Azithromycin

ANDA 65404, held by Chartwell Rx. Azithromycin.

As of Nov 13, 2026, ANDA 65404 (Azithromycin), held by Chartwell Rx, was first approved by FDA on Feb 11, 2008, with 8 approved supplements and 0 published complete response letters.

First approved: Feb 11, 2008
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Feb 11, 2008	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
AzithromycinEQ 250MG BASE · tablet;oral	Azithromycin	Rx

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 12, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Apr 7, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Apr 7, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Apr 7, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Apr 7, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Feb 12, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Aug 5, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Nov 3, 2009	Supplement 1Manufacturing	Approved	None posted
Feb 11, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 65404
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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