Cefizox In Dextrose 5% In Plastic Container, Cefizox In Plastic Container

NDA 50589, held by Astellas. Ceftizoxime Sodium.

As of Nov 14, 2026, NDA 50589 (Cefizox In Dextrose 5% In Plastic Container, Cefizox In Plastic Container), held by Astellas, was first approved by FDA on Oct 3, 1984, with 13 approved supplements and 0 published complete response letters.

First approved: Oct 3, 1984
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Oct 3, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Products

4 strengths and forms


Cefizox In Dextrose 5% In Plastic ContainerEQ 20MG BASE/ML · injectable;injection	Ceftizoxime Sodium	Discontinued
Cefizox In Dextrose 5% In Plastic ContainerEQ 40MG BASE/ML · injectable;injection	Ceftizoxime Sodium	Discontinued
Cefizox In Plastic ContainerEQ 20MG BASE/ML · injectable;injection	Ceftizoxime Sodium	Discontinued
Cefizox In Plastic ContainerEQ 40MG BASE/ML · injectable;injection	Ceftizoxime Sodium	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Mar 13, 2009	Supplement 8Labeling	Approved	None posted
Mar 13, 2009	Supplement 5Labeling	Approved	None posted
Jan 14, 2005	Supplement 13Labeling · Standard review	Approved	Letter
Feb 26, 1996	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 13, 1995	Supplement 9Manufacturing · Standard review	Approved	None posted
May 24, 1993	Supplement 11Labeling · Standard review	Approved	None posted
Sep 25, 1992	Supplement 10Labeling	Approved	None posted
Feb 6, 1992	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 6, 1992	Supplement 6Labeling	Approved	None posted
Feb 6, 1992	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 12, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 15, 1985	Supplement 2Labeling	Approved	None posted
Apr 16, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 3, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50589
Drugs@FDA: Overview at FDA
Company: Astellas Pharma

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