Phisohex

NDA 6882, held by Sanofi Aventis US. Hexachlorophene.

As of Nov 13, 2026, NDA 6882 (Phisohex), held by Sanofi Aventis US, was first approved by FDA on Apr 19, 1949, with 11 approved supplements and 0 published complete response letters.

First approved: Apr 19, 1949
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Apr 19, 1949	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Phisohex3% · emulsion;topical	Hexachlorophene	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Jul 27, 2009	Supplement 35Labeling · Standard review	Approved	None posted
May 27, 2003	Supplement 33Labeling · Standard review	Approved	Letter
Dec 19, 2001	Supplement 32Manufacturing	Approved	None posted
Apr 3, 1990	Supplement 31Labeling	Approved	None posted
Dec 7, 1989	Supplement 29Manufacturing	Approved	None posted
Jul 17, 1989	Supplement 30Labeling	Approved	None posted
Mar 23, 1988	Supplement 28Manufacturing	Approved	None posted
Apr 9, 1984	Supplement 26Labeling	Approved	None posted
Nov 5, 1982	Supplement 27Manufacturing	Approved	None posted
May 15, 1981	Supplement 25Manufacturing	Approved	None posted
Feb 21, 1975	Supplement 16Labeling	Approved	None posted
Apr 19, 1949	Original application	Approved	None posted

Identifiers

Application: NDA 6882
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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