Chloromycetin

NDA 50143, held by Parkedale. Chloramphenicol.

As of Nov 13, 2026, NDA 50143 (Chloromycetin), held by Parkedale, was first approved by FDA on Jun 1, 1951, with 14 approved supplements and 0 published complete response letters.

First approved: Jun 1, 1951
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

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

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chloromycetin25MG/VIAL · for solution;ophthalmic	Chloramphenicol	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Aug 14, 1996	Supplement 16Labeling	Approved	None posted
Dec 1, 1988	Supplement 5Manufacturing	Approved	None posted
Sep 29, 1986	Supplement 4Manufacturing	Approved	None posted
Nov 8, 1983	Supplement 1Labeling	Approved	None posted
Sep 23, 1983	Supplement 2Manufacturing	Approved	None posted
Sep 28, 1982	Supplement 15Manufacturing	Approved	None posted
Apr 8, 1981	Supplement 14Manufacturing	Approved	None posted
Jan 8, 1981	Supplement 13Labeling	Approved	None posted
Nov 8, 1979	Supplement 12Labeling	Approved	None posted
Aug 3, 1978	Supplement 11Manufacturing	Approved	None posted
Jun 29, 1978	Supplement 10Labeling	Approved	None posted
Feb 23, 1977	Supplement 9Manufacturing	Approved	None posted
Feb 24, 1958	Supplement 8Manufacturing	Approved	None posted
Aug 30, 1956	Supplement 6Manufacturing	Approved	None posted
Jun 1, 1951	Original application	Approved	None posted

Identifiers

Application: NDA 50143
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