Azithromycin

Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 65246, held by Pliva. Azithromycin.

As of Nov 14, 2026, ANDA 65246 (Azithromycin), held by Pliva, was first approved by FDA on Jul 6, 2006, with 13 approved supplements and 0 published complete response letters.

First approved: Jul 6, 2006
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin for oral suspension USP and other antibacterial drugs, azithromycin for oral suspension USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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
Jul 6, 2006	Original application	Approved	Letter

Products

2 strengths and forms


AzithromycinEQ 200MG BASE/5ML · for suspension;oral	Azithromycin	Rx
AzithromycinEQ 100MG BASE/5ML · for suspension;oral	Azithromycin	Rx

All 14 submissions, including labeling and manufacturing supplements


May 28, 2023	Supplement 30Labeling · Standard review	Approved	None posted
Jan 13, 2020	Supplement 25Labeling · Standard review	Approved	None posted
Jan 13, 2020	Supplement 26Labeling · Standard review	Approved	None posted
Jun 28, 2017	Supplement 19Labeling · Standard review	Approved	None posted
Jun 28, 2017	Supplement 22Labeling · Standard review	Approved	None posted
Jun 28, 2017	Supplement 23Labeling · Standard review	Approved	None posted
Jun 28, 2017	Supplement 24Labeling · Standard review	Approved	None posted
Jul 11, 2013	Supplement 16Labeling · Standard review	Approved	None posted
Feb 28, 2013	Supplement 15Labeling · Standard review	Approved	None posted
Dec 18, 2012	Supplement 14Labeling · Standard review	Approved	None posted
Feb 28, 2012	Supplement 11Labeling	Approved	None posted
Oct 22, 2009	Supplement 5Labeling	Approved	None posted
Sep 28, 2009	Supplement 7Labeling	Approved	None posted
Jul 6, 2006	Original application	Approved	Letter

Identifiers

Application: ANDA 65246
Drugs@FDA: Overview at FDA
Company: PLIVA

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