Ceftriaxone

ANDA 65180, held by Apotex. Ceftriaxone Sodium.

As of Nov 15, 2026, ANDA 65180 (Ceftriaxone), held by Apotex, was first approved by FDA on May 12, 2006, with 6 approved supplements and 0 published complete response letters.

First approved: May 12, 2006
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
May 12, 2006	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
CeftriaxoneEQ 1GM BASE/VIAL · injectable;injection	Ceftriaxone Sodium	Rx

All 7 submissions, including labeling and manufacturing supplements


Jan 13, 2022	Supplement 11Labeling · Standard review	Approved	None posted
Sep 11, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Sep 11, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Mar 2, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Mar 2, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Aug 20, 2012	Supplement 4Labeling	Approved	None posted
May 12, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 65180
Drugs@FDA: Overview at FDA
Company: Apotex

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