Chloramphenicol

Sold as Chloroptic, Chloromycetin. Every FDA application for this active ingredient: 6 branded and 12 generic.

As of Nov 15, 2026, FDA lists 18 applications for Chloramphenicol (sold as Chloroptic, Chloromycetin), first approved Jun 1, 1951, with 0 new uses approved and 0 published complete response letters.

First approved: Jun 1, 1951
Applications: 18
New uses approved: 0
Complete response letters: 0

Clinical Trials

4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Clinical, Dermoscopic, and Mycological Characteristics of Tinea Capitis in ChildrenFungal Infection by Site, Tinea Capitis · Sohag University	—	Not yet recruiting	Sep 3, 2026
Clinical, Dermoscopic, and Mycological Evaluations of Resistant DermatophytosisFungal Skin Infection, Tinea Corporis · Sohag University	—	Not yet recruiting	Sep 1, 2026
Chloramphenicol, Tetracycline, Zinc Oxide and Eugenol Paste (CTZ Paste) for Emergency Dental Treatment in Public Health Settings: A Randomized TrialPulp Disease, Dental, Pulp Necrosis · University of Sao Paulo	Early phase 1	Not yet recruiting	Apr 21, 2026
Lesion Sterilization and Tissue Repair Antibiotic Paste Versus Zinc Oxide and Eugenol Pulpectomy for Treatment of Primary Molars With Pulp NecrosisPulp Necrosis · University of Faisalabad	Phase 1 / Phase 2	Not yet recruiting	Mar 16, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jun 1, 1951	ChloromycetinNDA 50143	Parkedale	14	Discontinued
Jun 1, 1951	ChloromycetinNDA 50156	Parkedale	39	Discontinued
Mar 30, 1953	ChloromycetinNDA 50205	Parkedale	27	Discontinued
Jun 20, 1967	MychelANDA 60851	Armenpharm	0	Discontinued
Mar 20, 1968	ChloropticNDA 50091	Allergan	38	Discontinued
Oct 1, 1968	ChloramphenicolANDA 60133	Altana	0	Discontinued
Jul 21, 1970	Chloroptic S.O.P.ANDA 61187	Allergan	10	Discontinued
Nov 18, 1970	OphthochlorANDA 61220	Parkedale	1	Discontinued
Apr 26, 1973	EconochlorANDA 61645	Alcon	0	Discontinued
May 14, 1974	EconochlorANDA 61648	Alcon	2	Discontinued
Apr 28, 1980	ChloramphenicolANDA 62247	Ivax Sub Teva Pharms	4	Discontinued
Aug 31, 1981	ChloramphenicolANDA 62042	Epic Pharma LLC	1	Discontinued
Mar 31, 1982	OptomycinANDA 62171	Optopics	0	Discontinued
Sep 25, 1985	ChloramphenicolANDA 62628	Alcon	10	Discontinued
—	ChlorofairANDA 62437	Pharmafair	0	Discontinued
—	ChlorofairANDA 62439	Pharmafair	0	Discontinued
—	ChloromycetinNDA 50153	Parke Davis	0	Discontinued
—	ChloromycetinNDA 50183	Parke Davis	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA