Azithromycin

ANDA 65366, held by Extrovis. Azithromycin.

As of Nov 13, 2026, ANDA 65366 (Azithromycin), held by Extrovis, was first approved by FDA on May 30, 2007, with 4 approved supplements and 0 published complete response letters.

First approved: May 30, 2007
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
May 30, 2007	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
AzithromycinEQ 500MG BASE · tablet;oral	Azithromycin	Discontinued

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 18, 2020	Supplement 9Labeling · Standard review	Approved	None posted
May 18, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Apr 9, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Aug 25, 2014	Supplement 7Labeling · Standard review	Approved	None posted
May 30, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 65366
Drugs@FDA: Overview at FDA
Company: Extrovis

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