Cefoxitin

ANDA 65051, held by Hikma. Cefoxitin Sodium.

As of Nov 15, 2026, ANDA 65051 (Cefoxitin), held by Hikma, was first approved by FDA on Sep 11, 2000, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 11, 2000
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
Sep 11, 2000	Original application	Approved	Letter

Products

2 strengths and forms


CefoxitinEQ 1GM BASE/VIAL · injectable;injection	Cefoxitin Sodium	Rx
CefoxitinEQ 2GM BASE/VIAL · injectable;injection	Cefoxitin Sodium	Rx

All 2 submissions, including labeling and manufacturing supplements


Dec 19, 2003	Supplement 1Labeling	Approved	None posted
Sep 11, 2000	Original application	Approved	Letter

Identifiers

Application: ANDA 65051
Drugs@FDA: Overview at FDA
Company: Hikma

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