Cefoxitin

ANDA 65312, held by Hospira Inc. Cefoxitin Sodium.

As of Nov 15, 2026, ANDA 65312 (Cefoxitin), held by Hospira Inc, was first approved by FDA on Feb 13, 2006, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 13, 2006
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Feb 13, 2006	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
CefoxitinEQ 10GM BASE/VIAL · injectable;injection	Cefoxitin Sodium	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jun 12, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Mar 5, 2008	Supplement 4Labeling	Approved	None posted
Feb 13, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 65312
Drugs@FDA: Overview at FDA
Company: Hospira

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