Azithromycin

ANDA 205666, held by Amneal. Azithromycin.

As of Nov 13, 2026, ANDA 205666 (Azithromycin), held by Amneal, was first approved by FDA on Jul 19, 2018, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 19, 2018
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jul 19, 2018	Original application	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
AzithromycinEQ 100MG BASE/5ML · for suspension;oral	Azithromycin	Discontinued
AzithromycinEQ 200MG BASE/5ML · for suspension;oral	Azithromycin	Discontinued

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 14, 2022	Supplement 9Labeling · Standard review	Approved	None posted
Jul 23, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Jul 19, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 205666
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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