Chloromycetin

NDA 50205, held by Parkedale. Chloramphenicol.

As of Nov 13, 2026, NDA 50205 (Chloromycetin), held by Parkedale, was first approved by FDA on Mar 30, 1953, with 27 approved supplements and 0 published complete response letters.

First approved: Mar 30, 1953
Supplements approved: 27
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

Date	Submission	Status	Documents
Mar 30, 1953	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chloromycetin0.5% · solution/drops;otic	Chloramphenicol	Discontinued

All 28 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 13, 2009	Supplement 26Labeling · Standard review	Approved	None posted
Mar 13, 2009	Supplement 19Labeling	Approved	None posted
Mar 13, 2009	Supplement 14Labeling	Approved	None posted
Mar 13, 2009	Supplement 9Labeling	Approved	None posted
Apr 23, 1997	Supplement 27Manufacturing	Approved	None posted
Nov 21, 1996	Supplement 25Labeling · Standard review	Approved	None posted
Sep 14, 1989	Supplement 3Manufacturing	Approved	None posted
Jun 23, 1988	Supplement 2Labeling	Approved	None posted
Sep 25, 1986	Supplement 1Manufacturing	Approved	None posted
May 29, 1981	Supplement 24Manufacturing	Approved	None posted
Jan 8, 1981	Supplement 23Labeling	Approved	None posted
Jan 22, 1980	Supplement 22Labeling	Approved	None posted
Aug 3, 1978	Supplement 21Manufacturing	Approved	None posted
Feb 23, 1977	Supplement 20Manufacturing	Approved	None posted
Sep 10, 1974	Supplement 17Labeling	Approved	None posted
May 3, 1974	Supplement 16Manufacturing	Approved	None posted
Feb 7, 1974	Supplement 15Labeling	Approved	None posted
Apr 22, 1971	Supplement 13Labeling	Approved	None posted
Apr 6, 1969	Supplement 12Labeling	Approved	None posted
Aug 29, 1966	Supplement 18Manufacturing	Approved	None posted
Dec 10, 1963	Supplement 11Labeling	Approved	None posted
Jun 11, 1963	Supplement 10Labeling	Approved	None posted
Jul 26, 1962	Supplement 8Labeling	Approved	None posted
May 19, 1961	Supplement 7Labeling	Approved	None posted
Jun 18, 1954	Supplement 6Manufacturing	Approved	None posted
Jul 7, 1953	Supplement 5Manufacturing	Approved	None posted
Jun 22, 1953	Supplement 4Manufacturing	Approved	None posted
Mar 30, 1953	Original application	Approved	None posted

Identifiers

Application: NDA 50205
Drugs@FDA: Overview at FDA
Company: Parkedale Pharmaceuticals

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