Claforan In Sodium Chloride 0.9% In Plastic Container, Claforan In Dextrose 5% In Plastic Container

NDA 50596, held by Sterimax. Cefotaxime Sodium.

As of Nov 13, 2026, NDA 50596 (Claforan In Sodium Chloride 0.9% In Plastic Container, Claforan In Dextrose 5% In Plastic Container), held by Sterimax, was first approved by FDA on May 20, 1985, with 30 approved supplements and 0 published complete response letters.

First approved: May 20, 1985
Review: Standard
Supplements approved: 30
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below

Date	Submission	Status	Documents
May 20, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Claforan In Sodium Chloride 0.9% In Plastic ContainerEQ 20MG BASE/ML · injectable;injection	Cefotaxime Sodium	Discontinued
Claforan In Dextrose 5% In Plastic ContainerEQ 20MG BASE/ML · injectable;injection	Cefotaxime Sodium	Discontinued
Claforan In Sodium Chloride 0.9% In Plastic ContainerEQ 40MG BASE/ML · injectable;injection	Cefotaxime Sodium	Discontinued
Claforan In Dextrose 5% In Plastic ContainerEQ 40MG BASE/ML · injectable;injection	Cefotaxime Sodium	Discontinued

All 31 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 23, 2015	Supplement 42Labeling · Standard review	Approved	Label Letter
Apr 21, 2014	Supplement 41Manufacturing · Standard review	Approved	None posted
Feb 21, 2014	Supplement 40Labeling · Standard review	Approved	Label Letter
May 3, 2013	Supplement 39Manufacturing · Standard review	Approved	None posted
Sep 9, 2011	Supplement 37Labeling · Standard review	Approved	Label Letter
May 27, 2009	Supplement 36Labeling · Standard review	Approved	Letter
Feb 21, 2008	Supplement 35Labeling · Standard review	Approved	Letter Label
Sep 2, 2004	Supplement 31Labeling · Standard review	Approved	None posted
Jun 23, 2004	Supplement 30Labeling · Standard review	Approved	Letter
Jan 18, 2002	Supplement 23Labeling · Standard review	Approved	Letter
Sep 6, 2001	Supplement 28Manufacturing · Standard review	Approved	None posted
Jul 27, 2001	Supplement 27Manufacturing · Standard review	Approved	None posted
Apr 12, 2001	Supplement 26Manufacturing · Standard review	Approved	None posted
Apr 10, 2001	Supplement 25Manufacturing · Standard review	Approved	None posted
Feb 18, 2000	Supplement 24Manufacturing · Standard review	Approved	None posted
Apr 24, 1997	Supplement 22Labeling · Standard review	Approved	None posted
Dec 23, 1996	Supplement 20Labeling · Standard review	Approved	None posted
Sep 24, 1996	Supplement 10Labeling	Approved	None posted
Apr 30, 1996	Supplement 18Labeling · Standard review	Approved	None posted
Nov 22, 1994	Supplement 13Labeling · Standard review	Approved	None posted
Sep 14, 1994	Supplement 16Labeling · Standard review	Approved	None posted
Sep 2, 1994	Supplement 17Labeling · Standard review	Approved	None posted
Jun 16, 1994	Supplement 14Manufacturing · Standard review	Approved	None posted
May 19, 1994	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 10, 1992	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 5, 1992	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 7, 1989	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 23, 1985	Supplement 2Labeling	Approved	None posted
Jul 23, 1985	Supplement 3Labeling	Approved	None posted
Jun 13, 1985	Supplement 1Labeling	Approved	None posted
May 20, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50596
Drugs@FDA: Overview at FDA
Company: Sterimax Inc.

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