Chlorhexidine Gluconate

Treats gingivitis as characterized. ANDA 74522, held by Pharm Assoc. Chlorhexidine Gluconate.

As of Nov 15, 2026, ANDA 74522 (Chlorhexidine Gluconate), held by Pharm Assoc, was first approved by FDA on Dec 15, 1995, with 13 approved supplements and 0 published complete response letters.

First approved: Dec 15, 1995
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATION Chlorhexidine gluconate oral rinse, 0.12% 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, 0.12% 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 14 submissions below

Date	Submission	Status	Documents
Dec 15, 1995	Original application	Approved	None posted

Products

1 strengths and forms

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

All 14 submissions, including labeling and manufacturing supplements


Dec 26, 2024	Supplement 19Manufacturing	Approved	None posted
Oct 18, 2021	Supplement 17Manufacturing	Approved	None posted
Aug 30, 2001	Supplement 11Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 10Manufacturing	Approved	None posted
Nov 19, 1999	Supplement 9Manufacturing	Approved	None posted
Jun 15, 1998	Supplement 7Manufacturing	Approved	None posted
Feb 24, 1998	Supplement 8Labeling	Approved	None posted
Sep 2, 1997	Supplement 6Manufacturing	Approved	None posted
Sep 2, 1997	Supplement 5Manufacturing	Approved	None posted
Sep 2, 1997	Supplement 4Manufacturing	Approved	None posted
Sep 2, 1997	Supplement 3Manufacturing	Approved	None posted
Jan 31, 1997	Supplement 2Manufacturing	Approved	None posted
Apr 29, 1996	Supplement 1Manufacturing	Approved	None posted
Dec 15, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74522
Drugs@FDA: Overview at FDA
Company: Pharmaceutical Associates

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