ANDA 65265, held by Hikma. Azithromycin.
As of Nov 13, 2026, ANDA 65265 (Azithromycin), held by Hikma, was first approved by FDA on Jan 18, 2007, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 18, 2007 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| AzithromycinEQ 500MG BASE/VIAL · injectable;injection | Azithromycin | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 7, 2016 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jan 3, 2013 | Supplement 3Labeling | Approved | None posted |
| Jan 18, 2007 | 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
