Chlorhexidine Gluconate

Treats gingivitis as characterized. ANDA 77789, held by Pharmobedient. Chlorhexidine Gluconate.

As of Nov 15, 2026, ANDA 77789 (Chlorhexidine Gluconate), held by Pharmobedient, was first approved by FDA on Jun 18, 2009, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 18, 2009
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATION 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 oral rinse 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 3 submissions below

Date	Submission	Status	Documents
Jun 18, 2009	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Aug 8, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Jul 28, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Jun 18, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 77789
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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