Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 217036, held by Zhejiang Poly Pharm. Azithromycin.
As of Nov 13, 2026, ANDA 217036 (Azithromycin), held by Zhejiang Poly Pharm, was first approved by FDA on Jul 27, 2023, with 0 approved supplements and 0 published complete response letters.
Azithromycin for oral suspension 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 27, 2023 | 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 |
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
