Cefotan

NDA 50588, held by Pai Holdings Pharm. Cefotetan Disodium.

As of Nov 13, 2026, NDA 50588 (Cefotan), held by Pai Holdings Pharm, was first approved by FDA on Dec 27, 1985, with 17 approved supplements and 0 published complete response letters.

First approved: Dec 27, 1985
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of CEFOTAN and other antibacterial drugs, CEFOTAN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Nov 25, 1991	Supplement 2Efficacy (new indication or use)	Approved	None posted
Dec 27, 1985	Original applicationNew molecular entity · Standard review	Approved	Review

Products

3 strengths and forms

Product	Active ingredient	Marketing
CefotanEQ 1GM BASE/VIAL · injectable;injection	Cefotetan Disodium	RxReference drug
CefotanEQ 2GM BASE/VIAL · injectable;injection	Cefotetan Disodium	RxReference drug
CefotanEQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Cefotetan Disodium	Discontinued

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 9, 2017	Supplement 32Labeling · Standard review	Approved	Letter Label
Dec 9, 2015	Supplement 31Manufacturing · Standard review	Approved	None posted
Jun 25, 2004	Supplement 30Labeling · Standard review	Approved	Letter Label
Jun 20, 2003	Supplement 29Labeling · Standard review	Approved	Label Letter
Mar 4, 2003	Supplement 27Labeling · Standard review	Approved	Label Letter
Aug 5, 1999	Supplement 26Labeling · Standard review	Approved	None posted
Oct 20, 1995	Supplement 25Labeling · Standard review	Approved	None posted
Sep 12, 1995	Supplement 21Labeling · Standard review	Approved	None posted
Sep 15, 1994	Supplement 23Manufacturing · Standard review	Approved	None posted
Jul 30, 1993	Supplement 22Labeling · Standard review	Approved	None posted
Jul 30, 1993	Supplement 20Labeling · Standard review	Approved	None posted
Sep 29, 1992	Supplement 19Labeling	Approved	None posted
May 18, 1992	Supplement 18Labeling	Approved	None posted
Nov 25, 1991	Supplement 16Labeling	Approved	None posted
Nov 25, 1991	Supplement 14Labeling	Approved	None posted
Nov 25, 1991	Supplement 4Labeling	Approved	None posted
Nov 25, 1991	Supplement 2Efficacy (new indication or use)	Approved	None posted
Dec 27, 1985	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 50588
Drugs@FDA: Overview at FDA
Company: PAI Holdings Pharm

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