ANDA 90057, held by Samson Medcl. Ceftriaxone Sodium.
As of Nov 15, 2026, ANDA 90057 (Ceftriaxone), held by Samson Medcl, was first approved by FDA on Apr 25, 2014, with 2 approved supplements and 0 published complete response letters.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for Injection and other antibacterial drugs, Ceftriaxone 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 |
|---|---|---|---|
| Apr 25, 2014 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| CeftriaxoneEQ 100GM BASE/VIAL · injectable;injection | Ceftriaxone Sodium | Rx |
| Jan 13, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| May 12, 2016 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 25, 2014 | 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
