Ceftriaxone

ANDA 65169, held by Sandoz. Ceftriaxone Sodium.

As of Nov 15, 2026, ANDA 65169 (Ceftriaxone), held by Sandoz, was first approved by FDA on May 9, 2005, with 8 approved supplements and 0 published complete response letters.

First approved: May 9, 2005
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
May 9, 2005	Original application	Approved	None posted

Products

4 strengths and forms


CeftriaxoneEQ 250MG BASE/VIAL · injectable;intramuscular, intravenous	Ceftriaxone Sodium	Rx
CeftriaxoneEQ 500MG BASE/VIAL · injectable;intramuscular, intravenous	Ceftriaxone Sodium	Rx
CeftriaxoneEQ 1GM BASE/VIAL · injectable;intramuscular, intravenous	Ceftriaxone Sodium	Rx
CeftriaxoneEQ 2GM BASE/VIAL · injectable;intramuscular, intravenous	Ceftriaxone Sodium	Rx

All 9 submissions, including labeling and manufacturing supplements


Jan 13, 2022	Supplement 35Labeling · Standard review	Approved	None posted
Mar 5, 2016	Supplement 25Labeling · Standard review	Approved	None posted
Mar 5, 2016	Supplement 26Labeling · Standard review	Approved	None posted
Feb 5, 2014	Supplement 22Labeling · Standard review	Approved	Letter Label
Jul 13, 2011	Supplement 18Labeling	Approved	None posted
Nov 24, 2010	Supplement 14Labeling	Approved	None posted
Jun 5, 2009	Supplement 8Labeling	Approved	None posted
Jan 14, 2009	Supplement 6Labeling	Approved	None posted
May 9, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 65169
Drugs@FDA: Overview at FDA
Company: Sandoz

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