Azithromycin

Treats infections caused by susceptible strains of the designated microorganisms in the…. ANDA 65501, held by Gland Pharma Ltd. Azithromycin.

As of Nov 13, 2026, ANDA 65501 (Azithromycin), held by Gland Pharma Ltd, was first approved by FDA on Nov 9, 2009, with 8 approved supplements and 0 published complete response letters.

First approved: Nov 9, 2009
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Azithromycin for injection is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Azithromycin for injection is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Community-acquired pneumonia in adults Pelvic inflammatory disease To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin 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 9 submissions below

Date	Submission	Status	Documents
Nov 9, 2009	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
AzithromycinEQ 500MG BASE/VIAL · injectable;injection	Azithromycin	Rx

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 13, 2023	Supplement 17Labeling · Standard review	Approved	None posted
Jan 27, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Jan 27, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Jan 27, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Jan 5, 2017	Supplement 7Labeling · Standard review	Approved	None posted
Mar 19, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Aug 25, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Aug 24, 2010	Supplement 1Labeling	Approved	None posted
Nov 9, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 65501
Drugs@FDA: Overview at FDA
Company: Gland Pharma

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