Ceftriaxone

ANDA 65245, held by Fresenius Kabi USA. Ceftriaxone Sodium.

As of Nov 15, 2026, ANDA 65245 (Ceftriaxone), held by Fresenius Kabi USA, was first approved by FDA on Feb 15, 2006, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 15, 2006
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Feb 15, 2006	Original application	Approved	None posted

Products

4 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Aug 4, 2011	Supplement 5Labeling	Approved	None posted
Jun 3, 2010	Supplement 3Labeling	Approved	None posted
Apr 21, 2009	Supplement 2Labeling	Approved	None posted
Jan 16, 2009	Supplement 1Labeling	Approved	None posted
Feb 15, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 65245
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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