Azithromycin

ANDA 65508, held by Apotex Corp. Azithromycin.

As of Nov 13, 2026, ANDA 65508 (Azithromycin), held by Apotex Corp, was first approved by FDA on Jul 13, 2011, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 13, 2011
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
Jul 13, 2011	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
AzithromycinEQ 600MG BASE · tablet;oral	Azithromycin	Discontinued

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 20, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Jun 26, 2013	Supplement 1Labeling · Standard review	Approved	None posted
Jul 13, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 65508
Drugs@FDA: Overview at FDA
Company: Apotex

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