Chloromycetin

NDA 50156, held by Parkedale. Chloramphenicol.

As of Nov 13, 2026, NDA 50156 (Chloromycetin), held by Parkedale, was first approved by FDA on Jun 1, 1951, with 39 approved supplements and 0 published complete response letters.

First approved: Jun 1, 1951
Supplements approved: 39
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 40 submissions below

Date	Submission	Status	Documents
Jun 1, 1951	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chloromycetin1% · ointment;ophthalmic	Chloramphenicol	Discontinued

All 40 submissions, including labeling and manufacturing supplements


Feb 3, 1999	Supplement 39Manufacturing	Approved	None posted
Feb 3, 1999	Supplement 38Labeling	Approved	None posted
Feb 25, 1998	Supplement 40Manufacturing	Approved	None posted
Aug 27, 1996	Supplement 34Labeling	Approved	None posted
Aug 27, 1986	Supplement 36Manufacturing	Approved	None posted
Nov 8, 1983	Supplement 35Labeling	Approved	None posted
Jul 22, 1983	Supplement 2Manufacturing	Approved	None posted
Apr 19, 1983	Supplement 1Manufacturing	Approved	None posted
Apr 19, 1983	Supplement 33Manufacturing	Approved	None posted
Mar 24, 1982	Supplement 32Manufacturing	Approved	None posted
Jan 8, 1981	Supplement 31Labeling	Approved	None posted
Dec 30, 1979	Supplement 30Manufacturing	Approved	None posted
May 19, 1977	Supplement 29Manufacturing	Approved	None posted
Feb 23, 1977	Supplement 28Manufacturing	Approved	None posted
Jul 11, 1973	Supplement 27Labeling	Approved	None posted
Mar 23, 1973	Supplement 24Labeling	Approved	None posted
Mar 23, 1973	Supplement 26Labeling	Approved	None posted
Sep 12, 1972	Supplement 21Labeling	Approved	None posted
Aug 9, 1972	Supplement 25Labeling	Approved	None posted
Jun 27, 1972	Supplement 23Manufacturing	Approved	None posted
Mar 22, 1972	Supplement 22Manufacturing	Approved	None posted
Jul 12, 1971	Supplement 20Labeling	Approved	None posted
May 3, 1971	Supplement 19Labeling	Approved	None posted
Oct 28, 1969	Supplement 18Manufacturing	Approved	None posted
Nov 5, 1964	Supplement 17Manufacturing	Approved	None posted
Dec 10, 1963	Supplement 15Labeling	Approved	None posted
Dec 10, 1963	Supplement 16Labeling	Approved	None posted
Aug 26, 1963	Supplement 14Labeling	Approved	None posted
Jun 11, 1963	Supplement 13Labeling	Approved	None posted
Apr 8, 1963	Supplement 12Labeling	Approved	None posted
Jul 26, 1962	Supplement 11Labeling	Approved	None posted
Dec 1, 1961	Supplement 9Labeling	Approved	None posted
Dec 1, 1961	Supplement 10Labeling	Approved	None posted
May 19, 1961	Supplement 7Labeling	Approved	None posted
May 19, 1961	Supplement 8Labeling	Approved	None posted
Apr 17, 1957	Supplement 6Manufacturing	Approved	None posted
Aug 17, 1955	Supplement 5Manufacturing	Approved	None posted
Apr 30, 1953	Supplement 4Manufacturing	Approved	None posted
Sep 9, 1952	Supplement 3Manufacturing	Approved	None posted
Jun 1, 1951	Original application	Approved	None posted

Identifiers

Application: NDA 50156
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