Ceftriaxone In Plastic Container

ANDA 65224, held by Baxter Hlthcare. Ceftriaxone Sodium.

First approved: Aug 23, 2005
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Aug 23, 2005	Original application	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Ceftriaxone In Plastic ContainerEQ 20MG BASE/ML · injectable;injection	Ceftriaxone Sodium	Rx
Ceftriaxone In Plastic ContainerEQ 40MG BASE/ML · injectable;injection	Ceftriaxone Sodium	Rx

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 7, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Mar 22, 2024	Supplement 14Labeling · Standard review	Approved	None posted
Jan 13, 2022	Supplement 13Labeling · Standard review	Approved	None posted
Aug 30, 2013	Supplement 8Labeling	Approved	None posted
Jun 18, 2009	Supplement 7Labeling	Approved	None posted
Mar 5, 2008	Supplement 6Labeling	Approved	None posted
Oct 22, 2007	Supplement 3Labeling	Approved	None posted
Sep 12, 2007	Supplement 4Labeling	Approved	None posted
Apr 24, 2007	Supplement 2Labeling	Approved	None posted
Aug 23, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 65224
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters