Azithromycin

Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 65209, held by Sandoz. Azithromycin.

As of Nov 13, 2026, ANDA 65209 (Azithromycin), held by Sandoz, was first approved by FDA on Nov 14, 2005, with 14 approved supplements and 0 published complete response letters.

First approved: Nov 14, 2005
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Azithromycin is a macrolide antibacterial indicated for the treatment of adult patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:

Sexually Transmitted Diseases
Mycobacterial Infections To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 1.1 Sexually Transmitted Diseases

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Nov 14, 2005	Original application	Approved	None posted

Products

1 strengths and forms

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

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 22, 2021	Supplement 32Labeling · Standard review	Approved	None posted
Jan 8, 2020	Supplement 30Labeling · Standard review	Approved	None posted
Feb 1, 2019	Supplement 25Labeling · Standard review	Approved	None posted
Feb 1, 2019	Supplement 26Labeling · Standard review	Approved	None posted
Jan 5, 2017	Supplement 23Manufacturing	Approved	None posted
May 14, 2015	Supplement 21Labeling · Standard review	Approved	None posted
Jun 25, 2013	Supplement 19Labeling · Standard review	Approved	None posted
Oct 9, 2012	Supplement 17Labeling · Standard review	Approved	None posted
Mar 12, 2012	Supplement 16Labeling	Approved	None posted
Jul 1, 2011	Supplement 14Labeling	Approved	None posted
Aug 19, 2010	Supplement 10Labeling	Approved	None posted
Jun 30, 2008	Supplement 7Labeling	Approved	None posted
Jan 29, 2008	Supplement 6Labeling	Approved	None posted
Jun 20, 2007	Supplement 4Labeling	Approved	None posted
Nov 14, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 65209
Drugs@FDA: Overview at FDA
Company: Sandoz

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