Azithromycin

Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 65225, held by Pliva. Azithromycin.

As of Nov 14, 2026, ANDA 65225 (Azithromycin), held by Pliva, was first approved by FDA on Nov 14, 2005, with 11 approved supplements and 0 published complete response letters.

First approved: Nov 14, 2005
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Azithromycin tablets are 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 12 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 12 submissions, including labeling and manufacturing supplements


Apr 18, 2020	Supplement 33Labeling · Standard review	Approved	None posted
Apr 18, 2020	Supplement 32Labeling · Standard review	Approved	None posted
Sep 5, 2017	Supplement 31Labeling · Standard review	Approved	None posted
Sep 5, 2017	Supplement 30Labeling · Standard review	Approved	None posted
Sep 5, 2017	Supplement 27Labeling · Standard review	Approved	None posted
Mar 20, 2015	Supplement 24Labeling · Standard review	Approved	None posted
Jun 26, 2013	Supplement 20Labeling · Standard review	Approved	None posted
Feb 28, 2013	Supplement 19Labeling · Standard review	Approved	None posted
Dec 18, 2012	Supplement 18Labeling · Standard review	Approved	None posted
Feb 28, 2012	Supplement 16Labeling	Approved	None posted
Jul 30, 2010	Supplement 15Labeling	Approved	None posted
Nov 14, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 65225
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