ANDA 65439, held by Fresenius Kabi USA. Aztreonam.
As of Nov 15, 2026, ANDA 65439 (Aztreonam), held by Fresenius Kabi USA, was first approved by FDA on Jun 18, 2010, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of aztreonam for injection, USP and other antibacterial drugs, aztreonam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 18, 2010 | Original application | Approved |
| Nov 29, 2021 | Supplement 9Labeling · Standard review | Approved | None posted |
| Nov 29, 2021 | Supplement 14Labeling · Standard review | Approved | None posted |
| Apr 28, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 28, 2015 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 18, 2010 | 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
