Zithromax

NDA 50733, held by Pfizer. Azithromycin.

As of Nov 14, 2026, NDA 50733 (Zithromax), held by Pfizer, was first approved by FDA on Jan 30, 1997, with 28 approved supplements and 0 published complete response letters.

First approved: Jan 30, 1997
Review: Standard
Supplements approved: 28
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ZITHROMAX is a macrolide antibacterial drug indicated for the treatment of the following infections caused by designated susceptible microorganisms:

Community-acquired pneumonia in adults
Pelvic inflammatory disease in adults To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX and other antibacterial drugs, ZITHROMAX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

Date	Submission	Status	Documents
Jan 30, 1997	Original applicationNew dosage form · Standard review	Approved	Letter Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
ZithromaxEQ 500MG BASE/VIAL · injectable;injection	Azithromycin	DiscontinuedReference drug

All 29 submissions, including labeling and manufacturing supplements


Jul 13, 2026	Supplement 52Labeling · Standard review	Approved	Letter Label
Jan 6, 2022	Supplement 49Manufacturing	Approved	Letter Label
Nov 22, 2021	Supplement 50Labeling · Standard review	Approved	Letter Label
Apr 24, 2019	Supplement 47Labeling · Standard review	Approved	Label
Mar 29, 2017	Supplement 46Labeling · Standard review	Approved	Letter Label
Feb 10, 2017	Supplement 43Labeling · Standard review	Approved	Label Letter
May 24, 2016	Supplement 40Labeling · Standard review	Approved	Letter Label
Jun 24, 2014	Supplement 38Manufacturing · Standard review	Approved	None posted
Jun 6, 2014	Supplement 31Labeling · Standard review	Approved	Letter Label
Feb 19, 2013	Supplement 35Labeling · Standard review	Approved	Letter Label
Jun 6, 2012	Supplement 34Labeling · Standard review	Approved	Label Letter
Nov 16, 2011	Supplement 33Labeling · Standard review	Approved	Letter Label
Jan 28, 2011	Supplement 30Labeling · Standard review	Approved	Label Letter
Aug 11, 2010	Supplement 29Labeling · Standard review	Approved	Label Letter
Mar 6, 2009	Supplement 23Labeling · Standard review	Approved	Label Letter
Oct 25, 2007	Supplement 18Labeling · Standard review	Approved	Letter Label
Jan 15, 2004	Supplement 13Labeling · Standard review	Approved	Letter
Jan 15, 2004	Supplement 12Labeling · Standard review	Approved	Letter
Jun 12, 2003	Supplement 7Labeling · Standard review	Approved	Letter
Oct 16, 2002	Supplement 6Labeling · Standard review	Approved	Letter
Jul 22, 2002	Supplement 10Labeling · Standard review	Approved	Letter
Mar 13, 2002	Supplement 9Manufacturing · Standard review	Approved	Letter
Dec 10, 2001	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 28, 2001	Supplement 5Labeling · Standard review	Approved	Label
Nov 11, 2000	Supplement 4Labeling · Standard review	Approved	None posted
Nov 22, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 19, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 20, 1999	Supplement 1Labeling · Standard review	Approved	None posted
Jan 30, 1997	Original applicationNew dosage form · Standard review	Approved	Letter Review

Identifiers

Application: NDA 50733
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