Cefoxitin

ANDA 65464, held by Acs Dobfar Spa. Cefoxitin Sodium.

As of Nov 15, 2026, ANDA 65464 (Cefoxitin), held by Acs Dobfar Spa, was first approved by FDA on Aug 31, 2011, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 31, 2011
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Aug 31, 2011	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Jun 20, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Aug 31, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 65464
Drugs@FDA: Overview at FDA
Company: ACS Dobfar

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