ANDA 65329, held by Acs Dobfar. Ceftriaxone Sodium.
As of Nov 15, 2026, ANDA 65329 (Ceftriaxone), held by Acs Dobfar, was first approved by FDA on Jul 24, 2008, with 7 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Before instituting treatment with Ceftriaxone for Injection, USP, 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 |
|---|---|---|---|
| Jul 24, 2008 | Original application | Approved | None posted |
| CeftriaxoneEQ 500MG BASE/VIAL · injectable;injection | Ceftriaxone Sodium | Rx |
| CeftriaxoneEQ 1GM BASE/VIAL · injectable;injection | Ceftriaxone Sodium | Rx |
| CeftriaxoneEQ 2GM BASE/VIAL · injectable;injection | Ceftriaxone Sodium | Rx |
| Jan 13, 2022 | Supplement 19Labeling · Standard review | Approved | None posted |
| Mar 2, 2016 | Supplement 10Labeling · Standard review | Approved | None posted |
| Nov 7, 2014 | Supplement 7Labeling · Standard review | Approved | None posted |
| May 2, 2012 | Supplement 6Labeling | Approved | None posted |
| Nov 29, 2010 | Supplement 4Labeling | Approved | None posted |
| Jan 24, 2010 | Supplement 2Labeling | Approved | None posted |
| Oct 15, 2009 | Supplement 1Labeling | Approved | None posted |
| Jul 24, 2008 | 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
