Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 65488, held by Chartwell Rx. Azithromycin.
As of Nov 13, 2026, ANDA 65488 (Azithromycin), held by Chartwell Rx, was first approved by FDA on May 15, 2015, with 5 approved supplements and 0 published complete response letters.
Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 15, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| AzithromycinEQ 100MG BASE/5ML · for suspension;oral | Azithromycin | Rx |
| AzithromycinEQ 200MG BASE/5ML · for suspension;oral | Azithromycin | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 23, 2025 | Supplement 8Labeling · Standard review | Approved | None posted |
| May 11, 2018 | Supplement 6Manufacturing | Approved | None posted |
| Aug 24, 2017 | Supplement 2Labeling · Standard review | Approved | |
| Aug 24, 2017 | Supplement 3Manufacturing | Approved | None posted |
| May 25, 2016 | Supplement 1 | Approved | |
| May 15, 2015 | Original application | Approved | None posted |
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
