ANDA 65150, held by Teva. Azithromycin.
As of Nov 13, 2026, ANDA 65150 (Azithromycin), held by Teva, was first approved by FDA on Nov 14, 2005, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 14, 2005 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| AzithromycinEQ 600MG BASE · tablet;oral | Azithromycin | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 22, 2021 | Supplement 20Labeling · Standard review | Approved | None posted |
| Nov 15, 2021 | Supplement 19Labeling · Standard review | Approved | None posted |
| Oct 18, 2017 | Supplement 15Labeling · Standard review | Approved | None posted |
| Oct 18, 2017 | Supplement 16Labeling · Standard review | Approved | None posted |
| Oct 18, 2017 | Supplement 17Labeling · Standard review | Approved | None posted |
| Mar 20, 2015 | Supplement 12Labeling · Standard review | Approved | None posted |
| Mar 20, 2015 | Supplement 13Labeling · Standard review | Approved | None posted |
| Feb 28, 2013 | Supplement 10Labeling · Standard review | Approved | None posted |
| Dec 18, 2012 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jul 1, 2011 | Supplement 8Labeling | Approved | None posted |
| Dec 13, 2010 | Supplement 6Labeling | Approved | None posted |
| Jul 28, 2010 | Supplement 5Labeling | Approved | None posted |
| Nov 30, 2009 | Supplement 4Labeling | Approved | None posted |
| Feb 12, 2009 | Supplement 3Labeling | Approved | None posted |
| Nov 14, 2005 | 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
