Zithromax

NDA 50730, held by Pfizer. Azithromycin.

As of Nov 13, 2026, NDA 50730 (Zithromax), held by Pfizer, was first approved by FDA on Jun 12, 1996, with 24 approved supplements and 0 published complete response letters.

First approved: Jun 12, 1996
Review: Priority
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Nov 13, 2000	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jun 12, 1996	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
ZithromaxEQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Azithromycin	DiscontinuedReference drug

All 25 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 13, 2026	Supplement 46Labeling · Standard review	Approved	Letter Label
Nov 22, 2021	Supplement 43Labeling · Standard review	Approved	Letter Label
Apr 24, 2019	Supplement 41Labeling · Standard review	Approved	Letter Label
Mar 29, 2017	Supplement 37Labeling · Standard review	Approved	Letter Label
Feb 10, 2017	Supplement 35Labeling · Standard review	Approved	Letter Label
May 23, 2016	Supplement 34Labeling · Standard review	Approved	Label Letter
Jun 6, 2014	Supplement 29Labeling · Standard review	Approved	Letter Label
Feb 19, 2013	Supplement 31Labeling · Standard review	Approved	Letter Label
Nov 2, 2012	Supplement 27Labeling · Standard review	Approved	Letter Label
Jun 6, 2012	Supplement 30Labeling · Standard review	Approved	Label Letter
Jan 28, 2011	Supplement 26Labeling · Standard review	Approved	Label Letter
Aug 11, 2010	Supplement 25Labeling · Standard review	Approved	Label Letter
Mar 6, 2009	Supplement 21Labeling · Standard review	Approved	Label Letter
Oct 25, 2007	Supplement 14Labeling · Standard review	Approved	Letter Label
Mar 24, 2004	Supplement 11Labeling · Standard review	Approved	Label Letter
Jan 15, 2004	Supplement 12Labeling · Standard review	Approved	Letter
Oct 16, 2002	Supplement 7Labeling · Standard review	Approved	Letter
Jul 22, 2002	Supplement 10Labeling · Standard review	Approved	Letter
Dec 4, 2001	Supplement 9Manufacturing · Priority review	Approved	None posted
Nov 13, 2000	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Nov 11, 2000	Supplement 4Labeling	Approved	None posted
Jan 20, 2000	Supplement 3Manufacturing · Priority review	Approved	None posted
Nov 19, 1999	Supplement 2Manufacturing · Priority review	Approved	None posted
Aug 12, 1997	Supplement 1Manufacturing · Priority review	Approved	None posted
Jun 12, 1996	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 50730
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