Cefuroxime Sodium

ANDA 64035, held by Watson Labs Inc. Cefuroxime Sodium.

As of Nov 15, 2026, ANDA 64035 (Cefuroxime Sodium), held by Watson Labs Inc, was first approved by FDA on Feb 26, 1993, with 18 approved supplements and 0 published complete response letters.

First approved: Feb 26, 1993
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Feb 26, 1993	Original application	Approved	None posted

Products

2 strengths and forms


Cefuroxime SodiumEQ 750MG BASE/VIAL · injectable;intramuscular, intravenous	Cefuroxime Sodium	Discontinued
Cefuroxime SodiumEQ 1.5GM BASE/VIAL · injectable;injection	Cefuroxime Sodium	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Dec 8, 2000	Supplement 18Manufacturing	Approved	None posted
May 4, 1998	Supplement 17Manufacturing	Approved	None posted
Feb 23, 1998	Supplement 16Manufacturing	Approved	None posted
Aug 20, 1997	Supplement 15Manufacturing	Approved	None posted
Oct 4, 1996	Supplement 13Manufacturing	Approved	None posted
Oct 4, 1996	Supplement 14Manufacturing	Approved	None posted
Jul 2, 1996	Supplement 11Manufacturing	Approved	None posted
May 10, 1996	Supplement 12Labeling	Approved	None posted
Mar 6, 1996	Supplement 10Labeling	Approved	None posted
Oct 26, 1995	Supplement 9Manufacturing	Approved	None posted
Jan 27, 1995	Supplement 8Manufacturing	Approved	None posted
Dec 13, 1994	Supplement 6Labeling	Approved	None posted
Aug 18, 1994	Supplement 7Manufacturing	Approved	None posted
Mar 15, 1994	Supplement 4Manufacturing	Approved	None posted
Mar 15, 1994	Supplement 5Manufacturing	Approved	None posted
Aug 17, 1993	Supplement 3Manufacturing	Approved	None posted
Aug 13, 1993	Supplement 1Manufacturing	Approved	None posted
May 20, 1993	Supplement 2Labeling	Approved	None posted
Feb 26, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 64035
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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