Ceftriaxone

ANDA 65342, held by Hikma Farmaceutica. Ceftriaxone Sodium.

As of Nov 15, 2026, ANDA 65342 (Ceftriaxone), held by Hikma Farmaceutica, was first approved by FDA on Jan 10, 2008, with 7 approved supplements and 0 published complete response letters.

First approved: Jan 10, 2008
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jan 10, 2008	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 8 submissions, including labeling and manufacturing supplements


Jan 13, 2022	Supplement 22Labeling · Standard review	Approved	None posted
Sep 11, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Sep 11, 2020	Supplement 14Labeling · Standard review	Approved	None posted
Aug 29, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Aug 4, 2011	Supplement 9Labeling	Approved	None posted
Jul 6, 2010	Supplement 7Labeling	Approved	None posted
Nov 20, 2009	Supplement 4Labeling	Approved	None posted
Jan 10, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 65342
Drugs@FDA: Overview at FDA
Company: Hikma Farmacêutica

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