ANDA 64125, held by Acs Dobfar Spa. Cefuroxime Sodium.
As of Nov 15, 2026, ANDA 64125 (Cefuroxime Sodium), held by Acs Dobfar Spa, was first approved by FDA on May 30, 1997, with 6 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Cefuroxime for Injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pyogenes, and Escherichia coli. Urinary Tract Infections caused by Escherichia coli and Klebsiella spp.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 30, 1997 | Original application | Approved | None posted |
| Cefuroxime SodiumEQ 750MG BASE/VIAL · injectable;intramuscular, intravenous | Cefuroxime Sodium | Rx |
| Cefuroxime SodiumEQ 1.5GM BASE/VIAL · injectable;injection | Cefuroxime Sodium | Rx |
| Oct 8, 2021 | Supplement 13Labeling · Standard review | Approved | None posted |
| Apr 12, 2016 | Supplement 9Labeling · Standard review | Approved | None posted |
| Nov 21, 2012 | Supplement 6Labeling | Approved | None posted |
| Jan 31, 2007 | Supplement 5Labeling | Approved | None posted |
| Aug 23, 2004 | Supplement 3Labeling | Approved | None posted |
| Sep 23, 1999 | Supplement 1Manufacturing | Approved | None posted |
| May 30, 1997 | Original application | Approved | None posted |
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
