Zithromax

Treats mild to moderate infections caused by susceptible strains of the designated…. NDA 50710, held by Pfizer. Azithromycin.

As of Nov 13, 2026, NDA 50710 (Zithromax), held by Pfizer, was first approved by FDA on Oct 19, 1995, with 31 approved supplements and 0 published complete response letters.

First approved: Oct 19, 1995
Review: Standard
Supplements approved: 31
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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

Acute bacterial exacerbations of chronic bronchitis in adults
Acute bacterial sinusitis in adults
Uncomplicated skin and skin structure infections in adults
Urethritis and cervicitis in adults
Genital ulcer disease in men
Acute otitis media in pediatric patients (6 months of age and older)
Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) ( 1.1, 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below

Date	Submission	Status	Documents
Dec 14, 2001	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 14, 2001	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 20, 1996	Supplement 1Efficacy (new indication or use)	Approved	None posted
Oct 19, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
ZithromaxEQ 100MG BASE/5ML · for suspension;oral	Azithromycin	RxReference drug
ZithromaxEQ 200MG BASE/5ML · for suspension;oral	Azithromycin	RxReference drug

All 32 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 13, 2026	Supplement 54Labeling · Standard review	Approved	Letter Label
Nov 22, 2021	Supplement 51Labeling · Standard review	Approved	Label
Apr 24, 2019	Supplement 49Labeling · Standard review	Approved	Label Letter
Mar 30, 2017	Supplement 46Labeling · Standard review	Approved	Letter Label
Feb 10, 2017	Supplement 44Labeling · Standard review	Approved	Label Letter
May 23, 2016	Supplement 43Labeling · Standard review	Approved	Letter Label
Jun 7, 2014	Supplement 37Labeling · Standard review	Approved	Letter Label
Feb 19, 2013	Supplement 39Labeling · Standard review	Approved	Label Letter
Nov 2, 2012	Supplement 34Labeling · Standard review	Approved	Letter Label
Jun 6, 2012	Supplement 38Labeling · Standard review	Approved	Label Letter
Jan 28, 2011	Supplement 33Labeling · Standard review	Approved	Label Letter
Aug 11, 2010	Supplement 32Labeling	Approved	Label Letter
Mar 6, 2009	Supplement 28Labeling · Standard review	Approved	Label Letter
Oct 25, 2007	Supplement 23Labeling · Standard review	Approved	Letter Label
Apr 27, 2004	Supplement 19Labeling · Standard review	Approved	Letter
Jan 15, 2004	Supplement 21Labeling · Standard review	Approved	Letter Label
Jan 15, 2004	Supplement 17Labeling · Standard review	Approved	Letter Label
Dec 18, 2003	Supplement 20Labeling · Standard review	Approved	Letter
Jun 20, 2003	Supplement 16Labeling · Standard review	Approved	Letter
Oct 16, 2002	Supplement 7Labeling · Standard review	Approved	Letter
Jul 22, 2002	Supplement 14Labeling · Standard review	Approved	Letter
May 24, 2002	Supplement 11Labeling · Standard review	Approved	Review Letter Label
Dec 14, 2001	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 14, 2001	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 10, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 11, 2000	Supplement 6Labeling · Standard review	Approved	None posted
Nov 22, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 8, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 20, 1996	Supplement 1Efficacy (new indication or use)	Approved	None posted
Mar 18, 1996	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 14, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 19, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50710
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