Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 207398, held by Aurobindo Pharma Ltd. Azithromycin.
As of Nov 13, 2026, ANDA 207398 (Azithromycin), held by Aurobindo Pharma Ltd, was first approved by FDA on Jul 5, 2018, with 2 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 |
|---|---|---|---|
| Jul 5, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| AzithromycinEQ 500MG BASE · tablet;oral | Azithromycin | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 12, 2022 | Supplement 9Labeling · Standard review | Approved | None posted |
| May 14, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jul 5, 2018 | 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
