Chloramphenicol

ANDA 62042, held by Epic Pharma LLC. Chloramphenicol.

As of Nov 15, 2026, ANDA 62042 (Chloramphenicol), held by Epic Pharma LLC, was first approved by FDA on Aug 31, 1981, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 31, 1981
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Aug 31, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chloramphenicol0.5% · solution/drops;ophthalmic	Chloramphenicol	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Feb 11, 1992	Supplement 10Labeling	Approved	None posted
Aug 31, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 62042
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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