ANDA 65048, held by Hikma. Cefuroxime Sodium, Cefuroxime.
As of Nov 15, 2026, ANDA 65048 (Cefuroxime Sodium, Cefuroxime), held by Hikma, was first approved by FDA on Jan 9, 2004, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Cefuroxime for Injection 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 |
|---|---|---|---|
| Jan 9, 2004 | 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 |
| Cefuroxime1.5G/20ML · injectable; injection | Cefuroxime | Rx |
| Cefuroxime1.5G/100ML · injectable; injection | Cefuroxime | Rx |
| Jul 7, 2021 | Supplement 18Labeling · Standard review | Approved | None posted |
| Jul 7, 2021 | Supplement 19Labeling · Standard review | Approved | None posted |
| Nov 16, 2019 | Supplement 17Labeling · Standard review | Approved | None posted |
| Apr 12, 2016 | Supplement 14Labeling · Standard review | Approved | None posted |
| Jan 16, 2008 | Supplement 8Labeling | Approved | None posted |
| Jan 9, 2004 | 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
