Ceftriaxone

ANDA 65328, held by Acs Dobfar. Ceftriaxone Sodium.

As of Nov 15, 2026, ANDA 65328 (Ceftriaxone), held by Acs Dobfar, was first approved by FDA on Jul 24, 2008, with 11 approved supplements and 0 published complete response letters.

First approved: Jul 24, 2008
Supplements approved: 11
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 12 submissions below

Date	Submission	Status	Documents
Jul 24, 2008	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
CeftriaxoneEQ 10GM BASE/VIAL · injectable;injection	Ceftriaxone Sodium	Rx

All 12 submissions, including labeling and manufacturing supplements


Jan 13, 2022	Supplement 16Labeling · Standard review	Approved	None posted
Mar 2, 2016	Supplement 12Labeling · Standard review	Approved	None posted
Nov 26, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Mar 22, 2013	Supplement 9Labeling · Standard review	Approved	None posted
Aug 24, 2012	Supplement 7Labeling	Approved	None posted
Sep 30, 2011	Supplement 5Labeling	Approved	None posted
Aug 4, 2011	Supplement 8Labeling	Approved	None posted
Jan 4, 2010	Supplement 3Labeling	Approved	None posted
Jan 4, 2010	Supplement 4Labeling	Approved	None posted
Dec 29, 2009	Supplement 2Labeling	Approved	None posted
Oct 26, 2009	Supplement 1Labeling	Approved	None posted
Jul 24, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 65328
Drugs@FDA: Overview at FDA
Company: ACS Dobfar

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