Cefaclor

ANDA 64086, held by Ivax Sub Teva Pharms. Cefaclor.

As of Nov 14, 2026, ANDA 64086 (Cefaclor), held by Ivax Sub Teva Pharms, was first approved by FDA on Apr 28, 1995, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 28, 1995
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Apr 28, 1995	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
CefaclorEQ 187MG BASE/5ML · for suspension;oral	Cefaclor	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Dec 9, 1998	Supplement 2Manufacturing	Approved	None posted
May 30, 1997	Supplement 1Manufacturing	Approved	None posted
Apr 28, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 64086
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