Prevacare R

ANDA 72292, held by J And J. Chlorhexidine Gluconate.

As of Nov 15, 2026, ANDA 72292 (Prevacare R), held by J And J, was first approved by FDA on Jan 28, 1992, with 5 approved supplements and 0 published complete response letters.

First approved: Jan 28, 1992
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
Jan 28, 1992	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prevacare R0.5% · solution;topical	Chlorhexidine Gluconate	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jan 18, 2000	Supplement 5Manufacturing	Approved	None posted
Dec 7, 1998	Supplement 1Manufacturing	Approved	None posted
Dec 7, 1998	Supplement 2Manufacturing	Approved	None posted
Dec 7, 1998	Supplement 3Manufacturing	Approved	None posted
Dec 7, 1998	Supplement 4Labeling	Approved	None posted
Jan 28, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 72292
Drugs@FDA: Overview at FDA
Company: J And J

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