Azithromycin

ANDA 65360, held by Aurobindo Pharma USA. Azithromycin.

As of Nov 13, 2026, ANDA 65360 (Azithromycin), held by Aurobindo Pharma USA, was first approved by FDA on Jan 8, 2007, with 5 approved supplements and 0 published complete response letters.

First approved: Jan 8, 2007
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jan 8, 2007	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
AzithromycinEQ 600MG BASE · tablet;oral	Azithromycin	Discontinued

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 22, 2021	Supplement 10Labeling · Standard review	Approved	None posted
Nov 15, 2021	Supplement 9Labeling · Standard review	Approved	None posted
Jun 11, 2018	Supplement 8Labeling · Standard review	Approved	None posted
Feb 10, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Aug 9, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Jan 8, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 65360
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma USA

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