Hibistat

NDA 18300, held by Molnlycke Hlth. Chlorhexidine Gluconate.

As of Nov 13, 2026, NDA 18300 (Hibistat), held by Molnlycke Hlth, was first approved by FDA on May 23, 1980, with 17 approved supplements and 0 published complete response letters.

First approved: May 23, 1980
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
May 23, 1980	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hibistat0.5% · solution;topical	Chlorhexidine Gluconate	OTCReference drug

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 19, 2018	Supplement 19Labeling · Standard review	Approved	Letter Label
May 24, 2012	Supplement 18Labeling · Standard review	Approved	Letter
Jan 13, 2004	Supplement 15Manufacturing · Standard review	Approved	Letter
Jan 13, 2004	Supplement 14Manufacturing · Standard review	Approved	Letter
Feb 18, 2000	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 19, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 9, 1996	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 14, 1994	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 22, 1992	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 15, 1989	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 4, 1989	Supplement 6Labeling	Approved	None posted
May 9, 1988	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 4, 1985	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 10, 1981	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 16, 1981	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 29, 1980	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 26, 1980	Supplement 1Manufacturing · Standard review	Approved	None posted
May 23, 1980	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18300
Drugs@FDA: Overview at FDA
Company: Molnlycke Hlth

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