Chlorhexidine Gluconate

Treats gingivitis as characterized. ANDA 74291, held by Lyne. Chlorhexidine Gluconate.

As of Nov 15, 2026, ANDA 74291 (Chlorhexidine Gluconate), held by Lyne, was first approved by FDA on Dec 28, 1995, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 28, 1995
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Chlorhexidine Gluconate Oral Rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 28, 1995	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chlorhexidine Gluconate0.12% · solution;dental	Chlorhexidine Gluconate	Rx

All 5 submissions, including labeling and manufacturing supplements


Feb 4, 2009	Supplement 16Labeling	Approved	None posted
Oct 23, 2000	Supplement 5Manufacturing	Approved	None posted
Oct 6, 1998	Supplement 3Manufacturing	Approved	None posted
Dec 18, 1997	Supplement 2Labeling	Approved	None posted
Dec 28, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74291
Drugs@FDA: Overview at FDA
Company: Lyne Laboratories

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