Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 208249, held by Cspc Ouyi. Azithromycin.
As of Nov 13, 2026, ANDA 208249 (Azithromycin), held by Cspc Ouyi, was first approved by FDA on Oct 25, 2018, with 1 approved supplement 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 |
|---|---|---|---|
| Oct 25, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| AzithromycinEQ 500MG BASE · tablet;oral | Azithromycin | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 1, 2019 | Supplement 1Manufacturing | Approved | None posted |
| Oct 25, 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
