Brian Care

ANDA 71419, held by Soapco. Chlorhexidine Gluconate.

As of Nov 15, 2026, ANDA 71419 (Brian Care), held by Soapco, was first approved by FDA on Dec 17, 1987, with 9 approved supplements and 0 published complete response letters.

First approved: Dec 17, 1987
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Dec 17, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Brian Care4% · solution;topical	Chlorhexidine Gluconate	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Nov 2, 1994	Supplement 12Manufacturing	Approved	None posted
Jul 13, 1992	Supplement 9Labeling	Approved	None posted
Nov 26, 1991	Supplement 10Manufacturing	Approved	None posted
Feb 9, 1990	Supplement 8Labeling	Approved	None posted
Feb 9, 1990	Supplement 7Manufacturing	Approved	None posted
Feb 9, 1990	Supplement 6Manufacturing	Approved	None posted
Mar 23, 1989	Supplement 5Manufacturing	Approved	None posted
Nov 3, 1988	Supplement 3Manufacturing	Approved	None posted
Nov 3, 1988	Supplement 2Manufacturing	Approved	None posted
Dec 17, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71419
Drugs@FDA: Overview at FDA
Company: SOAPCO

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