Aureomycin

NDA 50404, held by Lederle. Chlortetracycline Hydrochloride.

As of Nov 14, 2026, NDA 50404 (Aureomycin), held by Lederle, was first approved by FDA on Jan 23, 1950, with 18 approved supplements and 0 published complete response letters.

First approved: Jan 23, 1950
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Jan 23, 1950	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aureomycin1% · ointment;ophthalmic	Chlortetracycline Hydrochloride	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Dec 1, 1988	Supplement 4Manufacturing	Approved	None posted
May 23, 1986	Supplement 3Manufacturing	Approved	None posted
Oct 26, 1983	Supplement 1Manufacturing	Approved	None posted
May 13, 1975	Supplement 19Manufacturing	Approved	None posted
May 8, 1974	Supplement 17Manufacturing	Approved	None posted
May 7, 1974	Supplement 18Manufacturing	Approved	None posted
Dec 20, 1973	Supplement 16Manufacturing	Approved	None posted
Oct 10, 1973	Supplement 15Manufacturing	Approved	None posted
Jan 15, 1969	Supplement 14Manufacturing	Approved	None posted
May 1, 1963	Supplement 13Labeling	Approved	None posted
Apr 6, 1961	Supplement 12Manufacturing	Approved	None posted
Sep 18, 1959	Supplement 11Manufacturing	Approved	None posted
Apr 9, 1959	Supplement 10Manufacturing	Approved	None posted
Apr 1, 1958	Supplement 9Labeling	Approved	None posted
Mar 11, 1952	Supplement 8Manufacturing	Approved	None posted
Jan 2, 1951	Supplement 7Manufacturing	Approved	None posted
Apr 7, 1950	Supplement 6Labeling	Approved	None posted
Mar 31, 1950	Supplement 2Labeling	Approved	None posted
Jan 23, 1950	Original application	Approved	None posted

Identifiers

Application: NDA 50404
Drugs@FDA: Overview at FDA
Company: Lederle Laboratories

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