Cefepime In Plastic Container

NDA 50817, held by Baxter Hlthcare. Cefepime Hydrochloride.

As of Nov 13, 2026, NDA 50817 (Cefepime In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Aug 5, 2008, with 7 approved supplements and 0 published complete response letters.

First approved: Aug 5, 2008
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Cefepime Injection is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: pneumonia; empiric therapy for febrile neutropenic patients; uncomplicated and complicated urinary tract infections; uncomplicated skin and skin structure infections; and complicated intra-abdominal infections (used in combination with metronidazole). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime Injection and other antibacterial drugs, Cefepime Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Aug 5, 2008	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter

Products

2 strengths and forms


Cefepime In Plastic ContainerEQ 1GM BASE/50ML (EQ 20MG BASE/ML) · injectable;injection	Cefepime Hydrochloride	RxReference drug
Cefepime In Plastic ContainerEQ 2GM BASE/100ML (EQ 20MG BASE/ML) · injectable;injection	Cefepime Hydrochloride	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Jun 25, 2026	Supplement 15Labeling · Standard review	Approved	Letter Label
Jul 29, 2025	Supplement 12Labeling · Standard review	Approved	Letter Label
May 1, 2020	Supplement 8Labeling · Standard review	Approved	Letter Label
May 9, 2016	Supplement 7Labeling · Standard review	Approved	Label Letter
Jun 4, 2014	Supplement 3Labeling · Standard review	Approved	Label Letter
Sep 6, 2012	Supplement 4Labeling · Standard review	Approved	Label Letter
Jun 30, 2010	Supplement 1Labeling	Approved	Label Letter
Aug 5, 2008	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter

Identifiers

Application: NDA 50817
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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