Chloramphenicol

ANDA 62247, held by Ivax Sub Teva Pharms. Chloramphenicol.

As of Nov 15, 2026, ANDA 62247 (Chloramphenicol), held by Ivax Sub Teva Pharms, was first approved by FDA on Apr 28, 1980, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 28, 1980
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 28, 1980	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chloramphenicol250MG · capsule; oral	Chloramphenicol	Discontinued

All 5 submissions, including labeling and manufacturing supplements


May 30, 1997	Supplement 11Manufacturing	Approved	None posted
Nov 16, 1992	Supplement 9Manufacturing	Approved	None posted
Sep 2, 1992	Supplement 10Labeling	Approved	None posted
Aug 14, 1992	Supplement 8Manufacturing	Approved	None posted
Apr 28, 1980	Original application	Approved	None posted

Identifiers

Application: ANDA 62247
Drugs@FDA: Overview at FDA
Company: IVAX 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