ANDA 65168, held by Sandoz. Ceftriaxone Sodium.
As of Nov 15, 2026, ANDA 65168 (Ceftriaxone), held by Sandoz, was first approved by FDA on May 17, 2005, with 7 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 17, 2005 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| CeftriaxoneEQ 10GM BASE/VIAL · injectable;injection | Ceftriaxone Sodium | Rx |
| Jan 13, 2022 | Supplement 32Labeling · Standard review | Approved | None posted |
| Mar 5, 2016 | Supplement 22Labeling · Standard review | Approved | None posted |
| Mar 5, 2016 | Supplement 23Labeling · Standard review | Approved | None posted |
| Jan 31, 2014 | Supplement 19Labeling · Standard review | Approved | |
| Feb 17, 2012 | Supplement 15Labeling | Approved | None posted |
| Sep 23, 2010 | Supplement 9Labeling | Approved | None posted |
| Jan 14, 2009 | Supplement 5Labeling | Approved | None posted |
| May 17, 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
