ANDA 211318, held by Fosun Pharma. Azithromycin.
As of Nov 13, 2026, ANDA 211318 (Azithromycin), held by Fosun Pharma, was first approved by FDA on Mar 17, 2021, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 17, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| AzithromycinEQ 500MG BASE ยท tablet;oral | Azithromycin | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 23, 2024 | Supplement 2Manufacturing | Approved | None posted |
| Mar 17, 2021 | 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
