Zithromax

Treats mild to moderate infections caused by susceptible strains of the designated…. NDA 50711, held by Pfizer. Azithromycin.

As of Nov 13, 2026, NDA 50711 (Zithromax), held by Pfizer, was first approved by FDA on Jul 18, 1996, with 29 approved supplements and 0 published complete response letters.

First approved: Jul 18, 1996
Review: Standard
Supplements approved: 29
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ZITHROMAX (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 30 submissions below

Date	Submission	Status	Documents
Jul 18, 1996	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
ZithromaxEQ 250MG BASE · tablet;oral	Azithromycin	RxReference drug

All 30 submissions, including labeling and manufacturing supplements


Jul 13, 2026	Supplement 53Labeling · Standard review	Approved	Letter Label
Nov 22, 2021	Supplement 50Labeling · Standard review	Approved	Label Letter
Apr 24, 2019	Supplement 47Labeling · Standard review	Approved	Label Letter
Mar 30, 2017	Supplement 43Labeling · Standard review	Approved	Letter Label
Feb 10, 2017	Supplement 41Labeling · Standard review	Approved	Label Letter
May 23, 2016	Supplement 40Labeling · Standard review	Approved	Letter Label
Jun 7, 2014	Supplement 34Labeling · Standard review	Approved	Letter Label
Feb 19, 2013	Supplement 36Labeling · Standard review	Approved	Label Letter
Nov 2, 2012	Supplement 32Labeling · Standard review	Approved	Label Letter
Jun 6, 2012	Supplement 35Labeling · Standard review	Approved	Label Letter
Jan 28, 2011	Supplement 31Labeling · Standard review	Approved	Label Letter
Aug 11, 2010	Supplement 30Labeling	Approved	Label Letter
Mar 6, 2009	Supplement 24Labeling · Standard review	Approved	Label Letter
Oct 25, 2007	Supplement 19Labeling · Standard review	Approved	Letter Label
Jan 15, 2004	Supplement 17Labeling · Standard review	Approved	Letter Label
Jan 15, 2004	Supplement 15Labeling · Standard review	Approved	Letter Label
Dec 18, 2003	Supplement 16Labeling · Standard review	Approved	Letter
Oct 16, 2002	Supplement 8Labeling · Standard review	Approved	Letter
Jul 22, 2002	Supplement 12Labeling · Standard review	Approved	Letter
May 24, 2002	Supplement 9Labeling · Standard review	Approved	Review Label Letter
May 20, 2002	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 10, 2001	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 11, 2000	Supplement 6Labeling · Standard review	Approved	None posted
Feb 9, 2000	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 6, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 22, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 6, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 15, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
May 16, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 18, 1996	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 50711
Drugs@FDA: Overview at FDA
Company: Pfizer

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