Benzamycin

Treats acne vulgaris. NDA 50557, held by Valeant Intl. Benzoyl Peroxide; Erythromycin.

As of Nov 13, 2026, NDA 50557 (Benzamycin), held by Valeant Intl, was first approved by FDA on Oct 26, 1984, with 14 approved supplements and 0 published complete response letters.

First approved: Oct 26, 1984
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Erythromycin-Benzoyl Peroxide Topical Gel is indicated for the topical treatment of acne vulgaris.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Oct 26, 1984	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Benzamycin5%;3% · gel;topical	Benzoyl Peroxide; Erythromycin	RxReference drug

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 5, 2014	Supplement 38Manufacturing · Standard review	Approved	None posted
Jan 27, 2003	Supplement 25Manufacturing · Standard review	Approved	Label
Aug 28, 2002	Supplement 24Manufacturing · Standard review	Approved	None posted
Mar 21, 2002	Supplement 23Manufacturing · Standard review	Approved	None posted
Apr 17, 2001	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 6, 2001	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 27, 2000	Supplement 20Manufacturing · Standard review	Approved	None posted
Jun 11, 1997	Supplement 19Manufacturing · Standard review	Approved	None posted
Mar 5, 1996	Supplement 18Labeling · Standard review	Approved	None posted
Jun 8, 1995	Supplement 17Labeling · Standard review	Approved	None posted
Oct 21, 1994	Supplement 15Labeling	Approved	None posted
Apr 13, 1993	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 7, 1993	Supplement 14Manufacturing · Standard review	Approved	None posted
Sep 15, 1989	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 26, 1984	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 50557
Drugs@FDA: Overview at FDA
Company: Valeant Intl

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