NDA 50810, held by Thea Pharma. Azithromycin.
As of Nov 13, 2026, NDA 50810 (Azasite), held by Thea Pharma, was first approved by FDA on Apr 27, 2007, with 9 approved supplements and 0 published complete response letters.
AzaSite is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms: CDC coryneform group G Efficacy for this organism was studied in fewer than 10 infections. Haemophilus influenzae Staphylococcus aureus Streptococcus mitis group Streptococcus pneumoniae
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 27, 2007 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Azasite1% · solution/drops;ophthalmic | Azithromycin | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 25, 2024 | Supplement 17Labeling · Standard review | Approved | |
| Nov 17, 2021 | Supplement 19Labeling · Standard review | Approved | |
| Mar 12, 2013 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Oct 16, 2012 | Supplement 12Manufacturing · Standard review | Approved | |
| Jul 5, 2012 | Supplement 14Labeling · Standard review | Approved | |
| Mar 31, 2011 | Supplement 7Labeling · Standard review | Approved | |
| May 6, 2009 | Supplement 1Labeling · Standard review | Approved | |
| May 6, 2009 | Supplement 2Manufacturing | Approved | |
| May 6, 2009 | Supplement 5Labeling · Standard review | Approved | |
| Apr 27, 2007 | Original applicationNew dosage form · Standard review | 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
