Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 211147, held by Zydus Lifesciences. Azithromycin.
As of Nov 13, 2026, ANDA 211147 (Azithromycin), held by Zydus Lifesciences, was first approved by FDA on Jul 31, 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 31, 2018 | 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 |
|---|---|---|---|
| Mar 17, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jan 13, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 31, 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
