Steri-Stat

ANDA 70104, held by Matrix Medcl. Chlorhexidine Gluconate.

As of Nov 15, 2026, ANDA 70104 (Steri-Stat), held by Matrix Medcl, was first approved by FDA on Jul 24, 1986, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 24, 1986
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 24, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Steri-Stat4% · solution;topical	Chlorhexidine Gluconate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Dec 3, 1990	Supplement 3Manufacturing	Approved	None posted
Dec 3, 1990	Supplement 2Manufacturing	Approved	None posted
Nov 3, 1988	Supplement 1Labeling	Approved	None posted
Jul 24, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70104
Drugs@FDA: Overview at FDA
Company: Matrix Medical

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