Azithromycin

Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 65211, held by Sandoz. Azithromycin.

As of Nov 13, 2026, ANDA 65211 (Azithromycin), held by Sandoz, was first approved by FDA on Nov 14, 2005, with 13 approved supplements and 0 published complete response letters.

First approved: Nov 14, 2005
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
AzithromycinEQ 250MG BASE · tablet;oral	Azithromycin	Rx

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 8, 2020	Supplement 34Labeling · Standard review	Approved	None posted
Feb 14, 2019	Supplement 30Labeling · Standard review	Approved	None posted
Nov 12, 2016	Supplement 29Labeling · Standard review	Approved	None posted
May 14, 2015	Supplement 25Labeling · Standard review	Approved	None posted
Dec 3, 2014	Supplement 24Manufacturing	Approved	None posted
Jun 25, 2013	Supplement 22Labeling · Standard review	Approved	None posted
Oct 9, 2012	Supplement 20Labeling · Standard review	Approved	None posted
Oct 9, 2012	Supplement 18Labeling	Approved	None posted
Jul 1, 2011	Supplement 16Labeling	Approved	None posted
Mar 26, 2010	Supplement 12Labeling	Approved	None posted
Feb 19, 2009	Supplement 11Labeling	Approved	None posted
Apr 30, 2008	Supplement 8Labeling	Approved	None posted
Feb 27, 2008	Supplement 1Labeling	Approved	None posted
Nov 14, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 65211
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