Paroex

ANDA 76434, held by Sunstar Americas. Chlorhexidine Gluconate.

As of Nov 15, 2026, ANDA 76434 (Paroex), held by Sunstar Americas, was first approved by FDA on Nov 29, 2005, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 29, 2005
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 29, 2005	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Paroex0.12% · solution;dental	Chlorhexidine Gluconate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


May 2, 2014	Supplement 2Labeling	Approved	None posted
Nov 29, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 76434
Drugs@FDA: Overview at FDA
Company: Sunstar Americas

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