Ceftriaxone

ANDA 65268, held by Facta Farma. Ceftriaxone Sodium.

As of Nov 15, 2026, ANDA 65268 (Ceftriaxone), held by Facta Farma, was first approved by FDA on Feb 28, 2007, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 28, 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
Feb 28, 2007	Original application	Approved	None posted

Products

2 strengths and forms


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 4, 2011	Supplement 5Labeling	Approved	None posted
Dec 5, 2008	Supplement 4Labeling	Approved	None posted
Jan 10, 2008	Supplement 3Labeling	Approved	None posted
Feb 28, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 65268
Drugs@FDA: Overview at FDA
Company: Facta Farma

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