ANDA 203294, held by Eugia Pharma. Azithromycin.
As of Nov 13, 2026, ANDA 203294 (Azithromycin), held by Eugia Pharma, was first approved by FDA on Jun 19, 2015, with 7 approved supplements and 0 published complete response letters.
Azithromycin for injection is a macrolide antibacterial drug indicated for the treatment of the following infections caused by designated susceptible microorganisms: Community-acquired pneumonia in adults Pelvic inflammatory disease in adults To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 19, 2015 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| AzithromycinEQ 500MG BASE/VIAL · injectable;injection | Azithromycin | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 29, 2026 | Supplement 18Labeling · Standard review | Approved | None posted |
| Aug 2, 2023 | Supplement 12Labeling · Standard review | Approved | None posted |
| Aug 2, 2023 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jan 27, 2020 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jan 27, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jan 27, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 30, 2016 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 19, 2015 | Original application | Approved |
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
