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 |
|---|---|---|---|
| Nov 8, 2021 | Original application | Approved | None posted |
| Jan 31, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 8, 2021 | 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
