Periochip

NDA 20774, held by Dexcel Pharma. Chlorhexidine Gluconate.

As of Nov 13, 2026, NDA 20774 (Periochip), held by Dexcel Pharma, was first approved by FDA on May 15, 1998, with 10 approved supplements and 0 published complete response letters.

First approved: May 15, 1998
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
May 15, 1998	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Periochip2.5MG · tablet;dental	Chlorhexidine Gluconate	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Jul 3, 2013	Supplement 13Manufacturing · Standard review	Approved	None posted
Nov 8, 2012	Supplement 12Labeling · Standard review	Approved	Letter Label
Jan 12, 2012	Supplement 11Labeling · Standard review	Approved	Label Letter
Jun 8, 2011	Supplement 10Labeling	Approved	Label Letter
Mar 2, 2004	Supplement 7Labeling · Standard review	Approved	Label Letter
Dec 15, 2002	Supplement 3Labeling · Standard review	Approved	Letter Label
Feb 21, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 22, 2001	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 29, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 5, 1999	Supplement 1Manufacturing · Standard review	Approved	None posted
May 15, 1998	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Identifiers

Application: NDA 20774
Drugs@FDA: Overview at FDA
Company: Dexcel Pharma

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