Ceftriaxone

ANDA 65230, held by Hospira Inc. Ceftriaxone Sodium.

As of Nov 15, 2026, ANDA 65230 (Ceftriaxone), held by Hospira Inc, was first approved by FDA on Aug 2, 2005, with 6 approved supplements and 0 published complete response letters.

First approved: Aug 2, 2005
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Aug 2, 2005	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 7 submissions, including labeling and manufacturing supplements


Apr 20, 2011	Supplement 14Labeling	Approved	None posted
Aug 31, 2010	Supplement 13Labeling	Approved	None posted
Aug 27, 2009	Supplement 11Labeling	Approved	None posted
Aug 27, 2009	Supplement 12Labeling	Approved	None posted
Nov 14, 2008	Supplement 7Labeling	Approved	None posted
Nov 14, 2008	Supplement 10Labeling	Approved	None posted
Aug 2, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 65230
Drugs@FDA: Overview at FDA
Company: Hospira

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