Chlorhexidine Gluconate

ANDA 74356, held by Sciegen Pharms. Chlorhexidine Gluconate.

As of Nov 15, 2026, ANDA 74356 (Chlorhexidine Gluconate), held by Sciegen Pharms, was first approved by FDA on May 7, 1996, with 5 approved supplements and 0 published complete response letters.

First approved: May 7, 1996
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
May 7, 1996	Original application	Approved	None posted

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Apr 20, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Feb 27, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Jun 30, 2010	Supplement 5Labeling	Approved	None posted
Aug 24, 2009	Supplement 4Labeling	Approved	None posted
Oct 24, 2003	Supplement 2Labeling	Approved	None posted
May 7, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74356
Drugs@FDA: Overview at FDA
Company: ScieGen Pharmaceuticals

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