Chloromycetin

NDA 50155, held by Parkedale. Chloramphenicol Sodium Succinate.

As of Nov 14, 2026, NDA 50155 (Chloromycetin), held by Parkedale, was first approved by FDA on Feb 20, 1959, with 30 approved supplements and 0 published complete response letters.

First approved: Feb 20, 1959
Supplements approved: 30
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below

Date	Submission	Status	Documents
Feb 20, 1959	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
ChloromycetinEQ 1GM BASE/VIAL · injectable;injection	Chloramphenicol Sodium Succinate	DiscontinuedReference drug

All 31 submissions, including labeling and manufacturing supplements


Aug 9, 2005	Supplement 39Labeling	Approved	Label Letter
Dec 14, 1999	Supplement 37Labeling	Approved	None posted
Aug 11, 1999	Supplement 38Manufacturing	Approved	None posted
Mar 8, 1999	Supplement 36Manufacturing	Approved	None posted
Aug 24, 1994	Supplement 35Manufacturing	Approved	None posted
Jun 16, 1994	Supplement 34Manufacturing	Approved	None posted
Apr 21, 1988	Supplement 6Manufacturing	Approved	None posted
Jan 22, 1988	Supplement 5Manufacturing	Approved	None posted
Jun 10, 1987	Supplement 3Manufacturing	Approved	None posted
Mar 28, 1986	Supplement 2Manufacturing	Approved	None posted
Jan 31, 1984	Supplement 1Manufacturing	Approved	None posted
May 26, 1981	Supplement 33Manufacturing	Approved	None posted
Mar 26, 1980	Supplement 32Manufacturing	Approved	None posted
Dec 10, 1979	Supplement 31Labeling	Approved	None posted
Dec 7, 1978	Supplement 30Manufacturing	Approved	None posted
Aug 3, 1978	Supplement 29Manufacturing	Approved	None posted
Apr 4, 1978	Supplement 28Manufacturing	Approved	None posted
Nov 10, 1977	Supplement 26Manufacturing	Approved	None posted
Oct 17, 1977	Supplement 25Manufacturing	Approved	None posted
Jul 16, 1977	Supplement 24Manufacturing	Approved	None posted
Feb 23, 1977	Supplement 23Manufacturing	Approved	None posted
Jul 22, 1975	Supplement 18Manufacturing	Approved	None posted
Jun 11, 1974	Supplement 19Manufacturing	Approved	None posted
Oct 9, 1973	Supplement 17Manufacturing	Approved	None posted
Jul 28, 1966	Supplement 16Manufacturing	Approved	None posted
Jun 25, 1962	Supplement 13Manufacturing	Approved	None posted
Jun 25, 1962	Supplement 12Manufacturing	Approved	None posted
May 5, 1961	Supplement 10Manufacturing	Approved	None posted
May 5, 1961	Supplement 9Manufacturing	Approved	None posted
Mar 22, 1961	Supplement 8Labeling	Approved	None posted
Feb 20, 1959	Original application	Approved	None posted

Identifiers

Application: NDA 50155
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