Cefotaxime

ANDA 65071, held by Hikma. Cefotaxime Sodium.

First approved: Nov 20, 2002
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Nov 20, 2002	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
CefotaximeEQ 10GM BASE/VIAL · injectable;injection	Cefotaxime Sodium	Discontinued

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 8, 2020	Supplement 14Labeling · Standard review	Approved	None posted
Jun 8, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Jun 8, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Nov 20, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 65071
Drugs@FDA: Overview at FDA
Company: Hikma

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