Ceftriaxone

ANDA 65294, held by Cephazone Pharma. Ceftriaxone Sodium.

As of Nov 15, 2026, ANDA 65294 (Ceftriaxone), held by Cephazone Pharma, was first approved by FDA on Mar 26, 2007, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 26, 2007
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Mar 26, 2007	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 4 submissions, including labeling and manufacturing supplements


Aug 20, 2012	Supplement 4Labeling	Approved	None posted
Dec 5, 2008	Supplement 1Labeling	Approved	None posted
Dec 5, 2008	Supplement 2Labeling	Approved	None posted
Mar 26, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 65294
Drugs@FDA: Overview at FDA
Company: Cephazone Pharma

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