Labeling · Standard review | Approved | |
| Dec 27, 2012 | Supplement 29Manufacturing · Standard review | Approved | |
| Aug 16, 2012 | Supplement 30Labeling · Standard review | Approved | |
| Aug 16, 2012 | Supplement 28Labeling · Standard review | Approved | |
| Aug 16, 2012 | Supplement 27Labeling · Standard review | Approved | |
| Jul 20, 2010 | Supplement 26Labeling | Approved | |
| Mar 3, 2010 | Supplement 25Labeling | Approved | |
| Oct 23, 2008 | Supplement 22Manufacturing | Approved | |
| Jun 3, 2008 | Supplement 14Manufacturing | Approved | |
| May 9, 2007 | Supplement 18Labeling · Standard review | Approved | |
| Dec 8, 2006 | Supplement 12Labeling · Standard review | Approved | |
| Nov 21, 2006 | Supplement 15Manufacturing | Approved | |
| Oct 11, 2006 | Supplement 16Labeling · Standard review | Approved | |
| Oct 10, 2006 | Supplement 13Manufacturing | Approved | |
| Apr 3, 2006 | Supplement 10Manufacturing · Standard review | Approved | |
| Dec 27, 2005 | Supplement 11Manufacturing · Standard review | Approved | |
| May 3, 2005 | Supplement 8Manufacturing · Standard review | Approved | |
| Jul 7, 2004 | Supplement 7Labeling · Standard review | Approved | |
| Jun 10, 2004 | Supplement 6Labeling · Standard review | Approved | |
| Aug 20, 2003 | Supplement 4Manufacturing · Standard review | Approved | |
| Apr 26, 2002 | Supplement 2Manufacturing · Standard review | Approved | |
| Nov 27, 2001 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 14, 2000 | 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
